Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Oesophageal disorder, Paraesthesia, Productive cough, Sialoadenitis
Clinical narrative: Strangling feeling in esophagus with productive phlegm; difficulty swallowing; chest, neck, and head (eyes, sinus, ear, under the ears in neck area) pressure; extreme dryness of the mouth, throat, and intestines;; numbness and tingling of the head; numbness and tingling of the head; dizziness; shortness of breath; muscle spasms in legs and back; Strangling feeling in esophagus with productive phlegm; dehydration; weakness; hypoglycemia; left sided salivary gland infection; This is a spontaneous report from a contactable nurse (patient). A 37-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0179, Expiration date was not reported) via an unspecified route of administration, administered in arm left on 18Jul2021 at 16:00 (age at vaccination: 37-years-old) as dose 2, single for COVID-19 immunization (pharmacy or drug store). The patient medical history included hypothyroidism, gastritis, TB in right salivary gland, pneumonia, bronchitis, and influenza. The patient was not pregnant at the time of vaccination. The patient had previously taken first dose of bnt162b2 (PFIZ-ER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0179, Expiry date was not reported) via an unspecified route of administration, administered in arm right on 27Jun2021 at 16:00 (age at vaccination: 37-years-old) as dose 1, single for COVID-19 immunization and had experienced warm feeling, nausea. The patient had no known allergies. The patient concomitant medications included levothyroxine sodium (SYNTHROID); spironolactone (SPIRONOLACTONE); multivitamin. On 29Jul2021 at 19:30, the patient was hospitalized for 2 days and had experienced strangling feeling in esophagus with productive phlegm, difficulty swallowing, chest, neck, and head (eyes, sinus, ear, under the ears in neck area) pressure; extreme dryness of the mouth, throat, and intestines; numbness and tingling of the head, dizziness, shortness of breath, muscle spasms in legs and back, left sided salivary gland infection, dehydration, weakness, hypoglycemia. Therapeutic measures were taken as a result of strangling feeling in esophagus with productive phlegm, difficulty swallowing, chest, neck, and head (eyes, sinus, ear, under the ears in neck area) pressure; extreme dryness of the mouth, throat, and intestines; numbness and tingling of the head, dizziness, shortness of breath, muscle spasms in legs and back, left sided salivary gland infection, dehydration, weakness, hypoglycemia and included Decadron, Normal Saline. The patient was hospitalized for 2 days. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of the events was recovering.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Vaccina-tion failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.