| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2856476 | 09/02/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
|
Suspected vaccination failure; Will give you shingle, happened to 3 people I know; This serious case...
Suspected vaccination failure; Will give you shingle, happened to 3 people I know; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in specified number of patients 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: Will give you shingle, happened to 3 people I know). 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 to be unrelated to Shingles vaccine. The company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 18-AUG-2025 This case was reported by a consumer via interactive digital media. The reporter reported that do not get shingles shot it would give you shingles. It had happened to 3 people whom the reporter knew. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2856477 | 09/02/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
|
Suspected vaccination failure; I had the vaccine and got shingles this week; This serious case was r...
Suspected vaccination failure; I had the vaccine and got shingles this week; 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. In AUG-2025, 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 had the vaccine and got shingles this week). 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: 22-AUG-2025 This case was reported by a patient via interactive digital media. The patient had the shingles vaccine and got shingles this week. The patient went right to the doctor, and he gave the patient medications and he said it should be a lighter case, and it was. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2856478 | M | 09/02/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Pain in extremity
Pain in extremity
|
a sore arm for 2 days; This non-serious case was reported by a consumer via interactive digital medi...
a sore arm for 2 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm (Verbatim: a sore arm for 2 days). The outcome of the pain in arm was resolved (duration 2 days). It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine. Linked case(s) involving the same patient: US2025AMR110667 Additional Information: GSK Receipt Date: 23-AUG-2025 This case was reported by a consumer via interactive digital media. The reporter reported that her husband got the vaccine last year. Better safe than sorry and our different insurance providers both covered it. No side effects for either of us except a sore arm for 2 days.
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| 2856479 | 09/02/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Blister, Herpes zoster, Pain, Vaccination failure; Blister, Herpes zoster, Pain,...
Blister, Herpes zoster, Pain, Vaccination failure; Blister, Herpes zoster, Pain, Vaccination failure
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Suspected vaccination failure; still got shingles right now pretty painful blisters; This serious ca...
Suspected vaccination failure; still got shingles right now pretty painful blisters; 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: still got shingles right now pretty painful blisters). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 28-AUG-2025 This case was reported by a patient via interactive digital media. The reporter reported that had the 2 shots and still got shingles and right now pretty painful blisters. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2).
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| 2856480 | F | NY | 09/02/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMVB030A |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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2nd dose received late; This non-serious case was reported by a nurse via call center representative...
2nd dose received late; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB030A, expiry date 30-APR-2025) for prophylaxis. Previously administered products included Menveo (1st dose received in JUL-2024 with batch number AMVA994Z and expiry date 30-APR-2025) and Menactra (received in 2019). In AUG-2025, the patient received the 2nd dose of Menveo. In AUG-2025, an unknown time after receiving Menveo, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose received late). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 04-AUG-2025 The nurse called to inform that a patient that had already completed the Menactra. The patient received two doses of Menveo and the second dose was late which led lengthening of vaccination schedule.
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| 2856481 | 25 | F | MO | 09/02/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
5P2P7 |
Exposure during pregnancy, Wrong product administered
Exposure during pregnancy, Wrong product administered
|
Administered during pregnancy; Bexsero instead of Hep B vaccine; This non-serious prospective pregna...
Administered during pregnancy; Bexsero instead of Hep B vaccine; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 25-year-old female patient who received Men B NVS (Bexsero) (batch number 5P2P7, expiry date 31-JAN-2026) for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis. On 25-JUL-2025, the patient received Bexsero. The patient did not receive Hepatitis B vaccine. On 25-JUL-2025, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Bexsero instead of Hep B vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Administered during pregnancy). The outcome of the wrong vaccine administered and vaccine exposure during pregnancy were not applicable. Pregnancy exposure: Pregnancy Exposure (Bexsero): To mother in second trimester Pregnancy Exposure (Hepatitis B vaccine): To mother in second trimester Pregnancy Outcome: Pregnancy was ongoing 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: 05-AUG-2025 Bexsero was accidentally administered to a 20-week pregnant patient instead of Hepatitis B vaccine, which led wrong vaccine administered. The reporter consented to follow up.
