| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2851389 | ME | 07/28/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
947931 |
No adverse event, Product storage error
No adverse event, Product storage error
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Temperature Excursion for a Total of Six Days, Four Patients Received it After the Excursion; Initia...
Temperature Excursion for a Total of Six Days, Four Patients Received it After the Excursion; Initial report received on 15-Jul-2025. A nurse reported that a patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the product had experienced a temperature excursion for a total of 6 days. No medical history or concomitant medications were reported. On 23-Jun-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number 947931, expiration date 15-May-2027, and NDC number 43528-003-01) intramuscularly. The reporter noted a temperature excursion for a total of 6 days prior to the vaccination. No adverse reactions were reported. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2851390 | 07/28/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Blister, Blister rupture, Herpes zoster, Pain, Pruritus; Vaccination failure
Blister, Blister rupture, Herpes zoster, Pain, Pruritus; Vaccination failure
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Suspected vaccination failure; Shingles on my upper thigh; This serious case was reported by a consu...
Suspected vaccination failure; Shingles on my upper thigh; 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 (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. In JUL-2025, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on my upper thigh). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 13-JUL-2025 This case was reported by a patient via interactive digital media. Patient had the Shingrix vaccine but still got shingles on his/her upper thigh. It was not fun at all. He/she was taking Valtrex, and it had been a week since the blisters appeared. Some had broken and were drying, while others still needed to break. Ice packs helped. It was painful, itchy, and annoying. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix
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| 2851391 | 07/28/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Burning sensation, Pruritus, Rash, Vaccination failure
Burning sensation, Pruritus, Rash, Vaccination failure
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Suspected vaccination failure; Could this be shingles; spots popped out; I had burning; have had the...
Suspected vaccination failure; Could this be shingles; spots popped out; I had burning; have had the vaccine I had burning and itching; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 70-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Could this be shingles), burning sensation (Verbatim: I had burning), pruritus (Verbatim: have had the vaccine I had burning and itching) and papule (Verbatim: spots popped out). The outcome of the vaccination failure, shingles and papule were not reported and the outcome of the burning sensation and pruritus were resolved (duration 1 week). It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, pruritus and papule to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, burning sensation, pruritus and papule to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 16-JUL-2025 This case was reported by a patient via interactive digital media. The patient reported that this could be shingles and have had the vaccine and had burning, itching and about 6 spots popped out. It was very itchy and burning for about a week. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
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| 2851433 | 1 | F | IN | 07/28/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y013582 X023718 |
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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Caller states patient was not experiencing any symptoms at this time; Caller reported patient receiv...
Caller states patient was not experiencing any symptoms at this time; Caller reported patient received both VARIVAX and PROQUAD vaccines at same office visit.; This spontaneous report was received from a healthcare professional regarding a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 03-JUN-2025, the patient was vaccinated with both Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) 0.5 mL administered subcutaneously in the left thigh (lot number reported as X023718, which has been verified as valid, expiration date reported and validated as 26-SEP-2025) (strength and vaccination scheme were not reported); and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot number reported as Y013582, which has been verified as valid, expiration date reported and validated as 03-FEB -2026) (strength, dose, route of administration, vaccination scheme, and anatomical site of injection were not reported) (Overdose). Both vaccines were administered as prophylaxis and reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot numbers and expiration dates were not reported). The reporter stated that the patient was not experiencing any symptoms at the time of report. Follow up information has been received from a supervisor on 20-JUN-2025, referring to the 12-months-old female patient. It was reported that on 03-JUN-2025, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot number reported as Y013582, expiration date reported as "02-FEB-2026" which has been verified as valid, expiration date validated as 03-FEB -2026) in the right thigh; On the same date the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot number reported as X023718, expiration date reported as "25-SEP-2025" which has been verified as valid, expiration date validated as 26-SEP -2025) in the left thigh. The patient was vaccinated with private funds at a private doctor's office/hospital. It was confirmed by the patient's mother via call that no adverse reactions occurred.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02818127-02818123 , CLIC number : , ESTAR number : , IRMS number : 500UW00000ciKzfYAE|20062025230039|1298 , Central date : 2025-06-21 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2293871 , MNSC case number : 02818127 , MNSC interaction number : 02818123 , Integration log UniqueID : 500UW00000ciKzfYAE|20062025230039|1298 , Service cloud CaseID : 500UW00000ciKzfYAE
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| 2851434 | 4 | F | ME | 07/28/2025 |
MMRV |
MERCK & CO. INC. |
Z002990 |
No adverse event, Product storage error
No adverse event, Product storage error
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No other AE; product which underwent a TE was administered to a patient; This spontaneous report was...
No other AE; product which underwent a TE was administered to a patient; This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 11-JUN-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), 0.5 mL, administered as prophylaxis (lot number reported as Z002990, which has been verified as valid, expiration date reported and validated as 14-JUL-2026) (strength, vaccination scheme, route of administration, and anatomical site of injection were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were not reported). The administered dose was exposed to a temperature excursion of 46 Fahrenheit degree (F) for 51 hours and 5 minutes (Product storage error). No other adverse events were reported. Follow up information has been received on 11-JUL-2025. This report was regarding a 4-year-old female patient. The patient's demographic information has been updated. On 11-JUN-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), administered on the right arm as the first dose.
