| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2851542 | CA | 07/28/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
|
No adverse event, Product preparation issue
No adverse event, Product preparation issue
|
only the DTAP-IPV portion of the PENTACEL was administered with no reported adverse event; Initial i...
only the DTAP-IPV portion of the PENTACEL was administered with no reported adverse event; Initial information received on 24-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who was administered only with the dtap-ipv portion of the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunisation and only the dtap-ipv portion was administered with no reported adverse event (single component of a two-component product administered) (latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, they wanted to know how to move forward. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2851543 | 4 | M | OR | 07/28/2025 |
DTAPIPV |
SANOFI PASTEUR |
U7838AA |
Unevaluable event
Unevaluable event
|
N/A
N/A
|
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| 2851544 | 9 | M | AZ | 07/28/2025 |
MMRV |
MERCK & CO. INC. |
Y015989 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
Patient received an MMRV vaccine, after reviewing physical record card when parent brought it back t...
Patient received an MMRV vaccine, after reviewing physical record card when parent brought it back to the front desk for updating, patient was only due for Varicella portion of vaccine at this time.
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| 2851545 | 50 | M | NJ | 07/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7ZM55 |
Hypoacusis, Tinnitus
Hypoacusis, Tinnitus
|
Per patient: Tinnitus in both ears began around March 1, 2025. The symptoms worsened significantly ...
Per patient: Tinnitus in both ears began around March 1, 2025. The symptoms worsened significantly and became more pronounced in the left ear following administration of the second Shingrix dose on July 22, 2025.
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| 2851546 | 44 | M | OK | 07/28/2025 |
COVID19 |
MODERNA |
|
Bronchoscopy abnormal, Dyspnoea, Lung disorder
Bronchoscopy abnormal, Dyspnoea, Lung disorder
|
I cannot breathe!
I cannot breathe!
|
โ | โ | ||||
| 2851547 | 77 | F | NE | 07/28/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
39LB7 |
Injected limb mobility decreased, Injection site reaction, Muscle tightness, Mya...
Injected limb mobility decreased, Injection site reaction, Muscle tightness, Myalgia
More
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Severe soreness and muscle tightness in the right deltoid (injection site) to the point that the pat...
Severe soreness and muscle tightness in the right deltoid (injection site) to the point that the patient said they could barely move their arm. They are managing at home with alternating hot/cold packs and ibuprofen along with trying to move as much as possible. They began these after onset Sunday evening (7/27) and were continuing today. So far they have not gotten much relief, but they will continue treatments and update us.
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| 2851558 | 0.5 | M | 07/28/2025 |
RV1 |
GLAXOSMITHKLINE BIOLOGICALS |
3Z34X |
Extra dose administered
Extra dose administered
|
Administered 1 extra dose of Rota PO .
Administered 1 extra dose of Rota PO .
|
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| 2851559 | 77 | F | HI | 07/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
PJ353 |
Injection site erythema, Injection site swelling, Pyrexia
Injection site erythema, Injection site swelling, Pyrexia
|
FEVER AND SWOLLEN/REDNESS OF INJECTION SITE FOR 5 DAYS FOLLOWING THE VACCINATION
FEVER AND SWOLLEN/REDNESS OF INJECTION SITE FOR 5 DAYS FOLLOWING THE VACCINATION
|
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| 2851560 | 68 | F | 07/28/2025 |
FLU3 TDAP |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
U8764BB L5229 |
Confusional state, Dyspnoea, Hyperhidrosis; Confusional state, Dyspnoea, Hyperhi...
Confusional state, Dyspnoea, Hyperhidrosis; Confusional state, Dyspnoea, Hyperhidrosis
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Hard to breathe, confusion, sweating
Hard to breathe, confusion, sweating
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| 2851561 | VA | 07/28/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
Unevaluable event
Unevaluable event
|
None stated.
None stated.
|
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| 2851562 | 61 | M | OR | 07/28/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Chronic obstructive pulmonary disease, Computerised tomogram abnormal, Frontotem...
