Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Chills, Fatigue, Muscle spasms, Pyrexia
Clinical narrative: Chills; Leg cramps; fever; tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9809), in left arm, on 26Feb2021 as dose 2, single (Lot number: EN6203), in left arm and on 28Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "BRIP1 genetic mutation" (unspecified if ongoing). There were no concomitant medications. The following information was reported: CHILLS (non-serious) with onset 04Apr2022, outcome "unknown"; MUSCLE SPASMS (non-serious) with onset 04Apr2022, outcome "unknown", described as "Leg cramps"; PYREXIA (non-serious) with onset 04Apr2022, outcome "unknown", described as "fever"; FATIGUE (non-serious) with onset 04Apr2022, outcome "unknown", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Received call from consumer regarding the Pfizer COVID 19 vaccine booster. She was concerned that maybe it might be an adverse event she was having. She had 4th booster on Friday, 01Apr2022. Monday, she broke out in hives. She does not know whether or not it was that or that her nerves are shot. She just found out her husband had cancer last week. She just wants to have it documented for proper statistics for the whole covid thing in case Pfizer may have had other people with the same thing. She did go see her primary. She does not have an address or email for him. The only place the hives are not prevalent on was her face, arms and feet. When asked to provide outcome, she stated that she takes Benadryl at night, so next day some are better, but she will have a new bunch, so she is continually breaking out. They have decreased or changed and are not as inflamed looking. The Benadryl does help. If this was something to get one more person to report so they can call it a side effect, she wanted to report it. She confirmed that all 4 doses were the Pfizer COVID 19 vaccine. She takes no other medications other than her normal blood pressure and cholesterol medications, which she was taking prior to getting the vaccine. She did take a steroid and finished it 28Mar2022. It was one of those packs. It was Prednisone and you took 20 mg for 3 days and then 10 mg for 4 days. Last dose was 28Mar2022. She does not have a lot or expiration. She discarded it.  She has High blood pressure, high cholesterol and acid reflux and all were diagnosed prior to getting the vaccine. She had Shingles vaccine, Shingrix on 22Feb2022. They said you could have it on the same date, but she did not. That was the 1st dose. Unknown lot and expiration. She got a card to remind her when to come back She is to go back around 22Apr2022. Pfizer Suspect Vaccine and Vaccination Details Vaccine Lot Number: 9895 Vaccine Lot Expire Date: Unknown Time the Vaccination Was Given: 10:15 am. Anatomical Location of Administration of Pfizer vaccine considered as suspect: Injected in left arm. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): Vaccine Name: Pfizer COVID 19 vaccine Lot Number / Expiry Date: FF8839 expiration unknown Route, Anatomical Location: Injected in left arm. No. of Previous Doses: 2 Date: 28Sep2021 Age at Immunization if date not available: Vaccine Name: Pfizer COVID 19 vaccine Lot Number / Expiry Date: EN6203 expiration unknown Route, Anatomical Location: Injected in left arm. No. of Previous Doses: 1 Date: 26Feb2021 Age at Immunization if date not available: \ Vaccine Name: Pfizer COVID 19 vaccine Lot Number / Expiry Date: EM9809 expiration unknown Route, Anatomical Location: Injected in left arm. No. of Previous Doses: 0 Date: 05Feb2021, LOT EM9809 expiration is unknown, injected in left arm. Age at Immunization if date not available. Provide the time of onset of AE(s): Hives - in the morning when she got up. She thought they were bug bites because they went to the winery and she did not think anything of it. She then thought maybe they were in her bed and she stripped her bed and the next day it was worse and noticed it was hives. Patient was require visit to the Physician Office. She saw her primary care and suggested she use hydrocortisone and take Benadryl and keep an eye on it. If it got any worse to call. AE(s) following prior vaccinations: Hers all happened within first 12 hours. After first 24 hours, she was fine. She got Chills, Leg cramps, fever and was tired. It lasts for 12 hours and it is gone. So it was Between 10 am in the morning when she got the shot until 10am next day. Only happens between 10pm and 10am. That was with all 4 of the Pfizer Covid19 vaccines. Her husband had nothing. No further details provided on his vaccine. She BRIP1 genetic mutation. She has known about it for 6 years. She was really strangely ANA positive for 3 consecutive blood test for every 6 months and everything was fine. That started in 2018 and just had doctor check in Jul2021, to make sure she was still negative and has now been negative for 2 years. Relevant Tests: None She knows about genetic mutation. She would like to know if this has been reported before.