| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2818780 | 86 | M | NJ | 12/31/2024 |
UNK UNK CHIK CHIK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER VALNEVA USA, INC. VALNEVA USA, INC. |
24B011 24B011 |
Blood sodium decreased, Confusional state, Heart rate increased, Lethargy, Pulmo...
Blood sodium decreased, Confusional state, Heart rate increased, Lethargy, Pulmonary oedema; Pyrexia; Blood sodium decreased, Condition aggravated, Confusional state, Dehydration, Diabetic metabolic decompensation; Heart rate increased, Lethargy, Pulmonary oedema, Pyrexia
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Extreme lethargy started after 2-3 days. On 7th day, extreme confusion (no idea where he was, where ...
Extreme lethargy started after 2-3 days. On 7th day, extreme confusion (no idea where he was, where son went, etc). Called ambulance and transported to Medical Center. Had fevers up to 103, elevated heart rate, fluid in lungs, low sodium
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โ | |||||
| 2204322 | 30 | M | GA | 03/29/2022 |
COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA |
011F21A 037B21A 037B21A 011F21A 011F21A |
Dystonia, Neck pain, Nystagmus, Speech disorder; Blood test normal, Computerised...
Dystonia, Neck pain, Nystagmus, Speech disorder; Blood test normal, Computerised tomogram normal, Dysphemia, Electroencephalogram normal, Laboratory test normal; Magnetic resonance imaging normal, Muscle contractions involuntary, Paralysis, Seizure like phenomena; Blood test normal, Computerised tomogram normal, Dysphemia, Electroencephalogram normal, Laboratory test normal; Magnetic resonance imaging normal, Muscle contractions involuntary, Paralysis, Seizure like phenomena
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Dystonia, neck pain, speech disturbance, nystagmus - pt. was prescribed Keppra, but did not work.
Dystonia, neck pain, speech disturbance, nystagmus - pt. was prescribed Keppra, but did not work.
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| 2832665 | F | TN | 03/21/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Investigation, Magnetic resonance imaging, Nerve injury, Osteonecrosis, Pleurisy...
Investigation, Magnetic resonance imaging, Nerve injury, Osteonecrosis, Pleurisy; Pulmonary embolism, Renal impairment, Sepsis, Thrombosis, X-ray
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blood clots in her lungs; declining kidney function; sepsis; nerve complications; pleurisy; multifoc...
blood clots in her lungs; declining kidney function; sepsis; nerve complications; pleurisy; multifocal avascular necrosis; her body sent out thousands of clots; This is a literature report from License Party for the following literature source(s). A 31-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Nov2020 (unspecified if ongoing); "hypertrophic cardiomyopathy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "her body sent out thousands of clots"; OSTEONECROSIS (medically significant) with onset Jul2021, outcome "not recovered", described as "multifocal avascular necrosis"; PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "blood clots in her lungs"; RENAL IMPAIRMENT (medically significant), outcome "unknown", described as "declining kidney function"; SEPSIS (medically significant), outcome "unknown"; NERVE INJURY (medically significant), outcome "unknown", described as "nerve complications"; PLEURISY (medically significant), outcome "unknown". Clinical course: the patient was used to caring for others as the director of a nursing home until she developed a condition that caused her bones to rot after taking the Covid shot. The patient (at the time of the article was 34 years old), was working at a nursing home in her native state when the Covid pandemic hit in 2020. She watched patients die alone and missed her son's birthday out of fear of becoming infected and bringing the virus home with her. In January 2021, Covid vaccines became available and, feeling a sense of duty to protect her patients, she took the Pfizer vaccine. She experienced no immediate side effects, but in Jul2021, the patient developed 'unbearable' pain in both of her hips. She was told she had arthritis at 31 years old and had to use a wheelchair when the pain made it too hard to walk. Believing her pain was something else, another doctor ordered an magnetic resonance imaging (MRI), which revealed the patient's hip bones were literally rotting, and she underwent her first hip replacement in Dec2021. The second followed a few months later in 2022. However, her hips were just the beginning. Over the next nearly four years - and still ongoing today ๏ฟฝ the patient would undergo surgeries on both shoulders and knees, three surgeries on her elbow, one on her left foot and she was scheduled to have another procedure on her right foot. About a year after her ordeal began, one of her doctors attributed her complications to her bout of Covid in late Nov2020 and subsequent vaccines. The patient told the social media: 'The pain is so debilitating. I have never felt so helpless in my entire life. I've always been trying to be the best provider I could be caring for other people.' However, due to the patient's condition, she had to quit her job as a nurse and director in an elder care home and go on disability. She continued: 'Now I can't even drive my kids to school in the morning anymore... it's devastating. I have really had to mourn the life that I thought I was going to have because I will no longer be able to be the same person I've always wanted to be because of a virus and a vaccine. It's absolutely destroyed my life, and so I've had to just totally sit back and reevaluate everything.' The patient attributed her ailments to the shot. The patient she has experienced nerve complications - the researchers said vaccine injuries can manifest differently from patient to patient. Prior to her vaccine, the patient had been living with hypertrophic cardiomyopathy - thickening of the heart muscle - but her condition was well managed under the care of a cardiologist. Since her new symptoms began, she has seen doctors across multiple specialties, including orthopedics and a geneticist. She told this website her geneticist attributes her complications to a combination of her Covid infection and the vaccines. The doctor told her when she received the vaccine it prompted an immune response and her body sent out thousands of clots that cut off the blood supply to her bones and joints, which causes them to collapse and die. The patient's other doctors believe she has the autoimmune diseases either lupus or rheumatoid arthritis, but diagnostic tests have come back negative or inconclusive. She has been diagnosed with multifocal avascular necrosis (AVN), also called multifocal osteonecrosis (MFON). AVN is a condition in which bones throughout the body lose their blood supply, causing them to die. It can be caused by trauma to the body, like broken or fractured bones. A 2023 study investigated the relationship of avascular necrosis (AVN) and Covid infection in 17 patients. Researchers found 82 percent of patients complained of pain in both hips, leading nearly 18 percent to undergo total hip replacements and they concluded 'there is a risk of developing AVN after Covid-19.' There is no published research on the connection between AVN and Covid vaccines. Functional neurologist at the Neuro Center Dr (redacted), who is not involved in the patient's care, told social media AVN can be triggered by inflammation and blood clotting abnormalities. These, Dr (redacted) said, have been documented both in severe Covid cases and post-vaccination adverse reactions. He explained: 'Given that Covid-19 is known to affect the vascular system and trigger inflammatory responses, it is plausible that a vaccine administered soon after an infection could further exacerbate these effects, particularly in individuals with underlying predispositions.' Since her hip replacements, the patient has also undergone a partial left shoulder replacement in Sep2022 and had three surgeries on her elbow to remove dead bone and repair a nerve in Jan2023, Aug2024 and November 2024. She underwent a right knee replacement in Aug2023, a partial right shoulder replacement in May2023, a left knee replacement in Feb2023 and in Jul2023 her left heel broke and had to be surgically repaired. The patient would then undergo surgery in the next few weeks to repair another fracture in her right foot. She told this website: 'Even though I have had all of these replacements and surgeries I am still in constant deep bone pain every day. 'It isn't as bad as bone death pain but some days are still unbearable. The pain is so bad some days it takes everything I have to get out of bed and move, let alone be a mother and wife. 'Doctors think I will likely suffer with bone pain for the rest of my life.' Not only has she had to cope with AVN, her doctors said the infection and vaccine triggered a 'domino effect' in her body, leading to blood clots in her lungs, declining kidney function, sepsis and pleurisy - inflammation of the lining in the lungs and chest cavity. The patient believes in vaccines, when she first started speaking out about her experience with the Covid shot, she said she was met with people questioning whether she was an anti-vaxxer. The patient, however, has always been pro-vaccine and she and her children received all the recommended shots. Now, however, she is extremely wary of new ones. She told this website she will never get or give her children another Covid vaccine but has no problem getting them routine vaccinations of shots that have been around and researched for decades. The patient said: 'I did everything that I needed to do, vaccinating my children. I was vaccinated, but I will never get another flu shot or COVID vaccine, and I won't give my kids either as well. They will get... the other ones that have been well studied and researched, and there's lots of information on over the years. I just think that newer vaccines, before mandated, need to be researched because these are people's lives that it's destroying.' Therapeutic measures were taken as a result of osteonecrosis. BNT162B2 is under agreement with BIONTECH SE.; Sender's Comments: Based on the temporal relationship, the association between the reported events with BNT162b2 can not be fully 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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| 2832666 | F | VA | 03/21/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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diagnosed with COVID; diagnosed with COVID; This is a spontaneous report received from a Consumer or...
diagnosed with COVID; diagnosed with COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 74-year-old female 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with COVID". During an inbound call for financial assistance, a 75-year-old retired caller mentioned they had just been diagnosed with COVID-19. When asked about adding an email address to their account, the caller explained they did not have an email and struggled with accessing messages. After listening to the consents, the caller apologized, stating they had just come from the doctor's office. The caller inquired whether one could recover from COVID-19 without medication and expressed hope that prayer might help. They also voiced frustration that despite choosing Pfizer inoculations, they still contracted the virus. Toward the end of the call, the caller complimented the representative for speaking clearly, which was appreciated by someone with "old ears." . The patient indicated that they were referring to Pfizer inoculations. The patient did not clarify what the inoculations were for only that they still got COVID after getting them.
