Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Skin irritation, Somnolence
Clinical narrative: nausea; insomnia; once again slightly irritated; dehydrated; chills; headache; extremely drowsy; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EN6203) via intramuscularly in arm on 05Mar2021 at 15:40 (age at the time of the vaccination 69 year) as dose 2, single for COVID-19 immunization, levocetirizine dihydrochloride (XYZAL ALLERGY 24HR, Lot number was not reported) via an unspecified route of administration from 05Mar2021 16:40 to 05Mar2021, at 5 mg, via an unspecified route of administration from 06Mar2021 to 10Mar2021, at 2.5 mg for an unspecified indication and fexofenadine hydrochloride (ALLEGRA, Lot number was not reported) via an unspecified route of administration from 10Mar2021 to 11Mar2021, at unspecified dose for an unspecified indication. Medical history included hepatitis A from 1975 to 1976 (contracted from food (Recovered)), benign ovarian cysts endometriosis (Laparoscopy (Recovered)), brucellosis from 1987 to 1993 (cured with Doxycycline), shinglesfrom 2005 to 2005 (very mild case), benign uterine polyp from 2007 to 2007 (D+C), blood pressure, osteoporosis, vaginal atrophy and vitamins. Prior vaccinations (within 4 weeks) were none. Concomitant medications included olmesartan medoxomil (BENICAR) for blood pressure, raloxifene hydrochloride (EVISTA) for osteoporosis, estradiol (ESTRACE) for vaginal atrophy, magnesium oxide for vitamins, tocopheryl acetate (VITAMIN E-400) for vitamins, vitamin d3 (VITAtaken for supplementation therapy from an unspecified start date and ongoing. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EN6201) via intramuscularly in arm on 11Feb2021 (age at the time of the vaccination 69 year) as dose 1, single for COVID-19 immunization and experienced rash developed on my inner thigh, headache and fatigue. On 03Mar2021, she consulted with an allergy/Immunology Specialist. To (Hopefully) prevent a rash from the second shot, he advised to take levocetirizine Dihydrochloride after the second shot and for an additional 6 nights. She had the 2nd shot at 4pm on 5Mar. She took 5mg of Xyzal 24 hour (Levocetirizine) one hour after the shot. No rash appeared. On 06Mar2021, the patient was extremely dehydrated in the morning, experienced chills, slight headache and extremely drowsy from the xyzal and cut the dose down to 2.5 mg for the next 4 nights (06Mar through 09Mar). She remained extremely drowsy from the antihistamine, even with the lower dose. On 09Mar2021, the patient once again slightly irritated. Although no rash visually appeared, on 09Mar the area on her inner thighs, where the rash previously appeared from the first shot, was once again slightly irritated. On the night of 10Mar, the doctor switched her to Allegra, a non-sedating antihistamine. On 10Mar2021, the patient experienced nausea and insomnia. She saw the doctor again on 11Mar. All antihistamines were discontinued due to their side effects. The doctor prescribed Mometasone Cream which she used on her inner thighs on the evenings of 11,12 and 13 Mar. So far, So good. She discontinued the use of the mometasone cream on 14Mar. although the skin remained visually clear, the skin was still slightly irritated. (more so at night, she was able to sleep). Because a hot bath or shower would worsen the irritated, she took only tepid showers. She consulted with a dermatologist on 15Apr. He confirmed that the patient should avoid hot showers and he thought that the irritation would eventually subside. By the end of April the skin was no longer irritated. In summary, the skin irritation lasted 2 half months after the rash that was caused by the first dose of the vaccine. Therapeutic measures were taken as a result of once again slightly irritated (irritability). The action taken in response to the events for levocetirizine dihydrochloride was permanently withdrawn on 10Mar2021 and for fexofenadine hydrochloride was permanently withdrawn on 11Mar2021. The outcome of the event dehydration, extremely drowsy and nausea was unknown. On 06Mar2021, the outcome of the event chills and headache recovered. On an unspecified date in Apr2021, the event once again slightly irritated recovered. The outcome of the event insomnia was recovering.  No follow-up attempts are possible. No further information is expected.