| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2823978 | U | 01/31/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; gave me the worst case of shingles; This serious case was reported by...
Suspected vaccination failure; gave me the worst case of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: gave me the worst case of shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 18-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that a patient received Shingles vaccine and it gave patient the worst case of shingles three separate physician had ever seen. Odds was patient would not get it at without the vaccination. Patient added take chances without it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
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| 2823979 | U | 01/31/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Herpes zoster, Pain, Vaccination failure
Herpes zoster, Pain, Vaccination failure
|
Suspected vaccination failure; still had a mild case of shingles; This serious case was reported by ...
Suspected vaccination failure; still had a mild case of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had shingles once before there was a vaccine). On an unknown date, the patient received Shingrix. In DEC-2024, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still had a mild case of shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 18-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that no vaccine was foolproof. The patient had the vaccine and had a mild case of shingles last month. The patient also had shingles before there was a vaccine. This time it was mild, less painful and healed so much quicker. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
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| 2823980 | M | KS | 01/31/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
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Product confusion, Wrong product administered
Product confusion, Wrong product administered
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band colors on prefilled syringes of Flulaval and Boostrix are similar (Green) and the labels are ha...
band colors on prefilled syringes of Flulaval and Boostrix are similar (Green) and the labels are hard to read, it played a role in administration error; received the Flulaval vaccine inadvertently instead of Boostrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a adult male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. In DEC-2024, the patient received FluLaval 2024-2025 season. On an unknown date, the patient did not receive Boostrix. In DEC-2024, an unknown time after receiving FluLaval 2024-2025 season and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: received the Flulaval vaccine inadvertently instead of Boostrix). On an unknown date, the patient experienced product label confusion (Verbatim: band colors on prefilled syringes of Flulaval and Boostrix are similar (Green) and the labels are hard to read, it played a role in administration error). The outcome of the wrong vaccine administered and product label confusion 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: 03-JAN-2025 The nurse reported that about one week ago (from the date of reporting), an adult patient received the Flulaval vaccine inadvertently instead of Boostrix, which led to wrong vaccine administered. The reporter stated since the band colors on the prefilled syringes of Flulaval and Boostrix were similar (Green), and the labels were hard to read, it played a role in the administration error, which led to product label confusion. The reporter did not have the lot number from the Flulaval vaccine.
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| 2823981 | F | 01/31/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Injection site erythema, Injection site mass
Injection site erythema, Injection site mass
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bumps; red around the injection site; This non-serious case was reported by a consumer via call cent...
bumps; red around the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 03-JAN-2025, the patient received the 1st dose of Shingrix. On 04-JAN-2025, 1 days after receiving Shingrix, the patient experienced injection site erythema (Verbatim: red around the injection site). On 05-JAN-2025, the patient experienced mass (Verbatim: bumps). The outcome of the injection site erythema and mass were not resolved. It was unknown if the reporter considered the injection site erythema and mass to be related to Shingrix. It was unknown if the company considered the injection site erythema and mass to be related to Shingrix. Additional Information: GSK Receipt Date: 06-JAN-2025 The reporter reported that a patient received the first dose of Shingrix on Friday afternoon, 3rd January 2025. Also stated her arm was red around the injection site around 12 PM on Saturday, 4th January 2025. She reported her arm started to bother her a lot in the evening on Saturday. Also stated that by 1 AM Sunday, 5th January 2025 the redness had spread a lot and she had a couple of bumps that were very dark red and flesh colored under the bumps. The patient stated she had never had a reaction like this from any other vaccine.
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| 2823982 | 61 | M | OK | 01/31/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Pruritus
Pruritus
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itching on his trunk; This non-serious case was reported by a consumer via call center representativ...
itching on his trunk; This non-serious case was reported by a consumer via call center representative and described the occurrence of pruritus in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 16-JUL-2024). On 20-NOV-2024, the patient received the 2nd dose of Shingrix. In NOV-2024, 5 days after receiving Shingrix, the patient experienced pruritus (Verbatim: itching on his trunk). The patient was treated with prednisone. The outcome of the pruritus was not resolved. It was unknown if the reporter considered the pruritus to be related to Shingrix. It was unknown if the company considered the pruritus to be related to Shingrix. Additional Information: GSK Receipt Date: 06-JAN-2025 Around 5 days after his second dose, he experienced itching on his trunk. He took prednisone for 5 days and after finishing the medication, the itching has come back. The reporter did not consent to follow-up.
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| 2823983 | F | TX | 01/31/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Inappropriate schedule of product administration
Inappropriate schedule of product administration
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patient got her 1st dose in 2021 and her 2nd dose in 2024; This non-serious case was reported by a c...
patient got her 1st dose in 2021 and her 2nd dose in 2024; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Patient received 1st dose of Shingrix in 2021). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient got her 1st dose in 2021 and her 2nd dose in 2024). The outcome of the drug dose administration interval too long was unknown. Additional Information: GSK Receipt Date: 06-JAN-2025 The reporter was a 66-year-old female patient. The patient reported on 6th January 2025, that she received both doses of Shingrix at a local pharmacy. The patient did not recall in which arm she received the vaccines and the Lot number and Expiry date were unknown. The patient reported that she got her 1st dose in 2021 and her 2nd dose in 2024 which led to lengthening of vaccinations schedule. (Drug dose administration interval too long).
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| 2823984 | M | CT | 01/31/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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patient did not receive Twinrix dose yet; This non-serious case was reported by a pharmacist via cal...
patient did not receive Twinrix dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old male patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (patient got a dose of Twinrix a year ago). On an unknown date, the patient did not receive Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient did not receive Twinrix dose yet). The outcome of the incomplete course of vaccination was 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: 14-JAN-2025 The pharmacist reported that the patient got a dose of Twinrix a year ago. The reporter asked question the patient needs to start over the series. Till the time of reporting, the patient did not receive dose of Twinrix, which led to incomplete course of vaccination.
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| 2823985 | F | PA | 01/31/2025 |
COVID19 COVID19 COVID19 |
JANSSEN JANSSEN JANSSEN |
Unknown Unknown Unknown |
Bladder dysfunction, Carpal tunnel syndrome, Cervical radiculopathy, Chronic fat...
Bladder dysfunction, Carpal tunnel syndrome, Cervical radiculopathy, Chronic fatigue syndrome, Lumbar radiculopathy; Lumbar spinal stenosis, Mononeuropathy, Myalgia, Pain, Pain in extremity; Peripheral nerve lesion, Peroneal nerve palsy, Polyneuropathy, Spinal osteoarthritis
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Polyneuropathy, unspecified; Myalgia; Foot Drop; Lesion of ulnar nerve, unspecified upper limb; Chro...
Polyneuropathy, unspecified; Myalgia; Foot Drop; Lesion of ulnar nerve, unspecified upper limb; Chronic pain syndrome; Radiculopathy, cervical region; Pain in unspecified limb; Lumbar stenosis; Dysfunction, bladder; Spinal stenosis, lumbar region with neurogenic claudication; Spondylosis without myelopathy or radiculopathy, lumbar region; Radiculopathy, lumbar region; Unspecified mononeuropathy of unspecified lower limb; Carpal tunnel syndrome, bilateral upper limb; Chronic fatigue syndrome; This spontaneous report received from a patient concerned an adult female patient. The patient's weight was 100 pounds and height was 65 inches. Age at time of vaccination was unknown. The patient's concurrent conditions included: null, and other pre-existing medical conditions included: does the patient have any allergies? : not asked was there drug abuse or illicit drug usage? : unknown does the patient consume alcohol? : unknown does the patient smoke? : unknown. No past medical history was reported. The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose and frequency not reported, administered on 18-Aug-2021, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up. No concomitant medications were reported. On an unspecified date, the patient experienced polyneuropathy, unspecified, myalgia, foot drop, lesion of ulnar nerve, unspecified upper limb, chronic pain syndrome, radiculopathy, cervical region, pain in unspecified limb, lumbar stenosis, dysfunction, bladder, spinal stenosis, lumbar region with neurogenic claudication, spondylosis without myelopathy or radiculopathy, lumbar region, radiculopathy, lumbar region, unspecified mononeuropathy of unspecified lower limb, carpal tunnel syndrome, bilateral upper limb, and chronic fatigue syndrome. (dose series 1). Patient underwent two microdiscectomy surgeries๏ฟฝone in November 2021 and another in February 2023. These surgeries were just the start of countless medical tests and pain management procedures. The diagnoses have left patient body weak and constantly fatigued. She can barely walk, and her blood pressure remains high without any clear explanation. Every day is a struggle, filled with physical pain and emotional heartbreak. The injuries she suffered didn't just affect her body; they took away her livelihood, her ability to care for her family, and even her home. Despite all her efforts to seek help, patient received no financial or medical support. Patient felt abandoned, left to face this battle alone. The action taken with janssen covid-19 vaccine was not applicable. The outcome of polyneuropathy, unspecified, myalgia, foot drop, lesion of ulnar nerve, unspecified upper limb, chronic pain syndrome, radiculopathy, cervical region, pain in unspecified limb, lumbar stenosis, dysfunction, bladder, spinal stenosis, lumbar region with neurogenic claudication, spondylosis without myelopathy or radiculopathy, lumbar region, radiculopathy, lumbar region, unspecified mononeuropathy of unspecified lower limb, carpal tunnel syndrome, bilateral upper limb and chronic fatigue syndrome was not reported. This report was serious (other medically important condition).; Sender's Comments: V0; Polyneuropathy; The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
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| 2823986 | F | VA | 01/31/2025 |
COVID19 COVID19 |
JANSSEN JANSSEN |
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Headache, Neuralgia, Pain, Pyrexia, Red blood cell sedimentation rate increased;...