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| 2832670 | M | TX | 03/21/2025 |
HPV9 |
MERCK & CO. INC. |
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Anogenital dysplasia, Colonoscopy abnormal
Anogenital dysplasia, Colonoscopy abnormal
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Consumer was diagnosed in February with "anal Intraepithelial neoplasia (ain iii)" after h...
Consumer was diagnosed in February with "anal Intraepithelial neoplasia (ain iii)" after having colonoscopy in November 2024. Consumer said he has had vaccines from Merck before, but did not remember which types or when.; This spontaneous report has been received from a consumer and refers to himself, a 68-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an unspecified vaccine (indication, expiration date, lot #, strength, dose number, route and anatomical site of administration were not reported). The patient did not remember which types of vaccines received or when. On an unknown date on February 2025, the patient experienced anal Intraepithelial neoplasia (ain iii) after having colonoscopy in November 2024. At the reporting time, the outcome of the event was unknown. The causal relationship between the event and an unspecified vaccine was not provided. Upon internal review, the event of anal Intraepithelial neoplasia was determined to be medically significant. Follow up information has been received on 19-MAR-2025 from a registered nurse (RN) from the physician's office. The RN shared the only information concerning vaccines was Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9) listed in patient chart (date of administration, dose, route, lot# and expiration date were not provided) for prophylaxis. I was the patient's primary physician who ordered the vaccination. This office has no information concerning it completion. Also, the patient was not taken any company oncology medications. Additional information is not expected. The causality assessment between the event and Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9) was not reported. This was a previous Invalid report due to lack of therapy identification, however, upon follow up it was confirmed that the patient received Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9).
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| 2832671 | 11 | M | GA | 03/21/2025 |
UNK UNK UNK UNK FLUX FLUX UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
X025115 X025115 V18415MA V18415MA WT8413MA WT8413MA X023113 X023113 |
No adverse event, Product storage error; No adverse event, Product storage error...
No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error
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No adverse event; Improper storage of oroduct in use; This spontaneous report was received from a co...
No adverse event; Improper storage of oroduct in use; This spontaneous report was received from a consumer referring to a 12-year-old male patient. Information regarding the patient's pertinent medical history, drug allergies, reactions, or concomitant medications was not provided. Concurrent conditions included autism (Autism spectrum disorder) and attention deficit and hyperactivity disorder. On 23-OCT-2024, the patient was vaccinated with an improperly stored dose of human papillomavirus 9-valent vaccine, recombinant suspension for injection (GARDASIL9), administered intramuscularly for prophylaxis (dose, vaccination scheme frequency, anatomical location were not reported, lot number X025115 with an expiration date not provided but upon internal validations established as 19-MAY-2026) and with a dose of quadrivalent influenza vaccine (INFLUENZA VACCINE INACT SPLIT 4V) administered intramuscularly for an unknown indication dose, vaccination scheme frequency, anatomical location were not reported, lot number V18415MA, expiration date not provided). The administered dose of the vaccine experienced a temperature excursion 6 degrees Fahrenheit up to 14 degrees Fahrenheit for 30 minutes, as recorded by a data logger. There was no adverse effect reported.; Sender's Comments: Priority: 4 , Is case serious: No , Index user: Index date: 2025-03-13 , MNSC number: , CLIC number: , ESTAR number: , IRMS number: Central date: 2025-03-13 , Classification: DMC, Attachment description: Post Marketing Basic , Safety case number:
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| 2832672 | 60 | 03/21/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failu...
Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failure
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Suspected Vaccination failure; I got shingles anyway; This serious case was reported by a consumer v...
Suspected Vaccination failure; I got shingles anyway; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 60-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 4 months after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got shingles anyway). 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 and Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 16-MAR-2025 This case was reported by a patient via interactive digital media. The patient said he/she dreaded them, so when patient turned 60 got the two step Shingles shot and four months later, the patient got shingles anyway. The patient said believe them when they said it hurted This case was considered as suspected vaccination failure since the details regarding the 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, and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to Shingles vaccine.
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| 2832673 | F | 03/21/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Ophthalmic herpes zoster, Vaccination failure
Ophthalmic herpes zoster, Vaccination failure
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Suspected vaccination failure; still got shingles which affected her eyes; This serious case was rep...
Suspected vaccination failure; still got shingles which affected her eyes; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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 ophthalmic herpes zoster (Verbatim: still got shingles which affected her eyes) (serious criteria GSK medically significant). The outcome of the vaccination failure and ophthalmic herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 15-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine and still got shingles which affected her eyes. The follow-up could not be possible as no contact details were available. 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
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| 2832674 | 03/21/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; I got both and my shingles reactivated; This serious case was reporte...
Suspected vaccination failure; I got both and my shingles reactivated; 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got both and my shingles reactivated). 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 and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 16-MAR-2025 This case was reported by a patient via interactive digital media. The patient got both (shingles vaccine) and shingles reactivated. The follow-up could not be possible as no contact details were available. 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (1st dose)and Shingles vaccine (2nd dose) .
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| 2832675 | 03/21/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Pain, Vaccination failure
Herpes zoster, Pain, Vaccination failure
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Suspected Vaccination failure; still got shingles /extremely painful; This serious case was reported...
Suspected Vaccination failure; still got shingles /extremely painful; 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: still got shingles /extremely painful). 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 to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 15-MAR-2025 The patient reported he/she got the vaccines and still got shingles an extremely painful condition that nobody wanted. 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2832676 | 63 | F | FL | 03/21/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
L5229 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient received a tdap vaccine on 01/25/2025 and received a second dose on 03/20/2025. I called the...
Patient received a tdap vaccine on 01/25/2025 and received a second dose on 03/20/2025. I called the patient today and she said she is feeling fine. No side effects to report at the moment.
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| 2832685 | 74 | M | SD | 03/21/2025 |
COVID19 FLU3 PNC20 |
MODERNA SANOFI PASTEUR PFIZER\WYETH |
3043501 U8429CA LG5575 |
Cranial nerve paralysis, Vision blurred; Cranial nerve paralysis, Vision blurred...
Cranial nerve paralysis, Vision blurred; Cranial nerve paralysis, Vision blurred; Cranial nerve paralysis, Vision blurred
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PT PRESENTED WITH BLURRED VISION TO ER AND WAS DIAGNOSED WITH 6 CRANIAL NERVE PALSY
PT PRESENTED WITH BLURRED VISION TO ER AND WAS DIAGNOSED WITH 6 CRANIAL NERVE PALSY
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| 2832686 | 50 | F | CA | 03/21/2025 |
MMR |
MERCK & CO. INC. |
y013131 |
Pruritus, Rash
Pruritus, Rash
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itching and rash on arm
itching and rash on arm
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| 2832687 | 2 | F | CT | 03/21/2025 |
HEPA |
MERCK & CO. INC. |
X025908 |
Injection site pruritus, Injection site swelling, Nodule, Ultrasound scan abnorm...
Injection site pruritus, Injection site swelling, Nodule, Ultrasound scan abnormal
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Bump at location of injection site still present and itchy 8 months later . Still trying to find dia...
Bump at location of injection site still present and itchy 8 months later . Still trying to find diagnosis
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| 2832688 | 53 | M | CA | 03/21/2025 |
COVID19 COVID19 COVID19 COVID19 FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 |
MODERNA MODERNA MODERNA MODERNA GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. |
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Activated partial thromboplastin time, Arthralgia, Blood creatine phosphokinase,...
Activated partial thromboplastin time, Arthralgia, Blood creatine phosphokinase, Differential white blood cell count, Electrocardiogram; Fibrin D dimer normal, Full blood count, Gait disturbance, Impaired work ability, Influenza; Loss of personal independence in daily activities, Malaise, Metabolic function test, Muscle spasms, Pain; Pain in extremity, Prothrombin time, Sciatica, Ultrasound Doppler normal; Activated partial thromboplastin time, Arthralgia, Blood creatine phosphokinase, Differential white blood cell count, Electrocardiogram; Fibrin D dimer normal, Full blood count, Gait disturbance, Impaired work ability, Influenza; Loss of personal independence in daily activities, Malaise, Metabolic function test, Muscle spasms, Pain; Pain in extremity, Prothrombin time, Sciatica, Ultrasound Doppler normal; Activated partial thromboplastin time, Arthralgia, Blood creatine phosphokinase, Differential white blood cell count, Electrocardiogram; Fibrin D dimer normal, Full blood count, Gait disturbance, Impaired work ability, Influenza; Loss of personal independence in daily activities, Malaise, Metabolic function test, Muscle spasms, Pain; Pain in extremity, Prothrombin time, Sciatica, Ultrasound Doppler normal; Activated partial thromboplastin time, Arthralgia, Blood creatine phosphokinase, Differential white blood cell count, Electrocardiogram; Fibrin D dimer normal, Full blood count, Gait disturbance, Impaired work ability, Influenza; Loss of personal independence in daily activities, Malaise, Metabolic function test, Muscle spasms, Pain; Pain in extremity, Prothrombin time, Sciatica, Ultrasound Doppler normal; Activated partial thromboplastin time, Arthralgia, Blood creatine phosphokinase, Differential white blood cell count, Electrocardiogram; Fibrin D dimer normal, Full blood count, Gait disturbance, Impaired work ability, Influenza; Loss of personal independence in daily activities, Malaise, Metabolic function test, Muscle spasms, Pain; Pain in extremity, Prothrombin time, Sciatica, Ultrasound Doppler normal
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Patient Information ? Name: ? Age: 53 ? Sex: Male ? Address: ? Phone: ? Email: Vaccine Informatio...
