| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2833627 | 41 | M | CT | 03/28/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
AK334 |
Extra dose administered
Extra dose administered
|
APRN alerted nursing staff through Teams Chat to give a TDAP vaccine to a patient . I did not see t...
APRN alerted nursing staff through Teams Chat to give a TDAP vaccine to a patient . I did not see the message when it was sent, and 10 minutes later provider came to the lab where nurses work and asked if we had seen the message and the patient had been waiting. I prepared the vaccine, scanned the vaccine in the patient's chart and went to the patient room I believed I was supposed to go to. I was rushing a bit because I knew the patient had been waiting. In the room I asked the patient his first name starting with the same letter and he confirmed. Unfortunately, I did not ask any other identifiers, as I was concerned he had been waiting for a while. I explained to the patient that he would be getting a TDAP and proceeded to ask the following standard questions we ask prior to giving any vaccine, He said no to all of these. He agreed to take the vaccine and asked if it could be administered in the right arm. I then gave the vaccine, and afterwards he asked if he was still going to see the provider. At that moment I realized that this was not the patient the provider wanted me to give the vaccine to, as he always asks for vaccines after he has seen the patient. I asked the patient to repeat his name, and he said initials. I asked why he confirmed his name started with a different letter and he said he was distracted with his phone. I had to explain to the patient what happened. He asked if there was any danger getting the TDAP if he did not need it at this time. I looked in his chart and saw he had a TDAP in 2023. I told him this would not be detrimental to his health, but apologized for the incident and told him I would report this to his provider, my managers and take all the proper channels to report what happened. The patient was very nice about it, and said he understood it was a mistake but he was not going to pursue any actions. I reported the incident to my supervisor and she contacted our regional manager for the next step which was to report the incident to VAERS as well as our own company adverse event reporting system.
More
|
||||||
| 2833628 | 61 | M | WI | 03/28/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
945659 |
Vaccination error
Vaccination error
|
Patient was given vaccine that wasn't on his care gap. No patient history of vaccine being rec...
Patient was given vaccine that wasn't on his care gap. No patient history of vaccine being received or administered in patients chart previously, however. Outcome, provider discussed with patient the vaccination issue.
More
|
||||||
| 2833629 | 4 | F | DC | 03/28/2025 |
VARCEL |
MERCK & CO. INC. |
|
Exposure to communicable disease, Pyrexia, Rash, Varicella post vaccine, Varicel...
Exposure to communicable disease, Pyrexia, Rash, Varicella post vaccine, Varicella virus test positive
More
|
Pt was visiting family from 3/8 to 3/15. Shortly after they left, they became aware that young fami...
Pt was visiting family from 3/8 to 3/15. Shortly after they left, they became aware that young family member they were visiting went on to develop Varicella infection. Pt was fine and seen on 3/18 at primary care office for 4yo routine visit, in which Varicella vaccine 2nd dose was given. Pt went on to develop lowgrade fever and rash c/w mild case of Varicella beginning on 3/27. Seen in primary care office that day and PCR testing from skin swab confirmed Varicella infection. Unclear if symptoms are due to vaccine or wild-type infection after known exposure.
More
|
||||||
| 2833630 | 50 | F | OR | 03/28/2025 |
TDAP |
SANOFI PASTEUR |
U8252AA |
Injected limb mobility decreased, Muscular weakness, Myalgia, Neuralgia, Paraest...
Injected limb mobility decreased, Muscular weakness, Myalgia, Neuralgia, Paraesthesia
More
|
muscle paralysis, difficulty lifting or using left arm. difficulty applying pressure or holding anyt...
muscle paralysis, difficulty lifting or using left arm. difficulty applying pressure or holding anything with left arm. nerve pain and tingling in in left hand. muscle weakness, exessery muscle soreness. had to wear an arm splint for pain relief and support. No muscular inflammation or pain initially following vaccine. Muscle paralysis began less than 24 hours after vaccine administration in left deltoid/shoulder area.
More
|
||||||
| 2833631 | 18 | M | FL | 03/28/2025 |
MENB MNQ |
PFIZER\WYETH SANOFI PASTEUR |
gf4147 u8375AA |
Erythema, Pyrexia; Erythema, Pyrexia
Erythema, Pyrexia; Erythema, Pyrexia
|
fever - tylenol and motrin, right arm redness and streaks - Urgent care gave steroids.
fever - tylenol and motrin, right arm redness and streaks - Urgent care gave steroids.
|
||||||
| 2833632 | 82 | F | NC | 03/28/2025 |
COVID19 |
MODERNA |
3043823 |
Asthenia, Feeling cold, Nausea, Sleep disorder, Tremor
Asthenia, Feeling cold, Nausea, Sleep disorder, Tremor
|
EVENING OF SHOT PT STATES SHE WAS "FREEZING COLD AND COULD NOT STOP SHAKING AND HAD SOME NAUSEA...
