Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: woke up cramping in the middle of the night/stomach with cramps; upset stomach/misery stomach/had to go running to the bathroom; diarrhea; soreness in the arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (woke up cramping in the middle of the night/stomach with cramps), ABDOMINAL DISCOMFORT (upset stomach/misery stomach/had to go running to the bathroom), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (soreness in the arm) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 009C21A, 009C21A and 012H21B) for COVID-19 vaccination.     Previously administered products included for Urinary tract infection: Macrobid. Past adverse reactions to the above products included No adverse event with Macrobid. Concurrent medical conditions included Urinary tract infection, Sulfonamide allergy and Allergy to antibiotic. Concomitant products included MIRABEGRON (MYRBETRIQ), PREDNISONE and GLYCOPYRRONIUM BROMIDE (ROBINUL) for an unknown indication.   On 24-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 06-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 06-Apr-2022, the patient experienced ABDOMINAL PAIN (woke up cramping in the middle of the night/stomach with cramps), ABDOMINAL DISCOMFORT (upset stomach/misery stomach/had to go running to the bathroom), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (soreness in the arm) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN (woke up cramping in the middle of the night/stomach with cramps) had resolved, ABDOMINAL DISCOMFORT (upset stomach/misery stomach/had to go running to the bathroom), DIARRHOEA (diarrhea) and HEADACHE (headache) outcome was unknown and PAIN IN EXTREMITY (soreness in the arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No-Negative.         In last night she woke up cramping in the middle of the night and had to go running to the bathroom. She could get back to sleep after going to the bathroom.  patient taking Blood pressure medicine, Medicines for endoscopy. treatment medication included Drink liquids and Stay rested.   This case was linked to MOD-2022-535527, MOD-2022-535529, MOD-2022-535530 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow up document contain reporter information updated, batch no and dose details were added.