| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2853556 | F | TN | 08/11/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Malaise
Malaise
|
the night of dose 1 caused general unwell feeling; This non-serious case was reported by a consumer ...
the night of dose 1 caused general unwell feeling; This non-serious case was reported by a consumer via sales rep and described the occurrence of feeling unwell in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced feeling unwell (Verbatim: the night of dose 1 caused general unwell feeling). The outcome of the feeling unwell was resolved (duration 2 days). It was unknown if the reporter considered the feeling unwell to be related to Shingrix. It was unknown if the company considered the feeling unwell to be related to Shingrix. Additional Information: GSK Receipt Date: 14-JUL-2025 The reporter reported that the night of dose 1 caused general unwell feeling. The reporter described it as kicking her butt related to the overall symptoms she felt for the 2 days after taking dose 1. After 2 days she fully recovered and planned to take dose 2.
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| 2853557 | 08/11/2025 |
MEN |
UNKNOWN MANUFACTURER |
UNK |
Malaise
Malaise
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kids were sick all the time after jabs; This non-serious case was reported by a consumer via interac...
kids were sick all the time after jabs; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, an unknown time after receiving Meningococcal B vaccine, the patient experienced sickness (Verbatim: kids were sick all the time after jabs). The action taken with Meningococcal B vaccine was unknown. The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Meningococcal B vaccine and Meningococcal B Vaccine Pre-Filled Syringe Device. It was unknown if the company considered the sickness to be related to Meningococcal B vaccine and Meningococcal B Vaccine 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: 04-AUG-2025 This case was reported by a patient via interactive digital media. The reporter reported that the reporter kids were sick all the time after jabs. This was 1 of 3 cases reported by same reporter.; Sender's Comments: US-GSK-US2025AMR101196:Case created for kids US-GSK-US2025AMR103054:Same reporter/daughter
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| 2853558 | IL | 08/11/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Anger, Frustration tolerance decreased, Herpes zoster, Vaccination failure
Anger, Frustration tolerance decreased, Herpes zoster, Vaccination failure
|
suspected vaccination failure; I have had this twice, I still feel the effects from second time; Thi...
suspected vaccination failure; I have had this twice, I still feel the effects from second time; This serious case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included malignant lymphoma. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have had this shit twice, I still feel the effects from second time). 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 Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK receipt date: 02-AUG-2025 The patient reported that his/her oncologist had recommended that he/she receive the shingles vaccine because he/she had cancer lymphoma. He/she had already experienced shingles twice and was still feeling the effects from the second time. The patient went to local pharmacy where they quoted dollar 210 for the vaccine. Just one mile down the road quoted dollar 263 for the same vaccine over dollar 50 more. He/she had Medicare and previously had prescription coverage, but he/she was told he/she no longer qualified because his/her monthly social security disability income was dollar 1,841, which was apparently too high. The patient was frustrated and angry about how pharmacies could charge so much for a necessary vaccine, and how prices could vary so drastically between locations so close to each other. He/she considered sending this issue to office to see what they thought, because he/she believed someone should be held accountable. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of 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 Shingrix.
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| 2853559 | 08/11/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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suspected vaccination failure; had shingles twice; This serious case was reported by a consumer via ...
suspected vaccination failure; had shingles twice; 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, 5 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles twice). 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: 04-AUG-2025 This case was reported by a patient via interactive digital media. The patient reported that the vaccines did not work because he/she had the vaccine and he/she had shingles twice in a year about 5 years after his/her vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of 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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| 2853560 | 08/11/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Dyspnoea
Dyspnoea
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I have breathing problems since the RSV vaccine; This non-serious case was reported by a consumer vi...
I have breathing problems since the RSV vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of difficulty breathing in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced difficulty breathing (Verbatim: I have breathing problems since the RSV vaccine). The outcome of the difficulty breathing was not reported. It was unknown if the reporter considered the difficulty breathing to be related to RSV vaccine. It was unknown if the company considered the difficulty breathing to be related to RSV vaccine. Additional Information: GSK Receipt Date: 01-AUG-2025 This case was received by the patient via interactive digital media. Reporter reported that he/she had breathing problems since the RSV vaccine. Reporter wish that he/she had not gotten it.
