| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2804460 | 31 | M | CA | 10/31/2024 |
ANTH ANTH ANTH ANTH ANTH ANTH ANTH ANTH ANTH ANTH |
EMERGENT BIOSOLUTIONS EMERGENT BIOSOLUTIONS EMERGENT BIOSOLUTIONS EMERGENT BIOSOLUTIONS EMERGENT BIOSOLUTIONS EMERGENT BIOSOLUTIONS EMERGENT BIOSOLUTIONS EMERGENT BIOSOLUTIONS EMERGENT BIOSOLUTIONS EMERGENT BIOSOLUTIONS |
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Arthralgia, Bone pain, Chest discomfort, Dyspnoea, Myalgia; Toothache; Burning s...
Arthralgia, Bone pain, Chest discomfort, Dyspnoea, Myalgia; Toothache; Burning sensation, Chest X-ray normal, Chest discomfort, Chest pain, Dizziness; Dyspnoea, Dyspnoea exertional, Echocardiogram normal, Electrocardiogram normal, Immediate post-injection reaction; Injection site erythema, Injection site pain, Injection site pruritus, Nausea, Pain in extremity; Paraesthesia, Skin tightness, Toothache; Burning sensation, Chest X-ray normal, Chest discomfort, Chest pain, Dizziness; Dyspnoea, Dyspnoea exertional, Echocardiogram normal, Electrocardiogram normal, Immediate post-injection reaction; Injection site erythema, Injection site pain, Injection site pruritus, Nausea, Pain in extremity; Paraesthesia, Skin tightness, Toothache
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Muscle pain, chest tightness, shortness of breath, teeth pain and bone/joint pain
Muscle pain, chest tightness, shortness of breath, teeth pain and bone/joint pain
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| 2705265 | U | CA | 10/28/2023 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Blood disorder, Blood test; Blood test, Blood test abnormal
Blood disorder, Blood test; Blood test, Blood test abnormal
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wrong with my blood work; This is a spontaneous report received from a contactable reporter(s) (Cons...
wrong with my blood work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD DISORDER (non-serious), outcome "unknown", described as "wrong with my blood work". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results. Additional information: the patient received an injection for the COVID-19 virus and afterwards there was a "thing wrong with my blood work." The information on the batch/lot number for bnt162b2 omi xbb.1.5, has been requested and will be submitted if and when received.
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| 2847154 | 16 | M | AZ | 06/24/2025 |
HPV9 MENB MNQ |
MERCK & CO. INC. PFIZER\WYETH SANOFI PASTEUR |
X024560 GF4143 U8375AA |
Fall, Feeling abnormal, Pallor, Syncope, Tongue biting; Fall, Feeling abnormal, ...
Fall, Feeling abnormal, Pallor, Syncope, Tongue biting; Fall, Feeling abnormal, Pallor, Syncope, Tongue biting; Fall, Feeling abnormal, Pallor, Syncope, Tongue biting
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16 year old male fainted after reciving vaccines, and fell on the floor face first. bit his tongue....
16 year old male fainted after reciving vaccines, and fell on the floor face first. bit his tongue. blood pressure 99/64 pulse 55, Patient awake and oriented, looks pale and feels daze.
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| 2847155 | 74 | F | IA | 06/24/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
00358160848117 |
Limb mass
Limb mass
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Noticed she had about a 1/4-1/2 inch bump on her right wrist. It wasn't painful, but only appea...
Noticed she had about a 1/4-1/2 inch bump on her right wrist. It wasn't painful, but only appeared this afternoon. She put ice on it, which did appear to help. She described it as being like a ""burst blood vessel."
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| 2847156 | 25 | F | CA | 06/24/2025 |
COVID19 |
PFIZER\BIONTECH |
me6072 |
Blood test, Contusion, Eye pain, Headache, Influenza like illness
Blood test, Contusion, Eye pain, Headache, Influenza like illness
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Flu like symptoms, bruising of legs/arms, and severe headache/ocular pain
Flu like symptoms, bruising of legs/arms, and severe headache/ocular pain
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| 2847157 | 38 | F | AZ | 06/24/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
Z27PB |
Dizziness, Hyperhidrosis, Nausea, Pallor
Dizziness, Hyperhidrosis, Nausea, Pallor
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Patient received vaccine and sat in waiting room after. She became very pale, dizzy, sweaty and nau...
