| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2817969 | 69 | M | MA | 12/26/2024 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
LM7786 LM776 LM776 |
Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood ...
Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Rhabdomyolysis; Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Blood creatinine normal, Musculoskeletal stiffness; Myalgia
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Rhabdomyolysis while hiking. Increased CK Increased LFT. Tx: Rest, hydration. Resolved.
Rhabdomyolysis while hiking. Increased CK Increased LFT. Tx: Rest, hydration. Resolved.
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| 2829016 | 31 | F | PA | 03/02/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
|
Back pain, Blood test, Hyperhidrosis, Hypoaesthesia, Hypotonia; Loss of consciou...
Back pain, Blood test, Hyperhidrosis, Hypoaesthesia, Hypotonia; Loss of consciousness, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal, Myelitis transverse, Paralysis; Scan with contrast, Sleep disorder, Thirst; Back pain, Blood test, Hyperhidrosis, Hypoaesthesia, Hypotonia; Loss of consciousness, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal, Myelitis transverse, Paralysis; Scan with contrast, Sleep disorder, Thirst
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10 days after first dose I ended up waking up in the middle of the night extremely sweaty and thirst...
10 days after first dose I ended up waking up in the middle of the night extremely sweaty and thirsty, when i went to the kitchen, I went limp on the floor in a paralyzed state as if I had a mini stroke covered in sweat and unable to move for several minutes. Once i came to i was able to crawl to my husband who rushed me to hospital ER. December 2023- MRI shows signs ICP. March 2024- woke up and have lost feeling in lower limbs bilaterally. Sent to ER. After follow up with Neuro and many test, diagnosed with Transverse Myelitis. New studies linking Covid vaccine to TM, ICP, mini strokes.
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โ | |||||
| 2828914 | 03/01/2025 |
HPV9 |
MERCK & CO. INC. |
W031448 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No additional adverse event; An office manager called to report an AE where a dose of GARDASIL 9 was...
No additional adverse event; An office manager called to report an AE where a dose of GARDASIL 9 was administered to a patient after it's expiration date. No additional information provided to further clarify the details. No additional adverse effects reported. No additional AE; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported. On 25-FEB-2025, the patient was vaccinated with an expired dose of human papillomavirus 9-valent vaccine, recombinant suspension for injection (GARDASIL 9) administered as prophylaxis (Lot No. W031448 has been verified to be a valid lot number for [human papillomavirus 9-valent vaccine, recombinant suspension for injection], expiration date reported and upon internal validation established as 12-FEB-2025) (strength, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided) (expired product administered). No additional adverse event was reported (no adverse event).
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| 2828915 | FL | 03/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Herpes zoster, Pain, Pruritus, Vaccination failure
Herpes zoster, Pain, Pruritus, Vaccination failure
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Suspected vaccination failure; Shingles; This serious case was reported by a consumer via call cente...
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. In OCT-2024, the patient received Shingrix. In DEC-2024, less than 2 months after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure and shingles to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 19-FEB-2025 The patient had been dealing with shingles since middle of December 2024 and still had unbelievable itching ,pain constantly. The patient had tried everything and nothing has helped. The patient asked for suggestions that can help and this was after the vaccine in October. The patient was wondering how this help seemed not to have helped. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
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| 2828916 | 03/01/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Cough, Fatigue, Respiratory syncytial virus infection, Vaccination failure
Cough, Fatigue, Respiratory syncytial virus infection, Vaccination failure
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Respiratory syncytial virus infection; Suspected vaccination failure; This serious case was reported...
Respiratory syncytial virus infection; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 84-year-old patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Respiratory syncytial virus infection) (serious criteria hospitalization and GSK medically significant). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure and respiratory syncytial virus infection to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 20-FEB-2025 This case was reported by a patient via interactive digital media. The patient had the RSV vaccine and a few months later was in the hospital with the RSV infection. The patient was 84 years old, and it was horrible. After going home 8 days later stayed in room for a month, exhausted and coughing all time. The patient would definitely get the shot. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding respiratory syncytial virus infection 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine. Respiratory syncytial virus infection is an unlisted event which is considered unrelated to GSK RSV vaccine.
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| 2828917 | KY | 03/01/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
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Death
Death
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The two people that died from an RSV vaccine; This serious case was reported by a physician via call...