EVENING OF SHOT PT STATES SHE WAS "FREEZING COLD AND COULD NOT STOP SHAKING AND HAD SOME NAUSEA BUT NO VOMITING. WENT TO BED AND WAS UP ABOUT EVERY HOUR TO FIGURE OUT HOW TO GET TO BATHROOM TO PEE" NEXT MORNING "HAD NAUSEA OFF AND ON DURING THE DAY AND WAS STILL WEAK AND SHAKING" AND IS SHAKING UNTIL TODAY WHEN SHE CAME INTO REPORT HER REACTION.
More
|
||||||
| 2833633 | 1.17 | M | NC | 03/28/2025 |
MMRV |
MERCK & CO. INC. |
Y014307 |
No adverse event
No adverse event
|
No adverse event at this time
No adverse event at this time
|
||||||
| 2833634 | 5 | F | MD | 03/28/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
FLN7302 FAE2J7 |
Blood test, Electroencephalogram, Lumbar puncture, Magnetic resonance imaging, S...
Blood test, Electroencephalogram, Lumbar puncture, Magnetic resonance imaging, Seizure; Blood test, Electroencephalogram, Lumbar puncture, Magnetic resonance imaging, Seizure
More
|
3/23/25 had 3 seizures
3/23/25 had 3 seizures
|
โ | |||||
| 2833635 | 53 | F | GA | 03/28/2025 |
PNC20 VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
lk6650 7zm55 |
Injection site pain, Injection site reaction, Injection site swelling, Injection...
Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth; Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
More
|
Patient reports small injection site reaction (few cm wide red marking) on 3/26. By 3/28, reaction h...
Patient reports small injection site reaction (few cm wide red marking) on 3/26. By 3/28, reaction had spread to entire lower half of bicep (7inches wide by 7inches tall). Patient reports slight burning sensation, swelling and warm to the touch. Patient reports taking Benadryl with no relief.
More
|
||||||
| 2833636 | 66 | M | CA | 03/28/2025 |
PNC21 |
MERCK & CO. INC. |
Y013009 |
Erythema, Pain
Erythema, Pain
|
Pt received vaccine on 3/21 and came back to the pharmacy on 3/28. Patient still had red marking 8&q...
Pt received vaccine on 3/21 and came back to the pharmacy on 3/28. Patient still had red marking 8"x5" redness but report pain and swelling has gone away
More
|
||||||
| 2833637 | 14 | M | ND | 03/28/2025 |
COVID19 |
MODERNA |
8080803 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Patient was given a 5-day expired dose of Moderna COVID vaccine. No adverse effects.
Patient was given a 5-day expired dose of Moderna COVID vaccine. No adverse effects.
|
||||||
| 2833638 | 30 | M | OH | 03/28/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
K4JH7 |
Underdose
Underdose
|
Patient received the pediatric dose of the Hep B vaccine instead of the adult dose.
Patient received the pediatric dose of the Hep B vaccine instead of the adult dose.
|
||||||
| 2833639 | 56 | F | NY | 03/28/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
7MR5N215N2 7MR5N215N2 |
Chills, Ear discomfort, Ear pain, Injection site rash, Injection site warmth; Ly...
Chills, Ear discomfort, Ear pain, Injection site rash, Injection site warmth; Lymph node pain, Lymphadenopathy, Myalgia, Pain, Rash
More
|
Muscle and body aches and shivering within 15 hrs of administering and 2 days later , hot painful r...
Muscle and body aches and shivering within 15 hrs of administering and 2 days later , hot painful rash on arm 1 inch under vaccine and 9 days after vax , Swollen and enlarged and painful right cervical lymph node in neck along with burning and pain in right ear CURRENTLY BEING TREATED AND WILL GO BACK IN ONE WEEK IF NO CHANGE
More
|
||||||
| 2833640 | 72 | F | AL | 03/28/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
Extra dose administered
Extra dose administered
|
A dose of RSV vaccine was administered when they had previously received a dose.
A dose of RSV vaccine was administered when they had previously received a dose.
|
||||||
| 2833641 | 1.33 | F | IA | 03/28/2025 |
COVID19 DTAPIPVHIB FLU3 HEPA MMR PNC20 VARCEL |
MODERNA SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
3044143 UK107AA UT8434MA X2233 X027447 HNS980 Y014868 |
Circumstance or information capable of leading to medication error, No adverse e...
Circumstance or information capable of leading to medication error, No adverse event; Circumstance or information capable of leading to medication error, No adverse event; Circumstance or information capable of leading to medication error, No adverse event; Circumstance or information capable of leading to medication error, No adverse event; Circumstance or information capable of leading to medication error, No adverse event; Circumstance or information capable of leading to medication error, No adverse event; Circumstance or information capable of leading to medication error, No adverse event
More
|
Pentacel was given on 2/28 intramuscularly in left thigh, possibly without the hib component. Spok...
Pentacel was given on 2/28 intramuscularly in left thigh, possibly without the hib component. Spoke with mom on the phone and she does not report any s/s. Was discovered in vaccine count. Mom is coming to administer single hib vaccination to patient to make up for the potentially missed vaccination on 3/31/2025.