Patient received vaccine and sat in waiting room after. She became very pale, dizzy, sweaty and nauseated. Called 911 but patient stated she did not want to ride in an ambulance. Her eyes looked dilated and her vision was blurry. She said she felt a "ball in her throat". She was able to speak and swallow and was given orange juice and a glucose tablet to make sure her sugar was not low. An Epi-pen was available for use if necessary. Patient was in waiting room for approximately an hour. As she was coming around, she mentioned pain in her lower abdomen. Her father, who was with her, stated he was going to take her to the ER to get checked out. I encouraged her to be seen even though she was improving to rule out any other complications.
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| 2847158 | 29 | F | OH | 06/24/2025 |
COVID19 |
MODERNA |
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Heart rate increased
Heart rate increased
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Sustained increased resting heart rate starting after administration. Increased ~15 bpm over a few m...
Sustained increased resting heart rate starting after administration. Increased ~15 bpm over a few months and has remained increased.
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| 2847159 | 63 | F | WA | 06/24/2025 |
COVID19 HEPA PNC20 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH |
ME6072 Z27PB LN4930 |
Erythema, Peripheral swelling; Erythema, Peripheral swelling; Erythema, Peripher...
Erythema, Peripheral swelling; Erythema, Peripheral swelling; Erythema, Peripheral swelling
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red arm and a little swollen (recommended Benadryl and monitor injection site)
red arm and a little swollen (recommended Benadryl and monitor injection site)
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| 2846818 | M | PA | 06/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Myalgia, Rash, Rash erythematous
Myalgia, Rash, Rash erythematous
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Rash; Muscle soreness; red rash on arm; This non-serious case was reported by a consumer via call c...
Rash; Muscle soreness; red rash on arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included heart rate irregular (Irregular heart beat). Previously administered products included Shingrix (received 1st dose on an unknown date). Concurrent medical conditions included blood pressure high (Blood pressure high), blood cholesterol increased (High cholesterol), diabetes (Diabetes), crohn's disease (Crohn's disease) and hidradenitis (Hidradenitis). Concomitant products included amlodipine, apixaban, clindamycin, dulaglutide (Trulicity), esomeprazole sodium (Nexium), furosemide (Lasix), gabapentin, hydrochlorothiazide, losartan, metformin, simvastatin, ustekinumab (Stelara) and colecalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, vitamin b1 nos (Multivitamin). In MAY-2025, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: Rash), muscle soreness (Verbatim: Muscle soreness) and red rash (Verbatim: red rash on arm). The outcome of the rash, muscle soreness and red rash were not resolved. It was unknown if the reporter considered the rash, muscle soreness and red rash to be related to Shingrix. It was unknown if the company considered the rash, muscle soreness and red rash to be related to Shingrix. Additional Information: GSK Receipt Date: 12-JUN-2025 The case was self reported by patient. The patient received Shingrix vaccine 3.5 weeks ago after that he experienced muscle soreness in his right arm which has not gone away. This now extends down to his right wrist and to the back of his arm. He had a red rash on this arm as well as on his waist.
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| 2846819 | 74 | F | MD | 06/23/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Injection site erythema, Injection site rash, Injection site swelling
Injection site erythema, Injection site rash, Injection site swelling
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Injection site rash; Injection site redness; Injection site swelling; This non-serious case was rep...
Injection site rash; Injection site redness; Injection site swelling; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. The patient's past medical history included gastric bypass (Gastric Bypass 20 years ago) and breast cancer (history of Breast cancer). Concomitant products included anastrozole, folic acid, escitalopram oxalate (Lexapro), ubidecarenone (Co Q-10), vitamin c and vitamin b12. On 11-JUN-2025, the patient received Arexvy (left arm). On 12-JUN-2025, 1 days after receiving Arexvy, the patient experienced injection site rash (Verbatim: Injection site rash), injection site erythema (Verbatim: Injection site redness) and injection site swelling (Verbatim: Injection site swelling). The outcome of the injection site rash, injection site erythema and injection site swelling were not resolved. It was unknown if the reporter considered the injection site rash, injection site erythema and injection site swelling to be related to Arexvy. It was unknown if the company considered the injection site rash, injection site erythema and injection site swelling to be related to Arexvy. Additional Information: GSK receipt date: The reporter was the husband of the patient. The patient received Arexvy on Wednesday 11 June 2025 in the left arm. The next day, the patient noticed a rash, redness and swelling at the injection site. The reporter had very limited contact information for the HCP.
