| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2840255 | 1.33 | M | WI | 05/09/2025 |
DTAPIPVHIB PNC20 |
SANOFI PASTEUR PFIZER\WYETH |
UK199AA LK6653 |
No adverse event, Product preparation issue, Wrong technique in product usage pr...
No adverse event, Product preparation issue, Wrong technique in product usage process; No adverse event, Product preparation issue, Wrong technique in product usage process
More
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Patient given Pentacel vaccine. Which consist of DTap, IPV & Hib. Patient did not receive Hib po...
Patient given Pentacel vaccine. Which consist of DTap, IPV & Hib. Patient did not receive Hib portion of vaccine. Manufacturer of vaccine Sanofi Paseur consulted. Writer instructed to give HIB portion of vaccine with 0.4% Chloride, no time frame recommended. Patient has no known signs or symptoms, or adverse reactions over the course of incident. Patients' legal guardian will be notified of diversion and instructed to bring patient into clinic to receive HIB portion of vaccine Staff retrained on how to properly administer vaccine to prevent future mistakes.
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| 2840256 | 75 | F | VA | 05/09/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Y019158 Y019158 |
Cellulitis, Erythema, Injection site erythema, Injection site swelling, Pain in ...
Cellulitis, Erythema, Injection site erythema, Injection site swelling, Pain in extremity; Peripheral swelling
More
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Patient states she experienced extreme redness and swelling in her left arm that radiated from injec...
Patient states she experienced extreme redness and swelling in her left arm that radiated from injection site down her arm. After 1 week of the redness and pain persisting, she visited the local emergency department and was diagnosed with cellulitis. She was prescribed steroid and antibiotic therapy
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| 2840257 | 31 | M | FL | 05/09/2025 |
COVID19 |
MODERNA |
032620A |
Atrial fibrillation, Condition aggravated
Atrial fibrillation, Condition aggravated
|
Atrial Fibrillation- August 2023
Atrial Fibrillation- August 2023
|
โ | โ | โ | |||
| 2840258 | 0.33 | M | WI | 05/09/2025 |
DTAPIPVHIB PNC20 RV1 |
SANOFI PASTEUR PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
UK199AA LK6653 32PF3 |
No adverse event, Product preparation issue; No adverse event, Product preparati...
No adverse event, Product preparation issue; No adverse event, Product preparation issue; No adverse event, Product preparation issue
More
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Patient given Pentacel vaccine. Which consist of DTap, IPV & Hib. Patient did not receive Hib po...
Patient given Pentacel vaccine. Which consist of DTap, IPV & Hib. Patient did not receive Hib portion of vaccine. Manufacturer of vaccine Sanofi Pasteur consulted, instructed to give Hib portion of vaccine with 0.4% Chloride, no time frame recommended. Patient has no known signs, symptoms, or adverse reactions over the course of incident. Patients' legal guardian will be notified of diversion and instructed to bring patient into clinic to receive HIB portion of vaccine Staff retrained on how to properly administer vaccine to prevent future mistakes.
More
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| 2840259 | 35 | F | IA | 05/09/2025 |
UNK |
UNKNOWN MANUFACTURER |
Z002626 |
Pruritus, Urticaria
Pruritus, Urticaria
|
diffuse, itchy hives
diffuse, itchy hives
|
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| 2840260 | 78 | F | PR | 05/09/2025 |
PNC20 |
PFIZER\WYETH |
LN4927 |
Feeling hot, Injected limb mobility decreased, Musculoskeletal stiffness, Pain i...
Feeling hot, Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity, Tenderness
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STIFFNESS, PAIN AND HEAT IN THE LEFT ARM, DIFFICULTY LIFTING THE ARM AND PRESSING FORCE ON IT.
