Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Facial nerve disorder, Fatigue, Nervousness
Clinical narrative: runny nose since day after getting shot; nervous about second shot; worried; facial neuropathy flare; facial neuropathy flare; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6201, expiry date not reported) via an unspecified route of administration, administered in left arm on 25Feb2021 08:30 at a single dose for COVID-19 immunisation. Medical history included facial neuropathy, sleep apnea from 2003, and Guillain-Barre syndrome from 2001. Patient said she had Guillain-Barre syndrome 20 years ago and has residual neuropathy from that. There were no concomitant medications. Patient have not had any other recent vaccinations or started any new medications. Patient called about the Pfizer COVID-19 vaccine shot, as she was supposed to call about possible side effects, to report. She said that she had her first dose of the vaccine on 25Feb2021 and hasn't had her second yet. She said that the first dose was injected in the morning, around 08:30AM. She said that there was a sticker on her vaccine card that says mRNA Pfizer-BioNTech, and (withheld), she didn't know what that means. She said actually that was abbreviation for (withheld), her vaccine provider. Her side effects included fatigue on an unspecified date in 2021, which she thinks a lot of people do have. She didn't know if this was available but she was hoping to advice about getting her second shot. She has had a runny nose since day after getting the shot, so since 26Feb2021, it hasn't stopped. She was not saying this was from the shot, it could be chronic runny nose, but it didn't stop. She said that the worst thing she was calling about was she has facial neuropathy flare in 2021, described as slight facial neuropathy which felt like it has flared since the shot. She was calling because she was nervous about second shot in 2021, since it flared with the first one a bit. She didn't want this to get worse, she can live with it currently, but she has heard people have more problems with the second dose and she didn't want to risk full blown neuropathy. She has done no treatment for the neuropathy, but for the runny nose there were a couple nights she took Benadryl and today she took Claritin, so put that she has taken sporadic over the counter stuff. No further details provided about Claritin or Benadryl. She has been experiencing continuous runny nose, flare of facial neuropathy, and fatigue. She was worried in getting the 2nd dose in 2021 and wanted to have recommendations as her doctor was reluctant in giving an advice whether she may have the 2nd dose or not. The patient reported that facial neuropathy flare as serious medically significant while the other events was non-serious adverse events. Patient was advised by the Pfizer colleague of the overall safety summary that indicated throughout the safety follow-up period to date, Bell's palsy (facial paralysis) was reported by four participants in the Pfizer-BioNTech COVID-19 Vaccine group. Onset of facial paralysis was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of Bell's palsy were reported in the placebo group. Currently available information is insufficient to determine a causal relationship with the vaccine. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19. The outcome of the events facial neuropathy flare, fatigue, nervous and worried was unknown. The event runny nose was not recovered.