| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2842384 | 79 | M | FL | 05/22/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
L5229 |
Unevaluable event
Unevaluable event
|
NONE
NONE
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| 2842385 | 22 | M | OH | 05/22/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
FC3181 FC3181 FC3181 FF2587 FF2587 FF2587 |
Arrhythmia, Asthenia, Blood thyroid stimulating hormone increased, Chest pain, E...
Arrhythmia, Asthenia, Blood thyroid stimulating hormone increased, Chest pain, Electrocardiogram abnormal; Fatigue, Fibrin D dimer normal, Full blood count normal, Hypertension, Immune system disorder; Myalgia, Pain, Pain in extremity, Ultrasound scan normal; Arrhythmia, Asthenia, Blood thyroid stimulating hormone increased, Chest pain, Electrocardiogram abnormal; Fatigue, Fibrin D dimer normal, Full blood count normal, Hypertension, Immune system disorder; Myalgia, Pain, Pain in extremity, Ultrasound scan normal
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Have gone to ER for shooting muscle pains. Feel like I've aged 10 years in 4 since the vax. Fat...
Have gone to ER for shooting muscle pains. Feel like I've aged 10 years in 4 since the vax. Fatigue and lack of energy namely. Stamina loss and Heart arrythmia. Immune system has severely decreased. I had a persistent chest pain for 3 months that would flare up at different times that only subsided after months of max supplementing potassium in my diet. I have changed all the variables of my lifestyle in favor of my health and yet my immune system is worse than it was when I was treating it like crap pre-vaccine. Pain continues at random points in legs, exact location varies as well. Ultrasound on right leg was negative.
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| 2842386 | 34 | F | WA | 05/22/2025 |
MMR TDAP |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
Y011709 M2G3Z |
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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No adverse event. Just reporting it as it is an extra dose.
No adverse event. Just reporting it as it is an extra dose.
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| 2842388 | 10 | F | CA | 05/22/2025 |
HPV9 |
MERCK & CO. INC. |
Y012864 |
Flushing, Urticaria
Flushing, Urticaria
|
After receiving HPV 9 vaccine at 4:54 PM, approximately 5-10min later patient reported having hives ...
After receiving HPV 9 vaccine at 4:54 PM, approximately 5-10min later patient reported having hives and was flush in the face. Charge Nurse checked on patient and informed Provider of symptoms and then she evaluated patient. Provider then ordered Benadryl 12.5 mg/5ml oral elixir 25mg and it was given at 5:19 PM. Patient was better and denied any other symptoms by 5:30 PM. Patient discharged by 5:40 PM with caregiver.
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| 2842389 | 15 | F | WA | 05/22/2025 |
VARCEL |
MERCK & CO. INC. |
|
Fatigue, Oropharyngeal pain, Vasodilatation
Fatigue, Oropharyngeal pain, Vasodilatation
|
Swollen neck veins, exhaustion, and sore throat.
Swollen neck veins, exhaustion, and sore throat.
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| 2842404 | 11 | F | HI | 05/22/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
Z005055 U8493AA KR75K |
Hypoaesthesia; Hypoaesthesia; Hypoaesthesia
Hypoaesthesia; Hypoaesthesia; Hypoaesthesia
|
See printed 05/08/2025 and 05/09/2025 medical / clinical notes / documentation. Phone call w/fathe...
See printed 05/08/2025 and 05/09/2025 medical / clinical notes / documentation. Phone call w/father. Last night, applied hot & cold compress to child's left forearm. At 7pm last night, father said child was able to feel a little below her left elbow. Father said while he was working today at 6:30am, child's mother called him & told him child's left forearm is able to feel again. Father also said he and child's mother does not want child to receive the 2nd HPV vaccination. After leaving our office after examination & vaccination, child opened the car door and was unable to feel w/her left forearm, from her left elbow to her fingers (HPV vaccination was admin in her left deltoid). Child returned to Dr's office. Dr. examined child. Child was able to move her upper left extremity but was unable to feel below her left elbow to her fingers. 4:23PM, 2 ibuprofen 200mg tablets given PO, 4:40PM, there was no change to child's left forearm. Dr recommended hot & cold compress during the night and to call her PRN.
