| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2852120 | 07/31/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Asthenia, Coeliac disease
Asthenia, Coeliac disease
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I am a Celiac; energy that I usually have daily has disappeared / extremely weak; This is a spontane...
I am a Celiac; energy that I usually have daily has disappeared / extremely weak; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COELIAC DISEASE (medically significant), outcome "unknown", described as "I am a Celiac"; ASTHENIA (non-serious), outcome "unknown", described as "energy that I usually have daily has disappeared / extremely weak". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2852121 | F | CA | 07/31/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
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COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. An elderly fe...
COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. An elderly female patient received BNT162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". Clinical course: Patient reported two times had COVID. Taken Paxlovid in the past when having COVID responded had it once. Whenever that was, mean that was a couple years ago. Patient was fully vaccinated, and have had Pfizer shots, all of them so, much gratitude. Patient thought had nine vaccine over the last four years. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2852122 | M | CA | 07/31/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
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COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. A male patien...
COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid as treatment for events. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2852123 | M | CA | 07/31/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
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COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. A male patien...
COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had COVID two times. Patient received Paxlovid as treatment. Reported that was a couple years ago. Patient was fully vaccinated, and have had Pfizer shots, all of them. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2852124 | 16 | F | SC | 07/31/2025 |
MEN MEN MENB MENB |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER PFIZER\WYETH PFIZER\WYETH |
|
Blood test, Chest discomfort, Electrocardiogram normal, Injection site rash, Pyr...
Blood test, Chest discomfort, Electrocardiogram normal, Injection site rash, Pyrexia; Rash, Vomiting; Blood test, Chest discomfort, Electrocardiogram normal, Injection site rash, Pyrexia; Rash, Vomiting
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chest felt heavy on 14Jul2025; rash all over stomach; 102 degree fever; vomiting; rash on the vaccin...
chest felt heavy on 14Jul2025; rash all over stomach; 102 degree fever; vomiting; rash on the vaccine injection site; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 28Jul2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 16-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 11Jul2025 as dose 1, single (Batch/Lot number: unknown) at the age of 16 years, in right arm for immunisation; meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI), on 11Jul2025 as dose number unknown, single, in left arm for immunisation. The patient's relevant medical history included: "vasovagal syncope" (unspecified if ongoing), notes: related to the low iron, hasn't had episode of that in a year, still takes iron so doesn't come to that anymore since patient was passing out all of the time; "low iron" (unspecified if ongoing); "Allergic to mangos" (unspecified if ongoing); "Birth control" (unspecified if ongoing); "allergies" (unspecified if ongoing); "passing out all of the time" (unspecified if ongoing); "heavy periods" (unspecified if ongoing); "little bit of a fever" (unspecified if ongoing). Concomitant medication(s) included: JUNEL oral taken for contraception, heavy menstrual bleeding (ongoing); XYZAL oral taken for hypersensitivity, start date: 2024 (ongoing); FERROUS SULFATE oral taken for blood iron decreased, start date: 2023 (ongoing). The following information was reported: VACCINATION SITE RASH (non-serious) with onset 12Jul2025, outcome "unknown", described as "rash on the vaccine injection site"; PYREXIA (medically significant) with onset 13Jul2025, outcome "not recovered", described as "102 degree fever"; RASH (non-serious) with onset 13Jul2025, outcome "unknown", described as "rash all over stomach"; VOMITING (medically significant) with onset 13Jul2025, outcome "unknown"; CHEST DISCOMFORT (non-serious) with onset 14Jul2025, outcome "unknown", described as "chest felt heavy on 14Jul2025". The event "chest felt heavy on 14jul2025" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Unknown results, notes: everything else seemed to be okay; Body temperature: (13Jul2025) 102 degree; Electrocardiogram: (unspecified date) normal. Therapeutic measures were taken as a result of pyrexia, vomiting. Clinical course: Th next morning patient had rash on the vaccine injection site. They thought it was a little reaction. Then the patient woke up at 3AM the next morning with 102 degree fever, fever continued, and vomiting. Did fluids, making sure patient was resting, gave Tylenol and Ibuprofen alternating those. Called the doctor's office to let know, and the doctor's office said to keep an eye on it. Later that day, the patient had rash all over stomach. The patient was in bed a couple of days and then went to the doctor and the ER because patient said chest felt heavy on 14Jul2025. Clarified and confirmed patient was not admitted into hospital, was seen in ER. Did EKG, which had abnormalities. Did a bunch of bloodwork and something else, cannot remember what. The reporter (mother) works for a cardiologist, so had a cardiologist look at the EKG, cardiologist said was normal for a 16-year-old to have some of those things. Patient swims and does track, heart is healthy. Not sure what the heaviness was. After the patient was speaking to friends, they said they had this before, no additional information provided, and no product names provided by caller. Caller wanted to report it. On 15Jul2025 patient saw HCP # to let know what had happened, and HCP is not going to give the next shot to patient next year, said not to worry about It. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The patient required ER visit for heaviness in chest and went to regular doctor to follow up on everything the day after. The information on the batch/lot number for meningococcal group b Rlp2086 will be requested and submitted if and when received.