More
|
||||||
| 2833642 | 48 | F | 03/28/2025 |
FLU3 |
SANOFI PASTEUR |
u8527a |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
Pharmacist administered Fluzone HD instead of Fluzone (regular). Patient had no complaints at time o...
Pharmacist administered Fluzone HD instead of Fluzone (regular). Patient had no complaints at time of report.
More
|
|||||||
| 2833643 | 0.33 | M | CA | 03/28/2025 |
DTAPHEPBIP HIBV PNC20 RV1 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
B532G Be9G7 LX4482 7E9Y2 |
Brief resolved unexplained event; Brief resolved unexplained event; Brief resolv...
Brief resolved unexplained event; Brief resolved unexplained event; Brief resolved unexplained event; Brief resolved unexplained event
More
|
BRUE, possible seizure
BRUE, possible seizure
|
โ | |||||
| 2833644 | 75 | F | 03/28/2025 |
FLU3 |
SANOFI PASTEUR |
U8532CA |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Patient received two high dose flu shots 1 month apart. Patient received 1 shot on 02/19/25 and the...
Patient received two high dose flu shots 1 month apart. Patient received 1 shot on 02/19/25 and the second on 03/14/25. Patient is feeling fine, reported no sickness.
More
|
|||||||
| 2833645 | 77 | F | FL | 03/28/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Aspiration pleural cavity, Blood test, Computerised tomogram thorax, Pleural eff...
Aspiration pleural cavity, Blood test, Computerised tomogram thorax, Pleural effusion, Respiratory distress; Ultrasound scan, X-ray
More
|
pleural effusion and respiratory distress resulting in multiple hospitalizations. 324/25-3/26/25 an...
pleural effusion and respiratory distress resulting in multiple hospitalizations. 324/25-3/26/25 and readmit 3/27/25 until current
More
|
โ | โ | โ | |||
| 2833646 | 68 | F | GA | 03/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
99D52 |
Injection site inflammation, Injection site reaction, Rash erythematous, Rash pr...
Injection site inflammation, Injection site reaction, Rash erythematous, Rash pruritic
More
|
SHINGRIX DOSE 2: PT HAD ITCHY RED INFLAMMED RASH WITHOUT BUMPS AT SITE OF INJECTION THAT LASTED AT L...
SHINGRIX DOSE 2: PT HAD ITCHY RED INFLAMMED RASH WITHOUT BUMPS AT SITE OF INJECTION THAT LASTED AT LEAST 2 WEEKS
More
|
||||||
| 2833647 | 41 | F | PA | 03/28/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
994915 |
Muscle swelling, Superficial vein prominence
Muscle swelling, Superficial vein prominence
|
LEFT HAND, PALM MUSCLE RIGHT BELOW THUMB WAS SLIGHTLY SWOLLEN . PATIENT IS NOT SURE IF ITS SWOLLEN,...
LEFT HAND, PALM MUSCLE RIGHT BELOW THUMB WAS SLIGHTLY SWOLLEN . PATIENT IS NOT SURE IF ITS SWOLLEN, OR IN THEIR HEAD, BUT IT SEEMS BIGGER THAN THEIR OTHER HAND WITH SLIGHTLY MORE PROMINENT VEINS
More
|
||||||
| 2833648 | 21 | F | TX | 03/28/2025 |
HPV9 TD TDAP |
MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
y012921 324BY U81222A |
Dizziness, Syncope, Vomiting; Dizziness, Syncope, Vomiting; Dizziness, Syncope, ...
Dizziness, Syncope, Vomiting; Dizziness, Syncope, Vomiting; Dizziness, Syncope, Vomiting
More
|
Adverse event: dizziness, fainted, and vomiting . Pharmacist gave her water and some candies. After ...
Adverse event: dizziness, fainted, and vomiting . Pharmacist gave her water and some candies. After she vomited, she felt better, no epi pen needed or EMS
More
|
||||||
| 2833649 | 0.5 | F | TX | 03/28/2025 |
DTPPVHBHPB PNC20 |
MSP VACCINE COMPANY PFIZER\WYETH |
2CA53C1 LX2497 |
Body temperature increased; Body temperature increased
Body temperature increased; Body temperature increased
|
Both vaccines were given at Well Check at 0955. Pt developed a temperature of 99.0 early afternoon,...
Both vaccines were given at Well Check at 0955. Pt developed a temperature of 99.0 early afternoon, then approximately at 1630, temp went up to 101.4. Pt vomited twice, last episode was at 1450.
More
|
||||||
| 2833650 | M | KY | 03/28/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
95d74 |
Underdose
Underdose
|
Adult patient administered pediatric dose of vaccine.
Adult patient administered pediatric dose of vaccine.
|
|||||||
| 2833651 | 51 | F | NY | 03/28/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
y019157 y019157 |
Arthralgia, Erythema, Induration, Injection site infection, Pain in extremity; U...
Arthralgia, Erythema, Induration, Injection site infection, Pain in extremity; Urticaria
More
|
Received vaccines On Friday 3/21/2025 and noticed arm soreness on Saturday and the walnut size on ...
