| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2842474 | 5 | M | OH | 05/23/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
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Blister, Nausea, Rash, Vomiting; Blister, Nausea, Rash, Vomiting
Blister, Nausea, Rash, Vomiting; Blister, Nausea, Rash, Vomiting
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5/18/25 developed nausea and vomiting, in late evening. 5/19/25 woke up with rash(blister-like) on a...
5/18/25 developed nausea and vomiting, in late evening. 5/19/25 woke up with rash(blister-like) on arm and spread to face. Was evaluated by provider on 5/19/25 and diagnosed with varicella. Mom reported that she had a shingles outbreak in April.
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| 2842475 | 1.42 | F | MI | 05/23/2025 |
TDAP |
SANOFI PASTEUR |
3CA30C1 |
Wrong product administered
Wrong product administered
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Patient was given Tdap vaccine instead of DTaP vaccine. No none symptoms, and expected to recover. H...
Patient was given Tdap vaccine instead of DTaP vaccine. No none symptoms, and expected to recover. Health department stated valid dose.
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| 2842476 | 33 | M | IL | 05/23/2025 |
COVID19 |
PFIZER\BIONTECH |
md3414 |
Oropharyngeal discomfort, Throat irritation
Oropharyngeal discomfort, Throat irritation
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Patient returned to pharmacy counter after sitting in his car for about 40 minutes. He stated his th...
Patient returned to pharmacy counter after sitting in his car for about 40 minutes. He stated his throat felt funny and scratchy. He said it occurred immediately after vaccination which was why he stayed and sat in his car. When it wasn't improving he came in. He was sat down and given a benadryl 25mg tablet. He stated he had received previous doses of covid vaccine at Pharmacy, so we called and they showed he had previously received both Pfizer (9/24) and Moderna (11/23). He never had any previous reaction. He laid down on the floor for about 1 hour. He asked for cool rag for his neck and water to drink. Pharmacists checked pulse which was ~60bpm and o2 sat was 96. He never experienced any difficulty breathing or swallowing. He did not think he needed EMS called. There was no visible reaction at the injection site. After about 2 hours in total, patient stated he felt fine to leave. Patient was contacted back today and stated he was fine and had no further side effects. He had been sent home with an additional benadryl that he stated he did not have to take.
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| 2842477 | 21 | M | CO | 05/23/2025 |
COVID19 |
PFIZER\BIONTECH |
LN0591 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
THIS PATIENT HAD NO ADVERSE REACTIONS WHEN WE CHECKED, BUT THIS REPORT IS ADMIISTERED 2ND DOSE INTER...
THIS PATIENT HAD NO ADVERSE REACTIONS WHEN WE CHECKED, BUT THIS REPORT IS ADMIISTERED 2ND DOSE INTERVAL ONLY ONE WEEK APART. THIS IS NOT RECOMMENDED DOSE. WE CHECKED THIS PATIENT IN SYSTEM, HE GAVE DIFFERENT NAME, NOT IN THE SYSTEM.
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| 2842478 | 30 | F | ID | 05/23/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
X4BK3 |
Malaise, No adverse event, Wrong product administered
Malaise, No adverse event, Wrong product administered
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Patient received the meningococcal B vaccine instead of hepatitis B. When the RN got a hold of the p...
Patient received the meningococcal B vaccine instead of hepatitis B. When the RN got a hold of the patient the next morning, she stated that she had no side effects from it and felt well. Her PCP felt that she was low risk for any complications with breastfeeding, so she advised for her to continue breastfeeding. Patient was notified of this and that she received the wrong vaccine.
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| 2842480 | 4 | F | TN | 05/23/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
5G23D |
Injection site erythema, Injection site reaction, Injection site swelling, Injec...
Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Skin tightness
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Swollen, red, tight, and hot deltoid at site of injection
Swollen, red, tight, and hot deltoid at site of injection
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| 2842481 | 4 | M | PA | 05/23/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
4L454 Z006279 |
Injection site erythema, Injection site swelling; Injection site erythema, Injec...
Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling
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ERYTHEMA AND SWELLING AT SITE OF THE VACCINES, MOM THINK SUPPER PART OF ARM WHERE THE DTAP/IPV WAS I...
ERYTHEMA AND SWELLING AT SITE OF THE VACCINES, MOM THINK SUPPER PART OF ARM WHERE THE DTAP/IPV WAS INJECTED
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| 2842482 | 70 | F | GA | 05/23/2025 |
PNC21 |
MERCK & CO. INC. |
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Joint swelling, Peripheral swelling
Joint swelling, Peripheral swelling
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Well the next day my feet and ankle were swollen and i was wearing sandals and they got tight on me ...
Well the next day my feet and ankle were swollen and i was wearing sandals and they got tight on me and that lasted about 2 days. They have started to go down. I did look up adverse events and saw that it was something that could happen.
