Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Fatigue, Hypoaesthesia
Clinical narrative: chest acne at about 48 hours; numbness or a desensitization on the left side of the body/she felt like it was numb on top of her back and neck area and left leg, arm, and upper back on same side; feeling tired although not as fatigued as she had been; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in arm left on 30Jul2021 17:00 as dose 2, single (age at vaccination: 42 years) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Lot number EN0196) via an unspecified route of administration in arm right on 09Jul2021 as dose 1, single (age at vaccination: 42 years) for covid-19 immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect, all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. Prior Vaccinations (within 4 weeks), any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. The adverse events following prior vaccinations was none. Other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity was none. On 30Jul2021, she experienced numbness or a desensitization on the left side of the body within 30 minutes of vaccine administration and it went away quickly within 15 minutes or so. On 01Aug2021, she had chest acne at about 48 hours and wanted to know if this was normal and had been previously reported. On an unspecified date 2021, she was also complaining of feeling tired although not as fatigued as she had been. And asked how long the vaccine is supposed to last (as in months), and if a booster will or is needed and if the current doses of the Pfizer covid 19 vaccine she received will protect her. It was stated that she had a bunch of chest acne and it did not itch or bother her, and she sent pictures to her dermatologist. Does not know who else to call. Was given this number from a friend and from the pamphlet. Wanted to know if this is a normal thing. When she got the second dose, she felt like it was numb on top of her back and neck area and left leg, arm, and upper back on same side she got the second shot. She had someone to ask the pharmacy to see if it was okay and they said this could happen. Said it was not the medicine itself, but from the nerves itself. Stated it was hard to read the writing on card given and she sent her sister a text picture of the acne. States her defensive patient, or kind of numbness left within 30 minutes of getting the shot. The adverse event did not result in emergency Room/Physician Office visit. Unable to provide expiry, or dose for the second dose and provides a lot number of what she thinks like start with either FA or FP7485 in left arm/shoulder area. Response received was Pfizer and BioNTech Provide Update on Booster Program in Light of the Variant: Initial data from the study demonstrate that a booster dose given 6 months after the second dose has a consistent tolerability profile while eliciting high neutralization titers against the wild type and the variant. While Pfizer and BioNTech believe a third dose of BNT162b2 has the potential to preserve the highest levels of protective efficacy against all currently known variants including Delta, the companies are remaining vigilant and are developing an updated version of the Pfizer-BioNTech COVID-19 vaccine that targets the full spike protein of the variant. The Companies anticipate the clinical studies to begin in Aug, subject to regulatory approvals vaccine efficacy in preventing both infection and symptomatic disease has declined six months post-vaccination, although efficacy in preventing serious illnesses remains high. Please note that the use of a 3rd or booster dose is not recommended or authorized and Pfizer does not suggest the use of the vaccine in any manner other than as described in the authorized EUA Prescribing Information. So far, studies suggest that the current authorized vaccines work on the circulating variants. Scientists will continue to study these and other variants. She said that it had been about 72 hours since her second dose. She asked if she was in the clear with any dangerous side effects. Response received was in Study 2, among participants 16 through 55 years of age who had received at least 1 dose of vaccine or placebo (Pfizer-BioNTech COVID-19 Vaccine = 10,841; placebo = 10,851), serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow-up were reported by 0.4% of Pfizer-BioNTech COVID-19 Vaccine recipients and by 0.3% of placebo recipients. States her daughter is due for the meningitis and HPV vaccines and they were delayed because she wanted to get the Covid vaccine first. She is fully vaccinated and now she wanted to know how long after getting the Covid vaccines can she get the meningitis and HPV vaccines or is it safe to get. Also asks how long is the Covid vaccine supposed to last 3-6 months or will a booster. The clinical outcome of the event feeling tired although not as fatigued as she had been was unknown and rest of the events was not resolved.  Information on the lot/batch number has been requested.