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| 2853561 | 16 | F | AR | 08/11/2025 |
HEP HEPA MMR TDAP UNK VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR UNKNOWN MANUFACTURER MERCK & CO. INC. |
3N2ND Y014585 Y008290 3CA30C1 X1D141M Y006522 |
Extra dose administered; Extra dose administered; Extra dose administered; Extra...
Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered
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Patient reported to Health Unit in need of vaccines for school. Patient's current WEB IZ record...
Patient reported to Health Unit in need of vaccines for school. Patient's current WEB IZ record only showed one TDAP, Hep A, Varicella, Meningitis, and HPV from 10/04/2023. Nurse administered TDAP, Hep B, MMR, VAR, Hep A, and Polio today due to shot record/ patient needing them. High school nurse reported earlier today to clerk, (name withheld), that the school did not have any other shot records on this particular patient. Nurse and clerk asked mom at different times if patient had any other shot records, mom reported not having any other shot records. High School nurse reached out after visit and sent Health Unit a shot record from the (withheld). Clerical entered in those records to patient's State WEB IZ record after the 08/06/25 visit was already completed. 08/06/2025 's vaccines are now invalid due to State Department of Health policies, however vaccines were needed at the time of the visit due to lack of vaccines on record. -(name withheld), RN
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| 2853562 | 10 | F | 08/11/2025 |
PNC20 |
PFIZER\WYETH |
MF0420 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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No adverse effects. Vaccine given at wrong interval.
No adverse effects. Vaccine given at wrong interval.
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| 2853563 | 70 | M | 08/11/2025 |
FLU3 HEPA |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
U8764BB Z27PB |
Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration
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Patient received Havrix 2nd dose one month early in series. First dose was given 03/11/25 and second...
Patient received Havrix 2nd dose one month early in series. First dose was given 03/11/25 and second dose was given 08/09/25 rather than 09/09/25
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| 2853565 | 08/11/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Pruritus, Vaccination failure
Herpes zoster, Pruritus, Vaccination failure
|
Suspected vaccination failure; I also am suffering an attack of shingles; This serious case was repo...
Suspected vaccination failure; I also am suffering an attack 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. 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 also am suffering an attack of shingles). 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 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: 03-AUG-2025 This case was reported by a patient via interactive digital media. The patient mentioned he/she got the vaccine, but also suffering an attack of shingles. The patient mentioned it was just on left forearm, but it was ugly and itches like mad. 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 Shingles vaccine.
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| 2853566 | 51 | F | 08/11/2025 |
HEP IPV TYP |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR |
9K34M Y1D03P1 Y2A04P1 |
Cough, Dizziness, Dyspnoea, Paraesthesia; Cough, Dizziness, Dyspnoea, Paraesthes...
Cough, Dizziness, Dyspnoea, Paraesthesia; Cough, Dizziness, Dyspnoea, Paraesthesia; Cough, Dizziness, Dyspnoea, Paraesthesia
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Patient reported the sensation of her throat closing in and shortness of breath approximately 10 min...
Patient reported the sensation of her throat closing in and shortness of breath approximately 10 minutes after receiving all three vaccines. She also reported dizziness and tingling all over. VS WNL. Patient also started coughing. Doctor notified. Doctor was at bedside assessing patient. EpiPen ordered and given. 911 called and patient was transferred Emergency department.
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| 2853567 | 17 | F | MI | 08/11/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
9JT4S |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Patient was not due for TDap vaccine. was given early.
Patient was not due for TDap vaccine. was given early.
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| 2853568 | 4 | F | IN | 08/11/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
Y49BZ |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
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Red and swollen at injection site-Local reaction- no tests needed
Red and swollen at injection site-Local reaction- no tests needed
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| 2853569 | 61 | M | WY | 08/11/2025 |
COVID19 |
MODERNA |
067F21A |
Skin discolouration, Vitiligo
Skin discolouration, Vitiligo
|
I had 3 shots of Moderna over the course of 2021. It is hard to identify Vitiligo until summer and I...
I had 3 shots of Moderna over the course of 2021. It is hard to identify Vitiligo until summer and I start to tan The following summer 2022 I noticed the backside of my leg at the bend was developing what I know now was Vitiligo. It seemed to be getting larger as the summer went on. Summer of 2023 the area on the back of my leg was larger and a few more spots on the front of my leg and the inside of the right forearm. Summer of 2024. I went to the dermatologist and they identified it as Vitiligo. The summer of 2025 the area on my legs and right forearm are larger and now it is on the left forearm.