STIFFNESS, PAIN AND HEAT IN THE LEFT ARM, DIFFICULTY LIFTING THE ARM AND PRESSING FORCE ON IT.
|
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| 2840261 | 66 | M | NY | 05/09/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
D4J9L |
Paraesthesia, Ultrasound scan
Paraesthesia, Ultrasound scan
|
patient stated after receiving vaccine his right arm is tingling, and possible nerve pain.
patient stated after receiving vaccine his right arm is tingling, and possible nerve pain.
|
โ | |||||
| 2840262 | 58 | M | FL | 05/09/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Tinnitus
Tinnitus
|
Tinnitus beginning 4 weeks after immunization
Tinnitus beginning 4 weeks after immunization
|
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| 2840264 | 05/09/2025 |
VARZOS VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK UNK |
Asthenia, Deafness unilateral, Diarrhoea, Discoloured vomit, Hyperhidrosis; Loss...
Asthenia, Deafness unilateral, Diarrhoea, Discoloured vomit, Hyperhidrosis; Loss of consciousness, Malaise, Mobility decreased, Nerve injury, Vaccination failure; Visual impairment, Zoster sine herpete
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Suspected vaccination failure; lost hearing in my right ear; passing out; Internal shingles; was los...
Suspected vaccination failure; lost hearing in my right ear; passing out; Internal shingles; was losing the sight in my right eye; lost my energy; got so sick; throwing up yellow stuff; sweat was dripping off; nerve damage; I lay in bed for three days; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly 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), hearing loss unilateral (Verbatim: lost hearing in my right ear) (serious criteria GSK medically significant), passed out (Verbatim: passing out) (serious criteria GSK medically significant), zoster sine herpete (Verbatim: Internal shingles), partial sight (Verbatim: was losing the sight in my right eye), loss of energy (Verbatim: lost my energy), sickness (Verbatim: got so sick), vomiting (Verbatim: throwing up yellow stuff), sweating (Verbatim: sweat was dripping off), post herpetic neuralgia (Verbatim: nerve damage) and bedridden (Verbatim: I lay in bed for three days). The outcome of the vaccination failure, hearing loss unilateral, passed out, partial sight, loss of energy, sickness, vomiting, sweating and post herpetic neuralgia were not reported and the outcome of the zoster sine herpete was not resolved and the outcome of the bedridden was resolved (duration 3 days). It was unknown if the reporter considered the vaccination failure, hearing loss unilateral, passed out, zoster sine herpete, partial sight, loss of energy, sickness, vomiting, sweating, post herpetic neuralgia and bedridden to be related to Shingles vaccine. The company considered the vaccination failure, hearing loss unilateral and passed out to be unrelated to Shingles vaccine. It was unknown if the company considered the zoster sine herpete, partial sight, loss of energy, sickness, vomiting, sweating, post herpetic neuralgia and bedridden to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 29-APR-2025 This case was reported by a patient via interactive digital media. The patient was 68 years old and his/her friend told that he/she need to get the shot so the patient did. And on way home the patient got so sick, by time he/she got home it took about 20 minutes. The sweat was dripping off him/her and the patient was throwing up yellow stuff and had run. It was yellow. The patient laid in bed for three days. And a year later the patient told to the doctor that he/she had knots on head and the doctor denied. Then the patient lost hearing in right ear and was losing the sight in right eye so he/she went to another doctor and found out that he/she had shingles inside of him/her and they didn't come out so the patient had been on medications for five years now and they were still inside him/her. but now they say that the patient had nerve damage. It was bad so he/she spent five years of going to hospital because of passing out and messed himself/herself and knots all over the body. The patient felt like he/she was dying from the inside. The patient also lost the energy it bad. It was reported as might be the shots help others people but he/she wish to god he/she would of never got the shot cause so far he/she lost five years of the life. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. Deafness unilateral and Loss of consciousness are unlisted events which are considered unrelated to GSK vaccine Shingles vaccine.