Received vaccines On Friday 3/21/2025 and noticed arm soreness on Saturday and the walnut size on Sunday that area got bigger and harder. Called primary on Monday and they saw patient and informed she had infection at site of injections and gave first antibiotic Bactrim. Then 3/27 woke up with red spot and hives. She picked up medication for clindamycin and prednisone 3/28.
More
|
||||||
| 2833661 | M | IA | 03/28/2025 |
MMR MMR |
MERCK & CO. INC. MERCK & CO. INC. |
Y013131 |
Inflammation; Inflammation
Inflammation; Inflammation
|
inflammation; This spontaneous report was received from a pharmacist and refers to a male patient of...
inflammation; This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. The patient's medical history, concurrent conditions were, and concomitant therapies were not reported. On 24-Feb-2025, the patient was vaccinated for prophylaxis with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Solution for injection (lot #Y013131, expiration date: 30-Jul-2026), 0.5 mL/ series) reconstituted with sterile diluent (BAXTER STERILE DILUENT). On an unspecified date in 2025, the patient probably experienced inflammation as the pharmacist received an order for methylprednisolone (MEDROL DOSE PACK). At the reporting time, the outcome of inflammation was unknown. The causal relationship between the event of inflammation and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) sterile diluent (BAXTER STERILE DILUENT) was not reported.
More
|
|||||||
| 2833662 | MA | 03/28/2025 |
VARCEL |
MERCK & CO. INC. |
Y011019 |
No adverse event, Product storage error
No adverse event, Product storage error
|
No adverse event; HCP called to report inadvertent administration of VARIVAX after a temperature exc...
No adverse event; HCP called to report inadvertent administration of VARIVAX after a temperature excursion. Vaccine was administered on 04MAR2025 to a patient. Limited demographics provided. No additional AE/PQC. No additional information. ? Names of vacc; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. HCP called to report inadvertent administration of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE) (dose, units, and route of administration were not reported) (lot #Y011019, expiration date: 18-Jun-2026) for prophylaxis after a temperature excursion (Product storage error). Vaccine was administered on 04-MAR-2025 to a patient. Temperature excursion was reported as follows: -12.13C for a time frame of 0 hours 39 minutes 0 seconds. Previous temperature excursion of -14.19C for 9 minutes; and -14.25C for 16 minutes. There was no additional AE/PQC (No adverse event).
More
|
||||||||
| 2833663 | 28 | F | 03/28/2025 |
HPV9 |
MERCK & CO. INC. |
|
Exposure during pregnancy
Exposure during pregnancy
|
sitting wait woman whose daughter is 28 and pregnant. Has HPV.; sitting wait woman whose daughter is...
sitting wait woman whose daughter is 28 and pregnant. Has HPV.; sitting wait woman whose daughter is 28 and pregnant. Has HPV.; This spontaneous prospective pregnancy report was received from a Consumer or other non-health professional and refers to a 28-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. The patient's gravidity was reported as 1 and information regarding her fetal outcome was not provided. On an unknown date, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) dose number 1 as prophylaxis (lot #, expiration date, dose, units, route of administration and anatomical location were not reported) (exposure during pregnancy). On an unknown date, the patient experienced human papillomavirus virus (HPV) infection (papilloma viral infection). By the reporting time, the patient had not recovered from the event papilloma viral infection, whereas regarding exposure during pregnancy was not provided. The causal relationship between the events and the suspect vaccine was not provided.
More
|
|||||||
| 2833664 | M | NC | 03/28/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
|
Incomplete course of vaccination, No adverse event; Incomplete course of vaccina...
Incomplete course of vaccination, No adverse event; Incomplete course of vaccination, No adverse event
More
|
HCP calling to report that her partner did not receive his 3rd dose of GARDASIL 9 that was due on 1/...
HCP calling to report that her partner did not receive his 3rd dose of GARDASIL 9 that was due on 1/31/2025 because his insurance denied it since he is 46 years old. First and second GARDASIL 9 doses were administered appropriately.; No adverse effects reported.; This spontaneous report was received from a nurse and refers to a 46-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patient was vaccinated with the first and second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, formulation, route of administration, lot # and expiration date were not reported) as prophylaxis. Health care professional (HCP) called to report that her partner did not receive his third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) that was due on 31-Jan-2025 because his insurance denied it since he was 46 years old (Incomplete course of vaccination). First and second doses were administered appropriately. No adverse effects reported (No adverse event).
More
|
|||||||
| 2833665 | 11 | M | MD | 03/28/2025 |
HPV9 |
MERCK & CO. INC. |
X014788 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
the patient did not report any adverse issues or side effects from the administered dose; Expired do...
the patient did not report any adverse issues or side effects from the administered dose; Expired dose was inadvertently administered to a patient on 03/10/2025. The dose had never undergone any temperature excursions; This spontaneous report was received from Other health professional and refers to a 11-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 10-Mar-2025, the patient was inadvertently vaccinated with and expired dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Injection, 0.5 mL, once (strength, route of administration, site of administration, and vaccination scheme were not provided; lot # X014788 which has been verified as a valid number, and expiration date reported and validated as 07-Mar-2025) as a prophylaxis. The dose had never undergone any temperature excursions. The patient did not report any adverse issues or side effects from the administered dose.
