| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2823763 | 43 | F | MI | 01/30/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
MZ379 |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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gave her a Dtap Polio (Kinrix) instead of a Tdap (Boostrix); she is 43 and I gave her a Dtap Polio; ...
gave her a Dtap Polio (Kinrix) instead of a Tdap (Boostrix); she is 43 and I gave her a Dtap Polio; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 43-year-old female patient who received DTPa-IPV (Kinrix) (batch number MZ379, expiry date 25-JAN-2025) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 13-JAN-2025, the patient received Kinrix. On an unknown date, the patient did not receive Boostrix. On 13-JAN-2025, an unknown time after receiving Kinrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: gave her a Dtap Polio (Kinrix) instead of a Tdap (Boostrix)) and inappropriate age at vaccine administration (Verbatim: she is 43 and I gave her a Dtap Polio). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15-JAN-2025 The nurse gave a Dtap Polio (Kinrix) instead of a Tdap (Boostrix) to adult patient, she was 43 which led to wrong vaccine administered and inappropriate age at vaccine administration. The nurse was told to call GlaxoSmithKline and get your recommendations on revaccination. The Vaccine Administration Facility was the same as Primary Reporter.
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| 2823764 | 48 | F | CA | 01/30/2025 |
COVID19 |
MODERNA |
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Urticaria
Urticaria
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Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (H...
Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. Patient's past medical history included: Hemangioma, Splenectomy, Migraines Patient's concurrent condition included: Anaphylactic reaction due to food additives, subsequent encounter, Allergic urticaria, Allergy to milk products, Allergy to seafood, Allergy to other foods,Allergy to carrageenan, Allergy to Polysorbate 80,Hemangioma of right eyelid,Cavernoma in hypothalamus, Environmental allergies, Allergy to birch, Allergy to Timothy grass,Allergy to red Oak, Allergy to hickory,Allergy to red cedar tree, Allergy to Johnson grass, Allergy to dogs, Allergy to cats, Allergy to mice,Oral allergy syndrome,Allergy to Sulfa, Allergy to Penicillin, Headaches. Patient's concomitant medication included: pneumonia vaccine, Meningitis vaccine, PNEUMOVAX,ZYRTEC [CETIRIZINE HYDROCHLORIDE], Allegra, Pepcid, PROPRANOLOL,TYLENOL,IBUPROFEN, Polysorbate 80. The patient's past medical history included Hemangioma, Anaphylactic shock due to food additives, Eyelid hemangioma, Cavernoma, Headache and Splenectomy. Concurrent medical conditions included Migraine, Allergic urticaria, Seafood allergy, Environmental allergy, Oral allergy syndrome, Penicillin allergy, Allergy to plants (Allergy to red Oak), Allergy to animals (Allergy to dogs), Food allergy (Allergy to other foods), Sulfonamide allergy, Grass allergy (Allergy to Timothy grass), Drug allergy (Allergy to Polysorbate 80), Allergy to animals (Allergy to cats), Allergy to animals (Allergy to mice), Grass allergy (Allergy to Johnson grass), Allergy to plants (Allergy to birch), Allergy to plants (Allergy to red cedar tree), Allergy to plants (Allergy to hickory), Food allergy (allergic to carrageenan) and Hives. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Hives, POLYSORBATE 80, Pneumococcal vaccine polysacch 23v (PNEUMOVAX), PROPRANOLOL, Paracetamol (TYLENOL) and IBUPROFEN for an unknown indication. In November 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). The patient was treated with Diphenhydramine hydrochloride (Benadryl) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives) had resolved. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown. On -NOV-2023, patient started therapy with Moderna COVID vaccine. Patient stated that she went to get the 2023 Moderna COVID vaccine at Pharmacy and the Polysorbate 80 within the vaccine gave her hives. Patient stated that she took Benadryl, and the hives resolved about 2 days later. This case was linked to US-MODERNATX, INC.-MOD-2025-781748 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2025: Live Follow-up ๏ฟฝ No New Information accepted; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781748:case for everybody
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| 2823765 | F | 01/30/2025 |
COVID19 |
MODERNA |
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COVID-19
COVID-19
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hospitalization due to COVID/she is getting over COVID; This spontaneous case was reported by a phar...
hospitalization due to COVID/she is getting over COVID; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (hospitalization due to COVID/she is getting over COVID) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Allergy to chemicals (Allergy to polysorbate). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (hospitalization due to COVID/she is getting over COVID) (seriousness criterion hospitalization). At the time of the report, COVID-19 (hospitalization due to COVID/she is getting over COVID) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments. The patient's age was reported to be over 65 years. No concomitant medications were reported. The reporter stated that the patient had specifically asked for Moderna as she was getting over COVID. The reporter stated that she ended up in hospital. The reporter believed the patient previously received a dose of Moderna since the patient had specifically asked for Moderna. The patient had an allergy to polysorbate and could not receive several vaccines. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.
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| 2823766 | M | WA | 01/30/2025 |
COVID19 |
PFIZER\BIONTECH |
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Deep vein thrombosis, Laboratory test, Pneumonia, Pulmonary thrombosis, Type 2 d...
Deep vein thrombosis, Laboratory test, Pneumonia, Pulmonary thrombosis, Type 2 diabetes mellitus
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Deep vein thrombosis; Blood clot in lungs; pneumonia; Type 2 Diabetic, borderline Type 1; This is a ...
