Information Center
Your Health. Your Family. Your Choice.
|
|
National Vaccine Information Center Your Health. Your Family. Your Choice. |
MedAlerts.org |
| Table |
 |   | |
| Age | Count | Percent |
| 6-17 Years | 269 | 100% |
| TOTAL | 269 | 100% |
| Case Details |
Administered by: School Purchased by: ?
Life Threatening? No Write-up: Systemic: Anaphylaxis-Medium, Systemic: Rash (other than injection site)-Mild, Systemic: Other- wheezing, shortness of breath, coughing-Medium | ||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: Approximately 15 minutes after vaccination, recipient developed tightness in throat. Taken into ambulance by EMTs. Seen by doctor at 20 minutes post vaccine. Patient developed stridor and shortness of breath. Treated for anaphylaxis- IM epinephrine x2, IV dexamethasone, 250 mL normal saline bolus. Transported to emergency department by EMS. | ||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? Yes Write-up: Anaphylactoid reaction; PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS This is a report from an interventional study source for sponsored by BioNTech, managed and reported by Pfizer on the sponsor''s behalf. The subject was in the open-label phase of the study when the event occurred. A 17-year-old female subject with a past medical history significant for multiple allergies with anaphylaxis received first dose of blinded therapy (BNT162;PLACEBO) on 20Nov2020 at 17:04 and second dose on 15Dec2020 at 15:16. Per protocol, the participant was unblinded and confirmed to have received placebo and subsequently received third dose of study vaccine (BNT162B2) on 25Jan2021 at 16:50, all via intramuscular route in left deltoid as single doses for COVID-19 immunization. Ongoing medical history included penicillin allergy from 2010, peanut allergy from 2004, legume allergy from 2012, chickpea allergy from 2012, chocolate allergy from 2012, flaxseed allergy from 2016, all with anaphylaxis; pollen allergy from 2007, and asthma and eczema both from 2003. Additional medical history included: tree nuts allergy from 2004 (anaphylaxis). Ongoing concomitant medications included salbutamol sulfate (PROAIR) from 2010 for asthma, epinephrine (AUVI Q) from 2005 for penicillin allergy, peanut allergy, tree nuts allergy, legume allergy, chickpea allergy, flaxseed allergy and chocolate allergy, cetirizine hydrochloride (ZYRTEC) from 2007 for pollen allergy, loratadine (CLARITIN) from 2007 for pollen allergy, and triamcinolone acetonide from 2007 for eczema. There were no concomitant vaccines administered on same date of study vaccine and no prior vaccinations (within 4 weeks prior to the first administration date of study drug). The subject experienced hives left arm on 27Jan2021 at 10:30, shortness of breath 27Jan2021 at 11:00 and a diagnosis of anaphylactoid reaction on 27Jan2021 at 10:30, which were considered as life threatening (the event was considered life-threatening as subject with known anaphylaxis with tree nuts and subject reported similar symptoms). Clinical course was reported as follows: On 27Jan2021 at 10:30 (2 days after receiving BNT162B2 injection on her left arm) the subject started developing hives on her left arm and used her epinephrine pen at 10:54 and shortly after developed shortness of breath at 11:00. The subject did not touch or consume anything new prior to developing the hives on her left arm and the shortness of breath. The subject was not seen by a school nurse and self-administered her epi-pen. The hives resolved at 11:04 and the shortness of breath resolved at 11:24. The subject denied any other symptoms and did not seek further medical attention. There were no relevant tests done. The action taken in response to the events for study vaccine (BNT162B2) was permanently withdrawn (reported as not applicable as per investigator). The subject was not dosed vaccination 4 on 17Feb2021 (Visit 102). Outcome of the events was recovered on 27Jan2021. The investigator reported that there was a reasonable possibility that the event anaphylactoid reaction was related to Dose 3 of the study vaccine (BNT162B2), but not related to dose 1 and dose 2 of blinded therapy (BNT162;PLACEBO), concomitant drugs or clinical trial procedure. Follow-up (27Jan2021 and 03Feb2021): Seriousness life-threatening justification, additional medical history (tree nuts allergy) and clinical course (did not touch or consume anything new before SAE). Follow-up (18Feb2021): New information reported includes: action taken with the blinded study vaccine. Follow-up (02Mar2021): New information reported includes: concomitant medication and action taken with the blinded study vaccine. Follow-up (11Mar2021): New information reported includes: SAE term updated to ''anaphylactoid reaction''. This is a final report for initial notification of a life threatening event. .; Sender''s Comments: The event ''anaphylactoid reaction'' is unlisted in the protocol''s Single Reference Safety Document (IB). Pfizer''s safety database was reviewed for cases reporting PF-07302048 or blinded therapy through 28-FEB-2021 for adverse events encoding to MedDRA (v.23.1J) Preferred Term(s) of Anaphylactoid reaction.Review of the database for the PT Anaphylactoid reaction had the following results: 0 serious clinical trial cases (0 of which were attributed to therapy) and 29 non clinical trial cases. The information available in this report is very limited. The Company considers that there is a reasonable possibility that ''anaphylactoid reaction'' is related to the study product. There is a plausible, although belated, time relationship between vaccination with BNT162b2 and onset of the event in a subject with a medical history of allergic diathesis; it is worth noting that symptoms resolved rapidly upon self-medication. From the available information for the rationale that led to attribution of a life-threatening seriousness criterion, it may not be justifiable based on past-history of anaphylaxis alone The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. | ||||||||||||||||
Administered by: Public Purchased by: ?