Patient Information ? Name: ? Age: 53 ? Sex: Male ? Address: ? Phone: ? Email: Vaccine Information ? Date of vaccination: February 19, 2025 (4:15 PM) ? Vaccines received: o Influenza Vaccine PF Trivalent 6+ MO (AFLURIA, FLUARIX, FLULAVAL, FLUZONE) o Moderna 12+Y (Blue Label Border 50 mcg/0.5 mL) COVID-19 Vaccine ? Location: Flu Clinic Adverse Event Description I went to Flu Clinic on February 19, 2025, specifically for an influenza vaccination due to the influenza A outbreak. The clinic staff informed me I was "behind" on my COVID-19 vaccination. As an essential worker, I felt compelled to receive both vaccines. When I asked if it was appropriate to receive both vaccines simultaneously in the same arm, the nurse assured me it was safe to do so. I clearly communicated my Factor V Leiden condition and history of blood clots, which is documented in my medical record, and clinic staff acknowledged this information prior to vaccination. I received both COVID-19 and influenza vaccines in my left arm on February 19, 2025. The following day I experienced expected symptoms similar to having both COVID and flu, requiring me to stay home from work. After returning to work, within 1-2 days, I began experiencing severe right leg pain. The pain is primarily and most consistently in my lower leg, with intermittent pain along my IT band and occasional, inconsistent pain in the gluteal region. The lower leg pain is the most severe. I have not experienced lower back pain at all, which makes the sciatica diagnosis questionable. The pain became so severe that it felt as though my leg had "seized up" and was almost broken. I attempted to relieve the pain through multiple stretching exercises without success. The pain has persisted for several weeks despite multiple medical visits and treatments. Now, nearly a month later (as of March 17, 2025), I still have severe pain that makes it very difficult to walk for more than a few minutes before I need to sit down. Medical Care Received 1. February 24, 2025: First Urgent Care visit o Treated with Flexeril for leg cramps o Symptoms were present for approximately 2 days at this point 2. February 28, 2025: First Emergency Department visit at Medical Center o Diagnosed with likely sciatica o Treated with Norco and Medrol (steroids) o D-dimer test performed (result 0.30, normal) o Complete blood count and basic metabolic panel performed o Physical exam showed normal leg exam, good DP and PT pulses, no swelling/edema o Instructions to take ibuprofen and Norco as needed for pain, and follow Medrol dose pack exactly as prescribed o Noted the temporal relationship between vaccines and symptom onset 3. March 7, 2025: Second Urgent Care visit with Dr. o Doctor strongly urged me to go to Medical Center immediately o Recommended additional testing including ultrasound, time test, and possibly MRI due to my Factor V Leiden history 4. March 7, 2025: Second Emergency Department visit at Medical Center (same day as Urgent Care) o Evaluated with physical exam and ultrasound for blood clot o Ultrasound showed no emergent abnormalities o Diagnosed with arthralgia of right lower leg o Multiple lab tests completed including CBC with Differential, Creatine Kinase, D-Dimer, Metabolic Panel, PTT and Prothrombin Time o ECG and Ultrasound of lower extremity veins performed o Prescribed Tylenol, Motrin, and voltaren gel o Recommended follow-up with primary care doctor within 3 days I have requested my complete medical records from all healthcare facilities involved, under the Health Insurance Portability and Accountability Act (HIPAA), specifically 45 CFR ๏ฟฝ 164.524. I have requested detailed records including vaccination information, lot numbers, all test results, provider notes, and documentation of my pre-existing Factor V Leiden condition disclosure. Current Status and Treatment ? Pain returned after initial improvement following steroid treatment ? Currently prescribed: o Cyclobenzaprine (Flexeril) 10mg for muscle spasm o Hydrocodone/acetaminophen (Norco) 5mg/325mg for pain o Methylprednisolone (Medrol) 4mg o Tylenol (acetaminophen) 1000mg every 6 hours o Motrin (ibuprofen) 600mg every 6 hours o Voltaren gel as needed ? Pain continues to interfere with walking and daily activities Relevant Medical History ? Factor V Leiden mutation ? History of deep venous thrombosis (DVT) 10 years ago ? Was on blood thinners for a long time Reason for Reporting I am reporting this event because: 1. The timing of my symptoms directly followed vaccination (physician notes document "received Covid and flu shots in L deltoid 3 days prior to symptom onset") 2. I have no history of sciatica or similar leg pain 3. I had no injury or event that would typically trigger these symptoms (medical records confirm "no direct trauma or unusual activity") 4. The symptoms have been severe and persistent despite multiple treatments 5. Multiple doctors have been unable to provide a clear explanation for my symptoms 6. Physical examinations and lab tests have been largely normal, with no physical findings that would explain the severe pain 7. The pain has not followed a typical sciatica pattern, as it's primarily in my lower leg and I have not experienced lower back pain 8. Some healthcare providers have acknowledged that vaccines can potentially cause inflammatory reactions in some individuals 9. Given my Factor V Leiden condition, I may have higher risk for unusual reactions involving inflammation or vascular issues I believe there may be a connection between receiving both vaccines simultaneously and the development of my symptoms, possibly due to an inflammatory response or other mechanism. I have had no other injuries, have done little to no exercise, and there is nothing else in my life that could explain these symptoms.
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| 2832689 | 65 | F | CT | 03/21/2025 |
PNC20 |
PFIZER\WYETH |
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Fatigue, Injection site pain, Tinnitus
Fatigue, Injection site pain, Tinnitus
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Pain at site, fatigue, ringing in both ears
Pain at site, fatigue, ringing in both ears
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| 2832690 | 71 | F | WA | 03/21/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Arthralgia, Loss of personal independence in daily activities, Pain in extremity
Arthralgia, Loss of personal independence in daily activities, Pain in extremity
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Severe shoulder pain, get worse when I use the shoulder, hard to get dressed or reach for items in t...
Severe shoulder pain, get worse when I use the shoulder, hard to get dressed or reach for items in the cabinet. Pain also showed up in the thumb joint and into the palm area. Pain is intermittent and is round 5 when sitting. When I use the shoulder pain can go to 8 or 9 and can cause me to drop things I am carrying.
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| 2832691 | 26 | F | CA | 03/21/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Antinuclear antibody positive, Blood gases abnormal, Dyspnoea, Feeding disorder,...
Antinuclear antibody positive, Blood gases abnormal, Dyspnoea, Feeding disorder, Fibrin D dimer increased; Sleep disorder
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Two days after receiving the vaccine, I woke up gasping and short of breath. I have been short of br...
Two days after receiving the vaccine, I woke up gasping and short of breath. I have been short of breath ever since. Unable to sleep or eat most days because lying in certain positions makes it impossible to breathe. My oxygen has dropped as low as 75% and I have been to the ER 3 times since November. I have seen a cardiologist, a neurologist, a rheumatologist, and a pulmonologist - none of them can pinpoint what is wrong. When I am sick, the shortness of breathe worsens dramatically.
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| 2832781 | 0.33 | F | OK | 03/21/2025 |
DTAPIPV RV5 |
SANOFI PASTEUR MERCK & CO. INC. |
U7838AA 2037483 |
Product administered to patient of inappropriate age; Product administered to pa...
Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
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Pt age 4m17d and was give vaccine recommended for age 4-6 yrs.
Pt age 4m17d and was give vaccine recommended for age 4-6 yrs.
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| 2832782 | 83 | F | DE | 03/21/2025 |
PNC20 |
PFIZER\WYETH |
LG5579 |
Erythema, Pruritus
Erythema, Pruritus
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Pt came into pharmacy on friday 3/21/25 after getting shot on 3/18 (tuesday) saying her arm was red ...
Pt came into pharmacy on friday 3/21/25 after getting shot on 3/18 (tuesday) saying her arm was red and itchy the day after. Arm was still red in bicep area but patient stated itchy feeling went away
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| 2832044 | PA | 03/20/2025 |
HPV9 |
MERCK & CO. INC. |
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Product storage error
Product storage error
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Nurse called to return a call from someone from Merck asking more information about a patient's...