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| 2842405 | 4 | F | NY | 05/22/2025 |
DTAP IPV MMR VARCEL |
SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
3CA20C1 Y1A212M Y019108 Y019318 |
Injection site reaction; Injection site reaction; Injection site reaction; Injec...
Injection site reaction; Injection site reaction; Injection site reaction; Injection site reaction
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Large local reaction (R) upper arm
Large local reaction (R) upper arm
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| 2842406 | 12 | M | MT | 05/22/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
Y015179 57H54 EB499 |
Injection site bruising; Injection site bruising; Injection site bruising
Injection site bruising; Injection site bruising; Injection site bruising
|
Bruising at injection site. Noticed after shower 2 days after injection. Not painful or bothersome t...
Bruising at injection site. Noticed after shower 2 days after injection. Not painful or bothersome to patient.
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| 2841927 | 1 | HI | 05/21/2025 |
MMRV |
MERCK & CO. INC. |
Y017511 |
No adverse event, Product storage error
No adverse event, Product storage error
|
No other information provided. No additional AEs/PQC reported.; vaccines administered after temperat...
No other information provided. No additional AEs/PQC reported.; vaccines administered after temperature excursions; This spontaneous report was received from an Other health professional and refers to a(n) 1-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Hepatitis A Vaccine, Inactivated (VAQTA) (manufacturer unknown) Prevenar 20 (Pneumococcal vaccine conj 20v (CRM197)) . On 15-Apr-2025, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), lot #Y017511, expiration date: 15-Apr-2026, dose number 1, (strength, dose, and vaccination scheme were not reported), administered by Subcutaneous route in Left Thigh, as Prophylaxis. On an unknown date, the vaccine underwent a temperature excursion of -9.8 Celsius Degrees during a timeframe of 2 h 3 m, with no previous temperature excursions. No adverse event was reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-04-28 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : , Central date : 2025-04-28 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
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| 2841928 | 4 | M | IL | 05/21/2025 |
MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
X026409 |
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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No symptoms reported; an expired dose of PROQUAD was administered to a 4-year-old male patient on 5/...
No symptoms reported; an expired dose of PROQUAD was administered to a 4-year-old male patient on 5/8/2025; This spontaneous report has been received from a Nurse referring to a 4-year-old male patient. The patient's concurrent conditions, pertinent medical history, previous drug reactions/allergies, and concomitant therapies were not provided. On 08-MAY-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (+) diluent, with valid lot # X026409 and expiration date: 07-May-2025 (strength, dose, frequency, route of administration, lot #, and expiration date were not provided) as prophylaxis (Expired product administered). No symptoms reported (No adverse event).
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| 2841929 | PA | 05/21/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
UNK |
Product preparation issue
Product preparation issue
|
inappropriate preparation of medication; inappropriate dose of vaccine administered.; This non-serio...
inappropriate preparation of medication; inappropriate dose of vaccine administered.; This non-serious case was reported by a consumer and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: inappropriate preparation of medication) and inappropriate dose of vaccine administered (Verbatim: inappropriate dose of vaccine administered.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 30-APR-2025 The reporter was the Clinic Administrator and needing some guidance on a situation that they had encountered here. The situation was that a CMA was getting a Menveo vaccine ready to administer and noticed that it was the last vial of the gray cap but that there were 2 vials of the orange caps left, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. She administered the correct dose with the two correct vials, but he/she was needing to see if there was a recommendation since we are not able to identify the patient that received only the gray top vial of the 4 other doses. The reporter had a report that identified the 4 patients.
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| 2841930 | M | NE | 05/21/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
|
He states he forgot to get dose 2 within the 2-6 month window; This non-serious case was reported by...
He states he forgot to get dose 2 within the 2-6 month window; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine in May 2024). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: He states he forgot to get dose 2 within the 2-6 month window). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date : 14-MAY-2025 The reporter stated that he received Shingrix dose 1 in May 2024. He was scheduled to get dose 2 May 20, 2025. He stated that he forgot to get dose 2 within the 2-6 month window. Till the time of reporting the patients did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
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| 2841931 | 05/21/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
|
Suspected vaccination failure; two vaccine and still get an out break, just not as bad; This serious...
