Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Vaccination site pain, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of DIPLOPIA (Developed double vision/horizontal diplopia), ASTHENOPIA (Tiredness in eyes), HEAD DISCOMFORT (Strong pressure component associated with them), FEELING ABNORMAL (Felt as though something trying to push eye out from inside) and DIZZINESS (lightheadedness) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011320A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Diplopia from October 2020 to December 2020. Previously administered products included for Product used for unknown indication: Influenza in October 2019. Past adverse reactions to the above products included No adverse event with Influenza. Concurrent medical conditions included Headache (Currently suffers from headaches, one every 2-3 weeks), Double vision (double vision this past Fall of 2020, possibly related to the 6th cranial nerve and viral related), Hypertension (Longstanding high blood pressure) since 11-Jan-2011, Anxiety since 11-Jan-2021, Allergic rhinitis since 11-Jan-1980, Herpes simplex type II since 11-Jan-1998, Drug allergy (Allergic to Bactrim) and Cranial nerve disorder in November 2020. Concomitant products included MOMETASONE FUROATE (NASONEX) from 12-May-2017 to an unknown date and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 12-May-2017 to an unknown date for Allergic rhinitis, SERTRALINE from 11-Jan-2011 to an unknown date for Anxiety, VALACICLOVIR HYDROCHLORIDE (VALTREX) from 11-Jan-1998 to an unknown date for Herpes simplex type II, ENALAPRIL from 11-Jan-2011 to an unknown date for Hypertension. On 22-Dec-2020 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Dec-2020, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (vaccination site pain). On 23-Dec-2020, the patient experienced DIZZINESS (lightheadedness). On 26-Dec-2020, the patient experienced HEADACHE (Moderate to severe headaches). On 05-Jan-2021, the patient experienced DIPLOPIA (Developed double vision/horizontal diplopia). On an unknown date, the patient experienced ASTHENOPIA (Tiredness in eyes), HEAD DISCOMFORT (Strong pressure component associated with them) and FEELING ABNORMAL (Felt as though something trying to push eye out from inside). The patient was treated with NAPROXEN SODIUM (ALEVE) for Headache, at a dose of 800 milligram and PARACETAMOL (TYLENOL) for Headache, at a dose of 1000 milligram. On 25-Dec-2020, VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (vaccination site pain) had resolved. At the time of the report, DIPLOPIA (Developed double vision/horizontal diplopia), HEAD DISCOMFORT (Strong pressure component associated with them), FEELING ABNORMAL (Felt as though something trying to push eye out from inside), DIZZINESS (lightheadedness) and HEADACHE (Moderate to severe headaches) had resolved and ASTHENOPIA (Tiredness in eyes) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DIZZINESS (lightheadedness) and HEADACHE (Moderate to severe headaches) to be related. No further causality assessments were provided for DIPLOPIA (Developed double vision/horizontal diplopia), ASTHENOPIA (Tiredness in eyes), HEAD DISCOMFORT (Strong pressure component associated with them), FEELING ABNORMAL (Felt as though something trying to push eye out from inside), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (vaccination site pain). Lab data included COVID-19 test done after the first dose with result negative. Description: The patient reported that headache that experienced were primarily located behind left eye. The headache would also be migratory in nature. It would move from behind his left eye to behind both eyes, or to encompass his entire head, or to be located at the back of his head, back to the left eye. The patient reported that no matter where they were located they were always painful and had a strong pressure component associated with them. The patient reported that at time his head felt like it would explode or split in two. This case was linked to MOD-2021-102245 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2021: Additional document received updated new events and medical history. On 02-May-2021: Follow-up received updated patient details, action taken, medical history, concomitant medications added, reporter causality updated, new events added.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  The patient's medical history of headaches (occurring one every 2-3 weeks), long standing high blood pressure and double vision remains confounders.