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| 2851435 | 1.42 | M | KS | 07/28/2025 |
HBHEPB |
MERCK & CO. INC. |
X020943 |
Circumstance or information capable of leading to medication error, Underdose
Circumstance or information capable of leading to medication error, Underdose
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a full dose was not administered - Patient was struggling during administration.; a full dose was no...
a full dose was not administered - Patient was struggling during administration.; a full dose was not administered - Patient was struggling during administration.; This spontaneous report was received from a healthcare professional and refers to a 17-month male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 07-Jul-2025, the patient received a not full dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), Injection (lot #X020943, expiration date: 06-Mar-2026) 0.5 mL (.5 ml), due to the patient was struggling during administration. At the reporting time, the outcome of the events was unknown.
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| 2851436 | VA | 07/28/2025 |
MMRV |
MERCK & CO. INC. |
Y017513 |
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 17-JUN-2025, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (0.5 mL, lot # Y017513, expiration date was not provided, but upon internal validation was established as 19-APR-2026; 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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| 2851437 | 07/28/2025 |
PNC21 |
MERCK & CO. INC. |
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Blister, Rash macular
Blister, Rash macular
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one patient experienced a red patch with big blisters after vaccination with CAPVAXIVE; one patient ...
one patient experienced a red patch with big blisters after vaccination with CAPVAXIVE; one patient experienced a red patch with big blisters after vaccination with CAPVAXIVE; This spontaneous report was received from a consumer or other non-health professional 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 patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as after vaccination, the patient experienced red patch (Erythema) with big blisters (Blister). At the reporting time, the outcome of the events was unknown. The causal relationship between the events and the suspect vaccine was not reported.
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| 2851438 | M | AZ | 07/28/2025 |
CHOL |
PAXVAX |
Unknown |
Contraindication to vaccination
Contraindication to vaccination
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The patient took antibiotic in the morning before administration of Vaxchora vaccine; Case reference...
The patient took antibiotic in the morning before administration of Vaxchora vaccine; Case reference number US-BN-2024-002179 is a spontaneous case initially received from nurse via Communications (reference number USBAV24-1613) on 10-Jul-2024 and concerns a male patient of unspecified age. The patient's current condition included Infected cyst. The patient's concomitant medications included antibiotic (brand name unknown). On an unspecified date, as reported the patient completed an antibiotic in the morning, and the patient forgot to tell nurse before administration of a dose of Vaxchora (batch number: unknown), at an unknown dose, orally, for unknown indication (explicitly coded 'labelled drug-drug interaction medication error'). At the time of the initial report, it was unknown if the patient experienced an adverse event due to Vaxchora. No further information was provided.; Reporter's Comments: A male patient of unspecified age completed an antibiotic in the morning, and the patient forgot to tell the nurse before administration of a dose of Vaxchora for unknown indication, which is considered as labelled drug-drug interaction medication error. It was unknown if the patient experienced an adverse event due to Vaxchora. Labelled drug-drug interaction medication error is considered as listed per company convention. The patient's current condition included infected cyst, and concomitant medications included antibiotic. Labelled drug-drug interaction medication error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unspecified age completed an antibiotic in the morning, and the patient forgot to tell the nurse before administration of a dose of Vaxchora for unknown indication, which is considered as labelled drug-drug interaction medication error. It was unknown if the patient experienced an adverse event due to Vaxchora. Labelled drug-drug interaction medication error is considered as listed per company convention. The patient's current condition included infected cyst, and concomitant medications included antibiotic. Labelled drug-drug interaction medication error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2851439 | F | 07/28/2025 |
CHOL |
PAXVAX |
Unknown |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Adult patient took 50 ml of Vaxchora vaccine; The patient took additional dose of Vaxchora one week ...
Adult patient took 50 ml of Vaxchora vaccine; The patient took additional dose of Vaxchora one week after the initial dose; Case reference number US-BN-2024-002211 is a spontaneous case initially received from a consumer via agency (reference number USBAV24-1709) on 18-Jul-2024 and concerns a *34-year-old* female patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took the dose of Vaxchora (batch number: unknown), at dose of 50 ml, orally, for indication *reported as cholera* (explicitly coded as 'vaccine underdose'). *On unspecified date, reported as week later, the patient took additional dose of Vaxchora (batch number: unknown), at a dose of 100 ml, via unknown route, after talking to a doctor (explicitly coded as 'extra dose administered'). *As reported, the patient did not experience any adverse event due to Vaxchora vaccine. * All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up report received from consumer on 06-Sep-2024: New information included patient's exact age, indication for Vaxchora administration, additional Vaxhora administration due to which extra dose was coded and confirmation that the patient did not experience any adverse event.; Reporter's Comments: A 34-year-old female patient took the dose of Vaxchora, at dose of 50 ml, orally, for indication reported as cholera, which is considered as vaccine underdose. On unspecified date, reported as week later, the patient took additional dose of Vaxchora, at a dose of 100 ml, via unknown route, after talking to a doctor, which is considered as extra dose administered. Underdose and extra dose administered are considered listed per company convention. The patient did not experience any adverse event due to Vaxchora vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 34-year-old female patient took the dose of Vaxchora, at dose of 50 ml, orally, for indication reported as cholera, which is considered as vaccine underdose. On unspecified date, reported as week later, the patient took additional dose of Vaxchora, at a dose of 100 ml, via unknown route, after talking to a doctor, which is considered as extra dose administered. Underdose and extra dose administered are considered listed per company convention. The patient did not experience any adverse event due to Vaxchora vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
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| 2851440 | WA | 07/28/2025 |
CHOL |
PAXVAX |
Unknown |
Product administration error
Product administration error
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The patient ate 15 minutes after taking a dose of Vaxchora vaccine; Case reference number US-BN-2024...