Deep vein thrombosis; Blood clot in lungs; pneumonia; Type 2 Diabetic, borderline Type 1; This is a spontaneous report received from a Consumer or other non HCP. A 66-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY THROMBOSIS (hospitalization), outcome "unknown", described as "Blood clot in lungs"; DEEP VEIN THROMBOSIS (hospitalization, medically significant), outcome "unknown"; PNEUMONIA (medically significant), outcome "unknown"; TYPE 2 DIABETES MELLITUS (medically significant), outcome "not recovered", described as "Type 2 Diabetic, borderline Type 1". The patient was hospitalized for pulmonary thrombosis (hospitalization duration: 11 day(s)). The patient underwent the following laboratory tests and procedures: lab: Unknown results. Therapeutic measures were taken as a result of pulmonary thrombosis, deep vein thrombosis. Clinical course: Patient who received the latest Comirnaty vaccine. He is having side effects that he was calling to report and wanted to speak to someone about that. After transfer clarified it's been a while since had the vaccine, but saw a published list of side effects and have couple those wanted to discuss. Clarified side effects she experienced as having deep vein thrombosis and had blood clots in lungs. Deep Vein Thrombosis, he explained he is on blood thinners to keep it from happening. Blood Clot in Lungs, confirmed he thinks itis gone. They pumped him with anticoagulants while in the hospital. He was in the hospital for 11 days due to this. He also added, now he is a Type 2 Diabetic, borderline Type 1 and he was not a diabetic before. He is on a lot of medication. Outcome is unable to provide, stated he is still holding on. He has to watch what he eats and take medication. Treatment: He clarified later the blood thinner as, Eliquis- 2.5mg twice a day, tablet, by mouth. He also clarified, the diabetic medication as Jardiance, dosage unknown and, Rybelsus dosage unknown. He confirmed this was the only Pfizer Comirnaty Vaccine he received. He added that he had pneumonia several times after receiving the vaccine. This occurred months after experiencing deep vein thrombosis and blood clot in lungs. However, does not know the dates to provide. He was hospitalized for a week(as reported). He had labs done during this time, but no further details provided. Prior Vaccinations (within 4 weeks): None. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2823767 | 39 | F | OH | 01/30/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EW0169 EW0169 EW0169 EW0169 EW0169 EW0169 EW0169 EW0169 |
Anti-thyroid antibody, Blood thyroid stimulating hormone, Dry eye, Ear pain, End...
Anti-thyroid antibody, Blood thyroid stimulating hormone, Dry eye, Ear pain, Endocrine ophthalmopathy; Eye pain, Graves' disease, Inappropriate schedule of product administration, Influenza like illness, Ocular discomfort; Pain in extremity, SARS-CoV-2 test, Thyroid function test, Thyroxine; COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test; Anti-thyroid antibody, Blood thyroid stimulating hormone, Dry eye, Ear pain, Endocrine ophthalmopathy; Eye pain, Graves' disease, Inappropriate schedule of product administration, Influenza like illness, Ocular discomfort; Pain in extremity, SARS-CoV-2 test, Thyroid function test, Thyroxine; COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
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graves; thyroid eye disease; had pain in her arms; she also felt sick like had the flu for about 24 ...
graves; thyroid eye disease; had pain in her arms; she also felt sick like had the flu for about 24 hours; eye pain; ear pain; dry eye; EYE PRESSURE; the first was done on 31Jul2021/the second dose was on 13Aug2021; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 43-year-old female patient received BNT162b2 (BNT162B2), on 13Aug2021 as dose 2, single (Lot number: EW0169) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "asthma attacks", start date: 2019 (unspecified if ongoing); "throwing up" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Metoprolol for blood pressure, reaction(s): "asthma attack"; Metoprolol for blood pressure, reaction(s): "phlegm"; Metoprolol for blood pressure, reaction(s): "spasms"; Metoprolol for blood pressure, reaction(s): "vasomotor reaction". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EW0158), administration date: 31Jul2021, when the patient was 39-year-old, for Covid-19 immunization, reaction(s): "had pain in her arms", "she also felt sick like had the flu for about 24 hours". The following information was reported: GRAVES' DISEASE (medically significant), outcome "unknown", described as "graves"; ENDOCRINE OPHTHALMOPATHY (medically significant), outcome "unknown", described as "thyroid eye disease"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had pain in her arms"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "she also felt sick like had the flu for about 24 hours"; EYE PAIN (non-serious), outcome "unknown"; EAR PAIN (non-serious), outcome "unknown"; DRY EYE (non-serious), outcome "unknown"; OCULAR DISCOMFORT (non-serious), outcome "unknown", described as "EYE PRESSURE"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "the first was done on 31Jul2021/the second dose was on 13Aug2021". The patient underwent the following laboratory tests and procedures: Anti-thyroid antibody: (02Nov2021) 98.9; Blood thyroid stimulating hormone: (02Nov2021) 1.72; SARS-CoV-2 test: (06Jan2022) Positive; Thyroid function test: (unspecified date) graves disease and thyroid eye disease; Thyroxine: (02Nov2021) 1.0. Therapeutic measures were taken as a result of graves' disease (methimazole).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500020504 same patient, different event, different dose of vaccine;
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| 2823768 | U | OH | 01/30/2025 |
COVID19 |
PFIZER\BIONTECH |
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Bedridden, Brain fog, Dizziness, Investigation
Bedridden, Brain fog, Dizziness, Investigation
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extreme dizziness; can't get out of bed; My head is almost never clear; This is a spontaneous r...
extreme dizziness; can't get out of bed; My head is almost never clear; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An 84-year-old patient received BNT162b2 (BNT162B2), 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: DIZZINESS (hospitalization), outcome "not recovered", described as "extreme dizziness"; BEDRIDDEN (non-serious), outcome "not recovered", described as "can't get out of bed"; BRAIN FOG (non-serious), outcome "unknown", described as "My head is almost never clear". The patient underwent the following laboratory tests and procedures: Test: all good. Clinical details: patient was 84 years old. Patient has been having extreme dizziness and was in the hospital. Tests were all good. His/her head was almost never clear. Sometimes he/she can't get out of bed. Patient had the Pfizer shot at the beginning of COVID. Patient asked if this could be from the vaccine. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2823785 | F | CT | 01/30/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Shingrix - Late second dose; This non-serious case was reported by a pharmacist via call center repr...