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| 2842483 | 13 | F | MO | 05/23/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
z92l4 |
Loss of consciousness, Syncope
Loss of consciousness, Syncope
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Patient fainted approximately 5-10 minutes after having received vaccine. Regained consciousness af...
Patient fainted approximately 5-10 minutes after having received vaccine. Regained consciousness after around 30 seconds and remained on floor while emergency staff monitored vitals. Patient was cleared to leave with no additional harm observed about 10-15 minutes later and was feeling much better.
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| 2842484 | 68 | F | PA | 05/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Blood test, Hypoaesthesia, Paraesthesia
Blood test, Hypoaesthesia, Paraesthesia
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Toes numb, followed 5 months later by feet and hands tingling (pins and needles feeling).
Toes numb, followed 5 months later by feet and hands tingling (pins and needles feeling).
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✓ | |||||
| 2842485 | 87 | F | MS | 05/23/2025 |
PNC20 |
PFIZER\WYETH |
lc5482 |
Joint swelling
Joint swelling
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pt arm now swollen to elbow. recommended pt go to pcp or urgent care. she was unsure if she was goin...
pt arm now swollen to elbow. recommended pt go to pcp or urgent care. she was unsure if she was going to bc "she dont like going to the doctor". she said she would see if son would take her today. at time of this report i am unsure if she actually went yet
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| 2842486 | 0.17 | M | MT | 05/23/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
5H95B |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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It was discovered that patient is 2 months old and this combo vaccine is only licensed for patients ...
It was discovered that patient is 2 months old and this combo vaccine is only licensed for patients 4-6 years of age. There have been no adverse events reported at this time. Provider has been informed
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| 2842490 | UT | 05/23/2025 |
MMRV |
MERCK & CO. INC. |
Y008789 |
No adverse event, Product storage error
No adverse event, Product storage error
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No adverse event; HCP calling to report T/E. PROQUAD was inadvertently administered on 4/23/2025. No...
No adverse event; HCP calling to report T/E. PROQUAD was inadvertently administered on 4/23/2025. No other information was known or provided. T/E case# 02794150, Request case# 02794185. No additional AE reported. No PQC reported . ? Names of vaccines invol; This spontaneous report was received from a nurse and refers to a(n) patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-Apr-2025, the patient was inadvertently vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y008789, expiration date: 30-Oct-2025), diluted in sterile diluent (MERCK STERILE DILUENT), (expiration date, and lot # were not reported), for Prophylaxis. The vaccine had a temperature excursion o 72 F for a timeframe of 216 hours, There were no previous temperature excursions. No adverse event was reported.
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| 2842491 | 05/23/2025 |
PNC21 |
MERCK & CO. INC. |
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Product administered to patient of inappropriate age, Product label on wrong pro...
Product administered to patient of inappropriate age, Product label on wrong product
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They thought Capvaxive was the same as Prevnar 20 so they gave the Capvaxive; Caller reported that t...
They thought Capvaxive was the same as Prevnar 20 so they gave the Capvaxive; Caller reported that they have copies of internal emails that they sent to the providers and they have been labeling another Merck product, Capvaxive, was being labeled as Prevnar 21.; They administered the product PCV-21/capvaxive to a baby.; This spontaneous report was received from a reporter and refers to a baby patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (dose, route of administration, vaccination site, lot # and expiration date were not reported) administered for prophylaxis. It was reported that the providers were labeling PCV-15 and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (reported as PCV-21/Capvaxive) as pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20) (reported as Prevnar), and now there has been an administration error (product label on wrong product). The product of PCV-21/capvaxive was administered to a baby and the PCV-21/Capvaxive was not indicated for use in babies (product administered to patient of inappropriate age). They thought Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was the same as pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20) so they gave the Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (wrong product administered). The office thought it was Prevnar with an extra serotype, but that was not what happened. There could be more mistakes because of the misrepresentation of other 2 products. It was concerning.
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| 2842492 | NY | 05/23/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Z003766 |
No adverse event, Product storage error; No adverse event, Product storage error
No adverse event, Product storage error; No adverse event, Product storage error
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A pharmacist called and reported that an improperly stored dose of VARIVAX was administered to a pat...
A pharmacist called and reported that an improperly stored dose of VARIVAX was administered to a patient. The caller did not have any other additional information to add to further clarify the details, including patient demographics or the dates of a; No adverse event; This spontaneous report was received from a/an Pharmacist and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Z003766, expiration date: 30-Jan-2027) administered by Unknown route. The patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), for the treatment of Prophylaxis. On an unknown date, the patient experienced A pharmacist called and reported that an improperly stored dose of VARIVAX was administered to a patient. The caller did not have any other additional information to add to further clarify the details, including patient demographics or the dates of a. On an unknown date, the patient experienced No adverse event. At the reporting time, the outcome of A pharmacist called and reported that an improperly stored dose of VARIVAX was administered to a patient. The caller did not have any other additional information to add to further clarify the details, including patient demographics or the dates of a and No adverse event was unknown. The action taken with Varicella Virus Vaccine Live (Oka-Merck) was reported as not applicable. The case ws determined to be non-valid due to lack of patient's identifiers.
