Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Middle insomnia, Pruritus, Rash
Clinical narrative: This is a spontaneous report from a contactable nurse (patient, self-reported). A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL1284 and expiration dates : Apr2021), via intramuscular route of administration in arm right on 08Jan2021 07:00 (at the age of 58-year-old) as second dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: ED5730 and expiration date: Apr2021), via intramuscular route of administration in arm left on 18Dec2020 07:00 as first dose, single dose for COVID-19 immunisation and experienced hives and whips all over upper and lower body with severe itching to include her neck the first time, tachycardia, diarrhea, severe rash and itching from head to toes including by scalp-it was pure torture, nausea, vomiting , severe itching all over body and redness. Patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. No other vaccine were received by the patient around the time of Pfizer-BioNTech COVID-19 Vaccine. Patient did not have any history of previous allergies to specific products or any conditions indicative of an Allergy. The patient was not taking any medications prior to the event being reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional vaccines administered on same date of the Pfizer Suspect was reported as none. Patient did not receive any recent vaccines for any other conditions prior to the event being reported. On 09Jan2021 (72 hours), the patient reported that second time awaken 19 hours later only this time it stayed on her legs and by morning it had her face and body covered with rash with severe itching. The patient was treated with diphenhydramine (BENADRYL) 50mg 9-4 hours and famotidine (PEPCID) for the events. Patient was not hospitalized. On an unspecified date and reported as 'no' for the following: Multiorgan involvement, Dermatological/Mucosal, Respiratory, Bilateral wheeze/bronchospasm, Stridor, Upper airway swelling, Respiratory distress, Tachypnoea, Increased use of accessory respiratory muscles, Recession, Cyanosis, Grunting, Hoarse voice, Difficulty breathing (without wheeze or stridor, Sensation of throat closure, Sneezing, Rhinorrhea, Cardiovascular, Measured hypotension, Shock, Capillary refill time greater than 3 second, Reduced central pulse volume, Decreased level of consciousness, Loss of consciousness, Gastrointestinal, Abdominal pain and for Dry cough: Unknown. Time lag from stop date, if event occurred after cessation of treatment: First time it lasted about 4 days after vaccine second time it started earlier and; lasted about 4 days. The outcome of the events was resolved on an unknown date in Jan 2021. Causal Relationship was yes was reported by the patient. Follow-up attempts are completed. No further information is expected.