| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2853329 | M | OH | 08/08/2025 |
MENB MENB |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
LMN4C LMN4C |
Asthenia, Chest X-ray normal, Dyspnoea, Electrocardiogram normal, Muscular weakn...
Asthenia, Chest X-ray normal, Dyspnoea, Electrocardiogram normal, Muscular weakness; X-ray
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Shortness of breath; Arm weakness/leg weakness; general weakness; This non-serious case was reported...
Shortness of breath; Arm weakness/leg weakness; general weakness; This non-serious case was reported by a other health professional via sales rep and described the occurrence of shortness of breath in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number LMN4C, expiry date 29-FEB-2028) for prophylaxis. Concurrent medical conditions included peanut allergy. On 23-JUL-2025, the patient received Bexsero. In JUL-2025, 6 hrs after receiving Bexsero, the patient experienced shortness of breath (Verbatim: Shortness of breath), weakness in extremity (Verbatim: Arm weakness/leg weakness) and weakness generalized (Verbatim: general weakness). The outcome of the shortness of breath and weakness in extremity were unknown and the outcome of the weakness generalized was not reported. It was unknown if the reporter considered the shortness of breath, weakness in extremity and weakness generalized to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the shortness of breath, weakness in extremity and weakness generalized to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 25-JUL-2025 The reporter reported that so whiting approximately 6 hours of receiving the vaccine (Bexsero), the patient was at work, and he had sudden unset leg and arm weakness, and shortness of breath. Apparently, he was recently being diagnoses with a peanut allergy, but he never had an episode. The reporter was thought he was preparing something at work with peanuts, so in the intervention they received epi pen, that did not do anything. Then he was taken to the emergency room. It sound that they did a chest x-ray and EKG, they did not really have a diagnose, other than general weakness. The vaccine administration facility was the same as primary reporter.
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| 2853330 | M | OR | 08/08/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
37R35 |
Device leakage, Underdose
Device leakage, Underdose
|
vaccine leaked underneath the syringe and needle causing the patient to not receive the full dose; v...
vaccine leaked underneath the syringe and needle causing the patient to not receive the full dose; vaccine leaked underneath the syringe and needle; Product complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 47-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 37R35, expiry date 21-OCT-2027) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced accidental underdose (Verbatim: vaccine leaked underneath the syringe and needle causing the patient to not receive the full dose), device connection issue (Verbatim: vaccine leaked underneath the syringe and needle) and pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the accidental underdose, device connection issue and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the device connection issue to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the device connection issue to be related to Boostrix and Boostrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 25-JUL-2025 Medical assistant was giving a tetanus tdap Boostrix confirmed to the patient and the needle was on the syringe like normally screwed on but when she injected it leaked underneath the syringe and needle and she was not able to finish up and if it was a defect with syringe or needle or something like that, which led to accidental underdose. The leak had occurred between the leur lock and needle and no damage at the box. The defect was discovered during the administration of the vaccine. They did everything that was required by our office standards but then one of our pharmacist said to call manufacturer and find out. It had happened in the past in other clinic thought like that happen if the needle was not correctly place. But she said everything was good but it kind of exploded on there. Could it have been a defective vial or she did wrong, like you guys heard about that happening. The partial vaccine was administered to the patient. Patient was given another dose as per office but making sure everything was ok and it was not a defect vial and concerned. Not splashed into the eye.
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| 2853331 | 13 | M | MO | 08/08/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
Y97N7 |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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Infanrix instead of Boostrix to a 13-year-old patient; administering Infanrix to a 13-year-old patie...
Infanrix instead of Boostrix to a 13-year-old patient; administering Infanrix to a 13-year-old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 13-year-old male patient who received DTPa (Infanrix) (batch number Y97N7, expiry date 29-JUL-2025) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 29-JUL-2025, the patient received Infanrix. The patient did not receive Boostrix. On 29-JUL-2025, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Infanrix instead of Boostrix to a 13-year-old patient) and inappropriate age at vaccine administration (Verbatim: administering Infanrix to a 13-year-old patient). The outcome of the wrong vaccine administered 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: 29-JUL-2025 Health Care Provider wanted to know how to proceed after administering Infanrix instead of Boostrix to a 13-year-old patient, which led to wrong vaccine administered and inappropriate age at vaccine administration.