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| 2852125 | F | CA | 07/31/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
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COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. An elderly fe...
COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. An elderly female patient received BNT162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". This is for the first Covid of the patient. The patient reported that she was fully vaccinated and had Pfizer shots. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500152235 same reporter/patient, different vaccine and event;US-PFIZER INC-202500152236 same reporter/patient, different vaccine and event;
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| 2852126 | F | LA | 07/31/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
QFA1818 QFA1818 |
Bursitis, Injected limb mobility decreased, Loss of personal independence in dai...
Bursitis, Injected limb mobility decreased, Loss of personal independence in daily activities, Magnetic resonance imaging abnormal, Musculoskeletal stiffness; Pain in extremity, Peripheral swelling
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she had limited range of motion with her left arm; can't shave, no ponytails; still feeling sor...
she had limited range of motion with her left arm; can't shave, no ponytails; still feeling sore and stiff; remained swollen; hurt like crazy; Initial information received on 23-Jul-2025 regarding an unsolicited valid non-serious case received from a patient. This case involves an unknown age female patient who had limited range of motion with her left arm, can't shave, no ponytails, still feeling sore and stiff, remained swollen and hurt like crazy after receiving Influenza Quadrivalent Recombinant Vaccine [Flublok]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Nov-2018, the patient received 0.5 ml dose of suspect Influenza Quadrivalent Recombinant Vaccine, unknown formulation, lot QFA1818, expiry date:30-Jun-2019, strength not reported via unknown route in the left deltoid for influenza. On 03-Nov-2018 the patient hurt like crazy (vaccination site pain) (latency :same day). On an unknown date the patient had limited range of motion with her left arm (vaccination site movement impairment), can't shave, no ponytails (loss of personal independence in daily activities), still feeling sore and stiff (musculoskeletal stiffness) and remained swollen (vaccination site swelling) (unknown latency). Reportedly,Patient said that she was not taking any pain meds such as Meloxicam, she used some ointments and ice packs. Through the years, she said that she had physical therapies, MRIs [Magnetic resonance imaging], she had seen multiple nice doctors.On one of her MRIs, she mentioned that she was informed that a little bursitis was seen,her doctor suggested surgery, but he did not guarantee that the swelling would go down. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.
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| 2852127 | 0.75 | M | CA | 07/31/2025 |
HIBV |
SANOFI PASTEUR |
UK093AB |
Product preparation error
Product preparation error
|
one of the medical assistants used sterile diluent to dilute ACTHIB instead of the diluent that come...
one of the medical assistants used sterile diluent to dilute ACTHIB instead of the diluent that comes with the vaccine with no reported adverse event; Initial information received on 29-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 9-month-old male patient and is reported one of the medical assistants used sterile diluent to dilute HIB (PRP/T) Vaccine [ACT-HIB] instead of the diluent that comes with the vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis b vaccine (Hep b vax) for Immunisation. On 29-Jul-2025 at 08:55 hour, the patient received a 0.5 ml (dose 3) of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection of lot UK093AB and expiry date: 30-Sep-2025 via intramuscular route in the left thigh Frequency: once, Strength: standard for Immunization and one of the medical assistants used sterile diluent to dilute acthib instead of the diluent that comes with the vaccine with no reported adverse event (product preparation error) (latency: on same day) . 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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| 2852128 | 0.5 | M | GA | 07/31/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK038AA |
Expired product administered
Expired product administered
|
expired PENTACEL was administered to a patient, with no reported adverse event; Initial information ...
expired PENTACEL was administered to a patient, with no reported adverse event; Initial information received on 30-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6-month-old male patient whom expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was administered to a patient, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided, no other immunizations. On 30-Jul-2025, the patient received a 0.5 ml dose (dose 1) of expired suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Powder and suspension for suspension for injection of lot UK038AA and expiry date: 30-Jun-2025 via intramuscular route in the right deltoid, Frequency: once, Strength: standard for immunization with no reported adverse event (expired product administered) (latency: on same day). 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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| 2852129 | 4 | F | MN | 07/31/2025 |
IPV |
SANOFI PASTEUR |
785555 |
No adverse event, Underdose
No adverse event, Underdose
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child was given 4.0 ml of IPOL rather than the usual 0.5 ml, with no reported adverse event; Initial...
child was given 4.0 ml of IPOL rather than the usual 0.5 ml, with no reported adverse event; Initial information received on 30-Jul-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 4 years old female patient who received 4.0 ml of IPV (VERO) [IPOL] rather than the usual 0.5 ml, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Measles vaccine live (Enders-Edmonston), Mumps vaccine live (Jeryl Lynn), Rubella vaccine live (Wistar RA 27/3), Varicella zoster vaccine live (Oka/Merck) [Proquad] for Immunisation. On 30-Jul-2025, the patient received 4 ml of dose 3 of IPV (VERO) Suspension for injection (strength- unknown, expiry date- 31-Oct-2026 and lot 785555) via unknown route in the thigh NOS (not otherwise specified) for Immunization rather than the usual 0.5 ml, with no reported adverse event (extra dose administered) (latency- same day). 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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| 2852131 | 49 | F | NY | 07/31/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
7mn4c |
Pain in extremity
Pain in extremity
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While speaking to patient on the phone, patient expressed soreness in arm from Bexsero Vaccine recei...