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| 2842493 | KY | 05/23/2025 |
MMR |
MERCK & CO. INC. |
X011431 |
No adverse event, Product storage error
No adverse event, Product storage error
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no adverse event; HCP called to report that an expired dose of MMRII was inadvertently administered ...
no adverse event; HCP called to report that an expired dose of MMRII was inadvertently administered to one patient on 04/28/2025. Caller confirmed the product has no history of temperature excursion. Permission given to contact HCP. No additional information provided.; This spontaneous report was received from Nurse Practitioner 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 28-Apr-2025, the patient was inadvertently vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X011431, expiration date: 19-Apr-2025), dose number 1, administered by Unknown route (strength, dose, frequency, vaccination scheme, and anatomical location were not reported) as Prophylaxis. No adverse event occurred. Caller confirmed the product has no history of temperature excursion.
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| 2842494 | NM | 05/23/2025 |
HBHEPB |
MERCK & CO. INC. |
Y005248 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE reported.; patient was administered PEDVAXHIB during a temperature excursion.; This...
No additional AE reported.; patient was administered PEDVAXHIB during a temperature excursion.; This spontaneous report was received from an office manager and refers to a(n) patient of unknown age and gender. The patient's medical history, conditions and concomitant therapies were not reported. On 22-Apr-2025, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), (lot #Y005248, expiration date: 17-Sep-2026) (1 dose), for prophylaxis, during a temperature excursion. The temperature was 0 degrees Celsius for a time frame of 1 hour. There were no previous temperature excursion. No additional Adverse Event was reported.
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| 2842495 | FL | 05/23/2025 |
RV5 |
MERCK & CO. INC. |
Unknown |
No adverse event, Product storage error
No adverse event, Product storage error
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no patient symptoms have been reported; ROTATEQ involved in a temperature excursion was administered...
no patient symptoms have been reported; ROTATEQ involved in a temperature excursion was administered to 1 patient; This spontaneous report was received from a Medical Assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored 1 dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), (strength, dose, formulation, route and site of administration not provided), lot # 4009341 was established as invalid upon internal validation, expiration date was reported as 24-NOV-2025, administered for prophylaxis (product storage error). The patient had no symptoms, no additional adverse event (AE) (no adverse event). On an unknown date, the suspect vaccine was involved in a temperature excursion of 32.0 degrees Fahrenheit (F) for 1 hour and 30 minutes. No previous excursions reported. Lot # is being requested and will be submitted if received.
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| 2842496 | MO | 05/23/2025 |
HEPA |
MERCK & CO. INC. |
Y006122 |
Expired product administered
Expired product administered
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No additional AE; HCP calling to report expired administration of VAQTA on 05/22/2025; This spontan...
No additional AE; HCP calling to report expired administration of VAQTA on 05/22/2025; This spontaneous report was received from a medical assistance referring to a patient, age and gender was not reported. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided. On 22-MAY-2025, the patient was vaccinated with an expiration dose of Hepatitis A Vaccine, Inactivated Suspension for injection (VAQTA), for prophylaxis (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number Y006122, with expiration date on 17-MAY-2025). (Expired product administered). There was not adverse event reported. (No adverse event).
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| 2842497 | M | CA | 05/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Injection site pain, Injection site swelling, Pruritus
Injection site pain, Injection site swelling, Pruritus
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patient had itching all over; Pain injection site; swollen at the injection site; This non-serious c...
patient had itching all over; Pain injection site; swollen at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (episode of Shingrix sometime around February and March of 2025), rash and scab. Concurrent medical conditions included disability. On 15-MAY-2025, the patient received the 1st dose of Shingrix (intramuscular, right arm) .5 ml. In MAY-2025, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain injection site) and injection site swelling (Verbatim: swollen at the injection site). On an unknown date, the patient experienced generalized pruritus (Verbatim: patient had itching all over). The outcome of the injection site pain and injection site swelling were unknown and the outcome of the generalized pruritus was not resolved. It was unknown if the reporter considered the injection site pain, injection site swelling and generalized pruritus to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site swelling and generalized pruritus to be related to Shingrix. Additional Information: GSK Receipt Date: 15-MAY-2025 The reporter was the patient. The patient reported on 15th May 2025, that he received the 1st dose of Shingrix vaccine at the beginning of May 2025 at a local pharmacy. The patient reported the vaccine was administered in the right arm. The patient reported that for the first 3 days he had pain at the injection site, and it was swollen. The patient reported that he had a previous episode of Shingrix sometime around February and March of 2025. The patient reported that he got the vaccine after his rash and scabbing was gone. The patient reported that after receiving the vaccine the patient had itching on the back, arm, chin, neck, head. The patient had itching all over. The patient reported that it had not improved. The patient described it was like welts or swelling spots. The reporter stated it was still happening and had not improved. The reporter reported that the patient did not see any rash, it was just itching. No additional information was reported. The patient declined to provide demographics and disconnected from the call abruptly. The agent was unable to obtain any additional information.
