Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Malaise, Oedema peripheral, Peripheral swelling
Clinical narrative: reaction in arm of a lot of swelling and redness in arm; reaction in arm of a lot of swelling and redness in arm; very sick; Caller had a 103 fever or higher; she experienced edema & redness in the arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 at 09:15 as dose 2, single (Lot number: ER8732, Expiration Date: 31Jul2021) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (First dose: 04MAR2021, lot: EN6204, NDC: unknown , expiration: 30Jun2021, route of administration: Caller would say probably left arm because right handed, but caller is not certain), administration date: 04Mar2021, when the patient was 57-year-old, for COVID-19 immunization, reaction(s): "First/second/booster dose: All three times after receiving Pfizer Covid Vaccine dose, was very, very, sick for like over 4 days", "First/Second/Booster dose: Had a reaction in arm of a lot of swelling and redness in arm where had first, second and booster dose Pfizer Covid Vaccine injections", "First/Second/Booster dose: Had a reaction in arm of a lot of swelling and redness in arm where had first, second and booster dose Pfizer Covid Vaccine injections". The following information was reported: PYREXIA (non-serious) with onset Apr2021, outcome "unknown", described as "Caller had a 103 fever or higher"; PERIPHERAL SWELLING (medically significant), ERYTHEMA (medically significant) all with onset Apr2021, outcome "unknown" and all described as "reaction in arm of a lot of swelling and redness in arm"; OEDEMA PERIPHERAL (non-serious) with onset Apr2021, outcome "unknown", described as "she experienced edema & redness in the arm"; MALAISE (non-serious) with onset Apr2021, outcome "unknown", described as "very sick". The events "reaction in arm of a lot of swelling and redness in arm", "very sick", "caller had a 103 fever or higher" and "she experienced edema & redness in the arm" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: 103. Therapeutic measures were taken as a result of pyrexia.  Clinical course: Indication as Reported by the Primary Source was to hopefully prevent death. The caller is a consumer who asked a question online and was supposed to call back this number. Caller states the question was regarding an adverse reaction the caller had to the Pfizer Covid Vaccine. All three times after receiving Pfizer Covid Vaccine dose the caller was very, very sick for like over 4 days began within 24 hours after receiving first, second and booster dose Pfizer Covid Vaccine. The caller had a reaction in arm of a lot of swelling and redness in arm where had first, second and booster dose Pfizer Covid Vaccine injections. This started maybe 24 hours after each first, second and booster dose. Caller was pretty clear, wasn't just an injection kind of soreness, caller's whole arm had swelling and tightness and heat. All three times after receiving Pfizer Covid Vaccine dose the caller was very, very sick for like over 4 days: Caller clarifies after 4 or 5 days the caller was much better. Caller had a 103 fever or higher, fever did not go over 104. Fever was pretty high within 24 hours of receiving each dose. Caller took fever reducer. Caller was completely recovered after like 5 days. Had a reaction in arm of a lot of swelling and redness in arm where had first, second and booster dose Pfizer Covid Vaccine injections: This went away. The caller knows there is some record somewhere. The caller consulted with the doctor after receiving each dose. Second dose: Had a reaction in arm of a lot of swelling and redness in arm where had second dose Pfizer Covid Vaccine injection: The caller went to the ER. The caller wasn't concerned about caller's arm, but doctor was most concerned about arm and suggested the caller take antibiotics. The caller did not take antibiotics. Caller believes caller went to the emergency room after receiving the second dose Pfizer Covid Vaccine. The caller was discharged from the ER. Vaccination Facility Type was was in a convention center there is a website for (hospital name). No 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. Caller went to the emergency room and was discharged from the emergency room. Prior Vaccinations (within 4 weeks) there was no list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Caller had adverse reaction after receiving shingles vaccine in last couple years. Shingles Vaccine: NDC/lot/expiration: unknown, caller does not have this information to provide. There were no medical History (including any illness at time of vaccination) and relevant Tests. Caller warm transferred in by (Name), NTID # with Pfizer Drug Safety REPORTUM:Y4GZ820M. Per (name) the caller voiced that she asked a question online and was suppose to call back in. Caller reports her last Pfizer Covid 19 Vaccine was in November. After receiving both vaccines and the booster she experienced edema & redness in the arm of the injection and felt very sick for over 4 days. When she seen her doctor at hospital for a physical in December she advised the caller that she couldn't receive anymore of the vaccines because the symptoms she experienced was an adverse reaction. Her HCP advised that if she received another vaccine she may go into anaphylactic. HCP advised the caller to follow up with (institution name) to see what she was allergic to. (institution name) advised they wouldn't be able to test her to see. She also reached out to medical and was told the same thing. Per caller she read that the Johnson & Johnson may be an alternative because it has different ingredients. Caller voiced she was having problems finding someone to observe her to make sure it's not problematic. Caller voiced it's unbelievably that her own doctor can't provide guidance. Per caller she is due for a booster and would like to be protected.   Follow-up attempts are completed. No further information is expected.