The two people that died from an RSV vaccine; This serious case was reported by a physician via call center representative and described the occurrence of unknown cause of death in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced unknown cause of death (Verbatim: The two people that died from an RSV vaccine) (serious criteria death and GSK medically significant). The reported cause of death was unknown. It was unknown if the reporter considered the unknown cause of death to be related to Arexvy. The company considered the unknown cause of death to be unrelated to Arexvy. Additional Information: GSK Receipt Date: 26-FEB-2025 The reporter reported that two people that have died from an RSV vaccine. The reporter would like to receive data on the circumstances surrounding their deaths. No further details provided.; Sender's Comments: Death is an unlisted event which is considered unrelated to GSK vaccine Arexvy.; Reported Cause(s) of Death: Unknown cause of death
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| 2828924 | 61 | M | TX | 03/01/2025 |
COVID19 |
PFIZER\BIONTECH |
Lp1780 |
Chills
Chills
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Severe chills
Severe chills
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| 2828925 | 59 | F | TN | 03/01/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA |
052E21A 052E21A 039D21A 039D21A |
Antiphospholipid syndrome, Blood test abnormal, Dizziness, Feeling abnormal, Hyp...
Antiphospholipid syndrome, Blood test abnormal, Dizziness, Feeling abnormal, Hypoaesthesia; Palpitations, Skin discolouration, Thrombosis; Antiphospholipid syndrome, Blood test abnormal, Dizziness, Feeling abnormal, Hypoaesthesia; Palpitations, Skin discolouration, Thrombosis
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Patient was feeling dizzy and heart felt like it was racing within 12 hours of being administered. ...
Patient was feeling dizzy and heart felt like it was racing within 12 hours of being administered. Heart normalized but the dizziness continued. Patient kept feeling bad and on 10/25/2021 she went to the doctor. At the beginning of the year her fingers began feeling numb and turning color until eventually they were a purple color. Patient was misdiagnosed to have Raynaud's but then later it was discovered that she had a blood clot in her arm restricting blood flow to her fingers. After issue with the clot was resolved she was referred to a Hematologist for testing and was diagnosed with Antiphospholipid syndrome.
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โ | โ | โ | |||
| 2828926 | 35 | F | MI | 03/01/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EL9265 EL9265 EL9265 |
Arthralgia, Blood test, Headache, Joint stiffness, Mast cell activation syndrome...
Arthralgia, Blood test, Headache, Joint stiffness, Mast cell activation syndrome; Muscular weakness, Nausea, Pain, Pyrexia, Undifferentiated connective tissue disease; Urine analysis, Whole body scan
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Bodyaches, headache, fever, joint stiffness and pain, muscle weakness, nausea. Vaccine resulted in ...
Bodyaches, headache, fever, joint stiffness and pain, muscle weakness, nausea. Vaccine resulted in UCTD and MCAS.
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โ | |||||
| 2828927 | 37 | M | IA | 03/01/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Blood test normal, Computerised tomogram, Electrocardiogram ambulatory, Electroc...
Blood test normal, Computerised tomogram, Electrocardiogram ambulatory, Electrocardiogram normal, Palpitations; Scan myocardial perfusion, X-ray
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Since I have gotten the shot my palpations have gotten worse I would only get them on occasion now w...
Since I have gotten the shot my palpations have gotten worse I would only get them on occasion now when I get them they last for days or weeks with no end nothing makes them calm down and I have ended up in the er many times due to this ongoing issue where I have had them now for a month and have to get a halter monitor put on
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| 2828928 | 11 | M | PA | 03/01/2025 |
MNQ MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
9M2R7 9M2R7 |
Erythema, Headache, Induration, Pruritus, Skin warm; Tenderness
Erythema, Headache, Induration, Pruritus, Skin warm; Tenderness
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Arm became red, hard, warm to the touch, tender, and itchy. Patient also c/o mild headache.
Arm became red, hard, warm to the touch, tender, and itchy. Patient also c/o mild headache.
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| 2828929 | 78 | F | FL | 03/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7ZM55 |
Dizziness, Loss of consciousness, Syncope
Dizziness, Loss of consciousness, Syncope
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Patient fainted the morning after receiving the SHINGRIX shot. She reported feeling lightheaded and ...
Patient fainted the morning after receiving the SHINGRIX shot. She reported feeling lightheaded and dizzy shortly before fainting, but mentioned she had a full breakfast and wasn't dehydrated in any way. Luckily, someone had caught her before she had passed out on the ground. She received medical attention promptly from an ambulance.
