Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular, Rash morbilliform, Rash pruritic
Clinical narrative: rash throughout the whole body/ rash was the worse; she broke out in an allover body rash that was itchy; red blotches on her back; measles looking spots on her stomach; skin felt itchy; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261; Expiration Date: 31May2021) via an unspecified route, administered in Right Arm on 29Jan2021 at 11:55 (60-year-old at vaccination) as a Dose 1, single for Covid-19 immunization. The patient's medical history included ongoing Sjoegren's syndrome in late 1990s and ongoing Rheumatoid Arthritis which was diagnosed in the late 1990s. She said she would see a rheumatologist for her condition. Reported she had outpatient surgery on her wrist 15Jan2021. She said, she was put under anesthesia (she did not know the name of the medications given to her or have the NDC, Lot, and Expiration Dates) and had a nerve block. There were no concomitant medications.  Vaccination Facility Type was reported as Hospital and not Military Facility. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. The patient had not received any other vaccine within 4 weeks prior vaccination. She said that she had a couple days afterward, where her skin felt itchy, but nothing major. She said approximately 8 days later (clarified as 06Feb2021) she broke out in a full body rash. She said the rash was all over her back, chest, stomach, and limbs. She said the rash lasted for several days. She said she treated the rash and itching with Benadryl, and a topical cream. She said today her back was still itchy. She said she had no change in her diet or the laundry products she used. She said she associated her rash with the COVID-19 Vaccine. She said she read a rash could happen within 48 hours after receiving the COVID-19 Vaccine, but what she read did not say anything about having a rash a week later. She said she wonders if she should get the second COVID 19 Vaccine, and if Pfizer had anyone report having a rash a week after receiving the COVID-19 Vaccine. She stated she worked in an administrative role at a healthcare organization. Reported today she still had red blotches on her back, and almost measles looking spots on her stomach. She said only her back still itches a little bit. She said Saturday (06Feb2021), Sunday (07Feb2021), and Monday (08Feb2021) her rash was the worse. She said she had itchy, raised, red spots allover her body, including her fingers. She said her rash and itching has improved, but she had a little itchiness, particularly, on her back today. She said yesterday (11Feb2021) she didn't recall having any itchiness. She said the rash lasted for several days. Reported she took Benadryl a few times a day on Saturday (06Feb2021), Sunday (07Feb2021), and Monday (08Feb2021). She said she stopped taking the Benadryl on Tuesday (09Feb2021) because the Benadryl wiped her out (clarifying the Benadryl made her very tired and sleepy). She said she stayed in bed on Saturday (06Feb2021), Sunday (07Feb2021), and Monday (08Feb2021) because she felt so tired and sleepy from the Benadryl. Benadryl Dye-Free 25mg capsules NDC Number: 50580-228-24 Lot Number: 1795510 Expiration Date: Jul2022 Reported up until yesterday, she had used Cortisone 10 Maximum Strength Creme with Aloe, 1 percent Hydrocortisone Anti-Itch Creme, topically, on her rash. She stated she did not see a UPC/NDC Number on the product tube, and no longer had the product's outer box, providing: UPC/NDC Number: Unknown Lot Number: 20D216 Expiration Date: Apr2023. On 06Feb2021, the patient took Benadryl dye-free capsule, 25mg capsule by mouth, a few times a day (Batch/lot number: 1795510, Expiration date: Jul2022, NDC number: 50580-228-24) as treatment medication for rash and itchy. No Investigation assessment was reported. No relevant test was reported. These events did not result emergency room/ physician office visit. The patient asked if she should get her second dose. The outcome of the events red blotches on her back, measles looking spots on her stomach was unknown and the outcome of other events was recovering.  Follow-up attempts completed. No further information expected.