Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Dysphagia, Heart rate, Hypoaesthesia, Oxygen saturation
Clinical narrative: Tachycardia; Numbness; Tingling in her mouth; Feeling of congestion in the back of her throat/throat congestion; She was able to talk in complete senses but was not able to swallow; She has been on pantoprazole but that was not working for her, so she switched to Pepcid; This is a spontaneous report from a contactable physician, based on information received by Pfizer. This case was received on 24-Mar-2021 (reference number: 5796050). This spontaneous case was reported by a physician and describes the occurrence of DRUG INEFFECTIVE (She has been on pantoprazole but that was not working for her, so she switched to Pepcid), TACHYCARDIA, HYPOAESTHESIA (Numbness), PARAESTHESIA ORAL (Tingling in her mouth) and RESPIRATORY TRACT CONGESTION (Feeling of congestion in the back of her throat/throat congestion) in a 34-year-old female patient who received Pantoprazole unk (batch no. Unknown) for an unknown indication. The occurrence of additional non-serious events is detailed below. Co-suspect product included COVID-19 VACCINE unk (batch no. Unknown) for COVID-19 immunisation. Previously administered products included for Depression: Meloxicam. Concurrent medical conditions included Gastritis. On 18-Mar-2021, the patient started COVID-19 VACCINE (unknown route), at an unspecified dose and frequency. On an unknown date, the patient started Pantoprazole (unknown route), at an unspecified dose and frequency. On an unknown date, the patient experienced DRUG INEFFECTIVE (She has been on pantoprazole but that was not working for her, so she switched to Pepcid), TACHYCARDIA, HYPOAESTHESIA (Numbness), PARAESTHESIA ORAL (Tingling in her mouth), RESPIRATORY TRACT CONGESTION (Feeling of congestion in the back of her throat/throat congestion) and DYSPHAGIA (She was able to talk in complete senses but was not able to swallow). At the time of the report, DRUG INEFFECTIVE (She has been on pantoprazole but that was not working for her, so she switched to Pepcid) and DYSPHAGIA (She was able to talk in complete senses but was not able to swallow) outcome was not reported and TACHYCARDIA, HYPOAESTHESIA (Numbness), PARAESTHESIA ORAL (Tingling in her mouth) and RESPIRATORY TRACT CONGESTION (Feeling of congestion in the back of her throat/throat congestion) was unchanged. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: heart rate was 130 so had tachycardia, the oxygen level was normal, no shortness of breath or chest pain. Pantoprazole (Unknown) was withdrawn on an unknown date. The action taken with COVID-19 VACCINE (Unknown) was not reported. For Pantoprazole (Unknown), the reporter did not provide any causality assessments. For COVID-19 VACCINE (Unknown), the reporter did not provide any causality assessments. Patient did notify the staff who provide with the vaccination. Patient was provided with Benadryl 50 mg, the symptoms improved, went home but when patient returned home developed numbness and tingling in the back of throat, throat congestion and reported to the urgent care where again they gave Benadryl, Claritin and they told patient to follow and prednisone 50 mg for five days, patient returned home again tachycardia continued, numbness and tingling, feeling of throat congestion continued. Patient called the urgent care, they recommended starting Albuterol nebulizer and following up with primary care. Patient was taking pantoprazole but when was put on prednisone gastritis got worst; had to put pantoprazole to Pepcid. Reporter Comment: The reporter's causality assessment was not reported for the events with pantoprazole and COVID-19 vaccine therapy. Company Comment: This is non-serious case report.  Pfizer is a Marketing Authorization Holder in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder has submitted the same report to the regulatory authorities.; Reporter's Comments: The reporter's causality assessment was not reported for the events with pantoprazole and COVID-19 vaccine therapy.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product Pantoprazole  to the development of event Lack of drug effect cannot be excluded. Lack of drug effect is considered unrelated to the suspected drug of BNT162B2. A possible contributory role of both suspect products to the development of the other 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.