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| 2828930 | 72 | F | GA | 03/01/2025 |
PNC21 |
MERCK & CO. INC. |
Y013009 |
Erythema, Pain in extremity, Rash, Urticaria
Erythema, Pain in extremity, Rash, Urticaria
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Patient came to the pharmacy and showed the spot on her arm, it was red, and the skin was raised ind...
Patient came to the pharmacy and showed the spot on her arm, it was red, and the skin was raised indicative or hives. Patient reported soreness in the arm still 2 days after vaccine. Patient was able to raise her arm and move it without discomfort other then general soreness. The rash itself was still painful to the touch. Instructed patient to take Benadryl to help with the histamine response, and to contact provider asap. Also instructed patient to monitor the site to make sure it doesn't get any bigger. If it continues expanding or any signs of anaphylaxis to seek immediate medical attention
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| 2828931 | 80 | M | 03/01/2025 |
PNC20 |
PFIZER\WYETH |
lg5579 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient received a second prevnar 20 shot. one in 2022 and one now in 2025. no adverse events were r...
Patient received a second prevnar 20 shot. one in 2022 and one now in 2025. no adverse events were reported at this time
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| 2828932 | 77 | F | AL | 03/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
93kk4 |
Rash, Swelling, Viral infection
Rash, Swelling, Viral infection
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Patient states she had swelling, and a viral episode breakout of the mouth that started 48 hours af...
Patient states she had swelling, and a viral episode breakout of the mouth that started 48 hours after vaccine
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| 2828933 | 62 | F | TX | 03/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Oral herpes, Ulcerative keratitis
Oral herpes, Ulcerative keratitis
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Sunday, february 16 I had Multiple fever blisters on bottom lip. Worst outbreak I ever had in 60 yea...
Sunday, february 16 I had Multiple fever blisters on bottom lip. Worst outbreak I ever had in 60 years. Saturday, March 1st I had corneal ulcer diagnosed by doctor.
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| 2828934 | 66 | F | FL | 03/01/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
LM2216 UT8463DA |
Injection site pain, Musculoskeletal chest pain, Pain, Periarthritis; Injection ...
Injection site pain, Musculoskeletal chest pain, Pain, Periarthritis; Injection site pain, Musculoskeletal chest pain, Pain, Periarthritis
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Evening after vaccine, left arm was extremely painful at injection site. Following week I experience...
Evening after vaccine, left arm was extremely painful at injection site. Following week I experienced sharp jabbing intermittent pain at left ribcage. Following weeks left arm a shoulder became extremely painful when trying to move frozen arm. Saw Dr 2 months after vaccines due to extremely painful and frozen shoulder. Dr diagnosed adhesive capsulitis. I was prescribed steroid pack, which I am taking for 6 days. Physical therapy was prescribed also, along with follow up if there are no improvements.
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| 2828935 | 76 | F | FL | 03/01/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255T2 |
Extra dose administered
Extra dose administered
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1st dose was given 9/25/2023 and then a 2nd dose was given 2/28/2025 (not recommended by cdc)
1st dose was given 9/25/2023 and then a 2nd dose was given 2/28/2025 (not recommended by cdc)
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| 2828936 | 57 | F | VA | 03/01/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Chills, Fatigue, Headache, Influenza like illness, Pain; Pyrexia
Chills, Fatigue, Headache, Influenza like illness, Pain; Pyrexia
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Severe flu-like symptoms including high fever, chills, aches, fatigue, headache
Severe flu-like symptoms including high fever, chills, aches, fatigue, headache
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| 2828937 | 56 | F | PR | 03/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
27LR2 |
Injection site erythema, Injection site inflammation, Injection site warmth
Injection site erythema, Injection site inflammation, Injection site warmth
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PATIENT STATED PRESENTED RED AREAS AROUND ADMINISTRATION AREA THAT LOOKED LIKE A MAP THEY WERE DISPE...
