Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Fatigue, Pruritus
Clinical narrative: Fatigue; Itchiness all over her body was reported as worsened; Itchiness all over her body; Redness around her neck and right breast; This is a spontaneous report from a contactable consumer or other non-hcp. A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EN6200) via intramuscular route of administration (age at vaccination 75-year) in Left Arm on 15Feb2021 at 03:30 PM as dose 1, single for COVID-19 immunization. Medical history included acid reflux, depression, high cholesterol, allergies and sinuses, from an unknown date and unknown if ongoing; it was reported that "she has allergies and sinuses. She has acid reflux and stomach issues. She also has depression. She used to take medication for her high cholesterol, but it affected other things and she stopped it. She clarifies further her mother stopped the medication she was taking for high cholesterol and she had a lot of side effects from it. She stopped it over a year ago and the caller doesn't have any name, NDC, Lot number or expiry date for it." Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY); diphenhydramine hydrochloride (BENADRYL); both taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes flu vaccine administered on an unspecified date in Nov2020; It was reported that she had her flu vaccine in Nov 2020 within 4 weeks of COVID vaccine. On an unspecified date in Feb2021 the patient experienced redness around her neck and right breast, on 17Feb the patient experienced itchiness all over her body, on an unspecified date itchiness all over her body was reported as worsened and the patient also experienced fatigue. AE's doesn't require to visit Emergency Room/Physician Office. The caller reported that "her mother received her first dose of Pfizer's COVID-19 vaccine on Monday, 15Feb2021. Two days after, her mother started itching and turned red. Now, its spots. She started giving her Benadryl yesterday. Her mother does have some pre-existing conditions. She has allergies and sinuses, and she takes Zyrtec all the time. She is not sure if this is from the Zyrtec or what. She does not where it came from. She has been giving her mother Benadryl and the redness started to away, but she is still itching. She has itching all over her body. The caller verifies the itchiness started on Wednesday, 17Feb2021. The redness started showing Thursday or Friday. Her mother has dry skin, so she put some regular cream on it. However, she just started to put coconut oil on it since this is more mild to soothe the pain and itching. Caller confirms the redness has improved. The itchiness has not. Her mother says it's very bad. When she takes a shower, the water makes it worse. The caller explains when she did start applying the coconut oil to her mother's skin, her mother says it still hurts. When she applied it to her mother's skin, her mother said it was like a burning sensation at first, but it does make it feel better afterwards. The caller has a picture of the redness. She explains the redness is around her neck and under one of her breasts, clarified as her right breast. The itching is really bad and is all over the place. Her mother is also fatigued. The caller clarifies she has been giving her mother a 25mg capsule of Benadryl every 6 hours. However, she doesn't have it with her to provide any NDC/UPC, Lot number or expiry date. The caller verifies she told her mother to stop taking the Zyrtec. She usually takes 10mg every night for her allergies and sinuses, but she stopped it. Caller confirms she doesnt have that product to provide NDC/UPC, Lot number or expiry date from. Her mother takes other medications for her stomach. She has acid reflux and takes medications for that and takes medication for depression." The clinical outcome of the 'itchiness all over her body' was not recovered, outcome of 'redness around her neck and right breast' was recovering, while the outcome of other events was unknown.   Description of Product Complaint: Caller's mother received her first dose of Pfizer's COVID-19 vaccine on Monday, 15Feb2021. Two days after, her mother started itching and turned red. Now, its spots. Caller explains she spoke with her mother's doctor. She was told to do Benadryl. Caller confirms the redness has improved. The itchiness has not. Her mother says it's very bad. When she takes a shower, the water makes it worse. The caller clarifies she has been giving her mother a 25mg capsule of Benadryl every 6 hours. However, she doesn't have it with her to provide any NDC/UPC, Lot number or expiry date. The caller verifies she told her mother to stop taking the Zyrtec. She usually takes 10mg every night for her allergies and sinuses, but she stopped it. Caller confirms she doesn't have that product to provide NDC/UPC, Lot number or expiry date. Ethnicity information is available. Vaccination facility information is available.  Follow-up attempts are completed. No further information is expected.