Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Confusional state, Decreased appetite, Headache, Insomnia
Clinical narrative: shoulder started getting sore, which went to neck; achiness/soreness; severe headaches; shoulder started getting sore, which went to neck; knocked us for a loop; sleeping since 11:00/was up throughout the night with a disruptive night sleep; bad dreams; waking up frightened; loss of appetite; This spontaneous case was reported by a patient and describes the occurrence of CONFUSIONAL STATE (knocked us for a loop), NECK PAIN (shoulder started getting sore, which went to neck), PAIN (achiness/soreness), INSOMNIA (sleeping since 11:00/was up throughout the night with a disruptive night sleep) and NIGHTMARE (bad dreams) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Sep-2022 at 4:00 PM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Sep-2022, the patient experienced CONFUSIONAL STATE (knocked us for a loop), INSOMNIA (sleeping since 11:00/was up throughout the night with a disruptive night sleep), NIGHTMARE (bad dreams), SLEEP TERROR (waking up frightened) and DECREASED APPETITE (loss of appetite). On 13-Sep-2022 at 9:00 PM, the patient experienced NECK PAIN (shoulder started getting sore, which went to neck), PAIN (achiness/soreness), HEADACHE (severe headaches) and ARTHRALGIA (shoulder started getting sore, which went to neck). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 3 times. At the time of the report, CONFUSIONAL STATE (knocked us for a loop), NECK PAIN (shoulder started getting sore, which went to neck), INSOMNIA (sleeping since 11:00/was up throughout the night with a disruptive night sleep), NIGHTMARE (bad dreams), SLEEP TERROR (waking up frightened), DECREASED APPETITE (loss of appetite) and ARTHRALGIA (shoulder started getting sore, which went to neck) outcome was unknown and PAIN (achiness/soreness) and HEADACHE (severe headaches) had not resolved.            No relevant concomitant medications were reported. On 25-Feb-2021, patient received first dose with lot number 023M20A. On 25-Mar-2021, patient received second dose with lot number 013A21A. On 02-NOV-2021, patient received third dose with lot number 077C21B. On 03-JUN-2022, patient received fourth dose with lot number 056M21A.  After the most recent dose of the vaccine it has knocked for a loop. Patient received the shot at 4:00 PM and by 9:00 PM his shoulder started getting sore, which went to neck, then became severe headaches and achiness. He's been sleeping since 11:00 PM last night, was up throughout the night with a disruptive night sleep, bad dreams, and was waking up frightened. This morning and up until recently he has been in bed all day. He has taken Tylenol 3 times  Currently he continues to have an achy feeling, headaches, and soreness.   This case was linked to MOD-2022-645647 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2022: Upon internal review on 21-Sep2022, non-significant correction was performed to correct the suspect product coding.