Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Paraesthesia, Pruritus, SARS-CoV-2 test, Tinnitus
Clinical narrative: dizzy; vertigo; ears were buzzing and hurt; ears were buzzing and hurt; immediately had a reaction called dead arm; itching; exhausted and tired; tingling and numbness in her whole arm from the place of injection down to the tips of her fingers; tingling and numbness in her whole arm from the place of injection down to the tips of her fingers; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 16Aug2021, this case now contains serious adverse reactions. Information processed together. This is a spontaneous report from a contactable other hcp (patient). A 63-year-old female patient received bnt162b2 (Pfizer/BioNTech COVID-19 vaccine), dose 1 intramuscularly, administered in left upper arm on 06Jul2021 13:30 (Lot Number: ER8732) as dose 1, single at the age of 63-year-old for COVID-19 immunisation. Medical history included stevens-johnson syndrome from Jul2015 and ongoing; diabetes from 01Jan2000 and ongoing; AAV (adenovirus infection) from Apr2017 and ongoing; TBI (traumatic brain injury) from 08Jul1997 and ongoing. The patient was not pregnant. The patient had known allergies. No covid prior vaccination. No covid tested post vaccination. No concomitant medications. No other vaccine in four weeks. No other medications in two weeks. No prior vaccinations. She immediately had a reaction called dead arm on 06Jul2021 13:40. She had tingling and numbness in her whole arm from the place of injection down to the tips of her fingers. She was taken to the emergency room in the clinic and they did her vitals and watched her for a while. Vitals were good and It didn't get worse. She was sent home after about an hour. She got dizzy, her ears were buzzing and hurt on 06Jul2021 15:00. She was itching, exhausted and tired on 06Jul2021. This lasted for 3-5 days. She felt like she was having vertigo and like she was not here on 06Jul2021 15:00. Some of the itching and ringing in her ears is still happening. it has been 2 weeks. The seriousness of immediately had a reaction called dead arm, vertigo, dizzy was medically significant. Events resulted in physician office visit and emergency room visit for 30 min. Therapeutic measures were taken as a result of all events except dizzy and vertigo. No treatment received for dizzy and vertigo. The patient underwent lab tests and procedures which included Covid: positive on 05Oct2020, negative on 06Jan2021. The other-HCP considered the Pfizer product had a casual effect to the adverse event. The outcome of dead arm was recovered on 06Jul2021. The outcome of dizzy and vertigo was recovered on 12Jul2021. The outcome of ears were buzzing and hurt was recovered on 13Jul2021. The outcome of other events was recovered in 2021.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the events limb discomfort, dizziness and vertigo and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.