Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: pulsating pain in the face/ neck pain; inflammatory response; extreme dizziness; Headache; a skin rash that began like acne in her face but spread all over the body; Fever; headache , headaches from the base of the spine very often; muscle pain; joint pain; she was not feeling good; no appetite; she felt very weak; she started to bleed very profusely for 5 weeks; patient experienced an allergic reaction presumably due to the vaccine; her neck and throat were swollen/her face was swollen; she could not breath at night/ shortness of breath/ she had not enough oxygen into her body; she felt tightness in her chest; Tired; her lymph nodes and armpits were swollen; This spontaneous case was reported by a patient and describes the occurrence of VAGINAL HAEMORRHAGE (she started to bleed very profusely for 5 weeks) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 050C21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Maybe more than once, but for sure on Mar2021.) in March 2021 and Pericarditis (pericarditis- more than a decade ago.). Family history included Allergy (maybe allergic to Penicillin because of family history, but unknown.) since an unknown date. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and PROBIOTICS NOS for an unknown indication.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2021, the patient experienced MALAISE (she was not feeling good), DECREASED APPETITE (no appetite), HEADACHE (headache , headaches from the base of the spine very often), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). In August 2021, the patient experienced VAGINAL HAEMORRHAGE (she started to bleed very profusely for 5 weeks) (seriousness criterion medically significant), HYPERSENSITIVITY (patient experienced an allergic reaction presumably due to the vaccine), SWELLING (her neck and throat were swollen/her face was swollen), DYSPNOEA (she could not breath at night/ shortness of breath/ she had not enough oxygen into her body), CHEST DISCOMFORT (she felt tightness in her chest), ASTHENIA (she felt very weak), LYMPHADENOPATHY (her lymph nodes and armpits were swollen) and FATIGUE (Tired). On an unknown date, the patient experienced PAIN (pulsating pain in the face/ neck pain), INFLAMMATION (inflammatory response), DIZZINESS (extreme dizziness), HEADACHE (Headache), RASH (a skin rash that began like acne in her face but spread all over the body) and PYREXIA (Fever). In August 2021, MALAISE (she was not feeling good), DECREASED APPETITE (no appetite), HEADACHE (headache , headaches from the base of the spine very often), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (she started to bleed very profusely for 5 weeks) and ASTHENIA (she felt very weak) was resolving, HYPERSENSITIVITY (patient experienced an allergic reaction presumably due to the vaccine) outcome was unknown and SWELLING (her neck and throat were swollen/her face was swollen), DYSPNOEA (she could not breath at night/ shortness of breath/ she had not enough oxygen into her body), CHEST DISCOMFORT (she felt tightness in her chest), PAIN (pulsating pain in the face/ neck pain), INFLAMMATION (inflammatory response), DIZZINESS (extreme dizziness), LYMPHADENOPATHY (her lymph nodes and armpits were swollen), HEADACHE (Headache), RASH (a skin rash that began like acne in her face but spread all over the body), FATIGUE (Tired) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: Positive.         It was reported that patient experienced symptoms like fatigue, headache, muscle pain, joint pain, no appetite, fever and not feeling good right after 2 dose for about 3 to 5 days and these symptoms were worse after 2nd dose. Two or three weeks after 2nd shot patient experienced an allergic reaction presumably due to the vaccine, patient started to bleed very profusely for 5 weeks, then it got a little bit better. symptoms like very week, tired, her neck and throat were swollen and  could not breath at night, her lymph nodes and armpits were swollen, face was swollen all these symptom were still ongoing but not as severe as before, they came and went away. It was reported that 2 or 3 weeks ago patient developed having fevers, extreme dizziness and weakness, fatigue, and a skin rash that began like acne in her face but spread all over the body that came and went away. Patient visited thyroid specialist, her primary HCP. Physician told that all this symptoms might be due to an inflammatory response to something, that looked like her body was fighting against something, but they were not knowing the cause yet. Patient will be visiting ENT in next days. Outcome for the events were reported as ongoing but some symptoms came and went away. They came and went away sometimes severe and sometimes light but were still very uncomfortable.  Treatment medication was reported as antibiotics and steroids.  Company comment- This spontaneous case concerns a 39-year-old female patient with no relevant medical history, who experienced unexpected, serious (medically significant) event of Vaginal haemorrhage which occurred on the same month of vaccination with a second dose of mRNA-1273. No further information was provided regarding this event. The outcome of the events was reported as resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-607279 (Patient Link).; Sender's Comments: This spontaneous case concerns a 39-year-old female patient with no relevant medical history, who experienced unexpected, serious (medically significant) event of Vaginal haemorrhage which occurred on the same month of vaccination with a second dose of mRNA-1273. No further information was provided regarding this event. The outcome of the events was reported as resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.