While speaking to patient on the phone, patient expressed soreness in arm from Bexsero Vaccine received today.
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| 2852132 | 12 | M | GA | 07/31/2025 |
DTAP HPV9 MNQ |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS |
Y7JC3 Y012865 343DD |
No adverse event, Wrong product administered; No adverse event, Wrong product ad...
No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered
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Patient was administered a DTaP (Infanrix), which is the wrong vaccine given to patient. The vaccine...
Patient was administered a DTaP (Infanrix), which is the wrong vaccine given to patient. The vaccine that was supposed to be administered was a Tdap. Patient was not harmed and had no reaction to vaccine administered.
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| 2852145 | 86 | F | 07/31/2025 |
PNC20 |
PFIZER\WYETH |
LP4948 |
Extra dose administered
Extra dose administered
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Immunization was given already in 2023 and then again in 2025
Immunization was given already in 2023 and then again in 2025
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| 2852146 | 12 | F | VA | 07/31/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
37R35 |
Syncope
Syncope
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Patient experienced brief syncope while sitting following administration of vaccine with immediate r...
Patient experienced brief syncope while sitting following administration of vaccine with immediate recovery. No reported adverse effect after additional 15 minute observation period.
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| 2852147 | 63 | F | CA | 07/31/2025 |
PNC20 |
PFIZER\WYETH |
LN4931 |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
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Patient came to the pharmacy to report reaction to Prevnar 20 shot. She showed the immunization sit...
Patient came to the pharmacy to report reaction to Prevnar 20 shot. She showed the immunization site, and it was very large red patch. She said it initially hurt and felted heated. Next day, it was itching. Itchiness has calm down but the site got even redder today. The redness is the size of an orange and looks inflammed.
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| 2852148 | 34 | F | OR | 07/31/2025 |
ANTH ANTH ANTH ANTH ANTH ANTH |
EMERGENT BIOSOLUTIONS EMERGENT BIOSOLUTIONS EMERGENT BIOSOLUTIONS EMERGENT BIOSOLUTIONS EMERGENT BIOSOLUTIONS EMERGENT BIOSOLUTIONS |
Un known lot # Un known lot # Unknown Unknown |
Diabetic neuropathy, Endometrial ablation, Female sterilisation, Impaired gastri...
Diabetic neuropathy, Endometrial ablation, Female sterilisation, Impaired gastric emptying, Intensive care; Laboratory test, Type 1 diabetes mellitus, Weight decreased; Diabetic neuropathy, Endometrial ablation, Female sterilisation, Impaired gastric emptying, Intensive care; Laboratory test, Type 1 diabetes mellitus, Weight decreased; Diabetic neuropathy, Endometrial ablation, Female sterilisation, Impaired gastric emptying, Intensive care; Laboratory test, Type 1 diabetes mellitus, Weight decreased
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After the last dose of my anthrax vaccine series I became a type 1 diabetic and then my other condit...
After the last dose of my anthrax vaccine series I became a type 1 diabetic and then my other conditions soon followed. I am 43 now and just got out of ICU after a week there. Doctors were lost trying to figure me out but got me stable enough to come home. I am still having issues and as time goes I feel as if I get worst. I am a very active individual that lives a healthy lifestyle. I've tried with the Veterans Affairs to help me with Vaccine injury but I can't seem to get any help. I don't feel I have much life in me I just lost 10 pounds and hope to recover soon before I have another episode.
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โ | โ | ||||
| 2852149 | 58 | F | CA | 07/31/2025 |
PNC20 |
PFIZER\WYETH |
LX4483 |
Injection site erythema, Injection site warmth, Pyrexia
Injection site erythema, Injection site warmth, Pyrexia
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Fever 2-3 days. Fever stopped 1-2 days. Fever returned days 2 days. Redness and warmth at injection...
Fever 2-3 days. Fever stopped 1-2 days. Fever returned days 2 days. Redness and warmth at injection site 7 days later.
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| 2852150 | 17 | F | CO | 07/31/2025 |
FLU3 MENB MNQ |
SANOFI PASTEUR PFIZER\WYETH SANOFI PASTEUR |
u8790aa ll0637 u8494aa |
Fall, Head injury, Imaging procedure, Loss of consciousness, Presyncope; Fall, H...
