Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Product formulation issue, Pyrexia
Clinical narrative: Confused; had to crawl to get to a counter in order to stand/patient could not stand; after a few hours she was saturated in sweat; maybe there's an ingredient that didn't agree with me/or got something else; hallucinations; extremely high fever of 103°F/high fevers; This spontaneous case was reported by a patient and describes the occurrence of HALLUCINATION (hallucinations) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 001M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Apr-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 22-Apr-2022, the patient experienced HALLUCINATION (hallucinations) (seriousness criterion medically significant) and PYREXIA (extremely high fever of 103°F/high fevers). On an unknown date, the patient experienced CONFUSIONAL STATE (Confused), DYSSTASIA (had to crawl to get to a counter in order to stand/patient could not stand), HYPERHIDROSIS (after a few hours she was saturated in sweat) and PRODUCT FORMULATION ISSUE (maybe there's an ingredient that didn't agree with me/or got something else). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, HALLUCINATION (hallucinations), CONFUSIONAL STATE (Confused), DYSSTASIA (had to crawl to get to a counter in order to stand/patient could not stand), HYPERHIDROSIS (after a few hours she was saturated in sweat), PYREXIA (extremely high fever of 103°F/high fevers) and PRODUCT FORMULATION ISSUE (maybe there's an ingredient that didn't agree with me/or got something else) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 103 degree F.         Patient stated she received her last booster of Moderna COVID-19 Vaccine on 22Apr2022 and she experienced a severe reaction with extremely high fever of 103°F and hallucinations. Patient reported being confused, didn't know how to get to a phone, had to craw to get to a counter in order to stand, can't stand, high fevers, after a few hours she was saturated in sweat. Patient stated maybe there was something different in there, maybe there's an ingredient that didn't agree with her, or got something else.  Patient stated that she had no reaction with her primary series and first booster. She only had a reaction to the second booster.  It is unknown if any treatment was given or if patient was under any concomitant or regular medication.  Patient wanted to know if she is a candidate to receive the Moderna bivalent booster  Company comment: This spontaneous case concerns a 71-year-old, female patient with no medical history information reported, who experienced the unexpected serious (medically significant) event of hallucination along with other non serious events including pyrexia and confusional state. The events occurred on the same day following forth dose of mRNA-1273 (described as most recent booster). As reported, patient experienced a severe reaction with extremely high fever of 103°F and hallucinations. Patient reported being confused, didn't know how to get to a phone, had to craw to get to a counter in order to stand, couldn't stand, had high fevers, after a few hours she was saturated in sweat. Patient stated maybe there was something different in there, maybe there's an ingredient that didn't agree with her, or got something else. Patient also stated that she had no reaction with her primary series and first booster, only had a reaction to the second booster. Concurrent pyrexia which patient experienced could have been contributing factor for hallucinations and confusion. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2022: Live significant Follow-up received: Added patient information and product quality compliant number. On 28-Oct-2022: Non significant follow up received: Added QE no (QE-023045); Sender's Comments: This spontaneous case concerns a 71-year-old, female patient with no medical history information reported, who experienced the unexpected serious (medically significant) event of hallucination along with other non serious events including pyrexia and confusional state. The events occurred on the same day following forth dose of mRNA-1273 (described as most recent booster). As reported, patient experienced a severe reaction with extremely high fever of 103°F and hallucinations. Patient reported being confused, didn't know how to get to a phone, had to craw to get to a counter in order to stand, couldn't stand, had high fevers, after a few hours she was saturated in sweat. Patient stated maybe there was something different in there, maybe there's an ingredient that didn't agree with her, or got something else. Patient also stated that she had no reaction with her primary series and first booster, only had a reaction to the second booster. Concurrent pyrexia which patient experienced could have been contributing factor for hallucinations and confusion. The benefit-risk relationship of mRNA-1273 is not affected by this report.