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โ | |||||
| 2853570 | 52 | F | LA | 08/11/2025 |
PPV |
MERCK & CO. INC. |
|
Headache, Injection site erythema, Injection site swelling, Pain, Pyrexia
Headache, Injection site erythema, Injection site swelling, Pain, Pyrexia
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fever, bodyaches, headache, and swelling and redness at injection site
fever, bodyaches, headache, and swelling and redness at injection site
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| 2853571 | 97 | F | IA | 08/11/2025 |
COVID19 |
MODERNA |
3043159 |
Death
Death
|
Resident passed away
Resident passed away
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โ | |||||
| 2853572 | 65 | F | WV | 08/11/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
P24D3 |
Extra dose administered
Extra dose administered
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The patient was given the RSV vaccination without the nurse/ provider checking the immunization quer...
The patient was given the RSV vaccination without the nurse/ provider checking the immunization query in the EMR. the patient had received the same vaccination on 11/21/2023. This dose was not needed.
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| 2853573 | 1 | M | OH | 08/11/2025 |
IPV IPV IPV IPV IPV IPV IPV IPV IPV IPV |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
Y1A212M Y1A212M Y1A212M Y1A212M Y1A212M |
Crying, Decreased appetite, Diarrhoea, Dysstasia, Fall; Gait disturbance, Gait i...
Crying, Decreased appetite, Diarrhoea, Dysstasia, Fall; Gait disturbance, Gait inability, Inability to crawl, Injection site reaction, Irritability; Rash erythematous, Skin discolouration, Vomiting; Diarrhoea, Dysstasia, Fall, Food refusal, Gait inability; Inability to crawl, Injection site rash, Pain, Screaming, Vomiting; Crying, Decreased appetite, Diarrhoea, Dysstasia, Fall; Gait disturbance, Gait inability, Inability to crawl, Injection site reaction, Irritability; Rash erythematous, Skin discolouration, Vomiting; Diarrhoea, Dysstasia, Fall, Food refusal, Gait inability; Inability to crawl, Injection site rash, Pain, Screaming, Vomiting
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Irritability, anorexia, vomiting, diarrhea, persistent crying, red spots with white rings on right l...
Irritability, anorexia, vomiting, diarrhea, persistent crying, red spots with white rings on right leg, pain, sudden inability to crawl, stand, and walk. Treated with Motrin, Tylenol, warm baths, massage, motility exercises. All adverse events have resolved except for the inability to walk. Baby is no longer screaming in pain, but cannot walk unassisted. He is very unstable, tries to take a step and falls over. Previously was walking independently for 3 weeks. He is unstable in both legs.
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| 2853574 | 31 | F | TN | 08/11/2025 |
UNK |
UNKNOWN MANUFACTURER |
X1C161M |
Erythema, Nausea, Vomiting
Erythema, Nausea, Vomiting
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Patient called the Health Dept 08/11/2025 stating that she experienced redness to her face/ears and ...
Patient called the Health Dept 08/11/2025 stating that she experienced redness to her face/ears and became hot with nausea approximately 45 min-1 hour after receiving vaccination. Patient denies any swelling or difficulty breathing. Patient states that she did throw up once during this time. She states that right after this she did take 50 mg Benedryl. Patient states that she had no other symptoms after throwing up and taking the benedryl. Medical director made aware of incident (Dr. withheld name).
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| 2853575 | 6 | M | MS | 08/11/2025 |
DTPPVHBHPB HEPA MMR VARCEL |
MSP VACCINE COMPANY MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
U8313AA Z003748 X027447 Y006582 |
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; No adverse event, Product administered to patient of inappropriate age
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Vaxelis vaccine Lot # U8313AA EXP: 092027 was given to patient out of age range. Vaxelis is not rec...
Vaxelis vaccine Lot # U8313AA EXP: 092027 was given to patient out of age range. Vaxelis is not recommended to be given after age 4. Patient is 6. No adverse reaction to vaccine.
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| 2853576 | 1.25 | F | GA | 08/11/2025 |
DTAPIPV UNK |
GLAXOSMITHKLINE BIOLOGICALS UNKNOWN MANUFACTURER |
4L454 X1D141M |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
|
Patient received two doses of polio on 8/11/25 at 0930am.
