Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Patient had a diagnosis of COVID-19; Lack of drug effect; Patient got sick before receiving booster shot, but she was not sure what kind of disease it was; Very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient had a diagnosis of COVID-19), DRUG INEFFECTIVE (Lack of drug effect), ILLNESS (Patient got sick before receiving booster shot, but she was not sure what kind of disease it was) and PAIN IN EXTREMITY (Very sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (since 3 years ago, under treatment with a lot of medications) and Penicillin allergy.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (Very sore arm). In October 2021, the patient experienced ILLNESS (Patient got sick before receiving booster shot, but she was not sure what kind of disease it was). On 27-Dec-2021, the patient experienced COVID-19 (Patient had a diagnosis of COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. On 16-Apr-2021, PAIN IN EXTREMITY (Very sore arm) had resolved. In October 2021, ILLNESS (Patient got sick before receiving booster shot, but she was not sure what kind of disease it was) had resolved. At the time of the report, COVID-19 (Patient had a diagnosis of COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication was reported by reporter.  It was reported that patient had no other vaccine given within 1 month prior to Moderna COVID-19 vaccine. Patient's booster dose was scheduled in Oct2021, However patient was sick and she was not aware what kind of disease it was, hence her HCP advised her to wait for few months to get the booster shot. After COVID-19 diagnosis, she was advised to wait for a few more months.  This is a spontaneous case concerning a 67-year-old female patient with a medical history of asthma and penicillin allergy, who experienced the events of COVID-19, drug ineffective, illness and pain in extremity. The event pain in extremity occurred on the same day after the second dose of mRNA - 1273 vaccine, the event illness was experienced approximately 6 months after the last dose of the vaccine. Patient had COVID-19 and the event drug ineffective was experienced a little over 8 months after the second dose of the vaccine. All the events were reported as non serious with the event pain in extremity resolving the same day, the event illness also resolved on the same month of occurrence while COVID-19 still had an unknown outcome at the time of report. The reporter's assessment was not provided.The benefit-risk relationship  of the vaccine is not affected by this report   This case was linked to MOD-2022-516772 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 67-year-old female patient with a medical history of asthma and penicillin allergy, who experienced the events of COVID-19, drug ineffective, illness and pain in extremity. The event pain in extremity occurred on the same day after the second dose of mRNA - 1273 vaccine, the event illness was experienced approximately 6 months after the last dose of the vaccine. Patient had COVID-19 and the event drug ineffective was experienced a little over 8 months after the second dose of the vaccine. All the events were reported as non serious with the event pain in extremity resolving the same day, the event illness also resolved on the same month of occurrence while COVID-19 still had an unknown outcome at the time of report. The reporter's assessment was not provided.The benefit-risk relationship  of the vaccine is not affected by this report