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| 2853332 | 48 | F | VA | 08/08/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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did not receive 2nd dose yet; This non-serious case was reported by a other health professional via ...
did not receive 2nd dose yet; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a female patient who did not receive HBV (Engerix B) for prophylaxis. Previously administered products included Engerix B (Engerix-B got the first one back in November 2024 with batch no. MD9SL and expiry date 8th December 2026). The patient did not receive the 2nd dose of Engerix B, the patient experienced incomplete course of vaccination (Verbatim: did not receive 2nd dose yet). The outcome of the incomplete course of vaccination 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: 30-JUL-2025 A Health Care Provider wanted to know how to proceed with a patient that wants to receive the second dose of Engerix-B after getting the first one back in November 2024. Till the time of reporting patient did not receive 2nd dose of Engerix B which led to incomplete course of vaccination.
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| 2853333 | 11 | F | IN | 08/08/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
Y012921 U8558BA 9JT4S |
Erythema, Pruritus; Erythema, Pruritus; Erythema, Pruritus
Erythema, Pruritus; Erythema, Pruritus; Erythema, Pruritus
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Benedryl helps with itch. Red covered area on torso also present. No adverse reaction noticed at v...
Benedryl helps with itch. Red covered area on torso also present. No adverse reaction noticed at vaccination sites.
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| 2853334 | 46 | F | LA | 08/08/2025 |
COVID19 |
PFIZER\BIONTECH |
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Urticaria chronic
Urticaria chronic
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Chronic hives treated biweekly Xolair and daily Xyzal
Chronic hives treated biweekly Xolair and daily Xyzal
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| 2853335 | 61 | F | AL | 08/08/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
|
Arthralgia, Chills, Dizziness, Fatigue, Hyperhidrosis; Injection site inflammati...
Arthralgia, Chills, Dizziness, Fatigue, Hyperhidrosis; Injection site inflammation, Injection site pain, Pain in extremity, Urinary incontinence
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Patient received PCV21 vaccine on 05 August 25 and woke up on 06 Aug 25 with sweating, left arm pai...
Patient received PCV21 vaccine on 05 August 25 and woke up on 06 Aug 25 with sweating, left arm pain, chills, light headedness, loss of control of bladder, fatigue, hip pain, right arm pain and generalized inflammation in the area of vaccination. Patient was seen in clinic 08 Aug 2025, and treated with the following medications for the next seven days: Zyretc 10mg, Pepcid 20mg, Hydrocortisone cream 1% , Decadron 4mg IM.
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| 2853336 | 5 | M | NE | 08/08/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
9KB9G |
Injection site induration, Injection site pain, Injection site swelling, Injecti...
Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
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LEFT UPPER ARM FROM SHOULDER TO ELBOW ALL AROUND THE ARM SWOLLEN AND FIRM AND WARM TO TOUCH AND PT. ...
LEFT UPPER ARM FROM SHOULDER TO ELBOW ALL AROUND THE ARM SWOLLEN AND FIRM AND WARM TO TOUCH AND PT. C/O STIFFNESS/ PAIN TO THE AREA
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| 2853338 | 60 | F | MI | 08/08/2025 |
PNC20 TD |
PFIZER\WYETH SANOFI PASTEUR |
|
Injection site erythema, Injection site mass, Pyrexia; Injection site erythema, ...
Injection site erythema, Injection site mass, Pyrexia; Injection site erythema, Injection site mass, Pyrexia
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Pt states after having both the tenus shot and the Prevnar shot from a week ago, she still has a kno...
Pt states after having both the tenus shot and the Prevnar shot from a week ago, she still has a knot from the injection area on her right arm. The Prevnar shot in the left arm she had redness on the injection area, that is finally getting better. She also had a fever after receiving both vaccines.
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| 2853339 | 1.08 | F | 08/08/2025 |
MMR |
MERCK & CO. INC. |
x019101 |
Expired product administered
Expired product administered
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Patient's were given expired vaccine two weeks after expiration date.
Patient's were given expired vaccine two weeks after expiration date.
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| 2853340 | 71 | F | WI | 08/08/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
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Erythema, Pruritus
Erythema, Pruritus
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Patient developed itching and redness 2 days after receiving the vaccination
Patient developed itching and redness 2 days after receiving the vaccination
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| 2853341 | WA | 08/08/2025 |
HEP |
UNKNOWN MANUFACTURER |
PN595 |
Expired product administered
Expired product administered
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Administration of an expired dose; This non-serious case was reported by a other health professional...