Chronic obstructive pulmonary disease, Computerised tomogram abnormal, Frontotemporal dementia, Muscle atrophy, Renal cancer
More
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Renal Cancer 2022, COPD 2021, FTD2021, MUSCLE WASTING 2022
Renal Cancer 2022, COPD 2021, FTD2021, MUSCLE WASTING 2022
|
โ | โ | ||||
| 2851346 | 67 | M | TX | 07/27/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
E19269 EN6202 |
Platelet count decreased, Thrombocytopenia, Tinnitus; Platelet count decreased, ...
Platelet count decreased, Thrombocytopenia, Tinnitus; Platelet count decreased, Thrombocytopenia, Tinnitus
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Thrombocytopenia and Tinnitus
Thrombocytopenia and Tinnitus
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| 2851347 | 16 | F | ND | 07/27/2025 |
COVID19 |
PFIZER\BIONTECH |
FD0809 |
Blindness unilateral, Ophthalmological examination abnormal, Visual field defect...
Blindness unilateral, Ophthalmological examination abnormal, Visual field defect, Visual impairment
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I started noticing visual impairments approximately 05/2024. That consisted of not being able to see...
I started noticing visual impairments approximately 05/2024. That consisted of not being able to see road signs in my peripheral vision which then made me notice I couldn't see anything in my peripheral without turning my head. I then went to my eye doctor 5/20/24. Who then advised me to see a specialist for diagnoses. I was able to see my first specialist 7/15/2024, who was not able to help me and recommended a different specialist. I don't recall the exact date but it was before the end of 2024. I still was unable to get diagnosed from that specialist as well. After receiving testing, it was noted that my left eye is considered blind. With a significant loss of vision. They then questioned if I should be driving, I told them I made a personal adjustment and put in a panoramic rear view mirror to help guide me, and I don't drive at night time EVER because of my lack of vision.
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โ | |||||
| 2851348 | 1 | F | NH | 07/27/2025 |
MMR |
MERCK & CO. INC. |
Y015551 |
Pyrexia, Rash, Rash papular
Pyrexia, Rash, Rash papular
|
High fever starting early morning of July 15th lasting until evening of July 16th. Mild raised spora...
High fever starting early morning of July 15th lasting until evening of July 16th. Mild raised sporadic rash, bump like over body. Second incident of high fever occurring early am of July 24th. Both times pediatrician notified. First event was to monitor fever second event required office visit First fever early 15th (day 8 post vaccine) through 16th, high fevers 101-102, called Pedi, sporadic rash, small raised bumps systemically, likely MMR, measles component Second fever early am of 24th (18 days post vaccine), high fevers 102-103.3. seen at pedi on 25th, likely MMR, mumps component, fever improved on day 3, temps 99-100.
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| 2851349 | 26 | F | AZ | 07/27/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
945665 |
Abdominal pain upper, Confusional state, Malaise, Migraine, Nausea
Abdominal pain upper, Confusional state, Malaise, Migraine, Nausea
|
Migraine for two days, nausea, stomach pain, confusion. General unwell.
Migraine for two days, nausea, stomach pain, confusion. General unwell.
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| 2851350 | 5 | F | CA | 07/27/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
|
Blister, Erythema, Pain, Pruritus, Skin swelling; Skin warm, Urticaria
Blister, Erythema, Pain, Pruritus, Skin swelling; Skin warm, Urticaria
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About 2 hrs after varicella vaccine. Noticed a hive on right side of hand wrist and did not disappe...
About 2 hrs after varicella vaccine. Noticed a hive on right side of hand wrist and did not disappear ( turned into blister by next day). The 2nd day I noticed 2 more. One on each of her legs. Area was very swollen , red, hot to the touch. The right wrist hive was turning into a blister with clear liquid. Blister was almost as big as a pencil eraser but had a very large red swollen spot around it. Applied cold hydrocortisone cream to lessen the itch and pain from swollen area and was Also given Zyrtec to reduce any allergic reaction. The fourth day red spots are still there with small blister on them but they seem to be healing little by little.
