| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2855357 | 53 | F | NJ | 08/24/2025 |
MMR |
MERCK & CO. INC. |
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Fatigue, Headache, Pain, Pyrexia, Rhinorrhoea
Fatigue, Headache, Pain, Pyrexia, Rhinorrhoea
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Starting about 36 hours later, severe body aches and severe headache, 102 fever, runny nose, exhaust...
Starting about 36 hours later, severe body aches and severe headache, 102 fever, runny nose, exhaustion. At 48 hours fever 101.5
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| 2855358 | 63 | F | FL | 08/24/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
793pt |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Pt received dose of Boostrix on 6/29/25 and received an additional dose on 8/22/25. Pt reported no a...
Pt received dose of Boostrix on 6/29/25 and received an additional dose on 8/22/25. Pt reported no adverse effects.
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| 2855375 | 80 | M | AL | 08/24/2025 |
COVID19 RSV |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
LM2210 54A7M |
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 ADVERSE EVENT REPORTED. THE PATIENT HAS ON RECORD 2 RSV Vaccinations. The patient received ABRY...
NO ADVERSE EVENT REPORTED. THE PATIENT HAS ON RECORD 2 RSV Vaccinations. The patient received ABRYSVO on 12/3/23 and AREXVY on 10/28/2024.
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| 2855376 | 65 | F | ME | 08/24/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Fatigue, Headache, Injection site pain, Injection site pruritus, Injection site ...
Fatigue, Headache, Injection site pain, Injection site pruritus, Injection site swelling; Injection site warmth, Malaise
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Large raised and warm area size of a softball just below injection site. Appeared the day after the ...
Large raised and warm area size of a softball just below injection site. Appeared the day after the injection and became bigger and sore. Still present 4 days later, still red, raised, warm, itchy. No associated fever. Other side effects of headache, malaise, fatigue lasted three days.
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| 2855377 | 2 | M | FL | 08/24/2025 |
DTAP |
SANOFI PASTEUR |
3CA55C1 |
Injection site erythema, Injection site pruritus, Injection site swelling, Rash
Injection site erythema, Injection site pruritus, Injection site swelling, Rash
|
2 yo M Pt presents in office accompanied by mother with c/o rash. Per mother both pt and sister have...
2 yo M Pt presents in office accompanied by mother with c/o rash. Per mother both pt and sister have red swollen sites where they received their dtap vaccines. Mom noticed the reaction yesterday. Mother site the swelling has gone down but the site is still red. Pt was itching the site. Pt was prescribed cephALEXin 250 mg/5 mL oral suspension 5.1 mL 3 times a day for 7 days.
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| 2855378 | 34 | F | PR | 08/24/2025 |
FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. |
406983 406983 |
Erythema, Limb mass, Pain in extremity, Pruritus, Rash; Skin warm
Erythema, Limb mass, Pain in extremity, Pruritus, Rash; Skin warm
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About 30 minutes after administration, I developed a mild rash on my abdomen and felt itchy. Betwee...
About 30 minutes after administration, I developed a mild rash on my abdomen and felt itchy. Between the second and fourth day, I developed a lump on my left arm that was painful, red, and hot.
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| 2855379 | 4 | F | FL | 08/24/2025 |
DTAP |
SANOFI PASTEUR |
3CA55C1 |
Injection site erythema, Injection site pruritus, Injection site swelling, Rash
Injection site erythema, Injection site pruritus, Injection site swelling, Rash
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Pt presents in office accompanied by mother with c/o rash. Per mother both pt and brother have red s...
Pt presents in office accompanied by mother with c/o rash. Per mother both pt and brother have red swollen sites where they received their dtap vaccines. Mom noticed the reaction yesterday. Mother site the swelling has gone down but the site is still red. Pt was itching the site. Pt was prescribed cephALEXin 250 mg/5 mL oral suspension 5.6 mL 3 times a day for 7 days
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| 2855314 | 18 | TX | 08/23/2025 |
HEP |
MERCK & CO. INC. |
Y014323 |
Incorrect dose administered
Incorrect dose administered
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No symptoms reported; HCP reports an 18 year old patient received a larger than recommended dose of ...
No symptoms reported; HCP reports an 18 year old patient received a larger than recommended dose of RECOMBIVAXHB on 07JUL2025. This was the patient's first dose and patient was administered 1.0mL. No symptoms reported. HCP provided consent to correspondence. No add; This spontaneous report was received from a medical assistant and refers to an 18-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 07-Jul-2025, the patient was vaccinated with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (lot #Y014323, expiration date: 12-Feb-2027) 1 mL administered by Unknown route as Prophylaxis. The reporter stated that the patient received a larger than recommended dose (Overdose). No symptoms reported.
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| 2855315 | 8 | F | IN | 08/23/2025 |
PPV |
MERCK & CO. INC. |
Y016291 |
Pain in extremity
Pain in extremity
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the patient's arm was hurting; This spontaneous report was received from a Physician and Health...
the patient's arm was hurting; This spontaneous report was received from a Physician and Healthcare Professional (also reported as Office Manager) and refers to a non-pregnant 8-year-old female patient. The patient had no medical history, drug reactions, allergies nor concomitant therapies. On 15-Jul-2025, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) intramuscular injection (lot #Y016291, expiration date: 06-Dec-2026 (also reported as "31-Dec-2026") 0.5 mL once administered by Intramuscular route (Anatomical site was not reported) as vaccine - low IG levels. The vaccine was administered by a healthcare professional. On an unspecified day, between 15-Jul-2025 and 16-Jul-2025, the patient's arm was hurting (Pain in arm). On 16-Jul-2025, her mother called the physician's office to report this information and sought advice on what to do. She was instructed to ice the arm and gave her Tylenol for pain. No laboratory tests were performed. The patient recovered from the event on 20-Jul-2025. The physician requested a lot check for the vaccine (lot #Y016291). The causal relationship between the event and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not provided. This is one of several cases from the same source.
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| 2855317 | F | MN | 08/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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Alopecia
Alopecia
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alopecia; This is a spontaneous report received from a Consumer or other non HCP from medical inform...
alopecia; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 14-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 and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "recovering". Batch/lot number is not provided, and it cannot be obtained. Additional information: Additional information: Caregiver stated that her daughter has alopecia and she was thinking maybe it was caused by Pfizer Covid19 vaccine but she can't prove it. She would like to know if there was any evidence that it can be caused by Pfizer Covid shot. Caregiver wanted to know the duration of treatment for Litfulo. She stated her daughter was taking Litfulo going on 2 years, should she continue taking it for for life. At Week 48: 43% of people taking LITFULO saw 80% or more scalp hair coverage." Caller is the mother of the patient her daughter was taking Litfulo going on for 2 years because she has alopecia. Caller mentioned that may be the alopecia was caused by the Pfizer Covid-19 vaccine. The caller verified the information provided by the transferring agent. Caller said that a doctor mentioned and said that alopecia can be caused by vaccines. She got the vaccine less than a year before developing alopecia. Alopecia started in October or Nov2022, and her went on Litfulo in 2024. She received the Covid-19 Vaccine in 2021 and never had alopecia before that or any health issues prior to that. Caller said that Litfulo is working great. Her daughter only has one place in the back of her head that is not growing back. If it was the covid shot that could cause alopecia, can it be reversed. She spoke to authority about this and there was nothing that they have found and nothing has been reported. Her daughter never had covid and never had anything health related. The report was filed with the information provided by the transferring agent and the caller.
