Age: 60.0
Sex: F
Vaccine: COVID19, UNK, UNK, UNK, UNK, UNK
Symptoms: COVID-19, Immunisation reaction, Malaise, SARS-CoV-2 test
Clinical narrative: She reacted badly to all of the Moderna Covid 19 vaccines; she was laid out for a week with the reaction; Tested positive for Covid 19 after being fully vaccinated with Moderna Covid 19 Vaccines and 2 Boosters; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (She reacted badly to all of the Moderna Covid 19 vaccines), MALAISE (she was laid out for a week with the reaction) and COVID-19 (Tested positive for Covid 19 after being fully vaccinated with Moderna Covid 19 Vaccines and 2 Boosters) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 058F21A, 038B21A and 044A21A) for COVID-19 prophylaxis.    Co-suspect products included non-company products METFORMIN HYDROCHLORIDE (METFORMIN ER) for an unknown indication, GABAPENTIN for an unknown indication, ROSUVASTATIN for an unknown indication, DIAZEPAM for an unknown indication and LISINOPRIL for an unknown indication.    The patient's past medical history included Stroke (11 Years Ago).   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started METFORMIN HYDROCHLORIDE (METFORMIN ER) (unknown route) 500 milligram once a day, GABAPENTIN (unknown route) 300 milligram three times a day, ROSUVASTATIN (unknown route) 5 milligram once a day, DIAZEPAM (unknown route) 5 milligram three times a day and LISINOPRIL (unknown route) 10 milligram once a day. On an unknown date, the patient experienced IMMUNISATION REACTION (She reacted badly to all of the Moderna Covid 19 vaccines), MALAISE (she was laid out for a week with the reaction) and COVID-19 (Tested positive for Covid 19 after being fully vaccinated with Moderna Covid 19 Vaccines and 2 Boosters). At the time of the report, IMMUNISATION REACTION (She reacted badly to all of the Moderna Covid 19 vaccines) and COVID-19 (Tested positive for Covid 19 after being fully vaccinated with Moderna Covid 19 Vaccines and 2 Boosters) outcome was unknown and MALAISE (she was laid out for a week with the reaction) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient was recently prescribed with Paxlovid for event COVID-19 and had not yet started taking it because she wanted to make sure that there were no interactions with her five medications (Diazepam, Gabapentin, Metformin, Lisinopril and Rosuvastatin) and Paxlovid. The patient thought she had another stroke since she had reacted badly to all the Moderna doses and was laid out for a week with the reaction. Stated she did not want to take Paxlovid if it was going to make her sick.  Treatment medications for events she reacted badly to all of the Moderna Covid 19 vaccines and she was laid out for a week with the reaction was not reported.  Company comment- This spontaneous case concerns a 61-year-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred at an unknown time after vaccination with a fourth dose of mRNA-1273. The patient was prescribed with paxlovid but hasn't taken it.  Outcome of the events was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 61-year-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred at an unknown time after vaccination with a fourth dose of mRNA-1273. The patient was prescribed with paxlovid but hasn't taken it.  Outcome of the events was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.