3 days after the injection, I starting have signs of migraine with aura. I’ve never had this before. The first episode was on day 3 after the shot, 2nd episode was on Jan. 5th, 3rd episode on Jan 18th, and again today (4th episode) on Jan 21st. Episode of flashing lights and blurred vision in both eyes that last for 20 min. Some are accompanied by headaches. NEVER had this before in my life.

non blanching rash, lower limbs.

patient is a 20 month old who received adult dose of covid vaccine instead of infant dosing on december 4, 2024. Patient had no adverse reaction and was well at appearing with no issues at most recent visit.

Registry immunization was down, Pt signed up to receive RSV vaccine on 1-18-25. Thoroughly went over the updated CDC guidelines and she was concerned with protection from RSV because she leaving to another country for 3 weeks and she has HX of asthma. Also, a friend of hers got RSV and was impacted and she did not want it. I was l led by her to believe she hasn’t received any prior doses. Later that day, I reverified the database to discover she had already received a dose on 11-22-23 RSv Arexvy. Spoke with Pt day after 1-19-25 to inform her of the second dose above CDC guidelines and she said she was fine, felt normal with just a sore arm as she has had in the past with other vaccines.

Tested positive for Flu type A; Lack of efficacy; Started having symptoms which have progressed to moderate and occasionally severe; This spontaneous case initially received on 13-Jan-2025, was reported by a non health professional and concerns an adult female patient. No medical history was reported Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): On 28-Dec-2024, the patient received Flucelvax (TIV) for an unknown indication, dose regimen: not reported, route of administration and anatomical location: not reported, Lot number: No batch number available, and wont be requested due to no follow-up consent. No additional suspect drugs. Adverse reactions/events and outcomes: On 12-Jan-2025, 15 days after vaccination, the patient experienced Lack of efficacy (Medically Significant, outcome: Not Reported). On 12-Jan-2025, 15 days after vaccination, the patient experienced Tested positive for Flu type A (Medically Significant, outcome: Unknown). Associated symptoms included: Started having symptoms which have progressed to moderate and occasionally severe. Patient received the Flucelvax vaccine on 28-Dec-2024 at a pharmacy. On 12-Jan-2025, she tested positive for Flu type A, started having symptoms on 10-Jan-2025 which had progressed to moderate and occasionally severe. Quality assurance informed that this is not a PTC just an adverse event. Flucelvax (TIV) action taken: Not Applicable Reporter assessment: the reporter did not provide a seriousness and causality assessment for the events.; Reporter’s Comments: Causality: Related for influenza and drug ineffective. Due to the spontaneous nature of the case, it is considered related for reporting purposes. However, the onset of protective effects of vaccination is usually 21 days post vaccination. This case is not considered an unusual failure of efficacy.

flu; flu vaccination causing uncontrollable shaking; Initial information received on 13-Jan-2025 regarding an unsolicited valid serious case received from a Patient. This case is linked to case 2024SA216487 (Same Patient). This case involves elderly female patient (weight-76.36 kg) who had flu and flu vaccination causing uncontrollable shaking after receiving Influenza Vaccine. The patient’s past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included COQ10, Omeprazole-Sodium Bicarbonate, Singulair 10 Mg Tablet, Memantine HCL 10 Mg Tablet, Levothyroxine Sodium 75 Mcg Tablet, Potassium Chloride 20 Meq Tablet Er, Lasix 40 Mg Tablet, Breo Ellipta 100-25 mcg Blst W/Dev, Lipitor 20 Mg Tablet, Atenolol 25 Mg Tablet, Albuterol Sulfate Hfa, Pradaxa 150 Mg Capsule for Product used for unknown indication. On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (unknown strength, dosage, expiry date, formulation, batch number and route) via unknown administration site for prophylactic vaccination. On an unknown date the patient developed flu (influenza) and flu vaccination causing uncontrollable shaking (tremor) (unknown latency) following the administration of Influenza Vaccine. Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, Patient Wanted To Inquire About Taking Dupixent Dose Following Hospitalization For Flu And Flu Vaccination Causing Uncontrollable Shaking. Patient Was In The Hospital With Flu, Dose Was Missed 10-Jan-2025, Needs To Know When Ok To Take Next Dose. Reports Missing A Dose Of Her Medication Dupixent, Mentioned Being In The Hospital And Having The Flu. Patient To Hold Off On Dose Of Dupixent If Comfortable In Tolerating A Prurigo Nodularis Flare Up Until Patient Stabilizes By Advising Patient To Take Next Dose On 24-Jan-2025 (Original Due 10-Jan-2025That Was Missed). Patient Advised That She Was Recently In The Hospital That Caused Her To Miss A Dose On 10-Jan-2025. Action taken with was not applicable. It was not reported if the patient received a corrective treatment for both the events. At time of reporting, the outcome was unknown for both the events. Seriousness criteria: The patient was hospitalized for the event (influenza).; Sender’s Comments: Sanofi company comment dated 20-Jan-2025: This case involves elderly female patient (weight-76.36 kg) who had flu and flu vaccination causing uncontrollable shaking after receiving Influenza Vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.