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| 2851351 | 25 | F | 07/27/2025 |
TDAP VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
|
Injection site cellulitis; Injection site cellulitis
Injection site cellulitis; Injection site cellulitis
|
cellulitis at site
cellulitis at site
|
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| 2851352 | 59 | F | KY | 07/27/2025 |
PNC20 |
PFIZER\WYETH |
LN4928 |
Headache, Nausea, Pain, Pyrexia, Vomiting
Headache, Nausea, Pain, Pyrexia, Vomiting
|
Nausea 7/26-7/27, vomiting 7/26, Fever 7/26-7/27, body aches 7/26, headache 7/26-7/27
Nausea 7/26-7/27, vomiting 7/26, Fever 7/26-7/27, body aches 7/26, headache 7/26-7/27
|
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| 2851353 | 28 | F | FL | 07/27/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
9JT4S |
Syncope
Syncope
|
Patient fainted for 5-10 seconds after receiving x1 dose of tdap
Patient fainted for 5-10 seconds after receiving x1 dose of tdap
|
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| 2851354 | 14 | F | NJ | 07/27/2025 |
HPV9 |
MERCK & CO. INC. |
Y014059 |
Injection site mass
Injection site mass
|
lump at injection site still present months after the injection
lump at injection site still present months after the injection
|
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| 2851355 | 73 | M | NY | 07/27/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
Chills, Feeling abnormal, Headache, Myalgia, Nausea; Pain in extremity, Pyrexia,...
Chills, Feeling abnormal, Headache, Myalgia, Nausea; Pain in extremity, Pyrexia, Rash
More
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73 yr old male I've had all of the Covid vaccines whenever reccommended by CDC (maybe 6 in al...
73 yr old male I've had all of the Covid vaccines whenever reccommended by CDC (maybe 6 in all?) Mon 7.8 25 Moderna 2024-2025 booster Thurs 7.17.25 symptoms started through Sat 7.19.25 felt terrible overall including: large leg rash on shin and calf (at site of injury 2 years earlier) myalgia, nausea headache chills mild arm soreness fever Fever 103.9degrees F peak Sat 9 am 7.18.25 headache began 1-2 days later Sun 7.20.25 somewhat better overall headache worse, terrible Thurs 7.24 .25 headache better Sat. 7.26.25 feeling almost normal still rash, but much improved
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| 2851356 | 61 | F | FL | 07/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7523j |
Pain, Rash, Swelling face
Pain, Rash, Swelling face
|
PT STATED SHE EXPERIENCED ACHY PAIN FOR A WEEK, RASH ON SHOULDER AND CHEST STILL PRESENT ON 7/27/25,...
PT STATED SHE EXPERIENCED ACHY PAIN FOR A WEEK, RASH ON SHOULDER AND CHEST STILL PRESENT ON 7/27/25, AND FACE SWELLING. She stated she had been using benadryl to calm the rash. I referred her to her primary doctor or a walk in clinic for the rash. The pain and facial swelling was gone.
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| 2851357 | 56 | F | FL | 07/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
594g2 |
Fatigue, Loss of personal independence in daily activities, Muscular weakness
Fatigue, Loss of personal independence in daily activities, Muscular weakness
|
Pt states general muscle weakness and fatigue since receiving Shingrix vaccine still continuing 2.5 ...
Pt states general muscle weakness and fatigue since receiving Shingrix vaccine still continuing 2.5 months later. She used to do weight training 4 days a week and spinning 2 times a week and not can't due to severity of weakness and fatigue. Husband who received shingles vaccine on same day is experiencing same issues (will submit separate VAERS for him). Nothing else has changed aside from receiving vaccine. She consulted with her primary and primary MD states side effects from vaccine usually last a couple of days and that he doesn't think weakness and fatigue is due to vaccine but cannot pinpoint any other source.
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| 2851358 | 24 | F | MI | 07/27/2025 |
RAB |
NOVARTIS VACCINES AND DIAGNOSTICS |
|
Dizziness, Dyspnoea, Dyspnoea exertional, Malaise, Pyrexia
Dizziness, Dyspnoea, Dyspnoea exertional, Malaise, Pyrexia
|
Fever for 24 hours, malaise. After 48 hours developed breathlessness and extreme dizziness, worsenin...
