Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling cold, Illness, Somnolence
Clinical narrative: He slept a lot/ bed sleeping for those two days; Sick; Left hip pain/ his left hip was hurting/ pain got worse and worse; Exhausted; Throwing up; He could not get warm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (He could not get warm), SOMNOLENCE (He slept a lot/ bed sleeping for those two days), ILLNESS (Sick), ARTHRALGIA (Left hip pain/ his left hip was hurting/ pain got worse and worse), FATIGUE (Exhausted) and VOMITING (Throwing up) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A, 044A21A and 008B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Prostate cancer and Immunocompromised. Concomitant products included PARACETAMOL (TYLENOL), ASPIRIN [ACETYLSALICYLIC ACID], PREDNISONE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), ATORVASTATIN, BUMETANIDE, CHOLECALCIFEROL, CLOPIDOGREL BISULFATE (PLAVIX), FAMOTIDINE (PEPCID [FAMOTIDINE]), FINASTERIDE (PROSCAR), METOPROLOL SUCCINATE (TOPROL XL), METFORMIN and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced FEELING COLD (He could not get warm) (seriousness criterion medically significant), ILLNESS (Sick) (seriousness criterion medically significant), ARTHRALGIA (Left hip pain/ his left hip was hurting/ pain got worse and worse) (seriousness criterion medically significant), FATIGUE (Exhausted) (seriousness criterion medically significant) and VOMITING (Throwing up) (seriousness criterion medically significant). On 27-Aug-2021, the patient experienced SOMNOLENCE (He slept a lot/ bed sleeping for those two days) (seriousness criterion medically significant). On 28-Aug-2021, SOMNOLENCE (He slept a lot/ bed sleeping for those two days) outcome was unknown. At the time of the report, FEELING COLD (He could not get warm), ILLNESS (Sick), ARTHRALGIA (Left hip pain/ his left hip was hurting/ pain got worse and worse), FATIGUE (Exhausted) and VOMITING (Throwing up) outcome was unknown.            Patient received the shots on in his left non dominant deltoid. He did not have symptoms with the second shot. The third shot felt like the first shot. Per reporter, she thought that patient was having a heart attack, however he was fine.  Patient's left hip pain, his left hip got worse.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-303240 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow Up received- Snapshot attached. Reporter information added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.