| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2856914 | F | 09/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective, Headache
COVID-19, Drug ineffective, Headache
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This is her 5th battle with Covid in the past 2 years despite having original vaccinations; This is ...
This is her 5th battle with Covid in the past 2 years despite having original vaccinations; This is her 5th battle with Covid in the past 2 years despite having original vaccinations; Today is the ninth day of this bout and is still experiencing a bad headache; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "This is her 5th battle with Covid in the past 2 years despite having original vaccinations"; HEADACHE (non-serious), outcome "unknown", described as "Today is the ninth day of this bout and is still experiencing a bad headache". Therapeutic measures were taken as a result of covid-19, drug ineffective. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. Clinical Course: The reporter expressed sincere gratitude for the generous help in providing Paxlovid for their daughter. The daughter had experienced her fifth episode of COVID 19 in the past two years despite having received the original vaccinations. On the ninth day of this bout, she was still experiencing a severe headache.The reporter inquired about any nearby studies on long term COVID or emotional support for her. This was considered a potential adverse event report for a non phone case.
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| 2856915 | 09/04/2025 |
UNK |
UNKNOWN MANUFACTURER |
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No adverse event, Syringe issue
No adverse event, Syringe issue
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syringe malfunction/tip of syringe broke off when it was tapped with a pen to get the air bubble out...
syringe malfunction/tip of syringe broke off when it was tapped with a pen to get the air bubble out; syringe malfunction/tip of syringe broke off when it was tapped with a pen to get the air bubble out; A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER BLINDED TRIAL This is a Pfizer sponsored interventional study report for protocol. A patient (age and gender not provided) was scheduled to receive investigational study product. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MALFUNCTION (non-serious), SYRINGE ISSUE (non-serious), outcome "unknown" and all described as "syringe malfunction/tip of syringe broke off when it was tapped with a pen to get the air bubble out". Additional Information: The investigational product syringe sat for 15 minutes followed by preparation of syringe. The tip of syringe broke off when it was tapped with a pen to get the air bubble out. The patient did not receive a dose with the damaged prefilled syringe of the investigational product. The patient was able to successfully get another dose from a replacement kit. Product Quality Group provided investigational results on 29Aug2023 for investigational product: The PFS that resulted in the complaint was not returned for evaluation. The photo provided has been examined to provide a possible root cause for the investigation. The root cause is assigned as Non-assignable. There was no adverse event. There was no impact to dosing as a replacement kit was used to provide the dose. There is no change to the quality release status for this packaged lot. This observation will be monitored for tracking and trending purposes through the complaint process. The complaint is confirmed, and the root cause is assigned as Non-assignable. The pre-filled syringe (PFS) that resulted in the complaint was not returned for evaluation. There was a photo provided showing the syringe broken by the tip area. The IP Manual instructions address correct preparation steps. The risk files have considered the hazard situation associated, risk control measures and verification of implementation and effectiveness are in place and risk level after post-mitigation is of "low". Therefore, no further actions are required. The blind has been broken for Protocol due to end of study unblinding. The patient was randomized to receive PF-07307405. The investigator considered there was not a reasonable possibility that the event "syringe malfunction/tip of syringe broke off when it was tapped with a pen to get the air bubble out" was related to PF-07307405, solution for injection. It is unknown if the event "syringe malfunction/tip of syringe broke off when it was tapped with a pen to get the air bubble out" was related to clinical trial procedure. No follow up attempts are possible. No further information is expected.
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| 2856916 | F | FL | 09/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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diagnosed with COVID; diagnosed with COVID; This is a spontaneous report received from a Consumer or...
diagnosed with COVID; diagnosed with COVID; This is a spontaneous report received from a Consumer or other non HCP. A 72-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 2022 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 Immunization; Bnt162b2 (dose 2), for COVID-19 Immunization; Bnt162b2 (dose 3 (booster)), for COVID-19 Immunization; Bnt162b2 (dose 4 (booster)), for COVID-19 Immunization; Bnt162b2 (dose 5 (booster)), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Sep2025, outcome "unknown" and all described as "diagnosed with COVID". Patient have been diagnosed with COVID this morning, and she's trying to see what medication would be covered under the plan that she have. Patient don't feel well and thought it happened as she have COVID. Patient had prescription for Paxlovid. Patient felt head is gonna explode. The patient had received all of the Pfizer COVID-19 vaccines, every single time there was a release. The patient believed she must have had around six shots by now and thought that such vaccination would render her basically immune. However, despite this, the patient still contracted COVID-19. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2856917 | F | CA | 09/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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COVID after Pfizer COVID shots/got sick; COVID after Pfizer COVID shots/got sick; This is a spontane...
COVID after Pfizer COVID shots/got sick; COVID after Pfizer COVID shots/got sick; This is a spontaneous report received from a Consumer or other non HCP. A 67-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization; Bnt162b2 (dose 2), for COVID-19 immunization; Bnt162b2 (dose number unknown (booster)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID after Pfizer COVID shots/got sick". Clinical course: The patient informed that she was prescribed the Paxlovid. She informed that she can't do anything online, (inaudible) was killing her. After hearing the consents, she informed that she was really confused on that. She didn't mind Pfizer having this stuff, she just have a problem with the government having her business. Pfizer, no problem, because she used a lot of Pfizer products, like the COVID, she definitely used only Pfizer. She had no problem with that. She didn't mind to research, cause she has done it for graft research. When asked if she had taken Paxlovid before, she informed, she has not. This was the first time they prescribed it to her. But during the pandemic, She had gotten the only Pfizer COVID shots and boosters. She has not used any other drug companies, like the other one, she can't remember the other company, but she always been with Pfizer because she didn't have any bad reaction with the first shot. So, she figured, let her stay with them and she has not had a problem until now. This was the first time, in this whole, like five years, that she has gotten COVID; no she never did. She had good luck with the Pfizer COVID shots and boosters. She has never had any problem. Everybody else has talked about how they got sick and you know with the reaction and she never got sick, never, never. Like the after, you know, the side effects, never had any of that. But the funny thing was, this weekend, she had planned to go get the booster and then she got sick. Now she was going to have to wait before she get the booster.