Fall, Head injury, Imaging procedure, Loss of consciousness, Presyncope; Fall, Head injury, Imaging procedure, Loss of consciousness, Presyncope; Fall, Head injury, Imaging procedure, Loss of consciousness, Presyncope
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Pt fell from chair after immunization given, hit her forehead. her body jerked a couple of times and...
Pt fell from chair after immunization given, hit her forehead. her body jerked a couple of times and then she regained consciousness after 10 seconds. Pt was fully aware within seconds of reawakening, not postictal, remembered the vaccination being administered. EMS was called to site for evaluation, mom was at pt's side the entire time. After evaluation by EMS. Mom acknowledged concern for life-threatening risk d/t her head injury, and agreed to take the pt directly to the ER for full evaluation. Pt left via ambulation with a steady gait accompanied by her mother. Mother drove her to a nearby ER. Later spoke with mom over the phone and they said she was evaluated in ER for head injury, no apparent TBI or brain bleed/swelling. Pt discharged home to follow up with Neuro. It was believed to be a vasovagal event
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| 2851724 | WA | 07/30/2025 |
MMRV |
MERCK & CO. INC. |
Y004545 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AEs were reported,; a patient received improperly stored vaccine.; This spontaneous re...
No additional AEs were reported,; a patient received improperly stored vaccine.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided. On 10-JUL-2025, the patient was vaccinated with 1 dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) solvent for solution for injection as prophylaxis and was improperly store (product storage error) (dose, route and anatomical site of administration (lot # Y004545 has been determined valid, expiration date reported and validated as 19-AUG-2025) by a health professional. The product was reconstituted with its sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date not provided). It was reported the vaccine was storage with a temperature: -9.6C for a time frame: 40 minutes. No previous temperature excursion. No additional adverse events (AE) no further information provided.
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| 2851725 | CA | 07/30/2025 |
HPV9 |
MERCK & CO. INC. |
Z005469 |
Skin laceration, Syringe issue
Skin laceration, Syringe issue
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Office did report the HCP involved did have a slight cut on a finger due to this break; occupational...
Office did report the HCP involved did have a slight cut on a finger due to this break; occupational exposure; Syringe broken; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the healthcare who was involved in administration of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) lot #Z005469, expiration date: 27-Feb-2026 (strength, dose, dose number, route and anatomical location were not provided) with a syringe broke for prophylaxis had a slight cut on a finger due to this break (Limb injury and occupational exposure). At the reporting time, the outcome limb injury of was not provided. The causal relationship between the event of limb injury and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided. This is one of two reports from the same reporter. This case was considered invalid due to lack of patients' identifiers.
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| 2851726 | F | 07/30/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Chills, Fatigue, Myalgia, Pyrexia
Chills, Fatigue, Myalgia, Pyrexia
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fever; chills; fatigue; muscle soreness; This non-serious case was reported by a pharmacist via sale...
fever; chills; fatigue; muscle soreness; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of fever in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: fever), chills (Verbatim: chills), fatigue (Verbatim: fatigue) and muscle soreness (Verbatim: muscle soreness). The outcome of the fever, chills, fatigue and muscle soreness were resolved. The reporter considered the fever, chills, fatigue and muscle soreness to be related to Shingrix. The company considered the fever, chills, fatigue and muscle soreness to be related to Shingrix. Additional Information: GSK Receipt Date: 21-JUL-2025 The patient reported that after receiving Shingrix this past year and 0 side effects with the first shot, but activity of daily living adverse events with shot 2, citing fever, fatigue, chills, myalgias. No complicating diagnosis and side effects resolved.
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| 2851735 | 18 | M | 07/30/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Unevaluable event
Unevaluable event
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I just want to know if they are FDA accredited because when I check They are not vaccine accredited ...
I just want to know if they are FDA accredited because when I check They are not vaccine accredited or allowed to administer vaccination.
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| 2851759 | 68 | M | OH | 07/30/2025 |
COVID19 |
PFIZER\BIONTECH |
EN6203 |
Aggression, Speech disorder, Syncope
Aggression, Speech disorder, Syncope
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Reported Symptoms: 10001488:AGGRESSION; 10001497:AGITATION; 10041469:SPEECH IMPAIRMENT NOS; 10042772...
Reported Symptoms: 10001488:AGGRESSION; 10001497:AGITATION; 10041469:SPEECH IMPAIRMENT NOS; 10042772:SYNCOPE; Narrative: Patient has PMH of having a stroke, suspected seizure (on seizure med because of it), stenosis of carotids (yearly ultrasound), and per CT large area of encephalomalacia is seen in the left frontal lobe. The symptoms listed here were patient was admitted to hospital around April 9, 2021 are being attributed to March 15, 2021 covid-19 injection (2nd shot, both by pfizer). This is farther out than normal adr of syncope is listed in the literature for this vaccine. Other Relevant HX: Other: SPEECH IMPAIRMENT; SYNCOPE; PHYSICAL AGGRESSION
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| 2851760 | 70 | M | OH | 07/30/2025 |
FLUX |
UNKNOWN MANUFACTURER |
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Lung disorder, Oropharyngeal pain, Pleurisy
Lung disorder, Oropharyngeal pain, Pleurisy
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Reported Symptoms: 10035618: PLEURISY; 1004137: SORE THROAT; 10051054: LUNG DISEASE; Narrative: Othe...