Fever for 24 hours, malaise. After 48 hours developed breathlessness and extreme dizziness, worsening when standing and walking. Having to catch breath while speaking.
More
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| 2851359 | 62 | F | TN | 07/27/2025 |
PNC21 |
MERCK & CO. INC. |
Y011819 |
Rash, Rash erythematous
Rash, Rash erythematous
|
LARGE RED RASH AREA THAT BEGAN THE EVENING AFTER VACCINATION AND SPREAD OVER THE NEXT 3 DAYS.
LARGE RED RASH AREA THAT BEGAN THE EVENING AFTER VACCINATION AND SPREAD OVER THE NEXT 3 DAYS.
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| 2851360 | 61 | M | FL | 07/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
594g2 |
Fatigue, Loss of personal independence in daily activities, Muscular weakness
Fatigue, Loss of personal independence in daily activities, Muscular weakness
|
Pt wife reports muscle weakness and fatigue still 2.5 months after receiving vaccine. Husband weight...
Pt wife reports muscle weakness and fatigue still 2.5 months after receiving vaccine. Husband weight trains and runs 4 times a week and now struggles to do so. Only change in routine has been receiving vaccine. Visited primary md and primary md states he doesn't believe muscle weakness they are both experiencing is related to vaccine but cannot pinpoint another cause.
More
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| 2851361 | 73 | M | NM | 07/27/2025 |
PNC20 |
PFIZER\WYETH |
|
Laboratory test, Pneumonia
Laboratory test, Pneumonia
|
I received the "new" pneumonia vaccine, 20 valent pcv20 on April 18, In July I was hosp...
I received the "new" pneumonia vaccine, 20 valent pcv20 on April 18, In July I was hospitialzied for pneumonia.
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โ | |||||
| 2851362 | 59 | F | TX | 07/27/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EW0179 EW0179 EW0186 EW0186 |
Allergy test negative, Aphonia, Dermatitis contact, Eczema, Hepatic enzyme incre...
Allergy test negative, Aphonia, Dermatitis contact, Eczema, Hepatic enzyme increased; Photosensitivity reaction, Pruritus, Swelling face; Allergy test negative, Aphonia, Dermatitis contact, Eczema, Hepatic enzyme increased; Photosensitivity reaction, Pruritus, Swelling face
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(1)Eczema type break out/swelling of the face (suspected photosensitive) suspectedly caused by cat. ...
(1)Eczema type break out/swelling of the face (suspected photosensitive) suspectedly caused by cat. 3 Medrol dose packs from July 2022-August 2022, (2)March 2023 another eczema type breakout and loss of voice possibly caused by tree pollen treated with Medrol dose packs and Tacrolimus cream. (3)May 2024 another eczema type breakout along with severe itching caused by poison ivy. Treated with 2 rounds of Medrol dose packs. (4) Severe raised liver enzymes (total 2600)
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| 2851382 | 65 | F | FL | 07/27/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
F4AC3 F4AC3 |
Computerised tomogram, Electrocardiogram, Full blood count, Ischaemic stroke, Ma...
Computerised tomogram, Electrocardiogram, Full blood count, Ischaemic stroke, Magnetic resonance imaging head abnormal; Musculoskeletal disorder, Speech disorder, Thrombectomy, Ultrasound scan
More
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Patient suffered an ischemic stroke and was transported by EMS to Hospital, CT scan, tPA therapy, th...
Patient suffered an ischemic stroke and was transported by EMS to Hospital, CT scan, tPA therapy, thrombectomy. Patient 4 days post is in Telemetry unit, positive MRI, speech deficits minor, right hand deficit significant, able to ambulate.
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โ | โ | โ | |||
| 2851383 | 50 | F | MN | 07/27/2025 |
VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
3273H 3273H 3273H 3273H 3273H 3273H 3273H 3273H |
Agitation, Alanine aminotransferase normal, Analgesic drug level therapeutic, As...
