| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2863670 | M | 10/07/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Neuralgia, Rash, Vaccination failure
Herpes zoster, Neuralgia, Rash, Vaccination failure
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Suspected vaccination failure; My husband had his shingles shots, and he had gotten shingles; He is ...
Suspected vaccination failure; My husband had his shingles shots, and he had gotten shingles; He is left with nerve pain still today; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult 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), shingles (Verbatim: My husband had his shingles shots, and he had gotten shingles) and post herpetic neuralgia (Verbatim: He is left with nerve pain still today). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved and the outcome of the post herpetic neuralgia was not resolved. The reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. The company considered the shingles and post herpetic neuralgia to be related to Shingles vaccine. Additional Information: GSK receipt date: 27-Sep-2025 This case was reported by a consumer via interactive digital media. The reporter reported that her husband had his shingles shots and he had gotten shingles before holiday last year. The rash wasn't as bad as it could of but he was left with nerve pain still today he always said he did not wish it on anyone. 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. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingles vaccine, in a adult male patient. Based on the available information a? possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
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| 2863671 | 10/07/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Discomfort, Herpes zoster, Vaccination failure; Discomfort, Herpes zoster, Vacci...
Discomfort, Herpes zoster, Vaccination failure; Discomfort, Herpes zoster, Vaccination failure
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suspected vaccination failure; Shingles twice; This serious case was reported by a consumer via inte...
suspected vaccination failure; Shingles twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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: Shingles twice). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 28-SEP-2025 This case was reported by a patient via interactive digital media. The patient was glad that had the two shots, because the shingles were still uncomfortable. And patient got them twice. 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: A case of Vaccination failure, unknown time after receiving 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
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| 2863672 | F | 10/07/2025 |
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; took 2 shingles shots and still got shingles; This serious case was r...
Suspected vaccination failure; took 2 shingles 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 adult female 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: took 2 shingles shots and still got shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. 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: 29-SEP-2025 This case was reported by a patient via interactive digital media. 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. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, unknown time after receiving 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine, in a adult female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
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| 2863673 | 10/07/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Eyelid ptosis, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure; Eye...
Eyelid ptosis, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure; Eyelid ptosis, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
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Suspected vaccination failure; shingle in one eye; one my face; a droopy eye lid; This serious case ...
Suspected vaccination failure; shingle in one eye; one my face; a droopy eye lid; 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, 2 years 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: shingle in one eye) (serious criteria GSK medically significant), facial herpes zoster (Verbatim: one my face) and eyelid ptosis (Verbatim: a droopy eye lid). The outcome of the vaccination failure and eyelid ptosis were not reported and the outcome of the ophthalmic herpes zoster and facial herpes zoster were resolved. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, facial herpes zoster and eyelid ptosis 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 facial herpes zoster and eyelid ptosis to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 30-SEP-2025 This case was reported by a patient via interactive digital media. The patient mentioned that he/she had a mild case of shingles on the face and one eye, along with a droopy eyelid. However, with medications, it did not last long. The patient had received both shots at least two or three years before this occurred. The patient enquired if anyone else had received the shots but still got shingles afterward. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure and Ophthalmic herpes zoster , 2 years after receiving Shingles vaccine (Dose 1 and Dose 2) in a patient. Based on the available information a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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| 2863674 | 32 | F | CA | 10/07/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
ET475 |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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patient received a dose of Boostrix instead of a dose of Infanrix; 32 months old patient received a ...
patient received a dose of Boostrix instead of a dose of Infanrix; 32 months old patient received a dose of Boostrix instead of a dose of Infanrix; 32 months old patient received a dose of Boostrix instead of a dose of Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 32-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number ET475, expiry date 08-MAY-2026) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis. Previously administered products included Infanrix (had 3 prior doses of Infanrix on an unknown date). On an unknown date, the patient received Boostrix and did not receive Infanrix. On an unknown date, an unknown time after receiving Boostrix the patient experienced wrong vaccine administered (Verbatim: patient received a dose of Boostrix instead of a dose of Infanrix), underdose (Verbatim: 32 months old patient received a dose of Boostrix instead of a dose of Infanrix) and inappropriate age at vaccine administration (Verbatim: 32 months old patient received a dose of Boostrix instead of a dose of Infanrix). The outcome of the wrong vaccine administered, underdose and inappropriate age at vaccine administration 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: 11-SEP-2025 Health center nurse called to report the maladministration of a dose of Tdap Boostrix instead of DTaP Infanrix to a 32 month old female patient. Reporter enquired that there was any advice on this to revaccinate and what were the safety protocols.
