Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Electroencephalogram, Magnetic resonance imaging, Rash
Clinical narrative: after last dose with Spikevax, on 1NOV2023 he experienced a Transient Global Amnesia (TGA) episode that lasted approximately 24 hours; caller experienced an exacerbated rash that he had before because he was exposed to orange agent; Classic TGA occurred at about 2:00 PM on 26 Oct 2023 and lasted about 4 to 6 hours as I was able to recover some memory; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Nov-2023 and was forwarded to Moderna on 07-Nov-2023.      This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT GLOBAL AMNESIA (after last dose with Spikevax, on 1NOV2023 he experienced a Transient Global Amnesia (TGA) episode that lasted approximately 24 hours) in a 77-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030336) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The caller explained that he had experienced several health conditions derived from cancer but did not give further details because he had a very long medical history.  The patient's past medical history included Prostate cancer (diagnosed on Nov-2022) in November 2022, Prostate cancer (Patient have had 90 medical visits last year and has hundreds of medical conditions related to prostate cancer), Granuloma, Lipoma, Transient global amnesia (already experienced 2 previous TGA episodes before getting any of the COVID-19 shots, 1st one between 2011 and 2014 (he did not remember the exact year), and 2nd episode happened on SEP-2019) in 2011, Rash, Hormone therapy, Radiation therapy (28 radiation treatment sessions so far) and Surgery (Patient had an outpatient surgery due to a reaction to hormone medication for cancer in regard to granuloma or lipoma.) on 17-Oct-2023. Concomitant products included INFLUENZA VACCINE INACT SPLIT 3V (FLUZONE HIGH DOSE) from 26-Oct-2023 to an unknown date for an unknown indication.    On 26-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 26-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced TRANSIENT GLOBAL AMNESIA (Classic TGA occurred at about 2:00 PM on 26 Oct 2023 and lasted about 4 to 6 hours as I was able to recover some memory). On 01-Nov-2023, the patient experienced TRANSIENT GLOBAL AMNESIA (after last dose with Spikevax, on 1NOV2023 he experienced a Transient Global Amnesia (TGA) episode that lasted approximately 24 hours) (seriousness criterion hospitalization) and RASH (caller experienced an exacerbated rash that he had before because he was exposed to orange agent). The patient was treated with VITAMIN B1 NOS at an unspecified dose and frequency and TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE [TRIAMCINOLONE ACETONIDE]) (topical) for Rash, at an unspecified dose and frequency. On 26-Oct-2023, TRANSIENT GLOBAL AMNESIA (Classic TGA occurred at about 2:00 PM on 26 Oct 2023 and lasted about 4 to 6 hours as I was able to recover some memory) had resolved. On 02-Nov-2023, TRANSIENT GLOBAL AMNESIA (after last dose with Spikevax, on 1NOV2023 he experienced a Transient Global Amnesia (TGA) episode that lasted approximately 24 hours) had resolved. At the time of the report, RASH (caller experienced an exacerbated rash that he had before because he was exposed to orange agent) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: CT scan with and without contrast : physicians found abnormalities only related to cancer but nothing that could explain Transient Global Amnesia. On an unknown date, Electrocardiogram: physicians found abnormalities only related to cancer but nothing that could explain Transient Global Amnesia. On an unknown date, Electroencephalogram: physicians found abnormalities only related to cancer but nothing that could explain Transient Global Amnesia. On an unknown date, Magnetic resonance imaging: physicians found abnormalities only related to cancer but nothing that could explain Transient Global Amnesia.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   On 26-Oct-2023, patient also received Fluzone HD shot on the other arm. Patient mentioned that after each one of the vaccines, patient experienced an exacerbated rash that he had before because he was exposed to orange agent, and the rash lasted approximately from a couple days to 1 week after each vaccine, and it was treated with Triamcinolone which was a steroid cream to treat topical rashes.   The first episode of Transient Global Amnesia occurred at about 2:00 PM on 26-Oct-2023 and lasted for about 4 to 6 hours as the patient was able to recover some memory.   Patient explained that after last dose with Spikevax vaccine, on 1-Nov-2023, he experienced a Transient Global Amnesia (TGA) episode that lasted for approximately 24 hours, and he lost presence and direction, he was awake and could converse with people but he did not know where he was, or what was he doing or where he was going. The physicians did not know what caused it but it was a suspected adverse reaction from the vaccine and CDC listed TGA as a condition related to COVID-19 vaccines; it was treated as a stroke or seizure and was translated in an ambulance to the hospital where the physicians gave him a shot of Vitamin B1 and he underwent 18 tests, MRI, CT scan with and without contrast, EKG, EEG, and the physicians found abnormalities only related to cancer but nothing that could explain TGA condition.   This case was linked to US-MODERNATX, INC.-MOD-2023-748588 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Nov-2023: Live significant follow-up received contain added events/second episode of Transient global amnesia and rash, upgraded seriousness of the case and narrative updated; Sender's Comments: Company Comment   This spontaneous case concerns a patient of  a 77-year-old male patient with medical history of Concomitant products included INFLUENZA VACCINE, prostate cancer under hormone and Radiation treatment; Rash, Transient global amnesia (already experienced 2 previous TGA episodes on 2011, 2014 and 2019), who experienced the seriousness criterion hospitalization unexpected event of Transient Global Amnesia; the unexpected event of Transient Global Amnesia (2nd. episode) and other expected event beginning the same day after 6th. dose of mRNA-1273.815 vaccine. The medical history is a contributor for the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2023-748588:Spikevax PFS case