Agitation, Alanine aminotransferase normal, Analgesic drug level therapeutic, Aspartate aminotransferase increased, Bacterial test negative; Blood creatine phosphokinase increased, Blood culture negative, Blood lactic acid increased, Borrelia test negative, C-reactive protein increased; CSF glucose increased, CSF lymphocyte count normal, CSF monocyte count negative, CSF neutrophil count increased, CSF protein increased; CSF red blood cell count positive, CSF virus no organisms observed, Computerised tomogram, Computerised tomogram head normal, Computerised tomogram normal; Confusional state, Discomfort, Drug screen negative, Electroencephalogram abnormal, Endotracheal intubation; Fungal test negative, Glycosylated haemoglobin normal, HIV test negative, Hepatitis A antibody negative, Hepatitis C antibody negative; Lymphocyte count increased, Magnetic resonance imaging head normal, Mental status changes, Monocyte count increased, Red blood cell sedimentation rate increased; Scan with contrast normal, Troponin increased, Urinary casts, White blood cell count increased
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Patient woke up middle of the night early in the AM 7/24 and couldn't get comfortable, took a T...
Patient woke up middle of the night early in the AM 7/24 and couldn't get comfortable, took a Tylenol, turned the fan on then went back to sleep. Family wound her confused/altered mental status in the AM and she was very agitated and not herself. At baseline she has normal cognitive functioning and behavior so that was abnormal for her. Brought into the ED by EMS and was ultimately intubated sedated for altered mental status and airway protection. She spiked one temp here in the ED but then no more. She returned from a camping trip recently so infectious causes were in the differential for encephalopathy but her CT head, Brain MRI, LP were all negative for infection. CT CAP negative for any abnormalities. Lactate was mildly elevated. She was extubated within ~48 hours and was awake, alert, talking normally and doesn't recall anything that happened.
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โ | โ | ||||
| 2851312 | KS | 07/26/2025 |
MMRV |
MERCK & CO. INC. |
Z003311 |
No adverse event, Product storage error
No adverse event, Product storage error
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Caller stated no patient symptoms have been reported.; Medical assistant called and reported 1 dose ...
Caller stated no patient symptoms have been reported.; Medical assistant called and reported 1 dose of PROQUAD was administered to a patient after being involved in a temperature excursion.; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided. On 20-JUN-2025, the patient received a dose of improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot # Z003311, has been verified to be valid, expiration 21-JUL-2026) 1 dose (strength, route, anatomical location were not reported) as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date not reported). No adverse events reported. It was reported that the temperature was -2.2 degrees Celsius (๏ฟฝC) , with time frame -10 ๏ฟฝC to 8๏ฟฝC for 48 hours 0 minutes 0 seconds, -14๏ฟฝC to -10๏ฟฝC for 67 Hours 40 Minutes 0 Seconds with no previous temperature excursion.
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| 2851313 | M | TX | 07/26/2025 |
PNC21 VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
Y011819 9L944 |
Cardiac monitoring, Chest pain, Inflammation, Injection site swelling, Swelling;...
Cardiac monitoring, Chest pain, Inflammation, Injection site swelling, Swelling; Cardiac monitoring, Chest pain, Inflammation, Injection site swelling, Swelling
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CHEST PAIN; INFLAMMATION OF THE CHEST; INJECTION SITE SWELLING; SWELLING OF THE CHEST; This spontane...