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| 2863675 | NM | 10/07/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
|
Expired product administered
Expired product administered
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Expired dose; This non-serious case was reported by a other health professional via call center repr...
Expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received MMR (Priorix) for prophylaxis. On 11-SEP-2025, the patient received Priorix. On 11-SEP-2025, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Expired dose). 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: 11-SEP-2025 Reporter noticed that in one of the fridges they had expired vaccines (Priorix) and was wondering if there was any information on how long the vaccines were stable after the listed expiration date. During the call, the reporter informed that they might thought Priorix expired dose was administered, however, they were not completely sure and for the same reason, the reporter did not provide any patient details. The batch number was not provided upon follow- up with the reporter. The vaccine administration facility was the same as primary reporter.
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| 2863676 | 68 | M | TN | 10/07/2025 |
COVID19 COVID19 |
JANSSEN JANSSEN |
1808978 1808978 |
Dysstasia, Fall, Gait disturbance, Magnetic resonance imaging, Nerve conduction ...
Dysstasia, Fall, Gait disturbance, Magnetic resonance imaging, Nerve conduction studies; X-ray
More
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Limping,falling. Can't stand on my on./NO CHANGES!
Limping,falling. Can't stand on my on./NO CHANGES!
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โ | |||||
| 2863677 | 37 | F | NJ | 10/07/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
u8823ba u8823ba |
Eye pruritus, Fatigue, Headache, Injection site erythema, Injection site pain; I...
Eye pruritus, Fatigue, Headache, Injection site erythema, Injection site pain; Injection site pruritus, Injection site swelling, Pruritus, Swelling face
More
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injection site swelling, erythema, itching and pain. Systemically- itchy, mild facial swelling (puff...
injection site swelling, erythema, itching and pain. Systemically- itchy, mild facial swelling (puffy, itchy eyes), fatigue, headache
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| 2863678 | 87 | M | 10/07/2025 |
COVID19 |
MODERNA |
3052586 |
Decreased appetite, Lethargy, Pyrexia, Vomiting
Decreased appetite, Lethargy, Pyrexia, Vomiting
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fever, vomiting, lethargic, and decrease in appetite
fever, vomiting, lethargic, and decrease in appetite
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| 2863680 | 40 | M | MD | 10/07/2025 |
FLU3 |
SANOFI PASTEUR |
UT8858KA |
Urticaria
Urticaria
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Broke out into hives. Treatment is still Cetirizine 10mg, Famotidine 20 mg, and Prednisone 20 mg.
Broke out into hives. Treatment is still Cetirizine 10mg, Famotidine 20 mg, and Prednisone 20 mg.
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| 2863681 | 65 | F | SC | 10/07/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
U8862CA U8862CA |
Chills, Enlarged uvula, Eye discharge, Eye swelling, Headache; Oropharyngeal pai...
Chills, Enlarged uvula, Eye discharge, Eye swelling, Headache; Oropharyngeal pain, Pyrexia
More
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had injection at 12:15 pm. By 3:15 pm started getting sore throat and my uvala was very swollen. H...
had injection at 12:15 pm. By 3:15 pm started getting sore throat and my uvala was very swollen. Had a bad headache. Took 2 Benadryl tablets - 25 mg tablets in case it was allergic reaction. By 4 pm, felt feverish and had chills. By 6:30 pm, eyes were very red and oozing a yellowish pus. Went to bed. Woke up this morning, sore throat/swollen uvala have greatly diminished. Eyes are swollen, red and still oozing the pus. No longer feel feverish or have chills. No headache.
