Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, COVID-19, Drug ineffective, Gait disturbance, Illness
Clinical narrative: Myocarditis; Pericarditis; Heart inflammation; Lung inflammation; Difficulty walking; Walks with cane; She was very sick; Covid positive; Covid positive; Legally blind in left eye after vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. Other Case identifier(s): MOD22-013986 (Moderna).  A female patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 2, single (Lot number: EN6206) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Feb2021 as dose 1, single (Lot number: 024M20A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLINDNESS UNILATERAL (medically significant) with onset 2021, outcome "unknown", described as "Legally blind in left eye after vaccination"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 31Dec2021, outcome "unknown" and all described as "Covid positive"; ILLNESS (non-serious) with onset 31Dec2021, outcome "unknown", described as "She was very sick"; GAIT DISTURBANCE (non-serious) with onset 2022, outcome "unknown", described as "Difficulty walking"; INFLAMMATION (non-serious) with onset 2022, outcome "unknown", described as "Heart inflammation"; PNEUMONITIS (non-serious) with onset 2022, outcome "unknown", described as "Lung inflammation"; MYOCARDITIS (medically significant) with onset 2022, outcome "unknown"; PERICARDITIS (medically significant) with onset 2022, outcome "unknown"; WALKING AID USER (non-serious) with onset 2022, outcome "unknown", described as "Walks with cane". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Dec2021) Positive, notes: She states that she was very sick, and found out that she was COVID Positive in the hospital on 31Dec2021.  Clinical course: Patient called to ask a question. She stated that she had called in the past. An agent searched and crosslinked with case numbers: Reporter reports that she was still experiencing symptoms after receiving the 2 primary doses of COVID-19 vaccine. She was asking, Can you track her name and lot number to your shots. She stated that she was very sick, and found out that she was COVID Positive in the hospital on 31Dec2021. And she received antibody infusion in the hospital. She stated that she was still sick, Heart inflammation, Lung inflammation, Legally blind in left eye after vaccination, Difficulty walking, and walks with cane. The hospital corrected her vaccination card and told her that the second shot she received was Pfizer, but she does not trust them. An agent asked if the doctor in the hospital diagnosed or talked about Myocarditis? She replied Yes she was diagnosed with Pericarditis and Myocarditis, but does not remember dates and do not have records. You may call the hospital and obtain records. She does not remember if she had heart inflammation after first or the second dose or after being COVID positive.  Conclusion: The complaint for Lack of Effect with the product for the COVID-19 Vaccine was investigated. The investigation included review of manufacturing records, analytical results at the time of lot release, retained reference samples, deviations, and complaint lot history trends. The final scope was limited to include the reported finished goods lot EN6206 , fill lot EN5339, the bulk formulated drug product lot EN5327. No returned complaint sample was received. All deviation investigations performed during the manufacturing process of the lot were reviewed. The conclusion of all investigations confirmed there was no quality issue which would affect the quality of the lot. No root cause or CAPA were identified as the complaint was not confirmed.  No follow-up attempts are possible. No further information is expected.