Headache, Neuralgia, Pain, Pyrexia, Red blood cell sedimentation rate increased; Visual impairment
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neuropathic pain; transient vision problems in her right eye; headache; diffuse myalgia; fever; burn...
neuropathic pain; transient vision problems in her right eye; headache; diffuse myalgia; fever; burning pain; elevated erythrocyte sedimentation rate; This spontaneous report received from a health care professional. This report was referenced in literature. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced neuropathic pain, transient vision problems in her right eye, headache, diffuse myalgia, fever, burning pain, and elevated erythrocyte sedimentation rate. (dose series 1) The patient developed a persistent pressure like headache accompanied by burning pain from the top of her scalp to her fingertips. Patient was started on prednisone by her primary care physician which helped some, but the headache never resolved completely. She had 3 emergency room visits for headache with negative imaging for intracranial pathology. She also reported transient vision problems in her right eye, which along with elevated erythrocyte sedimentation rate and C- reactive protein, prompted a rheumatology referral for concern of giant cell arteritis. She was started on Topiramate, Amitriptyline, and Pregabalin by her primary care physician. Her rheumatologic lab workup was negative. Patient was referred to us for management of nonspecific pain symptoms. On her initial evaluation, she reported diffuse burning like sensations with no specific dermatomal distribution. She also expressed diffuse aching muscle pain. Physical exam did not show sensory deficits or weakness. There was tenderness to palpation over the paraspinal muscles, and she was offered trigger point injections (TPIs). TPIs offered brief (1-2weeks) improvement in her pain, however after 2 years of treatment, the patient was unsatisfied with the temporary relief from TPIs. The patient requested a different direction in her pain management. The patient's prescriptions were adjusted and low-dose naltrexone was started. Over time, the patient's medications were adjusted until a balance of adequate analgesia and fatigue were achieved. Her regimen consisted of topiramate 50 mg twice a day, pregabalin 100mg in the morning and at noon (dosing per patient's preference, due to fatigue in the afternoon), baclofen20mg 3 times per day, and low-dose naltrexone 4.5mg once a day. She also expressed pain psychology therapy to bebeneficial. The action taken with janssen covid-19 vaccine was not applicable. The outcome of neuropathic pain, transient vision problems in her right eye, diffuse myalgia, burning pain and elevated erythrocyte sedimentation rate was not reported. The patient had not recovered from headache. The patient recovered from fever on an unspecified date. This report was serious (other medically important condition).; Sender's Comments: V0: Neuralgia : The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable
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| 2823987 | U | 01/31/2025 |
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. Reporter causality was not reported. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided. This case contains information for the 28th of 32 patients described by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781803:Patient 28; Reported Cause(s) of Death: Death unexplained
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| 2823988 | U | 01/31/2025 |
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 27 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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| 2823989 | U | 01/31/2025 |
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 18 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 18; Reported Cause(s) of Death: Death unexplained
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| 2823990 | U | 01/31/2025 |
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 8 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 8; Reported Cause(s) of Death: Death unexplained
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| 2823991 | U | 01/31/2025 |
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 9 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 9; Reported Cause(s) of Death: Death unexplained
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| 2823992 | U | 01/31/2025 |
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 10 out of 32. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report). Reporter did not allow further contact; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781803:Patient 10; Reported Cause(s) of Death: Death unexplained
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| 2823993 | U | 01/31/2025 |
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 11 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:; Reported Cause(s) of Death: Death unexplained
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| 2823994 | U | 01/31/2025 |
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 19 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. 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 19; Reported Cause(s) of Death: Death unexplained
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| 2823995 | U | 01/31/2025 |
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 medications were reported. It was unknown if the patient experienced any additional symptoms/events No treatment medications were reported. This case contains information for patient 20 out of 32 patients involved. 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).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781803:Patient 1 (Master Case); Reported Cause(s) of Death: Death unexplained
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| 2823996 | U | 01/31/2025 |
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 medications were reported. It was unknown if the patient experienced any additional symptoms/events No treatment medications were reported. This case contains information for patient 21 out of 32 patients involved. 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).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781803:Patient 1 (Master Case); Reported Cause(s) of Death: Death unexplained
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| 2823997 | U | 01/31/2025 |
COVID19 |
MODERNA |
UNKNOWN |
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) (batch no. UNKNOWN) 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. No treatment information was reported. This case contains information for patient 22 out of 32. This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report).; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-781803:master case (patient 22); Reported Cause(s) of Death: Unexplained death
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| 2823998 | 71 | F | 01/31/2025 |
COVID19 |
MODERNA |
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Anaphylactic reaction, Influenza
Anaphylactic reaction, Influenza
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anaphylaxia - closing up to the throat/coughs occasionally; flu; This spontaneous case was reported ...
anaphylaxia - closing up to the throat/coughs occasionally; flu; This spontaneous case was reported by a patient and describes the occurrence of ANAPHYLACTIC REACTION (anaphylaxia - closing up to the throat/coughs occasionally) in a 71-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cardiac arrhythmia NOS. Concurrent medical conditions included Iodine allergy. Concomitant products included Oseltamivir phosphate for an unknown indication. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On 26-Jan-2025, the patient experienced INFLUENZA (flu). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (anaphylaxia - closing up to the throat/coughs occasionally) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (anaphylaxia - closing up to the throat/coughs occasionally) outcome was unknown and INFLUENZA (flu) had not resolved. The patient had no vaccines in the last 4 weeks. Her previous doses included Moderna COVID-19 vaccine Spikevax - all of them except for 2024-2025 formula. It was reported that, she had the flu and had never taken Tamiflu in her life. Her doctor assigned it to her but the pharmacist asked her if she had any anaphylaxia - closing up to the throat. Patient stated that She had it with Moderna shot and she had to like to take an allergy medication before she even take the shot. Patient stated the anaphylaxis in the Tamiflu, it was due to the iodine in it. Patient was just wondering did the Moderna shot had anything iodine, then she would know she would have to eliminate the Tamiflu. Patient reiterated that every time she got the Moderna COVID-19 vaccine she experienced like her throat was closing out. The patient did not experience any additional symptoms/events. No treatment information was provided.; Reporter's Comments: Due to lack of biological plausibility, the event influenza was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.
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| 2823999 | F | 01/31/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
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Decreased appetite, Erythema, Eye discharge, Eyelid margin crusting, Fatigue; He...
Decreased appetite, Erythema, Eye discharge, Eyelid margin crusting, Fatigue; Headache, Hypersomnia, Malaise, Ocular hyperaemia, Pain of skin; Vaccination site erythema, Vaccination site pruritus
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eyes were reddened with crusty discharge from eye drops which contain the propylene glycol; skin ten...