The patient ate 15 minutes after taking a dose of Vaxchora vaccine; Case reference number US-BN-2024-002557 is a spontaneous case initially received from pharmacist via Communication (reference number USBAV24-2527) on 26-Sep-2024 and concerns a patient of unknown demographics. The patient's medical history and concomitant medication were not provided. On an unspecified date, the patient took a dose of Vaxchora (batch number: unknown), at an unknown dose, route, or site of administration, for an unknown indication. On the same day, reported as 15 minutes after taking Vaxchora vaccine, the patient ate (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vaxchora vaccine. No further information was provided.; Reporter's Comments: A patient of unknown demographics ate 15 minutes after the patient took a dose of Vaxchora for an unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vaxchora vaccine. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics ate 15 minutes after the patient took a dose of Vaxchora for an unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vaxchora vaccine. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2851441 | IL | 07/28/2025 |
CHOL |
PAXVAX |
Unknown |
Ear infection, Labelled drug-drug interaction medication error
Ear infection, Labelled drug-drug interaction medication error
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Three days after the vaccination with Vaxchora, the patient was started on Augmentin for an ear infe...
Three days after the vaccination with Vaxchora, the patient was started on Augmentin for an ear infection; Three days after the vaccination with Vaxchora, the patient was started on Augmentin for an ear infection; Case reference number US-BN-2024-002819 is a spontaneous case initially received from a pharmacist via agency (reference number: USBAV24-3131) on 26-Nov-2024 and concerns a patient of unspecified age and gender. The patient's medical history and concomitant medication details were not provided. On 22-Nov-2024, the patient took the first dose of Vaxchora vaccine (batch number: unknown) orally, at unknown dose, site of administration, for unknown indication. On an unspecified date, unknown amount of time after vaccination, the patient experienced ear infection. On 25-Nov 2024, three days after the vaccination with Vaxchora, the patient was started with Augmentin for an ear infection (explicitly coded as 'labelled drug-drug interaction medication error '). At the time of the initial report, the outcome of the event of ear infection was unknown. The reporter assessed the event of ear infection as non-serious and causality assessment for the event ear infection was not provided, No further information was provided.; Reporter's Comments: A patient of unspecified age and gender experienced a non-serious event of ear infection an unknown amount of time after the patient took the first dose of Vaxchora vaccine for unknown indication. Reportedly, three days after the vaccination with Vaxchora, the patient was started with Augmentin for an ear infection, which is considered as labelled drug-drug interaction medication error. Ear infection is unlisted and unexpected for Vaxchora per CCDS v1, whilst labelled drug-drug interaction medication error is listed and expected. The patient's medical history and concomitant medication details were not provided. The outcome of the event of ear infection was unknown. The causality for ear infection is considered as not related to Vaxchora, considering the nature of the event. Labelled drug-drug interaction medication error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unspecified age and gender experienced a non-serious event of ear infection an unknown amount of time after the patient took the first dose of Vaxchora vaccine for unknown indication. Reportedly, three days after the vaccination with Vaxchora, the patient was started with Augmentin for an ear infection, which is considered as labelled drug-drug interaction medication error. Ear infection is unlisted and unexpected for Vaxchora per CCDS v1 and USPI, whilst labelled drug-drug interaction medication error is listed and expected. The patient's medical history and concomitant medication details were not provided. The outcome of the event of ear infection was unknown. The causality for ear infection is considered as not related to Vaxchora, considering the nature of the event. Labelled drug-drug interaction medication error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
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| 2851442 | F | IN | 07/28/2025 |
CHOL |
PAXVAX |
4300322 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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The patient administered Vaxchora vaccine, which was expired on November 30th, five days ago; Case r...