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| 2856918 | M | 09/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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Cardiac disorder, Tinnitus
Cardiac disorder, Tinnitus
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heart problem; ringing on his ear; This is a spontaneous report received from a Consumer or other no...
heart problem; ringing on his ear; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart problem"; TINNITUS (non-serious), outcome "unknown", described as "ringing on his ear". Additional information: The patient is angry because he was administered Covid-19 vaccine from Pfizer and was forced to do it by his employer and wondering how to undo the damage that the vaccine done to him. He got heart problem and ringing on his ear after he got the shot. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2856919 | CT | 09/04/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK341AA |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
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inappropriate use due to administering only the dtap-ipv component of the pentacel to a patient, wit...
inappropriate use due to administering only the dtap-ipv component of the pentacel to a patient, without reconstituting the act-hib component with no reported adverse event; Initial information received on 02-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who received only the DTAP-IPV component of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)], without reconstituting the ACT-HIB component with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Sep-2025, the patient received only the DTAP-IPV component of the Unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection of standard strength, frequency once with lot UK341AA and expiry date 31-Aug-2026 via unknown route in unknown administration site for immunization, without reconstituting the ACT-HIB component with no reported adverse event (single component of a two-component product administered) (Latency same day). Reportedly, Reporter stated that one of the nurses administered pentacel to a patient, but they did not make the two vials. The nurse only administered the DTaP and IPV component, and not the Hib component. 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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| 2856920 | 1.17 | F | TX | 09/04/2025 |
HIBV |
SANOFI PASTEUR |
UK231AA |
No adverse event, Product preparation error
No adverse event, Product preparation error
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staff used sterile water to dilute ACT-HIB and administered it to a patient with no reported adverse...
staff used sterile water to dilute ACT-HIB and administered it to a patient with no reported adverse event; Initial information received on 02-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 14 months old female patient who was administered HIB (PRP/T) vaccine [ACT-HIB] and staff used sterile water to dilute it 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 Hepatitis a vaccine, Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr), Pneumococcal vaccine and Varicella zoster vaccine all for prophylactic vaccination (Immunisation). On 26-Aug-2025, the patient received a dose of 0.5 ml (dose 4) of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (lot UK231AA and expiry date: 30-Jun-2026) (strength: standard and frequency: once) via intramuscular route in right vastus lateralis for immunisation and staff used sterile water to dilute it with no reported adverse event (product preparation error) (Latency: same day). 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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| 2856921 | 1.25 | F | NE | 09/04/2025 |
HIBV |
SANOFI PASTEUR |
UK306AA |
No adverse event, Product preparation error
No adverse event, Product preparation error
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inappropriate use due to act-hib being reconstituted with the incorrect diluent and administered to ...
inappropriate use due to act-hib being reconstituted with the incorrect diluent and administered to a patient with no reported adverse event; Initial information received on 02-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional (Live follow up processed together on the same day). This case involves a 15 months old female patient who had inappropriate use due to HIB (PRP/T) Vaccine [ACT-HIB] being reconstituted with the incorrect diluent and administered to a patient 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 Pneumococcal vaccine conj 7v (CRM197) (Prevnar) and Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Infanrix) for Immunisation. On 29-Aug-2025, the patient received a 0.5 ml (dose 1) dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (strength: Standard, frequency: once, expiry date: 31-Aug-2026 and lot UK306AA) via unknown route in the left thigh as Immunization and inappropriate use due to act-hib being reconstituted with the incorrect diluent and administered to a patient with no reported adverse event (product preparation error) (latency; same day).. Action taken: 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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| 2856922 | 32 | M | CA | 09/04/2025 |
UNK |
UNKNOWN MANUFACTURER |
406984 |
Gingival pain, Gingival swelling, Pain in extremity
Gingival pain, Gingival swelling, Pain in extremity
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Pain in arm; Gums start to swell; Gum start to hurt a lot; This spontaneous case, initially received...
Pain in arm; Gums start to swell; Gum start to hurt a lot; This spontaneous case, initially received on 30-Aug-2025, was reported by a non-health professional and concerns an adult male patient. Administration of company suspect drug: On 29-Aug-2025, the patient received Flucelvax (TIV) for active immunization for the prevention of influenza disease, Dose regimen: 0.5 ml, Route of administration: not reported, Anatomical location: Not reported, Lot number: 406984. No additional suspect drugs. Adverse reactions/events and outcomes: On 29-Aug-2025, the patient experienced Gums start to swell (outcome: Not Reported), Pain in arm (outcome: Not Reported), Gum start to hurt a lot (outcome: Not Reported). The consumer stated that there was pain in his arm for like an hour and then the next day his gums started to swell and hurt a lot. In the previous night of this report started to hurt a lot. He had been taking Advil and got stiff. He planned to see his dentist. Flucelvax (TIV) action taken: Not Applicable Flucelvax (TIV) dechallenge: Not applicable Treatment medication: Advil Reporter's assessment: The reporter (patient) did not provide a seriousness or causality assessment for events reported.; Reporter's Comments: Due to spontaneous nature of case events were assessed as related for reporting purpose
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| 2856924 | 56 | M | TX | 09/04/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
30135BA 30135BA 30145BA 30145BA |
Blood creatinine increased, Blood test, Dialysis, Nephrectomy, Renal cancer; Ren...
Blood creatinine increased, Blood test, Dialysis, Nephrectomy, Renal cancer; Renal failure, Renal mass, Ultrasound scan; Blood creatinine increased, Blood test, Dialysis, Nephrectomy, Renal cancer; Renal failure, Renal mass, Ultrasound scan
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After receiving the vaccine, I had a check up with my nephrologist and she informed me that my creat...
After receiving the vaccine, I had a check up with my nephrologist and she informed me that my creatinine levels had skyrocketed from 2.4 to 13. I was placed in the hospital and given dialysis that day. My left kidney stopped working all together. Later into the treatment my right kidney was removed due to a nodule growth and the pathology came back as kidney cancer.