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| 2855329 | 17 | F | MN | 08/23/2025 |
MENB MENB |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
77KA5 77KA5 |
Dyskinesia, Eye movement disorder, Fatigue, Musculoskeletal stiffness, Nausea; P...
Dyskinesia, Eye movement disorder, Fatigue, Musculoskeletal stiffness, Nausea; Pallor, Syncope, Unresponsive to stimuli
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Writer administered vaccines in the exam room and then left patient with her mom and sister to print...
Writer administered vaccines in the exam room and then left patient with her mom and sister to print vaccination records for her to have proof for school and for her records that the vaccines were administered. When writer returned, patient stated she felt nauseous. She sat down with a cool washcloth on her neck and writer went across the hall to obtain an ice pack and juice for her. When writer returned it had looked like patient had fainted. Patient was very grey/pale. Writer attempted to put her legs up on another chair to assist with blood flow but then patient started jerking and was unresponsive. Her eyes rolled back, and she was stiffening. This went on for about a minute and then she came out of it and had no idea what had happened. She stated she was very tired, like her body was tired. She had never had a seizure before. Writer received permission from mother, (name withheld) to call 911. Writer and mom spoke to dispatch on speaker phone and went through their assessment with respirations and questions on her condition. They then said help was on the way. Writer went out to the front to notify staff that EMS would be arriving, but they were already walking in the door. Writer informed front desk staff person what had happened. Writer went back with EMS and police and explained with mom and patient what had happened. They checked her vitals and completed their assessment recommending transport to ER as this sounded like a seizure and perhaps a new condition. (name withheld) spoke with her husband and decided to go to (name withheld) ER and to transport patient herself. Ambulance crew stated they would follow just to be safe.
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| 2855330 | F | TX | 08/23/2025 |
HEP HEP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Attention deficit hyperactivity disorder, Choking, Diarrhoea haemorrhagic, Food ...
Attention deficit hyperactivity disorder, Choking, Diarrhoea haemorrhagic, Food allergy, Gastrooesophageal reflux disease; Injection site erythema, Injection site swelling, Milk soy protein intolerance, Mucous stools, Pyrexia
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Patient developed redness and swelling around the injection site within hours, diarrhea with mucus a...
Patient developed redness and swelling around the injection site within hours, diarrhea with mucus and blood within 12 hours, severe reflux she choked on within hours, and MSPI within days after vaccination. She was kept longer at the hospital after her birth to observe her. Since adverse reactions to vaccinations, patient has been diagnosed with severe ADHD and a corn allergy.
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| 2855331 | 16 | F | CA | 08/23/2025 |
MENB MENB MENB |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
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Blood glucose normal, Blood thyroid stimulating hormone normal, Computerised tom...
Blood glucose normal, Blood thyroid stimulating hormone normal, Computerised tomogram head normal, Differential white blood cell count normal, Electrocardiogram normal; Full blood count normal, Gait disturbance, Human chorionic gonadotropin negative, Loss of consciousness, Metabolic function test normal; Pain in extremity, Pyrexia, Thyroxine free normal, Troponin I normal, Urine analysis normal
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She received the vaccination at 11:00am on Aug. 20 and had no complaint, other than arm pain, that d...
She received the vaccination at 11:00am on Aug. 20 and had no complaint, other than arm pain, that day. She ate, drank, and went to sleep normally. Around 3:45am Aug. 21, she got up to use the bathroom and passed out on the bathroom floor. I woke up to a thumping noise, opened our bedroom door and saw her stumbling out of the bathroom. She took a few steps and passed out in the hallway, at that time we also discovered she had a fever. We called 911, she was admitted into the ER. She passed out there again on her way to the bathroom to give a urine sample. All tests came back normal, there had been no changes in her routine, other than the vaccination. She is still recovering from the fever (August 23), she has not passed out again, but we are watching her closely and she's just resting.
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| 2855332 | 61 | F | LA | 08/23/2025 |
HEPAB HEPAB HEPAB HEPAB HEPAB HEPAB HEPAB HEPAB HEPAB PNC21 PNC21 PNC21 PNC21 PNC21 PNC21 PNC21 PNC21 PNC21 TDAP TDAP TDAP TDAP TDAP TDAP TDAP TDAP TDAP VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS HEPAB HEPAB HEPAB HEPAB HEPAB HEPAB HEPAB HEPAB HEPAB PNC15 PNC15 PNC15 PNC15 PNC15 PNC15 PNC15 PNC15 PNC15 TDAP TDAP TDAP TDAP TDAP TDAP TDAP TDAP TDAP VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
AZ2A3 AZ2A3 AZ2A3 AZ2A3 AZ2A3 AZ2A3 AZ2A3 AZ2A3 AZ2A3 4CA04C1 4CA04C1 4CA04C1 4CA04C1 4CA04C1 4CA04C1 4CA04C1 4CA04C1 4CA04C1 23AH3 23AH3 23AH3 23AH3 23AH3 23AH3 23AH3 23AH3 23AH3 AZ2A3 AZ2A3 AZ2A3 AZ2A3 AZ2A3 AZ2A3 AZ2A3 AZ2A3 AZ2A3 2003579 2003579 2003579 2003579 2003579 2003579 2003579 2003579 2003579 4CA04C1 4CA04C1 4CA04C1 4CA04C1 4CA04C1 4CA04C1 4CA04C1 4CA04C1 4CA04C1 23AH3 23AH3 23AH3 23AH3 23AH3 23AH3 23AH3 23AH3 23AH3 |
Pain in extremity, Swelling face; Anxiety, Arthralgia, Chest X-ray, Chest discom...