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| 2842498 | 12 | M | CA | 05/23/2025 |
TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
EB499 EB499 |
Dizziness, Fatigue, Headache, Hyperhidrosis, Injection site pain; Tinnitus, Visi...
Dizziness, Fatigue, Headache, Hyperhidrosis, Injection site pain; Tinnitus, Vision blurred
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sore arm (area were vaccine was administered); Dizziness; Headache; Blurry vision; Sweating; Fatigue...
sore arm (area were vaccine was administered); Dizziness; Headache; Blurry vision; Sweating; Fatigue extreme; Tinnitus; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number EB499, expiry date 26-AUG-2027) for prophylaxis. On 18-MAY-2025, the patient received Boostrix (left arm). In MAY-2025, an unknown time after receiving Boostrix, the patient experienced injection site pain (Verbatim: sore arm (area were vaccine was administered)). On 18-MAY-2025, the patient experienced dizziness (Verbatim: Dizziness), headache (Verbatim: Headache), blurred vision (Verbatim: Blurry vision), sweating (Verbatim: Sweating), fatigue (Verbatim: Fatigue extreme) and tinnitus (Verbatim: Tinnitus). In MAY-2025, the outcome of the injection site pain was resolved. On 18-MAY-2025, the outcome of the dizziness, headache, blurred vision, sweating, fatigue and tinnitus were resolved. It was unknown if the reporter considered the dizziness, headache, blurred vision, sweating, fatigue, tinnitus and injection site pain to be related to Boostrix. It was unknown if the company considered the dizziness, headache, blurred vision, sweating, fatigue, tinnitus and injection site pain to be related to Boostrix. Additional Information: GSK receipt date: 19-MAY-2025 Patient's mother stated that bout 10 seconds after the patient was administered the vaccine, patient began to feel following symptoms (dizziness, bad headache, blurry vision, profuse sweating, extreme tinnitus, extreme fatigue). Patient was given some water to drink, and in about 5 to 10 minutes later, symptoms stopped. Patient had a sore arm (area were vaccine was administered) later that night. Symptoms did not recur and patient had fully recovered.
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| 2842499 | 05/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Hypersensitivity
Hypersensitivity
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allergy/allergic reaction from the 1st one; This non-serious case was reported by a consumer via int...
allergy/allergic reaction from the 1st one; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergic reaction (Verbatim: allergy/allergic reaction from the 1st one). The outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Shingrix. It was unknown if the company considered the allergic reaction to be related to Shingrix. Additional Information: GSK receipt date: 15-MAY-2025 The case was reported by the patient via interactive digital media. No doctor said that he/she did not need it because he/she had a allergy, allergic reaction from the 1st one.
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| 2842500 | 05/23/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; had two shingles episodes since the vaccine; This serious case was re...
Suspected vaccination failure; had two shingles episodes since the vaccine; 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. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (got shingles outbreaks several times a year as a stress response) and stress. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had two shingles episodes since the vaccine). The outcome of the vaccination failure and shingles were not reported. The reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. The company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 16-MAY-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she got shingles outbreaks several times a year as a stress response. He/she got the two-part Shingrix vaccine a year ago in 2024 (from the date of reporting). It made no difference. He/she had two shingles episodes since the vaccine, and they had not been any milder. This case was considered as suspected vaccination failure as details regarding 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (1st dose)and Shingrix(2nd dose)
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| 2842501 | 05/23/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; got shinglesfrom a friend who had ybr shingles shot; This serious cas...
Suspected vaccination failure; got shinglesfrom a friend who had ybr shingles shot; 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. 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) and shingles (Verbatim: got shinglesfrom a friend who had ybr shingles shot). 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 Shingles vaccine. It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 16-MAY-2025 This case was reported by a consumer via interactive digital media. Consumer reported that got shingles from a friend who had ybr shingles shot. 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2842502 | 05/23/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Skin exfoliation
Skin exfoliation
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skin peeling on hands and feet; This non-serious case was reported by a consumer via interactive dig...
skin peeling on hands and feet; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of skin peeling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. In APR-2025, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced skin peeling (Verbatim: skin peeling on hands and feet). The outcome of the skin peeling was not resolved. It was unknown if the reporter considered the skin peeling to be related to Shingles vaccine. It was unknown if the company considered the skin peeling to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 16-MAY-2025 This case was reported by a patient via interactive digital media. The patient got the 1st vaccination in April and had a severe allergic reaction, skin peeling on hands and feet and still peeling on the day of reporting. The patient was not sure if want the second one.
