Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Contracted COVID; Soreness in her arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm) and COVID-19 (Contracted COVID) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 004PWA, 039K20A and 039K20-2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shots. Past adverse reactions to the above products included Pain in arm with Flu shots.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced COVID-19 (Contracted COVID). On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in her arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness in her arm) and COVID-19 (Contracted COVID) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: (Positive) Positive.         Patient had no allergies.  No concomitant medications were provided.  It was reported that the symptoms improved.  It was reported that treatment maybe Tylenol for soreness, but reporter was unsure if patient took it.  Company Comment:  This is a spontaneous case, reported by a patient family member, concerning a 75-year-old female patient with no medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 supported by a positive SARS-CoV-2 test, which occurred a month after receiving the 2nd booster/4th dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine, with adverse event of pain in extremity, given at an interval of 28 days, approximately 7 months and 1 week prior to third mRNA-1273 vaccination and approximately 15 months prior to fourth mRNA-1273 vaccination. The patient also experienced soreness in her arm after receiving all doses of the Moderna COVID-19 vaccine. No further details about the clinical course and treatments for COVID-19 were provided. It was reported that treatment maybe Tylenol for soreness, but reporter was unsure if patient took it. It was reported that the events have resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to (Patient Link). Sender's Comments: This is a spontaneous case, reported by a patient family member, concerning a 75-year-old female patient with no medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 supported by a positive SARS-CoV-2 test, which occurred a month after receiving the 2nd booster/4th dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine, with adverse event of pain in extremity, given at an interval of 28 days, approximately 7 months and 1 week prior to third mRNA-1273 vaccination and approximately 15 months prior to fourth mRNA-1273 vaccination. The patient also experienced soreness in her arm after receiving all doses of the Moderna COVID-19 vaccine. No further details about the clinical course and treatments for COVID-19 were provided. It was reported that treatment maybe Tylenol for soreness, but reporter was unsure if patient took it. It was reported that the events have resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.