Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Mood swings, Nausea, Poor quality sleep
Clinical narrative: The worst period ever with bleeding / Having a really bad period; Feeling very very unwell; Had not experienced a period since she is taking birth control until now; Horrible mood swings; Anxiety; Not sleeping well; Each day gets worst; Headache; Nausea; This spontaneous case was reported by a patient and describes the occurrence of HEAVY MENSTRUAL BLEEDING (The worst period ever with bleeding / Having a really bad period), MALAISE (Feeling very very unwell), AMENORRHEA (Had not experienced a period since she is taking birth control until now), MOOD SWINGS (Horrible mood swings) and ANXIETY (Anxiety) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Endometriosis. Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL (LORYNA) for Birth control pill.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (The worst period ever with bleeding / Having a really bad period), MALAISE (Feeling very very unwell), AMENORRHEA (Had not experienced a period since she is taking birth control until now), MOOD SWINGS (Horrible mood swings), ANXIETY (Anxiety), POOR QUALITY SLEEP (Not sleeping well), FEELING ABNORMAL (Each day gets worst), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with IBUPROFEN (oral) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEAVY MENSTRUAL BLEEDING (The worst period ever with bleeding / Having a really bad period), MALAISE (Feeling very very unwell), AMENORRHEA (Had not experienced a period since she is taking birth control until now), MOOD SWINGS (Horrible mood swings), ANXIETY (Anxiety), POOR QUALITY SLEEP (Not sleeping well), FEELING ABNORMAL (Each day gets worst), HEADACHE (Headache) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she had endometriosis and since the vaccine was given she was experiencing the worst period ever, with bleeding and feeling very unwell. She reported that she had not experienced a period since she was taking birth control until now. She was having a really bad period, with horrible mood swings, anxiety and not sleeping well. Also said each day gets worst.  Company comment: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Headache and nausea are consistent with the known safety profile of the product.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Headache and nausea are consistent with the known safety profile of the product.