Nurse called to return a call from someone from Merck asking more information about a patient's AE with GARDASIL 9. She did not have a case number. During the call, the call was dropped. Call back attempted and left a message with a receptionist; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), Injection for prophylaxis (exact dose, dose number, route and site of administration, lot # and expiration date were not reported). On unknown date the patient experienced unspecified adverse event (reported as "nurse called to return a call from someone, asking more information about a patient's AE"). The outcome of adverse event was unknown. The causality between adverse event and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) was not provided.
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| 2832284 | F | VA | 03/20/2025 |
PNC21 |
MERCK & CO. INC. |
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Immediate post-injection reaction, Injection site erythema, Injection site swell...
Immediate post-injection reaction, Injection site erythema, Injection site swelling
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had some swelling at the injection site immediately after the injection.; had redness and swelling o...
had some swelling at the injection site immediately after the injection.; had redness and swelling of the arm and it had "migrated down the arm towards the elbow"; had redness and swelling of the arm and it had "migrated down the arm towards the elbow"; arm was slightly warm to the touch; This spontaneous report was received from a pharmacist via Company representative concerning to a female patient of unspecified age. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. On approximately 17-FEB-2025 (reported as "approximately 2 weeks ago"), the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) injection pre-filled syringe, 1 dosage form (dosage regimen, lot #, route of administration and expiration date were not reported) administered in an unspecified arm as prophylaxis. On the same date, immediately after the injection, the patient had some swelling at the injection site (vaccination site swelling). Pharmacist reported the patient then came back a week later and since an unspecified date in February 2005, she still had redness (vaccination site erythema) and swelling of the arm, and it had "migrated down the arm towards the elbow" (extensive swelling of vaccinated limb). Pharmacist stated arm was slightly warm to the touch (vaccination site warmth), but she did not think it was an infection, so she gave the patient some diphenhydramine (BENADRYL), and told her to ice the swelling and keep an eye on it. At the reporting time, the outcome of the events was not known, as pharmacist had reached out to the patient a couple of times since, but had not been able to get a hold of them to check in. No additional information was available. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported. Lot # is being requested and will be submitted if received.
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| 2832285 | UT | 03/20/2025 |
HPV9 |
MERCK & CO. INC. |
W026152 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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no adverse event; Expired vaccine used; This spontaneous report has been received from a consumer re...
no adverse event; Expired vaccine used; This spontaneous report has been received from a consumer regarding a 28-year-old patient of unknown gender. Information regarding medical history, concurrent conditions and concomitant therapies was not reported. On 04-MAR-2025, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis, 0.5 milliliters, lot number W026152 which has been verified to be valid, expiration date reported and validated as 21-JAN-2025. (strength, dose, scheme, route of administration, anatomical site not reported) (expired vaccine used). No temperature excursion occurred. No symptoms reported.
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| 2832286 | 03/20/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; I now get shingles 4 or more times a year.; This serious case was rep...
Suspected vaccination failure; I now get shingles 4 or more times a year.; 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: I now get shingles 4 or more times a year.). 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: 14-MAR-2025 This case was reported by a patient via interactive digital media. The patient received Shingles vaccine and now get shingles four or more times a year. The reporter said that have a blessed weekend. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case is linked with US2025AMR032002, reported by same reporter.; 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. US-GSK-US2025AMR032002:same reporter different patient
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| 2832287 | 52 | M | CA | 03/20/2025 |
COVID19 COVID19 |
JANSSEN JANSSEN |
Unknown Unknown |
Arthritis, COVID-19, Depression, Inflammation, Migraine; Muscle spasms, Muscle t...
Arthritis, COVID-19, Depression, Inflammation, Migraine; Muscle spasms, Muscle tightness, Muscular weakness, Nervous system disorder
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nerve issue; migraine; inflammation in head and down in leg and tail bone and; got covid after 6 mon...
nerve issue; migraine; inflammation in head and down in leg and tail bone and; got covid after 6 month of vaccination; arthritis changes from sever to mild; muscle cramps; muscle tight; muscle weak in joint; depression got bad; This spontaneous report received from a patient concerned a male patient in their 50's. The patient's height and weight were not reported. Age at time of vaccination 52 year old. The patient's past medical history included: iv user, and concurrent conditions included: heart murmur and depression, and other pre-existing medical conditions included: weight; 230 (units unspecified). The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose and frequency not reported, administered on Jun-2021, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced nerve issue, migraine, inflammation in head and down in leg and tail bone and, got covid after 6 month of vaccination, arthritis changes from sever to mild, muscle cramps, muscle tight, muscle weak in joint, and depression got bad. (Dose Series -1) Treatment medications included: prednisone for weird feels that something is their in my system. Patient had a rare reaction from covid vaccine, headache and rare achy pain, continuous headache, flashed light , migraine, inflammation in head and down in leg and tail bone, got covid after 6 month of vaccination. Consumer stated that his immune system was strong and did not need vaccine. Consumer said his reaction was headache which never went away, it was horrible for 2 days and better after 2 days but never went away, nerve issue. Consumer said he is 230 weight now and in diet, do exercises, arthritis changes from sever to mild, inflammatory nerve condition in tail bone, coccyx block his legs, muscle cramps, muscle tight, muscle weak in joint. Consumer said that he had a heart murmur and former IV user, had depression and due to headache depression got bad. Consumer stated patient have weird feels that something is their in my system, and tried prednisone and it feels better for short period of time. The action taken with janssen covid-19 vaccine was not applicable. The outcome of nerve issue, inflammation in head and down in leg and tail bone and, got covid after 6 month of vaccination, muscle cramps, muscle tight, muscle weak in joint and depression got bad was not reported. The patient had not recovered from migraine. The patient was recovering from arthritis changes from sever to mild. This report was non-serious.
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| 2832301 | NY | 03/20/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Expired product administered
Expired product administered
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The product expired on 24 FEB 2025 and was administered on 7 MAR 2025; This non-serious case was rep...
The product expired on 24 FEB 2025 and was administered on 7 MAR 2025; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received RSVPreF3 adjuvanted (Arexvy) (expiry date 24-FEB-2025) for prophylaxis. On 07-MAR-2025, the patient received Arexvy. On 07-MAR-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: The product expired on 24 FEB 2025 and was administered on 7 MAR 2025). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 10-MAR-2025 The reporter was physician who stated that a patient accidentally received an expired dose of Arexvy. The product expired on 24th February 2025 and was administered on 07th March 2025 which led to expired vaccine used.
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| 2832302 | F | MO | 03/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Impaired work ability, Injection site swelling, Malaise, Rash, Urticaria
Impaired work ability, Injection site swelling, Malaise, Rash, Urticaria
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Swelling at injection site; extreme hives; rash; malaise; This serious case was reported by a pharma...
Swelling at injection site; extreme hives; rash; malaise; This serious case was reported by a pharmacist via sales rep and described the occurrence of injection site swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: Swelling at injection site) (serious criteria other: Serious as per reporter), hives (Verbatim: extreme hives) (serious criteria other: Serious as per reporter), rash (Verbatim: rash) (serious criteria other: Serious as per reporter) and malaise (Verbatim: malaise) (serious criteria other: Serious as per reporter). The outcome of the injection site swelling, hives, rash and malaise were unknown. The reporter considered the injection site swelling, hives, rash and malaise to be related to Shingrix. The company considered the injection site swelling, hives, rash and malaise to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 13-MAR-2025 The pharmacist reported that one of their employees of the pharmacy (patient) was around 55 years old who experienced an extreme reaction to the first dose of vaccine. The patient missed multiple days of work and had to go to urgent care.; Sender's Comments: Injection site swelling, Urticaria, Rash and Malaise are listed events which, due to the following criteria (insufficient information on medical history, concurrent conditions, concomitant medications and time to onset) are considered unrelated to GSK vaccine Shingrix.
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| 2832303 | F | IL | 03/20/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Chest X-ray abnormal, Dysphonia, Dyspnoea, Foetal exposure during pregnancy, Inf...