Administration of an 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 Hepatitis B vaccine (batch number PN595) for prophylaxis. On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced expired vaccine used (Verbatim: Administration of an expired dose). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 30-JUL-2025 On 30 July 2025, a Clinic Manager from a pediatrics clinic had called to ask whether it was possible to determine the expiration date of a Hepatitis B vaccine (3 doses) after providing a lot number from 2017. After no search results were found for the provided lot number (PN595), the manager had mentioned that a patient had visited the clinic and reported receiving an expired dose back in 2017, which led to Expired vaccine used.
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| 2853342 | 11 | F | CT | 08/08/2025 |
HPV9 |
MERCK & CO. INC. |
z002903 |
Immediate post-injection reaction, Loss of consciousness, Syncope
Immediate post-injection reaction, Loss of consciousness, Syncope
|
Administered State: HPV, MenQuadfi, TDap immunization(s) as ordered. See immunization activity for ...
Administered State: HPV, MenQuadfi, TDap immunization(s) as ordered. See immunization activity for details. Patient denies any questions or concerns at this time. Patient had syncopal event immediately after administration of HPV vaccine. LOC less than thirty seconds. Laid patient flat on her back after regaining consciousness. Mom in exam room with patient. Provider aware. Went back in room with water for patient and she was alert, oriented, and offered no complaints.
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| 2853343 | 8 | M | NV | 08/08/2025 |
DTAP |
SANOFI PASTEUR |
3ca55c1 |
Wrong product administered
Wrong product administered
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Provider ordered Dtap instead of Tdap. MA did not catch before administration.
Provider ordered Dtap instead of Tdap. MA did not catch before administration.
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| 2853344 | 18 | F | SC | 08/08/2025 |
MNQ |
SANOFI PASTEUR |
u8361aa |
Wrong product administered
Wrong product administered
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Patient was expecting the menigitis B vaccine instead of this one.
Patient was expecting the menigitis B vaccine instead of this one.
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| 2853345 | 11 | M | GA | 08/08/2025 |
HPV9 TDAP |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
Y012508 LX494 |
Dizziness, Nausea; Dizziness, Nausea
Dizziness, Nausea; Dizziness, Nausea
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PATIENT FELT LIGHT HEADED FOR LESS THAN ONE MINUTE AFTER TDAP VACCINE, AND WHEN HPV WAS GIVEN LAST H...
PATIENT FELT LIGHT HEADED FOR LESS THAN ONE MINUTE AFTER TDAP VACCINE, AND WHEN HPV WAS GIVEN LAST HE BECAME NAUSEATED, AND LIGHT HEADED 94/64 BP HR 90 TAKEN AT 12:00 NOON, PATIENT DID NOT VOMIT, HE WAS PROVIDED A COKE, CRACKERS, COLD COMPRESS AND FAN WAS PLACED ON HIM. AFTER 5 MINUTES HE FELT BETTER AND HIS COLOR RETURNED IN HIS FACE. HE WAS ABLE TO AMBULATE WITH DAD TO CHECK OUT AND OUT OF THE BUILDING ON HIS OWN.
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| 2853346 | 79 | M | VA | 08/08/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
P2443 |
Dizziness, Impaired work ability, Malaise
Dizziness, Impaired work ability, Malaise
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on 8/8/25, patient came to pharmacy complaining of dizziness and general malaise after receiving twi...
on 8/8/25, patient came to pharmacy complaining of dizziness and general malaise after receiving twinrix vaccination. Patient stated that he hasn't been feeling well since vaccine administered and it is affecting his work.
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| 2853347 | 11 | M | NY | 08/08/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
5XA2J |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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incorrect meningococcal vaccine given, patient was supposed to receive meningococcal conjugate (menv...
incorrect meningococcal vaccine given, patient was supposed to receive meningococcal conjugate (menveo) vaccination, doctor placed order for meninogocccal B vaccine (bexsero), I did not double check the dosing and went according to doctor's orders and administered Men B (Bexsero) vaccine. Parent was advised of the below per pediatrician "Patient received bexsero vaccine instead of menveo vaccine today. Parent was notified by telephone at 11 am on 8/8/2025. Bexsero vaccine is approved for high risk patients age 10 years and older.I counseled parent that patient will have protection against meningitis bacterial strain B." No adverse or side effects noticed after administration of vaccine.
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| 2853348 | 39 | M | CA | 08/08/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
206A21A 206A21A |
Ankle fracture, Chills, Coagulopathy, Loss of consciousness, Malaise; Pyrexia
Ankle fracture, Chills, Coagulopathy, Loss of consciousness, Malaise; Pyrexia
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Extremely sick weekend after - chills - fever - then got severe issues with clotting likely - passed...
