Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Condition aggravated, Dermatitis, Dry skin, Erythema
Clinical narrative: Skin reaction red rash under both armpits: Caller stated the event started the first day after the first shot then still having reaction from the second shot; Skin reaction red rash under both armpits; Ears would get warm feeling very hot; after the second shot the flare up was quicker; skin is dry from being inflamed; skin is dry from being inflamed; blossoming under the armpits and they are rosy red but no blisters; hurt was always in the center of armpit not in the armpit; This is a spontaneous report from a contactable nurse (patient) via Medical information team. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 02Mar2021 14:00 (Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization. The patient previously had first dose of BNT162B2 (lot number: EM9809) on 09Feb2021 in the bicep left arm upper muscle for COVID-19 immunization. Medical history included surgery from an unknown date and unknown if ongoing. Concomitant medication included vitamin D3 taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took Miralax. The patient previously had first dose of BNT162B2 (lot number: EM9809) on 09Feb2021 in the bicep left arm upper muscle for COVID-19 immunization and Pneumonia shot and never had swelling. The patient had rosy arm pits red rash and sometimes get a reaction in ears, if it flares up and gets hot. The patient stated, "For 5 weeks I've been taking children's Benadryl. I had a quicker reaction with the second dose than I did the first one but I still had some lingering effects from the first dose when I got the second. How long do these side effects usually last?" The patient had second COVID 19 vaccine and also had first one. The first dose was on 09Feb21 and she had swelling in arm after shot and has been using a cool cloth on it and was better by the next day. The patient still feels it though and it has been five weeks. The patient tries to turn arm and can still feel it but it was not bad. A day later she had her first skin reaction which was a red rash under both armpits. The patient waited because she wanted to see what reactions she would have with second dose. The reaction from first dose happened for three weeks. The patient has been taking liquid Benadryl everyday sometimes during night and also cold wet compresses in armpits has helped with inflammation. The primary care doctor and talked to the patient to see if she should try some other medication before second shot and the nurse recommended she should not get second shot that she should see an allergist. The patient got second shot and talked to nurse there. The nurse told the patient she would have to come back at least four days after the second shot was due or it would not work together. The patient went ahead and got the vaccine and it has not been life threatening as of now. The patient saw an allergist three days after second shot. The patient had rosy red inflamed armpits and when it would flare up her ears would get warm feeling, very hot, but not anywhere else and it was just mainly bilateral armpit and then sometimes ears would get hot. The patient would take Benadryl. The physician told the patient to try to take Allegra 24 hours but the patient stated it did not work that it only worked for 12 hours and not the full 24 hours. The patient took the Allegra medication on Sunday morning and that it worked for her for about 12 hours and she knew she could not take any more Allegra but the Benadryl seemed to help. The allergist felt she made the right decision since her events are not life-threatening since it is not respiratory. The allergist saw her armpits agreed the children Benadryl was working and that she should stick with that. The patient stated, it is not going away been like this the whole time since 02Mar2021 and still having a reaction in her armpits. The patient stated after the second shot the flare up was quicker because first shot was already in system still. It was not a flare up like when someone can not eat seafood and stuff like that. The patient still has a rosy armpit. The patient has not seen her doctor since last year when she had a physical. The patient would inform her doctor about these events. The patient stated she is really blossoming under the armpits and they are rosy red but no blisters and her skin is dry from being inflamed all this time. She squeezes a rag under her armpits and that it is better during the day than at night, it is worse at night. The patient was only taking 20 mL of Benadryl in the morning and then evening before bed. The patient stated, "the first shot right at the beginning she had to take Benadryl in the middle of the night as well but got to where she was taking it 12 hours apart before second dose." The patient hopes she is not having to walk around with compresses in the summer as it is easier when it is cold and that she hopes this fazes. The patient was noticing since she had not taken a shower or hot bath this morning that she had rosy red cheeks like a rosy red U on her face. The second shot she asked the nurse to give in her back upper part of bicep in arm muscle since it was a better location and it did not swell up and it did not hurt. Caller stated the nurse the first time gave the shot like when you see people getting shots on tv they put it really high up in muscle. The patient considered the event as medically significant and that it is ongoing and has worsened. The hurt was always in the center of armpit not in the armpit. The past couple of days her skin has been dry. She has used hand cream but is afraid to put anything else on it because of reaction. Just annoying. The patient will probably put cream on it so it does not crack, it is very dry and it has not been dry like this. The patient has been putting water on at night which could have dried it out. Some days is worse than others more red. This is persisting. Soreness in arm happened right after first shot. The shot was given in the proper way but seemed like more of a reaction. The second shot is much better and that she does not feel it at all. The patient can still feel where the vaccine went in left arm. It was annoying but it does not keep her from moving her arm and it has been five weeks. Since it is not going away it is serious. The patient was not taking Benadryl in middle of day like before but it is itchy so she is going to go out in the cold and work in yard. Before first week or two she would use cool compresses all day and take Benadryl during day and then at night it petered out. The patient was hoping it will fade out eventually. The patient did not want to double up on Allegra as she is not sure what the reaction would be. The medical ingredient was Fexofenadine HCL 180mg antihistamine. The patient only took one pill as it did not work. 24 hour Allegra, 180mg antihistamine 15 tablets per box. The patient was taking Children Benadryl 20mL and would take at least every 6 six hours and was trying to hold off to now taking it 12 hours and will use cold compress if she has to. The patient usually takes Zyrtec for seasonal allergies like dust. She took no Zyrtec at all for either shots. She felt the Benadryl worked better and quicker. The patient was at the Allergist she asked what is in this vaccine like what chemical. She looked up the ingredients but did not understand. Her friend told her Polyethylene glycol was in both the Pfizer and Moderna vaccine. The patient had rosy red, inflamed armpits and when it would flare up her ears would get warm feeling, very hot, but not anywhere else and it was just mainly her bilateral armpits and then sometimes ears would get hot. The patient stated her primary care physician told her to try to take Allegra 24 hours but caller stated it did not work that it only worked for 12 hours and not the full 24 hours. The patient stated she took the Allegra medication on Sunday morning and that it worked for about 12 hours and she knew she could not take any more Allegra. The patient stated the medical ingredient was Fexofenadine HCL 180mg antihistamine. The patient stated she only took one pill as it did not work. Sample of the product was available to be returned. The packaging was sealed and intact. The outcome of the event "Ears would get warm feeling very hot" and "after the second shot the flare up was quicker" was unknown. The outcome of the rest of the events was not recovered.; Sender's Comments: Based on known safety profile, the contribution of the suspect drug to the onset of events rash and erythematous rash (allergy context) cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.