Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Eczema, Headache
Clinical narrative: eczema flare up, skin red, her left anterior chest was burning and itchy, skin pain; headache; on early Friday evening she ended up with joint pain that was so bad, she thought she was going to die. She said her wrist, elbows, fingers, hips, knees, every joint down to her ankles, hurt; This is a spontaneous report from a contactable nurse (patient; retired nurse) via a Pfizer-sponsored program.  A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN6201), via an unspecified route of administration in the right deltoid on 10Feb2021 at 12:35 PM (at age of 69 years old) at a single dose for COVID-19 immunization. The vaccine was administered to the patient at a convention center. The patient's medical history included eczema from 24Dec2018 and ongoing, rosacea (developed Rosacea at 65 years old), and the patient also reported that she used to be 5'4" and she lost 2 inches. She said she had a bone density test recently and was told she is 5'2". She said she objected to the measurement of 5'2", so the nurse told her to stand as tall as she can, and then the nurse noted her height as 5'2-1/2". There were no concomitant medications. There were no additional vaccines administered on same date of BNT162B2. The patient had no prior vaccinations within 4 weeks. On 12Feb2021, the patient experienced eczema flare up, skin red, her left anterior chest was burning and itchy, headache, skin pain, and "joint pain that was so bad, she thought she was going to die. She said her wrist, elbows. fingers, hips, knees, every joint down to her ankles, hurt".  The patient said she received her first COVID-19 Vaccine on 10Feb2021. She said everything was fine after she received her COVID-19 Vaccine. She didn't even have a mark on her arm where she received the COVID-19 Vaccine. The patient reported that she got the first dose of the COVID-19 vaccine on 10Feb2021 and is due to the second dose on 03Mar2021. Approximately 2 and half days later she got an eczema flare that was quite severe out of the blue since she was having eczema diagnosed since she was 67 (as reported; she is 69 today). She still has some itching and burning and she wondered if this was something that has been reported also for other psoriasis/eczema patients. She was concerned about taking the second dose since she thinks this may be caused by the vaccine as she stated that nothing has changed in her life aside the vaccination. The patient reported she takes tacrolimus for the treatment of her eczema. Also she said that she had some joint pain for a couple of days. She said 2-1/2 days later (Friday, 12Feb2021), out of the blue, she had an eczema flare up. She said she was diagnosed with eczema at 67 years old. She said Friday night (12Feb2021) into Saturday (13Feb2021) her left anterior chest was burning and itchy. She clarified her skin was really red and angry looking, and painful. She said she has not had any pain with her eczema in a long time. She said she took topical ointments and medication for the eczema flare up. She said she was surprised at the intensity of her eczema flare up. She clarified her initial diagnosis for eczema was on her left anterior chest and bra strap area, and arms. She said she has never had eczema on her face or any other part of her body. She said she was totally asymptomatic prior to getting her first COVID-19 Vaccine. She said on early Friday evening (12Feb2021) she ended up with joint pain that was so bad, she thought she was going to die. She said her wrist, elbows, fingers, hips, knees, every joint down to her ankles, hurt. She said she had a headache. She said by Sunday (14Feb2021) her joint pain and headache were gone. She said her symptoms went away so quickly. The patient asked if people reported a flare up with psoriasis or eczema after getting the COVID-19 Vaccine and if should she have any concerns about getting the second COVID-19 Vaccine shot on 03Mar2021. The patient her eczema treatment included a combination of oral and topical medications. She clarified she used more of the prescription topical lotion than the over-the-counter oral medications. She received Famotidine 10mg (clarified as Pepcid AC; NDC Number: 11673-031-65, Lot Number:  OFE2821, Expiration Date: Feb2022). Her doctor told her she could take up to 20mg of Famotidine if her symptoms were bad. She said on Friday (12Feb2021) and Saturday (13Feb2021) she took 20mg of the Famotidine until she felt her symptoms were under control. The patient also received cetirizine 10 mg (reported as generic Zyrtec; NDC Number: 11673-502-87, Lot Number: 8ME2877A, Expiration Date: Sep2022). The patient reported that she took 20mg of the generic Zyrtec for the itching. She said her doctor told her she can take up to 20mg of the generic Zyrtec, if needed for itching. She said otherwise, she would normally take 10mg generic Zyrtec, as needed. The patient also received Tacrolimus Ointment 0.1% (Protopic Ointment; NDC Number: 0168-0416-30, Lot Number: JZ8459, Expiration Date: Apr2021), applied to affected areas twice a day and Triamcinolone Acetonide Cream, 0.1% (she stated she refers to it as "TAC" Cream; NDC Number: 67877-251-80, Lot Number: Y064, Expiration Date: Oct2022). The patient reported that she uses the "TAC" Cream under her breasts where her bra sits because the "TAC" Cream is less expensive than the Tacrolimus Ointment 0.1%. She said she uses the "TAC" Cream as needed, and the "TAC" Cream keeps her skin hydrated. She said she used the Protopic Ointment (Tacrolimus Ointment 0.1%) on Friday (12Feb2021), and then switched to the "TAC" Cream. The patient has had no itching or pain since early Monday (15Feb2021). Her joint pain and headache treatment included Advil Liquid Gel 200mg (UPC Number: 305730169080, Lot Number: 56264, Expiration Date: Jun2023). She said she took a couple Advil Liquid Gels on Friday (12Feb2021). The patient reported that she switched from Tylenol to Motrin because the Motrin worked well. She clarified she meant Ibuprofen when she said Motrin. She said she calls everything Motrin when she is referring to Ibuprofen. She said she took Tylenol occasionally and never felt the Tylenol worked. She said she hasn't taken Tylenol in a long time. She said Tylenol didn't work as well as the NSAIDs. She did not have the Tylenol NDC, Lot, and Expiration Date. The patient reported that she takes Bufferin Brand Aspirin normally for pain. She said she sees someone who treats her holistically, and that person recommended the Bufferin Aspirin because it was not as damaging to the body. She said since the Bufferin Aspirin takes longer to work, she took the Advil Liquid Gel for faster pain relief.  No further details provided. The events eczema flare up, skin burning sensation, skin red, skin pain, joint pain, and headache were reported as serious - medically significant. The patient reported that she felt her symptoms were medically significant because her eczema flare up was so different from what she has ever experienced before. She said nothing had changed in her routine, and she has been in control of her eczema. She said she has had only very minor eczema flare ups. The events did not require a visit to emergency room and to physician office. The outcome of the events eczema flare up and skin red was recovering. The outcome of the events headache and joint pain was recovered on 14Feb2021. The outcome of the events skin burning sensation, skin pain, and itchy skin was recovered on 15Feb2021. The events eczema flare up, skin burning sensation, itchy skin, skin red, skin pain, joint pain, and headache were assessed by the (patient) as related to BNT162B2.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.