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| 2856925 | 17 | F | CA | 09/04/2025 |
HIBV |
SANOFI PASTEUR |
UK107AB |
Wrong product administered
Wrong product administered
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Pt was not due for ActHIB and was accidentally given this instead of Menveo. No issues or concerns, ...
Pt was not due for ActHIB and was accidentally given this instead of Menveo. No issues or concerns, patient will be returning for re-vaccination of proper vaccine in 3 more weeks.
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| 2856926 | 57 | M | CO | 09/04/2025 |
VARCEL |
MERCK & CO. INC. |
x021930 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Administered an expired vaccine. No adverse reactions.
Administered an expired vaccine. No adverse reactions.
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| 2856935 | 9 | F | OR | 09/04/2025 |
FLU3 |
SANOFI PASTEUR |
UT8817KA |
Dizziness, Fall, Head injury, Hyperhidrosis
Dizziness, Fall, Head injury, Hyperhidrosis
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Patient received flu vaccine, then saw her younger sister get vaccinated. She and her family had lef...
Patient received flu vaccine, then saw her younger sister get vaccinated. She and her family had left the room and were walking behind this RN on the way to checkout desk. Patient fell into this RN and then onto the floor, hitting her head on the wall. This RN did not see her lose consciousness, and she was conscious when she hit the floor. Patient reported that she had felt dizzy and then fell. She was diaphoretic for a few minutes afterward. She sat on the floor, drank some water and put a cold pack on her forehead. After about five minutes, she said she felt better and stood up. She walked out of the clinic on her own, accompanied by her mother.
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| 2856936 | 35 | F | WA | 09/04/2025 |
DTAP DTAP |
SANOFI PASTEUR SANOFI PASTEUR |
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Chest pain, Dyspnoea, Electrocardiogram, Inflammation, Limb mass; Magnetic reson...
Chest pain, Dyspnoea, Electrocardiogram, Inflammation, Limb mass; Magnetic resonance imaging, Pain, Peripheral swelling, X-ray
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Received TDap injection in my left arm ( 8/11)and started to experience aches the following week. On...
Received TDap injection in my left arm ( 8/11)and started to experience aches the following week. On Friday morning 8/22 the aches turn into pain, swelling and a knot in my left arm. I went to see the on call provider and she prescribed me 2 medication, prednisone ( I didn?t take due to other medication) and a muscle relaxer. This did not help, it just made my body hurt worse. She also advised me to get an MRI of both arms. After my visit I stated to experience chest pain and shortness of breath, which led me to emergency room
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| 2856937 | 57 | M | NC | 09/04/2025 |
PNC20 |
PFIZER\WYETH |
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Injection site hypoaesthesia
Injection site hypoaesthesia
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Numbness around site of injection, Measuring 5.5cm by 3.5cm. This was first noticed about 1 week aft...
Numbness around site of injection, Measuring 5.5cm by 3.5cm. This was first noticed about 1 week after the injection. No pain, redness, swelling or fever. I accidentally noticed that the area on my deltoid has lost any ability to feel touch.
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| 2856938 | 68 | M | SC | 09/04/2025 |
MNQ |
SANOFI PASTEUR |
u8438aa |
Wrong product administered
Wrong product administered
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pt was administered the wrong vaccine-was suposed to be mmr
pt was administered the wrong vaccine-was suposed to be mmr
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| 2856939 | 40 | F | FL | 09/04/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
036A21A 036A21A 036A21A 017B21A 017B21A 017B21A |
Abdominal pain upper, Biopsy, Blood test, Colitis ulcerative, Colonoscopy abnorm...
Abdominal pain upper, Biopsy, Blood test, Colitis ulcerative, Colonoscopy abnormal; Henoch-Schonlein purpura, Hypoaesthesia, Pain in extremity, Psoriasis, Type 2 diabetes mellitus; Ultrasound liver; Abdominal pain upper, Biopsy, Blood test, Colitis ulcerative, Colonoscopy abnormal; Henoch-Schonlein purpura, Hypoaesthesia, Pain in extremity, Psoriasis, Type 2 diabetes mellitus; Ultrasound liver
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The left side of my body felt numb. I called my doctor and she told me to come in in the morning. Th...
The left side of my body felt numb. I called my doctor and she told me to come in in the morning. The next morning I saw a doctor and he didn't know what to do so he sent me home and said don't worry. Shortly after I started getting stomach pains which led to an emergency room visit and eventually a colonoscopy and a diagnosis of Ulceritive Colitis. I was put on a slew of different medications and treatments and still have pain to this day. Simultaneously my body erupted with Psoriasis all over and no amount of medication helped- to this day I'm trying yet another medication. I also was experiencing leg pains which turned into an outbreak all over my legs and a diagnosis of Henoch Schonlein Purpura Vasculitis. Then I was also diagnosed at a type 2 diabetic. All my symptoms and many diagnosis were within days, weeks and months of taking the covid vaccines. No other family members of mine have any of these diseases. I have been in incredible pain since and has been life altering for both me and my family.
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| 2856940 | 61 | F | 09/04/2025 |
COVID19 |
MODERNA |
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Fatigue, Feeling hot, Headache, Pain in extremity, Pyrexia
Fatigue, Feeling hot, Headache, Pain in extremity, Pyrexia
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Don?t know which one I got they checked and made sure I got a different one from the one I had last ...
Don?t know which one I got they checked and made sure I got a different one from the one I had last time. I have a fever of over 100. Headache, my face is hot. My arm is sore and I?m very tired.
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| 2856941 | 65 | M | GA | 09/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
bg5j4 |
Extra dose administered
Extra dose administered
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Patient received initial dose of RSV vaccine on 9/11/24 and incorrectly received a second dose on 9/...