PATIENT STATED PRESENTED RED AREAS AROUND ADMINISTRATION AREA THAT LOOKED LIKE A MAP THEY WERE DISPERSE AROUND ADMINISTRATION AREA SHE REPORTED INFLAMATION ON AREA AND FEELING OF WARM ON THE SKIN. NO RASH OR ITCH OR FEVER OR OTHER SYMPTOM REPORTED . PATIENT STATED SHE USED COLD COMPRESSES ON AREA AND SYMPTOMS IMPROVE WITHIN DAYS AND SINCE SHE ALSO TAKES MELOXICAM INFLAMMATION IMPROVED . PATIENT WAS ORIENTED TO TALK TO PRIMARY CARE PHYSICIAN SINCE SHE IS WORRIED ABOUT ADMINISTERING THE VACCINE SECOND DOSE
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| 2828938 | 57 | F | AL | 03/01/2025 |
UNK |
UNKNOWN MANUFACTURER |
93et2 |
Dizziness, Nausea, Pain in extremity
Dizziness, Nausea, Pain in extremity
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patient said: dizzy, light headed, nausea and sore arm
patient said: dizzy, light headed, nausea and sore arm
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| 2828939 | 0.25 | M | TX | 03/01/2025 |
RV5 RV5 RV5 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Abdominal rigidity, Blood test, Computerised tomogram abdomen, Dehydration, Diar...
Abdominal rigidity, Blood test, Computerised tomogram abdomen, Dehydration, Diarrhoea; Emotional distress, Food allergy, Gastrointestinal pathogen panel, Gastrointestinal sounds abnormal, Haematochezia; Intussusception, Pyrexia, Rotavirus test positive, Ultrasound scan, Vomiting
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3/14 -3/15became dehydrated vomiting and diarrhea (hospital visit) tested positive for rotavirus 3...
3/14 -3/15became dehydrated vomiting and diarrhea (hospital visit) tested positive for rotavirus 3/29 admitted to hospital for continued symptoms and suspected Intussusception, hospital notes to back that up and noted his symptoms as guarding, inconsolable and fever also blood in stools discharged at the end of the day 3/30/2022 IV fluids received on all hospital visits. Doctors also noted hyperactive bowel sounds
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| 2828940 | 59 | F | MN | 03/01/2025 |
PNC21 |
MERCK & CO. INC. |
y013009 |
Erythema, Injection site swelling, Pain in extremity, Pruritus
Erythema, Injection site swelling, Pain in extremity, Pruritus
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Patient states that since the evening of injection she has developed a red red 1/2 the width of her ...
Patient states that since the evening of injection she has developed a red red 1/2 the width of her arm. It is painful and has bouts of itching. The skin is swollen she states and has been advancing from injection site to elbow
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| 2828941 | 74 | M | MA | 03/01/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Brain oedema, Cerebral haemorrhage, Concussion, Dizziness, Head injury; Syncope
Brain oedema, Cerebral haemorrhage, Concussion, Dizziness, Head injury; Syncope
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Less than 24 hours after vaccination, the patient experienced extreme dizziness and collapsed. He hi...
Less than 24 hours after vaccination, the patient experienced extreme dizziness and collapsed. He hit his head, causing a concussion, brain swelling, and bleeding in the brain. The patient was rushed to Hospital emergency room and transferred to Hospital trauma unit.
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โ | |||||
| 2828942 | 50 | F | AZ | 03/01/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EJ1685 EL1283 FF2587 |
Skin cancer; Skin cancer; Skin cancer
Skin cancer; Skin cancer; Skin cancer
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Skin cancer on left side of face 8/21 and skin cancer left shoulder in 2021 as well
Skin cancer on left side of face 8/21 and skin cancer left shoulder in 2021 as well
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| 2828943 | 68 | M | TX | 03/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
93kk4 |
Fall, Injury, Limb injury, Loss of consciousness
Fall, Injury, Limb injury, Loss of consciousness
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Patient states he fell on boat the next day and he passed out once he got home. Patient states fall...
Patient states he fell on boat the next day and he passed out once he got home. Patient states fall and passing out resulted in minor injuries and a hurt toe.
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| 2828945 | 40 | F | OR | 03/01/2025 |
COVID19 |
PFIZER\BIONTECH |
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Dyspnoea, Echocardiogram, Tachycardia
Dyspnoea, Echocardiogram, Tachycardia
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Tachycardia Heart rate 140-160 24hrs a day x 2 years, shortness of breathe x 2 years
Tachycardia Heart rate 140-160 24hrs a day x 2 years, shortness of breathe x 2 years
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| 2829024 | M | FL | 03/01/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
L5229 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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No adverse event. Duplicate dose. 1st given 7/24 & 2nd 2/25
No adverse event. Duplicate dose. 1st given 7/24 & 2nd 2/25
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| 2828711 | M | NM | 02/28/2025 |
HEP |
MERCK & CO. INC. |
Y006509 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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A HCP called to inquire about how to administer a second dose of RECCOMBIVAX HB that would be late a...