Chest X-ray abnormal, Dysphonia, Dyspnoea, Foetal exposure during pregnancy, Influenza; Laryngomalacia, Neonatal aspiration, Snoring, Upper respiratory tract infection
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laryngmalasia; series of 3-4 upper respiratory infections; contracting influenza A & B; daughter...
laryngmalasia; series of 3-4 upper respiratory infections; contracting influenza A & B; daughter inhaled amniotic fluid when birth occurred; This serious retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of laryngomalacia in a female infant exposed to RSVPreF3 adjuvanted (Arexvy) in utero. The mother received the product for prophylaxis. The parent's medical history included glipizide, prenatal vitamin and the mother was also taking a prenatal vitamin (started on 24th June 2023 and ended on 26th February 2024) and was also taking Glipizide 2.5mg for gestational diabetes (started on 18th December 2023 and ended on 26th February 2024). On 24-JAN-2024, the mother received Arexvy. The infant was diagnosed with laryngomalacia (Verbatim: laryngmalasia) (serious criteria GSK medically significant), upper respiratory tract infection (Verbatim: series of 3-4 upper respiratory infections), influenza (Verbatim: contracting influenza A & B) and fetal exposure during pregnancy (Verbatim: daughter inhaled amniotic fluid when birth occurred). The outcome of the laryngomalacia was not resolved and the outcome of the upper respiratory tract infection and influenza were not reported and the outcome of the fetal exposure during pregnancy was not applicable. It was unknown if the reporter considered the laryngomalacia, upper respiratory tract infection and influenza to be related to Arexvy. The company considered the laryngomalacia to be unrelated to Arexvy. It was unknown if the company considered the upper respiratory tract infection and influenza to be related to Arexvy. Pregnancy exposure: Gestation time at first exposure (Arexvy): 34 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Details (Neonate 1): Actual Delivery Date: Number of Fetuses/Neonates: 1 Pregnancy Outcome: Live neonate with a congenital anomaly Delivery Notes: The mother was 34 weeks pregnant during time of vaccination See case US2025AMR031575 for details regarding the mother case. Additional Information: GSK Receipt Date: 12-MAR-2025 The mother reported that she received Arexvy vaccine on from pharmacy and claimed that daughter (patient) inhaled amniotic fluid when birth occurred and had lungs drained. The mother claimed that daughter's pediatrician was not concerned and at 2.5 months,reporter's daughter sounded as if she smoked 1.5 packs of cigarettes per day (voice hoarseness, raspy voice, snoring, difficulty breathing). The reporter claimed that daughter's pediatrician stated there was not much that could be done, considering reporters' child's young age, but sucking out phlegm from nasal passages was the best treatment. The reporter claimed that daughter had multiple visits to pediatrician and hospital (no hospitalization required) for chest x-rays after contracting influenza A and B and also having a series of 3 to 4 upper respiratory infections. The reporter's daughter was taken to see Ear, Nose, and Throat (ENT) doctor and was then diagnosed with laryngomalacia. The reporter was requesting a call back to discuss that and claimed that none of her daughter's symptoms have subsided or have been cured. This case is linked with US2025AMR031575, reported by same reporter.; Sender's Comments: Laryngomalacia is an unlisted event which is considered unrelated to GSK vaccine Arexvy. US-GSK-US2025AMR031575:mother case
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| 2832304 | M | TN | 03/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Injection site discolouration, Injection site induration, Injection site swellin...
Injection site discolouration, Injection site induration, Injection site swelling
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severe localized reaction of the injection site that had a large area of swelling that hardened; sev...
severe localized reaction of the injection site that had a large area of swelling that hardened; severe localized reaction of the injection site that had a large area of swelling that hardened; impacted the pigmentation of that area of the patient's arm; adult approximately 45 years of age received Shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site swelling in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: severe localized reaction of the injection site that had a large area of swelling that hardened), injection site induration (Verbatim: severe localized reaction of the injection site that had a large area of swelling that hardened), injection site pigmentation changes (Verbatim: impacted the pigmentation of that area of the patient's arm) and inappropriate age at vaccine administration (Verbatim: adult approximately 45 years of age received Shingrix). The outcome of the injection site swelling, injection site induration and injection site pigmentation changes were resolved and the outcome of the inappropriate age at vaccine administration was not applicable. It was unknown if the reporter considered the injection site swelling, injection site induration and injection site pigmentation changes to be related to Shingrix. It was unknown if the company considered the injection site swelling, injection site induration and injection site pigmentation changes to be related to Shingrix. Additional Information: GSK Receipt Date: 14-MAR-2025 An adult approximately 45 years of age patient had been vaccinated with Shingrix dose 1 which led to inappropriate age at vaccine administration. The patient indicated that he had a severe localized reaction of the injection site that had a large area of swelling that hardened and the swelling was so significant if impacted the pigmentation of that area of the patient's arm. It was unknown if this was dose 1 or dose 2 of Shingrix. If it was dose 1 then it was unknown if patient returned for dose 2. The patient had now recovered.
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| 2832335 | 16 | M | AZ | 03/20/2025 |
VARCEL |
MERCK & CO. INC. |
Y013350 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE; TE for VARIVAX that occurred on 02/24/2025 and the vaccine was also inadvertently...
No additional AE; TE for VARIVAX that occurred on 02/24/2025 and the vaccine was also inadvertently administered on 02/26/2025; This spontaneous report was received from a health professional and refers to a 16-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-FEB-2025, a temperature excursion (TE) for Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) occurred (-11.4C for 1 hour 0 minutes 0 seconds). On 26-Feb-2025, the patient was inadvertently vaccinated with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) 0.5mL / once (lot #Y013350, expiration date: 02-Aug-2026), administered for prophylaxis. The vaccine was reconstituted with sterile diluent, solution for injection (product storage error). The patient did not experience any adverse issues or side effects related to the administration of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (no adverse event). No prior excursions were noted. No product quality complaint (PQC) was noted.; Reporter's Comments:
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| 2832336 | M | MA | 03/20/2025 |
PPV PPV PPV |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Immunoglobulin therapy, Therapy non-responder; Immunoglobulin therapy, Therapy n...
Immunoglobulin therapy, Therapy non-responder; Immunoglobulin therapy, Therapy non-responder; Immunoglobulin therapy, Therapy non-responder
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His response to pneumococcal polysaccharide vaccine was minimal; This literature marketed report has...
His response to pneumococcal polysaccharide vaccine was minimal; This literature marketed report has been received from the authors of a published literature article, and refers to a male patient of unknown age with recurrent sinus infections, pneumonia throughout childhood with chronic diarrhea, positive tissue transglutaminase IgA, and endoscopy with small bowel enteropathy leading to a diagnosis of celiac disease. Owing to recurrent infections, immunodeficiency evaluation at age 15 years revealed mildly low IgG level with normal IgA and elevated IgM levels. The patient had a pathogenic mutation in PIK3CD. On an unknown date, the patient was vaccinated with an unspecified pneumococcal vaccine (dose, route of administration, lot # and expiration date were not provided), for prophylaxis. His response to the suspect vaccine was minimal. The outcome of the event was not provided. He was started on immunoglobulin replacement leading to decreased infections. The authors of the article considered minimal response to the vaccine as related to pneumococcal vaccine. This is one of 3 reports derived from the same literature article (linked GSD #2266119 and 2266118).
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| 2832337 | 14 | F | 03/20/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
|
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
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No additional adverse event; Consumer called to report they received their first dose of GARDASIL 9 ...
No additional adverse event; Consumer called to report they received their first dose of GARDASIL 9 on 06/20/2017 and their second dose was administered 03/27/2019.; This spontaneous report was received from a physician and refers to a 16-year-old female patient. The patient's medical history, current conditions and concomitant medications was not reported. On 20-JUN-2017 patient was vaccinated with first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), (lot # and expiration date were not reported) and the second dose on 27-MAR-2019 (inappropriate schedule of product administration). No additional adverse event. Lot number is being requested and will be submitted if received.
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| 2832339 | M | MO | 03/20/2025 |
MMRV UNK |
MERCK & CO. INC. UNKNOWN MANUFACTURER |
Y009982 Y005457 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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No Side effects or symptoms reported.; HCP called to report PROQUAD and PEDVAX HIB were mixed and ad...
No Side effects or symptoms reported.; HCP called to report PROQUAD and PEDVAX HIB were mixed and administered to one patient.; This spontaneous report was received from a registered nurse and refers to 19-months-old male patient The patient's medical history, current conditions and concomitant therapies were not reported. On 13-MAR-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD), (lot #Y009982 who had been verified to be a valid lot number, expiration date reported and validated as 24-NOV-2025); and Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), (lot #Y005457 who had been verified to be a valid lot number, expiration date reported and validated as 06-NOV-2026) (exact doses, anatomical routes of administration, lot number and expiration date were not reported), both vaccines administered for prophylaxis. It was reported that the vaccines were mixed and administered to patient (product preparation issue). No additional adverse events.
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| 2832340 | F | MD | 03/20/2025 |
HPV9 |
MERCK & CO. INC. |
|
Papilloma viral infection
Papilloma viral infection
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HPV infection; This spontaneous report was received from a Physician and refers to an Adult female p...
HPV infection; This spontaneous report was received from a Physician and refers to an Adult female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, at age 10 or 11, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (dose, route of administration, anatomical location, lot # and expiration date were not reported). On an unknown date, the patient experienced HPV infection. At the reporting time, the outcome of HPV infection was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant was reported as not applicable. The causal relationship between the event of HPV infection and Human Papillomavirus 9-valent Vaccine, Recombinant was unknown/not reported/not provided. This is one of two reports received from the same reporter (case # 2262454).;
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| 2832341 | 1 | F | ID | 03/20/2025 |
VARCEL |
MERCK & CO. INC. |
Y002061 |
Product storage error
Product storage error
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Medical Assistant calling to report an adverse event regarding improperly stored and administered RO...