Patient received initial dose of RSV vaccine on 9/11/24 and incorrectly received a second dose on 9/2/25
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| 2856942 | 81 | F | FL | 09/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
F4AC3 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient received an RSV vaccine ( Arexvy ) at the pharmacy and had no adverse event. It was discove...
Patient received an RSV vaccine ( Arexvy ) at the pharmacy and had no adverse event. It was discovered afterwards that the patient had already received the Arexvy vaccine on 10/13/2023 at a pharmacy in another state.
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| 2856943 | 81 | M | FL | 09/04/2025 |
FLU3 RSV |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
UT8781AA F4AC3 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
More
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Patient received an RSV vaccine ( Arexvy ) at the pharmacy and had no adverse event. It was discove...
Patient received an RSV vaccine ( Arexvy ) at the pharmacy and had no adverse event. It was discovered afterwards that the patient had already received the Arexvy vaccine on 10/13/2023 at a pharmacy elsewhere.
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| 2856944 | 45 | M | TN | 09/04/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Cardiac failure congestive, Confusional state, Depressed level of consciousness,...
Cardiac failure congestive, Confusional state, Depressed level of consciousness, Dizziness, Heart rate increased; Hyperhidrosis, Muscular weakness, Pericarditis
More
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A week after the first dose, my heart began to raise and beat fast, experienced confusion, lighthea...
A week after the first dose, my heart began to raise and beat fast, experienced confusion, lightheaded, weakness in legs, sweating and almost lost consciousness. 1 week after the second dose, I was admitted with congestion heart failure. Currently on heart medications
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| 2856945 | 19 | F | WA | 09/04/2025 |
VARCEL |
MERCK & CO. INC. |
Y011712 |
No adverse event, Product storage error
No adverse event, Product storage error
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Patient received a vaccine from a freezes whose temperature was out of range for 22 hours total dura...
Patient received a vaccine from a freezes whose temperature was out of range for 22 hours total duration. At max 10.85F. Called Merck manufacturer and they supported use without any concerns about viability and stability. Still wanted to report. Pt reports no adverse reactions.
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| 2856946 | 73 | M | CA | 09/04/2025 |
PNC20 |
PFIZER\WYETH |
LP4947 |
Atrial fibrillation, Blood magnesium decreased, Diarrhoea, Electrolyte imbalance
Atrial fibrillation, Blood magnesium decreased, Diarrhoea, Electrolyte imbalance
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Diarrhea the same evening which pt notes lasted 2 weeks. Resulting electrolyte imbalance triggered a...
Diarrhea the same evening which pt notes lasted 2 weeks. Resulting electrolyte imbalance triggered atrial fibrillation. Pt delayed his own medical care and did not seek care until over a month later, so unclear how much can be ascribed to the initial vaccine event.
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| 2856562 | 51 | F | FL | 09/03/2025 |
VARZOS VARZOS |
MERCK & CO. INC. MERCK & CO. INC. |
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Blister, Breast cancer stage III, Chemotherapy, Ear pain, Headache; Herpes zoste...
Blister, Breast cancer stage III, Chemotherapy, Ear pain, Headache; Herpes zoster, Radiotherapy
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she developed shingles (blisters broke out on Thursday 8/14/2025) and symptoms of a headache; Earach...
she developed shingles (blisters broke out on Thursday 8/14/2025) and symptoms of a headache; Earache in left ear; Diagnosed with stage 3 breast cancer; This spontaneous report was received from a Physician and refers to a 59-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included Anastrozole (reported as anastrovole), Irbesartan (reported as irvesarton), Calcium, Vitamin D and Vitamin K. On 06-May-2014, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (lot #, expiration date, strength, route of administration, anatomical location not provided) as shingles vaccination. On an unspecified date in November 2021, the patient was diagnosed with stage 3 breast cancer for which had unspecified chemotherapy and radiation (reported as medical history). On an unspecified date, the patient recovered from this event (reported as "no evidence of disease"). On 11-Aug-2025, the patient experienced Earache in left ear. On 14-Aug-2025 (also reported as Thursday), the patient developed shingles (blisters broke out with rash on forehead on left side and some above the hairline) with symptoms of headache. Therefore, the patient went to "teledoc" and was prescribed valacyclovir (VALTREX). At the reporting time, the outcome of Earache and shingles was unknown. The causal relationship between all the events and Zoster Vaccine Live (ZOSTAVAX) was not reported. Upon internal review, the event of stage 3 breast cancer was determined to be medically significant.
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| 2856563 | NY | 09/03/2025 |
VARCEL |
MERCK & CO. INC. |
Y013349 |
No adverse event, Product storage error
No adverse event, Product storage error
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No adverse reactions reported associated to any of the administrations of either VARIVAX or PROQUAD ...
No adverse reactions reported associated to any of the administrations of either VARIVAX or PROQUAD to any of the patients involved./No additional AE; HCP called to report TE occurring on 6/20/2025 for VARIVAX and PROQUAD that were administered on multiple different dates to multiple patients.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 25-Jun-2025, the patient was vaccinated with improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) solution for injection, 0.5 ml, lot #Y013349, expiration date: 02-Aug-2026 (dose number, route of administration and anatomical location were not reported), for prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) solution for injection (expiration date, and lot # were not reported). On 20-Jun-2025, the vaccine underwent a temperature excursion of ๏ฟฝ 10 up to 8 (-4.76) Celsius (C) degrees for 30 minutes. There were no previous excursions. No additional adverse event was reported. The action taken with Varicella Virus Vaccine Live (Oka-Merck) and sterile diluent (Hollister-Stier STERILE DILUENT) was considered as not applicable.; Reporter's Comments: Keywords: MUL
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| 2856564 | 09/03/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Pain in extremity
Pain in extremity
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Arm slightly sore the next day; This non-serious case was reported by a consumer via interactive dig...
Arm slightly sore the next day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, 1 day after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: Arm slightly sore the next day). The outcome of the pain in arm was not reported. It was unknown if the reporter considered the pain in arm to be related to RSV vaccine. It was unknown if the company considered the pain in arm to be related to RSV vaccine. Additional Information: GSK Receipt Date: 28-AUG-2025 This case was reported by a patient via interactive digital media. The patient's arm was slightly sore the next day of vaccination.