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| 2842503 | 05/23/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Eye pain, Herpes zoster, Vaccination failure; Eye pain, Herpes zoster, Vaccinati...
Eye pain, Herpes zoster, Vaccination failure; Eye pain, Herpes zoster, Vaccination failure
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Suspected vaccination failure; now have shingles; terrible pain in my eye; This serious case was rep...
Suspected vaccination failure; now have shingles; terrible pain in my eye; 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: now have shingles) and eye pain (Verbatim: terrible pain in my eye). The outcome of the vaccination failure was not reported and the outcome of the shingles and eye pain were not resolved. It was unknown if the reporter considered the vaccination failure, shingles and eye pain to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and eye pain to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 16-MAY-2025 This case was reported by a patient via interactive digital media. The patient had the Shingles vaccine and booster dose of shingles about 5 years ago and at the time of reporting the patient had shingles. It's on the left side of face and head. The patient has terrible pain in eye. Going to get pressure checked in eye in just a few minutes. It was very painful. This case was considered as suspected vaccination failure as details regarding 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 , time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles (1st dose)and Shingles (2nd dose) .
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| 2842504 | 05/23/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; I got both shots and have had shingles twice since then; This serious...
Suspected vaccination failure; I got both shots and have had shingles twice since then; 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got both shots and have had shingles twice since then). 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 Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 17-MAY-2025 This case was reported by a patient via interactive digital media. The patient got both shots and have had shingles twice since then, worse than before he/she got the shots. The patient asked to do some research and stated, wish he/she had. This case was considered as suspected vaccination failure as details regarding 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 (h/o shingles, insufficient information provided about time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
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| 2842505 | 05/23/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Ophthalmic herpes zoster, Vaccination failure
Ophthalmic herpes zoster, Vaccination failure
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Suspected vaccination failure; I have it now in my eye area; This serious case was reported by a con...
Suspected vaccination failure; I have it now in my eye area; 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 shingles. 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) and ophthalmic herpes zoster (Verbatim: I have it now in my eye area) (serious criteria GSK medically significant). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster was not resolved. It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 18-MAY-2025 The case was received from the patient via interactive digital media. The reporter have it now in his/her eye area. This was 3rd time and he/she got the vaccine after 1st time. This case was considered as suspected vaccination failure as details regarding completion of primary 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Ophtalmic Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
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| 2842506 | 05/23/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Fatigue, Herpes zoster, Malaise, Neuralgia, Pain; Pyrexia, Vaccination failure
Fatigue, Herpes zoster, Malaise, Neuralgia, Pain; Pyrexia, Vaccination failure
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Suspected vaccination failure; I have them right now; nerve pain on all day; felt under the weather ...
Suspected vaccination failure; I have them right now; nerve pain on all day; felt under the weather all last week; 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. On an unknown date, the patient received Shingles vaccine. In MAY-2025, an unknown time after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: felt under the weather all last week). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I have them right now) and post herpetic neuralgia (Verbatim: nerve pain on all day). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the post herpetic neuralgia was resolved and the outcome of the feeling abnormal was resolved (duration 1 week). It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and feeling abnormal 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, post herpetic neuralgia and feeling abnormal to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-MAY-2025 The case was received from the patient via interactive digital media. The reporter reported that he/she had them right at the time of reporting. The reporter had the shots last fall thank goodness. The reporter felt under the weather all last week. Experience the nerve pain on all day Saturday and erupted Saturday night. The eruptions were minor for me but the pain, fatigue and fever were still very uncomfortable. The reporter was on anti-virals. The reporter thanked goodness for the vaccine. The reporter was sure he/she would have been very sick without it. This case was considered as suspected vaccination failure as details regarding completion of primary 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2842507 | 05/23/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Burning sensation, Herpes zoster, Vaccination failure
Burning sensation, Herpes zoster, Vaccination failure
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Suspected vaccination failure; i had t 3 times; This serious case was reported by a consumer via int...
Suspected vaccination failure; i had t 3 times; 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. 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) and shingles (Verbatim: i had t 3 times). 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 Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 18-MAY-2025 This case was reported by a patient via interactive digital media. The patient had it 3 times different, in the body, burning sensation, the vaccine did not work on patient. 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2842508 | 05/23/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; got shingles a few weeks ago; This serious case was reported by a con...