More
|
||||||
| 2833666 | F | MA | 03/28/2025 |
PNC21 |
MERCK & CO. INC. |
|
Chills, Gaze palsy, Pain, Pyrexia, Vaccination site swelling
Chills, Gaze palsy, Pain, Pyrexia, Vaccination site swelling
|
agent called on behalf of a consumer friend who reported via text that she experienced injection sit...
agent called on behalf of a consumer friend who reported via text that she experienced injection site redness and swelling after receiving CAPVAXIVE. The CAPVAXIVE was administered on 3/15/25 at a pharmacy. The consumer reported ha; headache; vaccination site swelling; fever; body chills; body aches; This spontaneous report was received from the patient's friend and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions included Celiac disease, and Asthma. Concomitant therapies were not reported. On 15-Mar-2025, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (strength, dose, dose number, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. On unspecified date in March 2025 at a pharmacy (also reported as: After receiving CAPVAXIVE), the patient experienced injection site redness and swelling , also experienced fever, body chills, body aches and headaches. It was mentioned that as of 17-MAR-2025, the patient reported feeling better, however the outcome of all adverse events was reported as recovering. The causal relationship between all adverse events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided.
More
|
|||||||
| 2833667 | 0.17 | CA | 03/28/2025 |
HPV9 |
MERCK & CO. INC. |
|
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
calling on behalf of Medical Assistant with a report of an adverse event regarding GARDASIL 9. FBE ...
calling on behalf of Medical Assistant with a report of an adverse event regarding GARDASIL 9. FBE reporting that the Medical Assistant stated: "A patient of our practice was inadvertently administered a dose of GARDASIL 9 when they were 2 month; No additional AE; This spontaneous report has been received from a certified medical assistant (C.M.A.) via company representative and refers to a 2-month-old patient of unknown gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided. On an unknown date, at the age of 2 months old, the patient was inadvertently administered a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) suspension for injection, 0.5 ml (lot#, expiration date, route of administration, anatomical location were not reported), for prophylaxis (Product administered to a patient of inappropriate age). At the reporting time, the patient was 11 years old and the reporter was inquiring if the patient would be eligible for vaccination with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) as they were within the recommended age. The reporter confirmed they did not receive any reports of the patient having any medical concerns or symptoms at the time they were administered the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) inadvertently. No additional adverse event was reported. Lot# is being requested and will be submitted if received.
More
|
|||||||
| 2833668 | MD | 03/28/2025 |
VARCEL |
MERCK & CO. INC. |
Y011712 |
No adverse event, Product storage error
No adverse event, Product storage error
|
No additional AE; Inbound call from HBP regarding T/E for VARIVAX on 1/29/2025. See T/E case #027760...
No additional AE; Inbound call from HBP regarding T/E for VARIVAX on 1/29/2025. See T/E case #0277601. HBP reported that vaccines were administered to patients. No symptomatic events reported. MD agrees to be correspondence contact for AE case. No additional AE/No PQC; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-MAR-2025, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka-Merck) (VARIVAX) solution for injection, 0.5 ml, lot #Y011712, expiration date: 02-JUL-2026 (route of administration and anatomical location were not provided), for prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection (lot# and expiry date were not reported). On 29-JAN-2025, the vaccine underwent a temperature excursion of 14.65 Fahrenheit (F) degrees for 13 hours and 15 minutes. There was no previous temperature excursion. Data logger was not involved. No symptomatic events, no additional adverse events were reported.
More
|
||||||||
| 2833669 | M | NJ | 03/28/2025 |
PNC15 PNC15 PNC15 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
|
Pneumonia, Sepsis; Pneumonia, Sepsis; Pneumonia, Sepsis
Pneumonia, Sepsis; Pneumonia, Sepsis; Pneumonia, Sepsis
|
pneumonia sepsis; pneumonia sepsis; This spontaneous report was received from an Other health profes...
pneumonia sepsis; pneumonia sepsis; This spontaneous report was received from an Other health professional (HCP) via field employee and refers to a Child male patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown dates, the patient was vaccinated 3 doses of Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) Suspension for injection, (indication, expiration date, and lot # were not reported) for prophylaxis. Reporter said that after the third dose the child developed pneumonia sepsis. This happened last year (in approximately 2024), the HCP did not have an exact date and the nurse who worked with the child was not available. Child was hospitalized. At the reporting time, the outcome of pneumonia sepsis was unknown. The causal relationship between the event of pneumonia sepsis and Pneumococcal 15-valent Conjugate Vaccine was not provided.
