Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Insomnia, Lymphadenopathy, Pain in jaw, Swelling face
Clinical narrative: lower jaw started to swell; underneath her earlobe got as big as a ball.; her jaw and the bulge were still hurting; I could not sleep at night to turn over; swollen lymph nodes; This is a spontaneous report from a contactable Consumer or other non-HCP (patient reported for herself). An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6198 and Expiry Date of Pfizer COVID 19 vaccine: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 at 15:50 (at the age of 80-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Additional vaccines administered on Same Date of the Pfizer Suspect was none. Medical history included allergic to codeine, allergic to bee stings and something else that she cannot remember. Patient had no medical history (including any illness at time of vaccination). Family History include daughter was allergic to sulfa. The patient concomitant medications were not reported. No Prior Vaccinations (within 4 weeks). History of all previous immunization with the Pfizer vaccine considered as suspect was none. On 06Mar2021, the patient experienced lower jaw started to swell and underneath her earlobe got as big as a ball. On an unspecified date in Mar2021, the patient experienced swollen lymph nodes and jaw and the bulge were still hurting. The clinical details of the events included: Consumer stated she went to one of your wonderful clinics on 04Mar2021; it was Thursday. Clarified she received the first dose of Pfizer COVID 19 vaccine 04Mar2021 at 15:50 PM in the left arm. By the weekend her jaw had swollen her ear lobe, she could not sleep at night to turn over and noticed a huge lump underneath her ear. After reading the Fact Sheet for vaccine recipients she considers it is a swollen lymph none. Then on Saturday or Sunday caller reported her lower jaw started to swell and underneath her earlobe got as big as a ball. She thought maybe she had a spider bite from working in the yard. (name) on Monday she went to see her doctor at the (clinic name). She saw (name). (name) she told the doctor three or four times she had the first COVID shot. The doctor could not tell anything was wrong and advised her to take Advil several times a day and put cold on it. She cannot remember how often she was to take Advil. The following days her jaw and the bulge were still hurting. (name) on Thursday, her girlfriend called and said the caller did not seem like herself and said did you read the paperwork they gave you at the clinic with the shot. She read it with her friend and at the very bottom it says swollen lymph nodes can be a side effect; her friend said that is what is wrong with you. She went back to the doctor on Friday with the paper and told them; she thinks she has swollen lymph nodes; that was what was wrong with her. Added she is 80 and very active and works in the lawn 5 hours a day. Now she was asking should she get the next dose and if she does not get it will she still be protected. She did take Advil and use the cold compress and yesterday her jaw was down to normal. The bulge was not hurting but she was unsure if it is totally gone; it was better today. She was scheduled to receive the second dose on 25Mar2021 at 1450. Restated she is wondering if she should be doing it again. Her children told her not to get the second dose and mentioned that she must be allergic to something in the vaccine. Added that she is allergic to bee stings and something else that she cannot remember. Mentioned that she was really kind of mad that the doctor at the clinic was not aware of the side effects of the vaccine and if her friend had not called, she would have never known. Next Monday she went to clinic was recommended to ice it and to take Advil. The AE(s) did not require a visit to physician or ER. Relevant tests were none. After reading the Fact Sheet for vaccine recipients she considers it was a swollen lymph node. Her next COVID-19 vaccination is scheduled for 25Mar2021. The patient was allergic to codeine, but considers she is overall a very active patient and does not have other medical conditions. Per EUA PI/Contraindications (LAB-1457-6.0, revised 01/2021) explained that a swollen lymph node after the 1st vaccination is not listed as a contraindication to the 2nd COVID-19 dose. Was referred to her doctor for individualized recommendations, they are the most familiar with her clinical history and may offer additional guidance. There was no Investigation Assessment. The patient outcome of the events lower jaw started to swell as resolved on 14Mar2021, the outcome of underneath her earlobe got as big as a ball was not resolved and the outcome of the other events was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.