| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2840868 | 51 | M | AZ | 05/13/2025 |
SMALLMNK |
BAVARIAN NORDIC |
FDP00016 |
No adverse event
No adverse event
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The treatment was the second of a two-series vaccination; the outcome was uneventful, with no sympto...
The treatment was the second of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reactions reported.
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| 2840869 | 53 | M | AZ | 05/13/2025 |
SMALLMNK |
BAVARIAN NORDIC |
FDP00015 |
No adverse event
No adverse event
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The treatment was the second of a two-series vaccination; the outcome was uneventful, with no sympto...
The treatment was the second of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
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| 2840870 | 1.25 | M | TN | 05/13/2025 |
VARCEL |
MERCK & CO. INC. |
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Pyrexia, Rash vesicular
Pyrexia, Rash vesicular
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Sustained fever over 103 for multiple days, chickenpox rash
Sustained fever over 103 for multiple days, chickenpox rash
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| 2840871 | 21 | M | AZ | 05/13/2025 |
SMALLMNK |
BAVARIAN NORDIC |
FDP000015 |
No adverse event
No adverse event
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The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptom...
The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
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| 2840872 | 28 | M | AZ | 05/13/2025 |
SMALLMNK |
BAVARIAN NORDIC |
FDP00016 |
No adverse event
No adverse event
|
The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptom...
The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
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| 2840873 | 72 | F | SD | 05/13/2025 |
PNC21 PNC21 VARZOS VARZOS |
MERCK & CO. INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
Y019157 Y019157 EK225 EK225 |
Fatigue, Injection site erythema, Injection site pain, Injection site swelling, ...
Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Pain; Rash; Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Pain; Rash
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PATIENT DESCRIBED REDNESS, SWELLING, SOARNESS AT INJECTION SITE. PATIENT STATES RASH ALL OVER FRONT ...
PATIENT DESCRIBED REDNESS, SWELLING, SOARNESS AT INJECTION SITE. PATIENT STATES RASH ALL OVER FRONT OF CHEST, FATIGUE, PAIN ALL OVER BODY. BUT BREATHING IS FINE, PATIENT DID NOT TAKE ANY OTC ANTIHISTAMINE OR PAIN RELEIVERS. WE ADVISED PATIENT TO TAKE BENADRYL AND TYLENOL OR ADVIL FOR PAIN. WE WILL CHECK UP ON HER IN A DAY; BUT ADVISED HER TO SEEK EMERGENCY/911 HELP IF SHE HAS ANY BREATHING OR SEVER PAIN ANYWHERE TONIGHT.
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| 2840874 | 68 | F | TX | 05/13/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Endometrial cancer, Hypoaesthesia, Immediate post-injection reaction, Influenza ...
Endometrial cancer, Hypoaesthesia, Immediate post-injection reaction, Influenza like illness, Pain in extremity; Postmenopausal haemorrhage, Pyrexia, Swollen tongue, Uterine mass
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Immediate reaction. My tongue started to swell so they had someone come and take my vitals. They had...
Immediate reaction. My tongue started to swell so they had someone come and take my vitals. They had me pull over and wait there for 30 minutes until they felt I was fine. Then, my arm began to feel numb and it hurt for another month. I also had flu-like symptoms (including fever) for 2 nights. Most importantly though, I started experiencing intermittent post-menopausal bleeding. Several months ago, I was diagnosed with endometrial cancer. I strongly suspect a relationship.
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โ | โ | ||||
| 2840875 | 18 | M | TN | 05/13/2025 |
HEP MNQ |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR |
4BX39 U8438AA |
Incorrect dose administered; Incorrect dose administered
Incorrect dose administered; Incorrect dose administered
|
Patient was given adult dose of Hep B vaccine but should have been the pediatric vaccine since he is...
Patient was given adult dose of Hep B vaccine but should have been the pediatric vaccine since he is 18. Attempted to contact patient but no answer. VM was left with patient to follow up with clinic. He has not contacted clinic with any side effects at this time.
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| 2840877 | 60 | F | IL | 05/13/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EP6955 EP6955 EP6955 EP6955 |
Bradykinesia, Dysarthria, Dysphonia, Electromyogram, Fatigue; Genetic testing, I...
Bradykinesia, Dysarthria, Dysphonia, Electromyogram, Fatigue; Genetic testing, Immediate post-injection reaction, Laboratory test, Loss of personal independence in daily activities, Magnetic resonance imaging; Muscular weakness, Musculoskeletal disorder, Nerve conduction studies, Neurological symptom, Pain; Slow speech, Ventilation/perfusion scan, Walking aid user, Wheelchair user
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My speech, walk, and arm strength were weaker and slower from the moment the 2nd shot went in my arm...
My speech, walk, and arm strength were weaker and slower from the moment the 2nd shot went in my arm. I went from playing tennis 3 times a week to my legs crossing in front of me and almost tripping me and my speech slurring. I can no longer speak in a clear and concise tone. I have to use a walker & wheelchair to get around. I need help to wash myself, get out of bed, and go to the bathroom. I experience fatigue and pain on a daily basis. I exhibit signs of ALS.
