Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Fatigue, Head injury, Headache, Maternal exposure during breast feeding
Clinical narrative: exhaustion; I fell backwards and my head hit the rug which was on top of the carpet; I also hit my head two nights ago (November 16th at 2:00am) by collapsing from exhaustion after my daughter did not want to stay in her crib; Headache; maternal exposure via breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (exhaustion), FALL (I fell backwards and my head hit the rug which was on top of the carpet), HEAD INJURY (I also hit my head two nights ago (November 16th at 2:00am) by collapsing from exhaustion after my daughter did not want to stay in her crib) and MATERNAL EXPOSURE DURING BREAST FEEDING (maternal exposure via breastfeeding) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination.     The patient's past medical history included Surgery (Surgery done on Hemangioma on scapula) in March 2019. Previously administered products included for an unreported indication: TDAP (Tdap (Adacel) vaccine given intramacularly on right deltoid.) on 22-Mar-2021. Concurrent medical conditions included Obsessive-compulsive disorder (I may need to increase my Zoloft Rx to manage my worsening anxiety) since 01-Jun-2021, Anaemic (Anaemic due to Hemangioma.), Hemangioma (Hemangioma on left breast and armpit untouched.), Venous malformation NOS (Venous Malformation is a congenital condition.) since 13-Jan-1994, Iron deficiency (Iron Deficiency due to Venous Malformation.) since 19-Mar-2019, Drug allergy (Allergic to Sulfa drug) and Drug allergy (Allergic to Ciproflaxin). Concomitant products included IRON SULPHATE from 05-May-2021 to an unknown date for Anemia, SERTRALINE HCL from 07-May-2021 to an unknown date for Obsessive-compulsive disorder.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (maternal exposure via breastfeeding). On 10-Nov-2021 at 8:00 AM, the patient experienced HEADACHE (Headache). On 16-Nov-2021, the patient experienced FATIGUE (exhaustion), FALL (I fell backwards and my head hit the rug which was on top of the carpet) and HEAD INJURY (I also hit my head two nights ago (November 16th at 2:00am) by collapsing from exhaustion after my daughter did not want to stay in her crib). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at a dose of 1 dosage form. On 09-Nov-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (maternal exposure via breastfeeding) had resolved. On 15-Nov-2021, HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (exhaustion), FALL (I fell backwards and my head hit the rug which was on top of the carpet) and HEAD INJURY (I also hit my head two nights ago (November 16th at 2:00am) by collapsing from exhaustion after my daughter did not want to stay in her crib) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the  actual delivery date was (privacy) and patient had breastfeeding for about 5 months and continues to breastfeed after the booster shot; no notable changes to the patient and baby. Company Comment : This spontaneous case concerns a 27-year-old, female patient with no relevant medical history, who experienced vaccine exposure during breast feeding with associated unexpected and expected, non-serious events. The event headache occurred approximately 12 hours after administration of the booster dose of the Moderna mRNA-1273. The patient took two doses of Advil (ibuprofen) for the headache. The event had resolved after approximately 4 days. The other unexpected and expected, non-serious events occurred 1 week after administration of the booster dose of the Moderna mRNA-1273. As per the report, these events occurred when the patient's daughter did not want to stay in her crib. No further information was provided. The outcomes of these events were unknown. The rechallenge was not applicable as no additional dosing will be given. The event headache had occurred after the first and second doses too, however, rechallenge was not applicable since medical treatment was given for its resolution. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-384858, MOD-2021-384808 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Significant Follow up received on 22-Nov-2021: Event added and relevant history updated.; Sender's Comments: This spontaneous case concerns a 27-year-old, female patient with no relevant medical history, who experienced vaccine exposure during breast feeding with associated unexpected and expected, non-serious events. The event headache occurred approximately 12 hours after administration of the booster dose of the Moderna mRNA-1273. The patient took two doses of Advil (ibuprofen) for the headache. The event had resolved after approximately 4 days. The other unexpected and expected, non-serious events occurred 1 week after administration of the booster dose of the Moderna mRNA-1273. As per the report, these events occurred when the patient's daughter did not want to stay in her crib. No further information was provided. The outcomes of these events were unknown. The rechallenge was not applicable as no additional dosing will be given. The event headache had occurred after the first and second doses too, however, rechallenge was not applicable since medical treatment was given for its resolution. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.