Life Threatening? No Write-up: Started having difficulty breathing Her throat started to close up | ||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? Yes Write-up: multi-phase anaphylaxis/several anaphylactic reactions; This is a spontaneous report from a contactable consumer (parent) from a Pfizer-sponsored program. A 17-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm, on 17Mar2021 at 12:45 (at the age of 17-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to sticking plaster (adhesive) and diabetes type 1. Family history included allergies to some antibiotics in the mother. The patient had no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced multi-phase anaphylaxis/several anaphylactic reactions in Mar2021, which caused hospitalization and was reported as an important medical event and life-threatening. The clinical course was reported as follows: The patient had multi-phase anaphylaxis following his first dose of vaccination. He went to three different hospitals and was in the pediatric intensive care unit (PICU) at the time of reporting. The patient was heavily sedated, intubated, and on a ventilator for 3 days. The clinical outcome of multi-phase anaphylaxis/several anaphylactic reactions was unknown. Follow-up attempts are completed. No further information expected. | ||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: severe reaction to the vaccine had a anaphylactic shock had 2 more the next day; This is a spontaneous report received from a contactable consumer. A 17-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history includes diabetic (reported as Takes diabetic med humaran). It was reported that the patient experienced severe reaction to the vaccine had an anaphylactic shock had 2 more the next day. It was added that very sedated fighting it so he dont die. The outcome of the event was unknown. Information on the lot/batch number has been requested. | ||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? Yes Write-up: Anaphylaxis (hives, oropharyngeal swelling, cough, shortness of breath) 20 mins following vaccine administration. Patient given epinephrine at vaccine site 20min after symptom onset with significant improvement in symptoms including improved pharyngeal swelling and resolution of hives. Patient presented to the emergency department 1.5 hours following onset of anaphylaxis with mild cough and mild pharyngeal swelling for observation. | ||||||||||||||||
Administered by: Private Purchased by: ?
Life Threatening? Yes Write-up: Patient had anaphylaxis with recorded trigger (Pfizer COVID vaccine). She received epinephrine onsite, and then an additional dose of 0.3mg in ED. She however, required required two more doses of 0.5mg epinephrine and racemic epi neb. She was admitted for further observation given need for multiple doses of epinephrine. At approximately 9:00 am (~18 hours post vaccine) a rapid response was called on 4/13 and patient was transferred to the PICU for further treatment. Patient also received the last dose of epinephrine 0.5mg at approximately 9:00 am (~18 hours post vaccine). Patient received famotidine 20mg IV x1 and methylprednisolone 90mg IV x2 in the PICU. Patient was discharged on 4/14 at 8:00 am from the PICU, approximately 41 hours post vaccine administration. Received a total of epinephrine x7 doses during the hospitalization. | ||||||||||||||||
Administered by: Public Purchased by: ?
Life Threatening? No Write-up: Vaccine was given at 3pm. At 4:30pm patient had a tight chest so he used his inhaler. At 8:30pm he went into anaphylaxis---red from head to toe, swollen hands and feet, could not move fingers or toes, lips blue and swollen. He was transported to the ER. | ||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: anaphylactic reaction; anaphylactic shock; vomiting; broke out head to toe in hives; trouble breathing; face swelling; This is a spontaneous report received from a Pfizer-sponsored program, Support received from a contactable consumer (patient''s parent). A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm on 08Apr2021 (Batch/Lot number was not reported) as 1st dose, SINGLE dose (at the age of 16 years old) for covid-19 immunisation. Medical history included asthma from 2018 and ongoing (Has been asthmatic about 3 years and has it under control and hasn''t had issues in years). The patient''s concomitant medications were not reported. Last time at the doctors office was for her well check in Oct or Nov. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 21Apr2021, the patient experienced anaphylactic reaction, anaphylactic shock, vomiting, broke out head to toe in hives, trouble breathing and face swelling. They are not sure if it (anaphylactic reaction) is related to the vaccine. She does not have any allergic issues of any kind and is not sure if it is from the vaccine. The patient has an appointment with an allergist on 05May2021. The pediatrician recommended she wait to get the second dose until after the mother talked to the allergist. She is scheduled for the second dose 30Apr2021. The consumer stated the daughter will miss her second dose tomorrow. The pediatrician told her to wait until speaking to the allergist. If the allergist clears her, it wont be until 05May2021. How long would it be until she can get the second dose. She is not sure if it is related or not. It was 2 weeks after. She ate some kind of granola bar that may have been the cause. Before she called 911 and they gave her epinephrine, it lasted anywhere between maybe up to 15 or 20 minutes. She went to the emergency room (ER) and had to be observed 4 to 5 hours and then went home. Treatment for the events included Epinephrine, steroids and she believes a dose of Pepcid. She was on steroids for like 4 days. The steroid was prednisone. Outcome of anaphylactic shock, vomiting, broke out head to toe in hives, trouble breathing, face swelling were recovered on 21Apr2021. Outcome of anaphylactic reaction was unknown. | ||||||||||||||||
Link To This Search Result:
https://medalerts.org/vaersdb/findfield.php?TABLE=ON&GROUP1=AGE&EVENTS=ON&SYMPTOMS[]=Anaphylactic+reaction+%2810002198%29&SYMPTOMS[]=Anaphylactic+shock+%2810002199%29&SYMPTOMS[]=Anaphylactoid+reaction+%2810002216%29&SYMPTOMS[]=Anaphylactoid+shock+%2810063119%29&SYMPTOMS[]=Anaphylaxis+prophylaxis+%2810049090%29&SYMPTOMS[]=Anaphylaxis+treatment+%2810002222%29&VAX=COVID19&VAXMAN=PFIZER/BIONTECH&WhichAge=range&LOWAGE=12&HIGHAGE=18
Copyright ©
2024 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166