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| 2846820 | 75 | M | MD | 06/23/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Injection site erythema
Injection site erythema
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redness at the injection site; This non-serious case was reported by a consumer via call center repr...
redness at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included supraventricular tachycardia (History of SVT - had ablation done to treat). Concomitant products included Multivitamin. On 11-JUN-2025, the patient received Arexvy (right arm). On 11-JUN-2025, less than a day after receiving Arexvy, the patient experienced injection site erythema (Verbatim: redness at the injection site). On 12-JUN-2025, the outcome of the injection site erythema was resolved (duration 1 day). It was unknown if the reporter considered the injection site erythema to be related to Arexvy. It was unknown if the company considered the injection site erythema to be related to Arexvy. Additional Information: GSK Receipt Date: 13-JUN-2025 The reporter was the patient. The patient received Arexvy on Wednesday 11 June 2025 in the right arm. The patient noticed redness at the injection site the day of the vaccination, and it was gone the next day.
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| 2846821 | 06/23/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
UNK |
Product preparation issue
Product preparation issue
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With the Menveo vaccine if we only gave the liquid part and did not mix with the other vial .; With ...
With the Menveo vaccine if we only gave the liquid part and did not mix with the other vial .; With the Menveo vaccine if we only gave the liquid part and did not mix with the other vial .; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: With the Menveo vaccine if we only gave the liquid part and did not mix with the other vial .) and inappropriate dose of vaccine administered (Verbatim: With the Menveo vaccine if we only gave the liquid part and did not mix with the other vial .). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 12-JUN-2025 This case was reported by a consumer via interactive digital media. The reporter reported that with the Menveo vaccine if they only gave the liquid part and did not mix with the other vial, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
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| 2846822 | 1 | F | MN | 06/23/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
GG39D |
Expired product administered
Expired product administered
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maladministration of Infanrix after the expiration date; This non-serious case was reported by a nur...
maladministration of Infanrix after the expiration date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-month-old female patient who received DTPa (Infanrix) (batch number GG39D, expiry date 07-JUN-2025) for prophylaxis. On 13-JUN-2025, the patient received Infanrix. On 13-JUN-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: maladministration of Infanrix after the expiration date). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 13-JUN-2025 Registered Nurse called to ask if they had to revaccinate after the maladministration of Infanrix after the expiration date which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter.
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| 2846823 | MD | 06/23/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
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Product preparation issue
Product preparation issue
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Incomplete dose/They have no way of knowing if patients just got the diluent; Incomplete dose/They h...
Incomplete dose/They have no way of knowing if patients just got the diluent; Incomplete dose/They have no way of knowing if patients just got the diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Incomplete dose/They have no way of knowing if patients just got the diluent) and inappropriate dose of vaccine administered (Verbatim: Incomplete dose/They have no way of knowing if patients just got the diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 16-JUN-2025 and 17-JUN-2025 The other health professional reported that they had several patients who may not have received full doses of Priorix vaccine. The other health professional asked what the recommendation regarding revaccination was. The other health professional stated that they bag the 2 components of Priorix together and put them in the box protected from light. They have no way of knowing if patients just got the diluent which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. She stated they bag them and band them together because this was an ongoing issue with the 2 component vaccines.
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| 2846824 | NJ | 06/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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Delaying second dose of shingrix; This non-serious case was reported by a physician via sales rep an...
Delaying second dose of shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose five years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Delaying second dose of shingrix). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 16-JUN-2025 The Vaccine Administration Facility was the same as Primary Reporter The reporter mentioned that a patient had first dose of Shingrix vaccine 5 years ago. The reporter asked how long after delaying second dose of Shingrix would the patient need to restart the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2846826 | 50 | F | TX | 06/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Diarrhoea, Headache, Oral herpes
Diarrhoea, Headache, Oral herpes
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Fever 1p1.7�f , headache, diarrhea. Will wait out at home and call dr if condition worsens.
Fever 1p1.7�f , headache, diarrhea. Will wait out at home and call dr if condition worsens.