More
|
โ | ||||||
| 2833671 | F | PA | 03/28/2025 |
HPV9 |
MERCK & CO. INC. |
|
Syncope
Syncope
|
fainted; This spontaneous report was received from a physician via a company employee and refers to ...
fainted; This spontaneous report was received from a physician via a company employee and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAR-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) (exact dose, expiration date, lot #, route of administration, and anatomical location were not reported) for prophylaxis. On that day, after receiving Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), the patient fainted. Once the patient was responsive again, she was assessed and allowed to leave with her father. The patient returned to school after their doctor's visit and proceeded to participate in normal activities during and after school, including sports, with no issue. No further issues were reported about this patient. At the reporting time, the outcome of the event was not reported. The causal relationship between the event of fainted and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) was not provided. Upon internal review, the events of fainted was determined to be medically significant.
More
|
|||||||
| 2833672 | TX | 03/28/2025 |
DTPPVHBHPB PNC15 RV5 |
MSP VACCINE COMPANY MERCK & CO. INC. MERCK & CO. INC. |
u7767aa Y005351 Y009786 |
No adverse event, Product administered to patient of inappropriate age; No adver...
No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age
More
|
no additional AE; HCP called to report a patient received ROTATEQ, VAXELIS and VAXNEUVANCE at 41 day...
no additional AE; HCP called to report a patient received ROTATEQ, VAXELIS and VAXNEUVANCE at 41 days instead of the recommended 42 day vaccination schedule. No side effects or symptoms reported. No Additional AE/ No PQC.; This spontaneous report was received from an other health professional and refers to a 1-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 03-Jan-2025, the patient was vaccinated with Pneumococcal 15-valent Conjugate Vaccine Injection (lot #Y005351, expiration date: 08-Jan-2027) 0.5 mL, Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #Y009786, expiration date: 20-Nov-2025) 2 mL, administered by Oral route and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine (VAXELIS), Injection (lot #u7767aa was an invalid lot#, expiration date was reported as 26-May-2026) 0.5 mL at 41 days instead of the recommended 42 day vaccination schedule (Product administered to patient of inappropriate age). No side effects or symptoms reported. No Additional AE (no adverse event).
More
|
||||||||
| 2833673 | M | 03/28/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Cardiac disorder, Heart valve replacement, Impaired work ability, Surgery
Cardiac disorder, Heart valve replacement, Impaired work ability, Surgery
|
Has a pig valve in his heart to save his life; that virus attacked his heart; has had multiple surge...
Has a pig valve in his heart to save his life; that virus attacked his heart; has had multiple surgeries; had to retire early from his bank; This serious case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a male 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 near death experience (Verbatim: Has a pig valve in his heart to save his life) (serious criteria GSK medically significant and life threatening), heart disorder (Verbatim: that virus attacked his heart) (serious criteria life threatening and clinically significant/intervention required), surgery (Verbatim: has had multiple surgeries) (serious criteria clinically significant/intervention required) and impaired work ability (Verbatim: had to retire early from his bank). The outcome of the near death experience, heart disorder, surgery and impaired work ability were not reported. The reporter considered the near death experience, heart disorder, surgery and impaired work ability to be related to Shingles vaccine. The company considered the near death experience, heart disorder, surgery and impaired work ability to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date : 22-MAR-2025 This case was reported by a patient via interactive digital media. The reporter stated that he/she took his chances. No vaccine for him/her. The shingles vaccine almost killed his brother in law and he was been fighted for his life eversince. Had a pig valve in his heart to save his life. The patient had multiple surgeries since and had to retired early from his bank management job. All because the vaccine , that virus attacked his heart.; Sender's Comments: Near death experience, Cardiac disorder, Surgery and Impaired work ability are unlisted events which are considered unrelated to GSK Shingles vaccine.
More
|
โ | |||||||
| 2833674 | 03/28/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Immediate post-injection reaction, Multiple sclerosis
Immediate post-injection reaction, Multiple sclerosis
|
Multiple sclerosis; This serious case was reported by a consumer via interactive digital media and d...
Multiple sclerosis; This serious case was reported by a consumer via interactive digital media and described the occurrence of multiple sclerosis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced multiple sclerosis (Verbatim: Multiple sclerosis) (serious criteria GSK medically significant). The outcome of the multiple sclerosis was not reported. It was unknown if the reporter considered the multiple sclerosis to be related to Shingles vaccine. The company considered the multiple sclerosis to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 22-MAR-2025 This case was reported by a patient via interactive digital media. The patient got Multiple sclerosis right after they gave a shingle vaccine.; Sender's Comments: Multiple sclerosis is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine
More
|
|||||||||
| 2833675 | 76 | F | IL | 03/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Dizziness, Headache, Tremor, Vertigo
Dizziness, Headache, Tremor, Vertigo
|
vertigo; Dizziness; Headache; shaky legs; This non-serious case was reported by a consumer via call ...
