Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Hallucination, Hypersensitivity, Inflammation, Mouth swelling
Clinical narrative: injection site pain; Hallucinations; Hair loss; Blurred Vision; Nearsighted issues; Problems with her night vision; Mental Confusion; Difficulty spelling words; Suicidal thoughts; Eye Itchiness; Inflammation on hands and feet (they felt puffy); Excruciating pain as if blood was on fire; Worst pain; Gasping with every step; Allergic reaction after eating pineapple, swelling of tongue and mouth; Allergic reaction after eating pineapple, swelling of tongue and mouth; Allergic reaction after eating pineapple, swelling of tongue and mouth; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations) and SUICIDAL IDEATION (Suicidal thoughts) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Vaccination: flu vaccine (a long time back). Past adverse reactions to the above products included Fibromyalgia with flu vaccine. Concurrent medical conditions included Allergy (Thimerosal).   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced BURNING SENSATION (Excruciating pain as if blood was on fire) and HYPERSENSITIVITY (Allergic reaction after eating pineapple, swelling of tongue and mouth). 21-Apr-2021, the patient experienced PAIN (Worst pain), DYSPNOEA (Gasping with every step), SWOLLEN TONGUE (Allergic reaction after eating pineapple, swelling of tongue and mouth) and MOUTH SWELLING (Allergic reaction after eating pineapple, swelling of tongue and mouth). On 27-Apr-2021, the patient experienced SUICIDAL IDEATION (Suicidal thoughts) (seriousness criterion medically significant). 27-Apr-2021, the patient experienced EYE PRURITUS (Eye Itchiness) and INFLAMMATION (Inflammation on hands and feet (they felt puffy)). On 10-May-2021, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant) and DYSLEXIA (Difficulty spelling words). 10-May-2021, the patient experienced ALOPECIA (Hair loss), VISION BLURRED (Blurred Vision), MYOPIA (Nearsighted issues), NIGHT BLINDNESS (Problems with her night vision) and CONFUSIONAL STATE (Mental Confusion). On an unknown date, the patient experienced VACCINATION SITE PAIN (injection site pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HALLUCINATION (Hallucinations), SUICIDAL IDEATION (Suicidal thoughts), EYE PRURITUS (Eye Itchiness), INFLAMMATION (Inflammation on hands and feet (they felt puffy)), ALOPECIA (Hair loss), VISION BLURRED (Blurred Vision), MYOPIA (Nearsighted issues), NIGHT BLINDNESS (Problems with her night vision), CONFUSIONAL STATE (Mental Confusion) and DYSLEXIA (Difficulty spelling words) had not resolved and BURNING SENSATION (Excruciating pain as if blood was on fire), PAIN (Worst pain), DYSPNOEA (Gasping with every step), SWOLLEN TONGUE (Allergic reaction after eating pineapple, swelling of tongue and mouth), MOUTH SWELLING (Allergic reaction after eating pineapple, swelling of tongue and mouth), HYPERSENSITIVITY (Allergic reaction after eating pineapple, swelling of tongue and mouth) and VACCINATION SITE PAIN (injection site pain) outcome was unknown.            Concomitant product use was not provided. Additional treatment included Japanese knot weed, vitamins, and pain killers.  Based on the current available information and temporal association between the use of the product and the start date of this events, a causal relationship cannot be excluded.     Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Followup information received on 02 Jun 2021 included vaccine dose information, events and their outcome.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this events, a causal relationship cannot be excluded.