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| 2856482 | F | 09/02/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Urticaria
Urticaria
|
extreme hives severe all over my neck and face and eventually spread to my whole body; This non-seri...
extreme hives severe all over my neck and face and eventually spread to my whole body; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, 1 day after receiving Arexvy, the patient experienced hives (Verbatim: extreme hives severe all over my neck and face and eventually spread to my whole body). The patient was treated with prednisone. The outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to Arexvy. It was unknown if the company considered the hives to be related to Arexvy. Additional Information: GSK Receipt Date: 05-AUG-2025 The case was self reported by patient. The patient received the vaccine Arexvy vaccine from doctor and the day after the vaccine got a terrible case of hives all over the neck and face and eventually spread to the whole body but it was extreme hives that got and the patient contacted the doctor and they gave a medicine pack, prednisone for 7 days, it was so severe.
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| 2856483 | 1 | F | TX | 09/02/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
5H773 |
Expired product administered
Expired product administered
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dose of Infanrix that had expired, was given to a patient; This non-serious case was reported by a n...
dose of Infanrix that had expired, was given to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-month-old female patient who received DTPa (Infanrix) (batch number 5H773, expiry date 13-JUL-2025) for prophylaxis. On 08-AUG-2025, the patient received Infanrix. On 08-AUG-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: dose of Infanrix that had expired, was given to a patient). 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: 08-AUG-2025 Nurse reported that a dose of Infanrix that had expired on 13 Jul 2025, was given on 08 Aug 2025 to a patient which led to expired vaccine used.
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| 2856484 | F | LA | 09/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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Late second dose; This non-serious case was reported by a pharmacist via call center representative ...
Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (patient received 1st dose in 2018 with batch number NX952 and expiry date 06th March 2020). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: Late second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 11-AUG-2025 On 11 August 2025, a pharmacist called to get guidance on the Shingrix vaccination series, the patient got the first shot back in 2018 and want to have the second shot this year which led to incomplete course of vaccination. The healthcare professional wanted to know if the complete series have to be restarted.
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| 2856485 | F | NC | 09/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
|
patient never came back for the 2nd dose; This non-serious case was reported by a pharmacist via cal...
patient never came back for the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (patient received the 1st Shingrix dose 2 or 3 years ago). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: patient never came back for the 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 19-AUG-2025 The pharmacist informed that a patient received the 1st Shingrix dose 2 or 3 years ago, but they did not have the specific date, the patient never came back for the second dose. Also wanted to know regarding the shingles vaccine, Shingrix, if they took 1 dose, how long is it good to repeat it, like if it's been 2 years, do they need to start over. 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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| 2856486 | 64 | M | SC | 09/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7523J |
Incorrect dose administered
Incorrect dose administered
|
Incorrect vaccine schedule; This non-serious case was reported by a pharmacist via call center repre...
Incorrect vaccine schedule; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 7523J) for prophylaxis. Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix). On 23-AUG-2025, the patient received the 2nd dose of Shingrix. On 23-AUG-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Incorrect vaccine schedule). The outcome of the drug dose administration interval too short was not applicable. Additional Information: GSK Receipt Date: 25-AUG-2025 The reporter reported that a patient here that got the Shingrix vaccine on 09th August 2025, and then they just got a notification he got a 2nd one in 23rd August 2025 which led to shortening of vaccination schedule. The vaccine administration facility was the same as primary reporter.
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| 2856487 | 83 | M | 09/02/2025 |
MENB MNQ |
PFIZER\WYETH SANOFI PASTEUR |
|
Injected limb mobility decreased, Limb discomfort, Peripheral swelling; Injected...
Injected limb mobility decreased, Limb discomfort, Peripheral swelling; Injected limb mobility decreased, Limb discomfort, Peripheral swelling
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After the 8/27 vaccination, the patient reported that his right arm is swollen with discomfort, he s...
After the 8/27 vaccination, the patient reported that his right arm is swollen with discomfort, he states he cannot use his fingers, cannot pick up a cup of coffee. All this happened after the vaccination. His left arm is fine.
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| 2856488 | 31 | F | KY | 09/02/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LN4930 LN4930 |
Erythema, Joint swelling, Pain in extremity, Peripheral swelling, Skin warm; Ten...