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| 2840265 | 63 | F | CA | 05/09/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
lm2221 tfaa2424 |
Muscular weakness, Pain in extremity; Muscular weakness, Pain in extremity
Muscular weakness, Pain in extremity; Muscular weakness, Pain in extremity
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Patient states that her arm pain and weakness after the vaccinations on 09/26/2024. Her symptoms ar...
Patient states that her arm pain and weakness after the vaccinations on 09/26/2024. Her symptoms are present only upon exertion (sports, yoga, swimming. etc...)
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| 2840266 | 12 | M | 05/09/2025 |
TDAP |
SANOFI PASTEUR |
|
Abdominal pain upper, Colitis ulcerative, Crohn's disease, Frequent bowel m...
Abdominal pain upper, Colitis ulcerative, Crohn's disease, Frequent bowel movements, Haematochezia
More
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Developed major ulcerative colitis and crohns disease. Never had any health issues ever! He develope...
Developed major ulcerative colitis and crohns disease. Never had any health issues ever! He developed stabbing pains in his stomach early December then started having blood in his stools frequently and unusual amounts.
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| 2840267 | 28 | F | CA | 05/09/2025 |
FLU3 |
SANOFI PASTEUR |
U8665EA |
Pruritus, Rash, Rash papular, Swelling face
Pruritus, Rash, Rash papular, Swelling face
|
Patient had raised bumps on left arm and swelling on chin and itching on arms and face. The patient ...
Patient had raised bumps on left arm and swelling on chin and itching on arms and face. The patient was administered 50 mg of benadryl in the right arm (deltoid) leading to a reduction in swelling. Furthermore, 25 mg of benadryl tablets were prescribed for ongoing use as needed until symptoms subsided.
More
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| 2840268 | 52 | M | WA | 05/09/2025 |
HEPA |
MERCK & CO. INC. |
x024966 |
Expired product administered
Expired product administered
|
expired vaccine administered.
expired vaccine administered.
|
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| 2840269 | 65 | F | OH | 05/09/2025 |
PNC20 |
PFIZER\WYETH |
|
Unevaluable event
Unevaluable event
|
None stated.
None stated.
|
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| 2840270 | 51 | M | GA | 05/09/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
8733 9266 |
Magnetic resonance imaging normal, Parosmia, Phantosmia; Magnetic resonance imag...
Magnetic resonance imaging normal, Parosmia, Phantosmia; Magnetic resonance imaging normal, Parosmia, Phantosmia
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I have developed an extreme sensitivity to smells. I have had an MRI and seen a ENT specialist and ...
I have developed an extreme sensitivity to smells. I have had an MRI and seen a ENT specialist and they can find nothing wrong. I also smell "phantom smells" such as chemical smells and exhaust even though there are no sources nearby.
More
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| 2840271 | 28 | F | CA | 05/09/2025 |
FLU3 |
SANOFI PASTEUR |
U8665EA |
Hypoaesthesia, Muscular weakness
Hypoaesthesia, Muscular weakness
|
Patient had numbness on the left cheek as well as numbness/weakness on the left arm/leg. Patient was...
Patient had numbness on the left cheek as well as numbness/weakness on the left arm/leg. Patient was administered 50 mg of benadryl in the right arm leading to a reduction in numbness. Furthermore, 25 ng of benadryl tablets were dispensed for ongoing use as needed until symptoms subsided.
More
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| 2840272 | 20 | M | TX | 05/09/2025 |
TDAP |
SANOFI PASTEUR |
U8015AA |
Fatigue, Vomiting
Fatigue, Vomiting
|
Donor called the center disclosing he threw up one time and felt tired once he arrived home. Denies ...
Donor called the center disclosing he threw up one time and felt tired once he arrived home. Denies any other symptoms. He stated he felt better after vomiting.
More
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| 2840273 | 26 | F | WA | 05/09/2025 |
TYP TYP |
BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. |
3004171 3004171 |
Abdominal discomfort, Abdominal pain upper, Nausea, Pruritus, Rash; Urticaria
Abdominal discomfort, Abdominal pain upper, Nausea, Pruritus, Rash; Urticaria
|
5/2/25: Dose #1, no significant side effects 5/4/25: Dose #2 - approximately 90 minutes after taking...
