Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Inappropriate schedule of product administration, Maternal exposure during breast feeding, Myalgia
Clinical narrative: been breastfeeding; arm is sore again; fever that was 101.8F; headache; muscle aches; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is sore again), PYREXIA (fever that was 101.8F), HEADACHE (headache), MYALGIA (muscle aches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Oct-2021, the patient experienced VACCINATION SITE PAIN (arm is sore again), PYREXIA (fever that was 101.8F), HEADACHE (headache), MYALGIA (muscle aches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (been breastfeeding). On 17-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, VACCINATION SITE PAIN (arm is sore again), PYREXIA (fever that was 101.8F), HEADACHE (headache), MYALGIA (muscle aches) and MATERNAL EXPOSURE DURING BREAST FEEDING (been breastfeeding) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Oct-2021, Body temperature: 101.8f (High) fever that was 101.8F.         Concomitant product use was not provided by the reporter.   ? No treatment information was provided.  CC: This case of maternal exposure during breast feeding and inappropriate schedule of product administration concerns a 25-year-old female patient with no relevant medical history who experienced non-serious expected events of headache, myalgia and vaccination site pain. The events occurred within 24 hours from the second dose of Spikevax, whereas the event of vaccination site pain occurred after both doses. Rechallenge was positive for the event of vaccination site pain since the event reoccurred after both doses whereas rechallenge for the remaining events was not applicable as the events occurred after the second dose so no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report   This case was linked to MOD-2021-355915 (Parent-Child Link). This case was linked to MOD-2021-356031 (Patient Link).   See case MOD-2021-355915 for details regarding the child case.  Reporter did not allow further contact; Sender's Comments: This case of maternal exposure during breast feeding and inappropriate schedule of product administration concerns a 25-year-old female patient with no relevant medical history who experienced non-serious expected events of headache, myalgia and vaccination site pain. The events occurred within 24 hours from the second dose of Spikevax, whereas the event of vaccination site pain occurred after both doses. Rechallenge was positive for the event of vaccination site pain since the event reoccurred after both doses whereas rechallenge for the remaining events was not applicable as the events occurred after the second dose so no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report