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| 2846827 | 59 | F | GA | 06/23/2025 |
VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Abdominal discomfort, Back pain, Chills, Decreased appetite, Fatigue; Headache, ...
Abdominal discomfort, Back pain, Chills, Decreased appetite, Fatigue; Headache, Hyperhidrosis, Pain in extremity, Paraesthesia, Pruritus; Rosacea
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Sweating & chills; fatigue; leg and back pain; headache; upset stomach; loss of appetite; extrem...
Sweating & chills; fatigue; leg and back pain; headache; upset stomach; loss of appetite; extreme fatigue; itching & rosacea (about 10 days post-vaccine); tingling in 3 fingers on left hand + left forearm + left shoulder + 2 fingers on right hand (about 11 days post-vaccine)
More
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| 2846828 | KY | 06/23/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
X012268 |
Expired product administered, No adverse event; Expired product administered, No...
Expired product administered, No adverse event; Expired product administered, No adverse event
More
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No symptoms or side effects; HCP called to report an expired dose of VARIVAX was administered to a p...
No symptoms or side effects; HCP called to report an expired dose of VARIVAX was administered to a patient on 6/18/2025.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-JAN-2023, the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) with sterile diluent (MERCK STERILE DILUENT) administered for prophylaxis (strength, lot number, expiration date, route and anatomical site of administration were not provided). On 18-JUN-2025, the patient was vaccinated with a second expired dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) injection, 0.5 mL, lot #X012268 [which has been verified go be valid lot number for Varicella Virus Vaccine Live (Oka-Merck)], expiration date reported and upon internal validation establish as 30-APR-2025. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT), lot #Y016370, expiration date: 13-MAY-2027 upon internal validation. Both were administered for prophylaxis (strength, route and anatomical site of administration were not provided). Expired dose supported by post expiry memo (Expired product administered). Despite multiple reiterations of the supported outcome, customer not comprehending outcome and hung up despite offer to look into further resources if unclear. No symptoms or side effects (No adverse event). No previous temperature excursion.
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| 2846829 | 2 | M | MA | 06/23/2025 |
COVID19 HEPA |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
LN8272 J4K4X |
Product storage error; Product storage error
Product storage error; Product storage error
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None reported symptoms- COVID vaccine given over 10 weeks after thawed and storage.
None reported symptoms- COVID vaccine given over 10 weeks after thawed and storage.
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| 2846833 | 0.33 | M | GA | 06/23/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
9D25P |
Dyskinesia, Hypotonia, Infant irritability, Nystagmus
Dyskinesia, Hypotonia, Infant irritability, Nystagmus
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After receiving vaccine -IRRITBILITY/ Not himself x 2 wks - Not as expressive Also noted what sounds...
After receiving vaccine -IRRITBILITY/ Not himself x 2 wks - Not as expressive Also noted what sounds like nystagmus/and random jerking movement of extremity
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| 2846891 | 1 | M | CO | 06/23/2025 |
HEPA HEPA |
MERCK & CO. INC. MERCK & CO. INC. |
Y013274 |
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
More
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No additional AE reported; E-mail received in the MNSC Contact Center mailbox on 03JUN2025 at 9:14 P...
No additional AE reported; E-mail received in the MNSC Contact Center mailbox on 03JUN2025 at 9:14 PM with RMPDS after hours case MRK-2025-0063 reporting an AE for VAQTA. Verbatim: "This medical assistant reported that a "15 month old" patient received his first dose of VAQTA; This spontaneous report was received from a Medical Assistant and refers to a 16-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 28-Feb-2025 (conflicting information as it was also reported as 28-Jan-2025), the patient was vaccinated with the first dose of Hepatitis A Vaccine, Inactivated (VAQTA),, dose number 1, 0.5 mL (0.5 mL), administered by Intramuscular route (lot # and expiration date were not reported). On 23-May-2025, the patient was vaccinated with the second dose of Hepatitis A Vaccine, Inactivated (VAQTA), (lot #Y013274, expiration date: 26-Dec-2025), dose number 2, 0.5 mL (0.5 mL), administered by Intramuscular route, both administered for prophylaxis, which was too early (inappropriate schedule of product administration). No adverse event was reported. Lot # for the first dose is being requested and will be submitted if received.
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| 2846892 | TX | 06/23/2025 |
HPV9 HPV9 HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y015599 |
Extra dose administered; Extra dose administered; Extra dose administered; Extra...
Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered
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patient reported no symptoms; Inadvertently administering a 4th dose of GARDASIL 9 to a 20 year old ...
patient reported no symptoms; Inadvertently administering a 4th dose of GARDASIL 9 to a 20 year old patient; This spontaneous report was received from a Nurse and refers to a(n) patient of unknown age and gender. The patient's medical history, concurrent conditions AND Concomitant therapies were not reported. On 30-Jan-2017, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose number 1, on 03-Apr-2017, dose number 2, and in August 2017, dose number 3, administered by Unknown route (lot # and expiration date were not reported). On 10-Jun-2025, the patient was inadvertently administered a fourth dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y015599, expiration date: 10-Feb-2027), administered by Unknown route (Extra dose administered). All doses administered for prophylaxis. The patient reported no symptoms or adverse events.
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| 2846893 | NV | 06/23/2025 |
PNC15 PNC15 |
MERCK & CO. INC. MERCK & CO. INC. |
Z003633 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
More
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No additional AE; extra dose of VAXNEUVANCE; This spontaneous report was received from a medical ass...
No additional AE; extra dose of VAXNEUVANCE; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patient was vaccinated with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) Suspension for injection (dose, route of administration, lot # and expiration date were not reported) as prophylaxis and completed 4-dose series. Then, on 13-Jun-2025, the patient was inadvertently administered an extra dose of this vaccine (lot #Z003633, expiration date: 24-May-2027) (dose and route of administration were not reported) also as prophylaxis (Extra dose administered). The patient did not report any symptoms (No adverse event).
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| 2846894 | F | 06/23/2025 |
HPV9 |
MERCK & CO. INC. |
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Incomplete course of vaccination
Incomplete course of vaccination
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the second was postponed twice due to surgeries; This spontaneous report was received from a 44-year...
the second was postponed twice due to surgeries; This spontaneous report was received from a 44-year-old female patient, referring to herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-DEC-2024, the patient was vaccinated with 1st dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) suspension for injection, administered for prophylaxis (dose, route of administration, anatomical location, lot # and expiration date were not reported). The 2nd dose of human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) was postponed twice due to unspecified surgeries (performed on unspecified dates). The outcome of the event was not reported. Causality assessment was not provided. Additional information is not expected.
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| 2846895 | VA | 06/23/2025 |
DTPPVHBHPB RVX |
MSP VACCINE COMPANY UNKNOWN MANUFACTURER |
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No adverse event, Product storage error; No adverse event, Product storage error
No adverse event, Product storage error; No adverse event, Product storage error
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No adverse event; HCP called to report inadvertent administration of ROTATEQ and VAXELIS after a tem...
No adverse event; HCP called to report inadvertent administration of ROTATEQ and VAXELIS after a temperature excursion that occurred on 07MAY2025. ROTATEQ and VAXELIS were administered to a patient on 21MAY2025. Limited demographics provided. HCP originally called on; This spontaneous report was received from a nurse practitioner and refers to a 5-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 21-MAY-2025, the patient was inadvertently vaccinated with improper stored dose of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis b [recombinant] vaccine (VAXELIS) suspension for injection (dose, route of administration, anatomical location, lot # and expiration date were not reported) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral solution administered by oral route (dose, lot # and expiration date were not reported); both administered as prophylaxis after a temperature excursion (that occurred on 07-MAY-2025) reported as 1.4 degree Celsius for 18 minutes. There was no previous temperature excursions. No additional adverse events reported. Lot# is being requested and will be submitted if received. This is one of the several reports received form the same reporter.; Reporter's Comments
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| 2846896 | M | 06/23/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
3RT93 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Kinrix was accidentally given to 11-year-old; This non-serious case was reported by a nurse via sale...
Kinrix was accidentally given to 11-year-old; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis. On 11-JUN-2025, the patient received Kinrix. On 11-JUN-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was accidentally given to 11-year-old). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 12-JUN-2025 Other HCP reported that Kinrix was accidentally given to 11-year-old, no symptoms were reported.
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| 2846897 | 4 | M | TX | 06/23/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
4L454 |
Gait disturbance, Injection site swelling, Product administered at inappropriate...
Gait disturbance, Injection site swelling, Product administered at inappropriate site
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Limping; administered a dose of Kinrix into the left thigh; Swollen Thigh; This non-serious case was...