Suspected vaccination failure; two vaccine and still get an out break, just not as bad; 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: two vaccine and still get an out break, just not as bad). 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: 14-MAY-2025 This case was reported by a patient via interactive digital media. The patient had two vaccine and still get an out break, just not as bad. 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 primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1 & 2).
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| 2841932 | F | MO | 05/21/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
39LB7 |
Product storage error
Product storage error
|
Administration after a below temperature excursion of 29.9 degree F as the minimum reached.; This no...
Administration after a below temperature excursion of 29.9 degree F as the minimum reached.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9 degree F as the minimum reached.). The outcome of the incorrect storage of drug 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: 15-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree F as the lowest reached for following product Boostrix, which led to incorrect storage of vaccine. The Vaccine Administration Facility was the same as Primary Reporter. No expiration date given for the vaccines nor date of administration. The reporter consented to follow up.; Sender's Comments: US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061574:Same reporter,Different patient US-GSK-US2025061573:Same reporter,Different patient US-GSK-US2025061572:Same reporter,Different patient US-GSK-US2025061571:Same reporter,Different patient US-GSK-US2025061570:Same reporter,Different patient US-GSK-US2025061569:Same reporter,Different patient US-GSK-US2025061568:Same reporter,Different patient US-GSK-US2025061567:Same reporter,Different patient US-GSK-US2025061565:Same reporter,Different patient US-GSK-US2025061564:Same reporter,Different patient US-GSK-US2025061563:Same reporter,Different patient US-GSK-US2025061562:Same reporter,Different patient US-GSK-US2025061561:Same reporter,Different patient US-GSK-US2025061560:Same reporter,Different patient US-GSK-US2025061559:Same reporter,Different patient US-GSK-US2025061558:Same reporter,Different patient US-GSK-US2025061557:Same reporter,Different patient US-GSK-US2025061556:Same reporter,Different patient US-GSK-US2025061555:Same reporter,Different patient US-GSK-US2025061554:Same reporter,Different patient US-GSK-US2025061553:Same reporter,Different patient US-GSK-US2025061552:Same reporter,Different patient US-GSK-US2025061551:Same reporter,Different patient US-GSK-US2025061550:Same reporter,Different patient US-GSK-US2025061549:Same reporter,Different patient US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061547:Same reporter,Different patient US-GSK-US2025061545:Same reporter,Different patient US-GSK-US2025061538:Same reporter,Different patient US-GSK-US2025061537:Same reporter,Different patient US-GSK-US2025061536:Same reporter,Different patient US-GSK-US2025061534:Same reporter,Different patient
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| 2841933 | NJ | 05/21/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
|
Expired product administered, No adverse event
Expired product administered, No adverse event
|
PENTACEL was given to patient 14 days after expiration with no reported adverse event; Initial infor...
PENTACEL was given to patient 14 days after expiration with no reported adverse event; Initial information received on 14-May-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age and unknown gender patient who received diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] 14 days after expiration with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine, Powder and suspension for suspension for injection,(lot number, expiry date and strength not reported) via unknown route in unknown administrative site for immunization, after 14 days of expiration with no reported adverse event (expired product administered) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2841934 | 6 | M | TX | 05/21/2025 |
TD |
SANOFI PASTEUR |
U7920AA |
Off label use
Off label use
|
off-label use as per local labelling due to administration of tenivac to a 6 year old patient with n...
off-label use as per local labelling due to administration of tenivac to a 6 year old patient with no reported ae; Initial information received on 15-May-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 6 year old male patient who received diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Teniva] with no reported AE (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-May-2025, the 6 years old male patient received an unknown dose (dose 1) of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection standard strength (lot U7920AA) (expiry date-unknown) via unknown route in unknown administration site for Immunization with no reported AE (off label use) (latency-same day). Reportedly-Nurse reported that the patient was 6 years old when they got their first dose of TENIVAC in the hospital and it was approved by their physician because the patient cannot get a pertussis shot. Action taken was not applicable.
