Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Erythema, Headache, Nausea
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient. A female patient received BNT162b2 (BNT162B2), on 17Aug2021 at 12:00 as dose 3 (booster), single (Lot number: EW0176), in left deltoid for Covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (ongoing), notes: Did not have symptoms just had bloodwork that diagnosed this; "Uveitis", start date: 2020 (ongoing), notes: Onset date about 2 years ago. Uveitis relapse on day 4 of this last reaction, around 19Apr2022; "Lupus" (unspecified if ongoing), notes: Lupus Onset date: Probably had all her life, but started having complications about 5 years ago; "She is immunocompromised" (unspecified if ongoing), notes: She is immunocompromised and over 50; "Vertigo" (ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE taken for antiphospholipid antibodies, start date: 2017; ZETIA taken for hyperlipidaemia; PREDNISOLONE taken for uveitis, start date: 2020. Vaccination history included: BNT162b2 (Dose: 1, Lot: EJ1685, dose injection to left deltoid at around 12:00), administration date: 22Dec2020, for COVID-19 immunization; BNT162b2 (Dose: 2, Lot: EK4176, dose injection to left deltoid at 12:00), administration date: 12Jan2021, for COVID-19 immunization. The following information was reported: HEADACHE (medically significant) with onset 18Aug2021 at 12:00, outcome "recovered" (Aug2021), described as "Third dose/First booster: headache"; SINUS CONGESTION (medically significant) with onset 18Aug2021 at 12:00, outcome "recovered" (Aug2021), described as "Third dose: Bad nasal or sinus congestion"; CHILLS (medically significant) with onset 18Aug2021 at 12:00, outcome "recovered" (Aug2021); DIZZINESS (medically significant) with onset 18Aug2021 at 12:00, outcome "recovered" (Aug2021); NAUSEA (medically significant) with onset 18Aug2021 at 12:00, outcome "recovered" (Aug2021); ERYTHEMA (medically significant), URTICARIA (medically significant) all with onset 18Aug2021 at 12:00, outcome "recovered" (Aug2021) and all described as "redness and hives at the injection site"; ERYTHEMA (medically significant) with onset 18Aug2021 at 12:00, outcome "recovered" (Aug2021), described as "redness and hives on both of her legs". Clinical course: This was a Follow-Up Report. Reference: Unknown. This Physician is also the patient who called regarding Pfizer product: Covid Vaccine. She had escalating bad reactions to her second, third and fourth doses of Covid Vaccine further described as: headache; nausea; chills; redness and hives at the injection site; redness and hives on both of her legs; dizziness; bad nasal or sinus congestion which was worse with the fourth dose. She needs to know what inert ingredients are in this Covid Vaccine. It asked are you allergic to gelatin and she was if it was bovine. She puts that on every time but they gave her the Covid Vaccine anyway. She called today to ask what the gelatin source or gelatin derivative was. When queried if this information had been reported to Pfizer caller explained that she reported this information to the pharmacy who she believed reported the information; and she also received an email from Pfizer about this but had no reference number to provide. She explained that she could take some Benadryl at least if she knows there's an ingredient she is allergic to in the Covid Vaccine; she was not against taking the Covid Vaccine, but wants to make sure for her personally that it's safe. She mentioned that with the first dose she experienced arm soreness at the injection site, redness at the injection site, and may have had a mild headache; all of which started about 24 hours after first dose was administered. She had recovered completely after about 1.5 days after onset of these events. All events that occurred with third dose/first booster she recovered completely from after about 3-4 days, exact date unknown other than Aug2021. Additional Vaccines Administered on Same Date of the Pfizer Suspect-If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect reported as None: Vaccination Facility Type reported as pharmacy. She clarified that as she had to hold medication to take the Covid Vaccines because there was an immunosuppressant agent she was just prescribed, but has not yet started taking, but it will be new. Additional Information Did any AE(s) require a visit to: Emergency Room reported as No. Physician Office reported as No. If the patient was hospitalized, how many days was the hospital stay reported as not hospitalized. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) reported as None. Family Medical History Relevant to AE (s) reported as None. Relevant Tests reported as None. No follow-up attempts are needed. No further information is expected. Sender's Comments: Based on the information currently available, The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded. 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.