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| 2863682 | 4 | TN | 10/07/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
|
Underdose
Underdose
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a four year old patient was given less than a full dose; This non-serious case was reported by a oth...
a four year old patient was given less than a full dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 4-year-old patient who received MMR (Priorix) for prophylaxis. On 04-SEP-2025, the patient received Priorix. On 04-SEP-2025, an unknown time after receiving Priorix, the patient experienced underdose (Verbatim: a four year old patient was given less than a full dose). The outcome of the underdose 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:16-SEP-2025 Pharmacy student calls on behalf of a medical group mentioning that a four-year-old patient was given less than a full dose. The reporter needs any guidance whether to revaccinate or what can we do from here. No further information was obtained in this call. The reporter was consented to follow up. The batch number was not provided upon follow up with the reporter.
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| 2863683 | 78 | F | 10/07/2025 |
FLU3 |
SEQIRUS, INC. |
407255 |
Wrong product administered
Wrong product administered
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Incorrect vaccine administered - patient wanted TDAP but received Fluad - patient eventually was goi...
Incorrect vaccine administered - patient wanted TDAP but received Fluad - patient eventually was going to get Fluad, will return for TDAP
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| 2863684 | 7 | F | MA | 10/07/2025 |
FLU3 |
SEQIRUS, INC. |
AX4142A |
Confusional state, Fall, Loss of consciousness, Syncope
Confusional state, Fall, Loss of consciousness, Syncope
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Patient fainted and fell to the ground about 5 minutes after receiving her Afluria injection at a va...
Patient fainted and fell to the ground about 5 minutes after receiving her Afluria injection at a vaccine clinic, pt seemed a bit confused after being briefly passed out, mom took her to the hospital for evaluation. pt also reported forgetting er water bottle and not drinking water on a hot day.
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| 2863685 | 78 | F | GA | 10/07/2025 |
PNC20 |
PFIZER\WYETH |
lp4948 |
Extra dose administered
Extra dose administered
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Patient had received Prevnar 20 in October 2023. Mistakenly administered another dose on 10/6/25. P...
Patient had received Prevnar 20 in October 2023. Mistakenly administered another dose on 10/6/25. Patient has not reported any adverse events.
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| 2863687 | 83 | M | CA | 10/07/2025 |
COVID19 |
PFIZER\BIONTECH |
na0738 |
Injection site pain, Wrong product administered
Injection site pain, Wrong product administered
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Site: Pain at Injection Site-Mild, Systemic: wrong vaccine was given-Mild, Additional Details: Patie...
Site: Pain at Injection Site-Mild, Systemic: wrong vaccine was given-Mild, Additional Details: Patient wanted moderna vaccine but was givenpfizer vaccine. upset
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| 2863688 | 76 | F | MA | 10/07/2025 |
FLUR4 |
PROTEIN SCIENCES CORPORATION |
U8823ba |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
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Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
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| 2863689 | 69 | F | NY | 10/07/2025 |
FLUA4 FLUA4 |
SEQIRUS, INC. SEQIRUS, INC. |
407241 407241 |
Abdominal pain, Asthenia, Fatigue, Hypertension, Lethargy; Lymphadenopathy, Pain...
Abdominal pain, Asthenia, Fatigue, Hypertension, Lethargy; Lymphadenopathy, Pain, Tachycardia
More
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Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Letha...
Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Hypertension-Medium, Systemic: Lymph Node Swelling-Mild, Systemic: Tachycardia-Severe, Systemic: Weakness-Medium, Other Vaccines: VaccineTypeBrand: comirnaty; Manufacturer: pfizer; LotNumber: NA0587; Route: intramuscular; BodySite: left arm; Dose: 00; VaxDate: 09/05/2025
More
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| 2863690 | 93 | F | CA | 10/07/2025 |
FLU4 |
SANOFI PASTEUR |
ut8763ha |
Injection site bruising, Injection site pruritus, Injection site swelling
Injection site bruising, Injection site pruritus, Injection site swelling
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Swelling at I...