Extremely sick weekend after - chills - fever - then got severe issues with clotting likely - passed out and broke ankle .
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| 2853349 | 19 | M | PA | 08/08/2025 |
MENB |
PFIZER\WYETH |
FN5547 |
Pyrexia, Rash
Pyrexia, Rash
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FEVER WITH RASH ON ELBOWS AND KNEES
FEVER WITH RASH ON ELBOWS AND KNEES
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| 2853350 | 22 | M | CA | 08/08/2025 |
YF |
SANOFI PASTEUR |
UK337AA |
Injection site swelling
Injection site swelling
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Member recieved Vaccine on August 7th. Patient woke up at 0630 and noticed swelling to right tricep....
Member recieved Vaccine on August 7th. Patient woke up at 0630 and noticed swelling to right tricep. States numbing at stie; no tenderness to palpation; redness at site. no difficulty breathing. Patient was seen by medical provider and treated with Triamcinolone Acetonide Cream USP 0.1% and Zyrtec 10mg.
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| 2853351 | 1.25 | F | NY | 08/08/2025 |
PPV |
MERCK & CO. INC. |
Y016291 |
Wrong product administered
Wrong product administered
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Patient was ordered Pneumococcal 15 for her 15 month well visit. I mistakenly administered Pneumococ...
Patient was ordered Pneumococcal 15 for her 15 month well visit. I mistakenly administered Pneumococcal 23. Immediately upon realizing my mistake, I notified the provider and she consequently contacted her supervisor. A UE report was made on the following day and the parents were notified.
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| 2853353 | 1 | F | MO | 08/08/2025 |
HEPA HEPA MMRV MMRV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
22GP3 22GP3 Y016874 Y016874 |
C-reactive protein increased, Liver function test, Metabolic function test, Pyre...
C-reactive protein increased, Liver function test, Metabolic function test, Pyrexia, Rash; Skin lesion, Tryptase; C-reactive protein increased, Liver function test, Metabolic function test, Pyrexia, Rash; Skin lesion, Tryptase
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2 weeks later she developed a rash. The rash started on her stomach and then rapidly moved to her ar...
2 weeks later she developed a rash. The rash started on her stomach and then rapidly moved to her armpints, legs and then to the diaper area/vulva. Then to her bottom followed by face and near her eyes. Mom denies any sores in her eyes, mouth or on the vaginal/anal mucosa. The rashes was flat red spots, never blisters, never crusted. It was not itchy. The day of the MMRV vaccine she had a fever, but not again after that first day. Mom denies petechiae or purpura (the lesions would always blanch with pressure). Since that time this rash would be present for about a week then go away for a week or so then come back. The subsequent episodes would start on the R leg (where she received her MMRV and Hepatitis A vaccines) then spread to the rest of the body. She is now received twice daily Zyrtec for potential urticarial response.
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| 2853354 | 57 | F | FL | 08/08/2025 |
FLU3 |
SANOFI PASTEUR |
TFAA2502 |
Diarrhoea, Inflammation, Urticaria, Vertigo
Diarrhoea, Inflammation, Urticaria, Vertigo
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Patient reported getting a whelt, nausea, diarrhea, inflammation and vertigo symptoms during the nig...
Patient reported getting a whelt, nausea, diarrhea, inflammation and vertigo symptoms during the night after vaccine.
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| 2853355 | 4 | M | MA | 08/08/2025 |
DTAPIPV MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
5G23D Y009430 017914 |
Erythema, Feeling hot; Erythema, Feeling hot; Erythema, Feeling hot
Erythema, Feeling hot; Erythema, Feeling hot; Erythema, Feeling hot
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large local reaction of warmth and redness, a little bit of erythema on his neck
large local reaction of warmth and redness, a little bit of erythema on his neck
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| 2853356 | 11 | M | TN | 08/08/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
YO10466 U8508AA LX494 |
Injection site bruising, Injection site erythema, Injection site induration, Inj...
Injection site bruising, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth; Injection site bruising, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth; Injection site bruising, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
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Day one post vaccine - warmth, redness, patient reported "bruised" appearane to left arm b...
Day one post vaccine - warmth, redness, patient reported "bruised" appearane to left arm below area where shots were given - seen in office 3 days post vaccine, left arm with 5x6 cm area of induration and warmth, itchy, able to move both arms well. left arm recieved TDap and Menquadfi. Right arm received HPV but no reaction on right arm.