Erythema, Joint swelling, Pain in extremity, Peripheral swelling, Skin warm; Tenderness
More
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8/30/25 My Shoulder is red and swollen since I had the pneumonia vaccine. 8/27/25 received Prevnar...
8/30/25 My Shoulder is red and swollen since I had the pneumonia vaccine. 8/27/25 received Prevnar 20 vaccine as ordered by MD States day after on 8/28/25, right arm pain, then red, swollen and warm to touch. States waited as thought is was a symptom that happens with shot and to see if "it" went away although didn't Denies SOA or chest pain Today states sites is back to normal although does have one site tender to touch
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| 2856489 | 72 | F | TX | 09/02/2025 |
FLU3 PNC21 |
SANOFI PASTEUR MERCK & CO. INC. |
u8764db z003579 |
Injection site erythema, Injection site pain, Injection site swelling, Injection...
Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain; Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
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friday 8/29: achy, pain, swelling at injection site, redness spreading to arm, hot to the touch, Sa...
friday 8/29: achy, pain, swelling at injection site, redness spreading to arm, hot to the touch, Saturday 8/30: still had redness had not worsened. came by pharmacy saturday around 10 am, advised pt to apply hydrocortisone, take benadryl, and ibuprofen, pt dosed all day saturday and sunday morning. 8/31: pt went to er, received steroid shot, antihistamine infusion, and oral antibiotic, Tueday 9/2: pt is feeling better and has improved
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| 2856490 | 50 | F | MD | 09/02/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
Diarrhoea, Injection site pain, Pain, Rash
Diarrhoea, Injection site pain, Pain, Rash
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Diarrhea, body aches, pain and tenderness at injection site, rash on chest
Diarrhea, body aches, pain and tenderness at injection site, rash on chest
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| 2856491 | 16 | F | NY | 09/02/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
ES49H #NR394 |
Expired product administered, No adverse event; Expired product administered, No...
Expired product administered, No adverse event; Expired product administered, No adverse event
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patient was given menveo that expired 7/31/2025. No side effect . Recommended revaccination. Parent ...
patient was given menveo that expired 7/31/2025. No side effect . Recommended revaccination. Parent prefers to wait 3 mos before revaccinating
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| 2856492 | 7 | M | MI | 09/02/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
5c79n |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
Kinrix vaccine inadvertently given to 7 year old patient. Patient has had no adverse side effects
Kinrix vaccine inadvertently given to 7 year old patient. Patient has had no adverse side effects
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| 2856493 | 17 | M | IN | 09/02/2025 |
HPV9 IPV MMR MNQ VARCEL |
MERCK & CO. INC. SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS NOVARTIS VACCINES AND DIAGNOSTICS MERCK & CO. INC. |
Z005055 Y1A212M Y010046 9M2R7 Y017915 |
Hyperhidrosis, Pallor, Seizure like phenomena; Hyperhidrosis, Pallor, Seizure li...
Hyperhidrosis, Pallor, Seizure like phenomena; Hyperhidrosis, Pallor, Seizure like phenomena; Hyperhidrosis, Pallor, Seizure like phenomena; Hyperhidrosis, Pallor, Seizure like phenomena; Hyperhidrosis, Pallor, Seizure like phenomena
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Seizure-like activity - pallor and diaphoretic
Seizure-like activity - pallor and diaphoretic
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| 2856494 | 76 | F | MA | 09/02/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
p2443 |
Swelling face, Swelling of eyelid
Swelling face, Swelling of eyelid
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Facial swelling, swollen eyelid on day following vaccination
Facial swelling, swollen eyelid on day following vaccination
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| 2856495 | 71 | M | MT | 09/02/2025 |
COVID19 |
MODERNA |
3046979 |
Underdose
Underdose
|
Inadvertent administration of pediatric dose.
Inadvertent administration of pediatric dose.
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| 2856496 | 2 | M | TN | 09/02/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
223Y9 |
Extra dose administered, Wrong patient received product
Extra dose administered, Wrong patient received product
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Patient was given a 5th (unnecessary dose) of this vaccine due to wrong patient identified during vi...
Patient was given a 5th (unnecessary dose) of this vaccine due to wrong patient identified during visit.
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| 2856497 | 57 | F | SD | 09/02/2025 |
PNC20 |
PFIZER\WYETH |
|
Injection site pruritus, Injection site rash, Injection site warmth, Pain in ext...