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: itching from the shoulder down and bruising and swelling by the lower arm or elbow that showed up 2 days after moving downwards-Medium, Additional Details: Pt was advised to follow up with her doctor
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| 2863691 | 52 | F | CA | 10/07/2025 |
FLU4 FLU4 FLU4 FLU4 FLU3 FLU3 FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
JS74h JS74h JS74h JS74h JS74H JS74H JS74H JS74H |
Injection site erythema, Injection site pain, Injection site swelling, Joint inj...
Injection site erythema, Injection site pain, Injection site swelling, Joint injury; Arthralgia, Erythema, Hypoaesthesia, Injected limb mobility decreased, Injection site reaction; Neuralgia, Pain, Pain in extremity, Paraesthesia, Peripheral swelling; Rash, Skin warm; Injection site erythema, Injection site pain, Injection site swelling, Joint injury; Arthralgia, Erythema, Hypoaesthesia, Injected limb mobility decreased, Injection site reaction; Neuralgia, Pain, Pain in extremity, Paraesthesia, Peripheral swelling; Rash, Skin warm
More
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Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injec...
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe
More
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| 2863692 | 54 | F | CA | 10/07/2025 |
FLUR4 |
PROTEIN SCIENCES CORPORATION |
U8832AA |
No adverse event, Syringe issue
No adverse event, Syringe issue
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Site: Bruising at Injection Site-Mild, Additional Details: This was not an adverse reaction. The syr...
Site: Bruising at Injection Site-Mild, Additional Details: This was not an adverse reaction. The syringe leaked and immunization was done again. The Bruise option was selected although there was no injury to this patient.
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| 2863693 | 65 | F | FL | 10/07/2025 |
FLU4 |
SANOFI PASTEUR |
u8830da |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
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Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
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| 2863694 | 70 | F | CA | 10/07/2025 |
FLU4 FLU4 |
SANOFI PASTEUR SANOFI PASTEUR |
u8859aa u8859aa |
Injection site bruising, Injection site erythema, Injection site pain, Injection...
Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling; Injection site vesicles, Joint injury, Lymphadenopathy, Pruritus
More
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Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection...
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Medium, Systemic: Allergic: Itch Generalized-Mild, Systemic: blister-Mild, Systemic: Lymph Node Swelling-Mild, Additional Details: blister at site
More
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| 2863695 | 17 | F | CA | 10/07/2025 |
FLUC4 |
SEQIRUS, INC. |
948410 |
Dizziness, Injection site pain, Loss of consciousness, Syncope, Unresponsive to ...
Dizziness, Injection site pain, Loss of consciousness, Syncope, Unresponsive to stimuli
More
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Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting ...
Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: PATINT WAS AT THE PHARMACY TO RECIEVE FLU AND POLIO VACCINES, SHE FAINTED AFTER RECIEVING THE VACCINES AND WAS BACK INTO CONSIOUSNESS AFTER FEW MINUTES, WAS DOING OKAY LATER. CHECKED BACK THE NEXT DAY WITH THE PATIENT'S FAMILY ON HOW SHE IS DOING AND PATIENT WAS DOING OKAY AND HAS SOME SORE ARM AT THE INJECTION SITE
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| 2863696 | 48 | M | SC | 10/07/2025 |
HEP HEP |
DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION |
946065 946065 |
Dizziness, Eye movement disorder, Flushing, Hyperhidrosis, Hypotension; Loss of ...
Dizziness, Eye movement disorder, Flushing, Hyperhidrosis, Hypotension; Loss of consciousness, Snoring, Syncope, Unresponsive to stimuli
More
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Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus...
