Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, SARS-CoV-2 test
Clinical narrative: Lower grade temperature; Light chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Feb2021 13:00 (Lot number: EN9581) at the age of 76 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy to vinegar" (unspecified if ongoing), notes: Verbatim: allergy to vinegar; "Anaemia" (unspecified if ongoing), notes: Verbatim: Anemic; "Always cold" (unspecified if ongoing), notes: Always cold; "Little rash" (unspecified if ongoing); "Swollen lips" (unspecified if ongoing); "Infection in her mouth" (unspecified if ongoing); "She broke out in hives" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "Allergy", notes: Verbatim: allergy to Erythromycin. Vaccination history included: Flu shot (Flu shot), for immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Lower grade temperature"; CHILLS (non-serious), outcome "unknown", described as "Light chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  Caller states she is calling to report a side effect to the Covid booster shot. Caller states she does have a question but doesn't know if we have the answer or not. States that about 1 month ago she had a virus and she went to the doctor and got a Covid test and it came back negative, but that so called virus she had seemed like it might have been the Delta. Caller relays she had the original shots in Feb2021 and it seems about the same as the side effects she had from the original shot. States she kept running a low grade temperature and they talked over quarantine as she hangs out at assistive living and with people her age and she quarantined for 2 weeks to be safe, she doesn't know but they are saying it's negative. Caller states it went away and she is fine now. Caller states she thought about it later and it's sort of good it's doing something and not just a shot of liquid in her arm like hello goodbye. States that she got it at 10am and walked across to church and worked all morning accepting donations for the thrift shop and had no problems, later she got the chills and low grade fever. Caller relays that by Saturday she felt fine, it was just Friday night and she slept pretty well and doesn't recall anything on Saturday. Caller states that people don't need to run to the ER if something like this happens, to just relax and take your time. Caller states she did have a little runny nose which she also had with that so called virus in between. States she was nonstop blowing, it wasn't discolored it was just clear like extra fluid in her. States this was similar with this runny nose. Caller states she is not totally convinced she didn't have the Delta and it doesn't matter to her at this point. States she will wear her mask when she flies to withheld to see family. Caller states she checked with her pharmacy when it was coming out to make sure it was 8 weeks and she has friends that get it and it's now 6 weeks and she was getting ready to walk over to church and she got online and they had a 10am opening. Caller states she had no soreness, nothing. Caller does not have NDC to provide. Caller states what is noted for her was an allergy to vinegar and to Erythromycin. Caller states she saw that on the thing that it is sort of related and she didn't have problems the 1st time and this happened like 30 years ago. Caller does not have dose, NDC, lot or expiry to provide. States what happened was with CPR training in the 1980's when they were putting gauze over the mouth she got an infection in her mouth and she got a shot and she broke out in hives. Caller states she is careful with some of the salves in tubes, sometimes she will get a little rash were that was so she avoids those. States it's nothing big, swollen lips and rash are not fun. States that after the shot they had her park a distance away and told her with the allergy they wanted her to stay 30 minutes and there was a nurse up there from the withheld where she could see her, everyone was nice and good about it. States she read a book for half an hour and was fine with no reactions and she appreciated the fact that they were careful about it. Additional Vaccines Administered on Same Date of the Pfizer Suspect: none, she didn't think it was very smart to get the flu vaccine but to wait awhile and not piling one thing after another in her body. Prior Vaccinations (within 4 weeks): unknown 4 States she usually does get Flu shot but she buried husband in Dec2020, he died year before that and it took 1 year for the funeral at Withheld. Caller states the Covid tests aren't completely reliable and they did a good swab, she has a small nose and they don't have to go that far and it was at the doctor office but it seemed to her it might be a possibility. States the test was negative. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL9266 and EN9581 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL9266, fill lot EL9257, lot EN9581, fill lot EN9580 and the formulated drug product lot EL9248 and EL9245. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Follow up attempts are completed. No further information is expected.