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| 2853357 | 64 | F | 08/08/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
|
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Twinrix late second dose; This non-serious case was reported by a pharmacist via call center represe...
Twinrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 1st dose back in 2023). On 01-AUG-2025, the patient received the 2nd dose of Twinrix. On 01-AUG-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix late second dose). The outcome of the drug dose administration interval too long 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: 01-AUG-2025 The pharmacist reported that a female adult patient received Twinrix first dose back on 2023. On 01-AUG-2025 patient got Twinrix second dose. No further information on lot numbers or expirations dates. The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Twinrix vaccine, later than the recommended interval, which led to lengthening of vaccination schedule.
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| 2853358 | 21 | F | NC | 08/08/2025 |
TDAP TDAP YF YF |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
4CA04C1 4CA04C1 UK138AA UK138AA |
Chills, Feeling cold, Hyperhidrosis, Oropharyngeal pain, Pain; Pyrexia, Sleep di...
Chills, Feeling cold, Hyperhidrosis, Oropharyngeal pain, Pain; Pyrexia, Sleep disorder, Tremor, Vomiting; Chills, Feeling cold, Hyperhidrosis, Oropharyngeal pain, Pain; Pyrexia, Sleep disorder, Tremor, Vomiting
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Pt reports waking up this morning at about 2 am feeling feverish with intense body chills and shakes...
Pt reports waking up this morning at about 2 am feeling feverish with intense body chills and shakes, feeling very cold and sweaty. She was able to fall back asleep, woke up again at about 9 am and took Tylenol and immediately vomited for several minutes. Pt states she no longer feels feverish or nauseous, just a little sore from the shaking and a mild sore throat form the vomiting. Pt states she has been able to eat a few saltines and drink gatorade without vomiting. Pt states she feels mostly back to normal now. Pt encouraged to seek medical attention for a full evaluation. Pt states she's feeling better so she will not be seeking medical attention at this time.
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| 2853359 | 46 | M | SC | 08/08/2025 |
FLU3 |
SANOFI PASTEUR |
ut8779ja |
Pruritus
Pruritus
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Patient had itching following administration
Patient had itching following administration
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| 2853360 | 18 | F | OH | 08/08/2025 |
MENB MNQ |
PFIZER\WYETH SANOFI PASTEUR |
LF5303 U8574AA |
Pain in extremity, Peripheral swelling, Pruritus, Pyrexia, Urticaria; Pain in ex...
Pain in extremity, Peripheral swelling, Pruritus, Pyrexia, Urticaria; Pain in extremity, Peripheral swelling, Pruritus, Pyrexia, Urticaria
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Pt. Mother called at 10:06am stating she wanted to report a reaction to a vaccine. She stated that h...
Pt. Mother called at 10:06am stating she wanted to report a reaction to a vaccine. She stated that her daughter had vaccines yesterday and had a reaction. She listed the symptoms as: swollen and itchy hands, hives on hands and feet, fever of 100.1 and a sore arm. Mom stated that she already contacted her doctor for medical treatment. She requested to speak with nurse. I informed Mom that I could take a message and have a nurse call back to speak with her.
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| 2853361 | 12 | F | CA | 08/08/2025 |
TDAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U7983AA U7983AA |
Computerised tomogram head abnormal, Electroencephalogram abnormal, Epilepsy, Hy...
Computerised tomogram head abnormal, Electroencephalogram abnormal, Epilepsy, Hyperventilation, Magnetic resonance imaging head normal; Scalp haematoma, Seizure, Syncope, Ultrasound abdomen normal
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She had TDAP vaccine 8/14/25, then subsequently seen the following day 8/15 in quick care for syncop...
She had TDAP vaccine 8/14/25, then subsequently seen the following day 8/15 in quick care for syncopal episode, then subsequently in the ED that same day for seizures. She was admitted to the hospital and has been managed with neurology for epilepsy since then. Dad is unsure if incident was reported through the vaccine adverse events system at the time of the event, but would like to make sure it is.
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| 2853362 | 0.5 | F | NH | 08/08/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
|
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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No adverse reaction. Reported wrong vaccine given. Pediarix ordered. Infanrix given. Due to this err...
No adverse reaction. Reported wrong vaccine given. Pediarix ordered. Infanrix given. Due to this error pt is required to come back for further vaccine injections.