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| 2841935 | VA | 05/21/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK168AB |
No adverse event, Occupational exposure to product
No adverse event, Occupational exposure to product
|
the liquid dripped all over her hands with no reported adverse event; the liquid dripped all over he...
the liquid dripped all over her hands with no reported adverse event; the liquid dripped all over her hands with no reported adverse event; Initial information received on 15-May-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age and unknown gender physician and the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)] dripped all over her hands with no reported adverse event. On an unknown date, the suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine Suspension for injection (Unknown strength) with lot UK168AB and expiry date 31-Oct-2025 for Immunization dripped all over physician hands with no reported adverse event (accidental exposure to product) (exposure via skin contact). Reportedly, Bottle leaked. Replacement requested. HCP (Healthcare professional) stated she had pentacel and that when she went to pull up the liquid to use with a patient, the bottle leaked everywhere. HCP stated that it wasn't from the needle, that it was from the bottle itself and that she was unable to use it. HCP stated she did not notice a crack in the bottle, that the leak was not coming from the needle. HCP stated that, initially, she was unable to determine where the leak was coming from, that she has seen leaks before if a needle wasn't on tight enough. HCP stated she took the needle out and put it back in, but the leaking continued. HCP stated it was then that she noticed the leak was coming from "the soft portion in the center" of the bottle. HCP stated the liquid dripped all over her hands. HCP stated she pulled a second bottle from the same box and it worked fine Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
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| 2841936 | 0.5 | AR | 05/21/2025 |
HIBV |
SANOFI PASTEUR |
UK148AA |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
|
reconstituted ACT-HIB with sterile water with no reported adverse event; reconstituted ACT-HIB with ...
reconstituted ACT-HIB with sterile water with no reported adverse event; reconstituted ACT-HIB with sterile water and administered it to a patient; Initial information received on 19-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old with unknown gender patient who was administered with reconstituted HIB (PRP/T) Vaccine [ACT-HIB] with sterile water with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pediarix, Rotavirus vaccine and Prevnar 20 for Immunisation. On 14-May-2025, the patient received 0.5mL (dose 3) (frequency once) of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK148AA, expiry date 30-Sep-2025, strength standard) via intramuscular route in the right thigh for TB skin test (Immunisation) and reconstituted act-hib with sterile water and administered it to a patient (poor quality product administered), (product preparation error) (latency same day). Reportedly, reported called to ask if the ACTHIB dose needs to be repeated. They reported that one of their nurses reconstituted ACTHIB with sterile water and administered it to a patient. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
More
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| 2841971 | 4 | F | VA | 05/21/2025 |
DTAP DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
JF7DM 4L454 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
|
Patient received two doses of DTAP
Patient received two doses of DTAP
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| 2841972 | 72 | M | VA | 05/21/2025 |
MMR |
MERCK & CO. INC. |
Y015995 |
Erythema, Peripheral swelling
Erythema, Peripheral swelling
|
2 weeks after administration, patient woke with swelling and redness in hands, around all MCP's...
2 weeks after administration, patient woke with swelling and redness in hands, around all MCP's. This was temporary, and labs did not show any infection or significant underlying inflammatory condition.
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| 2841974 | 21 | F | 05/21/2025 |
COVID19 |
MODERNA |
|
No adverse event, Underdose
No adverse event, Underdose
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MOD 6m-11yrs was accidentally administered to an adult. - No known adverse effects.
MOD 6m-11yrs was accidentally administered to an adult. - No known adverse effects.
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| 2841975 | 1.33 | M | IN | 05/21/2025 |
DTAP HEP HEPA HIBV PNC20 VARCEL |
SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
3CA25C1 Y002554 Y011731 X017447 HM0312 Y011017 |
Extra dose administered; Extra dose administered; Extra dose administered; Extra...
Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered
More
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Patient was given a Hepatitis B fourth dose and no MMR first dose
Patient was given a Hepatitis B fourth dose and no MMR first dose
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| 2841976 | 19 | F | VA | 05/21/2025 |
HEPA |
MERCK & CO. INC. |
X026485 |
Expired product administered
Expired product administered
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Expired vaccine was administered. Once documenting expiration date error was found. Doctor was infor...