eyes were reddened with crusty discharge from eye drops which contain the propylene glycol; skin tenderness; skin tenderness and redness; eyes were reddened with crusty discharge from eye drops which contain the propylene glycol; eyes were reddened with crusty discharge from eye drops which contain the propylene glycol; not feeling well/general malaise; excessive sleeping/fatigue; decreased appetite/low appetite; excessive sleeping/fatigue; headache; the skin at the injection site which was at the left arm was red and was itching; the skin at the injection site which was at the left arm was red and was itching; This spontaneous case was reported by a nurse practitioner and describes the occurrence of EYELID MARGIN CRUSTING (eyes were reddened with crusty discharge from eye drops which contain the propylene glycol), MALAISE (not feeling well/general malaise), HYPERSOMNIA (excessive sleeping/fatigue), DECREASED APPETITE (decreased appetite/low appetite) and PAIN OF SKIN (skin tenderness) in an adult female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Adverse drug reaction NOS, Lichen sclerosis atrophicus and Colonoscopy in 2015. Previously administered products included for Lichen sclerosis atrophicus: CLOBETASOL (0.05% skin cream with propylene glycol); for Product used for unknown indication: systane ultra (night time), ESTRADIOL (Estradiol vaginal cream (topical medicine), ,) called Patagis 0.01 % for dermatologic issues.) and MIRALAX. Past adverse reactions to the above products included No adverse effect with CLOBETASOL, ESTRADIOL and systane ultra; and Sickness with MIRALAX. Concurrent medical conditions included Sjogren's. On 26-Jan-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. In January 2025, the patient experienced VACCINATION SITE PRURITUS (the skin at the injection site which was at the left arm was red and was itching) and VACCINATION SITE ERYTHEMA (the skin at the injection site which was at the left arm was red and was itching). On 26-Jan-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced MALAISE (not feeling well/general malaise), HYPERSOMNIA (excessive sleeping/fatigue), DECREASED APPETITE (decreased appetite/low appetite), FATIGUE (excessive sleeping/fatigue) and HEADACHE (headache). On an unknown date, the patient experienced EYELID MARGIN CRUSTING (eyes were reddened with crusty discharge from eye drops which contain the propylene glycol), PAIN OF SKIN (skin tenderness), ERYTHEMA (skin tenderness and redness), OCULAR HYPERAEMIA (eyes were reddened with crusty discharge from eye drops which contain the propylene glycol) and EYE DISCHARGE (eyes were reddened with crusty discharge from eye drops which contain the propylene glycol). In January 2025, VACCINATION SITE PRURITUS (the skin at the injection site which was at the left arm was red and was itching) and VACCINATION SITE ERYTHEMA (the skin at the injection site which was at the left arm was red and was itching) had resolved. At the time of the report, EYELID MARGIN CRUSTING (eyes were reddened with crusty discharge from eye drops which contain the propylene glycol), MALAISE (not feeling well/general malaise), HYPERSOMNIA (excessive sleeping/fatigue), DECREASED APPETITE (decreased appetite/low appetite), PAIN OF SKIN (skin tenderness), ERYTHEMA (skin tenderness and redness), OCULAR HYPERAEMIA (eyes were reddened with crusty discharge from eye drops which contain the propylene glycol), EYE DISCHARGE (eyes were reddened with crusty discharge from eye drops which contain the propylene glycol), FATIGUE (excessive sleeping/fatigue) and HEADACHE (headache) was resolving. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. Patient was using eyedrops because of Sjogrems for both eyes. When she stopped using it her eyes got better. Patient took a laxative MiraLax for the very first time and then really felt sick afterwards. MiraLax she took back in 2015 which had propylene glycol. It was reported that patient went to pick it up and looked at the ingredients and said, I did not think I want this one because of the trouble I had before, and because of the trouble with the eye drops and the trouble with the skin cream. Patient had the trouble with propylene glycol was with MiraLax first time. Patient used Clobetasol for Lichen Sclerosis, which was getting worse, a skin cream with propylene glycol. She had stopped it, and a biopsy was done after seeing her dermatologist and found out it was not Lichen Sclerosis but was something else. Patient reported that it was not treating the lichen sclerosis when it had treated it for, like 25 years that it had been working. The brand was Taro. It was reported that the patient had reactions post administration of the Moderna vaccine. She was not feeling well afterwards. She added she felt fine after the first ones. She reported that she cannot tolerate creams, or eye drops with it as well as MiraLax with propylene glycol. The symptoms were mild to moderate headache, general malaise, excessive sleeping/fatigue, decreased appetite/low appetite, all occurred by evening on the same day or 4 hours afterwards. All these symptoms were a little worse the next day but a little better today but still present. Patient then clarified she did not react to the vaccine, but she reacted to propylene glycol dermatologically with skin tenderness and redness. Patient never had a local reaction but the skin at the injection site which was at the left arm was red and was itching. Patient took the band aid off on Sunday night. But today injection site was fine. Today no longer itching and red. No treatment medication was reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
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| 2824000 | 68 | F | 01/31/2025 |
COVID19 COVID19 COVID19 PPV PPV PPV RVX RVX RVX |
MODERNA MODERNA MODERNA UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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COVID-19, Decreased appetite, Foot fracture, Gait disturbance, Illness; Limb inj...
COVID-19, Decreased appetite, Foot fracture, Gait disturbance, Illness; Limb injury, Nausea, Pain, Pain in extremity, Pyrexia; Rheumatoid arthritis, Rosacea; COVID-19, Decreased appetite, Foot fracture, Gait disturbance, Illness; Limb injury, Nausea, Pain, Pain in extremity, Pyrexia; Rheumatoid arthritis, Rosacea; COVID-19, Decreased appetite, Foot fracture, Gait disturbance, Illness; Limb injury, Nausea, Pain, Pain in extremity, Pyrexia; Rheumatoid arthritis, Rosacea
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I got Covid and I was so ill/Diarrhea, Loss of smell, Weariness; No appetite; Injured both feet prev...
I got Covid and I was so ill/Diarrhea, Loss of smell, Weariness; No appetite; Injured both feet previously/a badly broken big toe (twice) on right foot and a countertop fell on my left foot during a remodel; A badly broken big toe (twice) on right foot; Had trouble walking/she was unable to walk after getting the vaccine; Her feet have been very painful; Aches; She became ill after receiving the vaccine/She had the worst reaction to the COVID-19 injection.; Nausea; Fever; I have RA, and I have had the WORST problem with my feet; Rosacea, and I have had the WORST problem with my skin; This spontaneous case was reported by a patient and describes the occurrence of RHEUMATOID ARTHRITIS (I have RA, and I have had the WORST problem with my feet) in a 68-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products RSV vaccine for an unknown indication and Pneumococcal vaccine for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form, dose of RSV vaccine (unknown route) 1 dosage form and dose of Pneumococcal vaccine (unknown route) 1 dosage form. In October 2024, the patient experienced RHEUMATOID ARTHRITIS (I have RA, and I have had the WORST problem with my feet) (seriousness criterion medically significant) and ROSACEA (Rosacea, and I have had the WORST problem with my skin). On an unknown date, the patient experienced COVID-19 (I got Covid and I was so ill/Diarrhea, Loss of smell, Weariness), DECREASED APPETITE (No appetite), LIMB INJURY (Injured both feet previously/a badly broken big toe (twice) on right foot and a countertop fell on my left foot during a remodel), FOOT FRACTURE (A badly broken big toe (twice) on right foot), GAIT DISTURBANCE (Had trouble walking/she was unable to walk after getting the vaccine), PAIN IN EXTREMITY (Her feet have been very painful), PAIN (Aches), ILLNESS (She became ill after receiving the vaccine/She had the worst reaction to the COVID-19 injection.), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, RHEUMATOID ARTHRITIS (I have RA, and I have had the WORST problem with my feet), ROSACEA (Rosacea, and I have had the WORST problem with my skin), LIMB INJURY (Injured both feet previously/a badly broken big toe (twice) on right foot and a countertop fell on my left foot during a remodel), GAIT DISTURBANCE (Had trouble walking/she was unable to walk after getting the vaccine), PAIN IN EXTREMITY (Her feet have been very painful) and ILLNESS (She became ill after receiving the vaccine/She had the worst reaction to the COVID-19 injection.) had not resolved and COVID-19 (I got Covid and I was so ill/Diarrhea, Loss of smell, Weariness), DECREASED APPETITE (No appetite), FOOT FRACTURE (A badly broken big toe (twice) on right foot), PAIN (Aches), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown. Concomitant medication was not provided. Patient had 6 or 7 (lost track) Moderna vaccinations with some days in bed, fever, aches, and nausea. She took pneumonia and RSV recently and thought to wait till the end of October to update her Covid vaccine. Meanwhile, she got Covid and was so ill. She had RA, rosacea, and had the worst problem with her feet and skin since October. She also suffered from diarrhea, no appetite, loss of smell, and the weariness was horrendous. She had injured both feet previously, a badly broken big toe (twice) on right foot and a countertop fell on her left foot during a remodel. Her toes had been pretty brutal and several times she had trouble walking and wearing shoes had gotten awful. She became ill after receiving the vaccine and was confused about whether she should receive the next vaccine. She was afraid because she was unable to walk after getting the vaccine, and her feet had been very painful. She had the worst reaction to the COVID-19 injection. She had an appointment the next day. Treatment information was not reported. Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2025: Live follow-up received and added references. On 29-Jan-2025: Live follow-up received and updated event verbatim, added new events of pain in extremity, illness and updated narrative.; Reporter's Comments: Causality for Foot injury and Foot fracture was assessed as not related, due to mechanism of action. The benefit-risk relationship of product is not affected by this report.
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| 2824001 | U | CT | 01/31/2025 |
RSV |
PFIZER\WYETH |
KC7884 |
Device connection issue
Device connection issue
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Preparing the vaccine, and the tip of the vaccine, it broke off and they cannot attach the needle to...
Preparing the vaccine, and the tip of the vaccine, it broke off and they cannot attach the needle to the syringe; The initial case was missing the following minimum criteria: Product complaint only. Upon receipt of follow-up information on 22Jan2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Pharmacist from product quality group. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: KC7884, Expiration Date: 30Sep2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "Preparing the vaccine, and the tip of the vaccine, it broke off and they cannot attach the needle to the syringe". Additional information: They are preparing the vaccine, and the tip of the vaccine, it broke off and they cannot attach the needle to the syringe, they have already mixed the product and they are looking for the replacement. When paraphrased the concern: Reporter (Pharmacist) stated, they wanted to know if that was possible because the tip where the needle was supposed to go, it was like it broke off like that never happened before. Sample availability was unknown. Causality for "preparing the vaccine, and the tip of the vaccine, it broke off and they cannot attach the needle to the syringe" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
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| 2824002 | 65 | F | MO | 01/31/2025 |
PNC20 |
PFIZER\WYETH |
LJ5281 |
Injection site erythema, Injection site pain
Injection site erythema, Injection site pain
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burning and redness at the site of injection and down the arm to the elbow a week after injection/te...