5/2/25: Dose #1, no significant side effects 5/4/25: Dose #2 - approximately 90 minutes after taking, began experiencing a rash on her face, itchiness on both hands, and "mild hives" on one hand. Denies dyspnea, wheezing, or swelling. Went to sleep and those symptoms were resolved by the morning without intervention. The morning of 5/5, pt experience stomach pain and nausea, which became more severe by bedtime. Took Tums and Pepto Bismol. Today, pt continues to have some pain, but reports it is less severe than yesterday. Advised pt to stop taking. Continued to have stomach discomfort for 2 more days, but improved each day.
More
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| 2840274 | 0.75 | F | MI | 05/09/2025 |
DTAPIPVHIB HEP PNC20 |
SANOFI PASTEUR MERCK & CO. INC. PFIZER\WYETH |
UK149AB X027728 LK6655 |
Extra dose administered; Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered; Extra dose administered
|
Accidental administration of extra vaccine
Accidental administration of extra vaccine
|
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| 2840275 | 38 | F | MI | 05/09/2025 |
PNC15 PNC15 |
MERCK & CO. INC. MERCK & CO. INC. |
Y005465 Y005465 |
Blister, Erythema, Injected limb mobility decreased, Injection site erythema, In...
Blister, Erythema, Injected limb mobility decreased, Injection site erythema, Injection site pain; Injection site pruritus, Injection site swelling, Injection site warmth, Rash
More
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On day of vaccination, patient developed erythema at injection site, along w/ swelling, warmth, pain...
On day of vaccination, patient developed erythema at injection site, along w/ swelling, warmth, pain, and decreased range of motion. Over next few days, these symptoms have improved, on day 4 after vaccination, does still have warmth, swelling, and tenderness at the site. Erythema resolved. Has also been itching throughout this time. Using benadryl and cool compresses. On the same day, the patient also developed an area of erythema on the left lower extremity. This reduced in size, but on day 3 after vaccination, a 1 cm blister developed in the center of the region of erythema. Unclear if this leg rash is related or coincidental
More
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| 2840276 | 25 | F | WA | 05/09/2025 |
HPV9 |
MERCK & CO. INC. |
Y012921 |
Headache, Hot flush, Nausea, Syncope, Trismus
Headache, Hot flush, Nausea, Syncope, Trismus
|
Jaw locking, vasovagal syncope, nausea, L eye headaches, hot flashes
Jaw locking, vasovagal syncope, nausea, L eye headaches, hot flashes
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| 2840277 | 1.25 | M | NH | 05/09/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
3RT93 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
Patient was given Kinrix when below acceptable age for administration. Given in error. Patient had n...
Patient was given Kinrix when below acceptable age for administration. Given in error. Patient had no immediate adverse reaction when vaccine was administered, none reported by mom since vaccine administered.
More
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| 2840278 | 2 | M | WI | 05/09/2025 |
DTAPIPVHIB HEPA PNC20 |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH |
UK199AA J4K4X LK6653 |
No adverse event, Product preparation issue; No adverse event, Product preparati...
No adverse event, Product preparation issue; No adverse event, Product preparation issue; No adverse event, Product preparation issue
More
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Patient given Pentacel vaccine. Which consist of DTap, IPV & Hib. Patient did not receive Hib po...
Patient given Pentacel vaccine. Which consist of DTap, IPV & Hib. Patient did not receive Hib portion of vaccine. Manufacturer of vaccine Sanofi Paseur consulted. Writer instructed to give HIB portion of vaccine with 0.4% Chloride, no time frame recommended. Patient has no known signs, symptoms, or adverse reactions over the course of incident. Patients' legal guardian will be notified of diversion and instructed to bring patient into clinic to receive Hib portion of vaccine Staff retrained on how to properly administer vaccine to prevent future mistakes.