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| 2840372 | F | 05/12/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Immune system disorder, Nervous system disorder
Immune system disorder, Nervous system disorder
|
she has neuro and immune problems; she has neuro and immune problems; This non-serious case was repo...
she has neuro and immune problems; she has neuro and immune problems; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of immune disorder (nos) in a female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced immune disorder (nos) (Verbatim: she has neuro and immune problems) and neurological disorder nos (Verbatim: she has neuro and immune problems). The outcome of the immune disorder (nos) and neurological disorder nos were not reported. It was unknown if the reporter considered the immune disorder (nos) and neurological disorder nos to be related to Pediarix and Pediarix Pre-Filled Syringe Device. It was unknown if the company considered the immune disorder (nos) and neurological disorder nos to be related to Pediarix and Pediarix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 30-APR-2025 The patient's parents reported this case. The patient (daughter) received Pediarix and stated that she was convinced it's why she had neuro and immune problems. The reporter loved to see more data comparing them to other schedules and they all were toxic, but there's something up with GSK
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| 2840373 | 05/12/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Blepharitis, Eye inflammation, Herpes zoster, Photophobia, Vaccination failure
Blepharitis, Eye inflammation, Herpes zoster, Photophobia, Vaccination failure
|
Suspeceted vaccination failure; I had an outbreak of shingles on my forehead and face on the left s...
Suspeceted vaccination failure; I had an outbreak of shingles on my forehead and face on the left side/Not shingles in the eye, but inflammation of the eye due to inflammation of the eye lid; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included covid-19 (had Covid 3 times). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: I had an outbreak of shingles on my forehead and face on the left side/Not shingles in the eye, but inflammation of the eye due to inflammation of the eye lid). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was resolving. It was unknown if the reporter considered the vaccination failure and facial herpes zoster to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the facial herpes zoster to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 02-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had finally getting better after an outbreak of shingles on his/her forehead and face on the left side. The patient mentioned that it had been one solid month of hell. The patient reported that it involved his/her left eye it was not shingles in the eye, but inflammation of the eye due to inflammation of the eyelid. The patient still could not go outside on a sunny day without sunglasses inserts behind his/her regular glasses. This anti-vaccine person had certainly changed his views. The patient reported that by all means, he/she recommended getting the shingles vaccine. He/she also went back to getting the flu shot. The vaccine never hurt him/her. Some years it just worked better than other years.He/she never had a negative reaction to it. The patient reported that let him/her put it this way, he/she would not had made a very good spokesman for the antivaccine crowd. He/she would never argue with anyone ever again on vaccines. That had to be a personal choice weighing any potential side effects with potential benefit. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of facial herpes zoster were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2840374 | 05/12/2025 |
FLUR4 |
PROTEIN SCIENCES CORPORATION |
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Vaccination failure
Vaccination failure
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During the market research interview participant mentioned that Flublok was seen to not to be as eff...
During the market research interview participant mentioned that Flublok was seen to not to be as efficacious as it was before; Initial information received on 22-Apr-2025 regarding an unsolicited valid serious case received from a other health professional. This case involves market research interview participant mentioned that Influenza quadrivalent recombinant vaccine [Flublok QIV] was seen to not to be as efficacious as it was before. 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 Influenza quadrivalent recombinant vaccine (lot number, formulation and strength-unknown) via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation) and was seen to not to be as efficacious as it was before (Suspected clinical vaccine failure). Action taken was not applicable. Seriousness Criteria-The event is assessed as medically significant.; Sender's Comments: Sanofi company comment dated 29-APR-2025: This case involves market research interview participant mentioned that Influenza quadrivalent recombinant vaccine [Flublok QIV] was seen to not to be as efficacious as it was before. Further information regarding regarding allergic history, medical history, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
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| 2840375 | 31 | F | WA | 05/12/2025 |
FLU3 |
SANOFI PASTEUR |
U8442BA |
No adverse event, Product storage error
No adverse event, Product storage error
|
Max/low temperature reached: 8.5 ๏ฟฝC to 8.8 ๏ฟฝCDuration: 30 minutes with no reported adverse event...
Max/low temperature reached: 8.5 ๏ฟฝC to 8.8 ๏ฟฝCDuration: 30 minutes with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to US-SA-2025SA112035 (Master case) This case involves a 31 years old female patient who received influenza USP TRIVAL A-B subvirion vaccine [Fluzone] which was exposed to temperature excursion where max/low temperature reached: 8.5 ๏ฟฝc to 8.8 ๏ฟฝc duration: 30 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Apr-2025, influenza USP TRIVAL A-B subvirion vaccine [Fluzone] Suspension for injection (once) (strength- standard, expiry date- 20-Jun-2025and lot U8442BA) for Influenza immunisation was exposed to temperature excursion where max/low temperature reached: 8.5 ๏ฟฝc to 8.8 ๏ฟฝc duration: 30 minutes with no reported adverse event (product storage error). On 10-Apr-2025, the patient received 0.5 ml of influenza USP TRIVAL A-B subvirion vaccine via intramuscular route in the right deltoid for immunization. Reportedly, reason: Monthly cycle count, inventory checking. There was no previous excursion. Human error was involved. Product was administered post excursion. 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.; Sender's Comments: US-SA-2025SA113179: US-SA-2025SA113257: US-SA-2025SA114290: US-SA-2025SA113170: US-SA-2025SA112035:master case
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| 2840376 | 72 | M | AR | 05/12/2025 |
TDAP |
SANOFI PASTEUR |
U8115AA |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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administration of ADACEL to an elderly patient (72-year-old patient ) with no adverse event; Initial...
administration of ADACEL to an elderly patient (72-year-old patient ) with no adverse event; Initial information received on 21-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 72 years old elderly male patient who had administration of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 21-Apr-2025, the 72-year-old patient received a standard dose of 0.5 ml once of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (lot U8115AA, expiry date- 31-MAR-2026) via intramuscular route in the left deltoid for Immunization; with no adverse event (product administered to patient of inappropriate age) (latency- same day). Action taken was not applicable. Reportedly, Reporter asked if it would be accounted for the patient because the information only says it is up to 64 years of age. She asked if we have recommendations on how they should proceed from here. No Treatment was received. 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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| 2840377 | M | FL | 05/12/2025 |
TD |
SANOFI PASTEUR |
U8491AA |
No adverse event, Product storage error
No adverse event, Product storage error
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Product was administered after the excursion with no adverse event; Initial information received on ...
