Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Loss of consciousness, Myalgia, Skin discolouration, Urinary incontinence
Clinical narrative: When she woke up, she was in a pile of urine; entire area from my neck to my bottom was black and blue for months; a little chilly; she was sore; passed out from standing and she slowly got up, she passed out again; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out from standing and she slowly got up, she passed out again) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out from standing and she slowly got up, she passed out again) (seriousness criterion medically significant) and MYALGIA (she was sore). On an unknown date, the patient experienced URINARY INCONTINENCE (When she woke up, she was in a pile of urine), SKIN DISCOLOURATION (entire area from my neck to my bottom was black and blue for months) and CHILLS (a little chilly). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (passed out from standing and she slowly got up, she passed out again), URINARY INCONTINENCE (When she woke up, she was in a pile of urine), SKIN DISCOLOURATION (entire area from my neck to my bottom was black and blue for months), CHILLS (a little chilly) and MYALGIA (she was sore) outcome was unknown.            no concomitant medication reported  The patient received her first dose (lot # 032620A) of Moderna COVID19 Vaccine on 28Jan2021 and second dose (lot # 002A21A) on 25Feb021. Both doses were given in her left arm and from the same vaccination site. The first dose, she was a little chilly. The second dose, she felt chilly. The next morning 26Feb2021, she got out of bed, but then passed out from standing. She doesn't know how long she was gone for. She's never fainted or had a seizure in her entire life. When she slowly got up, she passed out again. When she woke up, she was in a pile of urine. Both times she fell on tile. The entire area from her neck to her bottom was black and blue for months. She was sore. She states she went down immediately. She doesn't know if it was passing out or a seizure.  Company comment: This case concerns a 69 year old female who experienced serious unexpected event of loss of consciousness one day after receiving the second dose of the Moderna Covid-19 vaccine. No medical history provided. Dechallenge is unknown and rechallenge is unknown. The benefit-risk relationship is not affected by this report of the Moderna Covid-19 vaccine.   This case was linked to MOD-2021-323790 (Patient Link).; Sender's Comments: This case concerns a 69 year old female who experienced serious unexpected event of loss of consciousness one day after receiving the second dose of the Moderna Covid-19 vaccine. No medical history provided. Dechallenge is unknown and rechallenge is unknown. The benefit-risk relationship is not affected by this report of the Moderna Covid-19 vaccine.