Patient received two doses of polio on 8/11/25 at 0930am.
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| 2853577 | 53 | F | NE | 08/11/2025 |
PNC20 |
PFIZER\WYETH |
LP4948 |
Erythema, Pain in extremity, Pyrexia, Skin warm
Erythema, Pain in extremity, Pyrexia, Skin warm
|
Severe arm pain, warmth and redness to entire upper arm, fever of 102
Severe arm pain, warmth and redness to entire upper arm, fever of 102
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| 2853578 | 81 | M | IA | 08/11/2025 |
COVID19 |
MODERNA |
23H22A |
Death
Death
|
Resident passed away
Resident passed away
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โ | |||||
| 2853579 | 63 | F | MI | 08/11/2025 |
UNK |
UNKNOWN MANUFACTURER |
Z006076 |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Product administered at inappropriate site
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Shot given to low in arm, redness, iches, hot to touch, sore
Shot given to low in arm, redness, iches, hot to touch, sore
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| 2853580 | 59 | F | VA | 08/11/2025 |
CHIK |
VALNEVA USA, INC. |
|
Arthralgia, Pyrexia
Arthralgia, Pyrexia
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Low grade fever and mild joint pains, 5 days after the vaccine
Low grade fever and mild joint pains, 5 days after the vaccine
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| 2853581 | 18 | F | PA | 08/11/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
5xa2j |
Injection site pain, Mobility decreased
Injection site pain, Mobility decreased
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Pain at injection site lasting 4 days post vaccination. No redness or swelling. Patient unable to mo...
Pain at injection site lasting 4 days post vaccination. No redness or swelling. Patient unable to move arm.
More
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| 2853582 | 34 | F | NJ | 08/11/2025 |
TDAP |
SANOFI PASTEUR |
U8352AA |
Discomfort, Injection site erythema, Injection site swelling, Injection site war...
Discomfort, Injection site erythema, Injection site swelling, Injection site warmth
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SWELLING, REDNES AND WARMTH TO THE INJECTION SITE, SWELLING APPROX 4IN X 4IN AND HAS BEEN SWOLLEN FR...
SWELLING, REDNES AND WARMTH TO THE INJECTION SITE, SWELLING APPROX 4IN X 4IN AND HAS BEEN SWOLLEN FROM DATE OF ADMIN TO DATE OF VAERS OPENED, DENIES ANY S/S OF PAIN AND NO S/S OF DISTRESS NOTED. ONLY C/O MINOR DISCOMFORT
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| 2853583 | 1.83 | M | MI | 08/11/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
z7l7h |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
Patient received a TDAP instead of a DTAP . Patient had no symptoms or issues after administration.
Patient received a TDAP instead of a DTAP . Patient had no symptoms or issues after administration.
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| 2853584 | 61 | M | NH | 08/11/2025 |
PNC21 RSV |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
Z003579 A4P5G |
Cellulitis, Erythema, Pain in extremity; Cellulitis, Erythema, Pain in extremity
Cellulitis, Erythema, Pain in extremity; Cellulitis, Erythema, Pain in extremity
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redness and pain, redness spread into a cellulitis-left arm which is the arm that the PCV21 was give...
redness and pain, redness spread into a cellulitis-left arm which is the arm that the PCV21 was given
More
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| 2853585 | 62 | M | WV | 08/11/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
35A77 |
Extra dose administered
Extra dose administered
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Pt asked provider for his 2nd Shingrix vaccine he stated he had only had 1 dose. 2nd dose was given,...
Pt asked provider for his 2nd Shingrix vaccine he stated he had only had 1 dose. 2nd dose was given, When billed to insurance it was denied due to insurance already paying for 2 doses. Pt received 1st dose 2/1/2024, 2nd dose 8/2/2024 and 3rd dose 7/24/2025. We have been unable to get ahold of the patient as he does not have a phone. We have sent a call our office letter to his home.
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| 2853586 | 08/11/2025 |
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; currently dealing with good case of shingles; This serious case was ...
suspected vaccination failure; currently dealing with good case 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. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd 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: currently dealing with good case of shingles). 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 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: 01-AUG-2025 This case was reported by a patient via interactive digital media. Patient got 2 shots, and he/she was currently (at the time of reporting) dealing with a good case of shingles around his/her right side. Patient's physician said it just made them less severe. This case was considered as suspected vaccination failure as details regarding time to onset 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2).