confusion that progressed to hallucinations; BP now runs from 145-150/195-98 mmHg, elevated blood pressure; confusion; a new lesion of progression; knot and pain in arm at injection site; knot and pain in arm at injection site; This is a solicited report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-017453 (BioNTech SE), 2018SA137109 (Sanofi). A 43-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; teriflunomide (AUBAGIO), since 12Apr2018) at 14 mg daily (14 mg, daily (once a day)), oral for multiple sclerosis; ofatumumab (KESIMPTA), first regimen) at first injection and second regimen) at second injection for multiple sclerosis; ozanimod hydrochloride (ZEPOSIA) for 26 days. The patient’s relevant medical history included: “total hysterectomy”, start date: 25Apr2017 (unspecified if ongoing), notes: without any hot flashes or mood swings; “lumbar puncture” (unspecified if ongoing), notes: spinal tap. Concomitant medication(s) included: VITAMIN D NOS taken for vitamin supplementation. The following information was reported: HALLUCINATION (medically significant), outcome “unknown”, described as “confusion that progressed to hallucinations”; BLOOD PRESSURE INCREASED (medically significant), outcome “recovered”, described as “BP now runs from 145-150/195-98 mmHg, elevated blood pressure”; CONFUSIONAL STATE (non-serious), outcome “unknown”, described as “confusion”; CENTRAL NERVOUS SYSTEM LESION (non-serious), outcome “unknown”, described as “a new lesion of progression”; VACCINATION SITE MASS (non-serious), VACCINATION SITE PAIN (non-serious), outcome “unknown” and all described as “knot and pain in arm at injection site”. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 145-150 mmHg; (unspecified date) 195-98 mmHg; (07Jan2025) 150/90 mmHg, notes: yesterday afternoon; (08Jan2025) 160/95 mmHg, notes: this morning; Magnetic resonance imaging: (unspecified date) a new lesion of progression, notes: Central nervous system lesion. The action taken for teriflunomide was dosage not changed; for ofatumumab and ozanimod hydrochloride was unknown. Therapeutic measures were taken as a result of blood pressure increased. The patient blood pressure (BP) being high, her pre-teriflunomide baseline BP now runs from 145-150/195-98 mmHg, elevated blood pressure. The consumer’s blood pressure was 150/90 yesterday afternoon and was 160/95 this morning. Treatment for elevated blood pressure included Losartan. Treatment for hot flashes included Estradiol. On an unknown date the patient received Pfizer covid vaccine. On an unknown date after unknown latency patient experienced knot and pain in at injection site (injection site mass and injection site pain). The patient sated her most recent MRI (magnetic resonance imaging) showed a new lesion of progression (Central nervous system lesion). Patient stated MRI done after she took second injection on Kesimpta. The action taken was not applicable for confusion, hallucination and central nervous system lesion; and no action taken and the therapy was continued for rest of the events for teriflunomide; unknown for all events for other suspects. Corrective treatment was losartan for blood pressure increased, not reported for rest. The event outcome was recovered/resolved blood pressure increased, unknown for injection site mass and injection site pain, confusion, hallucination and central nervous system lesion. The reporter causality was unassessable for confusion, hallucination and central nervous system lesion and not reported for other events. The company causality was not reportable for all events. The seriousness criteria was medically significant for hallucination. The reporter’s assessment of the causal relationship of “confusion that progressed to hallucinations”, “bp now runs from 145-150/195-98 mmhg, elevated blood pressure”, “confusion”, “a new lesion of progression” and “knot and pain in arm at injection site” with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Company Comment: Withheld company comment dated 27Nov2024: This case involves a 43-year-old female patient who experienced confusion that progressed to hallucinations, while she was treated with terifiunomide (Aubagio) and Pfizer Covid vaccine, Ofatumumab (Kesimptal and Ozanimod hydrochloride [Zeposia]. The causal role of drug cannot be excluded for event. However, lack of information regarding event details, patient’s compliance, treatment received, Jab data, medical and concomitant medications precludes the comprehensive assessment of the case. The case would be re-evaluated post the receipt of follow up information. Case serious was yes, company agent causal was no, case outcome was unknown. Batch/lot number is not provided, and it cannot be obtained. BNT162b2 is under agreement with BIONTECH SE.; Sender’s Comments: There is not a reasonable possibility that the reported events hallucination, blood pressure increased, confusion state, CNS lesion was related to the suspect product event most likely due to patient underlying contributory factors. Causality to the events vaccination site mass and vaccination site pain are most likely due to the vaccination.

