Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Lethargy, Nausea, Pain, Pyrexia
Clinical narrative: abdominal cramps/abdominal pain; body aches; extreme exhaustion; Vomiting; lethargic rest of day; nausea; chest pain; violent chills; shaking; pulse 83-153 bpm/rapid pulse/tachycardia/pulse 83-113 bpm; Fever 101.7; This is a spontaneous report from a contactable other health care professional (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EC3302), via an unspecified route of administration in the right arm on 02Feb2021 at 14:00 (at the age of 57-year-old), dose 2, single for COVID-19 immunisation. Medical history included allergy to vegetable leaves, plants-poison Ivey and allergy to NSAIDS. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) administered via an unspecified route of administration in the left arm on 12Jan2021 at 14:00 (at the age of 57-year-old), dose 1, single for COVID-19 immunisation and experienced fever 101.7, violent chills, nausea, pulse 83 - 113 bpm/rapid pulse, abdominal cramps, body aches, extreme exhaustion, chest pain, shaking, lethargic rest day, localized injection site urticarial, seems to have an autoimmune response, hives wrapped around her entire left ankle, ankle was swollen and not very comfortable. The patient previously took paracetamol (PCM), acetylsalicylic acid (Aspirin) and had allergy to these medications. The patient previously took the antihistamine cetirizine hydrochloride (Zyrtec) daily for allergy; metoprolol; levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. On 02Feb2021 at 20:00, the patient experienced fever of 101.7. On the same day at 21:00, the patient had violent chills, shaking, rapid pulse. On 03Feb2021, the patient had nausea ad chest pain. On 04Feb2021 at 02:00, the patient had fever and was lethargic rest of day. On an unspecified date the patient had abdominal cramps, vomiting, body aches, extreme exhaustion and a pulse rate of 83-153 beats per minute. There was multiorgan involvement of cardiovascular and gastrointestinal. The cardiovascular involvement included tachycardia and chest pain in the evening on 03Feb2021. The patient's resting pulse normally was 65 pulse and after vaccine it was 83-113 beats per minutes. The gastrointestinal involvement included abdominal pain, nausea, vomiting. The patient did not have decreased level of consciousness, no loss of consciousness, no dermatological/mucosal involvement, no generalized urticaria (hives), no generalized erythema, no angioedema (not hereditary), no generalized pruritus with skin rash, no generalized pruritus without skin rash, no generalized prickle sensation, no red and itchy eyes, and had no diarrhea. The patient did not require medical intervention for the events. The events did not require initiation of new medication or other treatment or procedure. The patient did not see in the emergency department, not hospitalized, not admitted to an Intensive Care Unit. The patient did not receive any recent vaccines for any other conditions prior to the events. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 vaccine prior to the events. The outcome of the events was recovered. The reporter considered that the COVID-19 vaccine had a causal effect to the adverse events.  No follow-up attempts are possible; No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021116136 Same reporter/patient/ product, different dose and events