CHEST PAIN; INFLAMMATION OF THE CHEST; INJECTION SITE SWELLING; SWELLING OF THE CHEST; This spontaneous report was received from a Physician and refers to a 52-year-old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and. The patient's concomitant medication included hydroxyzine 25mg, metoprolol tart 25mg, atorvastatin 10mg. The patient's concurrent conditions included high cholesterol, high blood pressure (HBP) and allergy to penicillin - hives. On 11-Apr-2025, the patient was vaccinated with the first dose of pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) lot number Y011819 and expiration date of 01-Oct-2025, intramuscularly in left arm and the first dose of Varicella zoster vaccine rgE (CHO) (SHINGRIX) intramuscularly in right arm, lot number 9L944 (expiration date was not reported) both for prophylaxis. On 12-Apr-2025, the patient experienced swelling/inflammation of the chest, severe chest pain, swelling of the left arm around injection site, currently wearing a heart monitor was prescribed famotidine recently. On that date, the patient was hospitalized for 3 days. The patient was order echography, magnetic resonance image (MRI), echocardiogram (EKG) and electrocardiogram. On 14-APR-2025, the patient was prescribed aspirin, ibuprofen and colchicine. The outcome of the events and the causal relationship between the events and the suspect vaccines were not provided.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : , Index date : 2025-07-17 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2840364 , Central date : 2025-07-17 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
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โ | ||||||
| 2851330 | 60 | F | FL | 07/26/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
f4ac3 |
Extra dose administered
Extra dose administered
|
Patient received Arexvy on 09/2024 and was given another one on 07/25/2025
Patient received Arexvy on 09/2024 and was given another one on 07/25/2025
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| 2851331 | 12 | F | CA | 07/26/2025 |
HPV9 HPV9 MNQ MNQ TDAP TDAP HPV9 HPV9 MNQ MNQ TDAP TDAP |
MERCK & CO. INC. MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
Y015760 Y015760 537LH 537LH 9JT4S 9JT4S y015760 y015760 537lh 537lh 9jt4s 9jt4s |
Headache, Loss of consciousness, Seizure, Unresponsive to stimuli; Condition agg...
Headache, Loss of consciousness, Seizure, Unresponsive to stimuli; Condition aggravated, Seizure; Headache, Loss of consciousness, Seizure, Unresponsive to stimuli; Condition aggravated, Seizure; Headache, Loss of consciousness, Seizure, Unresponsive to stimuli; Condition aggravated, Seizure; Headache, Loss of consciousness, Seizure, Unresponsive to stimuli; Condition aggravated, Seizure; Headache, Loss of consciousness, Seizure, Unresponsive to stimuli; Condition aggravated, Seizure; Headache, Loss of consciousness, Seizure, Unresponsive to stimuli; Condition aggravated, Seizure
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Patient experienced sudden onset of seizure approximately 1 minutes after receiving a vaccines. Sei...
Patient experienced sudden onset of seizure approximately 1 minutes after receiving a vaccines. Seizure lasted approximately 60 seconds. Patient was unresponsive during the episode but regained consciousness within 1 minutes post-event. Patient was gently guided to the floor and placed in the recovery position. Area was cleared to prevent injury. Patient was offered water and recovered without requiring additional emergency medication. Patient?s mother was present during the event, provided emotional support. A family member was contacted and arrived to provide transportation home. Patient?s mother returned later in the evening and reported that the patient was doing well. Post-Seizure Symptoms: Patient experienced a headache for a few hours following the event, which resolved without intervention. Overall Recovery: No new concerns were reported; patient remained stable and continued to recover throughout the day.
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| 2851332 | 67 | M | 07/26/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Chills, Injection site erythema, Injection site pain, Injection site swelling, M...
Chills, Injection site erythema, Injection site pain, Injection site swelling, Muscle spasms; Pollakiuria
More
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Patient's wife called the day after the second singles shot to report EXTREME swelling, redness...
Patient's wife called the day after the second singles shot to report EXTREME swelling, redness, and pain at injection site. Also, muscle cramps, chills, and increased urination. Advised to treat symptoms.
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| 2851333 | 66 | F | OR | 07/26/2025 |
VARZOS 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 GLAXOSMITHKLINE BIOLOGICALS |
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Chills, Dysstasia, Fatigue, Headache, Hyperhidrosis; Hypotension, Myalgia, Nause...
