Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Burns second degree, Incorrect route of product administration, Paraesthesia, Pruritus
Clinical narrative: tremor; tingling; itching; Caller think it was given incorrectly. She believe it was given intradermal and not in the muscle.; Looked like burning marks on the arm; had a second degree burn after getting the second dose. It was all back. It took a while to peel up. I really got a burn; This is a spontaneous report from a contactable consumer (patient reported for herself). It was not a customer engagement Program. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0161), via an unspecified route of administration, administered in Arm Left on 16Apr2021 at 13:00 (at the age of 66-years-old), as single for covid-19 immunisation. Patient medical history (including any illness at time of vaccination) was none. Family medical history relevant to AE(s) was none. Concomitant medications included ascorbic acid (VITAMIN C ACID); variety of vitamins in it including Vitamin B6 and lots of other things. The B12 in the vitamin is 1000mcg, B6 1mg, riboflavin 0.9mg, Biotin 60mcg, Pantothenic acid 1.8mg (MULTIVITAMIN); all taken for an unspecified indication, start and stop date were not reported. she said she had the flu vaccine and had no issue. She had been taking vaccines since 1997. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8730, Expiry date: Jul 2021), via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 13:00 (at the age of 66-year-old), as single for covid-19 immunisation and experienced swelling and itching and which went away. Additional Vaccines Administered on Same Date of the Pfizer Suspect were none. Prior Vaccinations within 4 weeks were none. AE(s) following prior vaccinations were none. On 16Apr2021, at night after the vaccination, the patient started itching, tingling on 17Apr2021, tremor on 21Apr2021. She had a second-degree burn; it was all back and looked like burning marks on the arm on an unspecified date in 2021. The clinical details of the events as follows: She stated that the second shot was given on 16Apr2021 by a student, and it was given incorrectly. She believes it was given intradermal and not in the muscle. she mentioned, she was screaming when she gave her the second dose. She gave it to her through skin and It did not go into her muscle. She wanted to know if there about any information on a dose administered via intradermal. She had a second degree burn after getting the second dose. It was all back. It took a while to peel up and it really got a burn. She spoke to the pharmacy, who told her to get an antibody test to make sure she got second dose. She got the same thing tingling and tremors. She felt tingling in her feet and all over her body. The tingling was there on her head, legs, arms and hands. The tremors were worse for the first week, she got the shot. She had itching head to toe, and for which took Benadryl for 3 days and It went away after 4 to 5 days. The itching went away. The tingling was constant. The tremors were still there. The tremors were less annoying than the tingling. She stopped coffee to see if she could try to help the tingling go away. She was trying to do stuff for the nerve, and It was not helping at all. She wanted to know if there were any patients that had the same thing. She stated that she is a Respiratory Therapist. She had not seen her new doctor yet. The tingling started a day or two later. She had a little tingling on 17Apr2021 and then it was intense by 21Apr2021. She said she was walking on the floors in the kitchen, and she felt it everywhere going on. She thought she should take her blood pressure. The tremors started on 21Apr2021. She could see her arms and legs moving. She said it was crazy and It was really intense. There were non-stop tremors and tingling was annoying. It was everywhere the muscles were working. The tremors were scary. She was mentally scared. She did not think it was serious. She stated that at the beginning it was, but at this point, it was not serious. She said that she would not have taken Benadryl if it was not serious. she had itching with the first dose. She said it had to be treated, but not too much. She mentioned that she did not think the vaccine went into the muscle and It was put under the skin. It was a student giving the shot. She wondered if that was the reason, she was still having all of these symptoms. She had pictures. She took the pictures back to the place where she had the vaccine to tell them they needed to train her to give the shot in the muscle. She wanted to know if this had seen with other patients. Her previous call was regarding events after the first dose it was unusual and crazy, but she found out other people had the same thing, so she felt better. The events did not result a visit to Emergency Room and Physician Office. Patient stated that she had not had any tests. She thought this would go away. Relevant Tests were none. She stated that the tingling and the itching were medically significant. The tremors were not serious. She stated that the tingling tremors and itching were related to the vaccine. The outcome of the event itching was resolved on 20Apr2021, the outcome of events tingling and tremor was not resolved and the outcome for other events was unknown at the time of this report.