Shingrix - Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Patient received first dose in 2021). On 01-NOV-2024, the patient received the 2nd dose of Shingrix. On 01-NOV-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Shingrix - Late second dose). The outcome of the drug dose administration interval too long was unknown. Additional Information: GSK Receipt Date: 10-JAN-2025 Pharmacist mentioned that a patient received the first dose of Shingrix in 2021 and second dose was given on 01-NOV-2024. The pharmacist asked if the patient should receive a third dose. The reporter did not share information about Shingrix doses such as lot number and expiration date. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
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| 2823786 | U | 01/30/2025 |
COVID19 |
MODERNA |
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Death
Death
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Caller said that 32 people of her family were killed because of the vaccine including her niece'...
Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided. This case is reported for patient 12 out of 32 patients. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781803:Patient 12; Reported Cause(s) of Death: Death unexplained
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| 2823787 | U | 01/30/2025 |
COVID19 |
MODERNA |
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Death
Death
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Caller said that 32 people of her family were killed because of the vaccine including her niece'...
Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case contains information for patient 13 out of 32. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781803:Patient 1 (Master case); Reported Cause(s) of Death: Death unexplained
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| 2823788 | U | 01/30/2025 |
COVID19 |
MODERNA |
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Death
Death
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Caller said that 32 people of her family were killed because of the vaccine including her niece'...
Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case contains information for patient 23 out of 32. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781803:Patient 1 (Master case); Reported Cause(s) of Death: Death unexplained
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| 2823789 | U | 01/30/2025 |
COVID19 |
MODERNA |
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Death
Death
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Caller said that 32 people of her family were killed because of the vaccine including her niece'...
Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided. This case is reported for patient 14 out of 32 patients. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781803:Patient 14; Reported Cause(s) of Death: Death unexplained
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| 2823790 | U | 01/30/2025 |
COVID19 |
MODERNA |
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Death
Death
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Caller said that 32 people of her family were killed because of the vaccine including her niece'...
Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case contains information for patient 2 out of 32. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781803:Patient 2; Reported Cause(s) of Death: Death unexplained
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| 2823791 | U | 01/30/2025 |
COVID19 |
MODERNA |
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Death
Death
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Caller said that 32 people of her family were killed because of the vaccine including her niece'...
Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case contains information for patient 29 out of 32. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781803:Patient 29; Reported Cause(s) of Death: Death unexplained
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| 2823792 | U | 01/30/2025 |
COVID19 |
MODERNA |
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Death
Death
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Caller said that 32 people of her family were killed because of the vaccine including her niece'...
Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case contains information for patient 15 out of 32. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781803:Patient 1 (Master case); Reported Cause(s) of Death: Death unexplained
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| 2823793 | U | 01/30/2025 |
COVID19 |
MODERNA |
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Death
Death
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Caller said that 32 people of her family were killed because of the vaccine including her niece'...
Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided. This case is reported for patient 30 out of 32 patients. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781803:Patient 30; Reported Cause(s) of Death: Death unexplained
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| 2823794 | U | 01/30/2025 |
COVID19 |
MODERNA |
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Death
Death
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Caller said that 32 people of her family were killed because of the vaccine including her niece'...
Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case contains information for patient 31 out of 32. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781803:Patient 31; Reported Cause(s) of Death: Death unexplained
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| 2823795 | U | 01/30/2025 |
COVID19 |
MODERNA |
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Death
Death
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Caller said that 32 people of her family were killed because of the vaccine including her niece'...
Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case contains information for patient 3 out of 32. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781803:Patient 3; Reported Cause(s) of Death: Death unexplained
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| 2823796 | U | 01/30/2025 |
COVID19 |
MODERNA |
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Death
Death
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Caller said that 32 people of her family were killed because of the vaccine including her niece'...
Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case contains information for patient 32 out of 32. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781803:Patient 32; Reported Cause(s) of Death: Death unexplained
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| 2823797 | U | 01/30/2025 |
COVID19 |
MODERNA |
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Death
Death
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Caller said that 32 people of her family were killed because of the vaccine including her niece'...
Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided. This case is reported for patient 24 out of 32 patients. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as " 32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as " 32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause and date of death. The benefit-risk relationship of product is not affected by this report. US-MODERNATX, INC.-MOD-2025-781803:Patient 24; Reported Cause(s) of Death: Death unexplained
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| 2823798 | U | 01/30/2025 |
COVID19 |
MODERNA |
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Death
Death
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Caller said that 32 people of her family were killed because of the vaccine including her niece'...
Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case contains information for patient 16 out of 32. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as " 32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as " 32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause and date of death. The benefit-risk relationship of product is not affected by this report. US-MODERNATX, INC.-MOD-2025-781803:Patient 16; Reported Cause(s) of Death: Death unexplained
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| 2823799 | U | 01/30/2025 |
COVID19 |
MODERNA |
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Death
Death
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Caller said that 32 people of her family were killed because of the vaccine including her niece'...
Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case contains information for patient 4 out of 32. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as " 32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as " 32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause and date of death. The benefit-risk relationship of product is not affected by this report. US-MODERNATX, INC.-MOD-2025-781803:Patient 4; Reported Cause(s) of Death: Death unexplained
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| 2823800 | U | 01/30/2025 |
COVID19 |
MODERNA |
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Death
Death
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Caller said that 32 people of her family were killed because of the vaccine including her niece'...
Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case contains information for patient 25 out of 32. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as " 32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as " 32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause and date of death. The benefit-risk relationship of product is not affected by this report. US-MODERNATX, INC.-MOD-2025-781803:Patient 1 (Master case); Reported Cause(s) of Death: Death unexplained
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| 2823801 | U | 01/30/2025 |
COVID19 |
MODERNA |
|
Death
Death
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Caller said that 32 people of her family were killed because of the vaccine including her niece'...
Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided. This case is reported for patient 5 out of 32 patients. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as " 32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as " 32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause and date of death. The benefit-risk relationship of product is not affected by this report. US-MODERNATX, INC.-MOD-2025-781803:Patient 5; Reported Cause(s) of Death: Death unexplained
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| 2823802 | U | 01/30/2025 |
COVID19 |
MODERNA |
|
Death
Death
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Caller said that 32 people of her family were killed because of the vaccine including her niece'...
Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case contains information for patient 17 out of 32. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as " 32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as " 32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause and date of death. The benefit-risk relationship of product is not affected by this report. US-MODERNATX, INC.-MOD-2025-781803:Patient 1 (Master case); Reported Cause(s) of Death: Death unexplained
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| 2823803 | U | 01/30/2025 |
COVID19 |
MODERNA |
|
Death
Death
|
Caller said that 32 people of her family were killed because of the vaccine including her niece'...
Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case contains information for patient 26 out of 32. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as " 32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as " 32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause and date of death. The benefit-risk relationship of product is not affected by this report. US-MODERNATX, INC.-MOD-2025-781803:Patient 26; Reported Cause(s) of Death: Death unexplained
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| 2823804 | U | 01/30/2025 |
COVID19 |
MODERNA |
|
Death
Death
|
Caller said that 32 people of her family were killed because of the vaccine including her niece'...
Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case contains information for patient 6 out of 32. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as " 32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as " 32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause and date of death. The benefit-risk relationship of product is not affected by this report. US-MODERNATX, INC.-MOD-2025-781803:Patient 6; Reported Cause(s) of Death: Death unexplained
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โ | |||||||
| 2823805 | U | 01/30/2025 |
COVID19 |
MODERNA |
|
Death
Death
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Caller said that 32 people of her family were killed because of the vaccine including her niece'...
Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case contains information for patient 7 out of 32. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781803:Patient 7; Reported Cause(s) of Death: Death unexplained
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| 2823806 | U | 01/30/2025 |
COVID19 |
MODERNA |
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Death
Death
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Caller said that 32 people of her family were killed because of the vaccine including her niece'...
Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. This case contains information for patient 1 out of 32. Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-781834, US-MODERNATX, INC.-MOD-2025-781835, US-MODERNATX, INC.-MOD-2025-781838, US-MODERNATX, INC.-MOD-2025-781839, US-MODERNATX, INC.-MOD-2025-781841, US-MODERNATX, INC.-MOD-2025-781791, US-MODERNATX, INC.-MOD-2025-781842, US-MODERNATX, INC.-MOD-2025-781844, US-MODERNATX, INC.-MOD-2025-781847, US-MODERNATX, INC.-MOD-2025-781848, US-MODERNATX, INC.-MOD-2025-781849, US-MODERNATX, INC.-MOD-2025-781851, US-MODERNATX, INC.-MOD-2025-781850, US-MODERNATX, INC.-MOD-2025-781846, US-MODERNATX, INC.-MOD-2025-781853, US-MODERNATX, INC.-MOD-2025-781854, US-MODERNATX, INC.-MOD-2025-781845, US-MODERNATX, INC.-MOD-2025-781856, US-MODERNATX, INC.-MOD-2025-781855, US-MODERNATX, INC.-MOD-2025-781858, US-MODERNATX, INC.-MOD-2025-781843, US-MODERNATX, INC.-MOD-2025-781859, US-MODERNATX, INC.-MOD-2025-781860, US-MODERNATX, INC.-MOD-2025-781864, US-MODERNATX, INC.-MOD-2025-781865, US-MODERNATX, INC.-MOD-2025-781866, US-MODERNATX, INC.-MOD-2025-781863, US-MODERNATX, INC.-MOD-2025-781867, US-MODERNATX, INC.-MOD-2025-781868, US-MODERNATX, INC.-MOD-2025-781869, US-MODERNATX, INC.-MOD-2025-781874, US-MODERNATX, INC.-MOD-2025-781878 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781834:Patient 12 US-MODERNATX, INC.-MOD-2025-781839:Patient 23 US-MODERNATX, INC.-MOD-2025-781844:Patient 15 US-MODERNATX, INC.-MOD-2025-781854:Patient 5 US-MODERNATX, INC.-MOD-2025-781835:Invalid Case For moderna and Pfizer product US-MODERNATX, INC.-MOD-2025-781838:Patient 13 US-MODERNATX, INC.-MOD-2025-781847:Patient 3 US-MODERNATX, INC.-MOD-2025-781842:Patient 2 US-MODERNATX, INC.-MOD-2025-781848:Patient 32 US-MODERNATX, INC.-MOD-2025-781853:Patient 25 US-MODERNATX, INC.-MOD-2025-781846:Patient 31 US-MODERNATX, INC.-MOD-2025-781850:Patient 16 US-MODERNATX, INC.-MOD-2025-781791:Patient 23 US-MODERNATX, INC.-MOD-2025-781845:Patient 30 US-MODERNATX, INC.-MOD-2025-781849:Patient 24 US-MODERNATX, INC.-MOD-2025-781851:Patient 4 US-MODERNATX, INC.-MOD-2025-781841:Patient 14 US-MODERNATX, INC.-MOD-2025-781855:Patient 17 US-MODERNATX, INC.-MOD-2025-781856:Patient 26 US-MODERNATX, INC.-MOD-2025-781859:Patient 27 US-MODERNATX, INC.-MOD-2025-781843:Patient 29 US-MODERNATX, INC.-MOD-2025-781858:Patient 6 US-MODERNATX, INC.-MOD-2025-781864:Patient 8 US-MODERNATX, INC.-MOD-2025-781867:Patient 11 US-MODERNATX, INC.-MOD-2025-781868:Patient 19 US-MODERNATX, INC.-MOD-2025-781863:Patient 18 US-MODERNATX, INC.-MOD-2025-781865:Patient 9 US-MODERNATX, INC.-MOD-2025-781866:Patient 10 US-MODERNATX, INC.-MOD-2025-781874:Patient 21 US-MODERNATX, INC.-MOD-2025-781860:Patient 7 US-MODERNATX, INC.-MOD-2025-781869:Patient 20 US-MODERNATX, INC.-MOD-2025-781878:master case (patient 22); Reported Cause(s) of Death: Death unexplained
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| 2823807 | F | 01/30/2025 |
COVID19 |
NOVAVAX |
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COVID-19, Haematological malignancy
COVID-19, Haematological malignancy
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She had Covid twice; She also has a blood cancer diagnosis; This serious initial Spontaneous safety ...