Chills, Dysstasia, Fatigue, Headache, Hyperhidrosis; Hypotension, Myalgia, Nausea, Pain, Pyrexia; Somnolence, Tenderness, Vomiting; Chills, Dizziness, Fatigue, Headache, Hypertension; Pain, Pyrexia; Chills, Dysstasia, Fatigue, Headache, Hyperhidrosis; Hypotension, Myalgia, Nausea, Pain, Pyrexia; Somnolence, Tenderness, Vomiting; Chills, Dizziness, Fatigue, Headache, Hypertension; Pain, Pyrexia
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Shingrix vaccine 7/24/2025 roughly 10:10 AM 50ug/0.5 ml Side effects: By 4:00 PM, started feeling...
Shingrix vaccine 7/24/2025 roughly 10:10 AM 50ug/0.5 ml Side effects: By 4:00 PM, started feeling tired, slight headache, slightly nauseous, muscular aches By 10:00 PM, extremely achy, very tired more nauseous, pains shooting through left side of head over ear, developed chills, then fever and drenching sweats. Skin sore to touch body-wide. By next morning 7/25/2025 6:00 AM, got up but developed hypotension and was not able to stay vertical. Vomited on myself and kitchen floor, and this was before attempting to eat anything. Could not keep water down, or my morning thyroid and hydrocortisone medication. Went back to bed. By 9:30 AM, was able to take medications with water, and ate breakfast. Sweats and chills gone. Extremely tired, slept most of day until 4:30 PM, when I was able to get up and stay up for the rest of the day. Morning of 7/26/2025. Still feeling tired, but less so than yesterday. Have tried calling Pharmacy this morning, finally reached Pharmacist. Relayed the information and got the dosage.
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| 2851336 | 12 | F | FL | 07/26/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
PG3RP |
Face injury, Fall, Syncope
Face injury, Fall, Syncope
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The client received the vaccine at 12:30pm and stood up and started to walk towards the door. The c...
The client received the vaccine at 12:30pm and stood up and started to walk towards the door. The client then fainted, fell face first into the floor at 12:35pm. The client was laid flat and put her feet up and was given ammonia to smell and an ice pack. Clients' parents refused 911. Partents advised to follow up with primary care and to watch for signs of concussion.
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| 2851337 | 55 | F | AR | 07/26/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Lymphadenopathy
Lymphadenopathy
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Reactive lymphadenopathy under left arm
Reactive lymphadenopathy under left arm
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| 2851338 | 83 | F | GA | 07/26/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
BG5J4 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Vaccine was not appropriate for patient because she received vaccine previously on 12/5/2023 and cur...
Vaccine was not appropriate for patient because she received vaccine previously on 12/5/2023 and current recommendations are for 1 dose. Patient has had no adverse reactions to vaccine.
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| 2851339 | 11 | M | RI | 07/26/2025 |
TDAP |
SANOFI PASTEUR |
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Injection site reaction, Local reaction, Rash, Rash papular, Streptococcus test ...
Injection site reaction, Local reaction, Rash, Rash papular, Streptococcus test negative
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Started with a red papular rash to arms, legs and back that was noticed 2 days after vaccine. Also ...
Started with a red papular rash to arms, legs and back that was noticed 2 days after vaccine. Also with normal local reaction to L deltoid
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| 2851340 | 34 | F | MO | 07/26/2025 |
TDAP |
SANOFI PASTEUR |
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Injection site erythema, Injection site pain, Injection site swelling, Injection...
Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
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Reaction localized to injection site erythema, heat, swelling, pain
Reaction localized to injection site erythema, heat, swelling, pain
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| 2851341 | 64 | F | GA | 07/26/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7zm55 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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pt had unknowingly received complete shingrix series in 2021. this dose was third injection. no adve...
pt had unknowingly received complete shingrix series in 2021. this dose was third injection. no adverse reactions noted.
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| 2851342 | 69 | F | 07/26/2025 |
COVID19 |
MODERNA |
3043837 |
Expired product administered
Expired product administered
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Pharmacist realized patient received expired vaccine after patient left the store. Pharmacist cal...
Pharmacist realized patient received expired vaccine after patient left the store. Pharmacist called the patient and explained .Patient said she will call to let us know when she will want to come in for revaccination.