Suspected vaccination failure; got shingles a few weeks ago; 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. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles a few weeks ago). 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 and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 18-MAY-2025 This case was reported by a patient via interactive digital media The patient just got shingles a few weeks ago (from the date of reporting) in 2025. After having the two-part shot eight years ago. The patient's physician said that if he/she had not had the shot it would have been way worse. The Shingrix shot was 90 percent, but the patient guesses that he/she got from the 10 percent. This case was considered as suspected vaccination failure as details regarding 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 laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Doses 1 and Dose 2).
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| 2842509 | M | TN | 05/23/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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suspected vaccination failure; develop a small case of shingles; This serious case was reported by a...
suspected vaccination failure; develop a small case of shingles; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (developed a small area of shingles over the years). Concurrent medical conditions included diabetes. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: develop a small case of shingles). 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 and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 16-MAY-2025 Patient had been vaccinated with both doses of Shingrix and he was a 74 year old man with diabetes. Patient developed a small area of shingles over the years before and after vaccination. Even though he got vaccinated he still continues to develop a small case of shingles sometimes. This case was considered as suspected vaccination failure as details regarding 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 primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
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| 2842510 | 05/23/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; had two shingles episodes since the vaccine; This serious case was re...
Suspected vaccination failure; had two shingles episodes since the vaccine; 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. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (shingles outbreaks several times a year) and stress. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had two shingles episodes since the vaccine). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 02-MAY-2025 This case was reported by a patient via interactive digital media. The patient get shingles outbreaks several times a year as a stress response. The patient got the two-part Shingrix vaccine a year ago (in 2024). It made no difference. The patient had two shingles episodes since the vaccine and they had not been any milder. This case was considered as suspected vaccination failure as details regarding 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 (h/o shingles, insufficient information provided about time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
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| 2842511 | 05/23/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; had shingles down my leg from my hip to my knee!; This serious case w...
Suspected vaccination failure; had shingles down my leg from my hip to my knee!; 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. 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) and shingles (Verbatim: had shingles down my leg from my hip to my knee!). 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 Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 20-MAY_2025 This case was reported by a patient via interactive digital media. Patient had the complete vaccine and had shingles down my leg from hip to knee. 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 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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| 2842512 | 05/23/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Pain, Vaccination failure
Herpes zoster, Pain, Vaccination failure
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Suspected Vaccination failure; I've had shingles 3 times; This serious case was reported by a c...
Suspected Vaccination failure; I've had shingles 3 times; 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. 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) and shingles (Verbatim: I've had shingles 3 times). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 6 months). It was unknown if the reporter considered the vaccination failure and shingles 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 to be related to Shingles vaccine. Additional Information: GSK Receipt Date :21-MAY-2025 This case was reported by a patient via interactive digital media. Reporter had shingles 3 times even after he/she got the vaccine all three times it lasted for 6 months. He/she had never been in so much pain for so long it was a nightmare. 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 details regarding 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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| 2842513 | 05/23/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Injection site erythema
Injection site erythema
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the redness from my injection site is spreading; This non-serious case was reported by a consumer vi...
the redness from my injection site is spreading; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a 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 injection site erythema (Verbatim: the redness from my injection site is spreading). The outcome of the injection site erythema was not reported. Additional Information: GSK Receipt Date: 20-MAY-2025 It was reported that redness from his/her injection site had spread.
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| 2842514 | 61 | F | CA | 05/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3334Y |
Extra dose administered, Wrong product administered
Extra dose administered, Wrong product administered
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inadvertently administered a third dose of Shingrix to a patient; wrong vaccine administered; This n...
inadvertently administered a third dose of Shingrix to a patient; wrong vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 3334Y, expiry date 25-MAR-2027) for prophylaxis. Co-suspect products included Varicella zoster vaccine live (Oka/Merck) (Varivax) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 26-MAR-2024) and Shingrix (received 2nd dose on 28-MAY-2024). Concomitant products included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE). On 14-MAY-2025, the patient received the 3rd dose of Shingrix. On an unknown date, the patient received Varivax. On 14-MAY-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: inadvertently administered a third dose of Shingrix to a patient) and wrong vaccine administered (Verbatim: wrong vaccine administered). The outcome of the extra dose administered and wrong vaccine administered were not applicable. Additional Information: GSK receipt date: 14-MAY-2025 and 15-MAY-2025 The reporter reported that the patient received 3rd dose of Shingrix vaccine which led to, extra dose administered. She had received her first dose of the varicella vaccine on 6th March 25 and had been scheduled for her second dose of varicella on 14th May 2025. When asked, the nurse did not provide a reason why the patient had received the varicella vaccine after the Shingrix vaccination.
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| 2842515 | 11 | F | GA | 05/23/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
9KB9G |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Unapproved age; This non-serious case was reported by a other health professional via call center re...