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| 2853587 | 47 | M | NV | 08/11/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Chest pain, Dyspnoea, Electrocardiogram, Pericardial drainage, Pericardial effus...
Chest pain, Dyspnoea, Electrocardiogram, Pericardial drainage, Pericardial effusion; Pericarditis, Ultrasound scan
More
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2 months After vaccination started having chest pain and shortness of breath. In Oct 2021 went to Ho...
2 months After vaccination started having chest pain and shortness of breath. In Oct 2021 went to Hospital and was misdiagnosed with heartburn and sent home due to excessive COVID 19 patients . Chest pain continued to progress so went to a different emergency room many months later, hospital ,and was admitted with 8 liters of fluid around heart and pericarditiis. Emergency surgery to remove fluid.
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โ | โ | โ | |||
| 2853588 | 16 | M | CO | 08/11/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
HP9987 |
Wrong product administered
Wrong product administered
|
Wrong Vaccine Given
Wrong Vaccine Given
|
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| 2853589 | 4 | F | NM | 08/11/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
4L454 Z005152 |
Injection site erythema, Injection site warmth; Injection site erythema, Injecti...
Injection site erythema, Injection site warmth; Injection site erythema, Injection site warmth
More
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RIGHT SITE 07/30/25 RED AND WARM TO TOUCH DENIES PAIN GOLF BALL SIZE SWELLING DR RECOMMENDED WARM CO...
RIGHT SITE 07/30/25 RED AND WARM TO TOUCH DENIES PAIN GOLF BALL SIZE SWELLING DR RECOMMENDED WARM COMPRESSES, MASSAGE AND RETURN IF SYMPTOMS WORSEN. PATIENT RETURNED 07/31/25 RIGHT SIGHT IMPROVING BUT LEFT SITE IS NOW HAVING REDNESS RECOMMENDATIONS IS THE SAME AS LEFT SITE WARM COMPRESS TO SITE AND MASSAGE RETURN IF NO IMPROVEMENT.
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| 2853590 | 64 | F | FL | 08/11/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
30 MCG/0.3ML 30 MCG/0.3ML |
Cardiac disorder, Catheterisation cardiac abnormal, Contrast echocardiogram, Dys...
Cardiac disorder, Catheterisation cardiac abnormal, Contrast echocardiogram, Dyspnoea, Ejection fraction decreased; Electrocardiogram, Left ventricular enlargement; Cardiac disorder, Catheterisation cardiac abnormal, Contrast echocardiogram, Dyspnoea, Ejection fraction decreased; Electrocardiogram, Left ventricular enlargement
More
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very weaked heart & short of breath, especially outside in the heat
very weaked heart & short of breath, especially outside in the heat
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| 2853591 | 57 | F | 08/11/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Z003579 Z003579 |
Dizziness, Feeling hot, Immediate post-injection reaction, Injection site erythe...
Dizziness, Feeling hot, Immediate post-injection reaction, Injection site erythema, Injection site haemorrhage; Injection site mass, Injection site pruritus, Injection site swelling
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Patient received pneumonia vaccine in right deltoid, immediately after vaccine while still in immuni...
Patient received pneumonia vaccine in right deltoid, immediately after vaccine while still in immunization booth the patient developed redness, itching, bleeding, bruising and a hard lump at the injection site. Pt also reported feeling hot and lightheaded. Rph instructed her to stay in the IMZ booth for monitoring and provided an ice pack. The patient did not report any symptoms of systemic allergic reaction like trouble breathing. She sat for about 15 minutes and stated that she felt a lot better and that the dizziness passed and some of the swelling and redness went down.
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| 2853592 | 71 | F | FL | 08/11/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
lp4947 lp4947 |
Injection site erythema, Injection site mass, Injection site pruritus, Injection...
Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling, Injection site warmth; Pyrexia
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** around injection site red, swollen/ puffy/ raised bump, circle like appearance, warm, itchy, feve...
** around injection site red, swollen/ puffy/ raised bump, circle like appearance, warm, itchy, fever all occurred that evening after the injection. ** Little improvement since vaccination - only took Tylenol.