vertigo; Dizziness; Headache; shaky legs; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included stent placement (Coronary artery disease history of stents 2 times). Concurrent medical conditions included hypothyroidism, coronary artery disease (Coronary artery disease history of stents 2 times), hyperlipidemia, blepharitis and hypertension. Concomitant products included levothyroxine sodium (Levothyroxine), metoprolol, doxycycline, atorvastatin and hydrocortisone. On 13-MAR-2025, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid) .5 ml. On 14-MAR-2025, 1 days after receiving Shingrix, the patient experienced dizziness (Verbatim: Dizziness), headache (Verbatim: Headache) and tremor limb (Verbatim: shaky legs). On an unknown date, the patient experienced vertigo (Verbatim: vertigo). The outcome of the dizziness, headache, tremor limb and vertigo were unknown. It was unknown if the reporter considered the dizziness, headache, tremor limb and vertigo to be related to Shingrix. It was unknown if the company considered the dizziness, headache, tremor limb and vertigo to be related to Shingrix. Additional Information: GSK Receipt Date: 18-DEC-2024 The patient reported that she received her Shingrix dose number one on 13th March 2025. Beginning on 14th March 2025 she began experiencing dizziness and headache along with shaky legs. The lot number for the dose was not provided to the patient. She was referred to an urgent care facility and was diagnosed with vertigo there. The name of the treating physician was not available. The patient's own Primary care physician had just recently retired, so she had no HCP to contact at this time.
More
|
||||||
| 2833676 | 40 | F | WV | 03/28/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
3E99M |
Extra dose administered
Extra dose administered
|
female patient was accidentally administered a 3rd dose of Menveo vaccine; This non-serious case was...
female patient was accidentally administered a 3rd dose of Menveo vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 40-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 3E99M, expiry date 31-DEC-2025) for prophylaxis. Previously administered products included Menveo (1st dose on 15th November 2024). Concomitant products included Meningococcal vaccine A/C/Y/W conj (CRM197) (Menveo). On 06-FEB-2025, the patient received Menveo (intramuscular, right deltoid) .5 ml. On 06-FEB-2025, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: female patient was accidentally administered a 3rd dose of Menveo vaccine). On 06-FEB-2025, the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the extra dose administered to be related to Menveo. It was unknown if the company considered the extra dose administered to be related to Menveo. Additional Information: GSK receipt date: 19-MAR-2025 The reporter stated that a female patient was accidentally administered a 3rd dose of Menveo vaccine on February 6th, 2025, in the right deltoid due to a charting error, which led to extra dose administered; the 2nd dose was not documented in the chart, The HCP reported that the patient was administered the 1st dose of Menveo on November 15, 2024, and the 2nd dose on January 15th, 2025. The HCP reported as medical history for this patient that she does not have a spleen.
More
|
||||||
| 2833677 | 03/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Pain
Pain
|
hurts; This non-serious case was reported by a pharmacist via sales rep and described the occurrence...
hurts; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of pain 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 pain (Verbatim: hurts). The outcome of the pain was resolved. The reporter considered the pain to be related to Shingrix. The company considered the pain to be related to Shingrix. Additional Information: GSK Receipt Date: 19-MAR-2025 Pharmacist shared that although patients complain about the first dose hurting more than other vaccines since they usually co-administer Shingrix with other vaccines, patients still return for the second dose. Patients that return for 2nd dose usually states that the second dose was not nearly as bad as the first dose. This was not related to an existing case.
More
|
|||||||||
| 2833678 | F | 03/28/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
X027446 |
Measles post vaccine
Measles post vaccine
|
Vaccine deprived measles; This serious case was reported by a nurse via sales rep and described the ...
Vaccine deprived measles; This serious case was reported by a nurse via sales rep and described the occurrence of measles in a 9-month-old female patient who received MMR (Priorix) (batch number X027446, expiry date 27-NOV-2025) for prophylaxis. On 20-FEB-2025, the patient received the 1st dose of Priorix (left thigh). On 23-FEB-2025, 3 days after receiving Priorix, the patient experienced measles (Verbatim: Vaccine deprived measles) (serious criteria other: Other medically imp. condition). On 01-MAR-2025, the outcome of the measles was resolving. The reporter considered the measles to be related to Priorix and Priorix Pre-Filled Syringe Device. The company considered the measles to be unrelated to Priorix and Priorix 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: 24-MAR-2025 Nurse reported that patient took 1st dose of Priorix vaccine and experienced vaccine deprived measles.; Sender's Comments: Measles is a listed event which, due to the following criteria (insufficient information provided about the clinical description and laboratory confirmation of disease) is considered unrelated to GSK vaccine Priorix and Priorix Pre-Filled Syringe Device.
More
|
||||||||
| 2833679 | 03/28/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Feeling abnormal, Herpes zoster, Pruritus; Feeling abnormal, Herpes zoster, Prur...
