Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tension headache
Clinical narrative: Left side of her face swelled up; whole cheek on the left side swelled up; Soreness when she eats, left cheek is still tender to the touch; Her jaw would get tight as if it was clamping when she eats; Tension headaches; This is a spontaneous report from a contactable consumer. A 48-year-old female consumer (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; EW0161, NDC number, expiry date; unknown, this information is not on the CDC vaccine record card.), Pfizer product, Pfizer Covid Vaccine manufacturer; unspecified, via an unspecified route of administration on 19Apr2021 at 02:15 pm at single dose (Dose: Unknown strength/volume/dose injection) in right arm up by the shoulder area for covid-19 immunization (Wanted to get the vaccine to be safe from COVID). Vaccination facility type was reported as unknown. Vaccine was administered at military facility. Patient Age at Time of Vaccination in Years was unknown. Patient's medical history included hearing impairment (Additional Information for Other Conditions; She has a cochlear implant, is completely deaf. She had cochlear surgery she believes in 2012. Onset date of hearing impairment unknown), high blood pressure (Onset date unknown other than shortly after cochlear surgery), guessed she is a little bit obese (dates unspecified). AE(s) following prior vaccination were reported as 2 weeks prior to cochlear surgery she had to receive a special type of meningitis vaccine and for probably 1 week she had a 102 degree fever and swelling in her entire face. She was admitted to the hospital but they never found out why. After being in the hospital maybe by the second day she started feeling better and the swelling went down, she had no more fever; but they kept her in the hospital for a whole week. This event is why she is thinking the events after the Pfizer Covid Vaccine could be related to the Pfizer Covid Vaccine; because her reaction following the special type of meningitis vaccine was similar to the events after the Pfizer Covid Vaccine, although not exactly the same. Vaccine/Brand Name; Unknown brand name-only known as a special type of meningitis vaccine specifically for people with a cochlear implant: Lot/NDC/Expiry unknown, caller does not have this information to provide. Vaccination Date; 2 weeks prior to cochlear surgery-cochlear surgery was in 2012. Family history and relevant tests were reported as none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EW0150) NDC/Expiry: Unknown, this information is not on the CDC vaccine record card, Dose: Unknown strength/volume/dose injection to right arm, up by the shoulder area via an unspecified route of administration on 29Mar2021 at 02:45 pm at single dose for covid-19 immunization. Patient's concomitant medications included losartan from an unspecified date in 2019 to ongoing for high blood pressure, amlodipine besylate from an unknown date in 2019 to ongoing for high blood pressure. Additional vaccine administered on same date of the Pfizer product was reported as none. Prior vaccination within 4 weeks was reported as none. Consumer was calling to report side effects after receiving a dose of the Pfizer Covid 19 vaccine.  She has no MI questions at this time. No details of her side effects were given. The report was not related to a study or programme. Pfizer Covid Vaccine; Dosage previously discontinued/treatment completed. Investigation assessment; no. This consumer is the patient who called regarding Pfizer Covid Vaccine. She has been administered both the first and second doses of Pfizer Covid Vaccine. She is not sure if the events she experienced following the Pfizer Covid Vaccine are related to the Pfizer Covid Vaccine. She reported tension headaches on 21Apr2021; soreness when she eats on 23Apr2021, onset time unknown, outcome improved, she can chew food without any pain, but her left cheek is still tender to the touch.; her jaw would get tight as if it was clamping when she eats on 23Apr2021, Onset time unknown. Outcome: Consumer only able to provide that tightness in jaw has stopped, further to date and outcome details unknown.; left side of her face swelled up on 26Apr2021 when it really was noticeable. Onset time unknown other than she thinks that night. Her whole cheek on the left side swelled up; but the swelling was just in the back by the jaw where the ear was, with swelling and tightness. She noticed her face started swelling up from her jaw to the ear. She has been taking Benadryl for event. By now the swelling is going down, her whole left cheek is still swollen on left side but improved. Started improving, going down on 27Apr2021. She did not read anything about left side of her face swelled up event. Asked for further information regarding the events she experienced relative to the Pfizer Covid Vaccine. Tension headaches are gone, tension headaches started easing maybe evening of 22Apr2021 and stopped probably that same evening after taking maybe a total of 4 Tylenol that day for the Tension headaches. Outcome specifics unknown other than stopped. The reported events did not require a visit to emergency room or physician's office but she has an appointment scheduled with her doctor for this coming Saturday, 01May2021. The patient was not hospitalized. Reporter seriousness for events was unspecified. The outcome of event tension headache was recovered on 22Apr2021, pain was recovering, tightness in jaw was unknown, swelling face was recovered on 27Apr2021 and cheek swelling was recovering.   No follow-up attempts are needed. No further information is expected.