Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Arms really heavy, can hardly lift them; Chest pain; Heart palpitations; Difficulty breathing; Migraine headache; Ears ringing; Pressure in chest; Really red face, cheeks; Chills; Nausea; Very high fever; Back pain a lot worse; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3247, Expiration date unknown), first dose via an unspecified route of administration, administered in right arm deltoid on 08Apr2021 at 14:30 to 15:00 (at the age of 60-year-old) as dose 1, single for COVID-19 immunisation at pharmacy/drug store. Medical history included intervertebral disc protrusion from 2003 and ongoing Verbatim: herniated disc and chronic back pain  patient medical continuing : yes, back pain from 2003 and ongoing Verbatim: herniated disc and chronic back pain  patient medical continuing : yes, ongoing epilepsy Verbatim: Epilepsy  Patient medical continuing : yes,  started at 16-year-old. Concomitant medications included carbamazepine (CARBAMAZEPINE) taken for seizure, start and stop date were not reported; phenytoin (DILANTIN [PHENYTOIN]) taken for an unspecified indication, start and stop date were not reported. No additional vaccines were administered on same date of the Pfizer suspect. The patient did not receive any vaccination within 4 weeks. The patient reported that on the Pfizer COVID-19 vaccine and Patient had very, very bad side effects. She was running a fever and had every side effect on the template from the pharmacy. She was not doing good and should probably be in the hospital. She could not drive her-self. On 08Apr2021, the patient had very high fever and back pain a lot worse. On 09Apr2021, she had chills, red face, cheeks, and nausea. On 10Apr2021, the patient experienced migraine headache, heart palpitations, difficulty breathing, pressure in chest, and ears ringing. On 14Apr2021, she had chest pain. On 15Apr2021, the patient experienced arms heavy, can hardly lift them. Adverse events did not require to visit emergency room or physician office. The reporter assessed arms heavy, can hardly lift them as medically significant. Upon follow-up received on 29Mar2021, it was reported that caller stated she went to the place where they said who we share information, and it was a lot of people. Caller stated she wanted all personal information, age, doctor, Carbamazepine and Dilantin use. Caller stated she wants all personal information retracted except for her name and address. Caller wanted to make sure that this agent had she wanted to cancel her personal information, age, and seizure medication information. No product quality complaint was reported. No medical information was requested. The outcome of very high fever, migraine headache and chills, ears ringing was recovering on an unspecified date in 2021, while outcome of back pain a lot worse, heart palpitations, pressure in chest, red face, cheeks, arms heavy, can hardly lift them and nausea was not recovered and outcome for other events was unknown.  Follow-up (29Mar2021): new information report was received from a consumer. This consumer (patient) reported in response to non-HCP telephonic follow-up activity which included that: Concomitant medication DILANTIN was added.  No follow-up attempts are needed. No further information is expected.