A HCP called to inquire about how to administer a second dose of RECCOMBIVAX HB that would be late according to the recommended schedule. The HCP stated a 32 year old patient received their first dose of RECOMBIVAX HB on 08/26/2024 and he was antici; No additional adverse event; This spontaneous report has been received from a nurse regarding a 32-year-old male patient. The patient's pertinent medical history, current conditions, concomitant medications, previous drug reactions or allergies were not reported. On 26-AUG-2024, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) suspension for injection (RECOMBIVAX HB), administered as prophylaxis 1 mL (Lot No. Y006509 has been verified to be a valid lot number for [hepatitis b vaccine (recombinant) suspension for injection], expiration date reported and upon internal validation established as 11-FEB-2027 (strength, route and anatomical location of administration and vaccination scheme frequency were not provided). It was stated that the nurse called to inquire about how to administer a second dose of the vaccine that would be late according to the recommended schedule as the patient supposed to come to the clinic to receive his second dose of the vaccine on 26-FEB-2025 (inappropriate schedule of product administration). No additional adverse event (AE) (no adverse event) was reported.
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| 2828712 | GA | 02/28/2025 |
DTAPHEPBIP HEP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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pediatric patient received Pediarix and Engerix-B the same day; This non-serious case was reported b...
pediatric patient received Pediarix and Engerix-B the same day; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis. Previously administered products included Pediarix (received on 24-SEP-2024). On 03-FEB-2025, the patient received Engerix B and Pediarix. On 03-FEB-2025, an unknown time after receiving Engerix B and Pediarix, the patient experienced overdose (Verbatim: pediatric patient received Pediarix and Engerix-B the same day). The outcome of the overdose 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: 03-FEB-2025. Practice Manager and explained that they administered an extra dose of Hepatitis B vaccine, since a pediatric patient received Pediarix and Engerix-B the same day which led to overdose. Caller mentioned that patient received a prior Pediarix dose and no prior Engerix-B doses. Lot number and expiration date for the vaccines were not asked by the agent, but practice manager gave consent to follow up with safety if additional information was needed.
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| 2828713 | 45 | F | FL | 02/28/2025 |
COVID19-2 |
MODERNA |
unknown |
Guillain-Barre syndrome, Investigation
Guillain-Barre syndrome, Investigation
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I had Guillain Barr๏ฟฝ with a very heavy paralysis; This spontaneous case was reported by a patient ...
I had Guillain Barr๏ฟฝ with a very heavy paralysis; This spontaneous case was reported by a patient and describes the occurrence of GUILLAIN-BARRE SYNDROME (I had Guillain Barr๏ฟฝ with a very heavy paralysis) in a 46-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. unknown) for COVID-19 prophylaxis. Concomitant products included Immunoglobulins and Steroids for an unknown indication. On 07-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 milliliter. On 22-Dec-2022, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced GUILLAIN-BARRE SYNDROME (I had Guillain Barr๏ฟฝ with a very heavy paralysis) (seriousness criterion medically significant). The patient was treated with Rehabilitation therapy for Guillain-Barre syndrome. On 08-Jan-2023, GUILLAIN-BARRE SYNDROME (I had Guillain Barr๏ฟฝ with a very heavy paralysis) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Investigation: after many tests and differentiated diagnostics, I had Guillain Barr๏ฟฝ with a very heavy paralysis. The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) was unknown. 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 medications were reported. After many tests and differentiated diagnostics, the patient had Guillain barre with a very heavy paralysis. The patient had full mobility now, after 2 years in physical rehab and therapies, the patient battles their consequences and sinkinesis in her face. No treatment medications were reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
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| 2828723 | 02/28/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv...
suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. 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: 21-FEB-2025 This case was reported by a patient via interactive digital media. Patient had vaccine and got shingles twice last year. Still shingles with him/her 4 months later. The patient further said it would be good if it worked. 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.
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| 2828724 | IL | 02/28/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
DD72H |
Extra dose administered, Product label confusion
Extra dose administered, Product label confusion
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Product Confusion; This non-serious case was reported by a nurse via call center representative and ...
