Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Blindness unilateral, Depression, Exposure during pregnancy, Laboratory test
Clinical narrative: MISCARRIAGE; DEPRESSED; SUDDENLY BECAME BLIND IN RIGHT EYE; SUFFERED A BLOOD CLOT IN MY RETINAL VEIN; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a patient via a company representative via media concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was pregnant at the time of vaccination. The patient was gravida 1, para 0. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 17-MAY-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 17-MAY-2021, the patient experienced vaccine exposure during pregnancy. The date of the patient's last menstrual period and expected delivery date were not reported. On 26-MAY-2021, the patient experienced became blind in right eye 9 days post vaccination. An incompetent retina specialist insisted that patient had retinitis pigmentosa. On 26-MAY-2021, patient suffered a blood clot in her retinal vein (six days). On an unspecified date, the patient experienced miscarriage, and depressed. Laboratory data (dates unspecified) included: Lab test (NR: not provided) blood clot. On an unspecified date in AUG-2022, patient underwent lab test (NR: not provided) not reported. On an unspecified date, patient underwent electroretinography scanning (a man scurried away to gather the results and came back telling patient what she already strongly suspected). Patient knew that he did not have retinitis pigmentosa. Her vision loss did not at all even somewhat go along with the progression of that hereditary disease. On an unspecified date, the pregnancy resulted in a spontaneous abortion. After going against the words of caution of some and patient's own better judgement and subjecting patient to what they knew was likely to cause blood clots causing any range of issues (commonly, blindness) up to and including death. The patient was concerned about the adverse events related to Janssen vaccine and questioned regarding its EUA approval. The reporter reported that "I cannot believe what I am reading and who it was posted by; an incompetent retina specialist. insisted I had retinitis pigmentosa when I suddenly went blind in my right eye in late May of 2021. That is, until I'd gone to facility and undergone electroretinography scanning - at my follow-up, the man at first seemed confused as to who I was or why I was there. I reminded him of my test two months prior. He scurried away to gather the results and came back telling me what I already strongly suspected. One thing is certain - I knew I did not have retinitis pigmentosa. My vision loss did not at all even somewhat go along with the progression of that hereditary disease. But the doctor was lazy and arrogant, a terrible combination. Anyway, what was wrong (and will always be wrong) with my eye was Your covid shot blinded my right eye forever! I suffered a blood clot in my retinal vein (one of them) six. days. After going against the words of caution of some and my own better judgement and subjecting myself to what you knew was likely to cause blood clots causing any range of issues (commonly, blindness) up to and including death. I can't wait until the time comes when your EUA bs protection shield is stripped away because you knowingly marketed and advertised as safe, a dangerous vaccine you knew would blind and kill people! The government should have permanently pulled your poison shot once it was suspended for those deaths -- since they no longer recommend it at all, I don't even know why they did re-approve it under EUA...well, actually, I do and they're despicable for it. Your negligence and blatant intentional harm of people for the money that flowed in with the contracts with the government to produce some bs shot with peak efficacy of 68 which rapidly declines from there and which literally kills people or permanently disables them and ruins their lives? I cannot wait until you get what's coming. Your company is known for being sued constantly and you consistently lose which is because the only thing that matters to you is money and you could not care less what happens to the people who put their trust in a self proclaimed family company. I hope your business fails but know that isn't likely what with the dozens and dozens of companies you operate that you bought out but left the original name while cutting all costs to a minimum including on quality control. You are an utter despicable disgrace. " The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suddenly became blind in right eye, miscarriage, vaccine exposure during pregnancy, suffered a blood clot in my retinal vein and depressed was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000229278, 90000256898 and 90000256840 The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as this record describes an adverse event (blindness due to blood clot and miscarriage) which does not meet the definition of a product quality complaint or explicitly allege a potency issue) based on the PQC evaluation/investigation performed. This case is a duplicate of 20221054273.  Additional information was received from a patient via a company representative via media on 26-OCT-2022. The following information was updated and incorporated into the case narrative: Case updated as valid. Event updated(blood clot to blood clot in retinal vein (recoded blood clot in retinal vein to (LLT) Retinal vein thrombosis), lab data added (lab test, electroretinography scanning), reporter (company representative) added. It was determined that nullification and deletion was required for Manufacturer Report Number (20221054273) as it was duplicate of Manufacturer Case Number (20220341285). All relevant information regarding Manufacturer Report Number (20221054273) will be submitted under Manufacturer Case Number (20220341285).; Sender's Comments: V3:. This follow-up updates that Manufacturer Report Number (20221054273) as duplicate of Manufacturer Case Number (20220341285); Adds information about event coding, lab details, reporter details. Updated.  20220341285-suffered a blood clot in my retinal vein. Follow-up received regarding Clinical Details. The event has a compatible/suggestive temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.  20220341285-suddenly became blind in right eye. Follow-up received regarding Clinical Details. The case causality is considered CONSISTENT. Rationale: As blindness in right eye is associated with of blood clot in retinal vein. Hence causality assessed in line with blood clot in retinal vein.   20220341285-covid-19 vaccine ad26.cov2.s -Miscarriage. Follow-up received regarding Clinical Details. The event(s) has unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.  20220341285-covid-19 vaccine ad26.cov2.s -vaccine exposure during pregnancy. Follow-up received regarding Clinical Details. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.