Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue, SARS-CoV-2 test
Clinical narrative: chills; body aches; headache; tired/ fatigue; other vaccine same date product=FLUAD QUAD; other vaccine same date product=FLUAD QUAD; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Oct2021 12:00 (Lot number: FF8841) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact sag 4v (FLUAD QUAD), intramuscular, administered in arm right, administration date 04Oct2021 (Lot number: 312838) as dose 1, single for immunisation. Relevant medical history included: "low thyroid", start date: 2015 (ongoing), notes: low thyroid. Concomitant medication(s) included: LEVOTHYROXIN taken for hypothyroidism (ongoing). Past drug history included: Sulfa drugs, reaction(s): "allergy", notes: Known allergies: Sulfa drugs. Vaccination history included: Pfizer covid-19 (DOSE 2, SINGLE, Time: 10:00 AM, Anatomical location: Left Arm, Route: Intramuscular , Lot no: EN6201 , Exp. Date: 30Jun2021), administration date: 26Feb2021, when the patient was 70 years old, for COVID-19 immunization; Pfizer covid-19 (DOSE 1, SINGLE, Time: 10:00 AM, Anatomical location: Left Arm, Route: Intramuscular , Lot no: EN5318 , Exp. Date: 31May2021), administration date: 05Feb2021, when the patient was 70 years old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 04Oct2021 22:00, outcome "recovered" (Oct2021), described as "chills"; PAIN (non-serious) with onset 04Oct2021 22:00, outcome "recovered" (Oct2021), described as "body aches"; HEADACHE (non-serious) with onset 04Oct2021 22:00, outcome "recovered" (Oct2021), described as "headache"; FATIGUE (non-serious) with onset 04Oct2021 22:00, outcome "recovered" (Oct2021), described as "tired/ fatigue"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 04Oct2021, outcome "unknown" and all described as "other vaccine same date product=FLUAD QUAD". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, pain, headache. Therapeutic measures were not taken as a result of fatigue, off label use, product use issue.  Additional information: Other medications in two weeks included Levothyroxin. No other vaccine in four weeks. About 10 hrs after the vaccines, patient developed chills and body aches and headache. It lasted for about 14 hours (also reported Patient had fatigue, body aches, and chills (no fever) for about 16 hours patient never felt it was serious). Patient took tylenol in the middle of the night and that helped (Therapeutic measures were taken as a result of chills, pain, headache included Tylenol). Afterwards patient felt tired. Feeling better after two days. The adverse effects were not as bad as after the first two Pfizer vaccines. Patient was reporting it because patient received, the Pfizer booster and the flu shot at the same time. The side effects this time were more pronounced than with the first two Pfizer vaccine patient was not sure if there was a connection or not. It was unknown If covid prior vaccination. Patient was not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.