Limping; administered a dose of Kinrix into the left thigh; Swollen Thigh; This non-serious case was reported by a physician via call center representative and described the occurrence of swelling of legs in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 4L454) for prophylaxis. Concomitant products included Mmr ii and Varicella zoster vaccine live (Oka/Merck) (Varivax). On 12-JUN-2025, the patient received Kinrix (left thigh). On 12-JUN-2025, less than a week after receiving Kinrix, the patient experienced limping (Verbatim: Limping) and vaccine administered at inappropriate site (Verbatim: administered a dose of Kinrix into the left thigh). In JUN-2025, the patient experienced swelling of legs (Verbatim: Swollen Thigh). The outcome of the swelling of legs was not resolved and the outcome of the limping was unknown and the outcome of the vaccine administered at inappropriate site was not applicable. It was unknown if the reporter considered the swelling of legs and limping to be related to Kinrix and Kinrix Pre-Filled Syringe Device. The reporter considered the vaccine administered at inappropriate site to be unrelated to Kinrix. It was unknown if the company considered the swelling of legs and limping to be related to Kinrix and Kinrix Pre-Filled Syringe Device. The company considered the vaccine administered at inappropriate site to be unrelated to Kinrix. 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: 13-JUN-2025 Physician stated that on 12th June 2025, she administered a dose of Kinrix into the left thigh of a pediatric patient, and mom noticed the patient was limping and complaining last night on 12th June 2025. The reporter stated that the patient did not let mom see the left thigh until today, 13th June 2025, and mom stated the left thigh was very, very big or swollen. Reporter stated that's all that was provided about these adverse events.
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| 2846898 | F | 06/23/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Diarrhoea, Rash
Diarrhoea, Rash
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Diarrhea; Rash over torso, arms, face; This non-serious case was reported by a consumer and describe...
Diarrhea; Rash over torso, arms, face; This non-serious case was reported by a consumer and described the occurrence of diarrhea in a 57-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 30-MAY-2025, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced diarrhea (Verbatim: Diarrhea) and rash (Verbatim: Rash over torso, arms, face). The outcome of the diarrhea was resolved and the outcome of the rash was not resolved. It was unknown if the reporter considered the diarrhea and rash to be related to Shingles vaccine. It was unknown if the company considered the diarrhea and rash to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 13-JUN-2025 The patient self-reported this case for herself. The patient had diarrhea and rash over torso, arms, face. The symptoms were not treated.
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| 2846899 | 06/23/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Pain
Pain
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Excruciating Pain for 6 weeks; This non-serious case was reported by a consumer via interactive digi...
Excruciating Pain for 6 weeks; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain 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 pain (Verbatim: Excruciating Pain for 6 weeks). The outcome of the pain was resolved (duration 6 weeks). It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 16-JUN-2025 This case was reported by a patient via interactive digital media. The patient had the most excruciating pain for 6 weeks, not letting up pain pills, did not help at all. The patient's family thought that he/she was going to die, and he/she had the shot maybe that's why the patient never got the cash.
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| 2846900 | 06/23/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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suspected vaccination failure; had the shot, but I am getting the shingles as often as before; This ...
suspected vaccination failure; had the shot, but I am getting the shingles as often as before; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had the shot, but I am getting the shingles as often as before). 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: 16-JUN-2025 This case was reported by a patient via interactive digital media. The patient reported that it was a personal choice he/she had received the shot, but he/she kept getting shingles as often as before. The patient reported that he/she just kept going back for the antiviral. 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, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
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| 2846901 | F | 06/23/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Pain, Vaccination failure
Herpes zoster, Pain, Vaccination failure
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Suspected vaccination failure; very painful attack of shingles; This serious case was reported by a ...
Suspected vaccination failure; very painful attack of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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 year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: very painful attack of shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to 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: 16-JUN-2025 This case was reported by a patient via interactive digital media. Reporter's mother-in-law had thought it was a great idea, and it had been highly recommended by her doctor. However, in less than a year, she suffered a very painful attack of shingles. She continued to suffer for many years. It left us wondering what good the shot had been if it had not offered protection. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
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| 2846902 | 06/23/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Eye pain, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure; Eye pain...
Eye pain, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure; Eye pain, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
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Suspected Vaccination failure; Shingles suffering with eye; both shots and came down with shingles; ...