Product was administered after the excursion with no adverse event; Initial information received on 21-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to other case US-SA-2025SA116224. This case involves an unknown age male patient who received diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult [tenivac] after the excursion with no adverse event The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Mar-2025, the patient received 0.5 ml of suspect diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult Suspension for injection of standard strength with lot U8491AA and expiry date 31-Mar-2027 once via intramuscular route in the left deltoid for immunisation after the excursion with no adverse event (poor quality product administered) (Latency same day) Reportedly, Duration of temperature excursion: 55 days, Maximum/minimum temperature reached: 11 ๏ฟฝC. Extended stability data did not cover the excursion. Human error not involved. Fridge malfunction. 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.; Sender's Comments: US-SA-2025SA116224:
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| 2840378 | F | FL | 05/12/2025 |
TD |
SANOFI PASTEUR |
U8491AA |
No adverse event, Product storage error
No adverse event, Product storage error
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Product was administered after the excursion with no adverse event; Initial information received on ...
Product was administered after the excursion with no adverse event; Initial information received on 21-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to other case US-SA-2025SA117087 This case involves an unknown age female patient who received diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult [tenivac] after the excursion with no adverse event. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On 27-Mar-2025, the patient received 0.5 ml of suspect diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult Suspension for injection of standard strength with lot U8491AA and expiry date 27-Mar-2027 once via intramuscular route in the left deltoid for immunisation after the excursion with no adverse event (poor quality product administered) (Latency same day) Reportedly, Duration of temperature excursion: 55 days, Maximum/minimum temperature reached: 11 ๏ฟฝC. Extended stability data did not cover the excursion. Human error not involved. Fridge malfunction 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.; Sender's Comments: US-SA-2025SA117087:
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| 2840379 | TN | 05/12/2025 |
FLU3 |
SANOFI PASTEUR |
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Expired product administered, No adverse event
Expired product administered, No adverse event
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expired FLUZONE NP was administered with no reported adverse event; Initial information received on ...
expired FLUZONE NP was administered with no reported adverse event; Initial information received on 21-Apr-2025 regarding an unsolicited valid non-serious case received from an other health professional. This case involves an unknown age and gender patient who got administered expired Influenza usp trival a-b subvirion no preservative vaccine [Fluzone] NP 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 expired dose of suspect influenza usp trival a-b subvirion no preservative vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Influenza (immunization) with no reported adverse event (expired product administered) (latency- same day). Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested. Action taken- 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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| 2840380 | UT | 05/12/2025 |
HIBV |
SANOFI PASTEUR |
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No adverse event, Product preparation error
No adverse event, Product preparation error
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HCP states that one of their medical assistants administered ACT-HIB using a sterile water instead o...
HCP states that one of their medical assistants administered ACT-HIB using a sterile water instead of the one provided with it with no reported adverse event; Initial information received on 22-Apr-2025 regarding an unsolicited valid non-serious case received from a consumer/Non-Healthcare Professional. This case involves an unknown age and unknown gender patient for whom hcp (Healthcare Professional) stated that one of their medical assistants administered HIB (PRP/T) Vaccine [ACT-HIB] using a sterile water instead of the one provided with it 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, hcp stated that one of their medical assistants administered HIB (PRP/T) Vaccine Powder and solvent for solution for injection (strength, dose, batch and expiry date unknown) via unknown route in unknown administration site for Immunization using a sterile water instead of the one provided with it with no reported adverse event (product preparation error) (same day latency). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. Action taken: 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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| 2840381 | 2 | F | ME | 05/12/2025 |
DTAP DTAPIPV |
SANOFI PASTEUR SANOFI PASTEUR |
3CA11C1 U8009AB |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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2-year-old QUADRACEL with DAPTACEL, so patient received two DTap with no reported adverse event; Ini...
2-year-old QUADRACEL with DAPTACEL, so patient received two DTap with no reported adverse event; Initial information received on 22-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 years old female patient who had received Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero) Vaccine [Quadracel (Vero)] And Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel], so the patient received two dtap with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Apr-2025, the patient received doses with dosage 0.5 ml of suspects Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero) Vaccine Suspension for injection (lot U8009AB, Expiry: 31-Jan-2026) and Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot 3CA11C1, Expiry: 31-DEC-2025) (Strength: Standard) via unknown route in unknown administration site as immunization, so patient received two dtap with no reported adverse event (extra dose administered) (Latency: same day). Reportedly, Reporter is calling to make there is no reaction or anything. Action taken: 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.; Sender's Comments: US-SA-2025SA119219:
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| 2840382 | 4 | M | NC | 05/12/2025 |
IPV |
SANOFI PASTEUR |
X1D141M |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
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inappropriate use due to the administration of 1 mL of IPOL to a patient instead of 0.5 mL with no r...