Medical Assistant calling to report an adverse event regarding improperly stored and administered ROTATEQ. Medical Assistant stated that the ROTATEQ was involved in a temperature excursion on 12/11/2024 and the product was potentially administered t; they have not had any reports of patients experiencing any medical concerns or symptoms after being administered; This spontaneous report was received from medical assistant refers to multiple patients of unknown ages and genders. Their medical history, concurrent conditions and concomitant therapies were not provided. On 11-DEC-2024, the patients were vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), formulation: oral liquid, lot # X023403, expiration date: 03-APR-2025, 2 milliliter (route of administration and anatomical location were not provided); hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: injection, lot # X024560, expiration date: 31-MAY-2026 (exact dose, route of administration and anatomical location were not provided); hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: injection, lot # Y000205, expiration date: 23-SEP-2026 (exact dose, route of administration and anatomical location were not provided); hepatitis a vaccine, inactivated (VAQTA), formulation: intramuscular injection, lot # Y007585, expiration date: 31-OCT-2025 (exact dose, route of administration and anatomical location were not provided); pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), formulation: injection, lot # X026480, expiration date: 12-JAN-2026 (exact dose, route of administration and anatomical location were not provided); and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II), formulation: injection, lot # X011431, expiration date: 19-APR-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered doses of were involved in a temperature excursion (product storage error), they had not had any reports of patients experiencing any medical concerns or symptoms after being administered. Follow-up information was received from the medical assistant on 13-FEB-2025. This spontaneous report pertained a 12-month-old female patient. She did not have any pre-existing conditions, birth defects, medical conditions, nor illnesses at vaccination. On 17-DEC-2024, the patient was vaccinated with the first dose Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) lyophilisate and solvent for solution for injection, lot#Y002061 (expiration date: 09-JAN-2026), along with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date not reported) in the right thigh as prophylaxis (dose and route of administration were not provided) that had gone through a temperature excursion as the storage fridge had been out of range, but this vaccine was viable , and no events occurred to the patient after the administration as reported by the patient's mother, after the medical assistant talked to her. The vaccine had been given in a private doctor's office by a medical professional. It was not available for return. This case was previously classified as non-valid, as there were no patient identifiers, but per follow-up, the reporter provided all the information regarding the patients and the vaccines that they had received after excursion. This was one of 5 reports received from the same reporter. This case has been migrated from the previous safety database to the current safety database and assigned new Case ID: 2265347. The previous case ID: 2501USA001924. As a consequence of migration, the follow-up report may indicate in the appropriate field that it is an initial report.
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| 2832342 | M | ID | 03/20/2025 |
DTPPVHBHPB PNC15 |
MSP VACCINE COMPANY MERCK & CO. INC. |
U7907AA X026480 |
No adverse event, Product storage error; No adverse event, Product storage error
No adverse event, Product storage error; No adverse event, Product storage error
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Medical Assistant calling to report an adverse event regarding improperly stored and administered RO...
Medical Assistant calling to report an adverse event regarding improperly stored and administered ROTATEQ. Medical Assistant stated that the ROTATEQ was involved in a temperature excursion on 12/11/2024 and the product was potentially administered t; they have not had any reports of patients experiencing any medical concerns or symptoms after being administered; This spontaneous report was received from a medical assistant referring to multiple patients of unknown ages and genders. Their medical history, concurrent conditions and concomitant therapies were not provided. On 11-DEC-2024, the patients were vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), formulation: oral liquid, lot # X023403, expiration date: 03-APR-2025, 2 milliliter (route of administration and anatomical location were not provided); hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: injection, lot # X024560, expiration date: 31-MAY-2026 (exact dose, route of administration and anatomical location were not provided); hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: injection, lot # Y000205, expiration date: 23-SEP-2026 (exact dose, route of administration and anatomical location were not provided); hepatitis a vaccine, inactivated (VAQTA), formulation: intramuscular injection, lot # Y007585, expiration date: 31-OCT-2025 (exact dose, route of administration and anatomical location were not provided); pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), formulation: injection, lot # X026480, expiration date: 12-JAN-2026 (exact dose, route of administration and anatomical location were not provided); and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II), formulation: injection, lot # X011431, expiration date: 19-APR-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered doses of were involved in a temperature excursion (product storage error), they had not had any reports of patients experiencing any medical concerns or symptoms after being administered. Follow-up information was received from the medical assistant on 13-FEB-2025. This spontaneous report pertained a 07-month-old male patient. He did not have any pre-existing conditions, birth defects, medical conditions, nor illnesses at vaccination. On 13-DEC-2024, the patient was vaccinated with the first dose of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) suspension for injection, lot#X026480 (expiration date: 12-JAN-2026) and with the first dose of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Hae... (VAXELIS) suspension for injection, lot#U7907AA (expiration date: 30-SEP-2026) (doses, anatomical locations, and routes of administration were not provided), both as prophylaxis that had gone through a temperature excursion as the storage fridge had been out of range, but this vaccines were viable , and no events occurred to the patient after the administration. The vaccine had been given in private doctor's office/hospital by a medical professional. It was not available for return. This case was previously classified as non-valid, as there were no patient identifiers, but per follow-up, the reporter provided all the information regarding the patients and the vaccines that they had received after excursion. This was one of 5 reports received from the same reporter. This case has been migrated from the previous safety database to the current safety database and assigned new Case ID: 2265348. The previous case ID: 2501USA001924. As a consequence of migration the follow-up report may indicate in the appropriate field that it is an initial report.
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| 2832343 | F | ID | 03/20/2025 |
DTPPVHBHPB PNC15 RV5 |
MSP VACCINE COMPANY MERCK & CO. INC. MERCK & CO. INC. |
U7907AA X026480 X023403 |
No adverse event, Product storage error; No adverse event, Product storage error...
No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error
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Medical Assistant calling to report an adverse event regarding improperly stored and administered RO...
Medical Assistant calling to report an adverse event regarding improperly stored and administered ROTATEQ. Medical Assistant stated that the ROTATEQ was involved in a temperature excursion on 12/11/2024 and the product was potentially administered t; they have not had any reports of patients experiencing any medical concerns or symptoms after being administered; This spontaneous report was received from a medical assistant and referred to multiple patients of unknown ages and genders. Their medical history, concurrent conditions and concomitant therapies were not provided. On 11-DEC-2024, the patients were vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), formulation: oral liquid, lot # X023403, expiration date: 03-APR-2025, 2 milliliter (route of administration and anatomical location were not provided); hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: injection, lot # X024560, expiration date: 31-MAY-2026 (exact dose, route of administration and anatomical location were not provided); hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: injection, lot # Y000205, expiration date: 23-SEP-2026 (exact dose, route of administration and anatomical location were not provided); hepatitis a vaccine, inactivated (VAQTA), formulation: intramuscular injection, lot # Y007585, expiration date: 31-OCT-2025 (exact dose, route of administration and anatomical location were not provided); pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), formulation: injection, lot # X026480, expiration date: 12-JAN-2026 (exact dose, route of administration and anatomical location were not provided); and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II), formulation: injection, lot # X011431, expiration date: 19-APR-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered doses were involved in a temperature excursion (product storage error), they had not had any reports of patients experiencing any medical concerns or symptoms after being administered. Follow-up information was received from the medical assistant on 13-FEB-2025. This spontaneous report pertained an 6-months-old female patient. She did not have any pre-existing conditions, birth defects, medical conditions, nor illnesses at vaccination. On 13-DEC-2024, the patient was vaccinated with the second dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) Oral solution, lot#X023403 (expiration date: 03-APR-2025), given orally (dose not provided); with the first dose of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) suspension for injection, lot#X026480 (expiration date: 12-JAN-2026) in the left thigh; and with the second dose of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Hae... (VAXELIS) suspension for injection, lot#U7907AA (expiration date: 30-SEP-2026) (doses and routes of administration were not provided), all as prophylaxis, that had gone through a temperature excursion as the storage fridge had been out of range, but this vaccine was viable , and no events occurred to the patient after the administration. The vaccine had been given in private doctor's office/hospital by a medical professional. It was not available for return. This case was previously classified as non-valid, as there were no patient identifiers, but per follow-up, the reporter provided all the information regarding the patients and the vaccines that they had received after excursion. This was one of 5 reports received from the same reporter. This case has been migrated from the previous safety database to the current safety database and assigned new Case ID: 2265349. The previous case ID: 2501USA001924. As a consequence of migration, the follow-up report may indicate in the appropriate field that it is an initial report.
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| 2832344 | M | ID | 03/20/2025 |
DTPPVHBHPB PNC15 RV5 |
MSP VACCINE COMPANY MERCK & CO. INC. MERCK & CO. INC. |
U7907AA X026480 X023403 |
No adverse event, Product storage error; No adverse event, Product storage error...
No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error
More
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Medical Assistant calling to report an adverse event regarding improperly stored and administered RO...