burning and redness at the site of injection and down the arm to the elbow a week after injection/tender, burning redness, spreading from site of injection, down in front of arms, to elbow.; burning and redness at the site of injection and down the arm to the elbow a week after injection/tender, burning redness, spreading from site of injection, down in front of arms, to elbow.; burning and redness at the site of injection and down the arm to the elbow a week after injection/tender, burning redness, spreading from site of injection, down in front of arms, to elbow.; burning and redness at the site of injection and down the arm to the elbow a week after injection/tender, burning redness, spreading from site of injection, down in front of arms, to elbow.; This is a spontaneous report received from a Pharmacist from medical information team, Program ID. A 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 21Jan2025 as dose number unknown 0.5 ml, single (Lot number: LJ5281, Expiration Date: 01May2026) at the age of 65 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), ERYTHEMA (non-serious) all with onset Jan2025, outcome "not recovered" and all described as "burning and redness at the site of injection and down the arm to the elbow a week after injection/tender, burning redness, spreading from site of injection, down in front of arms, to elbow.". Therapeutic measures were not taken as a result of pain in extremity, vaccination site pain, vaccination site erythema, erythema. Additional information: Pharmacist asked if a patient experiencing burning and redness at the site of injection after administration and down the arm to the elbow a week after injection. HCP stated, she's more concerned, it's spreading everyday, it's spreading further and further a week later. it was not a reaction we generally see. Patient experienced side effect they were not familiar with, calling to see if they can get some guidance on it. Events started just a couple days ago when clarified side effect that occurred, pharmacist stated, patient said, it was tender, burning redness, spreading from site of injection, down in front of arms, to elbow. Clarified, specific site of injection as, left arm deltoid muscle. Clarified, the burning and redness spreading from that left arm, down in front of left arm and left elbow. Generally, something like this will go away after a day or 2. Patient concerned so, pharmacist wanted to follow up, to see if there was any advice or information available on what they might be experiencing. Unknown when the burning and redness was first experienced by patient, pharmacist was made aware of this, yesterday, 27Jan2025. Patient said, it was getting worse. No treatment as of right now. it was annoying, not life threatening or anything, just an annoyance, really. Patient did not administer additional vaccines on same date of the Pfizer Suspect. No AE required to visit Emergency Room or Physician Office. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.
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| 2824003 | 14 | M | IL | 01/31/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EW0217 EW0217 EW0217 |
Arrhythmia, Blood test, Cardiac monitoring, Cardiac telemetry, Chest X-ray; Coug...
Arrhythmia, Blood test, Cardiac monitoring, Cardiac telemetry, Chest X-ray; Cough, Echocardiogram, Electrocardiogram, Heart rate, Investigation; Metabolic function test, Right ventricular enlargement, Ventricular tachycardia
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severe VTach; serious cardiac arrhythmias; right ventricle was enlarged; began to develop a dry coug...
severe VTach; serious cardiac arrhythmias; right ventricle was enlarged; began to develop a dry cough; This is a spontaneous report received from a Nurse from medical information team, Program ID. A 14-year-old male patient received BNT162b2 (BNT162B2), on 03Jul2021 as dose 2, single (Lot number: EW0217) at the age of 14 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "never smoked" (unspecified if ongoing), notes: Her son never smoked, vaped, or did drugs. There were no concomitant medications. Vaccination history included: BNT162b2 (Pfizer Covid-19 Vaccine first dose: , Lot: EW0168, Expiry: Unknown), administration date: 12Jun2021, when the patient was 14-year-old, for COVID-19 Immunization. The following information was reported: COUGH (non-serious) with onset Apr2024, outcome "not recovered", described as "began to develop a dry cough"; VENTRICULAR TACHYCARDIA (hospitalization, medically significant, life threatening) with onset 2024, outcome "unknown", described as "severe VTach"; ARRHYTHMIA (hospitalization, medically significant, life threatening), outcome "unknown", described as "serious cardiac arrhythmias"; RIGHT VENTRICULAR ENLARGEMENT (medically significant), outcome "not recovered", described as "right ventricle was enlarged ". The patient was hospitalized for arrhythmia (start date: 30Oct2024, discharge date: 15Nov2024, hospitalization duration: 17 day(s)). The events "serious cardiac arrhythmias" and "severe vtach" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) did not show anything; Cardiac monitoring: (unspecified date) Unknown results; Cardiac telemetry: (unspecified date) Unknown results; Chest X-ray: (unspecified date) did not show anything; Echocardiogram: (unspecified date) Unknown results; Electrocardiogram: (unspecified date) Unknown results; Heart rate: (unspecified date) 250; (unspecified date) higher; (unspecified date) 120; (unspecified date) 100's-110's; (unspecified date) 260; (unspecified date) worse; (06Aug2024) 250, notes: heart rate was beating out of his chest and his rate was 250; (15Aug2024) 250, notes: heart rate was beating out of his chest and his rate was 250; (unspecified date) heart racing 120's; His genetic testing: (unspecified date) shows nothing; Metabolic function test: (unspecified date) did not show anything. Therapeutic measures were taken as a result of arrhythmia, ventricular tachycardia, cough. Clinical course: The caller a consumer, calling in about his son and trying to get help because he had developed some serious cardiac arrhythmias as a result of taking the Pfizer Covid-19 vaccine. Since he got to the vaccine, he always ran a higher heart rate of 250 heart rate. The doctors do not know why he has developed the condition. Since he got the vaccine, he always ran a higher heart rate. The doctors do not know why he has developed the condition. Last year in Apr, he began to develop a dry cough and last year in Aug they didn't find anything but he was rushed to the emergency room with a heart rate of 250. She would like to know if it's the vaccine and wanted to report it as there are no answers as to why he has developed the condition, but they have speculated it could be the vaccine and she would like to see if it's related to the vaccine. Received the second dose of the Pfizer Covid-19 vaccine in Jul2021. Within a couple of months started having a higher heart rate. She asked the Nurse Practitioner if his heat rate was higher, it was around at 120. At home it was in the 100's-110's, but he had no symptoms. He is also a kid and they will not explain what is going on with him. They found out his right ventricle was enlarged when he was diagnosed with the cardiac arrhythmia and stated that it had been going on for a couple of years. He developed a cough for months but they did not pay attention to it and said that it was dry. It began to get worse. They prescribed in antibiotics and it did not do anything. Then it did not get any better and on 06Aug2024 he went back to the MD as the cough got worse and felt his heart racing all of the time. He could feel his heart racing 120's and it was not sustained and she would check his pulse at that time. He was sent for a EKG (electrocardiogram), chest x-ray, blood work, BMP (basic metabolic panel) and it did not show anything. This was on 06Aug2024. 15Aug2024 his heart rate was beating out of his chest and his rate was 250 and she took him to the ER (emergency room), and they had him on the monitor. He was tachycardic but did not have another event while at the hospital. He went home and was referred to a cardiologist. They ordered a Echocardiogram and an EKG (electrocardiogram) and cardiac monitor. He had a MCOT (Mobile Cardiac Outpatient Telemetry) monitor ordered for him. He never had the echo done because on 30Oct2024 his event monitor recorded severe tachycardia with sustained VTach. It was at least 45 seconds of sustained Vtach. Heart rate went over 260 on the monitor. Was taken to hospital emergency room and was admitted. Her son had no chest pain and mild sob, admitted he was having tachycardic episodes, but it would pass. He had a cardiac ablation on 04Nov2024. The procedure did not go well and took twice the length of time. They almost lost him in the procedure due to him going into severe VTach (ventricular tachycardia). During the procedure they were able to zap the faulty pathways in the heart, but they realized that they had jumped to the outside of the heart. The procedure had gone on so long they decided not to go into the chest to zap the outside of the heart because his condition was critical. He was brought to cardiac stepdown and went into VTach (ventricular tachycardia) and stayed in the cardiac ICU for a full week. Her son was sent home on 80mg Sotalol and it is really taking a toll on him. Went home with a heart monitor for a month. His doctor's can't find a reason for the arrythmias. His genetic testing shows nothing.; Sender's Comments: Based on the information available and plausible temporal association, the causal relationship between the reported serious events VENTRICULAR TACHYCARDIA , RIGHT VENTRICULAR ENLARGEMENT , ARRHYTHMIA and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
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| 2824004 | 80 | F | NY | 01/31/2025 |
COVID19 |
PFIZER\BIONTECH |
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Blood catecholamines, Normetanephrine urine increased, Palpitations, SARS-CoV-2 ...
Blood catecholamines, Normetanephrine urine increased, Palpitations, SARS-CoV-2 test
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Palpitations; she believed it was normetanephrine that was elevated; This is a spontaneous report re...
Palpitations; she believed it was normetanephrine that was elevated; This is a spontaneous report received from a Physician. An 81-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 19Sep2024 as dose 1, single at the age of 80 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hashimotos hypothyroiditis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amlodipine, notes: She had preexisting hypertension and was on treatment with amlodipine; Synthroid, start date: 1990, notes: She has hypothyroid Hashimoto's hypothryoiditis and at that date she was on 50mcg of Synthroid and has taken since the late 1990s; Baby aspirin, start date: 2015, notes: she also takes baby aspirin which she has taken since 2015; Atorvastatin, start date: 2015, notes: Was on atorvastatin 20mg back then and still is on that but had to discontinue it to take the Paxlovid and has been on the atorvastatin for a number of years since 2015. The following information was reported: PALPITATIONS (non-serious), outcome "recovered"; NORMETANEPHRINE URINE INCREASED (non-serious), outcome "unknown", described as "she believed it was normetanephrine that was elevated". The event "palpitations" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of palpitations. Additional information: After the vaccine, the patient developed palpitations that intensified, and she knew the palpitations were a possible consequence and the hypertension was a possible consequence and she was not too concerned and then it just got worse and worse. The palpitations finally resolved once she saw a specialist in hypertension and she had the values of her normetanephrine and metanephrine and those are considered stressor levels so she believed it was her normetanephrine that was elevated and does know it affects the angiotensin system and so the intervention was to stop the amlodipine and she could not get in touch with her HCP for a number of weeks and endured the palpitations and the cardiologist did a week long monitor and there was no abnormality on the monitor.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500020513 same patient/vaccine, diff events;
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| 2824005 | 40 | F | OH | 01/31/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
FN2908 FN2908 FN2908 FN2908 FN2908 FN2908 FN2908 |
Anti-thyroid antibody, Anti-thyroid antibody positive, Autoimmune disorder, Auto...