inappropriate use due to the administration of 1 mL of IPOL to a patient instead of 0.5 mL with no reported adverse event; Initial information received on 22-Apr-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves a 4 years old male patient who had inappropriate use due to the administration of 1 ml of IPV (VERO) [Ipol] to a patient instead of 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, Mumps vaccine, Rubella vaccine (Mmr); Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap); and Varicella zoster vaccine (Varicella vaccine) for Immunisation. On 22-Apr-2025, the patient received 1 ml Dose 4 of suspect IPV (VERO) Suspension for injection lot X1D141M and expiry date- 31-OCT-2026 via intramuscular route in the right thigh for Immunisation instead of 0.5 ml with no reported adverse event (extra dose administered) (latency- same day). Reportedly, the patient did not show any adverse events. Action taken- 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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| 2840383 | 05/12/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
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Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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inappropriate use due to providing an early dose of pentacal with no reported adverse event; Initial...
inappropriate use due to providing an early dose of pentacal with no reported adverse event; Initial information received on 23-Apr-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient with unknown age and gender who was inappropriately given an early dose of 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 Immunization and inappropriately used due to providing an early dose of pentacal with no reported adverse event (inappropriate schedule of product administration). Reportedly, Pentacal was inappropriately used due to providing an early dose which was not in accordance with the product labeling. Patient got the first dose and received the second dose 22 days later. They're trying to see if that would be considered a dose or an error and that dose should be repeated. 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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| 2840384 | 16 | F | MA | 05/12/2025 |
RAB |
SANOFI PASTEUR |
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Rash
Rash
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brushed against her head and it may have been a bat, and now the daughter has two bumps where it tou...
brushed against her head and it may have been a bat, and now the daughter has two bumps where it touched her; Initial information received on 24-Apr-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (mother). This case involves a 16 years old female patient who had brushed against her head and it may have been a bat, and now the daughter has two bumps where it touched her after receiving rabies (HDC) vaccine [Imovax Rabies]. 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 rabies (HDC) vaccine; Powder and solvent for suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation). Information on the batch number was requested corresponding to the one at time of event occurrence. On an unknown date the patient developed brushed against her head and it may have been a bat, and now the daughter has two bumps where it touched her (swelling) (unknown latency). Reportedly: Her daughter had received several vaccines of Imovax Rabies and she is wondering if receiving frequent dose of Imovax Rabies would make it less effective or maybe causing potential problem Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event.
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| 2840385 | 1.42 | F | VA | 05/12/2025 |
HIBV |
SANOFI PASTEUR |
UK198AA |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
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administered ACTHIB diluent that was not mixed with the lyophilized powder with no reported adverse ...
administered ACTHIB diluent that was not mixed with the lyophilized powder with no reported adverse event; Initial information received on 25-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 17 months old female patient who was administered with HIB (PRP/T) Vaccine [ACT-HIB] diluent that was not mixed with the lyophilized powder 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 Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap) for Immunisation. On 25-Apr-2025, the patient received 0.5ml of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK198AA, expiry date 31-Mar-2026, strength standard, frequency once) via intramuscular route in the right thigh for Immunisation. On an unknown date, the patient was administered with acthib diluent that was not mixed with the lyophilized powder with no reported adverse event (single component of a two-component product administered). 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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| 2840386 | NY | 05/12/2025 |
TDAP |
SANOFI PASTEUR |
3CA30C1 |
No adverse event, Product storage error
No adverse event, Product storage error
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temperature excursion: estimated less than 24 hours/temperature reached: 82 ๏ฟฝF/unsuitable product ...
temperature excursion: estimated less than 24 hours/temperature reached: 82 ๏ฟฝF/unsuitable product administered with no reported adverse event; Initial information received on 25-Apr-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 had temperature excursion: estimated less than 24 hours/temperature reached: 82 ๏ฟฝf/unsuitable product administered with no reported adverse event after receiving diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel]. 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-2/tetanus/5 AC pertussis vaccine; Suspension for injection with unknown strength (lot 3CA30C1 with expiry date 30-APR-2026) via unknown route in unknown administration site for Immunization; temperature excursion: estimated less than 24 hours/temperature reached: 82 ๏ฟฝf/unsuitable product administered with no reported adverse event (poor quality product administered). 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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| 2840387 | 2 | M | OH | 05/12/2025 |
HIBV |
SANOFI PASTEUR |
UJ995AA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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inappropriate use due to administration of an expired vaccine with no reported adverse event; Initia...
inappropriate use due to administration of an expired vaccine with no reported adverse event; Initial information received on 28-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 years old male patient with inappropriate use due to administration of an expired vaccine (HIB (PRP/T) VACCINE [ACT-HIB]) with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 28-Apr-2025, the patient received a dose 4 of suspect HIB (PRP/T) VACCINE dose 0.5 ml 1x(once) Powder and solvent for solution for injection (strength -standard) lot UJ995AA expiry date-28-Feb-2025 via intramuscular route in right leg for Immunization, inappropriate use due to administration of an expired vaccine with no reported adverse event (expired product administered) (latency same day). Action taken: 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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| 2840388 | 16 | M | 05/12/2025 |
MEN |
UNKNOWN MANUFACTURER |
UA493AA |
No adverse event, Product storage error
No adverse event, Product storage error
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ship date on shipping label is more than two days prior to receiving the vaccine and one dose was ad...