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| 2853363 | 61 | F | NC | 08/08/2025 |
PNC21 |
MERCK & CO. INC. |
Z004301 |
Peripheral swelling, Skin warm, Vomiting
Peripheral swelling, Skin warm, Vomiting
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Patient reported upper arm is swollen, hot to touch and this morning she vomited 1 time
Patient reported upper arm is swollen, hot to touch and this morning she vomited 1 time
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| 2853364 | 13 | F | CA | 08/08/2025 |
HPV9 |
MERCK & CO. INC. |
Y009051 |
Asthenia, Dizziness, Nausea, Syncope
Asthenia, Dizziness, Nausea, Syncope
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Approximately one minute after receiving HPV vaccine pt became weak, dizzy and very nauseated and th...
Approximately one minute after receiving HPV vaccine pt became weak, dizzy and very nauseated and then fainted briefly on the exam table where she was laying. Pt woke up very quickly and still felt dizzy for approximately 3 minutes. Patient was then able to continue to lay down until she felt ready to slowly stand with no difficulty. Patient ambulated with strait steady gait out of clinic with mother after 15-minute observation period.
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| 2853365 | 5 | M | CA | 08/08/2025 |
DTAP DTAP IPV IPV MMR MMR |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
Y7JC3 Y7JC3 Y1A201M Y1A201M N3429 N3429 |
Injection site erythema, Injection site mass, Injection site warmth, Lip erythem...
Injection site erythema, Injection site mass, Injection site warmth, Lip erythema, Lip pruritus; Lip swelling; Injection site erythema, Injection site mass, Injection site warmth, Lip erythema, Lip pruritus; Lip swelling; Injection site erythema, Injection site mass, Injection site warmth, Lip erythema, Lip pruritus; Lip swelling
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Mother reports 1 day after vaccination there was a red, hot, hard lump to the left deltoid where Dta...
Mother reports 1 day after vaccination there was a red, hot, hard lump to the left deltoid where Dtap was administered. Mother also reports patients lips are red, swollen and itchy. Nurse recommended seeking medical attention and to acquire medical documentation for provider back home as they are currently visiting.
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| 2853366 | 18 | F | TX | 08/08/2025 |
HPV9 |
MERCK & CO. INC. |
Y013565 |
Contusion, Head injury, Syncope
Contusion, Head injury, Syncope
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Pt fainted within the first hour status post HPV vaccine. Fainting resulted in a knot on head with ...
Pt fainted within the first hour status post HPV vaccine. Fainting resulted in a knot on head with bruising.
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| 2853367 | 47 | F | WA | 08/08/2025 |
RAB RAB RAB RAB |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
Y1A86P1 Y1A86P1 Y1A86P1 Y1A86P1 |
Burning sensation, Chills, Dizziness, Facial discomfort, Formication; Head disco...
Burning sensation, Chills, Dizziness, Facial discomfort, Formication; Head discomfort, Headache, Injection site pain, Muscle tightness; Burning sensation, Chills, Dizziness, Facial discomfort, Formication; Head discomfort, Headache, Injection site pain, Muscle tightness
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Approximately 48 hours after vaccine dose 1, the patient reported feeling some pressure and burning ...
Approximately 48 hours after vaccine dose 1, the patient reported feeling some pressure and burning in the head, as well as soreness at the injection site. Approximately 48 hours after vaccine dose 2, the patient reports developing burning in the brain and spinal cord, pressure in the head along with headache, dizziness, rigors, jaw clenching, a sense of skin crawling, and right-sided face pulling. As of today (9 days post dose 2), patient reports feeling that symptoms are about 50% improved but continue to persist.
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| 2853368 | 4 | F | IL | 08/08/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
5G23D Z007215 |
Erythema, Induration, Swelling; Erythema, Induration, Swelling
Erythema, Induration, Swelling; Erythema, Induration, Swelling
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redness, swelling, hardness
redness, swelling, hardness
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| 2853369 | CA | 08/08/2025 |
PNC20 |
PFIZER\WYETH |
LP4948 |
Injection site discolouration, Injection site erythema
Injection site discolouration, Injection site erythema
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Discoloration of Injection Site post-1-week of administration. Red irregularly shaped patch discover...
Discoloration of Injection Site post-1-week of administration. Red irregularly shaped patch discovered evening of 8/7/25. Patch presents as Moddled (somewhat resolved) as of 8/8/25. No reports of pain, itching, swelling nor retexturization of skin.