Suspected Vaccination failure; Shingles suffering with eye; both shots and came down with 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 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), ophthalmic herpes zoster (Verbatim: Shingles suffering with eye) (serious criteria GSK medically significant) and shingles (Verbatim: both shots and came down with shingles). The outcome of the vaccination failure and shingles were not reported and the outcome of the ophthalmic herpes zoster was not resolved. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster 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: 13-JUN-2025 This case was reported by a patient via interactive digital media. The patient had both shots and came down with shingles. 2 years later still suffering with eye. They thought he/she was going to lose eyesight. Thank heavens he/she did not. Still in pain every day with eye. 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, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
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| 2846903 | 06/23/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failu...
Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failure
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Suspected Vaccination failure; now got shingles; 1st one was painful; This serious case was reporte...
Suspected Vaccination failure; now got shingles; 1st one was painful; 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), shingles (Verbatim: now got shingles) and pain (Verbatim: 1st one was painful). The outcome of the vaccination failure and pain were 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. It was unknown if the reporter considered the pain to be related to 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. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 16-JUN-2025 This case was reported by a patient via interactive digital media The patient got shots last year in 2024 but now got shingles and was not happy that he/she got shot and the 1st one was painful The patient was so not sure if he/she should have gotten it and supposedly made it milder. This case was considered as suspected vaccination failure since the details regarding the 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
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| 2846904 | M | 06/23/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; vaccinated for shingles�and then got shingles; This serious case wa...
Suspected vaccination failure; vaccinated for shingles�and then got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: vaccinated for shingles�and then got shingles). The outcome of the vaccination failure and shingles were not reported. The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 14-JUN-2025 This case was reported by a patient via interactive digital media. The patient was vaccinated for shingles and then got shingles. The reporter suspect it was a reaction to the vaccine. Now, reporter was very hesitant to get the shingles vaccine. The reporter said that yes, patient got shingles as a reaction to the vaccine. 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, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
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| 2846905 | 74 | F | NC | 06/23/2025 |
PNC21 |
MERCK & CO. INC. |
Y019158 |
Injection site pain
Injection site pain
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Site: Pain at Injection Site-Mild, Additional Details: Prevnar-20 given at doctors appointment earli...
Site: Pain at Injection Site-Mild, Additional Details: Prevnar-20 given at doctors appointment earlier in the day, patient came to store to receive different vaccines, and asked about Capvaxive, patient accepted and was given additional pneumonia type vaccine in same day. Doctors office called in to investigate., Other Vaccines: VaccineTypeBrand: Prevnar-21; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: 06/10/2025, VaccineTypeBrand: Shingrix; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: 06/10/2025, VaccineTypeBrand: Boostrix; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: 06/10/2025
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| 2846907 | 75 | F | CA | 06/23/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
793pt |
Rash
Rash
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Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient got...
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient got a rash on upper and lower extremities, not too severe, told to take benedryl- not hot or spreading, no fever
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| 2846908 | 50 | M | IL | 06/23/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
KR75K |
Fatigue, Injection site pain, Injection site swelling, Lethargy, Limb injury
Fatigue, Injection site pain, Injection site swelling, Lethargy, Limb injury
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Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion /...
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Mild, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Other Vaccines: VaccineTypeBrand: CAPVAXIVE; Manufacturer: MERCK; LotNumber: Z002626; Route: IM; BodySite: LEFT ARM; Dose: ; VaxDate: UNKNOWN
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| 2846909 | 23 | F | GA | 06/23/2025 |
HPV9 |
MERCK & CO. INC. |
Y012508 |
Injection site pain, Injection site swelling
Injection site pain, Injection site swelling
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Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Inje...
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium
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| 2846910 | 72 | F | FL | 06/23/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
3X97J 3X97J |
Fatigue, Flushing, Hyperhidrosis, Injection site erythema, Injection site pain; ...
Fatigue, Flushing, Hyperhidrosis, Injection site erythema, Injection site pain; Lethargy, Nausea
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Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Exhaustion / ...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
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| 2846911 | 26 | F | CA | 06/23/2025 |
RAB |
NOVARTIS VACCINES AND DIAGNOSTICS |
FDP00683 |
Contusion, Loss of personal independence in daily activities, Rash, Urticaria
Contusion, Loss of personal independence in daily activities, Rash, Urticaria
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Systemic: Allergic: Rash Generalized-Severe, Systemic: welts, could not dress herself in the morning...