Medical Assistant calling to report an adverse event regarding improperly stored and administered ROTATEQ. Medical Assistant stated that the ROTATEQ was involved in a temperature excursion on 12/11/2024 and the product was potentially administered t; they have not had any reports of patients experiencing any medical concerns or symptoms after being administered; This spontaneous report was received from medical assistant refers to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On 11-DEC-2024, the patients were vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), formulation: oral liquid, lot # X023403, expiration date: 03-APR-2025, 2 milliliter (route of administration and anatomical location were not provided); hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: injection, lot # X024560, expiration date: 31-MAY-2026 (exact dose, route of administration and anatomical location were not provided); hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: injection, lot # Y000205, expiration date: 23-SEP-2026 (exact dose, route of administration and anatomical location were not provided); hepatitis a vaccine, inactivated (VAQTA), formulation: intramuscular injection, lot # Y007585, expiration date: 31-OCT-2025 (exact dose, route of administration and anatomical location were not provided); pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), formulation: injection, lot # X026480, expiration date: 12-JAN-2026 (exact dose, route of administration and anatomical location were not provided); and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II), formulation: injection, lot # X011431, expiration date: 19-APR-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. On 11-DEC-2024, administered doses of vaccines were involved in a temperature excursion (product storage error), they have not had any reports of patients experiencing any medical concerns or symptoms after being administered (no adverse event). Follow-up information was received from the medical assistant on 13-FEB-2025. This spontaneous report pertained a 2-months-old male patient. He did not have any pre-existing conditions, birth defects, medical conditions, nor illnesses at vaccination. On 12-DEC-2024, the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) Oral solution, lot#X023403 (expiration date: 03-APR-2025), given orally (dose not provided); with the first dose of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) suspension for injection, lot#X026480 (expiration date: 12-JAN-2026) in the left thigh; and with the first dose of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Hae... (VAXELIS) suspension for injection, lot#U7907AA (expiration date: 30-SEP-2026) in the right thigh (doses and routes of administration were not provided), all as prophylaxis, that had gone through a temperature excursion as the storage fridge had been out of range, but this vaccine was viable , and no events occurred to the patient after the administration. The vaccine had been given in private doctor's office/hospital by a medical professional. It was not available for return. This case was previously classified as non-valid, as there were no patient identifiers, but per follow-up, the reporter provided all the information regarding the patients and the vaccines that they had received after excursion. This was one of 5 reports received from the same reporter. This case has been migrated from the previous safety database to the current safety database and assigned new Case ID: 2265350. The previous case ID: 2501USA001924. As a consequence of migration, the follow-up report may indicate in the appropriate field that it is an initial report.
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| 2832345 | SC | 03/20/2025 |
VARCEL |
MERCK & CO. INC. |
X006981 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE.; HCP calling to report that patient received post expiry dose of VARIVAX. No Previ...
No additional AE.; HCP calling to report that patient received post expiry dose of VARIVAX. No Previous TE; This spontaneous report was received from a nurse (Licensed Practical Nurse [L.P.N.]) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 17-Mar-2025, the patient was vaccinated with an expired dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) single dose (lot #X006981 that was verified to be valid lot # with provided end established expiration date: 07-Mar-2025) administered for prophylaxis (exact dose, dose number, anatomical location and route of administration were not provided); reconstituted with sterile diluent (MERCK STERILE DILUENT), Solution for injection (expiration date, and lot # were not reported) (Expired product administered). No previous temperature excursion (TE) was reported. No additional adverse event (AE) was reported (no adverse event).
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| 2832347 | F | MA | 03/20/2025 |
PPV PPV PPV |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Therapy non-responder; Therapy non-responder; Therapy non-responder
Therapy non-responder; Therapy non-responder; Therapy non-responder
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did not respond to pneumococcal polysacharide vaccination; This literature marketed report has been ...
did not respond to pneumococcal polysacharide vaccination; This literature marketed report has been received from the authors of a published literature article, and refers to a female patient of unknown age. She had a history of recurrent strep throat in young childhood, but no other significant infections. At age 16 years, she was diagnosed with hypothyroidism with goiter and underwent total thyroidectomy with pathology noting significant lymphocytic infiltrate. She developed joint pains and fevers at age 32 years and was diagnosed with having seronegative rheumatoid arthritis. Trialed treatments included multiple immunemodulators including hydroxychloroquine, methotrexate, tumor necrosis factor inhibitors, andsteroids. She transitioned to abatacept with dramatic improvement in her joint pain and was tapered off steroids. During this time, she had moderate hypogammaglobulinemia in the setting of frequent upper respiratory infections. She had heterozygous CTLA-4 mutation. Her son was diagnosed with inflammatory bowel disease. On an unknown date, the patient was vaccinated with an unspecified pneumococcal vaccine (dose, route of administration, lot # and expiration date were not provided), for prophylaxis. She did not respond to the suspect vaccine. The outcome of the event was not provided. The authors of the article considered lack of response to the suspect therapy as related to pneumococcal vaccine. Lot # is being requested and will be submitted if received. This is one of 3 reports derived from the same literature article (linked GSD #2266119 and 2263700).
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| 2832348 | F | MA | 03/20/2025 |
PPV PPV PPV |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Therapeutic response decreased; Therapeutic response decreased; Therapeutic resp...
Therapeutic response decreased; Therapeutic response decreased; Therapeutic response decreased
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poor response to pneumococcal vaccination.; This literature marketed report has been received from t...
poor response to pneumococcal vaccination.; This literature marketed report has been received from the authors of a published literature article, and refers to a female of unknown age with history of autoimmune thyroid disease presented with recurrent mucocutaneous candidiasis. She was diagnosed with having autoimmune thyroid disease at age 7 years and on thyroid replacement. She had 6 lifetime pneumonias that responded to antibiotics and was recently found to have bronchiectasis on computed tomography scan. Since age 5 years, she had recurrent mucocutaneous candidiasis treated with numerous courses of fluconazole. Her sister was diagnosed with having type 1 diabetes at age 12 years and had less severe mucocutaneous candidiasis. IgG, IgA, and IgM levels were normal. IgG2 level was low. She had STAT1 GOF mutation. On an unknown date, the patient was vaccinated with an unspecified pneumococcal vaccine (dose, route of administration, lot # and expiration date were not provided), for prophylaxis. She had a poor response to the suspect vaccine. The outcome of the event was not provided. The authors of the article considered poor response to the suspect therapy as related to pneumococcal vaccine. Lot # is being requested and will be submitted if received. This is one of 3 reports derived from the same literature article (linked GSD #2266118 and 2263700).
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| 2832349 | VA | 03/20/2025 |
PNC15 |
MERCK & CO. INC. |
Y010032 |
No adverse event, Product storage error
No adverse event, Product storage error
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HCP called to report an TE in VAXNEUVANCE in which the vaccine was administered.; No other AE; This ...
HCP called to report an TE in VAXNEUVANCE in which the vaccine was administered.; No other AE; This spontaneous invalid report was received from a nurse practitioner and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE )((lot #Y010032, expiration date: 17-FEB-2027, for prophylaxis) (exact dose, route of administration, and anatomical location were not reported)) that on an unknown date underwent temperature excursion (TE). Vaccine was stored in the temperature of 27.1 F for 1 hour and 21 minutes. No adverse event was reported. This case is invalid due to unidentifiable patient.
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| 2832350 | 54 | M | CA | 03/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
33fd3 |
Dizziness, Injection site mass, Injection site swelling
Dizziness, Injection site mass, Injection site swelling
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Injection site lump; swollen at injection site; he felt light-headed and dizzy; This non-serious cas...
Injection site lump; swollen at injection site; he felt light-headed and dizzy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number 33fd3) for prophylaxis. On 08-MAR-2025, the patient received Shingrix (intramuscular) .5 ml. On 08-MAR-2025, less than a day after receiving Shingrix, the patient experienced injection site lump (Verbatim: Injection site lump), injection site swelling (Verbatim: swollen at injection site) and light headedness (Verbatim: he felt light-headed and dizzy). The outcome of the injection site lump, injection site swelling and light headedness were unknown. The reporter considered the injection site lump, injection site swelling and light headedness to be related to Shingrix. The company considered the injection site lump, injection site swelling and light headedness to be related to Shingrix. Additional Information: GSK Receipt Date: 10-MAR-2025 The healthcare professional was the reporter. The reporter stated she administered the first dose of Shingrix to a patient on 08th March 2025. The healthcare professional reported the consumer had a lump and swelling immediately at the injection site. Approximately 5 minutes post injection the patient stated he felt light-headed and dizzy. No further information was provided/obtained.; Sender's Comments: US-GSK-US2025AMR029594:Same reporter/ different patient
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| 2832351 | 72 | F | NY | 03/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Pain in extremity, Rash, Somnolence
Pain in extremity, Rash, Somnolence
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rash the size of a dime on her left arm; her first dose of SHINGRIX she was sleepy and her left arm ...
rash the size of a dime on her left arm; her first dose of SHINGRIX she was sleepy and her left arm was sore.; her first dose of SHINGRIX she was sleepy and her left arm was sore.; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 07-MAR-2025 16:56, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 07-MAR-2025, less than a day after receiving Shingrix, the patient experienced sleepiness (Verbatim: her first dose of SHINGRIX she was sleepy and her left arm was sore.) and pain in arm (Verbatim: her first dose of SHINGRIX she was sleepy and her left arm was sore.). On 08-MAR-2025, the patient experienced rash (Verbatim: rash the size of a dime on her left arm). The outcome of the rash was not resolved and the outcome of the sleepiness and pain in arm were unknown. It was unknown if the reporter considered the rash, sleepiness and pain in arm to be related to Shingrix. It was unknown if the company considered the rash, sleepiness and pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 10-MAR-2025 The consumer was the reporter. The patient had her first dose of Shingrix vaccine administered on 07th March 2025 at 4:56 pm in her left arm. The reporter stated the evening of 08th March 2025 she noticed a rash the size of a dime on her left arm. The reporter stated the rash was not located at the site of injection. Consumer states on the evening of 09th March 2025 the rash was the size of a lemon. The consumer stated on 10th March 2025, the rash remains the same size. The reporter stated the rash was not itchy, bothersome, or painful. The consumer stated after receiving her first dose of Shingrix she was sleepy and her left arm was sore. No other information was provided/obtained. This case has been linked to the US2025AMR029990 case reported by the same reporter.