Product Confusion; This non-serious case was reported by a nurse via call center representative and described the occurrence of product label confusion in a patient who received Men B NVS (Bexsero) (batch number DD72H, expiry date 30-NOV-2027) for prophylaxis. On an unknown date, the patient received the 3rd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced product label confusion (Verbatim: Product Confusion). The outcome of the product label confusion 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-FEB-2025 The reporter was a nurse from a pediatric office. She reports that they administer Bexsero vaccine. Inappropriate schedule of vaccine, the nurse states they order Bexsero and have been giving it at day one and one month later (as according to the old schedule) due to this an unknown number of patients would now have to receive a third dose. The office staff were unaware of the dosing schedule change because they did not receive a notification. If they had known, they could have advised the patients not to return until the 6 month mark. The nurse was confused as to why the paper copy package insert inside the Bexsero vaccine box (which expires in 2027) would still be showing the original dosing schedule, which led to product label confusion. The vaccine administration facility was the same as primary reporter.
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| 2828725 | M | PA | 02/28/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Central sleep apnoea syndrome, Foetal exposure during pregnancy, Hypotonia, Leth...
Central sleep apnoea syndrome, Foetal exposure during pregnancy, Hypotonia, Lethargy, Obstructive sleep apnoea syndrome; Respiratory syncytial virus infection, Tachycardia, Tachypnoea
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obstuctive sleep apnea; central sleep apnea; tachycardia; tachypnea; hypotonia; RSV; This serious re...
obstuctive sleep apnea; central sleep apnea; tachycardia; tachypnea; hypotonia; RSV; This serious retrospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of obstructive sleep apnea in a male infant exposed to RSVPreF3 adjuvanted (Arexvy) in utero. The mother received the product for prophylaxis. On an unknown date, the 33-year-old mother received Arexvy. The infant was diagnosed with obstructive sleep apnea (Verbatim: obstuctive sleep apnea) (serious criteria hospitalization), central sleep apnea syndrome (Verbatim: central sleep apnea) (serious criteria hospitalization and GSK medically significant), tachycardia (Verbatim: tachycardia) (serious criteria hospitalization), tachypnea (Verbatim: tachypnea) (serious criteria hospitalization), hypotonia (Verbatim: hypotonia) (serious criteria hospitalization) and respiratory syncytial virus infection (Verbatim: RSV) (serious criteria hospitalization). The outcome of the obstructive sleep apnea, central sleep apnea syndrome, tachycardia, tachypnea and hypotonia were not resolved and the outcome of the respiratory syncytial virus infection was unknown. It was unknown if the reporter considered the obstructive sleep apnea, central sleep apnea syndrome, tachycardia, tachypnea, hypotonia and respiratory syncytial virus infection to be related to Arexvy. The company considered the obstructive sleep apnea, central sleep apnea syndrome, tachycardia, tachypnea, hypotonia and respiratory syncytial virus infection to be unrelated to Arexvy. Pregnancy Details (Neonate 1): Actual Delivery Date: Pregnancy Outcome: Live neonate with no apparent congenital anomaly Delivery Notes: She delivered at 37 weeks and 1 day See case US2025021327 for details regarding the mother case. Additional Information: GSK Receipt Date: 19-FEB-2025 The health care professional reported that a patient's mother received Arexvy at 33 weeks gestation and the child was have having sleep apnea (central and obstructive) which began shortly after coming home from the hospital and also experienced tachycardia, tachypnea, and hypotonia. This all began after one week of being home and has been hospitalized a couple times since. Patient was seen as and outpatient today for a second opinion. The child was still continuing to experience symptoms. The child was on oxygen. The child also developed respiratory syncytial virus infection twice and was hospitalized for it. The first date of occurrence for respiratory syncytial virus infection was unknown as there are no details available but the child was hospitalized a second time for respiratory syncytial virus infection on 28-Jan-2025 respiratory syncytial virus infection for 5 days. The child also had an adverse reaction to his 2 month vaccines a very lethargic response that lasted for several days afterwards. The health care professional was unsure which vaccines the child received at his 2 month visit. No details regarding lot or expiration date of Arexvy is available or date which patient received Arexvy.; Sender's Comments: Obstructive sleep apnoea syndrome, Central sleep apnoea syndrome, Tachycardia, Tachypnoea, Hypotonia and Respiratory syncytial virus infection are unlisted event which is considered unrelated to GSK vaccine Arexvy. US-GSK-US2025021327:Mother case
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| 2828726 | 55 | M | CA | 02/28/2025 |
DTAPHEPBIP TDAP |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR |
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Dyspnoea, Heart rate increased, Nausea, Pain, Pyrexia; Dyspnoea, Heart rate incr...