The patient administered Vaxchora vaccine, which was expired on November 30th, five days ago; Case reference number US-BN-2024-002846 is a spontaneous case initially received from a nurse via agency (reference number: USBAV24-3222) on 05-Dec-2024 and concerns a *22-years-old* female patient. The patient's medical history and concomitant medication details were not provided. On 05-Dec-2024, the patient took the dose of the Vaxchora vaccine, (batch number: *4300322*; expiration date: 30-Nov-2024), *single dose packet*, orally, indication *reported as cholera*. It was reported that Vaxchora vaccine expired five days ago (explicitly coded as 'expired vaccine used'). At the time of the *follow-up* report, the patient *did not experience* any adverse event due to Vaxchora. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from the nurse on 31-Dec-2024: New information included added patient age, Vaxchora dosing details, and confirmed that the patient did not experience any adverse event due to Vaxchora.; Reporter's Comments: A 22-years-old female patient took the dose of the Vaxchora vaccine on 05-Dec-2024, which expired five days ago (expiration date: 30-Nov-2024), single dose packet, administered orally, for indication reported as cholera which is considered as expired vaccine used. Expired product administered is considered listed per company convention. At this point, the patient did not experience any adverse event due to Vaxchora. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 22-years-old female patient took the dose of the Vaxchora vaccine on 05-Dec-2024, which expired five days ago (expiration date: 30-Nov-2024), single dose packet, administered orally, for indication reported as cholera which is considered as expired vaccine used. Expired product administered is considered listed per company convention. At this point, the patient did not experience any adverse event due to Vaxchora. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
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| 2851443 | ME | 07/28/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
947931 |
No adverse event, Product storage error
No adverse event, Product storage error
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Temperature Excursion for a Total of Six Days, Four Patients Received it After the Excursion; Initia...
Temperature Excursion for a Total of Six Days, Four Patients Received it After the Excursion; Initial report received on 15-Jul-2025. A nurse reported that a patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization after the product had experienced a temperature excursion for a total of 6 days. No medical history or concomitant medications were reported. On 23-Jun-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number 947931, expiration date 15-May-2027, and NDC number 43528-003-01) intramuscularly. The reporter noted a temperature excursion for a total of 6 days prior to vaccination. No adverse reactions were reported. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2851444 | M | NJ | 07/28/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
946065 |
Interchange of vaccine products, No adverse event
Interchange of vaccine products, No adverse event
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Our Patient Received Twinrix As A Second Dose After Receiving A First Dose of Heplisav-B; Initial re...
Our Patient Received Twinrix As A Second Dose After Receiving A First Dose of Heplisav-B; Initial report received on 15-Jul-2025. A pharmacist reported that a 31-year-old male patient (race and ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received TWINRIX as a second dose. No medical history or concomitant medications were reported. In Jun-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 946065, expiration date 02-Nov-2027, NDC # 43528-0003-05, route and site not available). On an unknown date, after having been vaccinated with HEPLISAV-B, the patient received a dose of TWINRIX (no details provided) as a second dose of hepatitis B vaccination. The reporter stated that the patient had no other side effects reported. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2851445 | MO | 07/28/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Interchange of vaccine products
Interchange of vaccine products
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Patient Received 1 Dose of HEPLISAV-B, and Then 1 Dose of Engerix; Initial report received on 16-Jul...
Patient Received 1 Dose of HEPLISAV-B, and Then 1 Dose of Engerix; Initial report received on 16-Jul-2025. A medical assistant reported that a patient (age, gender, race, ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and received ENGERIX-B as the second dose. No medical history or concomitant medications were reported. On Jan-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not provided). On an unknown date, after having been vaccinated with HEPLISAV-B, the patient received ENGERIX-B (lot #, expiration date, and NDC # rote, and site not provided). No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2851446 | 60 | F | KS | 07/28/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
945664 |
Incomplete course of vaccination, No adverse event
Incomplete course of vaccination, No adverse event
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Got Their 1st Dose, Trying to Get Their 2nd Dose Over the One Month Mark; Initial report received on...
Got Their 1st Dose, Trying to Get Their 2nd Dose Over the One Month Mark; Initial report received on 21-Jul-2025. A pharmacist reported that a 60-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was trying to get the second dose over one month after the first. No medical history or concomitant medications were reported. On 22-May-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number 945664, expiration date 31-Jan-2027 and NDC number 43528-003-05)] intramuscularly in the left deltoid. On 21-Jul-2025, 61 days after receiving the first dose of HEPLISAV-B, the patient presented to the same pharmacy location as the first dose and attempted to get the second dose. The reporter contacted medical information to ask if the patient needed to restart the series. The second dose was not administered. No adverse reactions were reported. No additional information was reported. Company Comment The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2851447 | MD | 07/28/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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16-Year-Old Patient Received HEPLISAV-B; Initial report received on 21-Jul-2025. A pharmacist repor...
16-Year-Old Patient Received HEPLISAV-B; Initial report received on 21-Jul-2025. A pharmacist reported that a 16-year-old patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. No medical history or concomitant medications were reported. On 21-Jul-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available). The patient was 16 years old at the time of administration. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2851448 | 64 | F | UT | 07/28/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
946065 |
No adverse event, Product storage error
No adverse event, Product storage error
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Given HEPLISAV-B that Went Out of Temperature Range for 3 1/2 Hours; Initial report received on 22-J...