More
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| 2840279 | 0.67 | F | OR | 05/09/2025 |
HEPA |
MERCK & CO. INC. |
Y011731 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
none at this time
none at this time
|
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| 2840280 | 4 | F | MA | 05/09/2025 |
MMR |
MERCK & CO. INC. |
Y013130 |
Injection site reaction, Injection site swelling
Injection site reaction, Injection site swelling
|
Swelling and localized reaction where MMR administered
Swelling and localized reaction where MMR administered
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| 2840281 | 65 | F | WI | 05/09/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
Y7XG3 |
Vaccination site rash
Vaccination site rash
|
Patient presented with a non-itchy rash surrounding vaccine site. Will mark the margins and monitor...
Patient presented with a non-itchy rash surrounding vaccine site. Will mark the margins and monitor with help from daughter. will also take picture. We will follow up in 2 days
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| 2840282 | 3 | M | WI | 05/09/2025 |
DTAPIPVHIB HEPA |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
UK199AA |
No adverse event, Product preparation issue; No adverse event, Product preparati...
No adverse event, Product preparation issue; No adverse event, Product preparation issue
More
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Patient given Pentacel vaccine. Which consist of DTap, IPV & Hib. Patient did not receive Hib po...
Patient given Pentacel vaccine. Which consist of DTap, IPV & Hib. Patient did not receive Hib portion of vaccine. Manufacturer of vaccine Sanofi Paseur consulted. Writer instructed to give HIB portion of vaccine with 0.4% Chloride, no time frame recommended. Patient has no known signs, symptoms, or adverse reactions over the course of incident. Patients' legal guardian will be notified of diversion and instructed to bring patient into clinic to receive HIB portion of vaccine Staff retrained on how to properly administer vaccine to prevent future mistakes.
More
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| 2840283 | MT | 05/09/2025 |
RAB |
NOVARTIS VACCINES AND DIAGNOSTICS |
ARBA971C |
Expired product administered
Expired product administered
|
None Vaccine outdated
None Vaccine outdated
|
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| 2840284 | 18 | M | MI | 05/09/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
X4BK3 |
Unevaluable event
Unevaluable event
|
n/A
n/A
|
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| 2840285 | 61 | F | TX | 05/09/2025 |
PNC20 |
PFIZER\WYETH |
MA2519 |
Erythema, Pain in extremity
Erythema, Pain in extremity
|
Patient called describing having pain in left, little redness (05/08/2025) no fever. Patient was adv...
Patient called describing having pain in left, little redness (05/08/2025) no fever. Patient was advised to contact primarycare immedaitely or go to emergency.
More
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| 2840286 | 17 | M | NJ | 05/09/2025 |
MENB MNQ |
PFIZER\WYETH SANOFI PASTEUR |
LF5303 U8494AA |
Dizziness, Eye movement disorder, Generalised tonic-clonic seizure, Loss of cons...
Dizziness, Eye movement disorder, Generalised tonic-clonic seizure, Loss of consciousness, Posture abnormal; Dizziness, Eye movement disorder, Generalised tonic-clonic seizure, Loss of consciousness, Posture abnormal
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Pt. Given Men A vaccine on right deltoid and Men B on left deltoid Pt. Started to feel dizzy- as he...
