Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Hypotension, Off label use, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; BLOOD PRESSURE 80/40; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned an 83 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-hodgkin lymphoma (was immuno- compromised, that overproduces IGM, which is why he can't take any mRNA vaccines, "because they increase IGM), and other pre-existing medical conditions included: The patient was bedridden for different issues. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 1708609 and expiry: UNKNOWN) dose was not reported, 1 total, primary dose administered in right arm on 23-MAR-2021 for covid-19 prophylaxis.  On an unspecified date in NOV-2021 following vaccination with primary dose of covid-19 vaccine ad26.cov2.s, the patient had covid-19 with symptoms of coughing with no temperature, no trouble breathing, no pneumonia and tested positive for COVID-19 virus test on 08-NOV-2021 (confirmed covid-19 infection and confirmed clinical vaccination failure) (Dose number in series: 1). It was also reported that patient was home quarantined for 5 days (Date unspecified). On an unspecified date in 2021, the patient experienced COPD (Chronic obstructive pulmonary disease) (Dose number in series 1) and had received treatment with Doxycycline.  The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: 213D21A and expiry: UNKNOWN) dose was not reported, 1 total, first booster administered in right arm on 07-DEC-2021 for covid-19 prophylaxis.  On an unspecified date in FEB-2022 following vaccination with covid-19 vaccine ad26.cov2.s (first booster), the patient experienced diarrhea and viral infection with no temperature, no trouble breathing, and tested positive for COVID-19 virus test which was confirmed covid-19 infection and confirmed clinical vaccination failure (Dose number in series: 2). Laboratory data included: COVID-19 virus test Positive. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin not reported, batch number: 213D21A expiry: UNKNOWN) dose was not reported, 1 total, second booster administered at right arm on 02-AUG-2022 for covid-19 prophylaxis which was associated with Off label dosing frequency. Age at time of vaccination 83 years old. Concomitant medications included influenza vaccine for prophylactic vaccination. On 17-AUG-2022, the had the symptoms of diarrhea, temperature, vomiting, went in to the ER where his blood pressure 80/40 and was hospitalised from 17-AUG-2022 to 19-AUG-2022 (Dose number in series 3). The covid-19 virus test was found as positive and had confirmed covid-19 infection  (Dose number in series 3). The patient was discharged on 19-AUG-2022 with two days of hospitalization.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection, Off label dosing frequency and blood pressure 80/40 was not reported. This report was serious (Hospitalization Caused / Prolonged).  This case, involving the same patient is linked to 20221045009 and 20211208454.; Sender's Comments: V0: 20221046895-covid-19 vaccine ad26.cov2.s-confirmed covid-19 infection. The event(s) is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event(s) is considered not related.  20221046895-covid-19 vaccine ad26.cov2.s-blood pressure 80/40. The case causality is considered NOT RELATED. Rationale: Concurrent event of covid 19 infection with sign/symptoms of diarrhea and vomiting provide more plausible explanation