ship date on shipping label is more than two days prior to receiving the vaccine and one dose was administered with no reported adverse event; Initial information received on 28-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 16 years old male patient who received one dose of meningococcal A-C-Y-W135 (T CONJ) vaccine [menquadfi] and ship date on your shipping label is more than two days prior to receiving the vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 28-Apr-2025, the patient received an unknown dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection (lot UA493AA) (strength and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and ship date on shipping label is more than two days prior to receiving the vaccine with no reported adverse event (poor quality product administered) (Latency: same day). Reportedly, The medical assistant reported that they received a shipment of 10 vials of MENQUADFI today, 28 April 2025, at 9:00 AM. The medical assistant noted that the vaccines were still cold upon arrival, and the doctor and the nurse stated that the vaccine looks fine. 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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| 2840389 | 1 | F | NY | 05/12/2025 |
HIBV |
SANOFI PASTEUR |
UK193AA |
No adverse event, Product preparation error
No adverse event, Product preparation error
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received ACT-HIB that was reconstituted with sterile water instead of the accompanying saline diluen...
received ACT-HIB that was reconstituted with sterile water instead of the accompanying saline diluent, with no reported adverse event; Initial information received on 29-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 year old female patient who received HIB (PRP/T) Vaccine [Act-Hib] which was reconstituted with sterile water instead of the accompanying saline diluent, with no reported adverse events. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Varicella zoster vaccine live (Oka/Merck), Varicella zoster vaccine live (Oka/Merck) (Varivax) for Immunisation. On 24-Apr-2025, the patient received 0.5ml dose (once) of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection, Strength Standard, Expiry date 31-Mar-2026, lot UK193AA via intramuscular route in the left arm for immunisation which was reconstituted with sterile water instead of the accompanying saline diluent, with no reported adverse event (product preparation error) (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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| 2840391 | 27 | F | KY | 05/12/2025 |
TDAP |
SANOFI PASTEUR |
U8115AA |
Exposure during pregnancy, Inappropriate schedule of product administration, No ...
Exposure during pregnancy, Inappropriate schedule of product administration, No adverse event
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pregnant patient received two adacel doses with no reported adverse event; 2-weeks pregnant patient ...
pregnant patient received two adacel doses with no reported adverse event; 2-weeks pregnant patient was given two tdap within a six-week period with no reported adverse event; Initial information received on 29-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 26 years old female patient who was exposed to vaccine Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] in context of 2-weeks pregnant patient was given two tdap (adacel) within a six-week period with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was reported as 20-Aug-2024. The estimated due date is 20-May-2025. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Mar-2025, the 2 weeks pregnant patient received 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (strength: not reported) (lot: U8115AA, Expiry date: 31-Mar-2026) via intramuscular route in the right deltoid for immunization, with no reported adverse event (exposure during pregnancy) (latency: same day) and on 24-Apr-2025 she also received another 0.5 ml dose of vaccine (lot: U8232AA, Expiry date: 01-May-2026) via intramuscular route in the left deltoid for immunization, with no reported adverse event (extra dose administered) (latency: same day). Action taken : not applicable. Additionally, at time of reporting, the pregnancy is still ongoing. 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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| 2840392 | 0.33 | M | NM | 05/12/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK109AA |
No adverse event, Product storage error
No adverse event, Product storage error
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temperature excursion for vaccine as temperature reached: max: 4.3๏ฟฝC, low: 0.0๏ฟฝC duration: 1 hou...
temperature excursion for vaccine as temperature reached: max: 4.3๏ฟฝC, low: 0.0๏ฟฝC duration: 1 hour with no reported adverse event; Initial information received on 29-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 4 months old male patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] that had temperature excursion as temperature reached: max: 4.3 degree celsius, low: 0.0 degree celsius duration: 1 hour with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 25-Apr-2025, the patient received a dose of 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot UK109AA and expiry date 30-Sep-2025) (frequency: once and strength standard) via intramuscular route in unknown administration site for immunization and that had temperature excursion as temperature reached: max: 4.3 degree Celsius, low: 0.0 degree Celsius, duration: 1 hour with no reported adverse event (poor quality product administered) (Latency same day). Reportedly, There was no previous excursion. Human error was unknown and vaccine was administered post-excursion. Extended stability data did not cover the excursion. 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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| 2840393 | 05/12/2025 |
TDAP |
SANOFI PASTEUR |
|
No adverse event, Transcription medication error
No adverse event, Transcription medication error
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incorrect documentation of product administered/they think got the ADACEL but documented as Td with ...
incorrect documentation of product administered/they think got the ADACEL but documented as Td with no reported adverse event; Initial information received on 30-Apr-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 with diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] but it was incorrectly documented as td 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-2/tetanus/5 ac pertussis vaccine, Suspension for injection, lot number, strength and expiry not reported via unknown route in unknown administration site for immunization and it was incorrectly documented as td with no reported adverse event (transcription medication error). Information on the batch number was requested corresponding to the one at time of event occurrence 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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| 2840394 | 1.25 | M | NY | 05/12/2025 |
HIBV |
SANOFI PASTEUR |
UK042AA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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administration of an expired dose of act-hib with no reported ae; Initial information received on 30...
administration of an expired dose of act-hib with no reported ae; Initial information received on 30-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves 15 months old male patient who administered expired dose of HIB (PRP/T) vaccine[ACT-HIB] 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 diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Infanrix) and pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20) for immunisation. On 30-Apr-2025, the patient received a dose of 0.5 ml of expired suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (lot UK042AA and expiry date 31-Mar-2025) (frequency: once and strength: standard) via intramuscular route in the left thigh for Immunization with no reported adverse event (expired product 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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| 2840395 | 0.5 | M | IN | 05/12/2025 |
DTPPVHBHPB HIBV |
MSP VACCINE COMPANY SANOFI PASTEUR |
UK107AB |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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They explained that the patient received ACTHIB and VAXELIS on the same day with no reported adverse...