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| 2851343 | 68 | M | 07/26/2025 |
COVID19 |
MODERNA |
3043837 |
Expired product administered
Expired product administered
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Pharmacist realized patient received expired vaccine after patient left . Pharmacist called the pati...
Pharmacist realized patient received expired vaccine after patient left . Pharmacist called the patient and explained. Patient said he will call before coming in for revaccination.
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| 2851344 | 49 | M | VA | 07/26/2025 |
COVID19 |
MODERNA |
Na |
Gynaecomastia
Gynaecomastia
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Covid vacation at fair ground
Covid vacation at fair ground
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| 2851345 | 64 | F | CO | 07/26/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
DR4LB DR4LB |
Blister, Erythema, Peripheral swelling, Rash, Rash pruritic; Rash vesicular
Blister, Erythema, Peripheral swelling, Rash, Rash pruritic; Rash vesicular
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Began with a red bump on lower left leg, thought it was a bite. Turned into blistery top on bump. By...
Began with a red bump on lower left leg, thought it was a bite. Turned into blistery top on bump. By next day 10/03/24 legs were spotted with numerous sores. By 10/04/24 had chicken pox like extremely itchy spots and rash all over arms, torso, head and legs.
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| 2851108 | NY | 07/25/2025 |
RVX |
UNKNOWN MANUFACTURER |
X023474 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Patient is not symptomatic; expired ROTATEQ administered; This spontaneous report was received from ...
Patient is not symptomatic; expired ROTATEQ administered; This spontaneous report was received from a Nurse Practitioner 22-Jul-2025 and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-Jul-2025, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), administered orally (lot #X023474, expiration date: 11-Jul-2025)dose: 0.5 mL (dose number were not reporter) for Prophylaxis. No additional Adverse event or PQC reported.
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| 2851109 | 68 | F | TN | 07/25/2025 |
HPV9 |
MERCK & CO. INC. |
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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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FBE calling to report that a clinic administered GARDASIL 9 to a 68 year old female patient and agai...
FBE calling to report that a clinic administered GARDASIL 9 to a 68 year old female patient and again to a 48 year old female patient inadvertently. No dates of administration or other product information was provided. No other information. No other; No other AE; This spontaneous report was received from a Consumer or other non-health professional via Company representative and refers to a 68-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), Suspension for injection (dose, anatomical location, lot #, and expiration date were not reported) as prophylaxis (Product administered to patient of inappropriate age). No adverse events were provided. Additional information is not expected
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| 2851110 | 48 | F | TN | 07/25/2025 |
HPV9 |
MERCK & CO. INC. |
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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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FBE calling to report that a clinic administered GARDASIL 9 to a 68 year old female patient and agai...
FBE calling to report that a clinic administered GARDASIL 9 to a 68 year old female patient and again to a 48 year old female patient inadvertently. No dates of administration or other product information was provided. No other information. No other; No other AE; This spontaneous report was received from a Consumer or other non-health professional via Company representative and refers to a 48-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was inadvertently vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), Suspension for injection (dose, anatomical location, lot #, and expiration date were not reported) as prophylaxis (Product administered to patient of inappropriate age). No adverse events were provided. Additional information is not expected. This is one of two cases received from the same reporter.
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| 2851111 | 0.17 | TX | 07/25/2025 |
MMRV |
MERCK & CO. INC. |
Z008221 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Caller reported 2 month old patient inadvertently received PROQUAD. No other information provided. ...
Caller reported 2 month old patient inadvertently received PROQUAD. No other information provided. No additional AE/PQC reported.; Caller reported 2 month old patient inadvertently received PROQUAD. No other information provided. No additional AE/PQC reported.; This spontaneous report was received from a Nurse Practitioner on 22-Jul-2025 and refers to a 2-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 22-Jul-2025, the patient inadvertently received measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD), Injection, lot #Z008221, expiration date: 27-Oct-2026, 0.5 mL, administered by Intramuscular (IM) route for Prophylaxis (Product administered to patient of inappropriate age). No other information provided. No additional adverse event (AE)/product quality compliance (PQC) reported.
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