Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oral candidiasis, Pain in extremity, Product administered at inappropriate site, Skin tightness, Swelling face
Clinical narrative: Developed candida on her tongue; white blood cells were elevated; extreme face swelling; extremely painful lymph nodes in her neck due to swelling; Enormous fatigue; energy is still not normal; was only having some leg pain; she got the shot in her thigh; became hard to swallow; the skin is very tight; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0177; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in Thigh Left on 01Jul2021 at 15:00 as dose 1, single (at the age of 59-years-old) for COVID-19 immunization. The past Medical history included ongoing ileostomy from 1997; ongoing Delta Granule Storage Pool Deficiency, diagnosed about 3-4 months ago. In Feb2021, patient had the 1st shingles vaccine, but it was applied incorrectly so she had bursitis after that. She does not have the Lot/NDC/Expiry to provide. Concomitant medications included omeprazole (PRILOSEC [OMEPRAZOLE]) taken for gastric disorder from an unspecified start date and ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19 and not received any other vaccine within 4 weeks. It was reported that after the 1st dose of vaccine the patient was okay the first day and started having a terrible reaction. On 01Jul2021, patient was only having some leg pain the evening same day and the day after because she got the shot in her thigh. It was reported patient did yoga stretches on (02Jul2021) Friday the 2nd, and the leg pain was gone by the 3rd (03Jul2021); and stated until 03Jul2021 around 15:00 she felt great. But then exactly 48 hours later after vaccination, On 03Jul2021 at 15:00, patient had extreme face swelling and pain in the lymph nodes in her neck and also had Enormous fatigue. States that she walked 7 miles the morning of 03Jul2021, then by the afternoon around 3pm it felt like she hit a brick wall. There were about 3 days where she could not move. States that her energy is still not normal; she is still very tired. On Saturday, 03Jul2021, it felt like a switch was turned and her life was changed. The swelling in her face and lymph nodes got so bad in her face and neck that it was extremely painful and became hard to swallow, so her husband took her to the ER on 04Jul2021. She saw her Hematologist on 05Jul2021 (Monday) and told her that her white blood cells were elevated and No treatment received and also she Developed candida on her tongue. States that she is on her 3rd medication to get rid of it, but it is still the same. States that the problem now is that the face swelling is not going down. She still has very big cheeks and pain in her lymph nodes. Patient visited Immunologist on 12Jul2021 due to the continued swelling and pain in her face and lymph nodes. She saw an Immunologist by video call, who she also saw before she got the shot, but he doesn't know what to do. He told her that he has never seen a reaction to the Pfizer vaccine like this before. Caller states that this is very painful because of the swelling in her neck, the skin is very tight, like she has ping pong balls in her cheeks, and she is having to hold her neck because the lymph nodes there are swollen and always hurt. States that she is a teacher and must talk a lot and it always hurts. States that it's been 12 days, it's not getting any better and she is miserable; she cries all the time. She doesn't know how to get her face back and not have this pain. States that she is on her 3rd medication to get rid of it, but it is still the same. She was supposed to get the 2nd dose on 23Jul2021, but her doctors don't think she should get it because of the reaction she has had to the 1st dose. The patient underwent lab tests and procedures which included blood test: wbc elevated on 05Jul2021. Events resulted in Emergency Room and Physician Office visit. Therapeutic measures were taken as a result of developed candida on her tongue (oral candidiasis). The event outcome recovered for Leg pain on 03Jul2021, Unknown for Drug administered at inappropriate site and white blood cells were elevated and Not recovered for rest of the events.  Follow-up attempts are completed. No further information is expected.