They explained that the patient received ACTHIB and VAXELIS on the same day with no reported adverse event; Initial information received on 01-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to US-SA-2025SA128571 This case involves a 6-month-old male patient who received (Diphtheria vaccine toxoid, hepatitis b vaccine RHBSAG (yeast), HIB vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine INACT 3v (VERO), tetanus vaccine toxoid) (Vaxelis) and HIB (PRP/T) vaccine [ACT-HIB] on the same day with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Apr-2025, the patient received a 0.5ml dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UK107AB, expiry date-30-Sep-2025) standard strength via intramuscular route in the left thigh for Immunization and on the same day received an unknown dose of suspect Vaxelis not produced by Sanofi Pasteur Formulation, strength, expiry date and lot number-unknown via unknown route in unknown administration site for prophylactic vaccination (Immunisation) no reported adverse event (extra dose administered) (latency-same day). Reportedly-The patient was given two doses of HIB, no treatment was given. 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.; Sender's Comments: US-SA-2025SA128571:Vaxalis US-SA-2025SA128571:Vaxalis
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| 2840396 | 1 | M | LA | 05/12/2025 |
HIBV |
SANOFI PASTEUR |
UK148AA |
No adverse event, Product preparation error
No adverse event, Product preparation error
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administered a dose of Act-HIB that was reconstituted with a different diluent than the one provided...
administered a dose of Act-HIB that was reconstituted with a different diluent than the one provided with the product with no reported adverse event; Initial information received on 01-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient who was administered a dose of HIB (PRP/T) VACCINE [ACT-HIB] that was reconstituted with a different diluent than the one provided with the product 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 Pneumococcal vaccine conj 7v (CRM197), Pneumococcal vaccine conj 7v (CRM197) (Prevnar) and Hepatitis a vaccine, Hepatitis a vaccine (Hepatitis A) for Immunisation. On 30-Apr-2025, the patient received a dose 4 dose of suspect HIB (PRP/T) VACCINE dose 0.5 ml 1x(once) Powder and solvent for solution for injection lot UK148AA expiry date- 30-Sep-2025 via unknown route in unknown administration site for immunization (strength unknown) that was reconstituted with a different diluent than the one provided with the product with no reported adverse event (product preparation error) (latency same day). Action taken: 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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| 2840397 | 59 | F | KS | 05/12/2025 |
TDAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U8115AA U8115AA |
Blister, Erythema, Induration, Nodule, Pruritus; Skin warm, Swelling
Blister, Erythema, Induration, Nodule, Pruritus; Skin warm, Swelling
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it was a fluid filled blister; it got to be the size of a grapefruit, and it was hot; had a swollen ...
it was a fluid filled blister; it got to be the size of a grapefruit, and it was hot; had a swollen hard knot the size of a baseball; ad a swollen hard knot the size of a baseball and it was red; itching; Initial information received on 01-May-2025 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 59 years old female patient who had itching, had a swollen hard knot the size of a baseball, ad a swollen hard knot the size of a baseball and it was red, it got to be the size of a grapefruit, and it was hot and it was a fluid filled blister after receiving diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 28-Apr-2025, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine, Suspension for injection, lot U8115AA, unknown expiry date and strength, frequency: once, via unknown route in the right shoulder for immunisation. On 28-Apr-2025 the patient had itching (vaccination site pruritus) (latency: same day). On 29-Apr-2025 the patient had a swollen hard knot the size of a baseball (vaccination site swelling) and ad a swollen hard knot the size of a baseball and it was red (vaccination site erythema) (latency: 1 day). On 30-Apr-2025 the patient developed it got to be the size of a grapefruit, and it was hot (vaccination site warmth) and it was a fluid filled blister (vaccination site vesicles) (latency: 2 days). Action taken was not applicable. The patient was treated with Diphenhydramine hydrochloride, Diphenhydramine hydrochloride (Benadryl), Cetirizine hydrochloride, Cetirizine hydrochloride (Zyrtec), Famotidine, Famotidine (Pepcid) and Doxycycline, Doxycycline (Doxycycline) for all the events. At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.
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| 2840398 | 1.75 | F | MA | 05/12/2025 |
DTAP |
SANOFI PASTEUR |
2CA77C1 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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expired daptacel was administered to a patient with no reported adverse event; Initial information r...
expired daptacel was administered to a patient with no reported adverse event; Initial information received on 01-May-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 21 months old female patient who was administered with an expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-May-2025, the patient received 0.5 ml of dose 4 of an expired diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection (strength- standard, expiry date- 30-Apr-2025 and lot 2CA77C1) via intramuscular route in the left deltoid for Immunization with no reported adverse event (expired product 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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| 2840399 | TX | 05/12/2025 |
IPV |
SANOFI PASTEUR |
Y1A201M |
No adverse event, Product storage error
No adverse event, Product storage error
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possibly administered to a patient after the excursion; Duration of temperature excursion: 14 minute...