Unapproved age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa (Infanrix) (batch number 9KB9G, expiry date 07-JUL-2026) for prophylaxis. Concomitant products included Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Boostrix). On 14-MAY-2025, the patient received Infanrix. On 14-MAY-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Unapproved 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: 14-MAY-2025 Office Manager reported that they had a patient in office today. So, they gave her a dtap and a tdap vaccine. So, they were just wondering if there were any contraindications that they need to be concerned about? Consented to follow up. The second line agent provided the information that with this Infanrix shot at the age of 11 years which led to inappropriate age at vaccine administration, patient had 5 DTAP vaccines.
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| 2842516 | F | MO | 05/23/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
DL32D |
Product storage error
Product storage error
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several vaccines that were exposed to a below temperature excursion; This non-serious case was repor...
several vaccines that were exposed to a below 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 elderly female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number DL32D) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: several vaccines that were exposed to a below temperature excursion). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date :15-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion of 29.9 degree Fahrenheit as the lowest reached for product which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter. No expiration date given for the vaccines nor date of administration. This was 1 of 5 linked cases, reported by same reporter different patient.; Sender's Comments: US-GSK-US2025061534:same reporter US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061545:Same reporter,Different patient
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| 2842517 | F | MO | 05/23/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
DL32D |
Product storage error
Product storage error
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Administration after a below temperature excursion of 29.9�F as the minimum reached.; This non-ser...
Administration after a below temperature excursion of 29.9�F as the minimum reached.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number DL32D) and (batch number 44TR9) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9�F as the minimum reached.). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 15-MAY-2025 The registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree Fahrenheit as the lowest reached Arexvy which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter.; Sender's Comments: US-GSK-US2025061548:SAme reporter US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061545:
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| 2842518 | F | MO | 05/23/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
DL32D |
Product storage error
Product storage error
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Administration after a below temperature excursion of 29.9 degree Fahrenheit; This non-serious case ...
Administration after a below temperature excursion of 29.9 degree Fahrenheit; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number DL32D) and (batch number 44TR9) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9 degree Fahrenheit). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK receipt date: 15-MAY-2025 The nurse reported after giving several vaccines that were exposed to a temperature of 29.9 degree Fahrenheit as the lowest reached for Boostrix, which led to incorrect storage of drug. The Vaccine Administration Facility was the same as Primary Reporter.; Sender's Comments: US-GSK-US2025061548: US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061538:same patient,Different suspect US-GSK-US2025061545:
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| 2842519 | F | MO | 05/23/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
39LB7 |
Product storage error
Product storage error
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Administration after a below temperature excursion of 29.9�F as the minimum reached.; This non-ser...
Administration after a below temperature excursion of 29.9�F as the minimum reached.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 60-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) 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: Administration after a below temperature excursion of 29.9�F as the minimum reached.). 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: 15-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree F as the lowest reached for following product Boostrix, which led to incorrect storage of vaccine. The Vaccine Administration Facility was the same as Primary Reporter. No expiration date given for the vaccines nor date of administration. The reporter consented to follow up.; Sender's Comments: US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061545: US-GSK-US2025061538:
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| 2842520 | M | MO | 05/23/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
39LB7 |
Product storage error
Product storage error
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Administration after a below temperature excursion of 29.9�F as the minimum reached.; This non-ser...
Administration after a below temperature excursion of 29.9�F as the minimum reached.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) and (batch number 2B723) 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: Administration after a below temperature excursion of 29.9�F as the minimum reached.). 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: 15-MAY-2025 The registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree Fahrenheit as the lowest reached Boostrix which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter.; Sender's Comments: US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061545:
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| 2842521 | F | MO | 05/23/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
PG52S |
Product storage error
Product storage error
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several vaccines that were exposed to a below temperature excursion; This non-serious case was repor...
several vaccines that were exposed to a below 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 adult female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number PG52S) for prophylaxis. On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: several vaccines that were exposed to a below 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: 15-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion of 29.9 degree Fahrenheit as the lowest reached for product which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter. This is one of 4 linked cases reported by same reporter different patient.; Sender's Comments: US-GSK-US2025061548:same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061545:Same reporter,Different patient
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| 2842522 | F | MO | 05/23/2025 |
FLU3 HEPA MNQ RSV TDAP VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
PG52S 423NO AMVBO44A 44TR9 39LB7 M7G39 |
Product storage error; Product storage error; Product storage error; Product sto...
Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error
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Administration after a below temperature excursion of 29.9�F as the minimum reached; This non-seri...
