Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Somnolence
Clinical narrative: Angioedema; Shock; stridor; dry cough; Hoarse voice; Sneezing; Rhinorrhea; Dizzy; nausea; Hypotension; Weakness feeling; Generalized erythema; Generalized pruritus with skin rash; Generalized pruritus with skin rash; Diarrhoea; Vomiting; Throat closed in; the sides of the throat, down my neck , straight over my chest felt as if someone was squeezing me, chest felt heavy; Potential anaphylactic reaction; Difficulty breathing; severe brain fog; Severe chest pain hard to breath felt as if being smothered; difficult to sleep nights before as felt wired after the shot; bp slightly elevated 140/80; Became very groggy; eyes heavy, had about 3 sleep attacks; 3 sleep attacks; This is a spontaneous report from a contactable Health Care Professional (patient).   A 64-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN4206) at single dose, intramuscularly, in the left arm, on 05Mar2021 at 10:00 AM, for COVID-19 immunization. The patient also received hylan g-f 20 (SYNVISC), via an unspecified route of administration, in knee, on 04Mar2021, at single dose, for an unspecified indication. Relevant medical history included narcolepsy from an unspecified date, in 1973, cataplexy from an unspecified date, complex regional pain syndrome (CRPS) from an unspecified date, in 2003, osteoporosis from an unspecified date, gastrooesophageal reflux disease (GERD) from an unspecified date, hypertension from an unspecified date and arthritis from an unspecified date, in 2003. Concomitant medications included methylphenidate hydrochloride (RITALIN), imipramine, baclofen, atenolol, rosuvastatin calcium (CRESTOR), ezetimibe (ZETIA), imipramine hydrochloride (TOFRANIL), montelukast sodium (SINGULAIR), acetylsalicylic acid (BABY ASPIRIN) and clonidine, all taken for an unspecified indication, start and stop date were not reported. The patient reported allergy for drugs like lisinopril, spirolactone, ghb (gamma-Hydroxybutyric acid), epinephrine and all seizure type medications. The patient became very groggy, felt eyes heavy, had about 3 sleep attacks, on 06Mar2021, at 13:00. Also reported difficulty to sleep nights before as felt wired after the shot (insomnia) and bp was slightly elevated 140/80 on 07Mar2021. On 27Mar2021 at 13:00, throat closed in, felt the sides of the throat, down her neck, straight over her chest felt as if someone was squeezing her, chest felt heavy (severe chest pain hard to breath, felt as if being smothered, throat closing in severe chest heaviness). Severe brain fog. Potential anaphylactic reaction and difficulty breathing were reported. On an unspecified date, the patient experienced angioedema, shock, stridor, dry cough, hoarse voice, sneezing, rhinorrhea, dizzy, nausea, hypotension, weakness, generalized erythema, generalized pruritus with skin rash, diarrhoea and vomiting. Decrease level of consciousness and loss of consciousness were not reported. The patient underwent lab tests and procedures which included oxygen saturation: normal on 06Mar2021 and blood pressure measurement: 140/80, slightly elevated, heart rate: 99, respiratory rate: 20 on 07Mar2021. The patient was not hospitalized and was not admitted to an Intensive care unit. The patient did not have COVID prior to vaccination and the patient did not test COVID post vaccination. The patient recovered from throat constriction, chest heaviness, potential anaphylactic reaction and difficulty breathing. Clinical outcome of angioedema, shock, chest pain, stridor, dry cough, hoarse voice, sneezing, rhinorrhea, dizzy, nausea, hypotension, weakness, generalized erythema, generalized pruritus, skin rash, diarrhoea and vomiting was unknown. Outcome of the other events was reported as recovering.  Follow up attempts are completed. No further information is expected.  Follow up (26Mar2021): New information received from a contactable Health Care Professional includes: adverse events added, clinical course and case seriousness updated from non-serious to serious.   Follow-up (20Apr2021): New information received from a contactable Health Care Professional includes: medical history, concomitant medications details and additional adverse events added (Potential anaphylactic reaction and difficulty breathing added as additional adverse events).   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on known safety profile and/or temporal association, the contribution of the suspect drug to the onset of serious events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.