Reported Symptoms: 10035618: PLEURISY; 1004137: SORE THROAT; 10051054: LUNG DISEASE; Narrative: Other Relevant HX: Other: Sorethroat followed by pleurisy with lung damage over the next few months
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| 2851761 | 42 | M | OH | 07/30/2025 |
COVID19 |
PFIZER\BIONTECH |
FG3527 |
Headache
Headache
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Reported Symptoms: 10019211:HEADACHE; Narrative: Other Relevant HX: Other: HEADACHE
Reported Symptoms: 10019211:HEADACHE; Narrative: Other Relevant HX: Other: HEADACHE
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| 2851762 | M | OH | 07/30/2025 |
FLUX |
UNKNOWN MANUFACTURER |
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Rash
Rash
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Reported Symptoms: 10037844: Rash; Narrative: Other Relevant HX: Other: RASH
Reported Symptoms: 10037844: Rash; Narrative: Other Relevant HX: Other: RASH
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| 2851763 | 36 | M | WI | 07/30/2025 |
COVID19 |
MODERNA |
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Tachycardia
Tachycardia
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Reported Symptoms: 10043071:TACHYCARDIA; Narrative: Other Relevant HX: Other: TACHYCARDIA
Reported Symptoms: 10043071:TACHYCARDIA; Narrative: Other Relevant HX: Other: TACHYCARDIA
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| 2851764 | 72 | M | WI | 07/30/2025 |
FLUX |
UNKNOWN MANUFACTURER |
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Dyspnoea
Dyspnoea
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Reported Symptoms: 10013963:DDYSPNEA; Narrative: Other Relevant HX: Other: DYSPNEA.
Reported Symptoms: 10013963:DDYSPNEA; Narrative: Other Relevant HX: Other: DYSPNEA.
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| 2851765 | M | WI | 07/30/2025 |
BCG |
UNKNOWN MANUFACTURER |
|
Anaphylactic reaction
Anaphylactic reaction
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Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: Other Relevant HX: Other: ANAPHYLAXIS
Reported Symptoms: 10002218:ANAPHYLAXIS; Narrative: Other Relevant HX: Other: ANAPHYLAXIS
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| 2851766 | M | OH | 07/30/2025 |
FLUX |
UNKNOWN MANUFACTURER |
|
Influenza like illness
Influenza like illness
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Reported Symptoms: 10016797: FLU-LIKE SYMPTOMS; Narrative: Other Relevant HX: other: INFLUENZA-LIKE ...
Reported Symptoms: 10016797: FLU-LIKE SYMPTOMS; Narrative: Other Relevant HX: other: INFLUENZA-LIKE ILLNESS
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| 2851767 | 48 | M | WY | 07/30/2025 |
COVID19 |
MODERNA |
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Cellulitis
Cellulitis
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Reported Symptoms: 10007882:CELLULITIS; Narrative: Other Relevant HX: Other: CELLULITIS
Reported Symptoms: 10007882:CELLULITIS; Narrative: Other Relevant HX: Other: CELLULITIS
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| 2851768 | M | WI | 07/30/2025 |
COVID19 COVID19 COVID19 |
JANSSEN JANSSEN JANSSEN |
1802070 1802070 1802070 |
Coronary artery disease, Depression, Haematocrit decreased, Haemoglobin decrease...
Coronary artery disease, Depression, Haematocrit decreased, Haemoglobin decreased, Hyperlipidaemia; Hypertension, Platelet count normal, Pyrexia, Type 2 diabetes mellitus, White blood cell count increased; Wound closure
More
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Reported Symptoms: 10016558:FEVER; Narrative: Patient was a 73 y/o with hx of follicular lymphoma un...
Reported Symptoms: 10016558:FEVER; Narrative: Patient was a 73 y/o with hx of follicular lymphoma undergoing R-CHOP who was admitted and given COVID-19 vaccine. Patient experienced fevers (which occurred prior to vaccination) that continued with chemotherapy. Since fevers lasted several weeks, provider entered as adverse reaction. Other Relevant HX: Patient also received R-CHOP chemotherapy on 3/5/2021. Patient was admitted to the hospital 3/5/2021 until 3/21/2021. At time of admission, patient presented with subacute onset fevers and night sweats (and actually received vaccine following admission, so additional factors likely contributed to noted ADR of fevers). The following was indicated on patient's discharge summary: SECONDARY DISCHARGE DIAGNOSES: - Right groin abscess s/p I&D (02/25/2021) with wound vac (removed 3/22/21) - Type 2 diabetes mellitus compounded by steroid-induced hyperglycemia - Hypertension - Hyperlipidemia - Coronary artery disease - Depression - Fever, unspecified Other: FEVER
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| 2851820 | TX | 07/30/2025 |
VARCEL |
MERCK & CO. INC. |
Z003882 |
No adverse event, Product storage error
No adverse event, Product storage error
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Medical Assistant calling to report inadvertently administering VARIVAX vaccine after experiencing a...