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| 2853593 | 64 | F | WI | 08/11/2025 |
HEPAB TDAP VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
P2443 PX3P7 7523J |
Injection site pruritus, Injection site rash, Injection site reaction; Injection...
Injection site pruritus, Injection site rash, Injection site reaction; Injection site pruritus, Injection site rash, Injection site reaction; Injection site pruritus, Injection site rash, Injection site reaction
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Patient came in complaining of injection site reaction from shingles shot she received on Saturday. ...
Patient came in complaining of injection site reaction from shingles shot she received on Saturday. Stated it started itching and now has a localized rash near the injection site. Told her I would report it to VAERS and can use topical antiitch cream
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| 2853594 | 55 | F | DE | 08/11/2025 |
PNC20 |
PFIZER\WYETH |
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Pain, Pyrexia
Pain, Pyrexia
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Pt reported extreme pain, fever, ache within hour of vaccination and had to be hospitalized around 8...
Pt reported extreme pain, fever, ache within hour of vaccination and had to be hospitalized around 8/7/25 3:40 pm. She reported obtaining vicodin from the hospital. The pain subside and continue until at least 8/10/25
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| 2853595 | 21 | F | FL | 08/11/2025 |
HEP MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
T5D73 Y015020 Z005456 |
Lymphadenopathy; Lymphadenopathy; Lymphadenopathy
Lymphadenopathy; Lymphadenopathy; Lymphadenopathy
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Client reports lymph node swelling "thumb size" on left neck and behind left ear. Started ...
Client reports lymph node swelling "thumb size" on left neck and behind left ear. Started day after vaccinations (8/7/25) and is not worsening. No pain associated with swelling. Client requests to be reported to VAERS.
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| 2853596 | 4 | F | GA | 08/11/2025 |
MMRV |
MERCK & CO. INC. |
z009668 |
Injection site haemorrhage, Injection site mass, Pain in extremity
Injection site haemorrhage, Injection site mass, Pain in extremity
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Patient's mother showed RN bump on back of patient's arm after vaccine administered. Bump ...
Patient's mother showed RN bump on back of patient's arm after vaccine administered. Bump mother of patient was referring to was located above the bleeding injection site and towards the inside of the patient's arm, by patient's armpit. RN had patient and patient's mother wait in the hallway for a few minutes, and patient's mother returned saying she felt as though the bump had gotten larger due to vaccine. Patient stated her arm hurt but denied any itchiness or other symptoms. RN explained to mother of patient that a VAERS report would be entered into the system and encouraged mother of patient to seek medical attention if bump grows larger, becomes warm/irritated, or if any other emergency s/s appear (trouble breathing). Mother of patient verbalized her understanding.
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| 2853597 | 65 | F | FL | 08/11/2025 |
FLU3 RSV |
SEQIRUS, INC. PFIZER\WYETH |
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Nausea, Syncope; Nausea, Syncope
Nausea, Syncope; Nausea, Syncope
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Fainting, nausea.
Fainting, nausea.
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| 2853598 | 4 | F | MI | 08/11/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
U8209CB |
Erythema, Skin warm, Swelling
Erythema, Skin warm, Swelling
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Red, swollen, warm to touch. Patient seen at Urgent Care
Red, swollen, warm to touch. Patient seen at Urgent Care
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| 2853599 | 17 | F | OH | 08/11/2025 |
MENB MNQ |
PFIZER\WYETH SANOFI PASTEUR |
LF5302 U8271AB |
Dizziness, Loss of consciousness; Dizziness, Loss of consciousness
Dizziness, Loss of consciousness; Dizziness, Loss of consciousness
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Client received vaccines in clinic. After vaccination, client denied any lightheadedness/dizziness a...