he is now paralyzed; Had a stroke due to blood clot; stroke; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient’s relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant) with onset 2021, outcome “unknown”, described as “Had a stroke due to blood clot”; CEREBROVASCULAR ACCIDENT (medically significant) with onset 2021, outcome “unknown”, described as “stroke”; PARALYSIS (medically significant), outcome “unknown”, described as “he is now paralyzed”. Clinical course: It was reported that patient had a stroke due to blood clot. Reporter was calling because her husband got the COVID vaccine, three and half years ago. She said she did not know the name of it, but she is just said it was the COVID Vaccine through Pfizer.When probed to clarify the vaccine name as COVID-19 Vaccine, transferring agent stated, “Yes, she said I guess that might just be the name of it, COVID-19 vaccine and I was sure she was not sure for the actual name too. So, she said it was the Pfizer COVID vaccine that her husband received three and a half years ago.” The caller stated that her husband received the vaccine three and a half years ago and three months after receiving it, he had a stroke due to blood clot and he is now paralyzed.” she was calling to see if they could receive help for physical therapy because insurance is not helping much. I am not sure if there is anything like that because she did state that. She is looking for a help getting her husband physical therapy so, he could maybe walk again. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.

she knew someone that worked at her place of employment that developed GBS after the COVID shot; Patient also was reported to have Long Covid; This is a spontaneous report received from a Pharmacist from a sales representative. A patient (age and gender not provided) received COVID-19 Vaccine – Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient’s relevant medical history and concomitant medications were not reported. The following information was reported: POST-ACUTE COVID-19 SYNDROME (medically significant) with onset 2024, outcome “unknown”, described as “Patient also was reported to have Long Covid”; GUILLAIN-BARRE SYNDROME (medically significant) with onset 2024, outcome “unknown”, described as “she knew someone that worked at her place of employment that developed GBS after the COVID shot”. It was unknown if therapeutic measures were taken as a result of guillain-barre syndrome, post-acute covid-19 syndrome. Clinical course: It was reported that event happened approximately one year ago. She was unsure which COVID vaccine it was and unsure of the manufacturer (not known if Pfizer vaccine). Patient also was reported to have Long Covid. No other details provided. It was unknown if any treatment was received. It was unknown if patient received any other vaccines on the same date as the vaccine and unknown if the patient receive any other vaccines within 4 weeks PRIOR to the vaccine. It was unknown if the patient was taking any other medications within 2 weeks of the event starting. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender’s Comments: As there is limited information in the case provided, the causal association between the events Guillain-Barre syndrome, and post-acute COVID-19 syndrome; and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