Anti-thyroid antibody, Anti-thyroid antibody positive, Autoimmune disorder, Autoimmune thyroiditis, Blood pressure abnormal; Blood test, Blood thyroid stimulating hormone, Brain fog, Computerised tomogram, Conjunctivitis allergic; Constipation, Disturbance in attention, Ear pain, Endocrine ophthalmopathy, Eye haemorrhage; Graves' disease, Headache, Hypoaesthesia, Impaired quality of life, Influenza like illness; Investigation, Lung hyperinflation, Mood altered, Pain in extremity, Paraesthesia; Pneumonitis, Scan, Scan brain, Sinus disorder, Thyroid function test; Thyroid stimulating immunoglobulin, Thyroxine, Tri-iodothyronine, X-ray
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multiple autoimmune diseases/autoimmune was flaring up; Graves' disease/diagnosed with graves a...
multiple autoimmune diseases/autoimmune was flaring up; Graves' disease/diagnosed with graves and thyroid eye disease; Thyroid eye disease/diagnosed with graves and thyroid eye disease; vaccine has destroyed her life; Hashimoto's thyroiditis; lungs mild inflammatory with thickening again; pain in arms; right ear pain; allergic conjunctivitis; blood pressure; constipation; numbness and tingling and left ear completely numb; numbness and tingling and left ear completely numb; sinus one because she has sinus issues; changes in mood present; lack of concentration; brain fog; headache; thickening of the lungs/lungs were mildly hyperinflated; bleeding on the surface of her left eye; felt sick like had the flu; This is a spontaneous report received from a Consumer or other non HCP from medical information team and product quality group. A 42-year-old female patient received BNT162b2 (BNT162B2), on 17Jul2022 as dose 3 (booster), single (Lot number: FN2908) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "asthma attacks", start date: 2019 (unspecified if ongoing), notes: prior to covid coming; "thinks it was early covid", start date: 2019 (unspecified if ongoing); "constipation" (unspecified if ongoing), notes: did have some of that before; "sick", start date: 2019 (unspecified if ongoing), notes: prior to covid coming. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1, batch/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"; BNT162b2 (dose 2, batch/lot number EW0169), administration date: 13Aug2021, when the patient was 39-year-old, for COVID-19 immunization, reaction(s): "Graves", "thyroid eye disease", "had pain in her arms", "she also felt sick like had the flu for about 24 hours", "the first was done on 31Jul2021/the second dose was on 13Aug2021", "eye pain", "ear pain", "dry eye", "Hashimoto's". The following information was reported: EYE HAEMORRHAGE (medically significant) with onset 02Mar2023, outcome "unknown", described as "bleeding on the surface of her left eye"; LUNG HYPERINFLATION (non-serious) with onset 12Mar2024, outcome "unknown", described as "thickening of the lungs/lungs were mildly hyperinflated"; AUTOIMMUNE DISORDER (medically significant), outcome "not recovered", described as "multiple autoimmune diseases/autoimmune was flaring up"; GRAVES' DISEASE (medically significant), outcome "not recovered", described as "Graves' disease/diagnosed with graves and thyroid eye disease"; ENDOCRINE OPHTHALMOPATHY (medically significant), outcome "not recovered", described as "Thyroid eye disease/diagnosed with graves and thyroid eye disease"; IMPAIRED QUALITY OF LIFE (medically significant), outcome "not recovered", described as "vaccine has destroyed her life"; AUTOIMMUNE THYROIDITIS (medically significant), outcome "unknown", described as "Hashimoto's thyroiditis"; PNEUMONITIS (medically significant), outcome "unknown", described as "lungs mild inflammatory with thickening again"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in arms"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "felt sick like had the flu"; EAR PAIN (non-serious), outcome "unknown", described as "right ear pain"; CONJUNCTIVITIS ALLERGIC (non-serious), outcome "unknown", described as "allergic conjunctivitis"; BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "blood pressure"; CONSTIPATION (non-serious), outcome "unknown"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious), outcome "unknown" and all described as "numbness and tingling and left ear completely numb"; SINUS DISORDER (non-serious), outcome "unknown", described as "sinus one because she has sinus issues"; MOOD ALTERED (non-serious), outcome "unknown", described as "changes in mood present"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "lack of concentration"; BRAIN FOG (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown". The events "multiple autoimmune diseases/autoimmune was flaring up", "thyroid eye disease/diagnosed with graves and thyroid eye disease", "vaccine has destroyed her life", "bleeding on the surface of her left eye", "hashimoto's thyroiditis" and "allergic conjunctivitis" required physician office visit. The events "graves' disease/diagnosed with graves and thyroid eye disease" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Anti-thyroid antibody: (02Nov2021) 98.8, notes: high - for Hashimoto's and not for the graves diagnosis; (02Nov2021) 98.9; (17Jul2023) 306; (25Aug2023) it was way high; Anti-thyroid antibody positive: (28Aug2023) 8.30, notes: high; Blood test: (unspecified date) thyroid positive; (25Aug2023) Unknown results; Blood thyroid stimulating hormone: (02Nov2021) 1.72, notes: normal; (25Aug2023) 0.01, notes: low; Computerised tomogram: (unspecified date) diagnosed thyroid eye disease, notes: mild symmetric prominence and the outside eye was looking prominent; (unspecified date) shows the eye problems, notes: had to do it to diagnose her eyes; exam: (unspecified date) lungs with mild inflammatory with thickening again, notes: suspected in perihilar and basilar regions and has no pleural effusion or pneumothorax; Scan: (unspecified date) indicated thyroid eye disease; Scan brain: (unspecified date) negative; Thyroid function test: (unspecified date) diagnosed graves disease and thyroid eye disease, notes: thyroid levels; (unspecified date) Unknown results, notes: before she was vaccinated; Thyroid stimulating immunoglobulin: (25Aug2023) 5, notes: high - to diagnose her with graves; (28Aug2023) 5.42, notes: high; Thyroxine: (02Nov2021) 1.0, notes: normal; (25Aug2023) 1.61, notes: high; Tri-iodothyronine: (25Aug2023) 6.29, notes: high; X-ray: (unspecified date) lungs were mildly hyperinflated. Clinical course: The patient was calling about Pfizer COVID vaccine which destroyed caller's life, didn't want to take, got sick, has multiple autoimmune diseases now, Graves' disease, thyroid eye disease (TED). She wanted to report the timeline of that and wanted to know if there was a class action lawsuit going on. She wanted to report this as proof. The patient would love to have open dialogue, vaccine has destroyed her life, was living in (withheld), now living with parents in (withheld). The patient stated has destroyed life, now was having this clown operation, this was dealing with caller's life. The vaccine made patient sick and had to go to (withheld), took caller's life away, now sick. The patient had such a bad reaction and was still sick and has been sick many years now because of this and prefers to be contacted by phone. There was more a long term reaction and short term reaction and had pain in arms that lasted a little while and arm pain after being vaccinated and boosted that occurred after all three doses and she also felt sick like had the flu for about 24 hours; then long term was that she was diagnosed with graves and thyroid eye disease. She had eye pain after being vaccinated and later on was diagnosed because she did not have access to getting blood work because of the pandemic and did not get diagnosed until later. This was so bad it gives her anxiety. About 4 months later, she started having eye pain and that happened with symptoms right around there the week of covid and mostly her right eye and right ear pain and then she started to have dry eye up until then and after that it was like dry eye all the time and eye pain a lot. Then she did not do blood work testing and they gave us the vaccine free and did not pay for any follow up to see if they in fact did damage to bodies so she was in (redacted) but living in (redacted) at her parents when she got the vaccines and did not have access to a doctor while this autoimmune was flaring up. She then had a blood shot left eye and later on that started to build up and that was she thinks 30Jan2023 and had eye pain in the right eye that was sharp eye pain and this was not the blood shot time but was just a sharp eye pain again and had that in the right eye and then it came again for another incident on the bloodshot right eye on 02Mar2023 and there was bleeding on the surface of her left eye. The doctors were incompetent and thought this was from swimming but she swam her entire life and never had that knew something was wrong and they dismissed it and said it was from swimming. Then she saw another eye doctor on general ophthalmology and went on 20Feb2023 to another eye doctor and the other was a retinal eye doctor but this was the regular ophthalmologist Dr. (Name) and he misdiagnosed her and said she had dry eye so she got three misdiagnoses and knew it was something more serious happening so did speak to a doctor in 2022 for a virtual visit and she has all the doctor notes and did see someone on 11Jan2022 named Dr. (Name) to tell her that she had right side eye pain and pressure and deep eye pain and pressure that they thought likely from covid but the caller was vaccinated and did not think it was covid and thinks she had covid prior to this as she was throwing up all year and in 2019 prior to covid coming she was sick with asthma attacks and sick and gave it to her parents when she came back and thinks it was early covid then and all these symptoms happened after the vaccine. She saw another eye doctor on 25Feb2022 and saw Dr. (Name) who said she had eye pain and it was her right eye again and was always the right eye at first. She was looking at her medical chart on the website pulled from all hospitals she went to and was going to give the first time blood work tested and the unfortunate conundrum was that she only did thyroid bloodwork before she was vaccinated. Her thyroid levels was what diagnosed her with graves disease and thyroid eye disease was a component of that and comes from testing and looking at the eyes to be diagnosed by the eye doctor. On 02Nov2021, they tested her TSH, T4 and TPO levels and did not do a T3 and that may would have showed it; the thyroid antibodies of Hashimoto's were high and she already had that, and her thyroid antibodies were high so those were 98.8 for Hashimoto's and not for the graves diagnosis. The