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| 2853370 | 4 | F | AZ | 08/08/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
Z53J4 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Patient received expired vaccine, expiration date 06/07/2025, no adverse events after immunization
Patient received expired vaccine, expiration date 06/07/2025, no adverse events after immunization
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| 2853371 | 17 | F | MI | 08/08/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
57H54 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Pt received 3rd dose of Menveo rather than Bexero that was due. Pt has not complained of an adverse ...
Pt received 3rd dose of Menveo rather than Bexero that was due. Pt has not complained of an adverse reaction.
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| 2853372 | 18 | F | WA | 08/08/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
ES49H |
Dizziness, Hypotension, Syncope
Dizziness, Hypotension, Syncope
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Patient received vaccine and stood up approximately 1 minute later. She walked to the front counter ...
Patient received vaccine and stood up approximately 1 minute later. She walked to the front counter of the pharmacy to pickup her prescriptions, mentioned feeling light headed, and fainted approximately 5 minutes after receiving vaccine. Local paramedics called and they cleared patient.
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| 2853373 | 10 | F | CA | 08/08/2025 |
COVID19 |
MODERNA |
8081561 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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The patient received an adult dose of Moderna.
The patient received an adult dose of Moderna.
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| 2853374 | 1 | M | TX | 08/08/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
4L454 Z007853 |
Inappropriate schedule of product administration, Pyrexia; Inappropriate schedul...
Inappropriate schedule of product administration, Pyrexia; Inappropriate schedule of product administration, Pyrexia
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vaccine administered before time. Called patients mom and notify her that vaccine will not be valid ...
vaccine administered before time. Called patients mom and notify her that vaccine will not be valid she needs to return and get missing vaccine Hep A. Mother is aware and as per mom patient only got very low fever and doing good. No fever since the day vaccine was administered.
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| 2853375 | 18 | F | VA | 08/08/2025 |
MNQ MNQ MNQ MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
343DD 343DD 343DD 343DD |
Arthropod bite, Blood glucose normal, Brain fog, Differential white blood cell c...
Arthropod bite, Blood glucose normal, Brain fog, Differential white blood cell count, Erythema; Feeling hot, Full blood count, Full blood count normal, Hyperventilation, Hypoaesthesia; Joint contracture, Joint swelling, Laboratory test normal, Liver function test normal, Panic reaction; Paraesthesia, Renal function test normal, Thyroid function test normal, Urticaria
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Patient received Menveo vaccination on 7/30/25. Patient stated she started having tingling in both a...
Patient received Menveo vaccination on 7/30/25. Patient stated she started having tingling in both arms on 8/1/25 and her left ring finger went numb on 8/2/25. Patient went to the lake on 8/2/2025 and had some bug bites on her right leg after which she developed hives all over both legs and then both arms. Patient stated she then felt both ears were hot as well. She drove home and had brain fog on her way home and got lost. She eventually drove home and was panicked and hyperventilating. Patient stated both of her wrists contracted. Denied any fevers, chills, headache, syncope, or facial swelling. Patient's parents called EMS, and pt was brought to the ER. Patient had normal vitals in ER and was given a dose of Decadron and Benadryl with resolution of hives and wrist contractures. Patient stated her right index finger PIP swelled up after ER visit. She took Benadryl with some improvement, but not resolution, of right index finger PIP swelling and redness. Pt denied pain or injury. Patient was seen in office for a F/U ER visit on 08/06/2025. Patient denied current tingling, numbness, hives, brain fog, or trouble breathing. She had blood work done and was give a prescription for predniSONE (DELTASONE) 20 MG tablet; Take 3 tabs PO daily x 5 days, then 2 tabs PO daily x 5 days, then 1 tab PO daily x 5 days. Spoke to patient on 08/07/2025 and she had not picked up her prednisone prescription but was feeling much better.
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| 2853376 | 41 | M | ID | 08/08/2025 |
TDAP |
SANOFI PASTEUR |
U8366AA-P |
Arthralgia, Joint swelling, Musculoskeletal stiffness, Peripheral swelling
Arthralgia, Joint swelling, Musculoskeletal stiffness, Peripheral swelling
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Stiff neck, pain in joints of fingers of both hands and toes, swelling of hands and ankles/feet. St...
Stiff neck, pain in joints of fingers of both hands and toes, swelling of hands and ankles/feet. Stiff neck started to improve on 8/4/2025. Pain and swelling of hands and ankles/feet started on 8/3/2025. Continues with pain and swelling continues at same level at the time of this report. Referral to Occupational Health Clinic to be seen by a provider on 8/8/2025.