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| 2856565 | F | 09/03/2025 |
COVID19 |
MODERNA |
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Multiple sclerosis
Multiple sclerosis
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multiple sclerosis/autoimmune disease; This spontaneous case was reported by a consumer and describe...
multiple sclerosis/autoimmune disease; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (multiple sclerosis/autoimmune disease) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS (multiple sclerosis/autoimmune disease) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS (multiple sclerosis/autoimmune disease) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
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| 2856578 | 21 | M | 09/03/2025 |
ANTH |
EMERGENT BIOSOLUTIONS |
300216A |
Dizziness, Hyperhidrosis, Loss of consciousness, Pallor, Syncope
Dizziness, Hyperhidrosis, Loss of consciousness, Pallor, Syncope
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As he was walking after the vaccination, he started feeling dizzy and he fainted 10 minutes after va...
As he was walking after the vaccination, he started feeling dizzy and he fainted 10 minutes after vaccination. He became conscious right away but he was pale and sweating. His legs elevated and iced on the neck, and his vital was stable.
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| 2856579 | 43 | M | NY | 09/03/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EV8264 EV8264 EV8264 EL9809 EL9809 EL9809 |
Angiogram, Blood test, Cardiac failure chronic, Chemotherapy, Computerised tomog...
Angiogram, Blood test, Cardiac failure chronic, Chemotherapy, Computerised tomogram; Condition aggravated, Ejection fraction decreased, Food allergy, International normalised ratio increased, Magnetic resonance imaging; Plasma cell myeloma, Pulmonary thrombosis, Transient ischaemic attack; Angiogram, Blood test, Cardiac failure chronic, Chemotherapy, Computerised tomogram; Condition aggravated, Ejection fraction decreased, Food allergy, International normalised ratio increased, Magnetic resonance imaging; Plasma cell myeloma, Pulmonary thrombosis, Transient ischaemic attack
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Marc 30 3021 admitted to Hosp stdgec4 congestive heart failure with 70 clots in lungs. Put on Coumad...
Marc 30 3021 admitted to Hosp stdgec4 congestive heart failure with 70 clots in lungs. Put on Coumadin a week later IN the evening timesuffered TIA with a 2.7 INR PER THE DR who called that morning to discuss blood tests results. Diagnosed with an ejection fraction of 20. A week after that followed up with hemotologist do discuss how did he have a stroke while on Coumadin he informed us that I had multiple myeloma was then treated at MSK 6 months of chemo treatment then stem cell transplant. Multiple myeloma is a incurable cancer and I?m required to take chemo everyday amongst dozens of other medications
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| 2856587 | 09/03/2025 |
MMR |
MERCK & CO. INC. |
Y017208 |
Product contamination physical
Product contamination physical
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While drawing up the MMRV (ProQuad), a tiny piece of something silver was noticed to be floating aro...
While drawing up the MMRV (ProQuad), a tiny piece of something silver was noticed to be floating around in vial after sterile diluent was combined. This is the second vaccine noticed to have the same foreign piece in it. Measles, Mumps, Rubella and Varicella Virus Vaccine Live ProQuad NDC: 000647101 LOT: Y017208 Expiration: 04/13/2026.
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| 2856588 | F | 09/03/2025 |
JEV1 |
INTERCELL AG |
JEV23M11E |
Product label issue, Underdose
Product label issue, Underdose
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Between the dates 7/24/25 and 8/13/25 there were twenty Japanese Encephalitis vaccine shots given wi...
Between the dates 7/24/25 and 8/13/25 there were twenty Japanese Encephalitis vaccine shots given with a pediatric dose (0.25ml) to adults. This medication error was discovered when a nurse was reviewing the preparation steps for the vaccine, and it was realized that the technician was following the preparation steps to administer a pediatric dose and not the adult dose. The (withheld) Health Agency was contacted for guidance on the steps forward. We were advised to have the members come back to the clinic to receive the adult dose in order to be properly protected. There were two major contributions to the error: 1. Manufacturer inserts only included pictures for pediatric dose preparation and so it was easy to overlook the fine print for adult administration. 2. There are no markings on the syringe to indicate what volume of the vaccine is being administered. The pediatric dose is indicated at the red line, but there is no way to actually confirm the amount of liquid in the syringe being given.
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| 2856589 | CA | 09/03/2025 |
PNC20 |
PFIZER\WYETH |
LN4929 |
Product container issue, Underdose
Product container issue, Underdose
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Prevnar 20 medication bag was leaving prior to administration. Patient did not receive full dose of ...
Prevnar 20 medication bag was leaving prior to administration. Patient did not receive full dose of medication.
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| 2856628 | LA | 09/03/2025 |
HEP HEP HEP HEP |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y007989 |
Extra dose administered, Inappropriate schedule of product administration, No ad...
Extra dose administered, Inappropriate schedule of product administration, No adverse event; Extra dose administered, Inappropriate schedule of product administration, No adverse event; Extra dose administered, Inappropriate schedule of product administration, No adverse event; Extra dose administered, Inappropriate schedule of product administration, No adverse event
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No reported side effects.; Caller also stated the 3rd dose was administered late; 2 year old child w...
No reported side effects.; Caller also stated the 3rd dose was administered late; 2 year old child was administered an additional dose of RECOMBIVAX HB; This spontaneous report was received from a nurse and refers to a 2-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), Suspension for injection, dose number 1, (lot # and expiration date, route of administration and anatomical location were not reported) for prophylaxis. On an unknown date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), Suspension for injection, dose number 2, (lot # and expiration date, route of administration and anatomical location were not reported) for prophylaxis. On an unknown date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), Suspension for injection, dose number 3, (lot # and expiration date, route of administration and anatomical location were not reported) for prophylaxis and that dose was administered late (Inappropriate schedule of vaccine administered). On 11-AUG-2025, the patient was vaccinated with additional dose of Hepatitis B Vaccine (Recombinant) Suspension for injection (RECOMBIVAX HB) (lot #Y007989 was valid for formulation pre-filled syringe, expiration date: 06-DEC-2026, dose number 4, route of administration and anatomical location were not reported) for prophylaxis (Extra dose administered). No additional information to report. No reported side effects (No adverse event). No product quality complaint (PQC).