Feeling abnormal, Herpes zoster, Pruritus; Feeling abnormal, Herpes zoster, Pruritus
More
|
had the first one injection vaccine before getting shingles; itchy; annoying feelings; This non-seri...
had the first one injection vaccine before getting shingles; itchy; annoying feelings; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles 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, not applicable after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: had the first one injection vaccine before getting shingles), pruritus (Verbatim: itchy) and feeling abnormal (Verbatim: annoying feelings). The outcome of the shingles was resolved and the outcome of the pruritus and feeling abnormal were not resolved. It was unknown if the reporter considered the pruritus and feeling abnormal to be related to Shingles vaccine. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the pruritus and feeling abnormal to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 15-MAR-2025 The reporter said that get your vaccines. It has been over a year since the patient have had it. However, his/her neck still had these strange symptoms itchy and annoying feelings. The patient had the first one injection vaccine before getting shingles so his/her shingles might have been milder. The patient did get the two injections vaccine and so far, it was good.
More
|
|||||||||
| 2833680 | 03/28/2025 |
VARZOS VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK UNK |
Extra dose administered, Post herpetic neuralgia, Vaccination failure; Extra dos...
Extra dose administered, Post herpetic neuralgia, Vaccination failure; Extra dose administered, Post herpetic neuralgia, Vaccination failure; Extra dose administered, Post herpetic neuralgia, Vaccination failure
More
|
Suspected vaccination failure; 6 months later dealing with post herpetic neuralgia; 15 years later g...
Suspected vaccination failure; 6 months later dealing with post herpetic neuralgia; 15 years later got a triple dose of shingles; 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 and Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (twice). On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), post herpetic neuralgia (Verbatim: 6 months later dealing with post herpetic neuralgia) and extra dose administered (Verbatim: 15 years later got a triple dose of shingles). The outcome of the vaccination failure and post herpetic neuralgia were not reported and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the vaccination failure and post herpetic neuralgia to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the vaccination failure and post herpetic neuralgia to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 15-MAR-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she had shingles twice, got the vaccine, 15 years later got a triple dose of Shingles and 6 months later dealing with post herpetic neuralgia and it was horrendous. The reporter further stated, the physician said she wanted his/her body healed for a full year and then get the new vaccine and the booster shot. Patient received a triple dose of Shingles vaccine, which led to an extra dose administered. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding post herpetic neuralgia 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 the clinical description, details regarding laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1, Dose 2 and extradose)
More
|
|||||||||
| 2833681 | 03/28/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Pain, Vaccination failure
Herpes zoster, Pain, Vaccination failure
|
Suspected vaccination failure; still got the shingles; This serious case was reported by a consumer ...
Suspected vaccination failure; still got the shingles; 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 other: Serious as per reporter) and shingles (Verbatim: still got the shingles) (serious criteria other: Serious as per reporter). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 21-MAR-2025 The case was received from the patient via interactive digital media. The patient took the vaccine still got the shingles. Five years later the patient still have pain. This was some serious stuff. 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine
More
|
|||||||||
| 2833682 | 03/28/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
|
Suspected vaccination failure; I have had them for over a year. Still not totally gone. Nothing help...
Suspected vaccination failure; I have had them for over a year. Still not totally gone. Nothing helped. Had both shots.; 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, 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 have had them for over a year. Still not totally gone. Nothing helped. Had both shots.). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving. 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: 21-MAR-2025 This case was reported by a patient via interactive digital media. The patient had both the Shingles shots. The patient had shingles for over a year and still not totally gone, nothing helped. This case was considered as suspected vaccination failure as details regarding 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 vaccine Shingles vaccine(1st dose)and Shingles vaccine (2nd dose).
More
|
|||||||||
| 2833683 | 03/28/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
|
suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv...
suspected vaccination failure; shingles; 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: 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 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-MAR-2025 This case was reported by a patient via interactive digital media. The follow-up could not be possible as no contact details were available. Reporter stated that two friends they know got the Shingles vaccine and they both got shingles. 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 Shingles vaccine
More
|
|||||||||
| 2833684 | F | 03/28/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Pain
Herpes zoster, Pain
|
got shingles 4 weeks after getting my second shot/ painful; This non-serious case was reported by a ...
got shingles 4 weeks after getting my second shot/ painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 4 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: got shingles 4 weeks after getting my second shot/ painful). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 23-MAR-2025 This case was reported by a patient via interactive digital media. The patient got shingles 4 weeks after getting her second shot. She was lucky they were on her arm but painful. This was 1 of 3 linked cases reported by same reporter.; Sender's Comments: US-GSK-US2025AMR036210:Different Patient US-GSK-US2025AMR036211:Different Patient
More
|
||||||||
| 2833685 | 03/28/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
|
Suspected Vaccination failure; shingles; This serious case was reported by a consumer via interactiv...
Suspected Vaccination failure; shingles; 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, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 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 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-MAR-2025 This case was reported by a patient via interactive digital media. The patient had the vaccines and had shingles a year later. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
More
|
|||||||||
| 2833686 | 03/28/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
|
Suspected vaccination failure; still got the shingles; This serious case was reported by a consumer ...
Suspected vaccination failure; still got the shingles; 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: still got the 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 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-MAR-2025 This case was reported by a patient via interactive digital media. He/she got the shingles shot and still got the shingles but not. As bad as they could be This report is one of several cases received as part of a line-listing, each containing minimal information. No further information is expected.; 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.
More
|