Pt. Given Men A vaccine on right deltoid and Men B on left deltoid Pt. Started to feel dizzy- as he was walking to waiting room (said after) Sat in the chair CMA went to get water and mother notes- eyes and head drifted to side and passed out leaning towards her. As I ran to the waiting room- pt. With tonic clonic seziure of arms lasted < 5 sec, Pt. Immediately talking to mother afterwards Stood up and with some difficulty, slowly forced into laying position with legs elevated B/P: 96/63 HR:60 Gave about 8 of water and lollipop and 16 oz Pedialyte Repeat B/P: 107/73 HR:73 Given approx around 30 oz of water as started to finish Pedialyte and transferred to chair- sitting position- feeling better B/P: 119/80 HR: 64 Pt. Monitored in office for total of 30 min -- walked in waiting room
More
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| 2840287 | 2 | M | AL | 05/09/2025 |
HEPA |
MERCK & CO. INC. |
y0212227 |
Urticaria
Urticaria
|
urticarial rash
urticarial rash
|
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| 2840288 | 17 | F | IN | 05/09/2025 |
MENB MENB |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
99G34 99G34 |
Injection site erythema, Injection site pain, Injection site reaction, Injection...
Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth; Urticaria
More
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Call from mother 5-9-25 . Left arm (deltoid) swollen at injection site. 2x 4-5 inches "welt&qu...
Call from mother 5-9-25 . Left arm (deltoid) swollen at injection site. 2x 4-5 inches "welt" noted. Swelling is red and warm to touch. Did not check body temp. Has tried oral Benadryl on 5-8-25. Swelling did not improve and is worse today 5-9-25. Left arm is sore at injection site. No other complaints.
More
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| 2840289 | 05/09/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Neuropathy peripheral, Pain, Scar, Vaccination failure; Herpes zo...
Herpes zoster, Neuropathy peripheral, Pain, Scar, Vaccination failure; Herpes zoster, Neuropathy peripheral, Pain, Scar, Vaccination failure
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Suspected vaccination failure; I did everything right but yet I continue to suffer from neuropathy; ...
Suspected vaccination failure; I did everything right but yet I continue to suffer from neuropathy; i got shingles/ received both vaccines approximately 1.5 years ago; I did everything right but yet I continue to suffer from scaring; 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, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), neuropathy (Verbatim: I did everything right but yet I continue to suffer from neuropathy) (serious criteria GSK medically significant), shingles (Verbatim: i got shingles/ received both vaccines approximately 1.5 years ago) and scar (Verbatim: I did everything right but yet I continue to suffer from scaring). The outcome of the vaccination failure and shingles were not reported and the outcome of the neuropathy and scar were not resolved. It was unknown if the reporter considered the vaccination failure, neuropathy, shingles and scar to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure and neuropathy to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and scar to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 02-MAY-2025 This case was reported by a patient via interactive digital media. Consumer reported that got shingles very much like the woman in this photo. It was terribly painful, and this was after received both vaccines approximately 1.5 years ago. On the day the rash broke out and went on a regimen of antiviral medication. Consumer did everything right but yet continue to suffer from neuropathy and scaring. Reporter is also reported that the opinion is this outbreak could not have been any worse. He/ she also reported that it feels the vaccine did nothing for consumer. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2). Neuropathy peripheral is an unlisted event which is considered unrelated to GSK Shingles vaccine (Dose 1 & 2).
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| 2840290 | 58 | F | MA | 05/09/2025 |
HEP PNC20 |
DYNAVAX TECHNOLOGIES CORPORATION PFIZER\WYETH |
946060 LN4927 |
Injection site erythema, Injection site pain, Injection site warmth, Product adm...
Injection site erythema, Injection site pain, Injection site warmth, Product administered at inappropriate site; Injection site erythema, Injection site pain, Injection site warmth, Product administered at inappropriate site
More
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Patient experienced severe soreness rating 8/10, redness, and warmth at the injection site. Her symp...
Patient experienced severe soreness rating 8/10, redness, and warmth at the injection site. Her symptoms are improving, however the injection site remains red and warm. The injections seem to be have administered in the wrong location, below the deltoid muscle. This happened over the course of around 2 days.
More
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| 2840291 | 46 | F | GA | 05/09/2025 |
TDAP |
SANOFI PASTEUR |
u8232aa |
Dizziness
Dizziness
|
Shortly after receiving the vaccine the patient became dizzy and lightheaded. She laid on a bench i...