THE J&J VACCINE CAUSED ME TO LOSE MY HEALTH, MY FAMILY, MY CAREER, AND MY HOME.; INJURIES; MY BODY IS FAILING; Foot Drop; Chronic pain syndrome; Lesion of ulnar nerve, unspecified upper limb; Myalgia, unspecified site; Other lesions of median nerve, unspecified upper limb; Pain in unspecified limb; Radiculopathy, cervical region; Lumbar radiculopathy; Lumbar stenosis; Dysfunction, bladder; Spinal stenosis, lumbar region with neurogenic claudication; Spondylosis without myelopathy or radiculopathy, lumbar region; asthenia; Neurosurgery Microdisectomy; ER/Hospitalization; This spontaneous report received from a patient concerned a 42 year old of unspecified sex. The patient’s height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose and frequency not reported, administered on 18-Aug-2021, additional dosage information included: DOSE SERIES 1, for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-Aug-2021, the patient experienced er/hospitalization. On Nov-2021, the patient experienced neurosurgery microdisectomy. On an unspecified date, the patient experienced the j&j vaccine caused me to lose my health, my family, my career, and my home., injuries, my body is failing, foot drop, chronic pain syndrome, lesion of ulnar nerve, unspecified upper limb, myalgia, unspecified site, other lesions of median nerve, unspecified upper limb, pain in unspecified limb, radiculopathy, cervical region, lumbar radiculopathy, lumbar stenosis, dysfunction, bladder, spinal stenosis, lumbar region with neurogenic claudication, spondylosis without myelopathy or radiculopathy, lumbar region, and asthenia. The j&j vaccine caused to lose the patients health, family, career, and home. The patient have not received any financial/medical support for my injuries. Patient’s body is failing (dose series 1). On 30-aug-2021, ER/hospitalization (dose series 1). The initial diagnosis was: foot drop and was referred for neurosurgery (dose series 1).In Nov-2021, performed Microdisectomy. In feb-2023. Microdisectomy surgery (MRI scans/x-rays/ nerve-testing/ pain injection/ procedures. (dose series 1)Adverse events caused: 1) chronic pain syndrome (g89.4) 2) lesion of ulnar nerve, unspecified upper limb (g56.20) 3) myalgia, unspecified site (m79.10) 4) other lesions of median nerve, unspecified upper limb (g56.10) 5) pain in unspecified limb (m79.609) 6) radiculopathy, cervical region (m54.12) 7) lumbar radiculopathy (m54.16) 8) lumbar stenosis(m48.061) 9) dysfunction, bladder (n31.9) 10) spinal stenosis, lumbar region with neurogenicclaudication (m48.062) 11) spondylosis without myelopathy or radiculopathy, lumbar region(m47.816) (dose series 1). The action taken with janssen covid-19 vaccine was not applicable. The outcome of the j&j vaccine caused me to lose my health, my family, my career, and my home., injuries, my body is failing, foot drop, chronic pain syndrome, lesion of ulnar nerve, unspecified upper limb, myalgia, unspecified site, other lesions of median nerve, unspecified upper limb, pain in unspecified limb, radiculopathy, cervical region, lumbar radiculopathy, lumbar stenosis, dysfunction, bladder, spinal stenosis, lumbar region with neurogenic claudication, spondylosis without myelopathy or radiculopathy, lumbar region, asthenia, er/hospitalization and neurosurgery microdisectomy was not reported. This report was serious (other medically important condition).; Sender’s Comments: V0: Intervertebral disc operation/ Emergency care : The event 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 than the drug. Specifically: NATURE OF EVENT. Therefore, this event is considered not related.