Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Off label use, Pain in extremity, Peripheral swelling, Sitting disability
Clinical narrative: had a temperature of 101 degrees Fahrenheit; left underarm glands were tender and swollen; left underarm glands were tender and swollen; swelling inside her mouth, lips, fingertips, and toes; swelling inside her mouth, lips, fingertips, and toes; swelling inside her mouth, lips, fingertips, and toes; generalized chills; head felt heavy; Booster; received the 3rd dose on 02Sep2021; felt dizzy walking; couldn't sit up; received the 3rd dose on 02Sep2021; left arm was sore; felt like she had a bad flu reaction; This is a spontaneous report from a contactable consumer (patient) reported for herself.A 75-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number FC3181) via an Intramuscular route of administration on 02Sep2021 at 13:00 into left arm as dose 3, single for COVID-19 immunisation. The patient was allergy to Naproxyn (Naproxen)-reactions include mouth and lips swell. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route on 13Jan2021, as dose 1, single for COVID-19 immunisation. The patient had a milder reaction of swelling inside her mouth, lips, fingertips, and toes, generalized chills, her head felt heavy, had a temperature of 101 degrees Fahrenheit, left underarm glands were tender and swollen, left arm was sore, felt like she had a bad flu reaction, felt dizzy walking, felt like she couldn't sit up with the second dose of the Pfizer Covid-19 vaccine. Concomitant medication(s) included levocetirizine dihydrochloride (XYZAL); montelukast sodium (SINGULAIR); levothyroxine sodium taken for thyroid disorder, start and stop date were not reported. On an unspecified date Sep2021, the patient experienced left arm was sore, bad flu reaction, couldn't sit up. On 02sep2021, the patient experienced Chills, dizzy and head felt very heavy around 23pm, swelling inside her mouth, lips, fingertips, and toes and not quite tingly, but not normal - 10:00. On 03Sep2021, the patient experienced Temperature of 101 degrees Fahrenheit - It escalated starting around evening around dinner time. If she got shot around 1pm, then next morning at 10:00, she noticed it. Left underarm glands swollen and tender - In the early afternoon. Left arm soreness - Within two hours of getting each shot. She had no other symptoms after first shot. The adverse event did not result Emergency Room and Physician Office visit. She had a very bad reaction to the Shingles shot. The pharmacist was aware and he felt it was a more extreme reaction that she had. She clarified that she felt it was the Pneumonia shot and she went to the pharmacy and the Shingles was with DOH. IT was one of those two. She does not have a manufacturer, lot or expiration for either. She is allergic to Naprosyn or Naproxen Onset Date: Unknown. The inside of her mouth was swollen, lips felt swollen, fingers and toes swollen, and they were hot and tingly. They were distinctly tingly. She was prescribed the Naprosyn by a doctor and took one pill. She called the pharmacist the next morning because she also takes Synthroid. She thought she had a drug reaction and he said no, it was an allergic reaction to the Naprosyn or Naproxen, and he told her not to take either the Naprosyn or Naproxen or Aleve in the future. She does not have the manufacturer, lot or expiration for either the Naprosyn or Naproxen. She now takes the generic Levothyroxine. She no longer has the brand name Synthroid to provide a lot or expiration. She is sensitive to other medications but is not allergic. No further details provided. She had a severe allergic reaction, not direct contact, it was indirect contact, to insecticide. She runs a high ANA normally and dose have some autoimmune and this was all prior to getting vaccine. When she had airborne exposure to insecticide, they were spraying trees. The wind blew it on her. The doctor's called it Mast Cell activation reaction. She had huge whelps the size of dinner plates on her body for 3 weeks. When they did ANA then, it was in the high 300's. It showed as high. She thinks it was high in the past also. She wants to find out if there is any component of the vaccine that contains the same components of Naprosyn or Naproxen. She would also like to know if she is going to get a worse reaction the next time. She tried to hold off for as long as she could and she took two Tylenol in the late afternoon on 03Sep2021 and another two at 10pm at night on 03Se2021. This reaction to the third Pfizer COVID vaccine was a greater reaction than the reaction to the second shot. It was the same but more severe. If she has to get another vaccine, she wants to know if it will be even worse. Maybe there would be something like Benadryl she could take to keep symptoms in check and not invalidate the vaccine. No additional Vaccines were administered on Same Date of the Pfizer Suspect. he had first shot and had no reaction. She had second shot and had a reaction and 7 months later had third shot and had a greater reaction than she did for the second time. Her concern is she will have to continue in the future to have vaccines. If they will get worse each time, she is considering if she is allergic to one of the components or is it just her body. She is 75 years old and in good health. On Thursday, 02Sep2021, at 1pm, she had the Third dose of vaccine and probably noticed her symptoms about 11pm. She had the chills, was dizzy, and her head felt very heavy. Her temperature is usually 97.6 degrees Fahrenheit, and after she had chills and was dizzy and could not lift head off pillow, she took her temperature and it gradually rose. The highest it got to was 101 degrees Fahrenheit. It was hovering around 100.8 degrees, 100.7 degrees and 100.9 degrees Fahrenheit. The whole thing lasted 24-26 hours. She later said 24-30 hours of symptoms. She is most concerned about this symptom. She felt like the inside of her mouth, lips, fingertips and toes were swollen and not quite tingly, but not normal. All symptoms started during the night. She first noticed at 11pm on 02Sep2021 and by 03Sep2021, towards the morning, she was feeling what she described. She noticed a little bit into it. She had vaccine on left arm and under armpit where you have glands, under arm lower down near breast on side, she felt like glands were swollen and tender. She said it is still tender. She had that after the second shot and it lasted for weeks. She cannot feel lumps. It feels mushy. It felt swollen. Because she was dizzy, she tried to drink a lot of fluids. It was a challenge to walk to to bathroom because she did not trust her balance. She felt she could not get out of bed and it felt like a really bad flu case. When reading her vaccine card, she stated that she needs to get glasses to see card. She confirmed she needed glasses prior to getting vaccine. Her first vaccine was on 13Jan2021. Her arm was sore and she noticed it a few hours after the injection. She also noticed this with each one. She had no other symptoms with the first vaccine. 2nd dose of Pfizer COVID vaccine given 03Feb2021, Lot EL9203, expiration unknown. Injected in left arm in the muscle. Third dose of Pfizer COVID vaccine given 02Sep2021. FC3181, Expiration is unknown. Injected in left arm in the muscle. The clinical outcome of the events was not recovered for left underarm glands were tender and swollen and recovering for Chills, dizzy and head felt very heavy, swelling inside her mouth, lips, fingertips, toes, had a temperature of 101 degrees Fahrenheit and unknown for other events.  Information on the lot/ batch number has been requested.  Follow-up (09Sep2021): New follow-up spontaneous report from a contactable consumer included : Age at vaccination was removed as its discrepant, Suspect details (lot number, route of administration, anatomical location, administered date for first and second dose) were updated, New events(Tenderness, booster) were added along with relevant information, Case Narrative was updated.