Expired vaccine was administered. Once documenting expiration date error was found. Doctor was informed and patient was notified.
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| 2841977 | 65 | M | FL | 05/21/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
PFR; EN6200 PFR; EN6200 |
Chest pain, Chills, Dizziness, Dyspnoea, Fatigue; Hyperhidrosis, Malaise, Palpit...
Chest pain, Chills, Dizziness, Dyspnoea, Fatigue; Hyperhidrosis, Malaise, Palpitations, Scan myocardial perfusion
More
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2nd vaccination of COVID series given 3/12/21 (first given 2/19/21), and patient come to emergency d...
2nd vaccination of COVID series given 3/12/21 (first given 2/19/21), and patient come to emergency department on 5/24/21 with "two days of light headedness, chest pain, shortness of breath, and palpitations" however states that has had this previously. This has since resolved and underwent a cardiac work-up with preexisting cardiac stents, ruled out acute cardiac event though noted with new palpitations that was medically managed.
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| 2841978 | 11 | M | NY | 05/21/2025 |
HPV9 MNQ |
MERCK & CO. INC. SANOFI PASTEUR |
7KD5B U8369BA |
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
More
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Dose was administered inadvertently 18 days after the 1st dose of Menquadfi and 2nd dose of the HPV ...
Dose was administered inadvertently 18 days after the 1st dose of Menquadfi and 2nd dose of the HPV was given. The pharmaceutical companies were contacted. There hasn't been any reported adverse events at the time this report is made
More
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| 2841979 | 32 | F | WI | 05/21/2025 |
VARCEL |
MERCK & CO. INC. |
Y004555 |
Herpes zoster, Rash
Herpes zoster, Rash
|
Shingles appearing rash to chest. Given valtrex and oral steroids
Shingles appearing rash to chest. Given valtrex and oral steroids
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| 2841980 | 12 | F | PA | 05/21/2025 |
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 |
FDP00595 FDP00595 FDP00595 FDP00595 FDP00595 |
Antinuclear antibody negative, Balance disorder, Blood creatine phosphokinase no...
Antinuclear antibody negative, Balance disorder, Blood creatine phosphokinase normal, C-reactive protein normal, Decreased vibratory sense; Differential white blood cell count normal, Exercise tolerance decreased, Full blood count normal, Gait disturbance, Genetic testing; Glycosylated haemoglobin normal, Limb discomfort, Loss of personal independence in daily activities, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal; Metabolic function test normal, Muscular weakness, Pain in extremity, Red blood cell sedimentation rate normal, Reflex test normal; Thyroid function test normal, Urine analysis normal
More
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Patient was revaccinated on 3/20 with RIG due to not receiving RIG on 3/19 at R calf (site of scratc...
Patient was revaccinated on 3/20 with RIG due to not receiving RIG on 3/19 at R calf (site of scratch from fox's tooth). Received 2nd dose of Rabies vaccine on 3/22, and 3rd rabies vaccine on 3/26/25. 4th shot on 4/2/25. On 3/31 started with bilateral leg weakness and reported inability to run. Legs felt achy and off blance. On 4/17 unable to participate in a fire drill due to leg pain and weakness. Due to ongoing symptoms was seen in the ED on 4/25 where she was noted to have more of an antalgic gait rather than weakness and intact/full strength bilaterally that became limited due to discomfort. Reflexes were intact and symmetric. Mild vibration sense deficiet distally noted in toe compared to ankle. MRI of entire spine and brain was unremarkable. Admitted to the hospital from 4/25-4/28 and during this time retained full strength. Genetic testing was obtained due to concerns for possible CMT. Abnormal gait not sugestive of weakness or cerebellar abnormalities but appeared to be more functional as she showed improvement on repetition.
