Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Body temperature, COVID-19, Diarrhoea, Inappropriate schedule of product administration
Clinical narrative: Dose 1 and dose 2 from other manufacturer; COVID-19 infection; Low grade fever 99.3 F/ body temperature 99.3 F; Diarrhea; stomach cramping; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 infection), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (stomach cramping), PYREXIA (Low grade fever 99.3 F/ body temperature 99.3 F) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and dose 2 from other manufacturer) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    The patient's past medical history included COVID-19 (experienced runny nose which turned into a sinus infection (Confirmed covid-19 infection)) on 05-Dec-2021. Previously administered products included for Prophylactic vaccination: Janssen COVID-19 vaccine (COVID-19 vaccine AD26.COV 2.S)(Suspension for injection) (Dose number: 1, Batch number- 1808978 and Expiry date: 13-JUN-2021) on 01-Apr-2021. Past adverse reactions to the above products included No adverse event with Janssen COVID-19 vaccine (COVID-19 vaccine AD26.COV 2.S)(Suspension for injection).   On 28-Oct-2021, the patient received second dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 08-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL PAIN UPPER (stomach cramping). On 24-Apr-2022, the patient experienced DIARRHOEA (Diarrhea). On 25-Apr-2022, the patient experienced PYREXIA (Low grade fever 99.3 F/ body temperature 99.3 F). On 26-Apr-2022, the patient experienced COVID-19 (COVID-19 infection). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and dose 2 from other manufacturer). On 26-Apr-2022, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (stomach cramping) and PYREXIA (Low grade fever 99.3 F/ body temperature 99.3 F) had resolved. At the time of the report, COVID-19 (COVID-19 infection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and dose 2 from other manufacturer) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2022, Body temperature: 99.3 low grade fever 99.3 low grade fever. On 26-Apr-2022, SARS-CoV-2 test: result not reported COVID-19 PCR test: result not reported (waiting for the results) after received Spikevax (Dose number in series 3) and positive (Positive) COVID-19 rapid POC test ( rapid antigen) : Positive.         On 05-DEC-2021, patient experienced runny nose which turned into a sinus infection (confirmed covid-19 infection) which led to confirmed clinical vaccination failure (Dose number in series 2-Co-suspect Janssen COVID-19 vaccine). His past lab data included COBID-19 test negative.  No concomitant and treatment medications were reported.  Causality for Co-suspect Janssen COVID-19 vaccine was reported as possible. The other manufacturers case (20220452890) was associated with product quality complaint: 90000228220.  Company Comment: Company comment: This is a spontaneous case concerning a 33-year-old male  patient with previous history of COVID-19 on December 2021, who experienced the non-serious unexpected event of COVID-19 (AESI), approximately 16 after receiving third dose of COVID-19 vaccination with mRNA-1273 vaccine (two previous doses with ad26 Janssen covid-19 vaccine). Patient had abdominal pain upper, diarrhoea and pyrexia and a  SARS-CoV-2 test was performed with  a positive result. Further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 33-year-old male  patient with previous history of COVID-19 on December 2021, who experienced the non-serious unexpected event of COVID-19 (AESI), approximately 16 after receiving third dose of COVID-19 vaccination with mRNA-1273 vaccine (two previous doses with ad26 Janssen covid-19 vaccine). Patient had abdominal pain upper, diarrhoea and pyrexia and a  SARS-CoV-2 test was performed with  a positive result. Further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.