possibly administered to a patient after the excursion; Duration of temperature excursion: 14 minutesMaximum/minimum temperature reached: 46.2๏ฟฝ Fahrenheit with no reported adverse event; Initial information received on 01-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves patient of an unknown age and gender who had been possibly administered IPV (VERO) [IPOL] after the excursion; Duration of temperature excursion: 14 minutesMaximum/minimum temperature reached: 46.2๏ฟฝ Fahrenheit 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 had been possibly administered IPV (VERO) (Suspension for injection) (lot number: Y1A201M; expiry date: 31-Jan-2027) (strength unknown) after the excursion; Duration of temperature excursion: 14 minutesMaximum/minimum temperature reached: 46.2๏ฟฝ Fahrenheit with no reported adverse event for Immunization (poor quality product administered) (latency: same day). Reportedly, "Was it related to a human error? No" 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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| 2840400 | 52 | LA | 05/12/2025 |
TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR |
U8122AA |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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administration of ADACEL outside of the recommended interval with no reported adverse event; Initial...
administration of ADACEL outside of the recommended interval with no reported adverse event; Initial information received on 02-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 52 years old and unknown gender patient for whom diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix) and diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel], administration of adacel outside of the recommended interval with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 29-Apr-2025, the patient received an unknown dose (0.5ml) of diphtheria-2/tetanus/5 AC pertussis vaccine; Suspension for injection with unknown strength (lot U8122AA with expiry date 30-APR-2026) via intramuscular route in the right arm for Immunization and On 06-Mar-2025, the patient received an unknown dose of suspect diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) On 29-APR-2025 the patient developed administration of adacel outside of the recommended interval 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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| 2840401 | 0.33 | M | NC | 05/12/2025 |
HIBV |
SANOFI PASTEUR |
UK169AC |
Extra dose administered, No adverse event, Product preparation issue
Extra dose administered, No adverse event, Product preparation issue
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administered 2 doses of ACTHIB on the same day on one patient, with no reported adverse event; 2 dos...
administered 2 doses of ACTHIB on the same day on one patient, with no reported adverse event; 2 doses of ACTHIB was administered to a patient that were both incorrectly reconstituted with sterile water, with no reported adverse event; Initial information received on 05-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old male patient who incorrectly administered 2 doses of Hib (PRP/T) vaccine [Act-Hib] on the same day with no reported adverse event and these 2 doses were incorrectly reconstituted with sterile water, 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 diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (Pediarix) and rotavirus vaccine live reassort oral 5v (Rotateq) both for Immunisation.. On 30-Apr-2025, the patient received a (dose 2) of 1 ml dose of suspect Hib (PRP/T) vaccine, Powder and solvent for solution for injection, lot UK169AC, expiry date:28-Feb-2026,unknown strength, frequency: once, via intramuscular route in the right thigh for Immunization which was incorrectly administered to one patient on same day twice (extra dose administered) and both doses were incorrectly reconstituted with sterile water, with no reported adverse event (product preparation error) (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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| 2840402 | 0.17 | M | OR | 05/12/2025 |
IPV |
SANOFI PASTEUR |
Y1A201M |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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patient received ipol in the left leg and pediarix right leg. the ipol dose was an extra dose agains...
patient received ipol in the left leg and pediarix right leg. the ipol dose was an extra dose against polio because pediarix contains a dose against polio as one of its components with no reported ae; Initial information received on 05-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 weeks old male patient who received IPV (VERO) [IPOL] in the left leg and pediarix right leg the ipol dose was an extra dose against polio because pediarix contains a dose against polio as one of its components with no reported ae (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, Diphtheria vaccine toxoid, Hepatitis b vaccine rHBsAg (yeast), Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 3-component, Pertussis vaccine acellular 3-component, Polio vaccine inact 3v (Vero), Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid, Tetanus vaccine toxoid (Pediarix), HIB vaccine (HIB vaccine) and Rotavirus vaccine for Immunisation. On 05-May-2025, the patient received IPV (VERO) dose 0.5 ml 1x(once) Suspension for injection lot Y1A201M expiry date-31-Jan-2027 via unknown route in the left leg for Immunization (strength unknown) and pediarix right leg. the ipol dose was an extra dose against polio because pediarix contains a dose against polio as one of its components with no reported ae (extra dose administered) (latency same day). Action taken: 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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| 2840403 | 3 | F | MA | 05/12/2025 |
HIBV |
SANOFI PASTEUR |
UK208AA |
No adverse event, Product preparation error
No adverse event, Product preparation error
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ACTHIB that was reconstituted with a different diluent (0.9% Sodium Chloride) was administered to a ...
ACTHIB that was reconstituted with a different diluent (0.9% Sodium Chloride) was administered to a patient, with no reported adverse event; Initial information received on 06-May-2025 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 3 years old female patient for whom HIB (PRP/T) VACCINE [ACT-HIB] that was reconstituted with a different diluent (0.9% sodium chloride) 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. The list of concomitants as no other vaccines On 29-Apr-2025, the patient received a dose 4 of suspect HIB (PRP/T) VACCINE dose 0.5 ml 1x(once),Powder and solvent for solution for injection (Strength = standard) lot UK208AA expiry date-30-Apr-2026 via intramuscular route in the left deltoid for immunization that was reconstituted with a different diluent (0.9% sodium chloride) was administered to a patient, with no reported adverse event (product preparation error) (latency same day). Action taken: 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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| 2840405 | M | VA | 05/12/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK024AA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Patient received an expired dose on PENTACEL, with no reported adverse event; Initial information re...