Pain in extremity, Swelling face; Anxiety, Arthralgia, Chest X-ray, Chest discomfort, Computerised tomogram head; Computerised tomogram thorax, Cranial nerve disorder, Differential white blood cell count, Dizziness, Electrocardiogram; Eyelid function disorder, Facial paralysis, Facial paresis, Fibrin D dimer, Full blood count; Head discomfort, Hypertensive crisis, Injected limb mobility decreased, Insomnia, Loss of personal independence in daily activities; Mastication disorder, Metabolic function test, Mood altered, N-terminal prohormone brain natriuretic peptide, Nervous system disorder; Neurological symptom, Pain, Pain in extremity, Paraesthesia, Photophobia; Radiculitis brachial, Sensory disturbance, Shoulder injury related to vaccine administration, Sleep disorder, Tachycardia; Troponin I, Vision blurred, Visual impairment; Pain in extremity, Swelling face; Anxiety, Arthralgia, Chest X-ray, Chest discomfort, Computerised tomogram head; Computerised tomogram thorax, Cranial nerve disorder, Differential white blood cell count, Dizziness, Electrocardiogram; Eyelid function disorder, Facial paralysis, Facial paresis, Fibrin D dimer, Full blood count; Head discomfort, Hypertensive crisis, Injected limb mobility decreased, Insomnia, Loss of personal independence in daily activities; Mastication disorder, Metabolic function test, Mood altered, N-terminal prohormone brain natriuretic peptide, Nervous system disorder; Neurological symptom, Pain, Pain in extremity, Paraesthesia, Photophobia; Radiculitis brachial, Sensory disturbance, Shoulder injury related to vaccine administration, Sleep disorder, Tachycardia; Troponin I, Vision blurred, Visual impairment; Pain in extremity, Swelling face; Anxiety, Arthralgia, Chest X-ray, Chest discomfort, Computerised tomogram head; Computerised tomogram thorax, Cranial nerve disorder, Differential white blood cell count, Dizziness, Electrocardiogram; Eyelid function disorder, Facial paralysis, Facial paresis, Fibrin D dimer, Full blood count; Head discomfort, Hypertensive crisis, Injected limb mobility decreased, Insomnia, Loss of personal independence in daily activities; Mastication disorder, Metabolic function test, Mood altered, N-terminal prohormone brain natriuretic peptide, Nervous system disorder; Neurological symptom, Pain, Pain in extremity, Paraesthesia, Photophobia; Radiculitis brachial, Sensory disturbance, Shoulder injury related to vaccine administration, Sleep disorder, Tachycardia; Troponin I, Vision blurred, Visual impairment; Pain in extremity, Swelling face; Anxiety, Arthralgia, Chest X-ray, Chest discomfort, Computerised tomogram head; Computerised tomogram thorax, Cranial nerve disorder, Differential white blood cell count, Dizziness, Electrocardiogram; Eyelid function disorder, Facial paralysis, Facial paresis, Fibrin D dimer, Full blood count; Head discomfort, Hypertensive crisis, Injected limb mobility decreased, Insomnia, Loss of personal independence in daily activities; Mastication disorder, Metabolic function test, Mood altered, N-terminal prohormone brain natriuretic peptide, Nervous system disorder; Neurological symptom, Pain, Pain in extremity, Paraesthesia, Photophobia; Radiculitis brachial, Sensory disturbance, Shoulder injury related to vaccine administration, Sleep disorder, Tachycardia; Troponin I, Vision blurred, Visual impairment; Pain in extremity, Swelling face; Anxiety, Arthralgia, Chest X-ray, Chest discomfort, Computerised tomogram head; Computerised tomogram thorax, Cranial nerve disorder, Differential white blood cell count, Dizziness, Electrocardiogram; Eyelid function disorder, Facial paralysis, Facial paresis, Fibrin D dimer, Full blood count; Head discomfort, Hypertensive crisis, Injected limb mobility decreased, Insomnia, Loss of personal independence in daily activities; Mastication disorder, Metabolic function test, Mood altered, N-terminal prohormone brain natriuretic peptide, Nervous system disorder; Neurological symptom, Pain, Pain in extremity, Paraesthesia, Photophobia; Radiculitis brachial, Sensory disturbance, Shoulder injury related to vaccine administration, Sleep disorder, Tachycardia; Troponin I, Vision blurred, Visual impairment; Pain in extremity, Swelling face; Anxiety, Arthralgia, Chest X-ray, Chest discomfort, Computerised tomogram head; Computerised tomogram thorax, Cranial nerve disorder, Differential white blood cell count, Dizziness, Electrocardiogram; Eyelid function disorder, Facial paralysis, Facial paresis, Fibrin D dimer, Full blood count; Head discomfort, Hypertensive crisis, Injected limb mobility decreased, Insomnia, Loss of personal independence in daily activities; Mastication disorder, Metabolic function test, Mood altered, N-terminal prohormone brain natriuretic peptide, Nervous system disorder; Neurological symptom, Pain, Pain in extremity, Paraesthesia, Photophobia; Radiculitis brachial, Sensory disturbance, Shoulder injury related to vaccine administration, Sleep disorder, Tachycardia; Troponin I, Vision blurred, Visual impairment; Pain in extremity, Swelling face; Anxiety, Arthralgia, Chest X-ray, Chest discomfort, Computerised tomogram head; Computerised tomogram thorax, Cranial nerve disorder, Differential white blood cell count, Dizziness, Electrocardiogram; Eyelid function disorder, Facial paralysis, Facial paresis, Fibrin D dimer, Full blood count; Head discomfort, Hypertensive crisis, Injected limb mobility decreased, Insomnia, Loss of personal independence in daily activities; Mastication disorder, Metabolic function test, Mood altered, N-terminal prohormone brain natriuretic peptide, Nervous system disorder; Neurological symptom, Pain, Pain in extremity, Paraesthesia, Photophobia; Radiculitis brachial, Sensory disturbance, Shoulder injury related to vaccine administration, Sleep disorder, Tachycardia; Troponin I, Vision blurred, Visual impairment; Pain in extremity, Swelling face; Anxiety, Arthralgia, Chest X-ray, Chest discomfort, Computerised tomogram head; Computerised tomogram thorax, Cranial nerve disorder, Differential white blood cell count, Dizziness, Electrocardiogram; Eyelid function disorder, Facial paralysis, Facial paresis, Fibrin D dimer, Full blood count; Head discomfort, Hypertensive crisis, Injected limb mobility decreased, Insomnia, Loss of personal independence in daily activities; Mastication disorder, Metabolic function test, Mood altered, N-terminal prohormone brain natriuretic peptide, Nervous system disorder; Neurological symptom, Pain, Pain in extremity, Paraesthesia, Photophobia; Radiculitis brachial, Sensory disturbance, Shoulder injury related to vaccine administration, Sleep disorder, Tachycardia; Troponin I, Vision blurred, Visual impairment
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Patient reported experiencing a reaction following administration of four vaccines on 08/18/2025. sh...
Patient reported experiencing a reaction following administration of four vaccines on 08/18/2025. she stated she presented to the emergency room due to reaction and continues to experience facial symptoms like swelling and right arm hurts. specific details of treatment provided in the ER were not disclosed by the patient. outcome at this time : patient reports ongoing symptoms, no resolution yet.
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| 2855333 | 77 | F | MN | 08/23/2025 |
PNC21 |
MERCK & CO. INC. |
Z004301 |
Injection site reaction, Rash pruritic
Injection site reaction, Rash pruritic
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Itchy rash at the injection site on left upper arm/shoulder area.
Itchy rash at the injection site on left upper arm/shoulder area.
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| 2855334 | 60 | M | CA | 08/23/2025 |
PNC21 PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Blood test, Chest X-ray normal, Computerised tomogram head normal, Gait disturba...
Blood test, Chest X-ray normal, Computerised tomogram head normal, Gait disturbance, Guillain-Barre syndrome; Immunoglobulin therapy, Laboratory test, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Muscular weakness; Reflex test, Vibration test, Walking aid user
More
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Muscles in my legs gave out, unable to walk without crutches or walker; hospitalized and diagnosed w...
Muscles in my legs gave out, unable to walk without crutches or walker; hospitalized and diagnosed with GBS, given IVIG treatment over three days and have started improving with 10 days on in patient rehab
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| 2855335 | 60 | F | AZ | 08/23/2025 |
PNC20 |
PFIZER\WYETH |
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Arthralgia, Fatigue, Injection site pain, Myalgia
Arthralgia, Fatigue, Injection site pain, Myalgia
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Severe pain near injection site, muscle pain, joint pain, fatigue
Severe pain near injection site, muscle pain, joint pain, fatigue
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| 2855336 | 77 | F | FL | 08/23/2025 |
FLU3 RSV |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
U8764BB F4AC3 |
Pain in extremity; Pain in extremity
Pain in extremity; Pain in extremity
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Patient received a second dose of Arexvy outside of current CDC recommendations. They did not have a...
