Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Postmenopausal haemorrhage, Pyrexia
Clinical narrative: having some spotting; has been in menopause for 12 years and she had a full period; loss of appetite; difficulty breathing; severe body aches; low grade fever; chills; nasty headache; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (has been in menopause for 12 years and she had a full period) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy.   On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced DECREASED APPETITE (loss of appetite), DYSPNOEA (difficulty breathing), MYALGIA (severe body aches), PYREXIA (low grade fever), CHILLS (chills) and HEADACHE (nasty headache). On 14-Jul-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (has been in menopause for 12 years and she had a full period) (seriousness criterion medically significant). On an unknown date, the patient experienced INTERMENSTRUAL BLEEDING (having some spotting). The patient was treated with ALBUTEROL [SALBUTAMOL] for Adverse event, at an unspecified dose and frequency. At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (has been in menopause for 12 years and she had a full period) had resolved, DECREASED APPETITE (loss of appetite), DYSPNOEA (difficulty breathing), MYALGIA (severe body aches), PYREXIA (low grade fever), CHILLS (chills) and HEADACHE (nasty headache) outcome was unknown and INTERMENSTRUAL BLEEDING (having some spotting) had not resolved.            Patient stated that all the tests her gynecologist run were negative  Concomitant product use was not provided.  The patient's vaccine anatomical location was unknown. Patient had a full period starting at 14Jul2021 for about five days and then it stopped just for a few days and then she's been having some spotting since then Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events of Decreased appetite, dyspnea, myalgia, pyrexia, chills, and headache a causal relationship cannot be excluded. However there is very limited information regarding the events of post-menopausal hemorrhage and intermenstrual bleeding that has been provided at this time. No further information is expected at this time.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow up received, contains additional information and events Postmenopausal bleeding, spotting menstrual were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of Decreased appetite, dyspnea, myalgia, pyrexia, chills, and headache a causal relationship cannot be excluded. However there is very limited information regarding the events of post-menopausal hemorrhage and intermenstrual bleeding that has been provided at this time. No further information is expected at this time.