Patient received an expired dose on PENTACEL, with no reported adverse event; Initial information received on 06-May-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves an unknown age male patient who received an expired dose of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel], 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 and Pneumococcal vaccine conj 20v (CRM197), Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 06-May-2025, the patient received an expired 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (Strength- standard, frequency- once) lot UK024AA and expiry date- 30-APR-2025 via intramuscular route in the left interior thigh for Immunisation with no reported adverse event (expired product administered) (latency- same day). Action taken- 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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| 2840406 | IN | 05/12/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK026AA |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
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only the Dtap-IPV component was administered to a patient, with no reported adverse event; Initial i...
only the Dtap-IPV component was administered to a patient, with no reported adverse event; Initial information received on 07-May-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves a 19 months old and unknown gender patient where only the dtap-ipv component of 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. Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 29-Apr-2025, the patient received a dose 1 of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (Strength- standard) Suspension for injection (lot- UK026AA and expiration date- 30-JUN-2025) via intramuscular route in the left thigh for Immunisation where only the dtap-ipv component was administered to a patient, with no reported adverse event (single component of a two-component product administered) (latency- same day). Action taken- 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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| 2840459 | 0.17 | M | NJ | 05/12/2025 |
RV1 |
GLAXOSMITHKLINE BIOLOGICALS |
735K2 |
Unevaluable event
Unevaluable event
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The 1st dose of vaccine was administered at 2 months of age outside our facility on 3/11/2024. Patie...
The 1st dose of vaccine was administered at 2 months of age outside our facility on 3/11/2024. Patient started establishing care with our office later until 6 months old. the data of vaccine records was not entered to the office system until 8/22/2024, which caused misinterpretation of vaccine history. otherwise patient is not experiencing any adverse effects
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| 2840460 | 72 | M | IA | 05/12/2025 |
COVID19 |
MODERNA |
3043159 |
Death
Death
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passed away
passed away
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| 2840461 | 19 | F | NJ | 05/12/2025 |
TYP |
SANOFI PASTEUR |
X2A421ZM |
Nausea, Vomiting
Nausea, Vomiting
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The vaccine was administered at 06:45, the patient had 2 episodes of vomiting which lasted roughly 4...
The vaccine was administered at 06:45, the patient had 2 episodes of vomiting which lasted roughly 45 minutes. The patient began vomiting at 06:57 this episode of nausea/vomiting lasted about 10 minutes. Pt started to feel better and then began vomiting again at 07:15 which again lasted about 10 minutes. At 07:30 the patient was taken to see a medical provider and evaluated. Pt denies itching, rash, throat swelling or lip swelling after discussion with pharmacy advised against further typhoid vaccines pt was monitored without further progression of reaction and returned to training as symptoms resolved.
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| 2840462 | 74 | F | GA | 05/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Burning sensation, Miliaria, Rash
Burning sensation, Miliaria, Rash
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It was like burning rash and it broke out on both arms at the same time. And then it went to my legs...
It was like burning rash and it broke out on both arms at the same time. And then it went to my legs and my back, I went to the ER in 08 or 09 2024 and they told me it was a heat rash I waited until like a month ago to see a dermatologist.
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| 2840463 | 67 | F | NC | 05/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
58160-0823-11 |
Headache, Impaired work ability, Influenza like illness, Pain, Palpitations
Headache, Impaired work ability, Influenza like illness, Pain, Palpitations
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12 hours after vaccine was awaken with serious FLU like symptoms. I felt like I had been hit by a t...
12 hours after vaccine was awaken with serious FLU like symptoms. I felt like I had been hit by a truck, SEVERE headache, and heart palpitations. The racing heart while lying down was very concerning that I considered getting medical help. Issue were serious enough I was unable to work and was in bed like 20 hours. Took Advil and did not help with symptoms. I could not function in any capacity and would not have taken 2nd shot had I known of effects. Felt better after 2 days and wanted to report issues I had.
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| 2840464 | 4 | M | FL | 05/12/2025 |
DTAPIPV DTAPIPV MMRV MMRV |
SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
U8198AA U8198AA Y020300 Y020300 |
Cough, Injection site induration, Injection site oedema, Injection site reaction...
Cough, Injection site induration, Injection site oedema, Injection site reaction, Macule; Pyrexia, Rhinorrhoea; Cough, Injection site induration, Injection site oedema, Injection site reaction, Macule; Pyrexia, Rhinorrhoea
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2 days after the immunization, mother brings child because of fever, runny nose and mild cough - sis...
2 days after the immunization, mother brings child because of fever, runny nose and mild cough - sister had bee sick for 5 days. During physical exam a red macula of 6x7 c, indurated, non tender and not itchy, non-fluctuant, is noted in the right deltoid area. Edema is noticed, no pitting.
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| 2840465 | 16 | F | ID | 05/12/2025 |
HIBV |
MERCK & CO. INC. |
Y016315 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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no reaction experienced by patient, vaccine was given at wrong time. Mother of patient notified of e...
no reaction experienced by patient, vaccine was given at wrong time. Mother of patient notified of event.
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| 2840466 | 66 | M | WI | 05/12/2025 |
FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. |
388484 388484 |
Arthritis, Condition aggravated, Exostosis, Injection site pain, Magnetic resona...
Arthritis, Condition aggravated, Exostosis, Injection site pain, Magnetic resonance imaging abnormal; Tendon disorder, Tendon rupture, X-ray limb abnormal
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Persistent lingering left deltoid injection site pain since the immunization. Pain increases after w...
Persistent lingering left deltoid injection site pain since the immunization. Pain increases after work once he settles at home. Heating pad and ibuprofen is not helping. PredniSONE (Deltasone) 20 MG tablet; Take 2 Tablets by mouth one time a day for 5 days. Physical Therapy referral.
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