Patient received a second dose of Arexvy outside of current CDC recommendations. They did not have any side effects other than a sore arm.
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| 2855337 | 42 | F | AL | 08/23/2025 |
FLU3 |
SANOFI PASTEUR |
TFAA2501 |
Rash
Rash
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Patient reported a rash/breakout on chin that started roughly 30 minutes after the shot. She said it...
Patient reported a rash/breakout on chin that started roughly 30 minutes after the shot. She said it lasted about a day and a half and then resolved.
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| 2855338 | 72 | F | FL | 08/23/2025 |
FLU3 |
SANOFI PASTEUR |
u8764bb |
Erythema, Skin warm, Swelling
Erythema, Skin warm, Swelling
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Patient reported : redness / swelling / warm to the touch the morning after vaccination. At time p...
Patient reported : redness / swelling / warm to the touch the morning after vaccination. At time pt reported (~4Pm)- area looks less swollen / less red / still warm to the touch
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| 2855339 | 70 | F | FL | 08/23/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Arthralgia, Injection site pain, Injection site swelling, Myalgia, Nausea; Vomit...
Arthralgia, Injection site pain, Injection site swelling, Myalgia, Nausea; Vomiting
More
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pain at injection site and swelling at injection site began immediately. Two days later nausea, vom...
pain at injection site and swelling at injection site began immediately. Two days later nausea, vomiting, joint pain, and muscle pain began.
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| 2855340 | 66 | M | KY | 08/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
GJ952 |
Hyperhidrosis, Injection site mass, Pyrexia, Weight decreased
Hyperhidrosis, Injection site mass, Pyrexia, Weight decreased
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Patient states about 12 hours following his 2nd dose of shingrix he had fever, sweats and lost 3 pou...
Patient states about 12 hours following his 2nd dose of shingrix he had fever, sweats and lost 3 pounds. Also, bump at injection site about the size of the pea. He states he was better in about 36 to 48 hours and feels back to normal at this time.
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| 2855341 | 73 | F | GA | 08/23/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
F4AC3 |
Chills
Chills
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PT RECEIVED 2ND DOSE, WHICH IS OUTSIDE OF CURRENT GUIDELINES. PER CAREGIVER, PT ONLY EXPERIENCES CH...
PT RECEIVED 2ND DOSE, WHICH IS OUTSIDE OF CURRENT GUIDELINES. PER CAREGIVER, PT ONLY EXPERIENCES CHILLS THE FOLLOWING MORNING BUT FEELS WELL NOW. NO OTHER ADRS.
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| 2855342 | 67 | F | AL | 08/23/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Arthralgia, Injection site pain, Musculoskeletal pain, Neck pain, Pain; Pain in ...
Arthralgia, Injection site pain, Musculoskeletal pain, Neck pain, Pain; Pain in extremity
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Besides pain at the injection site, I had pain that radiated throughout my shoulder and down my arm....
Besides pain at the injection site, I had pain that radiated throughout my shoulder and down my arm. I had pain going down my neck along my shoulder blade. I treated it with pain medication until I saw my pain management doctor on Aug 19, 2025. She gave me trigger point injections along the affected nerves. The pain down my back has subsided some, but the pain down my arm is still present. It feels like my arm is being squeezed whenever I move it. After 3 weeks, this is a bit excessive for a reaction.
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| 2855343 | 1.17 | F | NM | 08/23/2025 |
MMRV MMRV MMRV MMRV MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Z007580 Z007580 Z007580 Z007580 Z007580 Z007580 |
Aphasia, Crying, Decreased appetite, Developmental regression, Dysstasia; Electr...
Aphasia, Crying, Decreased appetite, Developmental regression, Dysstasia; Electroencephalogram, Fall, Gait disturbance, Irritability, Magnetic resonance imaging; Screaming, Tongue disorder, Tremor, Vomiting; Aphasia, Crying, Decreased appetite, Developmental regression, Dysstasia; Electroencephalogram, Fall, Gait disturbance, Irritability, Magnetic resonance imaging; Screaming, Tongue disorder, Tremor, Vomiting
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My baby woke up at 7:00 am shaking on 8/4/2025 as if she had Parkinson's she was with tremors a...
My baby woke up at 7:00 am shaking on 8/4/2025 as if she had Parkinson's she was with tremors and she couldn't sit up on her own, the tremors went away in a few minutes, she didn't want to eat anything, and immediately began to vomit, she vomited 2 times a lot of liquid. I immediately called her pediatrician and they gave me an appointment the same day, I told them that she was having a bad reaction to the vaccine that they had given her which was the MMRV, because my girl was in perfect health before the MMRV vaccine, then she started w fever, the fever was always low from 37.5 to 37.9, I gave her Tylenol and the fever went down quickly I kept her monitored she had a low fever for 4 days The tremors would not stop. My baby learned to walk at 11 months and was already running all over the house, saying lots of words and repeating everything we told her, until one week after she was vaccinated with MMRV and now she can't walk properly. She falls and is unable to get up, and she can no longer say any more words. She was vaccinated with the MMRV on 7/28/2025 about 14 months old. On 8/7/2025 her symptoms began with a fever and with tremors which worsened by the hour, and she started to lose her steady movements, barely able to walk anymore. I took her to an emergency room on August 8th were she was immediately hospitalized her and released on Monday 8/11/2025. During the hospitalization they monitored her with an EEG for 48 hours and on Monday August 11th they put her to sleep with anesthesia to do an MRI. The vaccination and reports are attached, they said that this is a reaction to the MMRV vaccine which happens to some children and she just hapens to be one of them and that the expectations are that she will improve in weeks, months, or there could also be a sequelae of the adverse reaction she had, they talked about acute cerebellar ataxia, and now my daughter can't walk well and I have to carry her almost all day, she cries and gets irritated very easily now and I am desperate and too sad and worried about my little girl's health, especially because I don't know what to expect as she grows up and what adverse consequences it will have. In short, my baby girl has regressed in her normal cognitive and motor development. She'll now need constant neurological monitoring. She'll also need therapy to recover her motor and cognitive mobility. My baby is also having strange problems with her tongue. She's squirming and starts screaming, and she puts her hand over her mouth and tongue. This also lasts for a few minutes. I'm desperate. I can't sleep, watching over my baby's sleep in case she has a reaction while sleeping and something worse happens to her. I would like to submit all the reports and diagnosis, so we could be compensated for her continued therapy and treatments.
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| 2855344 | 19 | F | FL | 08/23/2025 |
HEP HEP MMR MMR |
DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION MERCK & CO. INC. MERCK & CO. INC. |
946907 946907 Y004117 Y004117 |
Dizziness, Loss of consciousness, Nausea, Peripheral coldness, Retching; Snoring...