Medical Assistant calling to report inadvertently administering VARIVAX vaccine after experiencing a temperature excursion. Products were supported. See TE Case# 02834802 filed. Permission to contact HCP was granted. Caller stated they will contact M; No additional AE; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Z005233, expiration date: 27-Feb-2027). On an unknown date, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Z003882, expiration date: 03-Feb-2027). On an unknown date, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported). The patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), for the treatment of prophylaxis. The patient started therapy with sterile diluent (MERCK STERILE DILUENT), for the treatment of prophylaxis. On an unknown date, the patient experienced No additional AE. On an unknown date, the patient experienced Medical Assistant calling to report inadvertently administering VARIVAX vaccine after experiencing a temperature excursion. Products were supported. See TE Case# 02834802 filed. Permission to contact HCP was granted. Caller stated they will contact M. At the reporting time, the outcome of No additional AE and Medical Assistant calling to report inadvertently administering VARIVAX vaccine after experiencing a temperature excursion. Products were supported. See TE Case# 02834802 filed. Permission to contact HCP was granted. Caller stated they will contact M was unknown. The action taken with Varicella Virus Vaccine Live (Oka-Merck) and sterile diluent was reported as not applicable. Follow-up information was received from a medical assistant and refers to a patient of unknown age and gender. The patient's initials were updated hence the case is no longer considered to be invalid. Concomitant therapies additionally included measles, mums and rubella vaccine (MMR II). It was specified that the patient was inadvertently vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Z003882, expiration date: 03-Feb-2027) after experiencing a temperature excursion os -13.3 C in time frame of 144 hours 0 minutes and 0 seconds (product storage error). The vaccine was reconscituted with sterile diluent solution for injection (MERCK STERILE DILUENT) (lot # and expiration date was not provided). No previous temperature excursion was noted.
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| 2851821 | TX | 07/30/2025 |
VARCEL |
MERCK & CO. INC. |
Z005233 |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
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Medical Assistant calling to report inadvertently administering VARIVAX vaccine after experiencing a...
Medical Assistant calling to report inadvertently administering VARIVAX vaccine after experiencing a temperature excursion.; No additional AE; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) . On an unknown date, the patient was inadvertently vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (valid lot #Z005233, expiration date: 27-Feb-2027) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided) after experiencing a temperature excursion of -13.3C in time frame of 144 hours 0 minutes and 0 seconds (product storage error). No previous temperature excursion was noted. No additional adverse event (AE) was reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-07-10 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : Patient 2 , Central date : 2025-07-10 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
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| 2851822 | TX | 07/30/2025 |
VARCEL |
MERCK & CO. INC. |
Z003882 |
No adverse event, Product storage error
No adverse event, Product storage error
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Medical Assistant calling to report inadvertently administering VARIVAX vaccine after experiencing a...
Medical Assistant calling to report inadvertently administering VARIVAX vaccine after experiencing a temperature excursion.; No additional AE; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) . On an unknown date, the patient was inadvertently vaccinated with Varicella Virus Vaccine Live (Oka- Merck) (VARIVAX), (invalid lot # Z003882, expiration date: 02-MAR-2027) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided) after experiencing a temperature excursion of -13.3C in time frame of 144 hours 0 minutes and 0 seconds (product storage error). No previous temperature excursion was noted. No additional adverse event (AE) was reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user :, Index date : 2025-07-10 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : Patient 4 , Central date : 2025-07-10 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
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| 2851823 | TX | 07/30/2025 |
VARCEL |
MERCK & CO. INC. |
Z003882 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE; Medical Assistant calling to report inadvertently administering VARIVAX vaccine af...
No additional AE; Medical Assistant calling to report inadvertently administering VARIVAX vaccine after experiencing a temperature excursion.; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) . On an unknown date, the patient was inadvertently vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (valid lot #Z003882, expiration date: 03-Feb-2027) as prophylaxis after experiencing temperature excursion of -13.3 C in time frame of 144 hours 0 minutes 0 seconds (product storage error). No previous temperature excursion was noted. The vaccine was reconscituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date was not reported).; Sender's Comments: Priority : 5 , Is case serious : No , Index user :, Index date : 2025-07-10 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : Patient 3 , Central date : 2025-07-10 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
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| 2851824 | TX | 07/30/2025 |
HPV9 |
MERCK & CO. INC. |
Y015179 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE/no PQC; experienced two temperature excursions; This spontaneous report was receive...
