Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cough, Oral disorder, Rash
Clinical narrative: Itchiness and bumps on Tuesday morning on her face neck and ears; itchiness and bumps on Tuesday morning on her face neck and ears; Dry cough; Patches of bumpy skin that itch; This is a spontaneous report received from a contactable consumer. A 67-year-old female patient received first dose of bnt162b2 (BNT162B2; Formulation: Solution for injection; Lot number: EN6199), via unspecified route of administration on Left arm on 22Mar2021 at single dose for covid-19 immunization. It was reported that Got the Pfizer 1st covid 19 vaccine on Monday experienced itchiness and bumps on Tuesday morning on her face neck and ears. Took Benadryl and when woke up was better but still has small patches and bumps took hydrocortisone cream and Allegra. Concerned about getting the 2nd shot. Anything I should do or i should not get the 2nd dose. Response: Spoke from Sponsor PI section 5 warnings and precautions 6 overall safety summary and cons. The seriousness was reported as non-serious. Upon follow up on 31Mar2021, Caller stated she received the COVID 19 vaccine a week ago today, 22Mar2021. Caller stated she was calling to report that when she received the shot around 11:30 or 12 Monday morning she seemed fine and then that night or morning she woke up around 4:30 Tuesday morning scratching in her sleep so bad, her chest, neck, face, ear horrible itch and she got up to look in the mirror thinking she had a rash. Caller stated she did not see any visible rash but she could feels bumps so she took Benadryl and went back to sleep. Caller stated in the morning she was still a little itchy and she has been taking Allegra during the day for the patches of bumpy skin that itch and Allegra seems to be helping and she has taken Cortisone cream to help with the itching. Caller stated the symptoms have started to get less but she is still experiencing symptoms a week after getting vaccine. Caller stated she was apprehensive about getting the second vaccine and wanted to know if this agent knew what she should do? Caller stated the doctor does not know anything about her symptoms and nothing about the COVID 19 vaccine that they are completely ignorant. Caller stated she does not think she will get the second vaccine because she is afraid the second one might make her sick. Caller stated she would like to be transferred to Clinic and she will tell them what is going on. Caller stated she has also started experiencing a dry cough since all this happened of getting the vaccine. Caller stated she is really concerned about the vaccine card showing the first vaccine but nothing for the second vaccine and she does not want it to be not valid but she is not sure. Dry cough: Caller stated this started earlier this week and that it is still going on since she just coughed. Caller stated that it has been about the same. Patches of bumpy skin that itch: Caller stated it started when she was scratching at 430 in the morning in her sleep and that it is still ongoing but not as bad. Caller stated that there is a patch on her left elbow and sporadically all around she runs her finger over it and feels bumps under it. Caller stated she took Benadryl and Allegra which seems to help. Caller stated in the morning she takes Allegra and it seems to be going away and thinks the antihistamine is helping. Caller stated she was going to go up there to the facility on 13Apr2021 for her second dose and tell them she does not want it because she had an allergic reaction and hopes they will mark the card that she showed up. Caller stated she is worried about in the future and it may cause a lot of problems not getting the second dose. Caller stated she is worried if she gets the second shot she might start swelling up or God knows what. Indication COVID 19 vaccine - Caller stated she received a notice from Well Star which is the healthcare providers around the area she lives and was scheduled to get one since the facility scheduled it for her. Caller stated she thought long and hard whether she wanted to get the vaccine as she was weary to get something that was not tested and she was proven that she should have waited as she is afraid she might itch the rest of her life. Treatment: Caller stated she took Benadryl when she woke up at night and then Allegra which has seemed to help since Benadryl puts her to sleep. Benadryl: Caller declined having the NDC, lot number, expiry. Caller stated she took children Tylenol liquid since she keeps it on hand in case her dog gets stung by a bee and since she was itching to death she took a cup full of Liquid Benadryl for relief. Caller stated it was embarrassing that she took something that she gives to her dog. Concomitant Products: Caller stated she has been on the same medications for blood pressure and thyroid been on for years and has had no issues. Caller stated that there is nothing new or different from the last couple of months. At 11:30 or 12:00 time the vaccination was given. Vaccination facility type was at hospital. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered. Adverse events do not require a visit to emergency Room nor physician office. There are no prior Vaccinations within 4 weeks. No AE(s) following prior vaccinations. The outcome of events was "Unknown".  Follow-up (29Mar2021): New information received from a contactable consumer: New clinical information (Product details, and new adverse event information) added.  No follow-up attempts are needed. No further information is expected.