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| 2856629 | NY | 09/03/2025 |
VARCEL |
MERCK & CO. INC. |
Y013349 |
No adverse event, Product storage error
No adverse event, Product storage error
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No adverse reactions reported associated to any of the administrations of either VARIVAX or PROQUAD ...
No adverse reactions reported associated to any of the administrations of either VARIVAX or PROQUAD to any of the patients involved./No additional AE; HCP called to report TE occurring on 6/20/2025 for VARIVAX and PROQUAD that were administered on multiple different dates to multiple patients.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 06-Aug-2025, the patient was vaccinated with improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) solution for injection, 0.5 ml, lot #Y013349, expiration date: 02-Aug-2026 (dose number, route of administration and anatomical location were not reported), for prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) solution for injection (expiration date, and lot # were not reported). On 20-Jun-2025, the vaccine underwent a temperature excursion of ๏ฟฝ 10 up to 8 (-4.76) Celsius (C) degrees for 30 minutes. There were no previous excursions. No additional adverse event was reported. The action taken with Varicella Virus Vaccine Live (Oka-Merck) and sterile diluent (Hollister-Stier STERILE DILUENT) was considered as not applicable. This is one of several reports from the same reporter.; Reporter's Comments: Keywords : MUL
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| 2856630 | M | NJ | 09/03/2025 |
PNC21 |
MERCK & CO. INC. |
2006889 |
Fatigue, Headache, Pain in extremity, Sleep disorder
Fatigue, Headache, Pain in extremity, Sleep disorder
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Received from the AE Self-Service Portal: Report submitted by Merck Employee Headache, sore arm, an...
Received from the AE Self-Service Portal: Report submitted by Merck Employee Headache, sore arm, and fatigue following shot administration. Arm pain led to sleep interruption. Case assigned/processed by agent on 8/27/2025. No additional AE/ N; sore arm; fatigue; Arm pain led to sleep interruption; This spontaneous report was received from 54-year-old male patient referring to himself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (invalid lot #2006889, expiration date: 26-Sep-2026), dose reported as 1 shot for prophylaxis. On 26-Aug-2025, the patient experienced headache, sore arm (pain in extremity), and fatigue following shot administration. Arm pain led to sleep interruption (sleep disorder). At the reporting time, the outcome of the events was not reported The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) regarding the events was not applicable. The causal relationship between the events and the suspect vaccine was not reported.
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| 2856633 | 54 | F | IL | 09/03/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Brain fog, Fatigue, Influenza like illness, Insomnia, Malaise; Muscular weakness
Brain fog, Fatigue, Influenza like illness, Insomnia, Malaise; Muscular weakness
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covid like symptoms; Flu like symptoms; Brain fog; severe muscle weakness; inability to sleep; fatig...
covid like symptoms; Flu like symptoms; Brain fog; severe muscle weakness; inability to sleep; fatigue; knocked her off her feet; This non-serious case was reported by a consumer via call center representative and described the occurrence of covid-19 in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included long covid-19 (Long COVID). Family history included atrial fibrillation (both her mother and brother were diagnosed with atrial fibrillation after vaccination with their third COVID vaccine). On 27-MAR-2025, the patient received the 1st dose of Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced covid-19 (Verbatim: covid like symptoms), influenza-like symptoms (Verbatim: Flu like symptoms), brain fog (Verbatim: Brain fog), muscle weakness (Verbatim: severe muscle weakness), sleeplessness (Verbatim: inability to sleep), fatigue (Verbatim: fatigue) and feeling abnormal (Verbatim: knocked her off her feet). The outcome of the covid-19, influenza-like symptoms, brain fog, muscle weakness, sleeplessness, fatigue and feeling abnormal were resolved. It was unknown if the reporter considered the covid-19, influenza-like symptoms, brain fog, muscle weakness, sleeplessness, fatigue and feeling abnormal to be related to Shingrix. It was unknown if the company considered the covid-19, influenza-like symptoms, brain fog, muscle weakness, sleeplessness, fatigue and feeling abnormal to be related to Shingrix. Additional Information: GSK Receipt Date: 04-AUG-2025 The consumer was the reporter. The reporter stated that she was vaccinated in her right arm with her first dose of Shingrix on 27th March 2025. The consumer states she developed covid like symptoms, inability to sleep, fatigue, severe muscle weakness, and brain fog all lasting 6-8 weeks. The consumer reported the adverse events post vaccination with SHINGRIX knocked her off her feet for a few weeks. The reporter stated she had a diagnosis of long Covid. The consumer reported that occupation as an equine massage therapist and she works with approximately 85 to 100 horses per week. The reporter stated she was physically fit and did lift weights. At the gym it was noted after having the Shingrix vaccination she could only lift half of the weight she was lifting prior to the vaccination. The consumer stated when she was experiencing Covid like symptoms post vaccination with Shingrix she did self-administer two COVID tests, both had negative results. The consumer did report both her mother and brother were diagnosed with atrial fibrillation after vaccination with their third Covid vaccine. No further information was provided/obtained.
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| 2856634 | F | CA | 09/03/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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given Twinrix as dose number one in the series Then the doctor gave me a different vaccine for Hep B...
given Twinrix as dose number one in the series Then the doctor gave me a different vaccine for Hep B only as the second dose; 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 female patient who did not receive HAB (Twinrix) for prophylaxis. Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix). On an unknown date, the patient did not receive the 2nd dose of Twinrix. The patient had incomplete course of vaccination (Verbatim: given Twinrix as dose number one in the series Then the doctor gave me a different vaccine for Hep B only as the second dose). 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: 04-AUG-2025 The patient self-reported this case. The patient was unwilling to give many details during the call due to was given Twinrix as dose number one in the series and then the doctor gave her a different vaccine for Hepatitis B only as the second dose of the series. Till the time of reporting, the patient did not receive 2nd dose of Twinrix (Hepatitis A antigen), which led to incomplete course of vaccination.
