Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Aggression, Anxiety, Asthenia
Clinical narrative: anxiety; weeping; irritable; upset stomach; dizziness; pain/Body aches; bloatiness or unsettled stomach; aggressive; He has no energy; nauseous; tiredness; This spontaneous case was reported by a patient and describes the occurrence of ANXIETY (anxiety), CRYING (weeping), IRRITABILITY (irritable), ABDOMINAL DISCOMFORT (upset stomach) and DIZZINESS (dizziness) in a 62-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043335) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu vaccine on 04-Nov-2024 and Pfizer Covid-19 vaccine (1st dose); for COVID-19 prophylaxis: Moderna covid-19 vaccine (2nd dose). Past adverse reactions to the above products included No adverse effect with Moderna covid-19 vaccine and Pfizer Covid-19 vaccine; and Vaccination adverse reaction with Flu vaccine. Concurrent medical conditions included Depression and Arthritis. Concomitant products included Paracetamol (Tylenol) for Arthritis.    On 25-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced ANXIETY (anxiety), CRYING (weeping), IRRITABILITY (irritable), ABDOMINAL DISCOMFORT (upset stomach), DIZZINESS (dizziness), PAIN (pain/Body aches), ABDOMINAL DISTENSION (bloatiness or unsettled stomach), AGGRESSION (aggressive), ASTHENIA (He has no energy), NAUSEA (nauseous) and FATIGUE (tiredness). At the time of the report, ANXIETY (anxiety), CRYING (weeping), IRRITABILITY (irritable), ABDOMINAL DISCOMFORT (upset stomach), DIZZINESS (dizziness), PAIN (pain/Body aches), ABDOMINAL DISTENSION (bloatiness or unsettled stomach), AGGRESSION (aggressive), ASTHENIA (He has no energy), NAUSEA (nauseous) and FATIGUE (tiredness) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2024-778820 (E2B Linked Report).  It was reported that patient took Tylenol when he needed it the most. He did not take it every day, but when he got the shot, he needed to take the maximum every day, which was 500 mg,1000 3 times a day, which is 3000. Patient did not go over the the maximum. He never go, He never take more than prescribed with any kind of medication. Caller confirmed it was 3000mg per day.  It was reported that he became more aggressive, nasty, he had anxiety, depression and crying out of nowhere. He also stated that he went to his doctor on 02-Dec-2024 and was advised to wait for a couple to few more days. He added that the depression and the anxiety were gnawing at him. He got the flu shot on 04-Nov-2024 and had a mild side effects which lasted for 2 days but the ones he was experiencing from the Spikevax was unbearable. He also termed these side effects as annoying and did not go away. He added he just feels very angry and just quite like crying spells out of nowhere. He also stated it made him really bad, horrible weeping, crying for like a half hour and just intense and then he wakes up in the morning like a bus hit him. He had no energy and added, it was horrible. Patient had body aches and no fever, no sore throat. None of those he did not had ad no vomiting. Sometimes he experiences gastro-related symptoms like upset stomach but not vomiting, no blood, no fever, no sore throat which he had to take an antacid. He feels nauseous a little. Patient was not those all the time, but, you know, just to feel uneasy like. Every night Patient had been taking Rolaids and acids. He never took Rolaids every night. Pepto-Bismol he had taking again on top with the Rola for the nauseousness. He had been taking Tylenol. Even the Tylenol was not taking the pain away, like very slightly. It had been effective. So He told her physician to prescribe his ibuprofen. he just picked it up this morning from the pharmacy, the ibuprofen. So  far he ain't feeling any relief. And he took it maybe 4 hours. He was taking Rolaids ultra strength antacids, chewable for bloatiness or unsettled stomach to kill the acid of any food he eats after dinner. Patient had an appointment with another physician 07-Jan-2025.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-778820:Patient's case