TPO bloodwork on 02Nov2021 was 98.9 and she thought since she was genetically predisposed she would not get vaccinated but all the doctors were forcing her to and Pfizer and all other companies said it was totally safe if you have autoimmune conditions. The antibodies mean she did not have it but the disease did not happen until after her vaccination; T4 was normal and was 1.0 and then TSH was 1.72 which was normal and the only one high was the antibodies which she already had. She went to the ER and the next time was then with heart palpitations on 25Aug2023 they did better testing there tested TSH 0.01 low, T4 was 1.61 high, T3 was 6.29 high so all abnormal and out of range; did the thyroglobulin antibody to diagnose her with graves and it was 5 which was high. Then there was also the few other bloodwork and the TPO again and it was way high after that was 306 and that was on 17Jul2023; did a thyroid stimulating immunoglobulin test and did it the same day at the hospital on 28Aug2023 and it was 5.42 high. On 28Aug2023 did a thyrotropin receptor antibody and was also high and was 8.30 and she never had those before never had thyroid positive blood work and once she had that, they tested all these extra things. Saw a doctor few days later and tested for more and prior to this diagnosis for graves disease she also saw an eye doctor that spring and saw Dr. (Name) on 14Jul2023 and she had dry eye in both eyes, allergic conjunctivitis and he put Hashimoto's thyroiditis but he said her eyes have mild swelling and noticed proptosis of the left eye and she has both Hashimoto's and graves antibodies at the same time; she believed it had to be vaccine and it was not a normal thing to have both high and low of thyroid disorders. Her left eye and right both had pain and the right had more pain and the left eye looks like it was bulging. Then she saw another doctor on 18Jul2023 and he said they needed to draw more studies about Graves disease since her eye was swollen and she saw Dr. (Name) and Dr (Name) and she was diagnosed with graves and in Jul prior to that her eye looked a little funky and it was a nightmare. She took Metoprolol for blood pressure and along with that methimazole on 26Aug. She has not worked and has been out of work and lost tons of money and it ruined her life. When she was in Greece, started those medications to counteract and believed it was pharmaceutical poisoning. The Metoprolol is ER succinate and was 25mg tablets and thinks she took one tablet once per day and the NDC 45963-0709-11 and on the tablets says A9. For the Methimazole one, it was by Strides and was 10mg and she was doing a half tablet three times a day at that point so really 5mg every time she would take it and it has NDC 64380-0213-01 and on the tablet was written EM10. She never took flu shots and never did these types of things and was not a medicine person and barely takes medicine because she always has reactions and the vaccine permanently altered her life. She got back to (redacted) at the end of Nov2023 to the (redacted) and went to the clinic 04Dec2023 and saw an ocular plastic surgeon and saw Dr. # and that doctor diagnosed her with graves and thyroid eye disease. From there she has spent over a year now from 2023 to now dealing with the clinic mostly and she has eye appointments and virtual visits and had to be on (redacted) because she was not working and this uprooted her entire life and was insane and she tried functional medicine to help her holistically with a AIP diet and GI health trying to clear up her constipation and she did have some of that before. Her thyroid has been vacillating between abnormal and normal based on diet and she was trying to fight this, and it has been abnormal and still abnormal now and probably was abnormal much longer. Doctors think she has had graves for 2 years and it was possible it was the vaccine and possibly then covid made it worse and the vaccine was supposed to stop it or make it less worse; she saw the post covid clinic and the nurse triaged her with pulmonology and cardiology and she was seeing endocrinology already and they did not see any heart damage as the vaccine picks and chooses where it affects and it can be sometimes in the brain, heart, lungs or thyroid or whatever. Pulmonology said she had some thickening of the lungs on 12Mar2024 and had an Xray done and could this be from Metoprolol reaction or from the vaccine; the Xray says her lungs were mildly hyperinflated on the current exam with mild inflammatory with thickening again suspected in perihilar and basilar regions and has no pleural effusion or pneumothorax. The caller did not want a CT scan due to not wanting more radiation and had a CT scan of her face and had to do it to diagnose her eyes. Dr. (Name) said it was possible it was the vaccine and they said everyone reacts differently. The scan shows the eye problems and she had thousands of tests because of this and blood work and she was never sick before. Asked will she get a copy of this report. She got back on Methimazole on 04Dec2023 because her eye doctor said she had graves disease and started it and had not had asthma like before and had numbness and tingling and left ear completely numb on Christmas morning; the doctor was in a panic and the patient's brain scan was negative and she had a sinus one because she has sinus issues and the eye scan they gave her indicated thyroid eye disease so the CT diagnosed thyroid eye disease and said mild symmetric prominence and the outside eye was looking prominent and she finally got off the Methimazole and was trying to treat this on 09Feb2024 and has been off since with functional medicine and she may need a thyroidectomy neck surgery and she should not get radioactive iodine so the choice was to get back on Methimazole or surgery on the thyroid. Post covid clinic said they discussed lung covid symptoms and triaged her and she did have changes in mood present and lack of concentration, brain fog, headache and eye pain. She would like to know if other patients have this horrible health crisis or anything she can use to help combat or reverse it. Therapeutic measures were taken as a result of graves' disease, endocrine ophthalmopathy, blood pressure abnormal.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500020994 same patient, different event/dose;US-PFIZER INC-202500020996 same patient, different event/dose;US-PFIZER INC-202500020995 same patient, different event/dose;
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| 2824006 | 80 | F | NY | 01/31/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, SARS-CoV-2 test, Vaccination failure
COVID-19, SARS-CoV-2 test, Vaccination failure
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COVID-19; COVID-19; This is a spontaneous report received from a Physician. An 81-year-old female p...
COVID-19; COVID-19; This is a spontaneous report received from a Physician. An 81-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 19Sep2024 as dose 1, single at the age of 80 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hashimotos hypothyroiditis" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; BABY ASPIRIN, start date: 2015; AMLODIPINE taken for hypertension, start date: 2015. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Jan2025, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jan2025) Positive. The clinical course was reported as follows: The patient got the vaccine on 19Sep2024 and was not totally shocked when she got COVID but thought the vaccine was protective but she was 80 and took PAXLOVID and her husband also got COVID so they both had it. She had Hashimoto's hypothyroidisms and at that date she was on 50 mcg of Synthroid and had taken since the late 1990s. Therapeutic measures were taken as a result of covid-19, vaccination failure.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMICRON (KP.2) cannot be excluded for event vaccination failure. This case will be reassessed upon receipt of additional information.
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| 2824007 | F | MS | 01/31/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Blood creatinine, Blood pressure measurement, Blood test, Cardiac failure conges...
Blood creatinine, Blood pressure measurement, Blood test, Cardiac failure congestive, Chronic kidney disease; Investigation, Systemic lupus erythematosus
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chronic kidney disease; congestive heart failure; Lupus; This is a spontaneous report received from ...
chronic kidney disease; congestive heart failure; Lupus; This is a spontaneous report received from a Consumer. A 58-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, 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: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant) with onset Jun2022, outcome "not recovered", described as "Lupus"; CHRONIC KIDNEY DISEASE (hospitalization, medically significant) with onset 2022, outcome "unknown"; CARDIAC FAILURE CONGESTIVE (hospitalization , medically significant) with onset 2022, outcome "unknown", described as "congestive heart failure". Clinical information: The patient had the first and second dose back in 2021. It was mentioned that the she developed chronic kidney disease. It was later narrated that the patient had never had an issue and she would always get her annual. Then, she started swelling and her blood pressure was going up and she was instructed to see her doctor. Her doctor told her to go to the emergency room (ER) immediately because she had fluid on her heart and lungs and her kidneys were not functioning properly. She went into the hospital in Sep2022 and was in there starting 22Sep2022 and was discharged until 21Oct2022. She was hospitalized for 23 days (as reported). The reason for the hospitalization was they told her it was chronic kidney disease and congestive heart failure. She also mentioned that she and her husband took a trip in Jun2022 and noticed that she had to keep trying to catch her breath while at the airport before. She did not think anything of it and thought she was just tired. She was told now she has Lupus and that was diagnosed while she was in the hospital (while still under the care of a nephrologist). They did a lot of testing and would draw blood and test her blood every day and her creatinine was so elevated it was over 5 and they thought they would have to put her on dialysis but put on her CYTOXAN. She was now on the preventative medication Mycophenolate Mofetil and still taking it. The events "chronic kidney disease" and "congestive heart failure" required emergency room visit. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2824008 | U | 01/31/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Condition aggravated, Dizziness, Illness, Immune system disorder, Loss of consci...