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| 2832352 | 03/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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I get firts dose april of 2024, and my second dose just now; This non-serious case was reported by a...
I get firts dose april of 2024, and my second dose just now; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (recived 1st dose on April 2024). 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: I get firts dose april of 2024, and my second dose just now). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK receipt date: 11-MAR-2025 This case was reported by a patient via (Chat bot) interactive digital media. The patient recived first dose April of 2024, and his/her second dose just now which led to, drug dose administration interval too long. The reporter had a question he/she need restart and get other shot.
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| 2832353 | M | 03/20/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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missed the booster; This non-serious case was reported by a consumer via interactive digital media a...
missed the booster; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a 5-year-old male patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero (received 2 doses on an unknown date). On an unknown date, the patient did not receive the 3rd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete course of vaccination (Verbatim: missed the booster). The outcome of the incomplete course of vaccination was not applicable. 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: 12-MAR-2025 This case was reported by a patient via (Bexsero GSK Cht bot) interactive digital media. The reporter reported that the patient had bexero vaccine when he was 19 months and 21months old, so two doses in total. The reporter was ask did he need 3rd booster dose. Till the time of reporting, the patient did not receive 3rd dose of Bexsero, which led to incomplete course of vaccination.
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| 2832354 | F | IA | 03/20/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
7D2Y4 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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a 15-month-old patient received a dose of Kinrix on 28/Feb/2025.; Kinrix was the 3rd dose for each (...
a 15-month-old patient received a dose of Kinrix on 28/Feb/2025.; Kinrix was the 3rd dose for each (DTap and IPV); This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis. Previously administered products included Vaxelis (received 1st dose of Vaxelis in May 2024) and Vaxelis (received 2nd dose of Vaxelis in August 2024). On 28-FEB-2025, the patient received the 3rd dose of Kinrix. On 28-FEB-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a 15-month-old patient received a dose of Kinrix on 28/Feb/2025.) and inappropriate schedule of vaccine administered (Verbatim: Kinrix was the 3rd dose for each (DTap and IPV)). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were not applicable. 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: 10-MAR-2025 On 10-Mar-2025 a reporter reported that vaccine was given prior to the recommended age. Reporter mentioned that a 15-month-old patient received a dose of Kinrix on 28/Feb/2025. Reporter also mentioned that patient received 2 prior doses of Vaxelis for their first 2 doses of DTaP and IPV, one in May and the other in August of 2024, which led to inappropriate schedule of vaccine administered and inappropriate age at vaccine administration. Kinrix was the 3rd dose for each DTap and IPV. The Vaccine Administration Facility is the same as Primary Reporter.
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| 2832355 | 2 | F | IA | 03/20/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
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Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Overdose; 2 year old female given Havrix 1440 adult; This non-serious case was reported by a pharmac...
Overdose; 2 year old female given Havrix 1440 adult; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 2-year-old female patient who received HAV (Havrix 1440 adult) for prophylaxis. On 11-MAR-2025, the patient received the 1st dose of Havrix 1440 adult. On 11-MAR-2025, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: Overdose) and adult product administered to child (Verbatim: 2 year old female given Havrix 1440 adult). The outcome of the overdose and adult product administered to child were not applicable. 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: 12-MAR-2025 The reporter reported that 2 year old female given Havrix 1440 EL.U/ml dose for 1st in Hepatitis A series on 11 MAR 2025 which led to Adult product administered to child and Overdose. They request to advise as pediatric patient received adult Havrix formulation. The vaccine administration facility was the same as primary reporter.
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| 2832358 | 61 | F | 03/20/2025 |
COVID19-2 COVID19-2 |
MODERNA MODERNA |
017H22A 017H22A |
Amnesia, Beta-2 glycoprotein antibody, Dizziness, Dysgeusia, Headache; Movement ...
Amnesia, Beta-2 glycoprotein antibody, Dizziness, Dysgeusia, Headache; Movement disorder, Muscle atrophy, Paraesthesia, Tremor
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Central nervous system gets shaky, get tremors; get very strong head aches; memory loss; metallic ta...
Central nervous system gets shaky, get tremors; get very strong head aches; memory loss; metallic taste on the tongue since last 2 years; light headedness and dizziness; muscle wasting; the patient can't exercise and can't move around, It's every day; tingling; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Central nervous system gets shaky, get tremors), HEADACHE (get very strong head aches), AMNESIA (memory loss), DYSGEUSIA (metallic taste on the tongue since last 2 years), DIZZINESS (light headedness and dizziness), MUSCLE ATROPHY (muscle wasting), MOVEMENT DISORDER (the patient can't exercise and can't move around, It's every day) and PARAESTHESIA (tingling) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Flu and Measles vaccine. Past adverse reactions to the above products included No adverse effect with Flu and Measles vaccine. Concurrent medical conditions included Thyroid disorder. On 21-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced TREMOR (Central nervous system gets shaky, get tremors) (seriousness criteria disability and medically significant), HEADACHE (get very strong head aches) (seriousness criteria disability and medically significant), AMNESIA (memory loss) (seriousness criteria disability and medically significant), DYSGEUSIA (metallic taste on the tongue since last 2 years) (seriousness criteria disability and medically significant), DIZZINESS (light headedness and dizziness) (seriousness criteria disability and medically significant), MUSCLE ATROPHY (muscle wasting) (seriousness criteria disability and medically significant), MOVEMENT DISORDER (the patient can't exercise and can't move around, It's every day) (seriousness criteria disability and medically significant) and PARAESTHESIA (tingling) (seriousness criteria disability and medically significant). The patient was treated with Naltrexone hydrochloride (Naltrexone) at a dose of low dose. At the time of the report, TREMOR (Central nervous system gets shaky, get tremors), HEADACHE (get very strong head aches), AMNESIA (memory loss), DYSGEUSIA (metallic taste on the tongue since last 2 years), DIZZINESS (light headedness and dizziness), MUSCLE ATROPHY (muscle wasting), MOVEMENT DISORDER (the patient can't exercise and can't move around, It's every day) and PARAESTHESIA (tingling) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Beta-2 glycoprotein antibody: Beta 2 glyco protein came from 150 to 120, they were supposed to be 20. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. Patient had a history of flu, measles, shingles vaccines and she alternated the flu vaccine with the covid vaccine, a pneumonia vaccine. It was reported that the patient red research papers and the Front Line COVID-19 Critical Care Alliance protocol regarding the spike protein. Patient wanted to know if there were tests, they could do to verify if they got vaccine injured because of the spike protein after 5 vaccines. Patient wanted to know what can be done to correct if they were vaccine injured. Patient did not want compensation but wanted assistance from Moderna. Patient was looking for advice and direction for their doctor to care for them. Patient's hematologist told them to not take mRNA vaccine anymore and patient had to wear it out. Patient took supplements, received Hydroxychloroquine & Naltrexone low dose as medication and they were not working. Patient were not clotting and antiphospholipid syndrome. This case was linked to US-MODERNATX, INC.-MOD-2025-783177 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2025: Live follow up received which contains non-significant information, reporter details and reference number were added.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-783177:Master case
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| 2832359 | 54 | M | IN | 03/20/2025 |
COVID19 |
MODERNA |
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Bell's palsy
Bell's palsy
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Bell's Palsy, most extreme symptoms dissipated after two months, but patient continue to have f...
Bell's Palsy, most extreme symptoms dissipated after two months, but patient continue to have feelings of numbness on the right side of face; This spontaneous case was reported by a patient and describes the occurrence of BELL'S PALSY (Bell's Palsy, most extreme symptoms dissipated after two months, but patient continue to have feelings of numbness on the right side of face) in a 54-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 13-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 17-Sep-2024, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced BELL'S PALSY (Bell's Palsy, most extreme symptoms dissipated after two months, but patient continue to have feelings of numbness on the right side of face) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's Palsy, most extreme symptoms dissipated after two months, but patient continue to have feelings of numbness on the right side of face) had not resolved. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.; Reporter's Comments: The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
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