Given HEPLISAV-B that Went Out of Temperature Range for 3 1/2 Hours; Initial report received on 22-Jul-2025. A healthcare coordinator reported that a 64-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had been out of temperature range for 3.5 hours. No medical history or concomitant medications were reported. On 17-Jul-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number 946065, expiration date 02-Nov-2027, and NDC number 43528-000 3-01) intramuscularly in the right deltoid. The HEPLISAV-B dose given was out of temperature range for 3.5 hours with a temperature low of -0.2 degrees Celsius. No other side effects reported. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2851449 | IL | 07/28/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
5XA2J |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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received the previous dosing schedule of 0 and more than 1 month instead of the current dosing sched...
received the previous dosing schedule of 0 and more than 1 month instead of the current dosing schedule; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in an unspecified number of patients who received Men B NVS (Bexsero) (batch number 5XA2J) for prophylaxis. On an unknown date, the patients received Bexsero .5 ml. On an unknown date, an unknown time after receiving Bexsero, the patients experienced inappropriate schedule of vaccine administered (Verbatim: received the previous dosing schedule of 0 and more than 1 month instead of the current dosing schedule). The outcome of the inappropriate schedule of vaccine administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 09-JUL-2025 The reporter was a Health Care Professional. The reporter stated that patients (unspecified amount) received Bexsero outside of the current dosing recommendations The patients received the previous dosing schedule of 0 and more than or equal to 1 month instead of the current dosing schedule which led to inappropriate schedule of vaccine administered. The HCP did not have specific patient identifiers
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| 2851450 | GA | 07/28/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
52n4S |
Wrong technique in product usage process
Wrong technique in product usage process
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introduced a syringe inside the prefilled syringe of Bexsero instead of following the instructions a...
introduced a syringe inside the prefilled syringe of Bexsero instead of following the instructions as per the PI; This non-serious case was reported by the other health professional via call center representative and described the occurrence of wrong technique in product usage process in a patient who received Men B NVS (Bexsero) (batch number 52n4S) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong technique in product usage process (Verbatim: introduced a syringe inside the prefilled syringe of Bexsero instead of following the instructions as per the PI). The outcome of the wrong technique in product usage process was not applicable. It was unknown if the reporter considered the wrong technique in product usage process to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the wrong technique in product usage process to be related to Bexsero and Bexsero 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: 18-JUL-2025 Healthcare professional reported that they introduced a syringe inside the prefilled syringe of Bexsero instead of following the instructions as per the prescribing information (PI) which led to wrong technique in product usage process.
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| 2851451 | 90 | F | 07/28/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Product preparation issue
Product preparation issue
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Diluent was administered but antigen was not on accident; Diluent was administered but antigen wasn&...
Diluent was administered but antigen was not on accident; Diluent was administered but antigen wasn't on accident; This non-serious case was reported by a physician via sales rep and described the occurrence of inappropriate dose of vaccine administered in a 90-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received the 1st dose of Arexvy (unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate dose of vaccine administered (Verbatim: Diluent was administered but antigen was not on accident) and inappropriate preparation of medication (Verbatim: Diluent was administered but antigen wasn't on accident). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable. Additional Information: GSK Receipt Date: 18-JUL-2025 Diluent was administered but antigen was not on accident which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
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| 2851452 | 07/28/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Expired product administered
Expired product administered
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that expired on 7/13/25; This non-serious case was reported by a physician via sales rep and describ...
that expired on 7/13/25; This non-serious case was reported by a physician via sales rep and described the occurrence of expired vaccine used in a patient who received DTPa (Infanrix) (expiry date 13-JUL-2025) for prophylaxis. On 24-JUL-2025, the patient received Infanrix. On 24-JUL-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: that expired on 7/13/25). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 24-JUL-2025 The physician reported that the patient received an expired dose of Infanrix vaccine, which led to expired vaccine used.
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| 2851453 | 07/28/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Malaise
Malaise
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vaccine made the patient sick; This non-serious case was reported by a consumer via interactive digi...
vaccine made the patient sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles, sickness, disability and ramsay-hunt syndrome. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: vaccine made the patient sick). The outcome of the sickness was resolved. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Additional Information: GSK receipt date: 21-JUL-2025 This case was reported by a patient via interactive digital media. The vaccine made the patient sick for a few days and shingles made the patient sick/disabled for months. (Look up Ramsay Hunt Syndrome) The patient reported that anyone who has had shingles and the vaccine will surely say it's worth it to get the second shot.
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| 2851454 | 07/28/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Arthralgia, Diarrhoea, Pyrexia, Rhinorrhoea
Arthralgia, Diarrhoea, Pyrexia, Rhinorrhoea
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Joint pain; fever; diarrea; Runny nose; This non-serious case was reported by a consumer via interac...
Joint pain; fever; diarrea; Runny nose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced joint pain (Verbatim: Joint pain), fever (Verbatim: fever), diarrhea (Verbatim: diarrea) and runny nose (Verbatim: Runny nose). The outcome of the joint pain, fever, diarrhea and runny nose were not reported. It was unknown if the reporter considered the joint pain, fever, diarrhea and runny nose to be related to Arexvy. It was unknown if the company considered the joint pain, fever, diarrhea and runny nose to be related to Arexvy. Additional Information: GSK Receipt Date:16-JUL-2025 This case was reported by a consumer via interactive digital media. The patient had taken vaccine and have experienced reaction joint pain, fever, diarrhea and runny nose.
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| 2851455 | IL | 07/28/2025 |
HIBV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Differing intervals for the booster dose.; This non-serious case was reported by a other health prof...
