Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Interchange of vaccine products, Loss of personal independence in daily activities, Off label use, Pyrexia
Clinical narrative: had a very high fever to 104; severe chills; couldn't get her head off of the pillow; bad headaches; extreme fatigue; 1st dose- 15Mar2021 Manufacture: Johnson and Johnson/had her booster dose on Saturday; 1st dose- 15Mar2021 Manufacture: Johnson and Johnson/had her booster dose on Saturday; had her booster dose on Saturday; sweating profusely; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Local reference (HZNR65AB).  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Dec2021 10:30 (Lot number: FD0809) at the age of 58 years as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID", start date: 24Nov2021 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Johnson and johnson covid vaccine (1st dose, Route, Anatomical Location: Left upper arm, Lot Number: 1805022, unknown expiry), administration date: 15Mar2021, when the patient was 57 years old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 18Dec2021 10:30, outcome "unknown" and all described as "1st dose- 15Mar2021 Manufacture: Johnson and Johnson/had her booster dose on Saturday"; IMMUNISATION (non-serious) with onset 18Dec2021 10:30, outcome "unknown", described as "had her booster dose on Saturday"; PYREXIA (non-serious) with onset 18Dec2021 22:30, outcome "recovered" (Dec2021), described as "had a very high fever to 104"; CHILLS (non-serious) with onset 18Dec2021 22:30, outcome "recovered" (Dec2021), described as "severe chills"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 18Dec2021 22:30, outcome "recovered" (Dec2021), described as "couldn't get her head off of the pillow"; HEADACHE (non-serious) with onset 18Dec2021 22:30, outcome "recovering", described as "bad headaches"; FATIGUE (non-serious) with onset 18Dec2021 22:30, outcome "recovering", described as "extreme fatigue"; HYPERHIDROSIS (non-serious) with onset Dec2021, outcome "unknown", described as "sweating profusely". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller says that on her information sheet it says that if she were to have an adverse reaction that she should call this number and she had the Pfizer booster on Saturday. Product clarified to the Pfizer COVID vaccine, booster dose. Event Details: She had her booster dose on Saturday and then 12 hours later she had a very high fever to 104, severe chills, she couldn't get her head off of the pillow, bad headaches and extreme fatigue. Confirmed that she had her booster dose on 18Dec2021 around 10:30 AM so her side effects all began at 10:30 PM on the same day, 18Dec2021. Inquired if her side effects went away and she says that she is very tired still today. Her fever probably broke in the middle of the night last night because she was sweating profusely. She still has the headache and the tiredness, but they are better. Lot Number: FD0809, the 0 could be an "O" but they put slashes through them. History: She had COVID the day before thanksgiving and she doesn't know if that has anything to do with this. She was tested on 24Nov2021. Nonadditional vaccines administered on same date of the Pfizer suspect. Prior Vaccinations (within 4 weeks) If applicable, No other vaccinations within four weeks prior to the first administration date of the suspect vaccine, No AEs following prior vaccinations.  No follow-up attempts are needed. No further information is expected.