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Life Threatening? Yes
Write-up: Anaphylactic shock; the patient began to cramp; Tachycardia; Hypotension; Decreased level of consciousness; Capillary refill time $g3 s; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. A 16-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 04Jun2021 (Batch/Lot Number: FC8889) as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 04Jun2021, seven minutes later, the patient developed Anaphylactic shock with Depressed level of consciousness, hypotension, Poor peripheral circulation and Tachycardia and the patient developed cramps. The ADRs were by the reporter reported as life threatening and the patient was given 0.3 mg adrenaline IM which was repeated 5 minutes later as the patient consciousness level again began to be affected and the patient began to cramp. The ADR Anaphylactic shock was recovered 04Jun2021 after 5 hours. Test results 04Jun2021 included: Blood pressure: min. 60/40 mmHg, max. 60/40 mmHg. Outcome of Depressed level of consciousness, hypotension, Poor peripheral circulation, Tachycardia and cramps was recovered 04Jun2021. SKIN AND MUCOUS MEMBRANE SYMPTOMS: None; AIRWAY SYMPTOMS: None; CARDIOVASCULAR SYMPTOMS: INCLUDED: Hypotension, Tachycardia, Capillary refill time $g3 s, Decreased level of consciousness NOT INCLUDED: Reduced central pulse volume, Loss of consciousness; GASTROINTESTINAL SYMPTOMS: None; No follow-up attempts possible. No further information expected. Information about batch number has been obtained.
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