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Additional Details: after second vaccine patient fainted and snorred with eyes rolled up which looked as a vasovagual effect, no convulsions, excessive sweating, 1 minute later patient regained conscionsness and BP measured 5 mins later was 121/83 with a 61 pulse, patient confirmed that he got the same reaction 5-6 times before while giving blood, but never with a vaccine, patient failed to mention that on the vaccine questionnaire , Other Vaccines: VaccineTypeBrand: flucelvax; Manufacturer: seqirus, inc; LotNumber: 407000; Route: im; BodySite: left deltoid; Dose: 1; VaxDate: 09/19/2025
More
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| 2863697 | 42 | M | NC | 10/07/2025 |
FLUC4 FLUC4 |
SEQIRUS, INC. SEQIRUS, INC. |
407799 407799 |
Confusional state, Loss of consciousness, Seizure, Syncope, Tremor; Unresponsive...
Confusional state, Loss of consciousness, Seizure, Syncope, Tremor; Unresponsive to stimuli
More
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Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Addition...
Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: Patient passed out twice and started shaking on both occassions. Once he regained consciousness after each episode he was confused and did not know what happened.
More
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| 2863699 | 1 | M | ME | 10/07/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
Z27PB |
Incorrect dose administered
Incorrect dose administered
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an adult Havrix immunization, administered to a pediatric patient, age of twelve months; an adult Ha...
an adult Havrix immunization, administered to a pediatric patient, age of twelve months; an adult Havrix immunization, administered to a pediatric patient, age of twelve months; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 12-month-old male patient who received HAV (Havrix 1440 adult) (batch number Z27PB, expiry date 27-AUG-2026) for prophylaxis. On 22-SEP-2025, the patient received Havrix 1440 adult. On 22-SEP-2025, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: an adult Havrix immunization, administered to a pediatric patient, age of twelve months) and adult product administered to child (Verbatim: an adult Havrix immunization, administered to a pediatric patient, age of twelve months). The outcome of the overdose and adult product administered to child 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: 22-SEP-2025 Pharmacist reported that they just wanted to contact the patient's parents to let them know about that error and they were wondering if there was anything specific that they should be looking for and if it would change the vaccinations guidelines.
More
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| 2863700 | 65 | F | MO | 10/07/2025 |
FLU4 FLU4 |
SANOFI PASTEUR SANOFI PASTEUR |
UT8820CA UT8820CA |
Eye swelling, Injection site swelling, Mouth swelling, Ocular hyperaemia, Pharyn...
Eye swelling, Injection site swelling, Mouth swelling, Ocular hyperaemia, Pharyngeal swelling; Swelling, Swelling face, Swollen tongue
More
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Site: Swelling at Injection Site-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-...
Site: Swelling at Injection Site-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient recieved vaccine around 10 am and called around 3 pm. Patient's husband said the reaction started at noon. Neck and throat was swollen and had red eyes.
More
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| 2863701 | 5 | M | FL | 10/07/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
3052553 3052553 |
Cold sweat, Hypotension, Injection site haemorrhage, Pallor, Presyncope; Pulse a...
Cold sweat, Hypotension, Injection site haemorrhage, Pallor, Presyncope; Pulse abnormal, Vomiting
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Systemic: Vomiting-Medium, Additional Details: After immunizations were given, patient looked at one...
Systemic: Vomiting-Medium, Additional Details: After immunizations were given, patient looked at one of his arms which was bleeding a little bit, band aid was placed. He then started to vomit. Per his parents, he has vomited / almost passed out at the sight of blood in the past. He sat down and continued to vomit. I took his blood pressure which was low 64/29 with thready pulse in 40s. He remained responsive but clammy and pale. I called 911. I elevated his legs. His color returned and vitals improved by the time EMS came. Agreed to go to ED, Other Vaccines: VaccineTypeBrand: Flucelvax; Manufacturer: Seqirus; LotNumber: 406999; Route: IM; BodySite: right arm; Dose: N/A; VaxDate: 09/19/2025
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| 2863702 | 26 | F | NY | 10/07/2025 |
COVID19-2 |
PFIZER\BIONTECH |
NA0587 |
Syncope, Unresponsive to stimuli
Syncope, Unresponsive to stimuli
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Systemic: Fainting / Unresponsive-Severe
Systemic: Fainting / Unresponsive-Severe
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| 2863703 | 45 | M | GA | 10/07/2025 |
FLUC4 |
SEQIRUS, INC. |
407799 |
Blood pressure increased, Dry skin, Hypertension, Pruritus
Blood pressure increased, Dry skin, Hypertension, Pruritus
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Systemic: Allergic: Itch Generalized-Mild, Systemic: Hypertension-Mild, Additional Details: Patient ...