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| 2856635 | IN | 09/03/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
UNK |
Injection site erythema
Injection site erythema
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possible redness at the injection site; possible swelling at the injection site; This non-serious ca...
possible redness at the injection site; possible swelling at the injection site; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On 29-JUL-2025, the patient received Menveo. On 01-AUG-2025, 3 days after receiving Menveo, the patient experienced injection site erythema (Verbatim: possible redness at the injection site) and injection site swelling (Verbatim: possible swelling at the injection site). The outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Menveo. It was unknown if the company considered the injection site erythema and injection site swelling to be related to Menveo. Additional Information: GSK receipt date: 08-AUG-2025 The pharmacy buyer called to report about a potential reaction following a Menveo vaccination. She mentioned possible redness and swelling at the injection site; Sender's Comments: US-GSK-US2025102722:Diffrent patient
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| 2856636 | M | CO | 09/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
4zs72 |
Product container issue, Skin laceration
Product container issue, Skin laceration
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cut finger/sliced the thumb with the glass; Syringe issue; Product complaint; This non-serious case ...
cut finger/sliced the thumb with the glass; Syringe issue; Product complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of laceration of finger in a male patient who received Herpes zoster (Shingrix) (batch number 4zs72, expiry date 26-APR-2025) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced laceration of finger (Verbatim: cut finger/sliced the thumb with the glass), syringe issue (Verbatim: Syringe issue) and pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the laceration of finger, syringe issue and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the syringe issue to be related to Shingrix. It was unknown if the company considered the syringe issue to be related to Shingrix. Additional Information: GSK receipt date: 08-AUG-2025 This Product Quality complaint was regarding Shingrix. Other HCP was giving Shingrix vaccines at pharmacy day before reporting and went to pop the top plastic cap off and the neck of the vial broke and shattered the glass. Reporter would like to see if they can get a replacement diluent for the Shingrix vaccine.
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| 2856637 | 18 | F | MN | 09/03/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
7MH25 |
Incorrect dose administered
Incorrect dose administered
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Engeirx-B adult dose administration in a 18-year-old patient; Overdose; This non-serious case was re...
Engeirx-B adult dose administration in a 18-year-old patient; Overdose; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 18-year-old female patient who received HBV (Engerix B adult) (batch number 7MH25, expiry date 07-DEC-2025) for prophylaxis. On an unknown date, the patient received Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: Engeirx-B adult dose administration in a 18-year-old patient) and overdose (Verbatim: Overdose). The outcome of the adult product administered to child and overdose 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: 14-AUG-2025 A nurse wanted to get safety information and want to know if there was any concern that they should inform the family. After one of her patients aged 18 received an adult dose of Engerix-B, which led to adult product administered to child and overdose. The vaccine administration facility was the same as primary reporter.
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| 2856638 | 21 | F | PA | 09/03/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
UNK |
Injection site erythema, Injection site pain, Injection site swelling, Injection...
Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
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pain around the injection site; swelling around the injection site; Injection site warmth; redness a...
pain around the injection site; swelling around the injection site; Injection site warmth; redness around the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 21-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. On 12-AUG-2025 18:30, the patient received Bexsero (intramuscular, left deltoid). On 13-AUG-2025, 1 days after receiving Bexsero, the patient experienced injection site pain (Verbatim: pain around the injection site), injection site swelling (Verbatim: swelling around the injection site), injection site warmth (Verbatim: Injection site warmth) and injection site erythema (Verbatim: redness around the injection site). The outcome of the injection site pain, injection site swelling, injection site warmth and injection site erythema were not resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site warmth and injection site erythema to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the injection site pain, injection site swelling, injection site warmth and injection site erythema 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: 15-AUG-2025 The reporter reported that patient received Bexsero vaccination and from beginning the following morning experienced pain, swelling, redness and swelling at and around the injection site. It has not yet subsided. No further information was obtained in this call.
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| 2856639 | F | 09/03/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
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Herpes zoster, Rash, Vaccination failure
Herpes zoster, Rash, Vaccination failure
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Suspected vaccination failure; Shingles; This serious case was reported by a consumer via call cente...
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In AUG-2025, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 27-AUG-2025 The reporter was the patient daughter. She stated that her mother received the Shingles vaccine in the past and she developed shingles 2 weeks ago. She reported that the rashes were still present. She did not know which shingles vaccines she received. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2856640 | M | 09/03/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Oral herpes
Oral herpes
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woke up to a mouthful of fever blisters; This non-serious case was reported by a consumer via intera...
woke up to a mouthful of fever blisters; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever blister in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced fever blister (Verbatim: woke up to a mouthful of fever blisters). The outcome of the fever blister was not reported. It was unknown if the reporter considered the fever blister to be related to Shingles vaccine. It was unknown if the company considered the fever blister to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 17-AUG-2025 This case was reported by a patient via interactive digital media. The reporter said to stay out of the sun after you get the shot. The reporter stated she and her husband (patient) got the first shot at same time. Two weeks to the day they both woke up to a mouthful of fever blisters. She believed the blisters were because they got the shot and went out in the sun. No reaction after the second shot. This case is linked with case US2025AMR106849 from the same reporter for wife.; Sender's Comments: US-GSK-US2025AMR106842:Case for wife
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| 2856641 | NY | 09/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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I never got the 2nd shot.; This non-serious case was reported by a consumer via call center represe...
I never got the 2nd shot.; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (patient had 1st dose 3 years ago). The patient received the 2nd dose of Shingrix, the patient experienced incomplete course of vaccination (Verbatim: I never got the 2nd shot.). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 24-AUG-2025 Patient had the 1st Shingrix shot 3 years ago. Patient never got the 2nd shot, which led to incomplete course of vaccination. Asked if he/she get the 2nd shot or start over.