Shortly after receiving the vaccine the patient became dizzy and lightheaded. She laid on a bench in the pharmacy for a few minutes until it stopped. I gave her a cold rag for her head and a bottle of water and observed the patient until she felt comfortable to leave the pharmacy.
More
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| 2840292 | 13 | F | TN | 05/09/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
h3n97 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
Vaccine was given too early.
Vaccine was given too early.
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| 2840293 | 77 | F | OH | 05/09/2025 |
PNC20 |
PFIZER\WYETH |
|
Injection site erythema, Injection site induration, Injection site pain, Injecti...
Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
More
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pt says she had pain in her left arm around the injection site the day of the vaccine. Within in th...
pt says she had pain in her left arm around the injection site the day of the vaccine. Within in the next couple of days in the area around the injection site it became hard. By 5/5/2025 it was hard and red. The size of the swelling around the injection site was 8cc wide x 10 cc long. The redness and the pain is starting to finally decrease but the size is still the same size. Pt will contact the pharmacy to let them know her symptoms and that she has reported.
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| 2840294 | 46 | M | MI | 05/09/2025 |
COVID19 FLU3 HEP HEPA MMR |
MODERNA GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
B0001 9CH4P 9K34M 4T93R Y010046 |
Expired product administered, No adverse event; Expired product administered, No...
Expired product administered, No adverse event; Expired product administered, No adverse event; Expired product administered, No adverse event; Expired product administered, No adverse event; Expired product administered, No adverse event
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No adverse event has been witnessed, vaccine was expired
No adverse event has been witnessed, vaccine was expired
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| 2840295 | 16 | F | MT | 05/09/2025 |
JEV1 |
INTERCELL AG |
JEV23K07E |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Pt was given 2nd dose of vaccine to soon. It was given 7 days after the initial dose, later discove...
Pt was given 2nd dose of vaccine to soon. It was given 7 days after the initial dose, later discovered it should have been 28 days.
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| 2840296 | 7 | M | CO | 05/09/2025 |
DTAP |
SANOFI PASTEUR |
3CA20C1 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Patient was administered dose of DTaP at the age of 7 years old 7 months. Client should have been g...
Patient was administered dose of DTaP at the age of 7 years old 7 months. Client should have been given Tdap vaccine for catch-up.
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| 2840297 | 32 | F | SC | 05/09/2025 |
VARCEL |
MERCK & CO. INC. |
Y011020 |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
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Patient presented with an adverse injection site reaction....redness and swelling around area. Urg...
Patient presented with an adverse injection site reaction....redness and swelling around area. Urgent care prescribed her, and antibiotic, Steroid cream, antihistamine and an oral steroid
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| 2840298 | 57 | F | CT | 05/09/2025 |
PNC21 |
MERCK & CO. INC. |
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Erythema, Pain, Pruritus, Skin warm, Swelling
Erythema, Pain, Pruritus, Skin warm, Swelling
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Patient stated soreness and swelling followed by redness, itching and warmness to the touch
Patient stated soreness and swelling followed by redness, itching and warmness to the touch
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| 2840299 | 42 | F | CA | 05/09/2025 |
HPV9 |
MERCK & CO. INC. |
xo24560 |
Erythema, Mobility decreased, Pain in extremity
Erythema, Mobility decreased, Pain in extremity
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On 4/30/25 patient received Garadsil 9 (NDC:00006412102, Lot: XO24560) in her right arm, but on 05/0...
On 4/30/25 patient received Garadsil 9 (NDC:00006412102, Lot: XO24560) in her right arm, but on 05/01/25 they experienced extreme pain in the left arm, redness, and couldn't move her left arm. She informed me that she went to the emergency room and recieved cetirizine, oral naproxen, and toradol injection to help with the pain. She has a follow up appointment with her primary doctor soon.