Systemic: Allergic: Rash Generalized-Severe, Systemic: welts, could not dress herself in the morning painful welts, bruise feeling-Severe, Additional Details: Benadryl is helping patient a lot and symptoms are resolving., Other Vaccines: VaccineTypeBrand: n/a; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
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| 2846912 | 67 | F | SC | 06/23/2025 |
COVID19 |
MODERNA |
3046731 |
Blister, Injection site pain, Injection site pruritus, Pruritus
Blister, Injection site pain, Injection site pruritus, Pruritus
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Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch Ge...
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: blisters that are drying up-Mild, Additional Details: pt states starting blistering that look like pimples several days after vaccine and it spread to other arm and cheek on face that is drying and still having pain at injection have not seeked medical care and just called me today about it. states will contact pcp in the morning and make appt. advsie to see medical attention sooner if condition worsens
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| 2846913 | 25 | F | FL | 06/23/2025 |
COVID19 |
PFIZER\BIONTECH |
md3414 |
Seizure
Seizure
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Systemic: Seizure-Mild, Additional Details: Patient seized for 15 seconds post vaccine. patient was...
Systemic: Seizure-Mild, Additional Details: Patient seized for 15 seconds post vaccine. patient was ok and alert after event. Patient was taken to local ER by frient. , Other Vaccines: VaccineTypeBrand: havrix; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: heplisav; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
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| 2846914 | 79 | F | IL | 06/23/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
E13499 |
Hypersensitivity, Injection site rash, Injection site swelling, Pruritus, Rash
Hypersensitivity, Injection site rash, Injection site swelling, Pruritus, Rash
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Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties...
Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Pt notified the pharmacy that she had swelling, itching, and rash occur around the injection site the next day. Pt states that ever since getting the first covid shot a couple years ago, she has developed allergies and sensitivities to unknown allergens. pt had not informed the pharmacist at the time of imz and just agreed to receive the Tdap as recommended. Pt has been taking oral antihistamin to help with the symptoms & stated will reach out to primary care for further management as necessary
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| 2846915 | 06/23/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; I took the shots and still got shingles; This serious case was report...
Suspected vaccination failure; I took the shots and still 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. 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 took the shots and still 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. 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: 15-JUN-2025 This case was reported by a patient via interactive digital media. The patient took the shingles shots and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK's Shingles vaccine.
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| 2846916 | 21 | F | MO | 06/23/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
y3z9p |
Presyncope, Syncope, Unresponsive to stimuli
Presyncope, Syncope, Unresponsive to stimuli
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Systemic: Fainting / Unresponsive-Mild, Additional Details: vasovagal response--pt knew it would hap...
Systemic: Fainting / Unresponsive-Mild, Additional Details: vasovagal response--pt knew it would happen and precautions were taken to prevent falling/injury
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| 2846917 | 60 | F | GA | 06/23/2025 |
PNC21 |
MERCK & CO. INC. |
z005765 |
Injection site swelling
Injection site swelling
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Site: Swelling at Injection Site-Mild
Site: Swelling at Injection Site-Mild
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| 2846918 | 72 | M | IL | 06/23/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
j9493 |
Arthralgia, Asthenia, Injection site pain, Paraesthesia
Arthralgia, Asthenia, Injection site pain, Paraesthesia
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Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Systemic: Tingling (specify: facia...
Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium
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| 2846919 | 43 | M | PA | 06/23/2025 |
HEP HEP |
DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION |
945664 945664 |
Impaired work ability, Injection site bruising, Injection site pain, Injection s...
Impaired work ability, Injection site bruising, Injection site pain, Injection site swelling, Joint injury; Mobility decreased
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Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Swelling at Inje...
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: pt is unable to lift his arm or use shoulder. now unable to work his job-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
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✓ | |||||
| 2846921 | 72 | M | IL | 06/23/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
h4279 |
Injection site pain, Injection site swelling
Injection site pain, Injection site swelling
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Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium
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| 2846922 | 66 | F | FL | 06/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
ts525 |
Injection site erythema, Injection site pain, Injection site pruritus
Injection site erythema, Injection site pain, Injection site pruritus
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injec...
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe
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