Dyspnoea, Heart rate increased, Nausea, Pain, Pyrexia; Dyspnoea, Heart rate increased, Nausea, Pain, Pyrexia
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Fever pain in body nausea fast heart rate can?t breathe
Fever pain in body nausea fast heart rate can?t breathe
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| 2828736 | 76 | F | NC | 02/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
ER5ZB |
Herpes zoster
Herpes zoster
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Despite prior vaccine, had quite severe case of shingles from 10/2023 - 1/2024
Despite prior vaccine, had quite severe case of shingles from 10/2023 - 1/2024
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| 2828737 | 1.25 | F | NC | 02/28/2025 |
DTAP HIBV |
SANOFI PASTEUR MERCK & CO. INC. |
2CA77C1 Y003146 |
Injection site erythema, Injection site warmth, Lymphocyte percentage, Neutrophi...
Injection site erythema, Injection site warmth, Lymphocyte percentage, Neutrophil percentage, White blood cell count increased; Injection site erythema, Injection site warmth, Lymphocyte percentage, Neutrophil percentage, White blood cell count increased
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Pt w/onset of progressive redness, warmth at injection site of Hib vaccine. Seen in office w/in 24hr...
Pt w/onset of progressive redness, warmth at injection site of Hib vaccine. Seen in office w/in 24hr - CBC checked with slight elevation WBC. Placed on Bactrim to cover possible abscess vs. localized site reaction.
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| 2828738 | 90 | F | OR | 02/28/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
8080803 388490 |
Injection site mass, Injection site pain; Injection site mass, Injection site pa...
Injection site mass, Injection site pain; Injection site mass, Injection site pain
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Pain ongoing - from shoulder to elbow in right arm. Lump in (R) deltoid still present. Has tried ice...
Pain ongoing - from shoulder to elbow in right arm. Lump in (R) deltoid still present. Has tried ice + heat pads. heat helps. Taking ibuprofen + APAP Scheduled 3/3/25 w/PCP
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| 2828806 | 64 | F | OH | 02/28/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
571480 571480 |
Arthralgia, C-reactive protein increased, Muscular weakness, Neck pain, Pain in ...
Arthralgia, C-reactive protein increased, Muscular weakness, Neck pain, Pain in extremity; Red blood cell sedimentation rate increased, Shoulder girdle pain
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Bilateral shoulder and girdle pain. Hand and neck pain grip weakness
Bilateral shoulder and girdle pain. Hand and neck pain grip weakness
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| 2828807 | 33 | M | TX | 02/28/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EL3248 EL3248 EL3248 EL3248 EL3248 |
Alpha tumour necrosis factor increased, Biopsy skin abnormal, Burning sensation,...
Alpha tumour necrosis factor increased, Biopsy skin abnormal, Burning sensation, Chronic fatigue syndrome, Cytokine increased; Dizziness, Exercise tolerance decreased, Fatigue, Headache, Impaired work ability; Interleukin level increased, Malaise, Mobility decreased, Muscle twitching, Muscular weakness; Paraesthesia, Postural orthostatic tachycardia syndrome, Quality of life decreased, Quantitative sudomotor axon reflex test, Tilt table test positive; Tinnitus, Vascular endothelial growth factor assay, Vision blurred, Vitreous floaters
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Burning and tingling of hands and feet, twitching, muscle weakness, headaches, crushing fatigue with...
Burning and tingling of hands and feet, twitching, muscle weakness, headaches, crushing fatigue with post-exertional malaise,, myalgic encephalomyelitis, POTS, dizziness, vision changes with blurry vision and floaters, tinnitus. Complete loss of quality of life. Inability to exercise, work, or even get out of bed most days. Damn you Pfizer for lying to us. As a doctor myself, I am stunned at your unethical practices. Shame on you. You have ruined my life.
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| 2828808 | 11 | M | FL | 02/28/2025 |
FLU3 FLU3 TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
495MK 495MK 42G27 42G27 |
Dizziness, Erythema, Feeling hot, Headache, Pruritus; Pyrexia, Swelling, Urticar...