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| 2841981 | 52 | F | MA | 05/21/2025 |
PNC20 VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
LX4484 93N4J |
Rash, Rash erythematous, Rash pruritic; Rash, Rash erythematous, Rash pruritic
Rash, Rash erythematous, Rash pruritic; Rash, Rash erythematous, Rash pruritic
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Patient seen 5/16 (4 days after vaccines administered) started noticing rash to her left upper arm ...
Patient seen 5/16 (4 days after vaccines administered) started noticing rash to her left upper arm 5/13. Notes rash is progressively worsening. The affected area is on her left shoulder, characterized by redness, induration, and pain, described as itchy and similar to the sensation of being hit. This is the first time she has experienced such a reaction to a vaccine, although she had a mild reaction to the second COVID vaccine, which was not as severe. She has previously received the shingles vaccine without any issues.
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| 2841982 | 87 | F | MO | 05/21/2025 |
PNC21 TDAP |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
y019157 eb499 |
Injection site swelling; Injection site swelling
Injection site swelling; Injection site swelling
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Patient called the pharmacy the day after receiving the vaccines. Patient stated their right arm (w...
Patient called the pharmacy the day after receiving the vaccines. Patient stated their right arm (where patient received Capvaxive vaccine) has a "swollen goose egg" where the vaccine was given. Patient states the swelling started a few hours after getting the vaccine.
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| 2841983 | 49 | F | OH | 05/21/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
|
Hypoaesthesia, Paraesthesia, Vaccination site mass
Hypoaesthesia, Paraesthesia, Vaccination site mass
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there is a lump at the vaccination site and my left hand pinky and ring fingers have been numb and t...
there is a lump at the vaccination site and my left hand pinky and ring fingers have been numb and tingling since the vaccination. No treatment has been sought yet.
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| 2841984 | 60 | F | 05/21/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
332L4 |
Feeling cold, Pain
Feeling cold, Pain
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patient described full body hurting, especially her left shoulder and chilling beginning roughly 8 h...
patient described full body hurting, especially her left shoulder and chilling beginning roughly 8 hours after injection.
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| 2841985 | 68 | M | NC | 05/21/2025 |
RSV RSV |
PFIZER\WYETH PFIZER\WYETH |
LL8398 LL8398 |
Antinuclear antibody negative, Antinuclear antibody positive, Arthralgia, Immuno...
Antinuclear antibody negative, Antinuclear antibody positive, Arthralgia, Immunoassay, Muscular weakness; Parvovirus B19 test negative, Spinal pain
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Within 2 hours of receiving RSV vaccine began having R shoulder and cervical spine sharp/arthritic p...
Within 2 hours of receiving RSV vaccine began having R shoulder and cervical spine sharp/arthritic pain that worsened in severity over the day. Awoke next morning with R arm weakness, finally to the ER 5/9/25 where he was admitted for "possible vaccine related acute arthritis". Given IV steroids, transitioned to oral steroids prior to discharge when symptoms drastically improved, walking independently in hall.
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| 2841986 | 0.17 | M | IN | 05/21/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
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Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Patient received 2 month vaccine on 5-03-25 prior to being released from hospital and was given the ...
Patient received 2 month vaccine on 5-03-25 prior to being released from hospital and was given the same vaccines in office again 5-16-25
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| 2841987 | 22 | M | MN | 05/21/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
LM2216 AW3227A |
Dizziness, Loss of consciousness, Syncope; Dizziness, Loss of consciousness, Syn...
Dizziness, Loss of consciousness, Syncope; Dizziness, Loss of consciousness, Syncope
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Prior to the vaccination, the patient stated that he sometimes gets lightheaded after vaccinations. ...
Prior to the vaccination, the patient stated that he sometimes gets lightheaded after vaccinations. At approximately 2:45pm, the patient received both the covid and the flu vaccination. After the vaccination, the patient fainted while sitting in the chair and was assisted to the floor. He appeared to lose consciousness for around 30 seconds. At 2:50pm, he regained consciousness, with a BP of 120/68. At 3:00pm, his BP was 110/70. Nurse continued to monitor patient, as he drank some apple juice and water, and sat down for 15 additional minutes. After resting, patient stated he was "feeling fine".