Injection site pruritus, Injection site rash, Injection site warmth, Pain in extremity
More
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My arm became sore shortly after receiving the vaccination. The soreness continued for several days....
My arm became sore shortly after receiving the vaccination. The soreness continued for several days. Approximately three days after receiving the vaccination, I developed a rash on my upper left arm that is approximately 2 inches by 3 inches. It itches and is warm to the touch. Cortisone cream does help with the itching.
More
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| 2856498 | 41 | M | FL | 09/02/2025 |
SMALLMNK SMALLMNK SMALLMNK |
BAVARIAN NORDIC BAVARIAN NORDIC BAVARIAN NORDIC |
96868 96868 96868 |
Antinuclear antibody negative, C-reactive protein normal, Chlamydia test positiv...
Antinuclear antibody negative, C-reactive protein normal, Chlamydia test positive, Ear pruritus, HIV antibody negative; Inflammation, Injection site swelling, Papule, Pruritus, Swelling; Syphilis test negative
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Patient reports had R arm swelling after the vaccination that started at vaccination area and progre...
Patient reports had R arm swelling after the vaccination that started at vaccination area and progressed entire R arm and to chest over a few days. As was in a travel clinic consultation also received a MCV4- Meningococcal vaccination and Typhoid vaccination the same day/time however on the LEFT DELTOID, both IM. MENINGOCOCCAL MCV4O Date Administered: Jun 05, 2025 13:00 Series: Booster Manufacturer: GLAXOSMITHKLINE Lot: 9X7CD Exp Date: Jan 31, 2026 NDC: 058160082730 Admin Route/Site: INTRAMUSCULAR/LEFT DELTOID Dosage: 0.5mL ++++++++++++++++++++++++++ Administered: TYPHOID, VICPS Date Administered: Jun 05, 2025 13:00 Series: Complete Manufacturer: SANOFI PASTEUR Lot: Y2A021M Exp Date: Mar 31, 2027 NDC: 049281079051 Admin Route/Site: INTRAMUSCULAR/LEFT DELTOID Dosage: 0.5mL Vaccine Information Statement(s): TYPHOID VIS Oct 30, 2019
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| 2856499 | 14 | M | NM | 09/02/2025 |
HPV9 |
MERCK & CO. INC. |
Y015599 |
No adverse event, Product storage error
No adverse event, Product storage error
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Clinic medication refrigerator (for vaccine storage) lost network connectivity to temperature alert ...
Clinic medication refrigerator (for vaccine storage) lost network connectivity to temperature alert systems after clinic hours. A temperature excursion occurred during the time of lost connectivity, and no alerts were generated as connectivity was disrupted. The temperature in the refrigerator, with refrigerated vaccines inside, reached freezing conditions for an unclear amount of time overnight within a 12 hour period. HPV vaccine from the refrigerator was administered to the patient before the temperature was found. No adverse effects noted, and the patient was brought back to clinic in the same week for revaccination per guidance from website.
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| 2856500 | 0.5 | M | OK | 09/02/2025 |
DTPPVHBHPB PNC20 RV5 |
MSP VACCINE COMPANY PFIZER\WYETH MERCK & CO. INC. |
U7907AA MF0416 2003166 |
Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration
More
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Vaccination was to late, past 15 weeks, to be able to give all 3 doses before infant is 8 months old...
Vaccination was to late, past 15 weeks, to be able to give all 3 doses before infant is 8 months old.
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| 2856501 | 0.58 | M | MI | 09/02/2025 |
PNC20 RV5 |
PFIZER\WYETH MERCK & CO. INC. |
LC5483 2091233 |
Extra dose administered, Infant irritability; Extra dose administered, Infant ir...
Extra dose administered, Infant irritability; Extra dose administered, Infant irritability
More
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Patient was seen in HD on 06/16/2025 and given 6 months vaccines DTAP/IPV/HIB/HEPB , PCV20 and Rotav...
Patient was seen in HD on 06/16/2025 and given 6 months vaccines DTAP/IPV/HIB/HEPB , PCV20 and Rotavirus. . His name was misspelled in Electronic MEdical record, so vaccines given produced new MCIR record and vaccines given did not merge with previousl y given vaccines. Mom brought him back in Aug for more vaccines and MCIR pulled was wrong spelling so he was given 4th dose of ROTa and 4th dose of PCV20 , within too short of interval.