She had Covid twice; She also has a blood cancer diagnosis; This serious initial Spontaneous safety report was received by Novavax on 23-Jan-2025 from a Consumer or other non-health professional via Novavax Medical Information (Case No. NOV25-00044). A 72-year-old Female was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) (Intramuscular) (Lot number was not provided in the report) on an unspecified date. No medical history was reported. No concomitant medications were reported. On an unspecified date after vaccination the patient experienced She also has a blood cancer diagnosis (PT: Haematological malignancy) (Serious: Other Medically Important Condition) and on an unspecified date after vaccination the patient experienced She had Covid twice (PT: COVID-19). At the time of reporting, the event outcome of Haematological malignancy was Unknown and COVID-19 was Unknown.; Sender's Comments: This 72-year-old Female experienced Haematological malignancy and COVID-19 after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The event Haematological malignancy was assessed as serious. The event COVID-19 was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Haematological malignancy and COVID-19 is considered Possible.
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| 2823808 | F | 01/30/2025 |
COVID19 |
PFIZER\BIONTECH |
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Bone pain, Joint range of motion decreased
Bone pain, Joint range of motion decreased
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the bone in my left arm is killing me/pain when i lift my arm; the bone in my left arm is killing me...
the bone in my left arm is killing me/pain when i lift my arm; the bone in my left arm is killing me/pain when i lift my arm; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2023 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY); alprazolam (XANAX). The patient's relevant medical history included: "copd" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; unknown manufacturer), for covid-19 immunization; Covid-19 vaccine (Dose 2; unknown manufacturer), for covid-19 immunization. The following information was reported: BONE PAIN (hospitalization, life threatening), JOINT RANGE OF MOTION DECREASED (hospitalization, life threatening), outcome "unknown" and all described as "the bone in my left arm is killing me/pain when i lift my arm". The event "the bone in my left arm is killing me/pain when i lift my arm" required emergency room visit. The action taken for fluticasone furoate, umeclidinium bromide, vilanterol trifenatate and alprazolam was unknown. Clinical course: When asked if the adverse reaction required her to go to the emergency room, the patient said, "yes because the bone in my left arm is killing me". Patient can feel pain in her bone and cannot lift up her arm and definitely need more than an x-ray because it would not show in the x-ray. This happens for doing the right thing, getting a booster shot for covid which she received 2 years ago (in 2023). She has pain when she lifts her arm. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
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| 2823809 | 68 | M | CA | 01/30/2025 |
PNC20 |
PFIZER\WYETH |
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Injection site pain, Pain
Injection site pain, Pain
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it has been 1 week , 6 days of injection site pain/when he moved arm the muscle was hurting.; This i...