Condition aggravated, Dizziness, Illness, Immune system disorder, Loss of consciousness; Myocarditis, Vertigo
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Myocarditis; myocarditis, I am going to see a doctor on that now, it is getting worse; Pass out; Imm...
Myocarditis; myocarditis, I am going to see a doctor on that now, it is getting worse; Pass out; Immune system is horrible; Vertigo; Dizzy; I am getting sicker; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown"; CONDITION AGGRAVATED (medically significant), outcome "unknown", described as "myocarditis, I am going to see a doctor on that now, it is getting worse"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "Pass out"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Immune system is horrible"; VERTIGO (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; ILLNESS (non-serious), outcome "unknown", described as "I am getting sicker". Additional information: Consumer stated, "No, that was okay. I am just curious, how do I find out what was put in the COVID shot (Clarified as Pfizer COVID-19 Vaccine) that I took in 2021 because I am seeing a lot of bad reports about a lot of bad chemicals that were in that shot that shouldn't have been in there and to be honest with you, do you have an antidote for it? Because I have been extremely unhealthy ever since I got that shot. No immune system, I am pretty sure I have myocarditis, I am going to see a doctor on that now, it is getting worse. I thought it would fade away, phase away but it is actually multiplying. My immune system is horrible. I get vertigo, I get dizzy, I pass out. I have got all kinds of complications from this so-called lifesaving vaccine shot, which actually we did not need. I do not know if you are aware of that. I am getting sicker every day. What is in it? I got to know because I have to get a doctor to get me antidote to get rid myself, this body before you turn on the 5G and everybody goes anybody, everybody goes mentally insane. We know it was all our hoax okay, so we will pass that part right, you know it was a hoax, right?" No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2824009 | M | NY | 01/31/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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Covid; Covid; This is a spontaneous report received from a Physician. An 80-year-old male patient r...
Covid; Covid; This is a spontaneous report received from a Physician. An 80-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jun2024 as dose 1, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19. The clinical course was reported as follows: Reporter and her husband got covid so they both had nirmatrelvir, ritonavir (PAXLOVID). Had no lots, expiry dates or NDC numbers for her husband's vaccines to provide.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMICRON (KP.2) cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information.
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| 2824010 | 39 | F | OH | 01/31/2025 |
COVID19 |
PFIZER\BIONTECH |
EW0158 |
Influenza like illness, Pain in extremity
Influenza like illness, Pain in extremity
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had pain in her arms; felt sick like had the flu; This is a spontaneous report received from a Consu...
had pain in her arms; felt sick like had the flu; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 39-year-old female patient received BNT162b2 (BNT162B2), on 31Jul2021 as dose 1, single (Lot number: EW0158) 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), notes: in 2019 prior to covid coming; "sick", start date: 2019 (unspecified if ongoing), notes: in 2019 prior to covid coming; "thinks it was early covid", start date: 2019 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "felt sick like had the flu"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered", described as "had pain in her arms". Additional information: There was more a long term reaction and short term reaction and had pain in her arms that lasted a little while and arm pain after being vaccinated and boosted that occurred after all three doses and she also felt sick like had the flu for about 24 hours.
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| 2824011 | M | 01/31/2025 |
COVID19 |
PFIZER\BIONTECH |
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Cardiac disorder, Immune system disorder, Vertigo
Cardiac disorder, Immune system disorder, Vertigo
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heart problems; Vertigo; destroyed his immune system; This is a spontaneous report received from a C...
heart problems; Vertigo; destroyed his immune system; This is a spontaneous report received from a Consumer or other non HCP. A 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 and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart problems"; VERTIGO (non-serious), outcome "unknown"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "destroyed his immune system". Additional information: The patient asked if he was going to get an antidote for what it was done. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2824012 | 51 | F | 01/31/2025 |
PNC20 |
PFIZER\WYETH |
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Injection site erythema, Injection site pain, Injection site swelling, Product p...
Injection site erythema, Injection site pain, Injection site swelling, Product preparation issue
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Redness at the injection site lasting for >1 week; swelling the injection site lasting for >1 ...
Redness at the injection site lasting for >1 week; swelling the injection site lasting for >1 week; pain at the injection site lasting for >1 week; Subcutaneous injection in back of upper arm (after not having shaken the pre-filled syringe per PI); Subcutaneous injection in back of upper arm (after not having shaken the pre-filled syringe per PI); This is a spontaneous report received from a Consumer or other non HCP. A 51-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 22Jan2025 at 17:30 as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years subcutaneous, in arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CENTRUM SILVER WOMEN 50+, start date: Jan2022; ASPIRIN [ACETYLSALICYLIC ACID], start date: Oct2024; ZEPBOUND, start date: Sep2024; NADOLOL, start date: May2020; OMEPRAZOLE, start date: Jan2019; TYLENOL, start date: Sep2024; BUPROPION, start date: Apr2021; VITAMIN D2, start date: Apr2021. The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 22Jan2025 at 17:30, outcome "unknown", INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 22Jan2025 at 17:30, outcome "not recovered" and all described as "Subcutaneous injection in back of upper arm (after not having shaken the pre-filled syringe per PI)"; VACCINATION SITE ERYTHEMA (non-serious) with onset 23Jan2025, outcome "not recovered", described as "Redness at the injection site lasting for >1 week"; VACCINATION SITE PAIN (non-serious) with onset 23Jan2025, outcome "not recovered", described as "pain at the injection site lasting for >1 week"; VACCINATION SITE SWELLING (non-serious) with onset 23Jan2025, outcome "not recovered", described as "swelling the injection site lasting for >1 week". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site swelling, vaccination site pain, incorrect route of product administration. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
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| 2824013 | M | NJ | 01/31/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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COVID after vaccines; COVID after vaccines; This is a spontaneous report received from a Consumer or...
COVID after vaccines; COVID after vaccines; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 78-year-old 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 and 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; Covid-19 vaccine (Dose 3; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID after vaccines". The event "covid after vaccines" required physician office visit. Clinical course: The patient just got out of the clinic and was told that he has COVID. So, he came to the pharmacy to get Paxlovid as prescribed, but it's too expensive. The patient has the insurance, but it's still too expensive. Patient is wondering if Pfizer could give him a coupon or maybe lower the price. 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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| 2824014 | M | IL | 01/31/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective, SARS-CoV-2 test
COVID-19, Drug ineffective, SARS-CoV-2 test
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get so far four times COVID vaccine by Pfizer/ have a COVID; get so far four times COVID vaccine by ...
get so far four times COVID vaccine by Pfizer/ have a COVID; get so far four times COVID vaccine by Pfizer/ have a COVID; This is a spontaneous report received from a Consumer, Program ID. A 59-year-old 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 and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "get so far four times COVID vaccine by Pfizer/ have a COVID". Clinical information: It was reported that the patient COVID vaccine by the Pfizer for four times but got COVID. He was COVID positive right now and his doctor send a prescription of PAXLOVID (at three tablets in the morning and 3 tablet in the night) to the pharmacy. However, his insurance did not approve the prescription and was asking what to do. 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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| 2824016 | U | 01/31/2025 |
FLU3 |
SANOFI PASTEUR |
UT8409AB |
Arthralgia, Insomnia, Mobility decreased, Pain in extremity, Polymyalgia rheumat...
Arthralgia, Insomnia, Mobility decreased, Pain in extremity, Polymyalgia rheumatica
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polymyalgia rheumatica; developed extreme soreness in my upper arms and shoulders; severely restrict...
polymyalgia rheumatica; developed extreme soreness in my upper arms and shoulders; severely restricted movements; sleepless nights; Initial information received on 25-Jan-2025 regarding an unsolicited valid serious case received from a Other health professional. This case involves, an unknown age and gender patient who had polymyalgia rheumatica after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Oct-2024, the patient received a dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe produced by unknown manufacturer (lot UT8409AB) (unknown strength, dosage, expiry date and route) in unknown administration site for prophylactic vaccination. On an unknown date in 2024, the patient developed polymyalgia rheumatica (unknown latency), extreme soreness in my upper arms and shoulders (arthralgia) (latency-Within one month), severely restricted movements (hypokinesia) and sleepless nights (insomnia) (unknown latency) following the administration of USP Trival A-B High Dose Subvirion Vaccine. Reportedly, Patient believed that this resulted from the high dosage of the vaccine. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was unknown for the event. Seriousness criteria: The event (polymyalgia rheumatica) was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 30-Jan-2025: This case involves, an unknown age and gender patient who had polymyalgia rheumatica after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
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| 2824017 | F | VA | 01/31/2025 |
YF |
SANOFI PASTEUR |
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Contraindicated product prescribed
Contraindicated product prescribed
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patient who is on an immune modifier, Skyrizi, was administered YF-VAX today, with no reported adver...
patient who is on an immune modifier, Skyrizi, was administered YF-VAX today, with no reported adverse event; Initial information received on 28-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age female patient who was on an immune modifier, SKYRIZI [RISANKIZUMAB], was administered Yellow Fever Vaccine [Yf-Vax] today, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient started taking SKYRIZI [RISANKIZUMAB], (form, strength, lot, expiry date: not reported) (Unknown dosage and frequency) for immune modifier (Immunomodulatory therapy). On 28-JAN-2025, the patient received an unknown dose of suspect Yellow Fever Vaccine - Us Solution for injection (strength: not reported) (lot number, expiry date: not reported) via unknown route in unknown administration site. On 28-JAN-2025 the patient who was on an immune modifier, skyrizi, was administered yf-vax today, with no reported adverse event (Contraindicated product administered) (latency: same day) following the administration of Yellow Fever Vaccine. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2824035 | M | NJ | 01/31/2025 |
HEP HEP |
MERCK & CO. INC. MERCK & CO. INC. |
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Blood immunoglobulin M normal, Hepatitis A antibody negative, Hepatitis B, Hepat...