Dizziness, Loss of consciousness, Nausea, Peripheral coldness, Retching; Snoring, Unresponsive to stimuli, Vision blurred; Dizziness, Loss of consciousness, Nausea, Peripheral coldness, Retching; Snoring, Unresponsive to stimuli, Vision blurred
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Patient was given MMR first on the left arm, then Hep B immediately after on the right arm. About 2...
Patient was given MMR first on the left arm, then Hep B immediately after on the right arm. About 2 minutes later, patient reported feeling dizzy, then suddenly lost consciousness (head dropped as if she fell asleep and sounded as if she was snoring). She was unresponsive for about 30 seconds, then suddenly regained consciousness. She seemed alert and said she felt fine and unaware she had passed out. She said she still was a little dizzy and was starting to feel nauseated, then lost consciousness again for about 20 seconds, again sounded like she was snoring and also made a gagging sound shortly after she regained consciousness. Mom was called and suggested she stay for a while and be observed. Patient said vision was a little blurry and skin was a little cold, but symptoms were slowing improving. Observed for an hour, while mom was trying to figure out what to do. Patient remained alert and oriented and patient claimed symptoms had resolved after about 20 minutes post-vaccinations. Blood pressure readings were taken, patient was given water and feet were elevated.
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| 2855345 | 75 | M | 08/23/2025 |
PNC20 |
PFIZER\WYETH |
ln4928 |
Cellulitis
Cellulitis
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patient developed cellulitis in vaccinated arm and sought treatment in the local emergency room
patient developed cellulitis in vaccinated arm and sought treatment in the local emergency room
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| 2855346 | 84 | F | KY | 08/23/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
006M20A 006M20A 006M20A 006M20A 006M20A 001B21A 001B21A 001B21A 001B21A 001B21A 006M20A 006M20A 006M20A 006M20A 006M20A 001B21A 001B21A 001B21A 001B21A 001B21A |
Acute left ventricular failure, Asthenia, Atrial fibrillation, Breast cancer sta...
Acute left ventricular failure, Asthenia, Atrial fibrillation, Breast cancer stage IV, Cardiac ablation; Cardiac monitoring, Cardiac resynchronisation therapy, Chest X-ray normal, Chest wall mass, Cough; Depression, Dyspnoea exertional, Ejection fraction decreased, Fall, Fatigue; Lead dislodgement, Mass excision, Oedema peripheral, Respiratory tract congestion, SARS-CoV-2 test negative; Skin laceration, Triple negative breast cancer; Acute left ventricular failure, Asthenia, Atrial fibrillation, Breast cancer stage IV, Cardiac ablation; Cardiac monitoring, Cardiac resynchronisation therapy, Chest X-ray normal, Chest wall mass, Cough; Depression, Dyspnoea exertional, Ejection fraction decreased, Fall, Fatigue; Lead dislodgement, Mass excision, Oedema peripheral, Respiratory tract congestion, SARS-CoV-2 test negative; Skin laceration, Triple negative breast cancer; Acute left ventricular failure, Asthenia, Atrial fibrillation, Breast cancer stage IV, Cardiac ablation; Cardiac monitoring, Cardiac resynchronisation therapy, Chest X-ray normal, Chest wall mass, Cough; Depression, Dyspnoea exertional, Ejection fraction decreased, Fall, Fatigue; Lead dislodgement, Mass excision, Oedema peripheral, Respiratory tract congestion, SARS-CoV-2 test negative; Skin laceration, Triple negative breast cancer; Acute left ventricular failure, Asthenia, Atrial fibrillation, Breast cancer stage IV, Cardiac ablation; Cardiac monitoring, Cardiac resynchronisation therapy, Chest X-ray normal, Chest wall mass, Cough; Depression, Dyspnoea exertional, Ejection fraction decreased, Fall, Fatigue; Lead dislodgement, Mass excision, Oedema peripheral, Respiratory tract congestion, SARS-CoV-2 test negative; Skin laceration, Triple negative breast cancer
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5/3/2021 - Saw patient for diagnosed dyspenea on exertion. Rx for 5 mg Lisinopril. 7/24/2021 - Urge...
5/3/2021 - Saw patient for diagnosed dyspenea on exertion. Rx for 5 mg Lisinopril. 7/24/2021 - Urgent care for fatigue. cough, and congestion. 7/30/21 - Urgent care for fatigue. cough, and congestion. 8/19/2021 - Increase Rx for depression. 2/1/2022 - Ejection fraction still low, so Cardiology Referral. 2/18/2022 - Dr. at hospital. Acute systolic CHF and 1 year fatigue. Rx for Toprol 25 mg. 3/16/2022 - Fall with head split open. ER noted patient was in AFIB. May 2022 - Patient had a heart monitor installed. Dr. at hospital. 8/28/2023 - Biventricular PPM and AV node ablation. Pacemaker installed. 3/11/2024 - 3/18/2024 - Hospital pacemaker upgrade to biventricular CRT on 3/15/2024. Hospital inpatient stay. Low energy and fatigue. 3/25/2024 - 3/26/2024 - Dislodged pacemaker lead extracted and replaced. Hospital inpatient stay. 4/25/2024 - 4/27/2024 - Hospitalization for heart medication changes since still low energy and fatigued. 5/7/2024 - 5/13/2024 - Hospitalization for procedures and heart medication changes since still low energy and fatigued. 5/20/2024 - 5/23/2024 - Diagnosed with BLE Edema for lower extremities. Given Lasix as blood thinner. Low energy and fatigue. 7/1/2025 - 7/3/2025 - Chest wall mass identified and suspected as a hematoma from pacemaker lead drips. Surgery scheduled to wash away the hematoma. 7/11/2025 - 7/12/2025 - During surgery chest wall mass identified as a tumor and cut-out by heart surgeon. July 2025 - Tumor identified as Triple Negative Breast Cancer. August of 2025 - No chemo or radiation suggested at 87 years old, so sent to palliative care with diagnosis of Stage 4 Breast Cancer.
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| 2855347 | 1.25 | M | FL | 08/23/2025 |
UNK |
UNKNOWN MANUFACTURER |
YO13130 |
Erythema multiforme
Erythema multiforme
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Erythema Multiforme
Erythema Multiforme
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| 2074911 | F | NV | 08/22/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Ankylosing spondylitis; Arthralgia, Burning sensation, Laboratory test, Pain in ...
Ankylosing spondylitis; Arthralgia, Burning sensation, Laboratory test, Pain in extremity
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spondyloarthropathy with ankylosing attributes or conditions; This is a spontaneous report received ...
spondyloarthropathy with ankylosing attributes or conditions; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 70-year-old female patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "mild fibromyalgia" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 17Sep2021, for COVID-19 immunization, reaction(s): "Ankylosing Spondylitis". The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "unknown", described as "spondyloarthropathy with ankylosing attributes or conditions". Therapeutic measures were taken as a result of ankylosing spondylitis. Clinical course: She has lots of things that happened after the vaccination that has now caused her lots of health problems and is on lots of medications. She wants to tell Pfizer what the vaccine did to her and her health for the last two, three or four years, clarifies as since 2021 since she got the second vaccination. She has very mild fibromyalgia intermittently that only affected her arm joint that was she confirms was diagnosed prior to the covid vaccine. She did not have immediate issues after first dose then states she cannot delineate since the doses were weeks apart but immediately after the second dose, her entire body was on fire on the inside and every joint in her body awakened with pain, joints that she had never felt before. Her primary doctor had never heard of this. She went to the fibromyalgia website and there were hundreds of reports of fibromyalgia patients experiencing the same thing. No further details provided. Treatment: did not know what treatment to get. When querying outcome states she was taking biologic medication now since the covid vaccine caused spondyloarthropathy with ankylosing attributes or conditions, states she does not know what it was called. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2855104 | M | NJ | 08/22/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Abdominal pain, Device leakage, Diarrhoea, Exposure via mucosa, Exposure via ski...
