Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cataract, Chills, Dizziness, Headache
Clinical narrative: Cataract / Rapid growth of a new cataract; blurred vision/ vision changed in weeks; very diaphoretic; "it felt like my skin hurt"; chills; generalized joint pain; Vomiting; Nausea; Dizziness; extreme headaches/ Debilitating headache; This spontaneous case was reported by a nurse and describes the occurrence of CATARACT (Cataract / Rapid growth of a new cataract), VISION BLURRED (blurred vision/ vision changed in weeks), DIZZINESS (Dizziness) and HEADACHE (extreme headaches/ Debilitating headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine), Sulfonamide allergy (Sulfa) and Drug allergy (Talwin). Concomitant products included WARFARIN for Atrial fibrillation, BUDESONIDE and DICYCLOMINE [DICYCLOVERINE] for Colitis, DULOXETINE HYDROCHLORIDE (CYMBALTA) for Depression, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Thyroid disorder.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant), HEADACHE (extreme headaches/ Debilitating headache) (seriousness criterion medically significant), VOMITING (Vomiting) and NAUSEA (Nausea). On 11-Apr-2021, the patient experienced HYPERHIDROSIS (very diaphoretic), PAIN OF SKIN ("it felt like my skin hurt"), CHILLS (chills) and ARTHRALGIA (generalized joint pain). On 17-May-2021, the patient experienced CATARACT (Cataract / Rapid growth of a new cataract) (seriousness criterion medically significant) and VISION BLURRED (blurred vision/ vision changed in weeks) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. On 12-Apr-2021, HYPERHIDROSIS (very diaphoretic), PAIN OF SKIN ("it felt like my skin hurt"), CHILLS (chills) and ARTHRALGIA (generalized joint pain) outcome was unknown. At the time of the report, CATARACT (Cataract / Rapid growth of a new cataract) and VISION BLURRED (blurred vision/ vision changed in weeks) had not resolved and DIZZINESS (Dizziness), HEADACHE (extreme headaches/ Debilitating headache), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CATARACT (Cataract / Rapid growth of a new cataract), DIZZINESS (Dizziness), HEADACHE (extreme headaches/ Debilitating headache), VOMITING (Vomiting) and NAUSEA (Nausea) to be related. No further causality assessments were provided for VISION BLURRED (blurred vision/ vision changed in weeks), HYPERHIDROSIS (very diaphoretic), PAIN OF SKIN ("it felt like my skin hurt"), CHILLS (chills) and ARTHRALGIA (generalized joint pain).    The patient reported that on 10 Apr 2021 (2 days after the second shot), she was literally confined to bed due to severe dizziness and a severe headache she feared it might be a cerebral bleed. After a few weeks she was unable to see the television or read road signs and thought it was because of the dirt on her glasses. But her vision continually got worse and she had to stop driving. She visited an ophthalmologist on 17 May 2021. She informed that the office medical technician was shocked that she had grown a large cataract so quickly that it was visible with the naked eye. The physician was also shocked that the patient had grown a cataract within a few months and suggested to have the surgery as soon as possible. The physician informed that the patient's vision in the left eye had reduced to 20/40. The patient was on the cusp of being unable to drive and was scheduled for a surgery in August 2021.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-Jun-2021, included information as: case was upgraded to serious. patient demographics were updated. Additional reporter details were added. Patient's medical history, concomitant medications and suspect details were added and updated. Serious and non-serious events were added and existing event information was updated. Narrative was updated accordingly.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded. Further information has been requested.