Sex: F
Vaccine: COVID19
Symptoms: Sinus congestion, Vaccination site erythema, Vaccination site urticaria
Clinical narrative: Second dose: chills; Third dose/First booster: headache; Second dose: nausea; redness and hives at the injection site; redness and hives at the injection site; Second dose: dizziness; Second dose: Bad nasal or sinus congestion; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 12Jan2021 at 12:00 as dose 2, single (Lot number: EK4176), in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (ongoing), notes: Hyperlipidemia Did not have symptoms just had bloodwork that diagnosed this.; "Uveitis", start date: 2020 (ongoing), notes: Uveitis Onset date about 2 years ago. Uveitis relapse on day 4 of this last reaction, around 19Apr2022; "She is immunocompromised" (unspecified if ongoing); "It asks are you allergic to gelatin and she is if it is bovine" (unspecified if ongoing), notes: It asks are you allergic to gelatin and she is if it is bovine; "Lupus" (unspecified if ongoing), notes: Probably had all her life, but started having complications about 5 years ago. Concomitant medication(s) included: HYDROXYCHLOROQUINE taken for lupus-like syndrome, start date: 2017; ZETIA taken for hyperlipidaemia; PREDNISOLONE taken for uveitis, start date: 2020. Vaccination history included: BNT162b2 (Adverse Event: First dose: arm soreness at the injection site, Time of Onset: (24-hour clock): 12:00, Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED), administration date: 23Dec2020, for COVID-19 Immunization, reaction(s): "arm soreness at the injection site", "redness at the injection site"; BNT162b2 (First dose, Adverse Event: First dose: May have had a mild headache, Time of Onset: (24-hour clock): 12:00, Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED)), administration date: 23Dec2020, for Covid-19 Immunization, reaction(s): "May have had a mild headache"; BNT162b2 (First dose:, Vaccine Lot Number: EJ1685, Vaccine Lot Expire Date: Unknown, not on the CDC vaccine record card., Time the Vaccination Was Given: 12:00, Anatomical Location of Administration of , Pfizer vaccine considered as suspect: Left deltoid), administration date: 22Dec2020, for Covid-19 Immunization. The following information was reported: SINUS CONGESTION (medically significant) with onset 13Jan2021 at 12:00, outcome "recovered" (16Jan2021), described as "Second dose: Bad nasal or sinus congestion"; CHILLS (medically significant) with onset 13Jan2021 at 12:00, outcome "recovered" (16Jan2021), described as "Second dose: chills"; DIZZINESS (medically significant) with onset 13Jan2021 at 12:00, outcome "recovered" (16Jan2021), described as "Second dose: dizziness"; NAUSEA (medically significant) with onset 13Jan2021 at 12:00, outcome "recovered" (16Jan2021), described as "Second dose: nausea"; HEADACHE (medically significant) with onset 13Jan2021 at 12:00, outcome "recovered" (16Jan2021), described as "Third dose/First booster: headache"; VACCINATION SITE ERYTHEMA (medically significant), VACCINATION SITE URTICARIA (medically significant) all with onset 13Jan2021 at 12:00, outcome "recovered" (16Jan2021) and all described as "redness and hives at the injection site". The patient underwent the following laboratory tests and procedures: Blood test: Hyperlipidemia, notes: Hyperlipidemia Did not have symptoms just had bloodwork that diagnosed this.  Clinical information: This Physician was also the patient who called regarding Pfizer product: Covid Vaccine. She has 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 were in this Covid Vaccine. It asked, are you allergic to gelatin and she is if it is 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 is. When queried if this information has 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 was allergic to in the Covid Vaccine; she is not against taking the Covid Vaccine, but wants to make sure for her personally that it's safe. AE(s) did not require a visit to Emergency Room or Physician Office. Patient was not hospitalized. No prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine. AE(s) following prior vaccinations: Soreness for a couple of days at the injection site, Vaccine/Brand Name: Flu shot/Brand name unknown. Vaccination Date: might have been in Jan2022, exact date unknown. Family Medical History Relevant to AE(s): None. Relevant Tests: None. Patient verified that there has been no testing, treatment or medical interventions performed relative to these events other than just at home over the counter pretty much just Tylenol and an antihistamine and for the bad nasal or sinus congestion took Sudafed.; 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.