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| 2853377 | 44 | F | TN | 08/08/2025 |
HEPA |
MERCK & CO. INC. |
Z003701 |
Extra dose administered
Extra dose administered
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ADMINISTERED HEP A DOSE WHEN PATIENT ALREADY HAD PREVIOUSLY RECEIVED 2 DOSES WITH THE 2ND DOSE BEING...
ADMINISTERED HEP A DOSE WHEN PATIENT ALREADY HAD PREVIOUSLY RECEIVED 2 DOSES WITH THE 2ND DOSE BEING ON 4/5/2019
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| 2853378 | 62 | M | MD | 08/08/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
CD44A U8508AA |
Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration
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The meningitis vaccine dosing schedule is as follows:, per ACIP guidelines. -Bexsero THREE dose sel...
The meningitis vaccine dosing schedule is as follows:, per ACIP guidelines. -Bexsero THREE dose selection: Day 0 , 1-2 months and 6 months -MenQuadfi TWO dose selection : Day 0, 2 months This patient administered first doses on 06/03/2025 and 2nd doses were administered on 07/17/2025 , 12 days prior to recommendation per ACIP guidelines. Pharmacist reached out to MDO, pending as he had to lvm- still pending contact HCP for direction
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| 2853379 | 4 | F | CA | 08/08/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Erythema, Peripheral swelling, Tenderness; Erythema, Peripheral swelling, Tender...
Erythema, Peripheral swelling, Tenderness; Erythema, Peripheral swelling, Tenderness
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Per mom received 4th dose of DTAP and second of MMR. Never had reaction in the past. Left arm (unsur...
Per mom received 4th dose of DTAP and second of MMR. Never had reaction in the past. Left arm (unsure which vaccine was given in this arm) redness and swelling over 2-3 days after vaccine given. Per patient sore to touch. Treated with single dose of Dexamethasone in the office 3 days after vaccine given.
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| 2853380 | 82 | F | CA | 08/08/2025 |
RAB RAB RAB RAB RAB RAB RAB RAB RAB RAB |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
fdp00683 fdp00683 fdp00683 fdp00683 fdp00683 |
Blood test, CSF white blood cell count increased, Clostridium difficile infectio...
Blood test, CSF white blood cell count increased, Clostridium difficile infection, Computerised tomogram normal, Confusional state; Dizziness, Encephalitis, Feeding disorder, Hypersomnia, Insomnia; Magnetic resonance imaging normal, Malaise, Mental status changes, Mobility decreased; Anxiety, Aphasia, CSF culture negative, Cerebral infarction, Clostridium test positive; Hypophagia, Klebsiella test positive, Magnetic resonance imaging head abnormal, Mental status changes; Blood test, CSF white blood cell count increased, Clostridium difficile infection, Computerised tomogram normal, Confusional state; Dizziness, Encephalitis, Feeding disorder, Hypersomnia, Insomnia; Magnetic resonance imaging normal, Malaise, Mental status changes, Mobility decreased; Anxiety, Aphasia, CSF culture negative, Cerebral infarction, Clostridium test positive; Hypophagia, Klebsiella test positive, Magnetic resonance imaging head abnormal, Mental status changes
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Pt was in the ER on 7/25/25 and was given the rabies vaccine. The next day after being vaccinated s...
Pt was in the ER on 7/25/25 and was given the rabies vaccine. The next day after being vaccinated she had trouble sleeping. By the next day she was dizzy and feeling unwell. On 7/28/25 she began feeling like she couldn't function. On 7/30/25 she was not able to function or could not eat. By 7/31/25 she was mental state was severely altered and she was no longer mobile. She was asked what year it was and she stated it was 1923. Her daughter took her to ER. The attending ER physician apologized stating she should have never been given that vaccine due to her medical condition. She was given a CT and MRI. All test were negative. She was admitted to the hospital for treatment. On August 5th, she did not wake up the entire day. She was not drug induced and would not flinch when having blood drawls. They ran multiple test and a lumbar puncture. She was told it was slight encephalitis. There were fourteen white blood cells in the cerebral spinal fluid when they did the lumbar puncture. They believe it is post vaccine related since she is immune compromised. They have since discovered others with her chronic health condition have also had these same symptoms post vaccine. After being there for four days she developed CDIFF which they do not believe this is related to the vaccine. She is currently still waiting on pending blood test w/ no official diagnosis and still currently hospitalized.
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