Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site hypersensitivity, Injection site warmth, Myalgia, Pyrexia, Tremor
Clinical narrative: Every spot where he had surgery - all the surgical locations - hurt at a level 9 or 10 out of 10; almost like tremors, for about 4.5 hours; loss of appetite; flu; He had lack of sleep, but that was probably due to all the pain he was in; The injection site is still red and tender to touch and feverish now.; diarrhea; sore arm; fever; shivers; headache; nausea; vomiting; fatigue; The injection site is still red and tender to touch; The injection site is still red and tender to touch; This spontaneous case was reported by a patient and describes the occurrence of PROCEDURAL PAIN (Every spot where he had surgery - all the surgical locations - hurt at a level 9 or 10 out of 10), TREMOR (almost like tremors, for about 4.5 hours), DECREASED APPETITE (loss of appetite), INFLUENZA (flu) and INSOMNIA (He had lack of sleep, but that was probably due to all the pain he was in) in a 66-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 205E23A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (ACETAMINOPHEN) for an unknown indication.  On 25-Sep-2023 at 1:30 PM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 25-Sep-2023 at 8:30 PM, the patient experienced PROCEDURAL PAIN (Every spot where he had surgery - all the surgical locations - hurt at a level 9 or 10 out of 10), TREMOR (almost like tremors, for about 4.5 hours), DECREASED APPETITE (loss of appetite), INFLUENZA (flu), INSOMNIA (He had lack of sleep, but that was probably due to all the pain he was in), VACCINATION SITE WARMTH (The injection site is still red and tender to touch and feverish now.), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (sore arm), PYREXIA (fever), CHILLS (shivers), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (The injection site is still red and tender to touch) and VACCINATION SITE PAIN (The injection site is still red and tender to touch). At the time of the report, PROCEDURAL PAIN (Every spot where he had surgery - all the surgical locations - hurt at a level 9 or 10 out of 10), TREMOR (almost like tremors, for about 4.5 hours), DECREASED APPETITE (loss of appetite), INFLUENZA (flu), INSOMNIA (He had lack of sleep, but that was probably due to all the pain he was in), VACCINATION SITE WARMTH (The injection site is still red and tender to touch and feverish now.), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (sore arm), PYREXIA (fever), CHILLS (shivers), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (The injection site is still red and tender to touch) and VACCINATION SITE PAIN (The injection site is still red and tender to touch) had not resolved.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   The patient had an unpleasant experience with most recent COVID vaccine, reported it to Moderna.  He stated it was a big mistake to get three vaccines at once on 09-Oct-2022.   The patient began, every single one he has had side effects - sore arm, maybe a mild fever. On 25-Sep-2023 was devastating. All of his unpleasant symptoms were very low grade fever, but he had uncontrollable body shivers, almost like tremors, for about 4.5 hours. He was taking his temperature, and he did not have one. He had a really bad headache. Every spot where he had surgery - all the surgical locations - hurt at a level 9 or 10 out of 10. He had diarrhea; he vomited. The injection site was still red and tender to touch and feverish now. The symptoms started 7.5-8 hours after he got the injection. He got the injection around 1:30 PM and the symptoms started around 8:30 that night. He stated these were not traditional symptoms as indicated online on the CDC pages. He stated he never had nausea, vomiting, or diarrhea before. He never had a problem with that. He did had fatigue. He had loss of appetite; he had no interest in eating. He had lack of sleep, but that was probably due to all the pain he was in. He stated the only one ongoing was sensitivity at the injection site, so that was not resolved. He might be a little more fatigued than usual, but he cannot point a finger at the vaccine doing that. He stated his sleep cycle was disturbed. The only thing he took was acetaminophen. He stated he was taking blood thinners and had a couple stents in his heart, so he cannot take anything stronger than that. He stated this was so different from the previous ones, so he knows he will be hesitant to take it again. He was so close to go to the emergency room, but he did not.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-743088, US-MODERNATX, INC.-MOD-2023-743089 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743088:monovalent case US-MODERNATX, INC.-MOD-2023-743089:bivalent case