More
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| 2856502 | 65 | F | FL | 09/02/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
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Arthralgia, Injection site erythema, Injection site pain, Injection site swellin...
Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth; Neck pain
More
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Swollen injection site; red area; hot; shoulder and neck pain on that side; pain at site 8 days late...
Swollen injection site; red area; hot; shoulder and neck pain on that side; pain at site 8 days later
More
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| 2856503 | 1 | M | NM | 09/02/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
42DM9 |
Product storage error
Product storage error
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Pt received dose of HepA vaccine from medication refrigerator that had experienced a temperature exc...
Pt received dose of HepA vaccine from medication refrigerator that had experienced a temperature excursion (too cold) the prior evening. Clinic staff were unaware of the temperature excursion as no alarms were generated due to loss of monitor connectivity. Vaccine administered before excursion was discovered. Pt rescheduled for a repeat vaccination per guidance from agency.
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| 2856504 | 54 | M | AK | 09/02/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
031A21A 031A21A 031A21A 001b21a 001b21a 001b21a |
Cerebrovascular accident, Computerised tomogram, Dizziness, Full blood count, Lo...
Cerebrovascular accident, Computerised tomogram, Dizziness, Full blood count, Loss of consciousness; Magnetic resonance imaging, Meningioma, Mitral valve replacement, Myocarditis, Pericarditis; Traumatic heart injury, Tumour excision, Ultrasound scan; Cerebrovascular accident, Computerised tomogram, Dizziness, Full blood count, Loss of consciousness; Magnetic resonance imaging, Meningioma, Mitral valve replacement, Myocarditis, Pericarditis; Traumatic heart injury, Tumour excision, Ultrasound scan
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dizzy, passed out. intraventricular meningioma. tumor identified at hospital 5/12/2021, resection ...
dizzy, passed out. intraventricular meningioma. tumor identified at hospital 5/12/2021, resection done at another facility 5/13/2021. This was followed by stroke, myocarditis and pericarditis. mitral valve damaged - open heart replacement starting April 15, 2025
More
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โ | โ | โ | |||
| 2856505 | 88 | F | GA | 09/02/2025 |
PNC21 |
MERCK & CO. INC. |
|
Erythema, Skin warm
Erythema, Skin warm
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Patient was given vaccine on 8/27/25. She reported that she usually gets redness that lasts several ...
Patient was given vaccine on 8/27/25. She reported that she usually gets redness that lasts several days after receiving a vaccine and consented to getting the vaccine. However, today (6 days later) she comes back reporting of redness. The arm where the vaccine was administered is red and warm. The area where the vaccine was administered is not red. The red patchy area appears much on the lower half of the side/back of her upper arm. Patient reports the red patch that appeared after the vaccine appeared later on. I recommended she go to the doctor just to have the physician examine the area and assess if she needs further care. She said her physician is too far away and will go to urgent care for examination.
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| 2856506 | 61 | F | 09/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
nr4t5 |
Headache, Oral mucosal blistering, Oropharyngeal pain, Pyrexia
Headache, Oral mucosal blistering, Oropharyngeal pain, Pyrexia
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fever, sore throat, headache, mouth blisters
fever, sore throat, headache, mouth blisters
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| 2856507 | 78 | M | MI | 09/02/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
Y019158 Y019158 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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Patient was administered the PCV 21 twice on 8/18/2025. No adverse reactions noted.
Patient was administered the PCV 21 twice on 8/18/2025. No adverse reactions noted.
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| 2856508 | 73 | F | ME | 09/02/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
NR4TS NR4TS |
Blood test normal, Discomfort, Headache, Injection site pain, Joint swelling; Sk...
Blood test normal, Discomfort, Headache, Injection site pain, Joint swelling; Skin tightness, X-ray normal
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Swelling right ankle causing tightness and discomfort x several days. Low grade headache for 3 days,...