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| 2840300 | 05/09/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Respiratory syncytial virus infection, Vaccination failure
Respiratory syncytial virus infection, Vaccination failure
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had rsv 2 months after vaccination; Suspected vaccination failure; This serious case was reported by...
had rsv 2 months after vaccination; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, 2 months after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: had rsv 2 months after vaccination) (serious criteria hospitalization). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure and respiratory syncytial virus infection to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 02-MAY-2025 This case was reported by a patient via interactive digital media. The patient stated he/she had respiratory syncytial virus infection 2 months after vaccination. The patient was in hospital for days. The patient stated hate to think if she/he had not been vaccinated. This case was considered as suspected vaccination failure as details regarding the laboratory confirmation regarding respiratory syncytial virus infection 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine RSV vaccine. Respiratory syncytial virus infection is an unlisted event which is considered unrelated to GSK vaccine RSV vaccine.
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| 2840301 | F | 05/09/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Respiratory syncytial virus infection, Vaccination failure
Respiratory syncytial virus infection, Vaccination failure
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Suspected vaccination failure; still got RSV and it was ruff; This serious case was reported by a co...
Suspected vaccination failure; still got RSV and it was ruff; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 94-year-old female 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: still got RSV and it was ruff). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date: 03-MAY-2025 This case was reported by the reporter via interactive digital media. The patient was reporter's mother. The reporter reported that his/her mom (patient) got the vaccine. She still got RSV, and it was ruff. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding respiratory syncytial virus infection 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 RSV vaccine.
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| 2840302 | 05/09/2025 |
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; got shingles; This serious case was reported by a consumer via intera...
Suspected vaccination failure; got 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. Previously administered products included Varicella zoster vaccine (received old vaccine on an unknown date). 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: got 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 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: 03-MAY-2025 This case was reported by a patient via interactive digital media. The patient said that in too had both the old and new 2 dose of new Shingles vaccine and got shingles. Not a bad case at all but it happened. His/her pharmacist was amazed. This case was considered as suspected vaccination failure since the details regarding 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 completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1& 2).
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| 2840303 | 05/09/2025 |
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; have had it a total of 6 times; This serious case was reported by a c...
Suspected vaccination failure; have had it a total of 6 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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: have had it a total of 6 times). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine 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: 03-MAY-2025 The case was received from the patient via interactive digital media. The reporter had been vaccinated twice, have had it a total of 6 times. The reporter reported that the vaccine just prevents you from possibly not getting it as bad. It was not a guarantee you would never get it again. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2).
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| 2840304 | 05/09/2025 |
VARZOS VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure; Herpes z...
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; I also had shingles for the first time at about age 22 and have had s...
Suspected vaccination failure; I also had shingles for the first time at about age 22 and have had shingles about 10 times and I'm now 72. Had first vaccine, and later had the newer two vaccine and still have gotten break thru shingles; later had the newer two vaccines; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 72-year-old 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 (had shingles first time at about age 22 and had shingles about 10 times). 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, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I also had shingles for the first time at about age 22 and have had shingles about 10 times and I'm now 72. Had first vaccine, and later had the newer two vaccine and still have gotten break thru shingles) and extra dose administered (Verbatim: later had the newer two vaccines). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure and shingles 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 shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 04-MAY-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she also had shingles for the first time at about age 22 and had shingles about 10 times and he/she was now 72. Had first vaccine, and later had the newer two vaccines and still had got breakthrough shingles, his/her doctor now had given a daily low dose of Valtrex. This case was considered as suspected vaccination failure as details regarding completion 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1, 2 & 3).
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| 2840305 | 05/09/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; I got shingles about a month after the shot. .; This serious case was...
Suspected vaccination failure; I got shingles about a month after the shot. .; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got shingles about a month after the shot. .). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 04-MAY-2025 This case was reported by a patient via interactive digital media. Consumer reported that his/her physician said that the shot doesn't work and that is why they advertise it all the time. Reporter said he/she got shingles about a month after the shot and also mentioned that never again will take these fake shots filled with poison. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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