Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Product preparation error, Pyrexia
Clinical narrative: Chest pain; Back pain; Headaches; Weakness in arm; I received an undiluted dose of the Pfizer covid 19 vaccine resulting in a dose higher than indicated in the FDA emergency use authorization; I received an undiluted dose of the Pfizer covid 19 vaccine resulting in a dose higher than indicated in the FDA emergency use authorization; Fatigue; Nausea; Fever; Chills; Sweats; Sore arm; Tingling arm; Lightheaded; Dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Jan2022 (Lot number: FL3198) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Site and route of injection: Right arm, Batch/Lot number: ER2613, Exp 31Jul2021), administration date: 22Mar2021, for Covid-19 Immunization; Bnt162b2 (Dose: 02, Site and route of injection: Right arm, Batch/Lot number: EW0164, Exp: 31Aug2021), administration date: 23Apr2021, for Covid-19 Immunization. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 03Jan2022, outcome "unknown" and all described as "I received an undiluted dose of the Pfizer covid 19 vaccine resulting in a dose higher than indicated in the FDA emergency use authorization"; CHEST PAIN (non-serious) with onset 08Jan2022, outcome "not recovered", described as "Chest pain"; BACK PAIN (non-serious) with onset 08Jan2022, outcome "not recovered", described as "Back pain"; HEADACHE (non-serious) with onset 08Jan2022, outcome "not recovered", described as "Headaches"; MUSCULAR WEAKNESS (non-serious) with onset 08Jan2022, outcome "unknown", described as "Weakness in arm"; FATIGUE (non-serious) with onset 2022, outcome "not recovered", described as "Fatigue"; NAUSEA (non-serious) with onset 2022, outcome "unknown", described as "Nausea"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 2022, outcome "unknown", described as "Chills"; HYPERHIDROSIS (non-serious) with onset 2022, outcome "unknown", described as "Sweats"; PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "Sore arm"; PARAESTHESIA (non-serious) with onset 2022, outcome "unknown", described as "Tingling arm"; DIZZINESS (non-serious) with onset 2022, outcome "unknown", described as "Lightheaded"; DIZZINESS (non-serious) with onset 2022, outcome "unknown", described as "Dizzy". The events "chest pain", "back pain", "headaches" and "weakness in arm" were evaluated at the emergency room visit.  Additional information: "On 03Jan2022, I received an undiluted dose of the Pfizer covid 19 vaccine resulting in a dose higher than indicated in the FDA emergency use authorization. I have had symptoms from the shot already. I am worried about the long-term effect this could have on my body." Added 1st and 2nd dose as historical vaccine and 3rd dose as suspect dose, vaccine facility information. No prior vaccinations within 4 weeks. No concomitant drugs. On 04Jan2022 I got a phone call in the morning informing me the pharmacist didn't dilute my shot. He had watched another pharmacist give the shot and noticed he forgot to do something. The person who called asked about my symptoms so I told her. As the week went on they got worse. On 08Jan2022 I went to the ER because my events got so bad Dr. didn't care.   No follow-up attempts are possible. No further information is expected.  Follow-up (15Feb2022): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no fur-ther information is expected.