Swelling right ankle causing tightness and discomfort x several days. Low grade headache for 3 days, tender to the touch vaccine area right arm x 7 days
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| 2856509 | 11 | F | VA | 09/02/2025 |
HEP HPV9 IPV MMR |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. SANOFI PASTEUR MERCK & CO. INC. |
3N2ND Y010466 Y1A201M Y014095 |
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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Client had IMZ records but received extra vaccineS doses as a result of those records not being acco...
Client had IMZ records but received extra vaccineS doses as a result of those records not being accounted for prior to vaccine administration.
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| 2856510 | 63 | F | IL | 09/02/2025 |
FLU3 FLU3 PNC21 PNC21 |
SEQIRUS, INC. SEQIRUS, INC. MERCK & CO. INC. MERCK & CO. INC. |
406983 406983 z006076 z006076 |
Blood glucose increased, Injection site swelling, Malaise, Pyrexia, Rash; Skin w...
Blood glucose increased, Injection site swelling, Malaise, Pyrexia, Rash; Skin warm; Blood glucose increased, Injection site swelling, Malaise, Pyrexia, Rash; Skin warm
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103 degree fever, rash, swelling of injection site, rash very warm, glucose 245, patient not feeling...
103 degree fever, rash, swelling of injection site, rash very warm, glucose 245, patient not feeling well.
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| 2856511 | 1.08 | F | CA | 09/02/2025 |
DTAP DTAP HEPA HEPA IPV IPV MMR MMR PNC21 PNC21 VARCEL VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
6 6 1 1 1 1 4 4 3 3 1 1 |
Aggression, Aphasia, Bacterial test, Eczema, Head banging; Heavy metal test, Inf...
Aggression, Aphasia, Bacterial test, Eczema, Head banging; Heavy metal test, Inflammatory marker test, Intentional self-injury, Laboratory test; Aggression, Aphasia, Bacterial test, Eczema, Head banging; Heavy metal test, Inflammatory marker test, Intentional self-injury, Laboratory test; Aggression, Aphasia, Bacterial test, Eczema, Head banging; Heavy metal test, Inflammatory marker test, Intentional self-injury, Laboratory test; Aggression, Aphasia, Bacterial test, Eczema, Head banging; Heavy metal test, Inflammatory marker test, Intentional self-injury, Laboratory test; Aggression, Aphasia, Bacterial test, Eczema, Head banging; Heavy metal test, Inflammatory marker test, Intentional self-injury, Laboratory test; Aggression, Aphasia, Bacterial test, Eczema, Head banging; Heavy metal test, Inflammatory marker test, Intentional self-injury, Laboratory test
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Became Non-verbal, Eczema, self harm, danger to others, head banging
Became Non-verbal, Eczema, self harm, danger to others, head banging
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| 2856512 | 58 | M | 09/02/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Y019157 Y019157 |
Chills, Diarrhoea, Injection site erythema, Injection site swelling, Pyrexia; Vo...
Chills, Diarrhoea, Injection site erythema, Injection site swelling, Pyrexia; Vomiting
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REDNESS AND SWELLING AT INJECTION SITE. DIARRHEA, FEVER, VOMITING, CHILLS.
REDNESS AND SWELLING AT INJECTION SITE. DIARRHEA, FEVER, VOMITING, CHILLS.
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| 2856513 | 61 | F | AR | 09/02/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
007B21A 007B21A 007B21A |
Blindness, Cataract, Dysarthria, Dysphagia, Eye discharge; Gastrostomy, Glossect...
Blindness, Cataract, Dysarthria, Dysphagia, Eye discharge; Gastrostomy, Glossectomy, Immediate post-injection reaction, Impaired healing, Radiotherapy; Swollen tongue, Tongue neoplasm malignant stage unspecified, Tongue ulceration, Tooth extraction
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I took the first shot and I had some sort of allergic reaction my eye started twitching but not bad....
I took the first shot and I had some sort of allergic reaction my eye started twitching but not bad. But then i got the second on a month later. Right after i had it my eye got really bad i started getting cataracts and was blind in a couple of months and stuff was coming out of it, and it was terrible. And my tongue was swelling on one side and i had an ulcer that wasn't healing and it started to get really bad and swelling. And i knew there was something going on and i thought it was cancer and they were just referring me all over. I mean one after the other. And no one knew what it was. I got stuck in the hospital and they didn't even look in my mouth. I ended up going to an ENT and had to get a part of my tongue taken out because it was cancer on my tongue and it was growing fast and they didn't get the margins during the first surgery. So they gave me another appointment and they got me in the first time he had a chance and the removed the rest and it restored some issues in my arm. I had to get my teeth removed and went through radiation. But then the last week its like i have not healed well at all. I still have a gastric tube and i will never be able to eat again or speak right. My tongue is tied down to the bottom of my pallet.
