Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Intentional product use issue, Suicidal behaviour, Tinnitus, Vision blurred
Clinical narrative: couldn't survive a week without committing suicide; More than 36 days have passed since first shot, More than 36 days after the first dose without receiving the second dose; Reaction to protein from vaccine; couldn't sleep; hyper immune reaction; couldn't concentrate, couldn't work, was running around in circles; Difficulty breathing; Headache; Joint pain; asthma worsened; Blurry vision; atypical reaction; all the joints of my body, not the muscles, became inflamed, was difficult to move my joints; tinnitus, couldn't hear; swelling of her eyes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SUICIDAL BEHAVIOUR (couldn't survive a week without committing suicide) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0Y3A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: influenza vaccine (reaction to high dose influenza vaccine   fever). Past adverse reactions to the above products included Muscle ache with influenza vaccine. Concurrent medical conditions included Shellfish allergy, Penicillin allergy, Food allergy (MSG), Drug allergy (macrodantin and sulfa), Seasonal allergy since 1984 and Asthma since 1984. Concomitant products included MULTIVITAMINS [VITAMINS NOS], ZINC PICOLINATE and VITAMIN D NOS for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced EYE SWELLING (swelling of her eyes), IMMUNISATION REACTION (atypical reaction), ARTHRITIS (all the joints of my body, not the muscles, became inflamed, was difficult to move my joints) and TINNITUS (tinnitus, couldn't hear). On 28-Feb-2021, the patient experienced ASTHMA (asthma worsened), VISION BLURRED (Blurry vision), HEADACHE (Headache) and ARTHRALGIA (Joint pain). On an unknown date, the patient experienced SUICIDAL BEHAVIOUR (couldn't survive a week without committing suicide) (seriousness criterion medically significant), INTENTIONAL PRODUCT USE ISSUE (More than 36 days have passed since first shot, More than 36 days after the first dose without receiving the second dose), FOOD ALLERGY (Reaction to protein from vaccine), INSOMNIA (couldn't sleep), HYPERSENSITIVITY (hyper immune reaction), DISTURBANCE IN ATTENTION (couldn't concentrate, couldn't work, was running around in circles) and DYSPNOEA (Difficulty breathing). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of 1 dosage form. On 25-Mar-2021, ASTHMA (asthma worsened), VISION BLURRED (Blurry vision) and HEADACHE (Headache) had resolved. On 28-Mar-2021, ARTHRALGIA (Joint pain) had resolved. At the time of the report, SUICIDAL BEHAVIOUR (couldn't survive a week without committing suicide), INTENTIONAL PRODUCT USE ISSUE (More than 36 days have passed since first shot, More than 36 days after the first dose without receiving the second dose), FOOD ALLERGY (Reaction to protein from vaccine), EYE SWELLING (swelling of her eyes), INSOMNIA (couldn't sleep), HYPERSENSITIVITY (hyper immune reaction), DISTURBANCE IN ATTENTION (couldn't concentrate, couldn't work, was running around in circles), IMMUNISATION REACTION (atypical reaction) and ARTHRITIS (all the joints of my body, not the muscles, became inflamed, was difficult to move my joints) outcome was unknown, TINNITUS (tinnitus, couldn't hear) had not resolved and DYSPNOEA (Difficulty breathing) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller states she had an atypical reaction that started two days after the vaccine, with tinnitus, swelling of her eyes, all the joints of her body, not the muscles, and it became inflamed and was difficult to move joints. 3 weeks after (She waited until she was sure she had immunity from the first vaccine) she had to go on high dose prednisone for 10 days. Caller states this was not an allergic reaction but a hyper immune reaction. She did not require epinephrine, adrenaline or antihistamines. Caller states she still has tinnitus and she does not want to have permanent tinnitus. She had an episode where she could not sleep, couldn't hear, could not concentrate, could not work, was running around in circles.  Company comments:Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Headache and arthralgia are consistent with the product safety profile.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14 Jul 2021 contained significant information.  Events and treatment drug were updated. Case upgraded to serious. On 14-Jul-2021: Upon internal review on 16-SEP-2022 non-significant correction was performed to update the case received from field.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Headache and arthralgia are consistent with the product safety profile.