Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling, Weight, Weight increased
Clinical narrative: Muscle pain; Pain of the joints; Excruciating pain because of bad back; Total body aches and it pains like a flu; Total body aches and it pains like a flu; Gained weight; Loose stool; Feeling need to urinate and defecate; Feeling need to urinate and defecate; Rapid heartbeat; Itchy all over; Constipation; Anaphylactic reaction; Tiredness; Insomnia; This is a spontaneous report from a contactable healthcare professional (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: FL3183), via an unspecified route of administration, administered in the left arm in the morning of 31Aug2021 (at the age of 61-years-old) as dose 2, single for COVID-19 immunization. Medical history included drug allergy, allergy to chemicals, allergy to vaccine, and insect bite/sting allergy. The patient took antihistamines for previous allergies. Concomitant medication Concomitant medication included methocarbamol (ROBAXIN). The patient previously received Tetanus vaccine, and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration, administered in the left arm in the mid-day of 10Aug2021 (lot number: FA7484) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines around the time of PFIZER-BIONTECH COVID-19 VACCINE. On 31Aug2021, the patient experienced anaphylactic reaction, respiratory distress, upper airway swelling, shock, decreased level of consciousness, bilateral wheeze/bronchospasm, increased use of accessory respiratory muscles, dry cough, hoarse voice, difficulty breathing (without wheeze or stridor), sneezing, rhinorrhea, measured hypotension, generalized pruritus with skin rash, generalized prickle sensation, localized injection site urticaria, red and itchy eyes, abdominal pain, tiredness, and insomnia. The patient was not seen in the emergency department, was not hospitalized, and was not admitted to an intensive care unit. There was multiorgan involvement with the anaphylactic reaction: Respiratory - bilateral wheeze/bronchospasm, upper airway swelling, respiratory distress, increased use of accessory respiratory muscles, dry cough, hoarse voice, difficulty breathing (without wheeze or stridor), sneezing, rhinorrhea; Cardiovascular - measured hypotension, shock, decreased level of consciousness; Dermatological/Mucosal - generalized pruritus with skin rash, generalized prickle sensation, localized injection site urticarial, red and itchy eyes; and Gastrointestinal - abdominal pain. On an unspecified date, the patient experienced muscle pain, pain of the joints, excruciating pain because of bad back, total body aches and it pains like a flu, gained weight, loose stool, feeling need to urinate and defecate, rapid heartbeat, itchy all over, and constipation. Therapeutic measures were not taken as result of the events anaphylactic reaction, respiratory distress, upper airway swelling, shock, decreased level of consciousness, bilateral wheeze/bronchospasm, increased use of accessory respiratory muscles, dry cough, hoarse voice, difficulty breathing (without wheeze or stridor), sneezing, rhinorrhea, measured hypotension, generalized pruritus with skin rash, generalized prickle sensation, localized injection site urticaria, red and itchy eyes, abdominal pain, tiredness, and insomnia. The patient underwent lab tests and procedures on 29Oct2021 which included hematology and clinical chemistry both with unknown results. The outcome of events anaphylactic reaction, respiratory distress, upper airway swelling, shock, decreased level of consciousness, bilateral wheeze/bronchospasm, increased use of accessory respiratory muscles, dry cough, hoarse voice, difficulty breathing (without wheeze or stridor), sneezing, rhinorrhea, measured hypotension, generalized pruritus with skin rash, generalized prickle sensation, localized injection site urticaria, red and itchy eyes, abdominal pain, tiredness, and insomnia was recovering while the outcome of the remaining events was unknown.; Sender's Comments: Based on the temporal relationship and known safety profile of BNT162B2, the reasonable possibility of an association between anaphylactic reaction and suspect product cannot be ruled out.