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| 2856514 | 1.17 | M | MI | 09/02/2025 |
DTAPIPV PNC20 |
SANOFI PASTEUR PFIZER\WYETH |
U8198AA LP4946 |
Product administered to patient of inappropriate age; Product administered to pa...
Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
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Patient was given a dose of Quadracel (DTaP + IPV). Patient is below the minimum age listed. CDC con...
Patient was given a dose of Quadracel (DTaP + IPV). Patient is below the minimum age listed. CDC consulted and following their recommendations.
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| 2856515 | 60 | F | WV | 09/02/2025 |
PNC15 VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
Z006076 55Th4 |
Diarrhoea, Injection site pain, Injection site swelling, Nausea, Vomiting; Diarr...
Diarrhoea, Injection site pain, Injection site swelling, Nausea, Vomiting; Diarrhoea, Injection site pain, Injection site swelling, Nausea, Vomiting
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Vomiting, diarrhea, chills, nausea, injection site swollen and painful
Vomiting, diarrhea, chills, nausea, injection site swollen and painful
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| 2856516 | 83 | F | FL | 09/02/2025 |
FLU3 |
SANOFI PASTEUR |
u8764bb |
Asthenia, Dysstasia, Mobility decreased, Peripheral swelling, Syncope
Asthenia, Dysstasia, Mobility decreased, Peripheral swelling, Syncope
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patients arm is still swollen, after she got the vaccine, she fainted 6 hours after and was unable t...
patients arm is still swollen, after she got the vaccine, she fainted 6 hours after and was unable to get up had to craw to bed. The next day she felt weak and was unable to get out of bed.
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| 2856517 | 81 | M | NH | 09/02/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
nd3c7 |
Cough, Expired product administered, Pain in extremity, Rhinorrhoea
Cough, Expired product administered, Pain in extremity, Rhinorrhoea
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Administered incorrectly given after the expiration date of 08/20/25. Soreness in arm reported in th...
Administered incorrectly given after the expiration date of 08/20/25. Soreness in arm reported in the arm administered with RSV vaccine. Some runny nose and cough reported. Covid 19 vaccine was administer in other arm (right arm) on the same day.
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| 2856518 | 68 | M | KY | 09/02/2025 |
TDAP TDAP TDAP TDAP VARZOS VARZOS VARZOS VARZOS TDAP TDAP TDAP TDAP VARZOS VARZOS VARZOS VARZOS TDAP TDAP TDAP TDAP VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
L5229 L5229 L5229 L5229 PJ353 PJ353 PJ353 PJ353 |
Blister, Herpes zoster, Hypoaesthesia, Joint swelling, Neuralgia; Rash, Rash pru...
Blister, Herpes zoster, Hypoaesthesia, Joint swelling, Neuralgia; Rash, Rash pruritic; Blister, Neuralgia; Blister, Hypoaesthesia, Injection site induration, Neuralgia, Peripheral swelling; Blister, Herpes zoster, Hypoaesthesia, Joint swelling, Neuralgia; Rash, Rash pruritic; Blister, Neuralgia; Blister, Hypoaesthesia, Injection site induration, Neuralgia, Peripheral swelling; Blister, Herpes zoster, Hypoaesthesia, Joint swelling, Neuralgia; Rash, Rash pruritic; Blister, Neuralgia; Blister, Hypoaesthesia, Injection site induration, Neuralgia, Peripheral swelling; Blister, Herpes zoster, Hypoaesthesia, Joint swelling, Neuralgia; Rash, Rash pruritic; Blister, Neuralgia; Blister, Hypoaesthesia, Injection site induration, Neuralgia, Peripheral swelling; Blister, Herpes zoster, Hypoaesthesia, Joint swelling, Neuralgia; Rash, Rash pruritic; Blister, Neuralgia; Blister, Hypoaesthesia, Injection site induration, Neuralgia, Peripheral swelling; Blister, Herpes zoster, Hypoaesthesia, Joint swelling, Neuralgia; Rash, Rash pruritic; Blister, Neuralgia; Blister, Hypoaesthesia, Injection site induration, Neuralgia, Peripheral swelling
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Patient received Shingrix in left arm but broke out in what provider treated as shingles in his righ...