it has been 1 week , 6 days of injection site pain/when he moved arm the muscle was hurting.; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 68-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 21Jan2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years intramuscular, in left arm for immunisation. The patient's relevant medical history included: "COVID-19", start date: Dec2024 (not ongoing); "Valley fever", start date: 2023 (ongoing); "Afib" (ongoing); "BPH" (ongoing); "Cholesterol" (ongoing). Concomitant medication(s) included: DIFLUCAN oral taken for coccidioidomycosis, start date: Dec2023 (ongoing); DABIGATRAN oral taken for atrial fibrillation; DILTIAZEM oral taken for atrial fibrillation, start date: Dec2023 (ongoing); TERAZOSIN oral taken for benign prostatic hyperplasia (ongoing); ROSUVASTATIN oral taken for blood cholesterol abnormal (ongoing). Past drug history included: Simvastatin for Cholesterol, notes: Probably started originally 10 -15 years ago and doesn't recall when switched. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21Jan2025, outcome "not recovered", described as "it has been 1 week , 6 days of injection site pain/when he moved arm the muscle was hurting.". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: the patient stated that he had injection site pain that was lasted 6 days now, almost a week. He was really just calling to see if it is normal. He talked to a nurse and she had no idea. He wanted to see what timeline would be for that kind of pain. He does want to mention he was not 100% sure but he thought that the pain for him only lasted about 2 days and from what he remember pain was gone and yesterday, 26Jan2025, he noticed it hurting, not horrible, when he moved arm the muscle was hurting. He does not know if it really went away, it seemed like went away and came back but he may not have noticed. States the pain was also when he pushed on it. outcome: well when it started right after he had it and next day it was about the same as that and when it restarted he guesses it's about the same. pain - there was the pain of the actual needle going in but the injection site pain was probably pretty soon after, within a couple hours. Like 1-2 hours later. Indication: because someone talked him into it finally. They kept asking him about it for several years and he finally saw a doctor and he said he really should based on his age. States that and he was not wanting to get pneumonia. Additional information on relevant medical history, It was reported that, the patient had Covid a month ago and recovered. He took Paxlovid for that, not within the 2 weeks of injection site pain, it was a month before. Valley fever did test positive Valley Fever but doesn't know if he was still positive. Had not been retested yet. Concomitant Medications: Dabigatran states that a little over year ago when he started valley fever, he had really bad symptoms. Had symptoms of AFib which he had never had before. He only had 2 little episodes when in the throws of valley fever but must be on this the rest of his life. Additional Information for Other medicines Rosuvastatin: used to be different many years ago and changed from simvastatin to this. Probably started originally 10 -15 years ago and doesn't recall when switched to this. Additional Information for Other medicines Terazosin: started taking about 6 months ago. Additional Information for Other medicines Diflucan: Has ongoing valley fever. He had Valley Fever a year ago and he tested positive again. Original start date Dec2023 and was on for 3 months. Was off Diflucan and back on about a month ago, 13Dec2024. The patient felt pretty confident it is normal. He hasn't had a vaccine last this long or go away and come back. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2823810 | 75 | F | FL | 01/30/2025 |
COVID19 |
PFIZER\BIONTECH |
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Erythema, Pruritus
Erythema, Pruritus
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Red, itchy arm; Red, itchy arm; This is a spontaneous report received from a Consumer or other non H...
Red, itchy arm; Red, itchy arm; This is a spontaneous report received from a Consumer or other non HCP. A 75-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 21Jan2025 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 14Jan2025 as dose number unknown, single; SECTRAL. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ERYTHEMA (non-serious), PRURITUS (non-serious) all with onset 21Jan2025 at 16:00, outcome "not recovered" and all described as "Red, itchy arm". Therapeutic measures were not taken as a result of erythema, pruritus. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2823811 | 60 | F | MI | 01/30/2025 |
FLU3 PNC20 |
GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH |
9H5J5 LJ5283 |
Rash papular, Rash pruritic; Rash papular, Rash pruritic
Rash papular, Rash pruritic; Rash papular, Rash pruritic
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large rash, itchy and still spreading and slightly swollen; This is a spontaneous report received fr...
large rash, itchy and still spreading and slightly swollen; This is a spontaneous report received from a Consumer or other non HCP. A 60-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 21Jan2025 at 15:48 as dose number unknown, 0.5ml single (Lot number: LJ5283, Expiration Date: 31May2026) at the age of 60 years intramuscular, in left deltoid for immunisation; influenza vaccine inact split 3v (FLULAVAL), on 21Jan2025 as dose number unknown, single (Lot number: 9H5J5, Expiration Date: 30Jun2025) for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: RASH PRURITIC (non-serious) with onset 26Jan2025, outcome "not recovered", described as "large rash, itchy and still spreading and slightly swollen". Therapeutic measures were taken as a result of rash pruritic. Additional information: Reporter (Medical assistant) was calling from a doctor's office, because they have a patient who had an adverse reaction to the Prevnar 20. The doctor was asking if there was anything else, she was using hydrocortisone cream (Treatment) and the doctor was recommending Benadryl for the adverse reaction (Treatment). Reporter stated that the patient was having a large rash, itchy and still spreading and slightly swollen. The patient was on several medications, Not on reporting day. Reporter stated, she still experiencing the reaction.
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| 2823812 | 61 | F | NY | 01/30/2025 |
COVID19 PNC20 |
MODERNA PFIZER\WYETH |
8080803 LJ5283 |
Arthralgia, Back pain, Gait disturbance, Muscle tightness, Musculoskeletal pain;...
Arthralgia, Back pain, Gait disturbance, Muscle tightness, Musculoskeletal pain; Arthralgia, Back pain, Gait disturbance, Muscle tightness, Musculoskeletal pain
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Left Psoas tightness; lower back pain; buttock pain; difficulty walking; hip pain; This is a spontan...
Left Psoas tightness; lower back pain; buttock pain; difficulty walking; hip pain; This is a spontaneous report received from a Nurse. A 61-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 18Jan2025 as dose 1, single (Lot number: LJ5283) at the age of 61 years, in right deltoid for immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Jan2025 as dose number unknown, single (Lot number: 8080803), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE TIGHTNESS (non-serious) with onset 19Jan2025 at 06:00, outcome "not recovered", described as "Left Psoas tightness"; MUSCULOSKELETAL PAIN (non-serious) with onset 19Jan2025 at 06:00, outcome "not recovered", described as "buttock pain"; GAIT DISTURBANCE (non-serious) with onset 19Jan2025 at 06:00, outcome "not recovered", described as "difficulty walking"; ARTHRALGIA (non-serious) with onset 19Jan2025 at 06:00, outcome "not recovered", described as "hip pain"; BACK PAIN (non-serious) with onset 19Jan2025 at 06:00, outcome "not recovered", described as "lower back pain". Therapeutic measures were taken as a result of muscle tightness, back pain, musculoskeletal pain, gait disturbance, arthralgia. Additional information: On 18Jan2025 received co-suspect Moderna 2024-2025 covid vaccine. Unknown if patient took any other medications within 2 weeks of the event starting. All symptoms associated with Left Psoas tightness including lower back pain, hip pain, buttock pain, difficulty walking, no prolonged hospitalization due to it. When asked what treatment received for the adverse event? So far, the pain was still existing as of this date.