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| 2841988 | 1.08 | M | WA | 05/21/2025 |
HEPA MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
A3X2K Y004115 Y014181 |
Electroencephalogram, Febrile convulsion; Electroencephalogram, Febrile convulsi...
Electroencephalogram, Febrile convulsion; Electroencephalogram, Febrile convulsion; Electroencephalogram, Febrile convulsion
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complex febrile seizure on 5/16/2025. seizure lasted 20 minutes
complex febrile seizure on 5/16/2025. seizure lasted 20 minutes
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| 2841989 | 66 | M | CA | 05/21/2025 |
COVID19 |
PFIZER\BIONTECH |
LP1776 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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expired BioEntech vaccine 04/26/2025 given on 05/20/2025. Ni ill effects described at the time of ad...
expired BioEntech vaccine 04/26/2025 given on 05/20/2025. Ni ill effects described at the time of administration
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| 2841990 | 62 | M | 05/21/2025 |
HEP HEPA |
DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS |
|
Arthralgia, Myalgia; Arthralgia, Myalgia
Arthralgia, Myalgia; Arthralgia, Myalgia
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Muscle and joint soreness in the arm/shoulder
Muscle and joint soreness in the arm/shoulder
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| 2841991 | 57 | F | CA | 05/21/2025 |
COVID19 |
MODERNA |
3044069 |
Chills, Headache
Chills, Headache
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Chills and Headache
Chills and Headache
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| 2841992 | 0.17 | M | PA | 05/21/2025 |
DTAPHEPBIP HIBV PNC20 RV1 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
9P329 2Z9F7 HN2630 32PF3 |
Sudden death; Sudden death; Sudden death; Sudden death
Sudden death; Sudden death; Sudden death; Sudden death
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sudden death within 24 hours
sudden death within 24 hours
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| 2841993 | 43 | F | WA | 05/21/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
039021A 039021A |
Antinuclear antibody, C-reactive protein, Differential white blood cell count, F...
Antinuclear antibody, C-reactive protein, Differential white blood cell count, Fatigue, Full blood count; Pain, Paraesthesia, Rash, Red blood cell sedimentation rate, Urticaria
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With a few days I started having pins and needles in my thighs and round me hips. After about a wee...
With a few days I started having pins and needles in my thighs and round me hips. After about a week of feeling it, I broke out in hives/rash, which was diagnosed by my primary doctor as shingles on 10/15/2025. Since there I have developed multiple health issues. Today I struggle with chronic fatigue, and constant body pains. Even laying down to sleep is painful
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| 2841994 | 72 | F | WI | 05/21/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
PJ353 |
Abdominal pain upper, Chills, Nausea, Pyrexia
Abdominal pain upper, Chills, Nausea, Pyrexia
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NAUSEA, STOMACH PAIN, FEVER, CHILLS
NAUSEA, STOMACH PAIN, FEVER, CHILLS
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| 2841995 | 78 | F | MA | 05/21/2025 |
PNC21 |
MERCK & CO. INC. |
Y019157 |
Pruritus, Skin warm
Pruritus, Skin warm
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ITCHY AND WARM TO THE TOUCH.
ITCHY AND WARM TO THE TOUCH.
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| 2841997 | 34 | F | WA | 05/21/2025 |
HEPA HEPA |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Chills, Constipation, Diarrhoea, Headache, Pyrexia; Vomiting
Chills, Constipation, Diarrhoea, Headache, Pyrexia; Vomiting
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SEVERE vomiting, fever, chills, constipation with diarrhea, pounding headache
SEVERE vomiting, fever, chills, constipation with diarrhea, pounding headache
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| 2841998 | 58 | F | 05/21/2025 |
PNC21 TDAP VARZOS |
MERCK & CO. INC. SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
Y019158 U8232AA F95YS |
Paraesthesia; Paraesthesia; Paraesthesia
Paraesthesia; Paraesthesia; Paraesthesia
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Patient received Adacel, Capvaxive, and 1st dose of Shingrix. Within about 2 minutes of completing v...