Patient received Shingrix in left arm but broke out in what provider treated as shingles in his right arm around four days later. He experienced an itchy rash, blisters on his palm and wrist, numbness and nerve pain in his right arm. Patient was treated with valtrex and gabapentin. Took gabapentin for one month but still experiencing numbness/nerve pain in his right arm, wrist still looks swollen and has rash (no visible blisters anymore),
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| 2856519 | 1.17 | F | IL | 09/02/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
z009076 z006737 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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Receive Varivax. This wasn't need. double dose.
Receive Varivax. This wasn't need. double dose.
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| 2856520 | 80 | WV | 09/02/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
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Dizziness, Dyspnoea, Hypertension, Malaise, Ventricular extrasystoles
Dizziness, Dyspnoea, Hypertension, Malaise, Ventricular extrasystoles
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I had the vaccine on Monday and the next day i was not feeling well and then i kept getting worse. O...
I had the vaccine on Monday and the next day i was not feeling well and then i kept getting worse. On saturday i ended up in the emergency room with a blood pressure of 101/100 and it has never been that high and i also had PVCS. And since then i can chew or swallow i am light headed and i cant breath. I have never had a reaction to any other vaccine reaction. I think that i have Guillain-Barre syndrome but no one will try and help me.
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| 2856521 | 5 | F | NV | 09/02/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
4L454 |
Injection site erythema, Injection site warmth
Injection site erythema, Injection site warmth
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Pt received vaccine in clinic 9/27/2025, mom brought pt back to the clinic 9/29/2025 reporting that ...
Pt received vaccine in clinic 9/27/2025, mom brought pt back to the clinic 9/29/2025 reporting that the injection site had redness and was warm to the touch. Provider saw pt and prescribed abx for presumed cellulitis
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| 2856522 | 36 | F | MS | 09/02/2025 |
HPV9 |
MERCK & CO. INC. |
Y015560 |
Injected limb mobility decreased, Pain in extremity
Injected limb mobility decreased, Pain in extremity
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Administered on 8/25/25. Pt notified clinic on 9/2/25, R arm hurting for 1week and sometimes unable ...
Administered on 8/25/25. Pt notified clinic on 9/2/25, R arm hurting for 1week and sometimes unable to lift arm. Pt advised to seek further evaluation from medical provider.
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| 2856523 | 88 | M | FL | 09/02/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
j9493 |
Pain in extremity
Pain in extremity
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very sore arm about an hour after the shot was given
very sore arm about an hour after the shot was given
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| 2856524 | 37 | M | MA | 09/02/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
016C21A 016C21A |
Arthralgia, Bradykinesia, Magnetic resonance imaging head, Pain, Single photon e...
Arthralgia, Bradykinesia, Magnetic resonance imaging head, Pain, Single photon emission computerised tomogram; Tremor
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***Preface: to be clear, I am not suggesting that the COVID 19 vaccines caused my adverse events; ho...
***Preface: to be clear, I am not suggesting that the COVID 19 vaccines caused my adverse events; however, in light of the timeframe of events, I think it is worthwhile to document correlation: about 2 weeks after my 2nd dose COVID 19 shot in May 2021, I developed a dull pain in my left elbow and one morning I noticed when raising my arm to open the refrigerator that the arm was slow to raise. About a month later, I developed a strong tremor in my left arm.
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| 2856525 | 65 | F | GA | 09/02/2025 |
PNC20 VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
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Pain in extremity, Peripheral swelling, Pruritus; Pain in extremity, Peripheral ...
Pain in extremity, Peripheral swelling, Pruritus; Pain in extremity, Peripheral swelling, Pruritus
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Arm pain, swelling, itching - Tx with naproxen, diphenhydramine, and acetaminophen
Arm pain, swelling, itching - Tx with naproxen, diphenhydramine, and acetaminophen
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