Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | 1 | 3052087 | IM |
Would get a little pain (alternating) in her eyes once or twice; Felt like a burning in her eyes right away after receiving the mNEXSPIKE 2025-2026; Like right now when blinking it itches/alternating itch to both eyes sometimes; little blurring and was a little dizzy; little blurring and was a little dizzy/blurriness of her vision; she did have a little headache; Started to get itchy eyes and itchy skin 2 hours after she had left/a facial itch and body itch too/itchy skin on her face and various parts of her body; had itchiness around her lips and might had one hive; Itchy skin on her face and various parts of her body; Also had itchiness around her lips and might had one hive and then had alternating itchy, burning eyes since then for 2 days; This spontaneous case was reported by a nurse and describes the occurrence of EYE PAIN (Would get a little pain (alternating) in her eyes once or twice), EYE IRRITATION (Felt like a burning in her eyes right away after receiving the mNEXSPIKE 2025-2026), EYE PRURITUS (Like right now when blinking it itches/alternating itch to both eyes sometimes), DIZZINESS (little blurring and was a little dizzy) and PRURITUS (Started to get itchy eyes and itchy skin 2 hours after she had left/a facial itch and body itch too/itchy skin on her face and various parts of her body) in a 79-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052087) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dry eye, Seasonal allergy (Sometimes), GERD (GERD which sometimes irritates the lungs a little bit), Irritable bowel syndrome, Asthma (asthma types but unspecified) and Allergy (Some allergies). Concomitant products included Ciclosporin (Restasis) for Dry eyes. On 29-Sep-2025, the patient received first dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. In 2025, the patient experienced PRURITUS (Started to get itchy eyes and itchy skin 2 hours after she had left/a facial itch and body itch too/itchy skin on her face and various parts of her body), URTICARIA (had itchiness around her lips and might had one hive), PRURITUS (Itchy skin on her face and various parts of her body), LIP PRURITUS (Also had itchiness around her lips and might had one hive and then had alternating itchy, burning eyes since then for 2 days) and HEADACHE (she did have a little headache). On 29-Sep-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced EYE PAIN (Would get a little pain (alternating) in her eyes once or twice), EYE IRRITATION (Felt like a burning in her eyes right away after receiving the mNEXSPIKE 2025-2026), EYE PRURITUS (Like right now when blinking it itches/alternating itch to both eyes sometimes), DIZZINESS (little blurring and was a little dizzy) and VISION BLURRED (little blurring and was a little dizzy/blurriness of her vision). On 29-Sep-2025, VISION BLURRED (little blurring and was a little dizzy/blurriness of her vision) had resolved. At the time of the report, EYE PAIN (Would get a little pain (alternating) in her eyes once or twice), EYE IRRITATION (Felt like a burning in her eyes right away after receiving the mNEXSPIKE 2025-2026), EYE PRURITUS (Like right now when blinking it itches/alternating itch to both eyes sometimes), DIZZINESS (little blurring and was a little dizzy), PRURITUS (Started to get itchy eyes and itchy skin 2 hours after she had left/a facial itch and body itch too/itchy skin on her face and various parts of her body), URTICARIA (had itchiness around her lips and might had one hive), PRURITUS (Itchy skin on her face and various parts of her body) and HEADACHE (she did have a little headache) had not resolved and LIP PRURITUS (Also had itchiness around her lips and might had one hive and then had alternating itchy, burning eyes since then for 2 days) outcome was unknown. For mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use), the reporter did not provide any causality assessments. The patient was generally healthy. The patient always received Moderna vaccines. It was reported that patient never received two vaccines at once and said that she did not even get the flu vaccine because she always waited 2 weeks in between. The patient had not received any other vaccines within the past 4 weeks prior to receiving the mNEXSPIKE 2025-2026. The patient experienced a little pain (alternating) in her eyes once or twice. Patient felt a burning in her eyes right away after receiving the mNEXSPIKE 2025-2026, which described as a little blurring and dizzy. The pharmacist said that they had heard that this happens sometimes, but it would go away, within an hour. The blurriness of her vision went away probably after an hour and a half. The burning was an initial thing, but after she left the pharmacy, where she recalled waiting for an hour and a half, she started to experience itchy eyes and itchy skin 2 hours after she had left. She also had itchiness around her lips and might have had one hive, then experienced alternating itchy, burning eyes since then for 2 days. She did not know if the itchy eyes were a normal reaction to the vaccine. She had read somewhere that it could happen for a couple of days. She had received all the Moderna vaccines before and never had this problem. This was the first time she had ever experienced the eye issue, and it had already been 2 days with mainly alternating itchiness in both eyes sometimes. Patient had a little bit of pain in the eye, but during the call, it was described as very itchy. Patient never experienced the eye concerns until the mNEXSPIKE 2025-2026. Patient also had facial itch and body itch too. Patient received a total of eight doses. The reporter added that patient was expecting it to happen but not with the eye-related side effect. Patient had a little headache. Patient always sticked with Moderna. Patient complained that after a couple of days, still felt itchy, with pain and burning eyes, as well as itchy skin on her face and various parts of her body. Sometimes it alternates, sometimes it affects both eyes simultaneously. The patient did not experience any additional symptoms/events. No treatment medications were reported. This case was linked to MOD-2025-786055 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2025: Live follow up received that contains non-significant information includes reporter's phone number, allergy and reference numbers were added.; Reporter's Comments: Concurrent medical conditions Dry eye, Seasonal allergy, Asthma and Allergies are confounders for the events. The benefit -risk relationship of product is not affected by this report.
Allergy (Some allergies); Asthma (asthma types but unspecified); Dry eye; GERD (GERD which sometimes irritates the lungs a little bit); Irritable bowel syndrome; Seasonal allergy (Sometimes)
Restasis