Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination complication, Vaccination site erythema, Vaccination site swelling
Clinical narrative: needle was put in and burned like hell and her head kind of exploded; arm was throbbing; pain rotated out everywhere after 30 minutes; burn a little regarding; incapacitated; injection site swelled and turned red; injection site swelled and turned red; non-anaphylactic reaction; nightmare; Bruise; This is a spontaneous report from a contactable consumer (patient). A 60-year-old (age at vaccination) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 22Feb2021 (lot number: EN6198; expiration date: 30Jun2021) as 1st dose, single, dose 2 via an unspecified route of administration on 15Mar2021 (lot number: EN6204; expiration date: 30Jun2021) as 2nd dose, single for COVID-19 immunisation and varicella zoster vaccine rge (cho) (SHINGRIX), via an unspecified route of administration, administered in left deltoid on 01May2021 (lot number was 9NH54 and expiration date was 14Oct2022), at an unknown, single dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient family history included shingles (caller mother had shingles). On an unspecified date, the patient experienced needle was put in and burned like hell and her head kind of exploded, arm was throbbing, pain rotated out everywhere after 30 minutes, burn a little regarding, incapacitated, injection site swelled and turned red and non-anaphylactic reaction. The clinical course of the event was reported as: caller stated that her pharmacist told her to report because she had Shingrix vaccine injection on 01May2021 and had a non-anaphylactic reaction but her reaction was epic and her pharmacist said that the company would want to know this information for the numbers related to the product. It was reported that her weight was when she was fully dressed. The caller stated for Shingrix vaccine, the needle was put in and burned like hell and her head kind of exploded and that was epic. The nurse said it did burn a little regarding the patient stating Shingrix vaccine burned upon administration; stated the nurse let her go but she wanted to stay in the store for a few minutes and it felt really awkward; her head settled down and her arm was throbbing and started screaming; stated the pain began in her lower back and her arm, head and right side of her hip and moved throughout her body and the pain rotated out everywhere after 30 minutes the pain settled down and she just had the pain in her arm. She stated the area where Shingrix was injected was almost like a baseball sized circle and was read and she had to drive to care for her parents and that made this a nightmare. She removed the band aid from the injection site because the band aid caused a bruise and the injection site swelled and she remembers taking the band aid off and not being able to put ice on it and could not bear the pain. She could not put ice or clothes on top of the injection site and could not take it. She reported her head was just killing her and it was ridiculous to had to use that arm and to lift it like a disabled arm, she would say she was incapacitated and only if forced could she do something under those conditions. She stated the injection site swelled and turned red and just continued to swell, turn red and was burning and hurting and did not go farther and was the size of a baseball. She reported that the other symptom was she had her head back down and no pain in her back anymore, no pain in her chest anymore, and no pain in her legs anymore. She stated the pain after Shingrix vaccine was localized but gave her a headache; states using that arm was insane and if she was not forced to use the arm she could not use it effectively and this was not an anaphylactic reaction and the reaction was not moving anywhere else; stated the area of the injection site is now black all around it like the nurse gave a bad vaccine but she did not do a bad job; stated she could see the dot where the Shingrix vaccine went in. Stated the indication for which she had Shingrix vaccine was that her mother had shown up with shingles and they took her to the emergency room on Sunday (as reported) with a rash that began to bubble so the caller called for her mother; stated her mother was transported to the hospital and the caller had been wearing gloves and thought it was contagious and it was shingles; states the six doctors for her mother in the ER pressed the caller to get Shingrix vaccine. Caller stated the reported reaction for Shingrix vaccine lasted 11 days and sort of calmed down and all she could see now was the red dot where the vaccine was administered; stated she was sure she would have to do Shingrix again due to her reaction and did not have an anaphylactic reaction but wanted to report this as she was told. The outcome of the events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.