Differing intervals for the booster dose.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Hib (Hiberix) for prophylaxis. Previously administered products included Hiberix (previously administering another brand and switched to Hiberix). On 11-JUL-2025, the patient received Hiberix. On 11-JUL-2025, an unknown time after receiving Hiberix, the patient experienced drug dose administration interval too long (Verbatim: Differing intervals for the booster dose.). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK receipt date: 11-JUL-2025 Other HCP reported about the administration of Hiberix's booster dose beyond the recommended interval, as they were previously administering another brand and switched to Hiberix, but were unaware of the need for an additional dose, which led to drug dose interval too long. Also asked was there any information available for the administration of Hiberix after the recommended interval. As the healthcare professional pressed on, the inquiry was escalated to global team. Also, HCP mentioned that they were not sure of how many patients were involved nor had any of their details.
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| 2851456 | F | NY | 07/28/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
7nx57 |
Underdose
Underdose
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Administration of pediatric dose; Administration of pediatric dose; This non-serious case was report...
Administration of pediatric dose; Administration of pediatric dose; This non-serious case was reported by a physician via call center representative and described the occurrence of adult use of a child product in a 20-year-old female patient who received HBV (Engerix B 10 mcg) (batch number 7nx57, expiry date 12-DEC-2026) for prophylaxis. Previously administered products included Engerix b (received 1st dose on 04-MAY-2005), Engerix b (received 2nd dose on 06-JUL-2005) and Engerix b (received 3rd dose on 21-SEP-2005). On 16-JUL-2025, the patient received the 4th dose of Engerix B 10 mcg. On 16-JUL-2025, an unknown time after receiving Engerix B 10 mcg, the patient experienced adult use of a child product (Verbatim: Administration of pediatric dose) and underdose (Verbatim: Administration of pediatric dose). The outcome of the adult use of a child product and underdose were not applicable. Additional Information: GSK Receipt Date: 16-JUL-2025 The patient's age was 20 years and 4 months The pediatrician reported that an adult accidentally received a pediatric dose of Engerix-B, which led to adult use of a child product and underdose. The Vaccine Administration Facility is the same as Primary Reporter.
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| 2851457 | 89 | F | MA | 07/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3x97j |
Incorrect route of product administration
Incorrect route of product administration
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Possible subcutaneous administration; This non-serious case was reported by a pharmacist via call ce...
Possible subcutaneous administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 89-year-old female patient who received Herpes zoster (Shingrix) (batch number 3x97j, expiry date 25-MAR-2027) for prophylaxis. On 09-APR-2025, the patient received Shingrix (subcutaneous). On 09-APR-2025, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Possible subcutaneous administration). The outcome of the intramuscular formulation administered by other route was not applicable. Additional Information: GSK receipt date: 16-JUL-2025 The pharmacist called stating patient received dose of Shingrix from another pharmacy and it was possible they received it subcutaneously which led to intramuscular formulation administered by other route.
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| 2851458 | 45 | M | NY | 07/28/2025 |
HEP HEP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Inappropriate schedule of product administration, Incomplete course of vaccinati...
Inappropriate schedule of product administration, Incomplete course of vaccination; Inappropriate schedule of product administration, Incomplete course of vaccination
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couldn't get the third dose; Interval is more than recommended between dose 1 and 2; This non-s...
couldn't get the third dose; Interval is more than recommended between dose 1 and 2; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in an adult male patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis. Previously administered products included Engerix B (Received 1st dose of Engerix B vaccine on 01-SEP-2024). On 12-OCT-2024, the patient received the 2nd dose of Engerix B. The patient did not receive the 3rd dose of Engerix B. On 12-OCT-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Interval is more than recommended between dose 1 and 2). The patient had incomplete course of vaccination (Verbatim: couldn't get the third dose). The outcome of the drug dose administration interval too long and incomplete course of vaccination were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 18-JUL-2025 Pharmacist wanted to know how to proceed with a patient that received the first two doses of Engerix-B back on 01-Sept-2024 and 12-Oct-2024, respectively, which led to drug dose administration interval too long. The patient couldn't get the third dose which led to incomplete course of vaccination and now wanted to receive it. These two doses were given in another facility.
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| 2851459 | F | FL | 07/28/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
|
Product preparation issue
Product preparation issue
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administered only the liquid component of the Arexvy; administered only the liquid component of the ...
administered only the liquid component of the Arexvy; administered only the liquid component of the Arexvy; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: administered only the liquid component of the Arexvy) and inappropriate dose of vaccine administered (Verbatim: administered only the liquid component of the Arexvy). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 18-JUL-2025 Physician reported that she administered only the liquid component of the Arexvy vaccine to her mother. The patient received only adjuvant of Arexvy, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
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| 2851460 | FL | 07/28/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
|
Product storage error
Product storage error
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10 different patients received a dose of Boostrix after a temperature excursion; This non-serious ca...
10 different patients received a dose of Boostrix after a temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a specified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: 10 different patients received a dose of Boostrix after a temperature excursion). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 18-JUL-2025 Registered nurse called to ask about the stability of Boostrix, after a temperature excursion of 12-degree Fahrenheit for 5 minutes. After agent confirmed the vaccines were not stable anymore the Nurse mentioned that they administered 10 doses of Boostrix after this temperature excursion to 10 different patients, which led to incorrect storage of drug. The reporter wants to ask that they need to revaccinate them or not. Nurse did not provide more details about initials, age or gender for the patients and did not have the lot number and expiration dates of the doses of Boostrix that were administered.