Client received vaccines in clinic. After vaccination, client denied any lightheadedness/dizziness and visual appearance same as baseline. Client was discharged from clinic with father. Soon after family left clinic (about 8:22AM), staff heard an abnormal wall creaking sound outside the office. Nursing staff investigated to find client unconscious with father in hallway outside of clinic waiting room exit door. Father was supporting client's head and neck. About five seconds after nursing arrived, client became spontaneously responsive and oriented. Father stated as they were leaving the office client stated becoming lightheaded and then passed out. Father was able to guide client to the floor; he denied any injury to client?s head or spinal cord. After two minutes of lying down, client asked to sit up. Client assisted to sitting position. Nurse asked client if she had breakfast before coming; client denied eating anything before the appointment. Fellow staff member retrieved water and fruit snacks for client. Father stated client has not been lightheaded or dizzy with vaccines in the past; however, two summers ago client became lightheaded and passed out after receiving her second set of ear piercings. Client tolerated sitting up and snack. After eight minutes, client stated feeling well enough to try standing. Client assisted to standing. Client denied feeling any lightheadedness/dizziness. Client released with father to private vehicle at 8:32AM.
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| 2853600 | 08/11/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Pain in extremity
Pain in extremity
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entire left arm to my fingers was pained for several months. Still get achiness from time to time; T...
entire left arm to my fingers was pained for several months. Still get achiness from time to time; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: entire left arm to my fingers was pained for several months. Still get achiness from time to time). The outcome of the pain in arm was not resolved. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 01-AUG-2025 This case was reported by a patient via interactive digital media. The patient received first Shingles shot, and his/her entire left arm to the fingers was pained for several months and still get achiness from time to time and it's been over five years. The patient said second shot, no thank you.
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| 2853601 | 54 | F | GA | 08/11/2025 |
PNC21 |
MERCK & CO. INC. |
Z003579 |
Extra dose administered
Extra dose administered
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Patient received a second dose of pneumonia vaccine after initial investigation of patient vaccine r...
Patient received a second dose of pneumonia vaccine after initial investigation of patient vaccine record with pharmacy's integrated vaccine recording site (STC) which is not in alignment with ACIP standards. She goes by a different last name now and is the reason the vaccine was given in error. Patient is aware that she was given a second dose and record has been updated.
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| 2853602 | 77 | F | WV | 08/11/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
FT95N |
Chills, Dysphagia, Seizure like phenomena
Chills, Dysphagia, Seizure like phenomena
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APPROXIMATELY 2 HOURS AFTER VACCINE ADMINISTRATION PATIENT REPORTED TO THE PHARMACY ON 8/11/25 THAT ...
APPROXIMATELY 2 HOURS AFTER VACCINE ADMINISTRATION PATIENT REPORTED TO THE PHARMACY ON 8/11/25 THAT SHE EXPERIENCE "SEIZURE-LIKE CONVULSIONS", CHILLS, AND DIFFICULTY SWALLOWING (FELT LIKE TONGUE WAS ENLARGED) FOR ABOUT 2 HOURS DURATION. SHE THEN SLEPT FOR 16 HOURS.
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| 2853603 | 5 | M | CO | 08/11/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
uk167aa |
Wrong product administered
Wrong product administered
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I pulled the incorrect vaccine. I pulled Pentacel instead of Quadracel. I did not pay attention to t...
I pulled the incorrect vaccine. I pulled Pentacel instead of Quadracel. I did not pay attention to the box I just seen DTAP/ IPV (which is what I needed) and did not pay attention correctly.
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| 2853604 | 24 | F | OH | 08/11/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
33FD3 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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No current adverse s/e however vaccine provided was in error. Was to be a varicella vaccination not ...
No current adverse s/e however vaccine provided was in error. Was to be a varicella vaccination not shingrix.
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| 2853605 | 54 | F | TX | 08/11/2025 |
PNC21 |
MERCK & CO. INC. |
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Fatigue, Influenza like illness, Pain in extremity, Peripheral swelling, Rash er...
Fatigue, Influenza like illness, Pain in extremity, Peripheral swelling, Rash erythematous
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severe arm pain, severe flu-like symptoms, fatigue, baseball size swelling of arm-all began day of ...
severe arm pain, severe flu-like symptoms, fatigue, baseball size swelling of arm-all began day of vaccine red rash lasting over 7 days
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| 2853606 | 58 | F | IN | 08/11/2025 |
PNC20 |
PFIZER\WYETH |
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Contusion
Contusion
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Left upper arm with a 2 cm bruise about halfway between the elbow and shoulder on the anterolateral ...
Left upper arm with a 2 cm bruise about halfway between the elbow and shoulder on the anterolateral aspect of the arm. On palpation there is non-discreet firmness under the bruise. The area is not tender to palpation.
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