Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; Chills; Lethargy; Muscle pain; This is a spontaneous report from a contactable pharmacist. A 45-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0196) intramuscularly administered in the arm right on 21Jun2021 10:00 as dose 1, single for covid-19 immunization. Medical history included psoriasis from 1999 and ongoing; adrenalectomy from 2004 and ongoing; and schwannoma from 2012 and ongoing. Relevant test included negative PCR on 06May2021. The patient was previously vaccinated with a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0186) intramuscularly in the left arm on 09Jun2021 13:00 for covid-19 immunisation and experienced vaccine had been in the freezer beyond the approved timeframe. Concomitant medications were not reported. On 01Jul2021, it was reported that the 1st dose was repeated on 21Jun2021 as recommended due to the Pfizer-BioNTech vaccine received on 09Jun2021 had been in the freezer beyond the approved time frame prior to being administered and the effectiveness cannot be guaranteed. On the repeated 1st dose, the patient experienced fever and chills (seriousness criteria: medically significant, persistent/significant disability/incapacity) on 21Jun2021 at around 6-7 PM and received Tylenol for both events. The patient also experienced lethargy and muscle pain (seriousness criteria: medically significant, persistent/significant disability/incapacity) on 21Jun2021 at around 6-7 PM but did not receive any treatment for these events. The patient recovered from all the adverse events on an unspecified date in 2021.  Information about batch/lot number has been requested.  Follow-up 22Jun2021: Follow-up attempts are completed. No further information is expected.  Follow-up (01Jul2021): New information received from a contactable pharmacist includes: historical vaccine data (previous vaccine received on 09Jun2021 was updated as historical vaccine), medical histories added, suspect vaccine data (new vaccine dosing information reported), reaction data (added events fever, chills, lethargy and, muscle pain; deleted previous event "vaccine was in the freezer longer than it was supposed to be before it is administered, it might not be effective; First vaccine that she was administered will not be counted") and, clinical course information. Case was upgraded to serious.; Sender's Comments: Based on the available information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events pyrexia ,chills,lethargy and myalgia. The impact of this report on the benefit/risk profile of the Pfizer product 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.,Linked Report(s) : US-PFIZER INC-2021701731 same reporter, same drug, different patient.