Blood immunoglobulin M normal, Hepatitis A antibody negative, Hepatitis B, Hepatitis B surface antibody negative, Hepatitis C test negative; Mononucleosis heterophile test negative, Vaccination failure, Viral load increased
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anti-HBs levels confirmed immunity. Despite this, our patient still developed an acute HBV infection...
anti-HBs levels confirmed immunity. Despite this, our patient still developed an acute HBV infection; Literature Report: This literature marketed report was received from the authors in a published literature article titled as stated above, concerning a 30-year-old male patient. The patient's concurrent conditions included human immunodeficiency virus (HIV), acquired immunodeficiency syndrome and Social alcohol drinker. Historical conditions included meningitis, syphilis, chlamydia, and anal herpes papillomavirus. Concomitant medications included efavirenz (+) emtricitabine (+) tenofovir. On an unknown date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant)(unknown manufacturer) Intramuscular Injection (strength, exact dose, route of administration, anatomical location, lot number and expiration date were not reported) as prophylaxis. On an unknown date in 2023, the hepatitis B surface antibody (anti-HBs) level before the change in therapy was 14.5 mIU/mL, consistent with immunity, and the hepatitis B surface antigen (HBsAg) was negative. Laboratory findings revealed a reactive HBsAg and hepatitis B core immunoglobulin M. HBV viral load was 52,200 IU/mL. Hepatitis C antibody, hepatitis A immunoglobulin M, and a monospot test were negative. In October 2023, the patient was transitioned from bictegravir (+) emtricitabine (+) tenofovir alafenamide (B/FTC/TAF) to cabotegravir (+) rilpivirine (CAB/RPV) for HIV infection. On unknown dates, HBV viral load results decreased to 27,700 IU/mL and 8,500 IU/mL. On an unknown day, the patient experienced vaccination failure, as despite being vaccinated, the patient developed an acute hepatitis B virus (HBV) infection. However, the patient's anti-HBs levels confirmed immunity with a level greater than 10 mIU/mL (14 mIU/mL). The outcome of the event of Vaccination failure was not reported. The causality assessment between Hepatitis B Vaccine (Recombinant)(unknown manufacturer) and the event of vaccination failure was considered as related. The authors concluded that the only other case report that provided an association with a patient with HIV, vaccinated from HBV, who developed an acute HBV infection after CAB/RPV treatment. A copy of the published article is attached as further documentation of the patient's experience.
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| 2824036 | F | 01/31/2025 |
HPV4 |
MERCK & CO. INC. |
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Papilloma viral infection
Papilloma viral infection
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Hello, I was made aware that the daughter of a cousin residing in another country was diagnosed with...
Hello, I was made aware that the daughter of a cousin residing in another country was diagnosed with HPV post Gardasil vaccination.; This spontaneous report was received from a Company Representative and refers to a 26-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported. On an unknown date in 2014, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, route of administration and anatomical site of injection were not provided). The reporter became aware that on an unspecified date, the daughter of a cousin residing in another country was diagnosed with Human Papillomavirus (HPV) following the vaccination (Papilloma viral infection). On an unknown date, her medical reports indicated a positive p16/Ki67 result; however, serotyping was not mentioned. At the time of reporting, the outcome of the event was unknown. The causal relationship between the reported event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported. No further information was provided.
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| 2824037 | U | FL | 01/31/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Incomplete course of vaccination
Incomplete course of vaccination
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Had One Dose Last Year in September of 2023 of the HEPLISAV-B; Initial report received on 12-Dec-202...
Had One Dose Last Year in September of 2023 of the HEPLISAV-B; Initial report received on 12-Dec-2024 with additional information received on 19-Dec-2024. A pharmacist reported that an adult patient (age and gender not provided) received one dose HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization in Sep-2023 but did not receive the next dose. No medical history or concomitant medications were reported. On 01-Sep-2023, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC # 43528-002-01, route, and site not available). At the time of reporting, the patient had not received the next dose. The reporter called to inquire if restarting the series was necessary. The patient had received HEPLISAV-B at a different location than the reporters. No other information was available. The reporter declined to be contacted for further information. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2824038 | F | WI | 01/31/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
945656 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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17 Year Old Received 1st Dose; Initial report received on 20-Dec-2024. A nurse practitioner reporte...
17 Year Old Received 1st Dose; Initial report received on 20-Dec-2024. A nurse practitioner reported that a 17-year-old (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. No medical history or concomitant medications were reported. On 20-Dec-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 945656, expiration 27-Jan-2027, NDC # 43528-0003-01) intramuscularly in the right deltoid. The reporter indicated that the patient's titers were negative and that they realized that the patient was under 18 years of age when HEPLISAV-B was administered. No adverse effects were reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2824039 | M | 01/31/2025 |
COVID19 UNK |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
LN0588 946638 |
Deafness neurosensory; Deafness neurosensory
Deafness neurosensory; Deafness neurosensory
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Sudden sensorineural hearing loss; This spontaneous case, initially received on 17-Jan-2025, was rep...
Sudden sensorineural hearing loss; This spontaneous case, initially received on 17-Jan-2025, was reported by a health professional (via Pfizer) and concerns an adult male patient. At the time of the event the patient had drug allergy. Administration of company suspect drug(s): On 06-Dec-2024, the patient received Flucelvax (TIV) for Indication not reported., dose: not reported, route of administration: not reported, anatomical location: left arm. Lot number: 946638. Non-company suspect drugs: Comirnaty (Tozinameran) Adverse reactions/events and outcomes: On 18-Dec-2024 20:00, the patient experienced Sudden sensorineural hearing loss (Medically Significant, outcome: Not recovered / Not resolved). The patient was treated with high dose steroid. The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s). The patient was not taking any other medications within 2 weeks of the event starting. Flucelvax (TIV) action taken: Not applicable Treatment medication: Steroid (high dose) Reporter's assessment: The reporter considered the events as non-serious and did not provide the causality of the events.; Reporter's Comments: Causality; Due to spontaneous nature of the case it is considered as related for reporting purposes and considering plausible temporality (after 13 days start of suspect drug). Brighton collaboration criteria is assessed as level 4 due to insufficient information provided.
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| 2824052 | 78 | F | FL | 01/31/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
LL942 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient received vaccination twice, had no short term side effects
Patient received vaccination twice, had no short term side effects
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| 2824053 | 21 | M | OK | 01/31/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
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Incorrect route of product administration, No adverse event
Incorrect route of product administration, No adverse event
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Was given SQ instead of IM. No adverse reaction occurred. Manufacture contacted and vaccine was stil...
Was given SQ instead of IM. No adverse reaction occurred. Manufacture contacted and vaccine was still valid and no redose needed.
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| 2824054 | 75 | M | VA | 01/31/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient was a walk-in 01/30/2025 - requested RSV, was asked by pharmacist if he has ever received an...
Patient was a walk-in 01/30/2025 - requested RSV, was asked by pharmacist if he has ever received an RSV and informed pharmacist he had not. System also did NOT reflect any past admin of RSV - per archived transaction and vaccine consent form records, appears that patient did receive an RSV from our store 10/19/2023 and patient was called 01/31/2025 and asked if he had ever received it in 2023 said he still had no recollection. Patient has experienced no issues, side effects or negative outcomes from second administration of RSV was not upset and requested vaccine because he thought he never had it.
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| 2824056 | 49 | F | CA | 01/31/2025 |
FLU3 |
SANOFI PASTEUR |
U8518SA |
Unevaluable event
Unevaluable event
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n/a
n/a
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| 2824057 | 65 | M | 01/31/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255T2 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient received duplicate dose of RSV vaccine. Initially received 4/2024. Reports no symptoms at th...
Patient received duplicate dose of RSV vaccine. Initially received 4/2024. Reports no symptoms at this time
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| 2824058 | 12 | F | HI | 01/31/2025 |
HPV9 |
MERCK & CO. INC. |
X022737 |
Loss of consciousness
Loss of consciousness
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Patient passed out after leaving clinic,per Mom she was out for around 30 sec. Patient given water t...
Patient passed out after leaving clinic,per Mom she was out for around 30 sec. Patient given water to drink and felt fine.
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