No additional AE/no PQC; experienced two temperature excursions; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, current conditions and concomitant therapies was not reported. On an unspecified date in 2025, the patient was vaccinated with an improper storage dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) as prefilled syringe formulation, at a dose of 0.5ml (lot #Y015179 who had been verified to be a valid lot number, expiration date reported and validated as 28-JAN-2027). The vaccine was administered as prophylaxis. On 14-JUL-2025, the vaccine experienced two temperature excursions. Temperature reported 47.3F with a time frame of 0 hours 50 minutes and 24 seconds, there was a previous temperature excursion of 47.5F for 0 hours 36 minutes and 51 seconds (Product storage error). No additional adverse event.
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| 2851826 | KY | 07/30/2025 |
VARCEL |
MERCK & CO. INC. |
Y006523 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE; Pharmacist calling to report inadvertently administering VARIVAX to patients after...
No additional AE; Pharmacist calling to report inadvertently administering VARIVAX to patients after a temperature excursion. Caller stated VARIVAX vaccine was "issued" to the facility on 8/9/2024 and was inadvertently stored in the refrigerated throughout administrat; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 13-Nov-2024, the patient was inadvertently vaccinated with improper stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), lot #Y006523, expiration date: 25-Mar-2026 (formulation, exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). It was reported that Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) vaccine was "issued" to the facility on 09-Aug-2024 and was inadvertently stored in the refrigerated throughout administrations. Administered dose of vaccine was exposed to the temperature excursion from 2 to 8 degrees Celsius (product storage error). No additional adverse event reported (no adverse event).
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| 2851827 | VA | 07/30/2025 |
MMRV |
MERCK & CO. INC. |
Z003309 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE/No PQC reported; HCP reporting that a patient received a dose of improperly stored ...
No additional AE/No PQC reported; HCP reporting that a patient received a dose of improperly stored PROQUAD. Reference TE case #02843001. HCP reported that she did not know the date the excursion occurred, but knows the PROQUAD was administered following the excursion. HCP reported; This spontaneous report was received from a 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 17-Jun-2025, the patient was vaccinated with improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), lot #Z003309, expiration date: 21-Jul-2026, 0.5 mL (formulation, route of administration and anatomical location were not provided). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). Administered dose of vaccine was exposed to the temperature excursion of 52.2 degrees Fahrenheit (product storage error). No symptoms or side effects were reported (no adverse event).
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| 2851828 | VA | 07/30/2025 |
MMRV |
MERCK & CO. INC. |
Z003309 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE/No PQC reported; HCP reporting that a patient received a dose of improperly stored ...
No additional AE/No PQC reported; HCP reporting that a patient received a dose of improperly stored PROQUAD. Reference TE case #02843001. HCP reported that she did not know the date the excursion occurred, but knows the PROQUAD was administered following the excursion. HCP reported; This spontaneous report was received from a 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 15-Jul-2025, the patient was vaccinated with improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), lot #Z003309, expiration date: 21-Jul-2026, 0.5 mL (0.5mL) (formulation, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). Administered dose of vaccine was exposed to the temperature excursion of 52.2 degrees Fahrenheit (product storage error). No symptoms or side effects were reported (no adverse event).
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| 2851829 | VA | 07/30/2025 |
MMRV |
MERCK & CO. INC. |
Y019173 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE/No PQC; a patient received a dose of improperly stored PROQUAD.; This spontaneous r...
No additional AE/No PQC; a patient received a dose of improperly stored PROQUAD.; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 18-Jul-2025, the patient was vaccinated with an improperly stored dose of measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot #Y019173, expiration date: 18-May-2026, 0.5 mL (strength, dose number, route and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (no details provided). The temperature excursion was: Temperature: 52.2๏ฟฝF, Time frame: Unknown, previous temperature excursion: not provided. No adverse events reported.
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| 2851830 | VA | 07/30/2025 |
VARCEL |
MERCK & CO. INC. |
Y019318 |
No adverse event, Product storage error
No adverse event, Product storage error
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No symptoms or side effects were reported; patient received a dose of improperly stored VARIVAX; Thi...
No symptoms or side effects were reported; patient received a dose of improperly stored VARIVAX; This spontaneous report was received from a healthcare professional and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 16-Jun-2025, the patient was vaccinated with a dose of improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (0.5ml, lot #Y019318, expiration date: 21-Nov-2026; route of administration, dose number in series and anatomical site were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent(MERCK STERILE DILUENT). The temperature excursion was 52.2 Fahrenheit degrees for unknown duration. The healthcare professional reported that she did not know the date the excursion occurred, but knows the Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was administered following the excursion. There was no previous temperature excursion. No adverse effects reported.
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| 2851831 | VA | 07/30/2025 |
MMRV |
MERCK & CO. INC. |
Z003309 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE; a patient received a dose of improperly stored PROQUAD; This spontaneous report wa...