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| 2823813 | M | PA | 01/30/2025 |
COVID19 |
PFIZER\BIONTECH |
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Death
Death
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Died; This is a spontaneous report received from a consumer. An adult male patient received BNT162b...
Died; This is a spontaneous report received from a consumer. An adult male patient received BNT162b2 Omicron (KP.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Hospitalization" (ongoing). The patient took concomitant medications. The patient received other medications in two weeks. Vaccination history included: COVID-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; COVID-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. No other vaccine was administered in four weeks or on the same date of the suspect COVID-19 vaccine. The following information was reported: DEATH (death, prolonged hospitalization, disability, life threatening, medically significant), outcome "fatal", described as "Died". Therapeutic measures were taken as a result of death. The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The patient's child was doing this for the patient as he died from getting the COVID-19 vaccines and boosters. The adverse events resulted in death, prolongation of existing hospitalization (treatment received during existing hospitalization), life-threatening illness (immediate risk of death from the event), and disability or permanent damage. Per patient's child, the patient did not recover from the event. The information on the batch/lot number for BNT162b2 Omicron (KP.2) will be requested and submitted if and when received.; Reported Cause(s) of Death: Died
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| 2823814 | M | GA | 01/30/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Back pain, Dyspnoea, Magnetic resonance imaging, Pain, Palpitations; Vaccination...
Back pain, Dyspnoea, Magnetic resonance imaging, Pain, Palpitations; Vaccination site pain, Weight
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constant pain in right side, where he got the shot and, back from lower area he got shot, towards th...
constant pain in right side, where he got the shot and, back from lower area he got shot, towards the back and, all the way up, pain in that lower back area, the right side, basically, his lower area; shortness of breath; heart just started racing; constant pain in right side, where he got the shot; constant pain in right side; towards the lungs, right where he got the shot, right near the buttocks; This is a spontaneous report received from a Consumer or other non HCP. A 42-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing), notes: controlled. There were no concomitant medications. Vaccination history included: Pfizer/biontech covid-19 vaccine (dose 1), for COVID-19 immunisation/COVID-19 immunisation/to leave the country. The following information was reported: BACK PAIN (non-serious), outcome "not recovered", described as "constant pain in right side, where he got the shot and, back from lower area he got shot, towards the back and, all the way up, pain in that lower back area, the right side, basically, his lower area"; DYSPNOEA (non-serious), outcome "not recovered", described as "shortness of breath"; PALPITATIONS (non-serious), outcome "not recovered", described as "heart just started racing"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "constant pain in right side, where he got the shot"; PAIN (non-serious), outcome "not recovered", described as "constant pain in right side; towards the lungs, right where he got the shot, right near the buttocks". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of back pain, dyspnoea, palpitations, vaccination site pain, pain. Additional information: The patient did not have any history of asthma in family, he did not have history of asthma. The patient other conditions was yes. The patient called and informed that the vaccine he got, maybe a year or 2 years ago, has been having some issues after having the shot. The patient clarified, he got 2 doses, the first and second. He was supposed to go back for third, wasn't positive that was a good idea because of what was happening. He had 2 doses, Pfizer Corona vaccine, has no prior vaccinations (within 4 weeks). The patient clarifying specific issue being referred to that patient experienced after corona vaccine, stated, it has been going on for last 2 or 3 years now, basically, has shortness of breath, has constant pain down in the area. Has created issue with like, breathing, heart just started racing, have to stop or slow down little bit, trying to catch breathing. Has constant pain in right side, where he got the shot and, back from lower area he got shot, towards the back and, all the way up, pain in that lower back area, the right side, basically, his lower area, where he got the shot, towards the lungs, right where he got the shot, right near the buttocks, where he got the shot. That was where he got the shot, where he has the pain. Clarified, caller had corona vaccine shot, near buttocks, on the right side. That was where he has the pain. He clarified, the pain and shortness of breath first started at same time, almost always together. Sometimes, pain in that area, he gets a little short of breath, heart starts racing, has to stop and catch his breath. The patient still goes through both pain and shortness of breath, seemed to be progressing (worsened). The patient never experienced that before he got the shot. The patient was thinking it was ok, was probably temporary, never seemed to go away. The patient was currently in pain management, using some kind of the asthma inhalers. The patient currently, has been going to pain management facility for pain situation. He has been taking inhaler for situation sometimes. The patient kept letting them know the situation, they still were not sure what situation was, they said they did not see anything there. They kept explaining situation, has not gotten anywhere with it. The patient clarified, referring to medical help or financial compensation. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2823815 | M | 01/30/2025 |
COVID19 |
PFIZER\BIONTECH |
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Ageusia, Anosmia, Paraesthesia
Ageusia, Anosmia, Paraesthesia
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tingling in the fingers; loss of smell and taste; loss of smell and taste; This is a spontaneous rep...
tingling in the fingers; loss of smell and taste; loss of smell and taste; This is a spontaneous report received from a Consumer or other non HCP. A 35-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset 01May2024, outcome "not recovered" and all described as "loss of smell and taste"; PARAESTHESIA (non-serious) with onset 01May2024, outcome "not recovered", described as "tingling in the fingers". Therapeutic measures were not taken as a result of paraesthesia, anosmia, ageusia. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2823816 | 11 | M | AZ | 01/30/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
1965046 U8113BA U7983AA |
Erythema, Pain in extremity, Peripheral swelling, Skin warm; Erythema, Pain in e...