Systemic: Allergic: Itch Generalized-Mild, Systemic: Hypertension-Mild, Additional Details: Patient stated they felt itchy and had dry skin patches. He took 2 benadryl tablets and repeatedly checked his blood pressure. He requested after an hour for an ambulance to be called because he did not feel better and he stated his blood pressure was high
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| 2863704 | 72 | M | MA | 10/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
G2ha7 |
Injection site pain
Injection site pain
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Site: Pain at Injection Site-Mild, Additional Details: Rx for shingrex was rejected this morning 09/...
Site: Pain at Injection Site-Mild, Additional Details: Rx for shingrex was rejected this morning 09/19 that pt already received series. checked profile doesnot show more thant one vaccine of shingrex in 06/2025. proceeded and left note to speak to pt. pt came for the vaccine and was immunized by the RN and passed thru. I called pt and checked imz profile. pt had 2 shingrex vaccines (11/2019 and 01/2020). plus had one in 06/2025. Today he came for the 2nd shingrex after june/2025. I spoke to pt's dr and the pt. Dr said pt should be ok
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| 2863705 | 72 | F | GA | 10/07/2025 |
FLU4 |
SANOFI PASTEUR |
ut8820ca |
Extra dose administered, Injection site erythema
Extra dose administered, Injection site erythema
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Site: Redness at Injection Site-Mild, Additional Details: Patient was given 2 doses of the flu shot ...
Site: Redness at Injection Site-Mild, Additional Details: Patient was given 2 doses of the flu shot in error. She has exhibited no side effects
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| 2863706 | 72 | M | MA | 10/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
99D52 |
Extra dose administered, Injection site pain
Extra dose administered, Injection site pain
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Site: Pain at Injection Site-Mild, Additional Details: Pt had completed shingrex series. Had the 1st...
Site: Pain at Injection Site-Mild, Additional Details: Pt had completed shingrex series. Had the 1st one in 11/2019, 2nd 01/2020 at a different pharmacy and state. Pt was given another shingrex on 06/19/2025 and came today 09/19/2025 to compete the series. I had put a note to check with pt but I did not notice he had already given the vaccine by the Nurse today. called pt's dr and pt. pt's dr said pt should be ok. spoke to pt, he is ok
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| 2863707 | 66 | F | NH | 10/07/2025 |
FLU4 |
SANOFI PASTEUR |
u8859aa |
Extra dose administered, Injection site pain
Extra dose administered, Injection site pain
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Site: Pain at Injection Site-Mild, Additional Details: patient was inadvertently given 2 doses of fl...
Site: Pain at Injection Site-Mild, Additional Details: patient was inadvertently given 2 doses of flu vaccine. At time of vaccination did not have any negative effects
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| 2863708 | 74 | M | TX | 10/07/2025 |
COVID19 |
PFIZER\BIONTECH |
my9550 |
Chest discomfort, Chest pain
Chest discomfort, Chest pain
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Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Patient come to the pharmac...
Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Patient come to the pharmacy to report sharp painful stabbing left chest pain 2 days after recieving covid vaccine. Patient states he did not follow up with medical provider or seek emergency care as pain would go come and go soon after.
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| 2863709 | 86 | F | CA | 10/07/2025 |
FLU4 FLU4 |
SANOFI PASTEUR SANOFI PASTEUR |
48859 48859 |
Chills, Injection site bruising, Injection site pruritus, Pyrexia, Rash; Urticar...
Chills, Injection site bruising, Injection site pruritus, Pyrexia, Rash; Urticaria
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Systemic: Allergic:...
