Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: if the vaccine was diluted correctly, and if the vaccine was administered within the 6 hours after dilution; Itching right away on right arm at injection and bandage site; it was like the mark of the bandaid was red; This is a spontaneous report from a contactable Nurse (patient) reported for herself. A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0180, Expiration date: unknown) via an unspecified route of administration, administered in right deltoid (reported as right upper arm, deltoid) on 16Jun2021 at 10:15 am (age at vaccination was 69 years) as dose 1, single for COVID-19 immunization. Medical history included ongoing adhesive tape allergy, ongoing heart problem, ongoing blood pressure, ongoing some kind of lung problem (not really diagnosed yet, she does not have definite diagnosis. Caller clarified they are still trying to find out what's wrong with the lung problem). The patient did not have any family medical history relevant to adverse event. Concomitant medications included losartan taken for blood pressure from an unspecified start date (reported as has been taking for years) and ongoing, amlodipine taken for blood pressure from an unspecified start date (reported as has been taking for less than Losartan, but maybe 3 years) and ongoing, spironolactone taken as mild diuretic and for blood pressure from 2019 and ongoing. The patient previously she took Tetanus shot, possibly combination shot with Diphtheria in Feb2017 for immunization and experienced rash all over the body. She never had diphtheria and never had childhood vaccinations. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. The patient did not receive any prior Vaccinations (within 4 weeks). The vaccination facility type was Pharmacy. The vaccine was not administered at Military Facility. On 16Jun2021 10:15, the patient experienced itching right away on right arm at injection and bandage site. On 16Jun2021, the patient was concerned about the preparation of the vaccine, if the vaccine was diluted correctly, and if the vaccine was administered within the 6 hours after dilution, afraid she received an incomplete first dose of the vaccine and experienced it was like the mark of the band aid was red. It was reported that while she was waiting to receive the first dose, she observed the staff at Walgreen's pharmacy take things out of the fridge and draw up into the syringe, in which the vaccine was then administered. She was concerned about the preparation of the vaccine, if the vaccine was diluted correctly, and if the vaccine was administered within the 6 hours after dilution. She stated she was one of the first patients in the morning to receive the vaccine, in which she did not witness any preparation or dilution of the vaccine and only the vaccine being drawn up into a syringe. She stated that she was in the pharmacy around 10 a.m. and two other people in the pharmacy came in to administer the vaccine. She does not believe she received a valid dose. She asked if she is able to have a full sense of security that the dose she received will develop sufficient antibodies if the dose was not administered within the 6 hour window after dilution of the vaccine and was the dose still potent. She had a feeling that she received an incomplete dose, or she was afraid there was not secure for administration of first dose of the Pfizer BioNTech Covid-19 Vaccine from Walgreens. Stated it was directly taken from refrigerator, without diluting, and administered to her, and she was worried about her safety, if it was a correct administration, and the second dose was scheduled on 07Jul2021. She could see the person and what she was doing and she saw her taking the vial out of the refrigerator, putting it into syringe, and didn't see where she put the syringe, and then she had customers, and caller stated she waited about a half an hour, if not more, after she pulled the vaccine out of the vial into the syringe. And then around 1000, two other workers came to the pharmacy and one of them, came and gave her vaccination, so her concern was, does she have full sense of security that vaccine wasn't diluted that morning and was diluted the day before. She went and read instructions and read how vaccine should be diluted, the little steps you have to take, and then she understood, and didn't know that before, but vaccine should be kept only 6 hours after they puncture it and dilute it, if they have some left, and this is her concern. She did not speak to anyone at the pharmacy about her concerns with their process, and at the time she wasn't aware, it was a few days after that, when she read how the procedure goes, because it was in the back of her mind that everything seemed to go wrong, they wanted to send her to a different pharmacy, and then she was waiting for so long, and people say they come and get it as soon as they fill out the application, and she was waiting for so long. She stated another interesting thing was the pharmacist who gave her shot, gave her a card and after a while came back and asked her for the card, and brought her another card. The caller asked just in case vaccine was old, diluted day before, because it was overnight, they are not working overnight in pharmacy, so if the vaccine was more than 12 hours or even more old after diluting, does she have full sense of security that she got the first dose. Caller added maybe she shouldn't consider that she got the first dose. Caller clarified her concern is the dilution of vaccine was more than the six hours old. Right after the first dose was given to her on 16Jun2021, there was an itchiness, but she believed it came from the bandage, because it went away after the bandage was taken off. Caller stated as soon as the needle went out and he put bandaid on, she felt itching right away. She stated later on when she took the bandaid off, it was like the mark of the bandaid was red, and clarifies the itching was on the right arm in the same place as the vaccine, and it resolved some time after 11:30 when she was home, and took bandaid off and put cold towel, and it went away. She confirmed no other treatment was done. She did not believe that she received a valid dose. She asked if she was able to have a full sense of security that the dose she received will develop sufficient antibodies if the dose was not administered within the 6 hour window after dilution of the vaccine and was the dose still potent. She added maybe she shouldn't consider that she got the first dose. She stated that her only question was does she have to consider that she received the one shot. The adverse events did not required a visit to Emergency Room or Physician Office. The outcome of events Itching right away on right arm at injection and bandage site and it was like the mark of the bandaid was red was resolved on 16Jun2021.