Administration after a below temperature excursion of 29.9�F as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a adult female patient who received Herpes zoster (Shingrix) (batch number M7G39) for prophylaxis. Co-suspect products included RSVPreF3 adjuvanted (Arexvy) (batch number 44TR9) and (batch number DL32D) for prophylaxis, DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) and (batch number 2B723) for prophylaxis, Men ACWY-CRM NVS (Menveo) (batch number AMVBO44A) and (batch number LB93L) for prophylaxis, HAV (Havrix) (batch number 423NO) for prophylaxis and Flu Seasonal TIV Dresden (Fluarix) (batch number PG52S) for prophylaxis. On an unknown date, the patient received Shingrix and Arexvy. On an unknown date, the patient received Boostrix. On an unknown date, the patient received Menveo. On an unknown date, the patient received Havrix and Fluarix. On an unknown date, an unknown time after receiving Shingrix, Arexvy, Boostrix, Menveo, Havrix and Fluarix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9�F as the minimum reached). 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: 15-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case 02294438 of 29.9 degree Fahrenheit as the lowest reached for following products: Arexvy (lot numbers: 44TR9 and DL32D), Boostrix (39LB7 and 2B723), Menveo (1 vial: AMVBO44A and LB93L), Havrix (423NO), Fluarix (PG52S) & Shingrix (M7G39) which led to incorrect storage of drug. The Vaccine Administration Facility is the same as Primary Reporter. No expiration date was given for the vaccines nor the date of administration. Consented to follow up.; Sender's Comments: US-GSK-US2025061548: US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061545:
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| 2842523 | M | MO | 05/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
M7G39 |
Product storage error
Product storage error
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Administration after a below temperature excursion of 29.9 degree Fahrenheit; This non-serious case ...
Administration after a below temperature excursion of 29.9 degree Fahrenheit; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Herpes zoster (Shingrix) (batch number M7G39) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9 degree Fahrenheit). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 15-MAY-2025 and 16-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a temperature excursion of 29.9 degree Fahrenheit as the lowest reached for Shingrix which led to incorrect storage of drug. The Vaccine Administration Facility was the same as Primary Reporter.; Sender's Comments: US-GSK-US2025061548: US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061545:
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| 2842524 | F | MO | 05/23/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
2B723 |
Product storage error
Product storage error
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Administration after a below temperature excursion of 29.9�F as the minimum reached.; This non-ser...
Administration after a below temperature excursion of 29.9�F as the minimum reached.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2B723) and (batch number 39LB7) 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: Administration after a below temperature excursion of 29.9�F as the minimum reached.). 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: 15-MAY-2025 The registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree Fahrenheit as the lowest reached Boostrix which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter.; Sender's Comments: US-GSK-US2025061548: US-GSK-US2025061548: US-GSK-US2025061564:SAME PATIENT SAME REPORTER, DIFFERENT SUSPECT US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061545:
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| 2842525 | 0.42 | F | SD | 05/23/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
Y49BZ |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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A 5 months old female patient received a dose of Kinrix; This non-serious case was reported by a nur...
A 5 months old female patient received a dose of Kinrix; 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 5-month-old female patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis. On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: A 5 months old female patient received a dose of Kinrix). 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: 20-MAY-2025 On 19th May 2025, an reporter called to report that they had administered a dose of Kinrix to a five month old female patient, which led to Inappropriate age at vaccine administration.
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| 2842526 | 1.5 | M | PA | 05/23/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
423NL |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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administration of the second dose of Havrix 4 months after the initial dose; This non-serious case w...
administration of the second dose of Havrix 4 months after the initial 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 short in a 18-month-old male patient who received HAV (Havrix) (batch number 423NL, expiry date 16-NOV-2025) for prophylaxis. Previously administered products included Havrix (received 1st dose of vaccine on 26th January 2024, batch no F3Y25, expiry date 15th February 2025). On 28-MAY-2024, the patient received the 2nd dose of Havrix. On 28-MAY-2024, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: administration of the second dose of Havrix 4 months after the initial dose). The outcome of the drug dose administration interval too short 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 :19-MAY-2025 An office coordinator called in to request data about the administration of the second dose of Havrix 4 months after the initial dose. The patient was 18 months of age at the time of the second dose. They requested medical information and declined to receive follow-up. The patient received 2nd dose of Havrix earlier than recommended interval, which led to shortening of vaccination schedule.
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| 2842527 | IA | 05/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
74NC9 |
Product preparation issue
Product preparation issue
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Wrong Solution Used (Dose mixed inadvertently with another diluent); was inadvertently given to a pa...
Wrong Solution Used (Dose mixed inadvertently with another diluent); was inadvertently given to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number 74NC9, expiry date 13-NOV-2026) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Wrong Solution Used (Dose mixed inadvertently with another diluent)) and inappropriate dose of vaccine administered (Verbatim: was inadvertently given to a patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 19-MAY-2025 Nurse calls to ask about the efficacy of the Shingrix dose that was inadvertently given to a patient. The nurse mixed a Shingrix vaccine with a regular diluent (non-specified from the Registered Nurse�s end). Vaccine detail was obtained in this call. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter.
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