Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Expired product administered, Immunisation, Product use issue, Urticaria
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 62 year-old female patient received bnt162b2 (COMIRNATY), administered in arm, administration date 17Oct2021 (Lot number: FF2590, Expiration Date: 21Dec2021) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm, administration date 17Oct2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "hives" (unspecified if ongoing); "COVID" (not ongoing), notes: Pertinent Details: Still has respiratory issues after having had COVID.; "Diabetes" (ongoing), notes: About 7 months prior to time of this report; "Unknown genetic trait where she can curl her tongue" (ongoing), notes: Onset Date: Congenital, Stop Date: Ongoing; "allergy to bell pepper" (ongoing); "diagnosed allergies" (unspecified if ongoing); "- compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic/ chromosomal abnormalities" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing), notes: endocrine abnormalities. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. Vaccination history included: Bnt162b2 (Dose:1, Lot: EN6202, Route, Anatomical Location: Injection to unknown upper arm), administration date: 24Mar2021, when the patient was 61 years old, for COVID-19 immunization; Bnt162b2 (Dose:2, Lot: EP7533, Route, Anatomical Location: Injection to unknown upper arm), administration date: 14Apr2021, when the patient was 61 years old, for COVID-19 immunization; Shingle vaccine (Lot Number/NDC/Expiry: Unknown, Route, Anatomical Location: one of the arms.), for immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 17Oct2021, outcome "unknown", described as "booster"; URTICARIA (non-serious) with onset Oct2021, outcome "unknown", described as "Hives"; DISEASE RECURRENCE (non-serious), outcome "unknown", described as "experiencing recurring Hive episodes at strange times"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 17Oct2021, outcome "unknown", described as "she mentioned this dose expired, she wondered what that meant-was not administered this dose after expired."; PRODUCT USE ISSUE (non-serious) with onset 17Oct2021, outcome "unknown", described as "Product use for unapproved combination". The event "hives" was evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria, disease recurrence. Additional information: This consumer was the patient reporting hives starting within 2-3 days of her being administered her third dose of Pfizer Covid-19 Vaccine. Patient was reading the paper of symptoms because she has always had hives but usually only gets them when she eats bell peppers. Since she took the third dose of Pfizer Covid-19 Vaccine shot she has been getting hives like all the time; and it takes like 2 or 3 rounds of Benadryl for 2 or 3 days to get rid of the hives. She asked if history of hives with bell peppers could be related to hives with booster dose which was her third dose of Pfizer Covid-19 Vaccine; for more information on hives with Pfizer Covid-19 Vaccine, if Pfizer knows something she doesn't. Onset date unknown other than back in the beginning, prior to any doses of Pfizer Covid-19 Vaccine. She reported having side effects with every COVID virus, but just normal side effects, nothing that lasted months down the road. The only lasting effect from COVID reported was respiratory issues that was still ongoing after having COVID.  This consumer was the patient reporting hives starting within 2-3 days of her being administered her third dose of Pfizer Covid-19 Vaccine. the third dose of Pfizer Covid-19 Vaccine she was adminsitered was on 17Oct2021, with onset of hives within 2-3 days of that administration of that third dose of Pfizer Covid-19 Vaccine-which would be onset date of approximately 19Oct2021-20Oct2021. Hives, Outcome was unknown, reporter provided that was hard to say because the hives kind of come and go; she had them today, but did not have them yesterday, and she definitely had not eaten any bell peppers. Caller verified that there had been no testing performed relative to this event. Diabetes but really it's high blood sugar Onset Date: About 7 months prior to time of this report. Pertinent Details: She was started on Metformin 500mg, she thinks twice daily maybe around 5 months prior to time of this report. After about 2 months on Metformin they changed it to Metformin 500mg extended release once a day. She guesses she does have obesity. Shingle vaccine (Lot Number/NDC/Expiry: Unknown, caller did not have this information to provide., Route, Anatomical Location: one of the arms, unknown which., Date: Unknown, she thinks a couple of days either before or after her third dose of Pfizer Covid-19 Vaccine; so would have been in Oct2021. Regarding treatment or medical interventions relative to this event she mentioned that the only relevant information was that she talked to her doctor while she was there and told the doctor what was going on with the hives; so the doctor prescribed patient Benadryl for the hives, of course. Patient uses Benadryl, but never before have hives been consistent like this, just on and off like it was with this event.  Benadryl, she had taken like 3 different Benadryl packages; 1 of them did expire, that why she went and got another pack; but she threw the expired package away, and also threw a second package away; she only had 1 package retained: Benadryl 25mg capsules:  Lot/Batch: might be P122179, but she wasn't able to locate anything specifically labeled as Lot/Batch Expiry: Oct2023 UPC: 6 1429939755 2. NDC: Unknown. Reporter: Address/Fax: Unknown. Primary: Address/Fax/Email: Unknown. Third dose was administered on 17Oct2021, NDC: 59267-1000-03, Lot: FF2590 Expiry: 21Dec2021 - she mentioned this dose expired, she wondered what that meant-was not administered this dose after expired. Dose: Unknown strength/volume/dose injection to unknown upper arm-patient verified details were the same for all 3 doses. Vaccine was not Administered at Military Facility, the suspect product dose was not; but her first two doses of Pfizer Covid-19 Vaccine were administered at a military facility. Injection to unknown upper arm No. of Previous Doses: This was dose 2 of 3., Date: 14Apr2021 Additional Vaccines Administered on Same Date of the Pfizer Suspect: Vaccine Name/Brand name: Unknown other than a flu shot, Lot Number/Expiry Date/NDC: Unknown, caller did not have this information to provide. Route, Anatomical Location: Injection to unknown arm other than the opposite arm than where the third dose of Pfizer Covid-19 Vaccine was administered that same day: 17Oct2021 Patient was not hospitalized. AE(s) following prior vaccinations was reported as None. Relevant Tests were reported as None. AE(s) did not require a visit to Emergency Room. No follow-up attempts are possible. No further information is expected.