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| 2851461 | 2 | M | CA | 07/28/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
Y49BZ |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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Maladministration of a KINRIX vaccine to a twenty five month old patient (wrong vaccine administered...
Maladministration of a KINRIX vaccine to a twenty five month old patient (wrong vaccine administered on a wrong age); This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 25-month-old male patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis. Previously administered products included Vaxelis (received on 19-AUG-2023) and Engerix B (received 2 doses on an unknown date). Concomitant products included Pediarix. On 10-JUL-2025, the patient received Kinrix. On 10-JUL-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Maladministration of a KINRIX vaccine to a twenty five month old patient (wrong vaccine administered on a wrong age)). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 21-JUL-2025 The nurse reported that the twenty five month old patient received Kinrix vaccine, and at the same time we administered the Pediarix vaccine. The reporter was ask was there any safety concern. The patient was administered with a previous Vaxelis vaccine (no vaccine schedule/doses confirmed from the licensed practical nurse๏ฟฝs end). The vaccine administration facility was the same as primary reporter. The patient received dose of Kinrix vaccine at an inappropriate age, which led to inappropriate age at vaccine administration.
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| 2851462 | 65 | M | CO | 07/28/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
29Z7E |
Expired product administered
Expired product administered
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Expired dose administered; This non-serious case was reported by a pharmacist via call center repres...
Expired dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 65-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 29Z7E, expiry date 01-JUL-2025) for prophylaxis. On 21-JUL-2025, the patient received Arexvy. On 21-JUL-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 21-JUL-2025 The pharmacist reported that there was a vaccine that was administered today (on the reporting day) and was expired for the vaccine, the diluent was still in date, but the vaccine itself was out of the date, which led to expired vaccine used. The reporter's manager had called to see how viable the vaccine still was and whether the patient needs to get revaccinated.
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| 2851463 | 12 | F | KS | 07/28/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
X449Y |
Extra dose administered
Extra dose administered
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administration of a second dose of Boostrix, 1 week apart from 1st dose; This non-serious case was r...
administration of a second dose of Boostrix, 1 week apart from 1st dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number X449Y, expiry date 20-OCT-2026) for prophylaxis. Concomitant products included Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Boostrix). On 21-JUL-2025, the patient received the 2nd dose of Boostrix. On 21-JUL-2025, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: administration of a second dose of Boostrix, 1 week apart from 1st dose). The outcome of the extra dose administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 22-JUL-2025 The reporter reported that there was administration of a second dose of Boostrix, 1 week apart to a patient, which led to extra dose administered. She called to know how proceed and if there were some safety comments to be shared with the parents of patient. The Vaccine Administration Facility was the same as Primary Reporter.
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| 2851464 | M | TX | 07/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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did not receive 2nddose of Shingrix yet; This non-serious case was reported by a pharmacist via call...
did not receive 2nddose of Shingrix yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (patient got the first shot back on 30 October 2022). The patient did not receive the 2nd dose of Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not receive 2nddose of Shingrix yet). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 22-JUL-2025 Other HCP reported to get guidance on Shingrix vaccination. He informed that a male elder patient got the first shot back on 30 October 2022 and did not complete the schedule. He wanted to know if the second dose can be administered or if the complete series has to be restarted. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2851465 | 56 | F | VA | 07/28/2025 |
PNC20 |
PFIZER\WYETH |
LN4931 |
Erythema, Pain, Pyrexia, Skin warm, Swelling
Erythema, Pain, Pyrexia, Skin warm, Swelling
|
Patient received Prevnar 20 in Left upper arm on Wednesday 7/23/2025. Patient stated redness started...
Patient received Prevnar 20 in Left upper arm on Wednesday 7/23/2025. Patient stated redness started on Thursday which was small and progressively advanced. Patient stated she developed a raised area with a fever and pain and warmth to the area on Thursday. Fever subsided on Friday. Tylenol was taken by patient. Patient came in on Monday 7/28/2025 and evaluated by Dr. . Described as a local reaction. Dr. advised patient to Motrin for pain. Patient had taken a photo of the area which was raised. Patient applied Hydrocortisone cream to the area. No raised area when patient came into the clinic. Also advised to return to clinic or seek ER care if worsening.
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| 2851466 | 1 | F | MI | 07/28/2025 |
IPV |
SANOFI PASTEUR |
Y1A201M |
Wrong product administered
Wrong product administered
|
IVP was given on accident. Patient was due for HIB and ended up getting IVP
IVP was given on accident. Patient was due for HIB and ended up getting IVP
|
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| 2851467 | 31 | F | MI | 07/28/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
K4JH7 |
Underdose
Underdose
|
Pt recieved the peds version of Hep B instead of adult dosage
Pt recieved the peds version of Hep B instead of adult dosage
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| 2851468 | 70 | F | WI | 07/28/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
|
No adverse event, Product storage error
No adverse event, Product storage error
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Temperature excursion: Vaccine froze as a result of inaccurate transportation to an outlying clinic....