Abdominal pain, Device leakage, Diarrhoea, Exposure via mucosa, Exposure via skin contact; Night sweats
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night sweats; abdominal pain; diarrhea; He was mixing and preparing TICE BCG and the vial sprayed in...
night sweats; abdominal pain; diarrhea; He was mixing and preparing TICE BCG and the vial sprayed into his face; he may have overfilled or added too much DILUENT; the vial sprayed into his face; TICE BCG did get on his lip and in his mouth.; Information has been received from Business Partner/CRO on 06-Jun-2025. This spontaneous report was received from a/an Other health professional and refers to a(n) 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 started therapy with BCG (TICE BCG LIVE), (indication, expiration date, and lot # were not reported). On an unknown date, the patient experienced he may have overfilled or added too much DILUENT. On an unknown date, the patient experienced the vial sprayed into his face. On an unknown date, the patient experienced TICE BCG did get on his lip and in his mouth.. On an unknown date, the patient experienced abdominal pain. On an unknown date, the patient experienced diarrhea. On an unknown date, the patient experienced night sweats. At the reporting time, the outcome of he may have overfilled or added too much DILUENT, the vial sprayed into his face, TICE BCG did get on his lip and in his mouth., abdominal pain, diarrhea and night sweats was unknown. The action taken with BCG was reported as unknown. The causal relationship between the event of the vial sprayed into his face and BCG was unknown/not reported/not provided. The causal relationship between the event of TICE BCG did get on his lip and in his mouth. and BCG was unknown/not reported/not provided. The causal relationship between the event of diarrhea and BCG was unknown/not reported/not provided. The causal relationship between the event of night sweats and BCG was unknown/not reported/not provided. The causal relationship between the event of abdominal pain and BCG was unknown/not reported/not provided. Lot # is being requested and will be submitted if received This is an invalid report due to lack of patient's identifier. Follow up information has been received from Other health professional on 30-JUL-2025. Patient demographics were updated. It was reported that a male physician was involved in the adverse events. On 27-MAY-2025, When preparing TICE BCG the physician "may have overfilled or added too much DILUENT (if his staff member did not measure correctly) and caused it to build up pressure and spray, but he's really not sure and cannot confirm" (Product preparation issue, Accidental exposure to product). Afterwards the male physician reported he was wearing glasses when the event occurred, but no a mask, so the TICE BCG did not get into his eyes, but a little TICE BCG did get on his lip and in his mouth [the vial sprayed into his face] (Exposure via skin contact, Exposure via mucosa). He removed his jacket and "washed up" his face immediately, but he was not able to shower until several hours later. On 05-JUN-2025, he stated he began experiencing intestinal symptoms such as abdominal pain, diarrhea and night sweats. Outcome for the events was unknown. Action taken and causality assessment with TICE BCG regarding the aforementioned events was unknown. This is one of several reports received from the same reporter. Batch/Lot number is being requested and will be submitted if received.
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| 2855105 | MD | 08/22/2025 |
MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
Z003308 |
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 additional AE; TE with administered PROQUAD; This spontaneous report was received from a physicia...
No additional AE; TE with administered PROQUAD; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. On 11-Aug-2025, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA [recombinant Human albumin]) (PROQUAD) administered as prophylaxis (Lot No. Z003308 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live], expiration date reported and upon internal validation established as 21-Jul-2026) (strength, dose number, exact dose quantity volume, route, anatomical location of administration and vaccination scheme frequency were not provided); that was reconstituted with sterile diluent (Lot No., expiration date, route and indication was not reported) (product storage error), after a temperature excursion of -14.55 degree Celsius (C) during a time frame of 35 minutes. No previous temperature excursion was reported. No additional information or adverse events or PQC were provided (no adverse event).
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| 2855106 | 4 | M | CA | 08/22/2025 |
VARCEL |
MERCK & CO. INC. |
Y017062 |
Product storage error
Product storage error
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HCP called to report TE occurring on 8/13/2025 for VARIVAX that was administered to two patients (se...
HCP called to report TE occurring on 8/13/2025 for VARIVAX that was administered to two patients (separate AE case created for other patient-see case #02857565) after TE on 8/14/2025. TE evaluation was communicated as 'supported' during the call. U; No additional AE; This spontaneous report was received from a nurse and refers to a 4-year-old male patient. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On 14-Aug-2025, the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Solution for injection (lot #Y017062, expiration date: 11-Oct-2026) reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (lot# and expiration date were not reported), 0.5 mL as prophylaxis, that underwent a temperature excursion of 5.5 F for 2 hours (on 13-Aug-2025), a previous excursion had occurred (03-Jul-2025, at 8.4F for an hour). This was one of 2 cases received by the same reporter. Lot # is being requested and will be submitted if received.
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| 2855107 | 4 | M | CA | 08/22/2025 |
VARCEL |
MERCK & CO. INC. |
Y017062 |
No adverse event, Product storage error
No adverse event, Product storage error
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HCP called to report TE occurring on 8/13/2025 for VARIVAX that was administered to two patients aft...
HCP called to report TE occurring on 8/13/2025 for VARIVAX that was administered to two patients after TE on 8/14/2025. TE evaluation was communicated as 'supported' during the call. Unknown if any adverse reactions were experienced after the admin; No additional AE; This spontaneous report was received from a nurse and refers to a 4-year-old male patient. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On 14-Aug-2025, the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Solution for injection (lot #Y017062, expiration date: 11-Oct-2026) reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (lot# and expiration date were not reported), 0.5 mL as prophylaxis, that underwent a temperature excursion of 5.5 F for 2 hours (on 13-Aug-2025), a previous excursion had occurred (03-Jul-2025, at 8.4F for an hour). This was one of 2 cases received by the same reporter. Lot # is being requested and will be submitted if received.
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| 2855108 | AL | 08/22/2025 |
UNK |
UNKNOWN MANUFACTURER |
Z004729 |
Syringe issue
Syringe issue
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No AE; Finger Flange Broken - During or After Injection; following administration while applying nee...
No AE; Finger Flange Broken - During or After Injection; following administration while applying needle safety cover , the glass PFS broke; This spontaneous report was received from a Nurse on 15-AUG-2025. The complaint description was reported as follow: Health care professional (HCP) called to report a product quality complaint (PQC) for Hepatitis B Vaccine (Recombinant) (RECOMBIVAX H) Suspension for injection (lot #Z004729, has been verified to be valid lot #, expiration date was provided and confirmed as: 04-Sep-2027). Caller reported that on 15-AUG-2025, following administration while applying needle safety cover, the glass pre-filled syringe (PFS) broke (Syringe issue). Caller stated that "it broke in half and shards were everyone". Finger flange broken, it broken into 2 pieces with multiple shards. No patient involved. No injury to patient or HCP. Product available for retrieval. No adverse event (AE) was reported. No additional PQC. Date PQC observed: 15-AUG-2025.