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Chills-Mild, Systemic: Fever-Mild, Additional Details: Daughter came in Saturday 9/20/25 to pick up benadryl for patient stating she received her high dose flu shot on Wednesday, by thursday she noticed a bruise on her arm plus hives beginning to appear. She also had chills and a fever. By friday, the hives had spread all over her body. She was taken to ER and give dexamethasone plus advised to take cetirizine + benadryl. Patient is recovering. Unsure if it was the flu shot that caused this, but believed so by ER doctor
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| 2863710 | 40 | M | CO | 10/07/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
NA0589 NA0589 NA0589 |
Asthenia, Confusional state, Dizziness, Fatigue, Flushing; Hyperhidrosis, Hypote...
Asthenia, Confusional state, Dizziness, Fatigue, Flushing; Hyperhidrosis, Hypotension, Lethargy, Syncope, Tinnitus; Tremor, Unresponsive to stimuli, Visual impairment
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Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Letha...
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Shakiness-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe, Additional Details: EMS was called and took over. Patient was speaking, Other Vaccines: VaccineTypeBrand: Fluarix 25-26; Manufacturer: GlaxoSmithKline; LotNumber: 9JC49; Route: IM; BodySite: Left deltoid; Dose: NA; VaxDate: 09/20/2025
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| 2863711 | 73 | F | VA | 10/07/2025 |
COVID19 |
MODERNA |
3052030 |
Arthralgia, Mobility decreased, Pain in extremity
Arthralgia, Mobility decreased, Pain in extremity
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Systemic: Joint Pain-Medium, Additional Details: Patient says she has difficulty raising her arm and...
Systemic: Joint Pain-Medium, Additional Details: Patient says she has difficulty raising her arm and has pain down the arm. No swelling or redness. Seems to be a problem with shoulder.
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| 2863712 | 79 | F | MI | 10/07/2025 |
FLU4 |
SANOFI PASTEUR |
u8830da |
Injection site bruising, Injection site erythema, Injection site pruritus, Injec...
Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling
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Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Additional Details: Pat...
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Additional Details: Patient reported on 09/19/2025, itchy and redness/bump at vaccine site after getting flu shot on 9/08/2025. She said it resolved after a few days.
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| 2863713 | 64 | F | CA | 10/07/2025 |
FLUR4 |
PROTEIN SCIENCES CORPORATION |
tfaa2504 |
Injection site pruritus
Injection site pruritus
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Site: Itching at Injection Site-Mild
Site: Itching at Injection Site-Mild
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| 2863714 | 19 | F | PA | 10/07/2025 |
HEP HEP HEP |
DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION |
945661 945661 945661 |
Dysphagia, Dyspnoea, Eye swelling, Injection site erythema, Injection site pain;...
Dysphagia, Dyspnoea, Eye swelling, Injection site erythema, Injection site pain; Injection site pruritus, Injection site swelling, Mouth swelling, Swelling face, Swollen tongue; Throat tightness
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Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Inject...
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: pt received 1st doses of exact same vaccines 1 month prior in august with no reaction, Other Vaccines: VaccineTypeBrand: varivax; Manufacturer: ; LotNumber: y019318; Route: subq; BodySite: left arm; Dose: 2; VaxDate: 09/12/2025, VaccineTypeBrand: priorix; Manufacturer: ; LotNumber: 4mg3e; Route: subq; BodySite: left arm; Dose: 2; VaxDate: 09/12/2025
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| 2863715 | 54 | M | NJ | 10/07/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
5n9l9 |
Injection site bruising, Injection site pain, Injection site swelling
Injection site bruising, Injection site pain, Injection site swelling
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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
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| 2863716 | F | FL | 10/07/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
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Incorrect route of product administration
Incorrect route of product administration
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IM administration; This non-serious case was reported by a pharmacist via call center representative...