Temperature excursion: Vaccine froze as a result of inaccurate transportation to an outlying clinic. Contacted the manufacturer and it was recommended that the patient be re-vaccinated. Patient did not have any adverse effects from the vaccination.
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| 2851469 | 60 | F | GA | 07/28/2025 |
PNC20 VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
LX4482 7zm55 |
Hypoaesthesia, Pain in extremity, Paraesthesia, Skin discolouration; Hypoaesthes...
Hypoaesthesia, Pain in extremity, Paraesthesia, Skin discolouration; Hypoaesthesia, Pain in extremity, Paraesthesia, Skin discolouration
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Patient complained of constant arm pain, numbness, discoloration on arm, and tingling fingers
Patient complained of constant arm pain, numbness, discoloration on arm, and tingling fingers
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| 2851470 | 58 | M | TX | 07/28/2025 |
PNC21 |
MERCK & CO. INC. |
Z003579 |
Erythema, Headache, Peripheral swelling, Pyrexia, Skin warm
Erythema, Headache, Peripheral swelling, Pyrexia, Skin warm
|
Pt complained of having severe headache that would not alleviate with OTC medications such as tyleno...
Pt complained of having severe headache that would not alleviate with OTC medications such as tylenol and advil. Pt stated having a high fever of 101 F. Fever has since subsided after a day along with the headache. Pt also stated arm swelled and is very red. Pt described swelling to be quite large from the shoulder to almost the bicep. The swelling is still present after 3 days and is still warm and red.
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| 2851471 | 35 | F | TX | 07/28/2025 |
VARCEL |
MERCK & CO. INC. |
Z004455 |
Erythema, Pain, Skin warm, Swelling, Tenderness
Erythema, Pain, Skin warm, Swelling, Tenderness
|
Patient reports received vaccine on Friday, 7/25/2025, Saturday "there was a little bump",...
Patient reports received vaccine on Friday, 7/25/2025, Saturday "there was a little bump", then on Sunday, is when she started feeling pain and increased swelling. Today EHN noted 60mmx70mm erythema, swelling and warm to touch. Patient rates pain 7/10, increased upon movement and tender to touch.
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| 2851472 | 65 | M | 07/28/2025 |
COVID19 |
MODERNA |
|
Death
Death
|
Resident expired on 7/26/2025
Resident expired on 7/26/2025
|
โ | ||||||
| 2851473 | 0.17 | F | CA | 07/28/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
D2343 |
No adverse event
No adverse event
|
No reaction noted
No reaction noted
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| 2851474 | 93 | M | IA | 07/28/2025 |
COVID19 |
MODERNA |
|
Death
Death
|
Resident expired
Resident expired
|
โ | |||||
| 2851475 | 94 | F | IA | 07/28/2025 |
COVID19 |
MODERNA |
|
Death
Death
|
Resident expired
Resident expired
|
โ | |||||
| 2851476 | 49 | F | PA | 07/28/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
Y3Z9P |
Pain, Pruritus, Swelling
Pain, Pruritus, Swelling
|
Started with slight pain and itching on 7/24/2025. Then everyday experienced pain with swelling. On...
Started with slight pain and itching on 7/24/2025. Then everyday experienced pain with swelling. On 7/28/2025, went to seek medical treatment at that time.
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| 2851477 | 72 | F | TX | 07/28/2025 |
COVID19 |
PFIZER\BIONTECH |
ME6072 |
Erythema, Pain
Erythema, Pain
|
redness and soreness
redness and soreness
|
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| 2851478 | 51 | F | TX | 07/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
MG5S9 |
Injection site erythema, Injection site nodule, Injection site swelling, Injecti...
Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth, Local reaction
More
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Patient called to report side effects following her shingles and pneumonia vaccinations in her left ...
Patient called to report side effects following her shingles and pneumonia vaccinations in her left arm. She mentioned experiencing tenderness that began last night, and this morning she observed a knot larger than a quarter. There is no itching, but she noted swelling, warmth, and redness in the area. The patient is seeking recommendations on how to alleviate these symptoms. 0908 am: I have spoken with patient and advised ice to affected area and Motrin as needed for pain/swelling. Call clinic if symptoms persist or worsen. Suspect local reaction to Shingles vaccine. Denies shortness of breath, fever, chills. Patient verbalized understanding and agreeable with treatment plan.
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| 2851479 | 11 | F | WI | 07/28/2025 |
HPV9 |
MERCK & CO. INC. |
Y012921 |
Loss of consciousness, Syncope
Loss of consciousness, Syncope
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VASOVAGAL SYNCOPE WITH BRIEF LOC AND TETANY (<10 SEC). MOVED TO FLOOR AND THEN BED, GIVEN JUICE ...
VASOVAGAL SYNCOPE WITH BRIEF LOC AND TETANY (<10 SEC). MOVED TO FLOOR AND THEN BED, GIVEN JUICE AND ICE PACKS. PATIENT FEELING BETTER WITHIN 5 MINUTES. NO FURTER COMPLAINTS/CONCERNS. PATIENT WALKED OUT OF OFFICE WITH MOM.
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