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| 2856642 | 09/03/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected Vaccination failure; had two shots to prevent Shingles but I still got Shingles; This ser...
Suspected Vaccination failure; had two shots to prevent Shingles but I still got Shingles; This serious case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Herpes Zoster vaccine and the 1st dose of Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine and Herpes Zoster vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had two shots to prevent Shingles but I still got Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Herpes Zoster vaccine and Herpes Zoster vaccine. The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine and Herpes Zoster vaccine. It was unknown if the company considered the shingles to be related to Herpes Zoster vaccine and Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 22-AUG-2025 This case was reported by a patient via interactive digital media. The have had two shots to prevent Shingles but still got Shingles. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles) is considered unrelated to GSK's Herpes Zoster vaccine (Dose 1 & 2).
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| 2856643 | F | SC | 09/03/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
4N222 |
Product preparation issue
Product preparation issue
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Maladministration of the liquid part only; Maladministration of the liquid part only; This non-serio...
Maladministration of the liquid part only; Maladministration of the liquid part only; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 60-year-old female patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis. On 22-MAR-2025, the patient received Priorix. On 22-MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate dose of vaccine administered (Verbatim: Maladministration of the liquid part only) and inappropriate preparation of medication (Verbatim: Maladministration of the liquid part only). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication 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: 15-AUG-2025 Pharmacist called to report that don't know if two patients were administered with the diluent only or maybe one of them was vaccinated with a full dose, which led to Inappropriate dose of vaccine administered and Inappropriate preparation of medication. The reporter was also wanted to be asked which would be the timeframe for revaccination or not. No further information was obtained in this call. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. The case had been linked to US2025105584, reported by the same reporter, for a different patient.; Sender's Comments: US-GSK-US2025105584:2nd patient, same reporter
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| 2856644 | 12 | M | IL | 09/03/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
UNK |
Extra dose administered
Extra dose administered
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extra dose of Menveo; Wrong vaccine administered; This non-serious case was reported by a other heal...
extra dose of Menveo; Wrong vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. Co-suspect products included HPV 16-18 (HPV vaccine) for prophylaxis. Previously administered products included Menveo (received first dose on 04-DEC-2024). On 28-JUL-2025, the patient received the 2nd dose of Menveo. On an unknown date, the patient received HPV vaccine. On 28-JUL-2025, an unknown time after receiving Menveo and not applicable after receiving HPV vaccine, the patient experienced extra dose administered (Verbatim: extra dose of Menveo) and wrong vaccine administered (Verbatim: Wrong vaccine administered). The outcome of the extra dose administered and wrong vaccine administered were not applicable. Additional Information: GSK Receipt Date: 15-AUG-2025 The reporter reported that the patient received his next one early, he was supposed to get HPV shot and had second dose of Menveo (1 vial) by accident, which led to wrong vaccine administered and extra dose administered. Vaccine administration facility was the same as primary reporter.
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| 2856645 | 63 | F | FL | 09/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Anxiety, Chest pain, Endocarditis, Fatigue, Myalgia
Anxiety, Chest pain, Endocarditis, Fatigue, Myalgia
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endocarditis; chest burning; fatigue; muscle pain; anxiety; This serious case was reported by a phys...
endocarditis; chest burning; fatigue; muscle pain; anxiety; This serious case was reported by a physician via call center representative and described the occurrence of endocarditis in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Flu unspecified (Influenza 2024-2025 Vaccine) for prophylaxis. In JUL-2025, the patient received Shingrix and the 1st dose of Influenza 2024-2025 Vaccine. In AUG-2025, less than a month after receiving Shingrix and Influenza 2024-2025 Vaccine, the patient experienced fatigue (Verbatim: fatigue), muscle pain (Verbatim: muscle pain) and anxiety (Verbatim: anxiety). On an unknown date, the patient experienced endocarditis (Verbatim: endocarditis) (serious criteria GSK medically significant) and chest burning (Verbatim: chest burning). The patient was treated with prednisone. In AUG-2025, the outcome of the chest burning was resolved. The outcome of the endocarditis, fatigue, muscle pain and anxiety were not reported. It was unknown if the reporter considered the endocarditis, chest burning, fatigue, muscle pain and anxiety to be related to Shingrix and Influenza 2024-2025 Vaccine. The company considered the endocarditis to be unrelated to Shingrix and Influenza 2024-2025 Vaccine. It was unknown if the company considered the chest burning, fatigue, muscle pain and anxiety to be related to Shingrix and Influenza 2024-2025 Vaccine. Additional Information: GSK Receipt Date: 08-AUG-2025 The physician called to inform that was administered the Flu vaccine (was not sure if it was Fluarix or Flulaval) and Shingrix together. After this the patient started developing chest burning and was admitted at the emergency room, where no arrythmias were found but endocarditis was not ruled out. Then, the patient was prescribed with prednisone for 1 week. After 10 days she discontinued the therapy and the chest burning symptoms were resolved but she started developing fatigue, muscle pain and anxiety. The physician called to get guidance after this episode, and they need clarification if something else needs to be done. Date of administration of both vaccines was sometime between 29 and 30 July 2025.; Sender's Comments: A case of Endocarditis, less than a month after receiving Shingrix and Influenza 2024-2025 Vaccine, in a 63-year-old female patient. Causal relation is indeterminate considering multiple vaccines given concomitantly.
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| 2856646 | M | NC | 09/03/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
42B52 |
Expired product administered
Expired product administered
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expired dose of Arexvy was administered; This non-serious case was reported by a pharmacist via call...
expired dose of Arexvy was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 75-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 42B52, expiry date 06-JUL-2025) for prophylaxis. On 22-AUG-2025, the patient received Arexvy (intramuscular). On 22-AUG-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: expired dose of Arexvy was administered). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 22-AUG-2025 The Pharmacist called to report an expired dose of Arexvy was administered to a 75-year-old patient, which led to expired vaccine used.
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