Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain, Abnormal faeces, Arthralgia
Clinical narrative: Return of period after completing menopause; Prurigo nodularis; Thrombocytosis; She stayed in bed for 3 days/She felt like a truck went over her body; Constant nonstop diarrhea; Severe body aches; Fever; irregular heartbeat immediately after receiving the vaccine; This spontaneous case was reported by a patient and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Return of period after completing menopause) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient never had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Allergy to antibiotic (Tetracycline), Penicillin allergy and Attention deficit disorder (Not until after the vaccine). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced HEART RATE IRREGULAR (irregular heartbeat immediately after receiving the vaccine). On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Return of period after completing menopause) (seriousness criterion medically significant), NEURODERMATITIS (Prurigo nodularis), THROMBOCYTOSIS (Thrombocytosis), DECREASED ACTIVITY (She stayed in bed for 3 days/She felt like a truck went over her body), DIARRHOEA (Constant nonstop diarrhea), MYALGIA (Severe body aches) and PYREXIA (Fever). The patient was treated with NORTRIPTYLINE at a dose of 70 milligram once a day and TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) at a dose of 60 injection every 3 weeks (for 6 months). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Return of period after completing menopause), NEURODERMATITIS (Prurigo nodularis), THROMBOCYTOSIS (Thrombocytosis), DECREASED ACTIVITY (She stayed in bed for 3 days/She felt like a truck went over her body), HEART RATE IRREGULAR (irregular heartbeat immediately after receiving the vaccine), DIARRHOEA (Constant nonstop diarrhea), MYALGIA (Severe body aches) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: 10 out 10. On an unknown date, Platelet count: High.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient was taking other medication.  On 06-Mar-2021, received second dose of Moderna COVID-19 Vaccine (Intramuscular) on right arm, batch number 029A21A. On 22-Mar-2022, received 1st booster dose of Moderna COVID-19 Vaccine (Intramuscular) on left arm, batch number 070H21A.  Patient also received 2nd booster via Intramuscular route.  Patient believed she had delayed reaction to the 1st dose of the vaccine. She had subcutaneous delayed reaction to the vaccine. She had thrombocytosis (high platelets) which makes blood clot. She had constant nonstop diarrhea like multiple times a day. She stayed in bed for 3 days. Immediately after receiving the vaccine, she had irregular heartbeat.  company comment-This spontaneous case report concerns a 54-year-old female patient with no relevant medical history, who experienced serious (medically significant) unexpected event of Postmenopausal haemorrhage, as well as non-serious unexpected events of Neurodermatitis, Thrombocytosis, Decreased activity, Hear rate irregular and Diarrhoea, as well as non-serious expected events of Pyrexia and Myalgia. As per reported information, it was stated that these events occurred as delayed reactions  to the first dose of the vaccine. Immediately after receiving the vaccine, the patient had irregular heartbeat. In addition, the patient had subcutaneous delayed reaction to the vaccine - a skin condition known as prurigo nodularis, as well as thrombocytosis (high platelets), constant nonstop diarrhea (multiple times a day), return of menstrual period after completing menopause, severe body aches and fever. The patient stayed in bed for 3 days. It was provided that the patient used nortriptyline for 4 months and Kenalog for 6 months. At the time of this report, no additional details regarding events were provided and the outcome of the events remained unknown. No further details were available for medical assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case report concerns a 54-year-old female patient with no relevant medical history, who experienced serious (medically significant) unexpected event of Postmenopausal haemorrhage, as well as non-serious unexpected events of Neurodermatitis, Thrombocytosis, Decreased activity, Hear rate irregular and Diarrhoea, as well as non-serious expected events of Pyrexia and Myalgia. As per reported information, it was stated that these events occurred as delayed reactions  to the first dose of the vaccine. Immediately after receiving the vaccine, the patient had irregular heartbeat. In addition, the patient had subcutaneous delayed reaction to the vaccine - a skin condition known as prurigo nodularis, as well as thrombocytosis (high platelets), constant nonstop diarrhea (multiple times a day), return of menstrual period after completing menopause, severe body aches and fever. The patient stayed in bed for 3 days. It was provided that the patient used nortriptyline for 4 months and Kenalog for 6 months. At the time of this report, no additional details regarding events were provided and the outcome of the events remained unknown. No further details were available for medical assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.