Dizziness, Erythema, Feeling hot, Headache, Pruritus; Pyrexia, Swelling, Urticaria; Dizziness, Erythema, Feeling hot, Headache, Pruritus; Pyrexia, Swelling, Urticaria
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Child had fever, swolle, hives , headaches , dizziness, redness , hot to touch and itchy.
Child had fever, swolle, hives , headaches , dizziness, redness , hot to touch and itchy.
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| 2828809 | 15 | M | WI | 02/28/2025 |
COVID19 |
MODERNA |
B0005 |
Expired product administered
Expired product administered
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Patient received a post beyond use date vaccine.
Patient received a post beyond use date vaccine.
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| 2828810 | 72 | M | FL | 02/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
4723s |
Asthenia, Brain fog, Loss of consciousness, Nervous system disorder
Asthenia, Brain fog, Loss of consciousness, Nervous system disorder
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Per the patient the following day, after receiving the shingles vaccines, he passed out in the bathr...
Per the patient the following day, after receiving the shingles vaccines, he passed out in the bathroom while brushing his teeth. He also felt weak for about 10days and has had a 'foggy' brain and his nerves are affected in his body.
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| 2828811 | 10 | M | FL | 02/28/2025 |
FLU3 HPV9 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
495MK YOO8640 |
Unevaluable event; Unevaluable event
Unevaluable event; Unevaluable event
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N/A
N/A
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| 2828812 | 86 | F | OH | 02/28/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
AE435 |
Immediate post-injection reaction, Injected limb mobility decreased, Pain in ext...
Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity
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Patient states that she had immediate pain after the injection. She states that the pain continued t...
Patient states that she had immediate pain after the injection. She states that the pain continued to get worse in the shoulder and going all the way down the arm. She has since had difficulty lifting her arm and also reaching out with the arm. She has not followed up with a physician at this time.
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| 2828813 | 76 | F | AR | 02/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
YZ9CY |
Diarrhoea, Flushing, Headache, Pyrexia, Rash
Diarrhoea, Flushing, Headache, Pyrexia, Rash
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Diarrhea, headache, fever, flushing in arm started within 24 hours of vaccine. Rash on arm started y...
Diarrhea, headache, fever, flushing in arm started within 24 hours of vaccine. Rash on arm started yesterday.
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| 2828814 | 57 | F | MI | 02/28/2025 |
COVID19 FLU3 |
NOVAVAX SEQIRUS, INC. |
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Alopecia, Pruritus, Rash; Alopecia, Pruritus, Rash
Alopecia, Pruritus, Rash; Alopecia, Pruritus, Rash
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Hair loss starting about one month after vaccination. Started with steroid cream which did not impro...
Hair loss starting about one month after vaccination. Started with steroid cream which did not improve hair loss. Itching/rash on hands and arms began in December 2024. used same steroid cream to treat which seems to have cleared hands and arms but not hair loss, hair loss getting progressively worse. December referred to dermatologist. Dermatologist did intramuscular steroid shots and prescribed a steroidal foam to use on scalp. That seemed to slow hair loss. Still losing hair but not at the fast pace.
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| 2828815 | 74 | F | 02/28/2025 |
MNQ |
SANOFI PASTEUR |
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Injection site reaction
Injection site reaction
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Patient was administered the MenQuadfi booster on 2/27 and experienced a reaction 14 mins after admi...
Patient was administered the MenQuadfi booster on 2/27 and experienced a reaction 14 mins after administration at injection site
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| 2828816 | 6 | F | PA | 02/28/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
5G23D Y016874 |
Erythema, Peripheral swelling; Erythema, Peripheral swelling
Erythema, Peripheral swelling; Erythema, Peripheral swelling
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swelling and redness of right upper arm
swelling and redness of right upper arm
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| 2828817 | 0.67 | M | MN | 02/28/2025 |
HIBV PNC20 |
MERCK & CO. INC. PFIZER\WYETH |
Y006392 Lx2497 |
Skin mass; Skin mass
Skin mass; Skin mass
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~2cm subcutaneous nodule occurred within 72 hours. Slightly improved in the next 48 hours. Patient...
~2cm subcutaneous nodule occurred within 72 hours. Slightly improved in the next 48 hours. Patient well otherwise.
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