Patient received Adacel, Capvaxive, and 1st dose of Shingrix. Within about 2 minutes of completing vaccine administration, patient complained of severe sharp pain in her back. She sat on the bench for a few minutes outside of the pharmacy. We took her blood pressure and pulse and those numbers appeared normal. Patient complained of no swelling or trouble breathing. She said her lips and cheeks were a little "tingly". Patient remained seated on the bench by the pharmacy for about 30 minutes. Her back pain significantly improved. She did say her lips still felt "tingly". Recommended patient to get otc benadryl to help with possible allergic reaction. Gave the patient 2 tablets of ibuprofen from my personal bottle. Patient left with her husband. Told them to go to ER if patient has trouble breathing.
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| 2841999 | 51 | F | MD | 05/21/2025 |
UNK |
UNKNOWN MANUFACTURER |
Y019158 |
Fatigue, Headache, Injection site irritation, Pain, Pyrexia
Fatigue, Headache, Injection site irritation, Pain, Pyrexia
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received Capvaxive vaccine and developed fever, body aches, irritation at injection, physical exhaus...
received Capvaxive vaccine and developed fever, body aches, irritation at injection, physical exhaustion, headache the evening after she got the vaccine.
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| 2842000 | 46 | F | WA | 05/21/2025 |
COVID19 |
PFIZER\BIONTECH |
MD3414 |
Chest pain, Oedema peripheral, Pain
Chest pain, Oedema peripheral, Pain
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Starting 5/20/25 evening: - Intermittent chest pain Shooting Pain - Radiates from her right side to ...
Starting 5/20/25 evening: - Intermittent chest pain Shooting Pain - Radiates from her right side to her left side Swelling - Significant swelling in her armpits treating with: tylenol and ibuprofen - minimal relief
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| 2842001 | 4 | F | OK | 05/21/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
Y49BZ |
Peripheral swelling
Peripheral swelling
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Localized swelling with induration approximately 15cm x 14cm right thigh started 24hrs after vaccina...
Localized swelling with induration approximately 15cm x 14cm right thigh started 24hrs after vaccination. Started as quarter sized & enlarged to triple size over night.
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| 2842002 | 68 | F | CA | 05/21/2025 |
PNC20 RSV |
PFIZER\WYETH PFIZER\WYETH |
LC1279 LN5487 |
Intraocular pressure increased; Intraocular pressure increased
Intraocular pressure increased; Intraocular pressure increased
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A patient reported experiencing an increase in eye pressure, describing the sensation as if her eyes...
A patient reported experiencing an increase in eye pressure, describing the sensation as if her eyes were "popping out." She sought medical attention and was prescribed multipe eye drops to alleviate the pressure. While the exact timeline was unclear, the patient began her eye drop prescription approximately two months after receiving her vaccination. The patient beliees her eye issues are linked to receiving two vaccines simultaneously, caliming that pharmacist "forced" or "promoted" her to get both at the same time. 12/30/2024 simbrinza 02/18/2025 latanoprost, dorzolamide 04/15/2025 loteprednol 05/02/2025 brimonidine
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| 2842003 | 75 | F | DC | 05/21/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
MG5S9 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient is not experiencing any adverse effects
Patient is not experiencing any adverse effects
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| 2842004 | 0.58 | M | MD | 05/21/2025 |
DTPPVHBHPB PNC20 RV5 |
MSP VACCINE COMPANY PFIZER\WYETH MERCK & CO. INC. |
UU7788AA LN4929 Y014320 |
Eye movement disorder, Hyporesponsive to stimuli, Immediate post-injection react...
Eye movement disorder, Hyporesponsive to stimuli, Immediate post-injection reaction, Pallor, Respiratory arrest; Eye movement disorder, Hyporesponsive to stimuli, Immediate post-injection reaction, Pallor, Respiratory arrest; Eye movement disorder, Hyporesponsive to stimuli, Immediate post-injection reaction, Pallor, Respiratory arrest
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Child had an episode immediately following vaccinations consisting of decreased responsiveness, pall...
Child had an episode immediately following vaccinations consisting of decreased responsiveness, pallor, "eyes rolled back". Mom reported "not breathing". Mom reported episode lasted 10 seconds, MA reported a few seconds.
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