IM administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a female patient who received MMR (Priorix) for prophylaxis. On 21-SEP-2025, the patient received the 1st dose of Priorix (intramuscular). On 21-SEP-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: IM administration). The outcome of the subcutaneous injection formulation administered by other route 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 :22-Sep-2025 The pharmacist asked that the route was SC (subcutaneous) in the box of Priorix, what if he/she did like IM (intramuscular), was that going to decrease the efficacy. The batch number was not provided upon follow up with the reporter. The Vaccine Administration Facility was the same as Primary Reporter.
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| 2863719 | 63 | F | CA | 10/07/2025 |
RSV |
PFIZER\WYETH |
mn0315 |
Injection site erythema, Injection site pruritus, Pruritus, Pyrexia, Rash
Injection site erythema, Injection site pruritus, Pruritus, Pyrexia, Rash
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Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: ...
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Fever-Mild, Other Vaccines: VaccineTypeBrand: abrysvo; Manufacturer: pfizer; LotNumber: mn0315; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
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| 2863720 | 87 | F | CA | 10/07/2025 |
FLU4 |
SANOFI PASTEUR |
ut8794da |
Extra dose administered, Injection site pain
Extra dose administered, Injection site pain
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Site: Pain at Injection Site-Mild, Systemic: NO ADVERSE REACTION.-Mild, Additional Details: DR. (wit...
Site: Pain at Injection Site-Mild, Systemic: NO ADVERSE REACTION.-Mild, Additional Details: DR. (withheld name) (ON-CALL MD) SAID THAT EVEN THOUGH PATIENT GOT 2 DOSES OF HIGH DOSE FLUZONE VACCINE WITHIN 5-10 DAYS APART, PATIENT WILL BE FINE. PATIENT SAID SHE GOT FLU SHOT FROM DR. (withheld name) OFFICE A FEW DAYS AGO AFTER I GAVE HER FLUZONE HIGH DOSE ON 9-20-2025, Other Vaccines: VaccineTypeBrand: fluzone high dose; Manufacturer: sanofi; LotNumber: NOT AVILABLE; Route: IM; BodySite: ARM (UNSURE); Dose: FIRST IN DR. (withheld name); VaxDate: 09/10/2025
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| 2863721 | 76 | F | MO | 10/07/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0738 |
Injection site bruising, Injection site erythema, Injection site pain, Injection...
Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
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Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injec...
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Bruising radiation down arm into back
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| 2863722 | 63 | M | HI | 10/07/2025 |
COVID19-2 |
MODERNA |
3052583 |
Syncope, Unresponsive to stimuli
Syncope, Unresponsive to stimuli
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Systemic: Fainting / Unresponsive-Mild, Other Vaccines: VaccineTypeBrand: FLUBLOK; Manufacturer: SA...
Systemic: Fainting / Unresponsive-Mild, Other Vaccines: VaccineTypeBrand: FLUBLOK; Manufacturer: SANOFI; LotNumber: U8832AA; Route: IM; BodySite: LEFT DELTOID; Dose: ; VaxDate: UNKNOWN
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| 2863723 | 13 | F | VA | 10/07/2025 |
COVID19 |
MODERNA |
3052579 |
No adverse event
No adverse event
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Systemic: no adverse reactions-Mild, Additional Details: Patient did not have any immediate reaction...
Systemic: no adverse reactions-Mild, Additional Details: Patient did not have any immediate reactions to vaccine
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| 2863724 | 76 | F | PA | 10/07/2025 |
FLU4 |
SANOFI PASTEUR |
U8859AA |
No adverse event, Syringe issue
No adverse event, Syringe issue
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Systemic: no allergic reaction. vaccine leaked/exploded while pushing down on plunger. 2nd vial had ...
Systemic: no allergic reaction. vaccine leaked/exploded while pushing down on plunger. 2nd vial had to be administered with no issue.-Mild, Additional Details: No allergic reaction. vaccine leaked/exploded while pushing down on plunger. 2nd vial had to be administered with no issue. Pt was aware and 2nd vaccine had no issue. 1st admin if any was administered it was minimal. No reaction occured. I had to choose one in order to submit. (I apologize if this is a duplicate - I did not get any confirmation for the first one I filled out.
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