Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: facial twitching/her entire side of her face was twitching: right side; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 54-year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 21Apr2021 09:00 (Lot number: EW0169, Expiration Date: 31Aug2021) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing), notes: RA, She had this condition for about 15 years; "Osteoarthritis" (ongoing), notes: She was diagnosed with this about 10 years ago, maybe 12.; "Anxiety disorder" (ongoing), notes: Condition has been ongoing for probably 20 years. The patient took concomitant medications. Past drug history included: Orencia for Rheumatoid Arthritis, notes: She has been taking it or about 8 years with zero problem. She says she had an Orencia infusion on 27Apr2021. The following information was reported: MUSCLE TWITCHING (non-serious) with onset 21Apr2021 09:05, outcome "recovered" (21Apr2021), described as "facial twitching/her entire side of her face was twitching: right side".  Additional information: Reporter seriousness for facial twitching was provided as unspecified. Is COVID-19 vaccine a Pfizer product: Yes. COVID-19 vaccine manufacturer was unspecified. NDC number of COVID-19 vaccine was unknown. The patient was taking COVID-19 vaccine (Verbatim) for ability to travel. Other Products were provided as yes. Orencia: (Start: Unspecified Stop: Ongoing). Additional Information for Orencia: She says she has been taking this for about 8 years with zero problems. She says she had gone 5 weeks in between doses because she was getting the vaccine and they wanted her to add another week. Investigation Assessment was provided as no. Osteoarthritis: She says it gives her neck issues and she usually deals with a headache. Orencia: Dosage text: 750 mg IV every 4 weeks. Additional Context: The caller said she is calling about the COVID vaccine. She says she had the first vaccine dose on 21Apr2021. She says she was thinking about it and the nurse never said anything about the fact that caller reported having some problems, so she thought she would check with us. She says she experienced facial twitching. She is questioning whether or not to get the second dose. Contact Details: When asked if she has ever been a healthcare provider she says years ago she was a dental assistant and also a CNA. Reporter email address declined. Primary care physician's address and email address unknown. Event Details: She said the facial twitching occurred within 5 minutes of the vaccine. She said she thinks she received the vaccine around 09:00 am. She would say it went away that same day. She said she did not think the facial twitching is still going. She said she maybe feels a little something but not like it was. She said her entire side of her face was twitching: right side. She said it hasn't been problematic; occasionally maybe it could be but she doesn't know. History: When asked about medications she says she is on nothing new. Vaccine Supplemental Form: Patient Age at Time of Vaccination in Years: 54. Pfizer Suspect Vaccine and Vaccination Details: First Dose; Time the Vaccination was Given: The caller says said she thinks she received the vaccine around 9:00 am. Anatomical Location of Administration of Pfizer Vaccine considered as suspect: left shoulder. Vaccination Facility Type was provided as Hospital. Vaccine administered at private Facility was provided as no. History of all previous immunizations with the Pfizer vaccine considered as suspect was none. Additional Vaccines administered on SAME DATE of the Pfizer suspect was none. Adverse Event: facial twitching. Time of Onset (24-hour clock): 5 minutes after her vaccination. She thinks her vaccination was around 09:00 am. Any AE(s) did not require a visit to Emergency Room and Physician Office. Prior Vaccinations within 4 weeks (List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s)): She says she had an Orencia infusion on 27Apr2021. AE(s) following prior vaccinations was none. Patients Medical History (Including any illness at time of vaccination): The caller denies being sick at the time of vaccination. She says she didn't even have a headache that day; normally she has a headache. Family Medical History relevant to AE(s) was none. Relevant Tests were none. She said the nurse gave her bottle of water and that might not have been the best response. She said this should have been recorded. Communication: The caller is referred to her primary care physician for any medical advice and guidance. The caller declines a transfer for general product questions and information. Vaccine Facility information available. Race information is available.  No follow-up attempts are possible. No further information is expected.