No additional AE; a patient received a dose of improperly stored PROQUAD; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 25-JUN-2025, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (lot # Z003309, expiration date was not provided, but upon internal validation was established as 21-JUL-2026) (0.5mL; dose number, strength, formulation, route and anatomical site were unknown) for prophylaxis, which was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (indication, expiration date, and lot # were not reported) (product storage error). No additional adverse event (no adverse event). The storage temperature of the vaccine was reported as 52.2 degrees Fahrenheit (F) for an unknown time frame. The previous temperature excursion was reported as not applicable. The outcome of the events was unknown.
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| 2851832 | 11 | F | GA | 07/30/2025 |
HPV9 |
MERCK & CO. INC. |
|
Anxiety, Dizziness
Anxiety, Dizziness
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lightheadedness; anxiety; This spontaneous report was received from a nurse on 24-Jul-2025, referrin...
lightheadedness; anxiety; This spontaneous report was received from a nurse on 24-Jul-2025, referring to a 11-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 24-Jul-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), administered by intramuscular route (lot # and expiration date were not reported) as prophylaxis of human papillomavirus (HPV). On 24-Jul-2025, the patient experienced anxiety and lightheadedness. The reporter believed that vaccination caused anxiety and lightheadedness was due to anxiety. She made a full recovery after 20 minutes of incident. The patient recovered from the events on that day. It is unknown if patient received their full doses. The action taken with human papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was reported as not applicable. The reporter considered the events to be related to Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9).
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| 2851833 | F | TX | 07/30/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Blister
Blister
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Blisters; This serious case was reported by a physician via sales rep and described the occurrence o...
Blisters; This serious case was reported by a physician via sales rep and described the occurrence of blister in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 15-MAY-2025, the patient received Shingles vaccine (left deltoid). On 15-MAY-2025, less than a day after receiving Shingles vaccine, the patient experienced blister (Verbatim: Blisters) (serious criteria other: serious as per reporter). The outcome of the blister was not resolved. The reporter considered the blister to be related to Shingles vaccine. The company considered the blister to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 15-MAY-2025 The patient had blisters after received a subsequent dose of Shingles vaccine. It persisted and tended to spread to additional areas. No other products were received by the patient.; Sender's Comments: A case of Blister, less than a day after receiving Shingles vaccine, in a female patient. Based on the available information, a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
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| 2851834 | M | 07/30/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Headache, Injection site pain, Pain
Headache, Injection site pain, Pain
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Headache; Injection site pain; Body aches; This non-serious case was reported by a consumer and desc...
Headache; Injection site pain; Body aches; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included major depression, mood disorder, normal thyroid function, hypogonadism male and insomnia. Concomitant products included venlafaxine, desvenlafaxine succinate monohydrate (Pristiq), quetiapine fumarate (Seroquel), testosterone cipionate and levothyroxine. On 15-JUL-2025, the patient received Shingrix. On 15-JUL-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain) and general body pain (Verbatim: Body aches). On 16-JUL-2025, the patient experienced headache (Verbatim: Headache). The outcome of the injection site pain, general body pain and headache were not resolved. It was unknown if the reporter considered the injection site pain, general body pain and headache to be related to Shingrix. It was unknown if the company considered the injection site pain, general body pain and headache to be related to Shingrix. Additional Information: GSK Receipt Date: 16-JUL-2025 The reporter reported that the patient received Shingrix vaccine and experienced injection site pain, headache, body ache and was using gym equipment 6 hours after injection. The symptoms were treated.
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| 2851835 | 30 | F | TX | 07/30/2025 |
HPV9 |
MERCK & CO. INC. |
Z005469 |
Abdominal distension, Menstruation irregular, Migraine, Muscle spasms
Abdominal distension, Menstruation irregular, Migraine, Muscle spasms
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Irregular menstrual bleeding that began 7/22/25 and has persisted at the time of this form's co...
Irregular menstrual bleeding that began 7/22/25 and has persisted at the time of this form's completion. Saturates approximately 2 pads/day. Migraine for 48 hours began 7/23/25. Cramping and bloating 7/23/25-7/26/25.
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| 2851836 | 1 | F | IN | 07/30/2025 |
MMR |
MERCK & CO. INC. |
|
Pyrexia, Vomiting
Pyrexia, Vomiting
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Vomiting and fever
Vomiting and fever
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| 2851837 | 1.5 | M | PA | 07/30/2025 |
VARCEL |
MERCK & CO. INC. |
Z005233 |
Pyrexia
Pyrexia
|
Fevers over 100.4F for 5+ days. Tylenol administered by parents
Fevers over 100.4F for 5+ days. Tylenol administered by parents
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| 2851838 | 38 | F | 07/30/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
2G3S9 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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The final Bexsero dose (3rd dose) was administered about 5 days too early.
The final Bexsero dose (3rd dose) was administered about 5 days too early.
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