Sex: F
Vaccine: COVID19
Symptoms: Nausea, Ocular hyperaemia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: 5 - 6 bowel movements; A little achy; Passed out; Dizziness; Arm tingling; Shaking; Chest burn; Triggered acid reflux; Stomach rolling around; Vision was blurry; Eyes bloodshot; Weakness; Funny feeling; Felt like a heart attack from the bad heart burn; Headache; Sore arm; Nausea; A spontaneous report was received from a consumer concerning a 55-years-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced passed out, headache, sore arm, dizziness, arm tingling, shaking, chest burn, triggered acid reflux, stomach rolling around, 5 - 6 bowel movements, vision was blurry, eyes bloodshot, a funny feeling, nausea, weakness, achy and felt like a heart attack from bad heartburn.   The patient's medical history included acid reflux.  Concomitant medication included lansoprazole.   On 08 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number 012L20A) at 13:07 intramuscularly in the deltoid muscle of her left arm for prophylaxis of COVID-19 infection.   On 08 Jan 2021, right after the first vaccination, the patient reported that she got a headache and sore arm but over all felt okay. As the day went on, she got dizzy and lightheaded. She went to bed around 22:30 but had to get up to use the bathroom. As she was getting up, she felt bad to the point where her husband asked her if she was okay, which she told him that her head felt funny and dizzy, and a couple of seconds later she couldn't see him anymore as if her vision was going blurry. Her husband took her to the couch, and she blacked out or passed out for a few seconds according to her husband. Shortly after she had aroused, her husband noticed that her eyes were bloodshot, and she said she felt weak, she was shaking, and her arm was tingly. At that time, her husband took her to the emergency room (this was about 12 hours after she got the Moderna COVID-19 shot). On arrival to the emergency room she felt confused and shaky. Shortly after arrival to the emergency room she was better and the worst of it was subsiding. The emergency room (ER) nurse said she could take paracetamol. The patient stated that she felt like she was physically there, but she was not mentally there. That day, the patient was discharged from the emergency room. Once home she had 5-6 bowel movements throughout the night (but not diarrhea), her stomach was rolling around almost as if she had a stomach virus, nausea, bad acid reflux to the point where her chest really burned. She felt like she was having a heart attack from the bad heart burn. She ended up taking lansoprazole to help.   On 09 Jan 2021, her head was still hurting while eating breakfast, so she took paracetamol, and it helped. She was a little achy but not a whole lot; it wasn't bad.   On 10 Jan 2021, she felt a little better but did still feel weak and shaky; however, her headache was gone.   On 11 Jan 2021, she had a funny feeling and dizziness.  Action taken with mRNA-1273 in response to the events was unknown.  The events of passed out and vision was blurry were considered resolved on 08 Jan 2021. The event of arm tingling was considered resolved on 09 Jan 2021. The event of headache was considered resolved on 10 Jan 2021. The event of shaking was considered resolved on 11 Jan 2021. The outcome of the events sore arm, dizziness, chest burn, triggered acid reflux, stomach rolling around, 5 - 6 bowel movements, eyes bloodshot, and funny feeling were unknown.; Reporter's Comments: This case concerns a 55-year-old female patient with medical history acid reflux who experienced a serious event of passed out and non-serious events of dizziness,  felt weak, shaking and her arm was tingly, confused, 5-6 bowel movements through the night, nauseous, triggered her acid reflux, felt like she was having a heart attack from the bad heart burn, chest burn, vision blurry,  eyes bloodshot, funny feeling, headache, sore arm, little achy and weak, within one day of the administration of the first and only dose of the mRNA-1273 (Lot number 012L20A, Exp. date: unknown).  Based on temporal association between the use of the product and the start date of the reported events and the absence of any other etiology factors, a causal association cannot be excluded. The events of headache and sore arm are consistent with the known safety profile of the vaccine.