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| 2855109 | 35 | F | NC | 08/22/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
2NG23 |
Drug ineffective, Incorrect route of product administration, Injection site eryt...
Drug ineffective, Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site swelling
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Injection intended for intramuscular route was administered in subcutaneous space, causing localized...
Injection intended for intramuscular route was administered in subcutaneous space, causing localized swelling, pain, redness and ineffectiveness.
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| 2855110 | 7 | F | MI | 08/22/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
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No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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NO ADVERSE EFFECT
NO ADVERSE EFFECT
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| 2855117 | 25 | F | IN | 08/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
MG5S9 |
Chills, Fatigue, Headache, Pain, Wrong product administered
Chills, Fatigue, Headache, Pain, Wrong product administered
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body ache; headache; fatigue; chills; accidentally administered the Shingrix vaccine to the patient ...
body ache; headache; fatigue; chills; accidentally administered the Shingrix vaccine to the patient instead of the Varicella vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of general body pain in a 25-year-old female patient who received Herpes zoster (Shingrix) (batch number MG5S9, expiry date 31-MAR-2025) for prophylaxis. Co-suspect products included Varicella zoster vaccine (Varicella vaccine) for prophylaxis. On 24-JUL-2025, the patient received Shingrix (left deltoid) .5 ml. The patient did not receive Varicella vaccine. On 24-JUL-2025, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: accidentally administered the Shingrix vaccine to the patient instead of the Varicella vaccine). On 25-JUL-2025, the patient experienced general body pain (Verbatim: body ache), headache (Verbatim: headache), fatigue (Verbatim: fatigue) and chills (Verbatim: chills). The outcome of the general body pain, headache, fatigue and chills were not resolved and the outcome of the wrong vaccine administered was not applicable. The reporter considered the general body pain, headache, fatigue and chills to be related to Shingrix. The company considered the general body pain, headache, fatigue and chills to be related to Shingrix. Additional Information: GSK Receipt Date: 25-JUL-2025 The reporter stated that the patient came in to receive the Varicella vaccine on July 24th, 2025, at 10:30am, but when the provider placed the order for the vaccine she just read Zoster on the box and did not double check the vial and accidentally administered the Shingrix vaccine to the patient instead of the Varicella vaccine. The patient reported to the office the next day (the 25th) experiencing severe body ache, severe headache, fatigue, and chills. The patient received Shingrix vaccine instead of varicella vaccine, which led to wrong vaccine administered.
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| 2855118 | M | 08/22/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
UNK |
Dizziness, Fall, Head injury, Seizure
Dizziness, Fall, Head injury, Seizure
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began seizing; Felt dizzy; fell backward; hit head; This serious case was reported by a other health...
began seizing; Felt dizzy; fell backward; hit head; This serious case was reported by a other health professional and described the occurrence of seizure in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On 13-AUG-2025, the patient received Menveo. On 13-AUG-2025, less than a day after receiving Menveo, the patient experienced seizure (Verbatim: began seizing) (serious criteria hospitalization and GSK medically significant), dizziness (Verbatim: Felt dizzy) (serious criteria hospitalization), fall (Verbatim: fell backward) (serious criteria hospitalization) and head injury (Verbatim: hit head) (serious criteria hospitalization). On 14-AUG-2025, the outcome of the seizure, dizziness, fall and head injury were resolved (duration 1 day). It was unknown if the reporter considered the seizure, dizziness, fall and head injury to be related to Menveo. The company considered the seizure, dizziness, fall and head injury to be unrelated to Menveo. Additional Information: GSK Receipt Date: 15-AUG-2025 Patient was in hospital for felt dizzy, felt backwards, hit head, began seizing.; Sender's Comments: A case of Seizure, Dizziness, Fall, Head injury, less than a day after receiving Menveo in a 17-year-old male patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
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| 2855120 | 78 | M | 08/22/2025 |
RSV RSV RSV |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Cardiac failure congestive, Cardiac stress test, Catheterisation cardiac, Chest ...
Cardiac failure congestive, Cardiac stress test, Catheterisation cardiac, Chest X-ray, Computerised tomogram head; Coronary arterial stent insertion, Cough, Echocardiogram, Heart valve incompetence, Paranasal sinus hypersecretion; Pneumonia, Sinus disorder, Throat clearing
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2nd day after R.S.V. shot became sinus crackling & drainage Followed with pneumonia & 3 diff...
2nd day after R.S.V. shot became sinus crackling & drainage Followed with pneumonia & 3 different antibiotics CT sinuses, inhalers, Mucinex & as of today 8-14-25 continues to cough & clear throat for 2 hours each day. Had 3 heart stents put in Feb 4, 2025 & heart valve regurgitation & now has congestive heart failure. Ecocardiogram, Heart Cath, stress test
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| 2855180 | 66 | M | MI | 08/22/2025 |
PNC21 |
MERCK & CO. INC. |
Z006076 |
No adverse event, Product storage error
No adverse event, Product storage error
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No adverse events reported; HCP called and reported Improperly stored CAPVAXIVE administered to one ...
No adverse events reported; HCP called and reported Improperly stored CAPVAXIVE administered to one patient with unknown demographics on unknown date and confirmed no symptoms or side effects reported. No additional AE/no PQC. CAPVAXIVE z006076 exp 9/11/2026 0 hours 51 minutes; This spontaneous report was received from a/an Nurse and refers to a(n) 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 started therapy with unknown dosage. On an unknown date, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (lot #z006076, expiration date: 11-Sep-2026) 0.5 mL (0.5mL/once). The patient started therapy with Pneumococcal 21-valent Conjugate Vaccine for the treatment of prophylaxis. The patient started therapy with for the treatment of prophylaxis. On an unknown date, the patient experienced HCP called and reported Improperly stored CAPVAXIVE administered to one patient with unknown demographics on unknown date and confirmed no symptoms or side effects reported. No additional AE/no PQC. CAPVAXIVE z006076 exp 9/11/2026 0 hours 51 minutes. On an unknown date, the patient experienced No adverse events reported. Follow up information was received from the nurse on 12-Aug-2025. This spontaneous report was referring to a(n) 66-year-old male patient. This case become valid upon follow up information. The patient's medical history included History of nephrolithiasis, History of dissection of artery, and Rash. The patient's concurrent conditions included Essential hypertension, Asymptomatic varicose veins of left lower extremity, Overweight (BMI 25.0-29.9), Mixed hyperlipidemia, Elevated prostate specific antigen (PSA), Benign prostatic hyperplasia with weak urinary stream, and Allergy to Penicillins. Historical drugs included Penicillin (Penicillin nos). Concomitant medications included Amlodipine (Amlodipine maleate), Tamsulosin (Tamsulosin hydrochloride). Vaccines were delivered to the office by courier. During transport vaccines were stored at an outof range temperature of 33F for 51 minutes (Product storage error). This was not immediately identified (The temperature excursion occurred as a result of a reading from a Digital Data Logger). Then On 14-Jul-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) injection, 0.5 mL (0.5mL/once, concentration:168 mcg/ml), (lot #Z006076, expiration date: 11-Sep-2026), administered by Intramuscular route for prophylaxis. No adverse events reported (No adverse event). Vaccines were then labeled do not use while they investigated the situation. The stability data provided supported use of the vaccine. The dose given was valid and was not repeated. The remaining nine doses were then released for use (Remaining 9 vaccines were held as do not use until stability data was obtained; those doses were then made available for use and have been administered) (capture in case 2322076). This is one of two reports received from the same reporter.
