Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Inappropriate schedule of product administration, Pruritus, Rash
Clinical narrative: rash all over the body; Itch; felt like she was near a flame; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). An 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP6955), second dose via an administered in left arm on 24Mar2021 at 13:50 (at the age of 84-year-old) as dose 2, single for COVID-19 immunisation. No medical history was not reported. No investigation assessment was reported. No relevant family medical history. No relevant lab test was reported. Concomitant medications included aliskiren fumarate, hydrochlorothiazide (TEKTURNA HCT) taken for hypertension from an unspecified start date and ongoing; glimepiride (GLIMEPIRIDE) taken for diabetes mellitus from an unspecified start date and ongoing; labetalol hydrochloride (LABETALOL HYDROCHLORIDE) taken for blood pressure measurement from an unspecified start date and ongoing; levocetirizine (LEVOCETIRIZINE) taken for chronic obstructive pulmonary disease from an unspecified start date and ongoing; montelukast sodium (MONTELUKAST SODIUM) taken for chronic obstructive pulmonary disease from an unspecified start date and ongoing; prednisone (PREDNISONE) taken for polymyalgia rheumatica from an unspecified start date and ongoing; dulaglutide (TRULICITY) taken for blood glucose abnormal from an unspecified start date and ongoing. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6204, Expiry date: 30Jun2021), first dose via an administered in left arm on 04Mar2021 at 13:50 (at the age of 84-year-old) as dose 1, single for COVID-19 immunisation, Demerol and experienced blood pressure decreased 8 to 10 years ago. Report is not related to a study or programme. No vaccine administered at military facility. No additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In the middle of the night on 26Mar2021, the patient experienced rash all over the body, itch, felt like she was near a flame and inappropriate schedule of vaccine administered on 24Mar2021. Adverse events did not require a visit to emergency room and require a physician visit, she saw the doctor twice, first on 01Apr2021 or 08Apr2021; and then again on Tuesday 20Apr2021 for the rash and itch. Consumer called regarding the Pfizer-BioNTech COVID 19 vaccine. Stated she wanted to report a bad side effect. Reports she received the first dose on 04Mar2021 at 13 :50 in the left arm. She received the second dose 24Mar2021 at 13:50 in the left arm. She has a terrible rash all over her body, legs, arms, chest, back and a bad itch. States she has been going out of her mind with the itch. Added she saw the doctor and he prescribed Mometasone Furoate 1% cream, but it was not correcting the itch. Provides lot number AB71762; expiration date Jun2022; NDC She still has the rash all over her body today. States she went to the doctor on 20Apr2021, and she went before that, but she does not remember the date. Later clarified she thinks she saw the doctor on 01Apr2021 or 08Apr2021. She got the rash in the middle of night going from Friday to Saturday 26MAR2021. She woke up like she was next to a flame like a fireplace; she has a terrible itch and she scratched; it looked like little pimples; in the morning it had multiplied; her skin was very red and looked like a piece of meat; you could see these little dots and they are still there on her legs and arms. She thought maybe she ate something. It was getting so bad all over, just raw looking pimples. Her niece and nephew told her to go to the doctor. That Saturday morning it started; it was not all over but now it is all over. At first, she looked, and it was like a mosquito bite, so she scathed it and when she woke up that one spot that was an inch by inch was grown to eight by eight and it is red, light-pink reddish, like a raw piece of meat. Adds when she got the vaccination, she told them she was allergic to Demerol. She has no product to provide NDC, lot or expiration date for Demerol. Reports when she was in ER, they gave her a Demerol injection and her blood pressure went down very fast or low she does not remember. The doctor told her not to take it because it dropped her blood pressure. This was 8 or 10 years ago. Product: Pfizer COVID 19 vaccine; treatment first dose 04Mar2021/second dose 24Mar2021; provides lot number and expiration date from vaccination card but does not see NDC. Lot number for first dose is EN6204. They gave her the papers and it says what is inside the vaccine, the terminology is medical, and she does not understand it. She does not know if there is something that she is allergic to in the vaccine. Consumer reported an adverse event for the Pfizer BioNTech COVID 19 vaccine mentions she saw the doctor and he prescribed Mometasone Furoate 1% cream, but it is not correcting the itch. Provides lot number AB71762; expiration date Jun2022; and NDC. Product strength and count size dispensed: 1%. Sample of the product was available to be returned. The events rash all over the body, itch was treated. The outcome of the event was reported as not resolved.  No follow-up attempts are needed. No further information is expected.