Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Poor quality product administered, Product temperature excursion issue
Clinical narrative: the vaccine administered to her was expired in its frozen state then was thawed; the vaccine passed its expiry date in Freezer storage, was thawed; the vaccine passed its expiry date in Freezer storage, was thawed; received a 3rd dose of the Comirnaty vaccine; received a 3rd dose of the Comirnaty vaccine; Chills; Extreme fatigue; This is a spontaneous report from a contactable consumer (patient) from Pfizer-sponsored program   A 72-year-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection), intra-muscular, administered in arm left on 07Sep2021 (Lot number: FC3184; Expiration Date was not reported, at the age of 72-year-old) as dose 3 (booster), 0.3 ML single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient's historical vaccine first dose included bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) Intramuscular administered in arm left on 11Feb2021 (Lot number: EL9269 and Expiration Date was not reported) of unspecified dose for COVID-19 immunisation and experience chills and extreme fatigue. The patient's Historical vaccine second dose included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection,) Intramuscular administered in arm left on 04Mar2021 (Lot number: EN6204 and Expiration Date was not reported) of unspecified dose for covid-19 immunisation. The patient Family medical history relevant to AE was not reported. Vaccination facility type was available. On 07Sep2021, the patient experienced the vaccine administered to her was expired in its frozen state then was thawed, the vaccine passed its expiry date in freezer storage, was thawed, received a 3rd dose of the Comirnaty vaccine. On unspecified date of Sep2021, she had chills, extreme fatigue. No Prior vaccination (within 4 weeks). No relevant tests and specific relevant tests. No PQC Present. Caller was a 72-year-old female who received a 3rd dose of the Comirnaty vaccine on 07Sep2021. Caller was informed by the pharmacy that the vaccine administered to her was expired in its frozen state then was thawed. Caller wanted to know the effectiveness of the Comirnaty vaccine through antibody testing. Caller stated that the safety of receiving a 4th dose of the Comirnaty vaccine in case there was a need for revaccination. She wanted to know if it's potentially dangerous. Caller wanted to know if she needs to be revaccinated. Caller added that the pharmacy told her that it is her choice if she wanted to be vaccinated again. The patient received booster shot after in temperature excursion on 07Sep2021 to: Unspecified date. No Investigation Assessment. The patient taking Pfizer COVID vaccine as prevention, going to be traveling out of state soon. Additional Context included warm transfer from with ; CEP. Consumer just got her booster shot, third shot of Pfizer COVID vaccine. Pharmacy contacted her and said she might have been given a beyond expiration date vaccine, Agent provided  number since she asked if she needs to get another vaccine. She confirmed contact details. Reports there was a temperature excursion from what they said it was frozen and it had expired in the frozen state but didn't notice it. It was thawed and given to 11 people, but she was the only one that received a booster. No further details provided. She did report this to the state. Booster due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Comment/Narrative included that it was her understanding that the vaccine passed its expiry date in Freezer storage, was thawed then given to 11 persons including herself. She was the only booster dose. The error was in vaccine storage and administration. Pharmacy staff failed to check vaccine expiry dates. Clinical consequences were unknown. She had a reaction to the vaccine the same as she had with the 1st dose chills, extreme fatigue both of these reactions were gone the next day. Outcome of chills, extreme fatigue was recovered on unspecified date of Sep2021.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.