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| 2855181 | 13 | NC | 08/22/2025 |
HBHEPB HBHEPB HBHEPB |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y005366 |
Wrong product administered; Wrong product administered; Wrong product administer...
Wrong product administered; Wrong product administered; Wrong product administered
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patient has not reported any symptoms; inadvertently administering a dose of PEDVAX HIB to a 13 year...
patient has not reported any symptoms; inadvertently administering a dose of PEDVAX HIB to a 13 year old patient who was scheduled to received a meningitis B BESTRO vaccine; This spontaneous report was received from a medical assistant and refers to a 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates (discrepancy, reported as 10-NOV-2005 and 05-MAR-2007), the patient was vaccinated with 1st and 2nd dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAX HIB) suspension for injection, administered for prophylaxis (dose, route of administration, anatomical location, lot# and expiry date were not reported). On 30-JUL-2025, the patient was inadvertently vaccinated with 3rd dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAX HIB) suspension for injection, lot #Y005366, expiration date: 05-NOV-2026, administered for prophylaxis (dose, route of administration and anatomical location were not reported) instead of scheduled meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO) (reported as "meningitis B BESTRO vaccine") (Wrong product administered). The patient had not reported any symptoms. Lot# (Dose 1 and 2) is being requested and will be submitted if received.
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| 2855182 | F | 08/22/2025 |
HPV9 |
MERCK & CO. INC. |
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Product preparation error
Product preparation error
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This is haunting me and has really gotten me worried that the vaccine might not be as effective.; My...
This is haunting me and has really gotten me worried that the vaccine might not be as effective.; My concern is that the second time the nurse didn't shake the syringe and I also forgot to remind her.; This spontaneous report was received from a 32-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, route of administration, lot # and expiration date were not reported) as prophylaxis, which was really difficult for her to purchase due to financial issues. But she decided to put her health and safety first despite everything. Her concern was that the second time the nurse didn't shake the syringe and the patient also forgot to remind her (Product preparation issue). It said on the package to "shake well before use". This was haunting the patient and had really gotten her worried that the vaccine might not be as effective (Worry). At the reporting time, the outcome of Worry was unknown. The action taken was not applicable. The causal relationship between the event of Worry and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not reported. Lot # is being requested and will be submitted if received.
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| 2855183 | 34 | CA | 08/22/2025 |
HPV9 |
MERCK & CO. INC. |
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Incomplete course of vaccination
Incomplete course of vaccination
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Pharmacist called and reported an interrupted dosing series of GARDASIL 9 for an adult patient. Pati...
Pharmacist called and reported an interrupted dosing series of GARDASIL 9 for an adult patient. Patient received their first dose of GARDASIL 9 in October 2024 and has not yet received any other doses; No additional AE/PQC.; This spontaneous report was received from a pharmacist and refers to a 34-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date in October 2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (dose, route of administration, vaccination site, lot # and expiration date were not reported) administered for prophylaxis. The pharmacist called to report an interrupted dosing series of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9). Since October 2024, the patient had not yet received any other doses (inappropriate schedule of product administration). No additional information was known by the reporter. No additional adverse event and no product quality complaint (PQC) was noted (no adverse event). Lot # is being requested and will be submitted if received.
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| 2855184 | GA | 08/22/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Z003883 |
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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HBP confirmed the patient involved did not experience any medical concerns or symptoms after the adm...
HBP confirmed the patient involved did not experience any medical concerns or symptoms after the administration of the improperly stored VARIVAX.; the VARIVAX was exposed to multiple temperature excursions beginning in May 2025 and stated that a dose of the VARIVAX was administered to the patient involved on 6/9/2025.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In the beginning of May 2025, Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was exposed to multiple temperature excursions. On 09-Jun-2025, the patient was vaccinated with a dose of the Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot #Z003883 and expiration date reported as 03-Feb-2027) 0.5 mL (dose frequency reported as: 0.5 mL / two dose series) (route of administration and vaccination site were not reported) administered for prophylaxis (product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). The patient involved did not experience any medical concerns or symptoms after the administration of the improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX). No additional information was provided. No additional adverse event (AE) and no product quality complaint (PQC) was noted (no adverse event).
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| 2855185 | 0.17 | M | ND | 08/22/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
M3475 |
Allergy test, Food allergy
Allergy test, Food allergy
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Patient became allergic to peanuts. He first had peanuts when he was just over a year old in Septemb...
Patient became allergic to peanuts. He first had peanuts when he was just over a year old in September of 2014.
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| 2855186 | 12 | F | OH | 08/22/2025 |
MNQ TDAP |
NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
AMXB079A PG3RP |
Anxiety, Epistaxis; Anxiety, Epistaxis
Anxiety, Epistaxis; Anxiety, Epistaxis
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After receiving vaccinations patient started with a bloody nose. Mother was able to get bleeding to ...
After receiving vaccinations patient started with a bloody nose. Mother was able to get bleeding to stop. During vaccinations CMA did report patient was really anxious. Mother called back about an hour or so later and report the patient had another bloody nose. Mother noted patient had never had a bloody nose before.
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| 2855187 | 12 | M | MN | 08/22/2025 |
FLU3 HPV9 |
SEQIRUS, INC. MERCK & CO. INC. |
406981 260CT2026 |
Urticaria; Urticaria
Urticaria; Urticaria
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Both vaccines given on same day. Has had flu vaccine multiple times in the past without incident. ...
Both vaccines given on same day. Has had flu vaccine multiple times in the past without incident. This was the first dose of Gardasil series. Developed full body hives (sparing face) the follow day in the afternoon. Was seen at clinic for follow up appointment. Was treated with oral prednisone taper along with antihistamine.
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| 2855188 | 62 | M | AZ | 08/22/2025 |
FLU3 |
SANOFI PASTEUR |
U8440AA |
Myocarditis
Myocarditis
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myocarditis
myocarditis
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| 2855189 | 55 | F | FL | 08/22/2025 |
PNC20 |
PFIZER\WYETH |
LX4486 |
Injected limb mobility decreased, Injection site pain, Sleep disorder
Injected limb mobility decreased, Injection site pain, Sleep disorder
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Left Upper Arm Pain: - Onset of pain began the day after receiving the Prevnar 20 vaccine, approxima...
Left Upper Arm Pain: - Onset of pain began the day after receiving the Prevnar 20 vaccine, approximately 3 days ago. - Describes pain as severe enough to prevent lifting the arm. - Pain localized to the deltoid area. - Applying ice and taking ibuprofen with minimal relief. - Pain disrupted sleep last night. - Denies fever, chills, warmth, redness, or swelling.
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