Erythema, Pain in extremity, Peripheral swelling, Skin warm; Erythema, Pain in extremity, Peripheral swelling, Skin warm; Erythema, Pain in extremity, Peripheral swelling, Skin warm
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Right arm swelling (10 mm), hot to the touch, redness, and pain. Started 1 day after injections. Par...
Right arm swelling (10 mm), hot to the touch, redness, and pain. Started 1 day after injections. Parents have been giving Benadryl every 4-6 hours and Tylenol for pain.
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| 2823817 | 56 | F | MD | 01/30/2025 |
COVID19 PNC20 |
PFIZER\BIONTECH PFIZER\WYETH |
LM7786 LJ5280 |
Injected limb mobility decreased, Pain in extremity, Rash macular, Tenderness; I...
Injected limb mobility decreased, Pain in extremity, Rash macular, Tenderness; Injected limb mobility decreased, Pain in extremity, Rash macular, Tenderness
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Patient experienced extreme soreness on right arm and could not move it beyond an acute angle. 4 day...
Patient experienced extreme soreness on right arm and could not move it beyond an acute angle. 4 days later, on Thursday, patient found red splotches further down the upper arm with distinct borders that was tender and painful to touch. Patient can now move arm freely and still experiences mild soreness.
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| 2823818 | 68 | F | CA | 01/30/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
4DS4N |
Swelling face
Swelling face
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swollen jaw
swollen jaw
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| 2823819 | 53 | F | WA | 01/30/2025 |
FLU3 |
SANOFI PASTEUR |
tfaa2425 |
Feeling cold
Feeling cold
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A few days after patient received flublok, patient experienced a cold sensation in fingers/face whic...
A few days after patient received flublok, patient experienced a cold sensation in fingers/face which still lingers somewhat to this day. Patient has seen a few doctors in regards to this but the cause is uncertain and some believe it may possibly have been due to the vaccine.
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| 2823820 | 0.42 | F | VA | 01/30/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
47xp4 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient was given extra HEP B Vaccine along with combination vaccination. NO adverse side effects o...
Patient was given extra HEP B Vaccine along with combination vaccination. NO adverse side effects or s/s of complications were observed in patient by staff.
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| 2823841 | 29 | M | OR | 01/30/2025 |
MMRV |
MERCK & CO. INC. |
X023599 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Proquad is not supposed to be given to anyone over the age of 12 years old. This patient is 29 years...
Proquad is not supposed to be given to anyone over the age of 12 years old. This patient is 29 years old.
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| 2823842 | 19 | M | OR | 01/30/2025 |
MMRV |
MERCK & CO. INC. |
X023876 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Proquad is not supposed to be given to anyone over the age of 12 years old. This patient is 19 years...
Proquad is not supposed to be given to anyone over the age of 12 years old. This patient is 19 years old.
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| 2823843 | 61 | M | 01/30/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7ZM55 |
Rash, Rash erythematous, Rash pruritic
Rash, Rash erythematous, Rash pruritic
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red, itchy hive-like rash on neck, back, and hip. pt stated it began about 1 week after the vaccine ...
red, itchy hive-like rash on neck, back, and hip. pt stated it began about 1 week after the vaccine was administered. used an OTC "itch cream" on it which did help. rash is still present. Advised patient to consult their prescriber to determine if the vaccine caused the reaction, and if patient should receive the second dose in the series.
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| 2823844 | 77 | F | NC | 01/30/2025 |
PNC20 |
PFIZER\WYETH |
LG5579 |
Extra dose administered
Extra dose administered
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ADMINISTRATION ERROR. DUPLICATE VACCINE. RECEIVED SEPTEMBER 2023
ADMINISTRATION ERROR. DUPLICATE VACCINE. RECEIVED SEPTEMBER 2023
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| 2823845 | 73 | F | OK | 01/30/2025 |
HEPAB VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
4DS4N 334T3 |
Head injury, Scan normal, Syncope; Head injury, Scan normal, Syncope
Head injury, Scan normal, Syncope; Head injury, Scan normal, Syncope
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syncope after getting IMZ, EMS cleared patient to follow up with primary, primary suggested walk-in ...
syncope after getting IMZ, EMS cleared patient to follow up with primary, primary suggested walk-in clinic, walk-in said to go to ER since patient hit her head
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| 2823846 | 73 | F | OK | 01/30/2025 |
PNC20 |
PFIZER\WYETH |
LJ5283 |
Injected limb mobility decreased, Injection site rash, Injection site warmth, Pe...
Injected limb mobility decreased, Injection site rash, Injection site warmth, Peripheral swelling
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Rash below injection site that started the day after injection. Infection and was given Augmentin 87...
Rash below injection site that started the day after injection. Infection and was given Augmentin 875 mg twice daily for 7 days. Swollen arm. Hot around injection site. Couldn't move or lift arm on day after vaccine.
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| 2823847 | 62 | F | FL | 01/30/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LJ5281 LJ5281 |
Contusion, Erythema, Inflammation, Pain in extremity, Peripheral swelling; Pruri...
Contusion, Erythema, Inflammation, Pain in extremity, Peripheral swelling; Pruritus, Swelling
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The next day ( 01/18/2025) following the vaccine, patient experienced bruising, swelling, inflamed ...
The next day ( 01/18/2025) following the vaccine, patient experienced bruising, swelling, inflamed area, pain. The next following days ) 01/18-23/ 2025) patient kept experiencing pain, new sign of itching and redness and on day 5 post vaccines the swelling increased, pain reaching the elbow. Patient went primacy doctor who prescribed oral antibiotic, topical steroid and pain medication.
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| 2823848 | 58 | F | FL | 01/30/2025 |
FLU3 |
SEQIRUS, INC. |
388489 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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N/A; received wrong vaccine for age group
N/A; received wrong vaccine for age group
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