| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2857726 | F | NJ | 09/10/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
|
Wrong product administered
Wrong product administered
|
Received their First Dose of HEPLISAV-B on July 21st 2025 Then Got ENGERIX-B instead of HEPLISAV-B 2...
Received their First Dose of HEPLISAV-B on July 21st 2025 Then Got ENGERIX-B instead of HEPLISAV-B 21-AUG-2025; Initial report received on 22-Aug-2025. A pharmacist in the reported that a patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 21-Jul-2025 and received ENGERIX-B as the second dose on 21-Aug-2025. No medical history or concomitant medications were reported. On 21-Jul-2025, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available). On 21-Aug-2025, 32 days after receiving HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine ENGERIX-B (lot number, expiration date, route, and site not available). No additional information was reported. Company Comment:; Sender's Comments: The company assessed the event as non-serious.
More
|
|||||||
| 2857727 | F | 09/10/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
|
Extra dose administered
Extra dose administered
|
Received HEPLISAV-B then Received Another Hepatitis B Shot; Initial report received on 25-Aug-2025. ...
Received HEPLISAV-B then Received Another Hepatitis B Shot; Initial report received on 25-Aug-2025. A consumer reported that she, a female patient, received HEPLISAV-B (hepatitis B vaccine) for the first dose of hepatitis B immunization, then received an unknown hepatitis B vaccine , and then received the second dose of HEPLISAV-B. No medical history or concomitant medications were reported. In Jul-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On 18-Aug-2025, approximately one month after receiving HEPLISAV-B, the patient received an unknown hepatitis B vaccine (lot number, expiration date, route, and site not available). On 22-Aug-2025, approximately one month after receiving HEPLISAV-B and 4 days after receiving a dose of an unknown hepatitis B vaccine , the patient received dose 2 of HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available). The reporter declined to provide further information. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
More
|
||||||||
| 2857728 | PA | 09/10/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
|
Therapy non-responder
Therapy non-responder
|
Had Complete ENGERIX-B Series and Complete HEPLISAV-B Series and is a Non-Responder to Hepatitis B V...
Had Complete ENGERIX-B Series and Complete HEPLISAV-B Series and is a Non-Responder to Hepatitis B Vaccines; Initial report received on 25-Aug-2025. A nurse reported that a patient received the complete HEPLISAV-B (hepatitis B vaccine) series after receiving the complete ENGERIX-B for hepatitis B immunization but continued to be a non-responder to the hepatitis B vaccines. No medical history or concomitant medications were reported. On an unknown date, the patient completed the ENGERIX-B hepatitis B vaccine series (lot numbers, expiration dates, NDC numbers, route, and sites not available). On an unknown date, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On an unknown date, the patient received dose 2 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On an unknown date, after receiving the complete HEPLISAV-B series, the patient was noted to be a non-responder to the hepatitis B vaccines. No additional information was reported. Company Comment: The company assessed the event as non-serious. The event is not immunologically confirmed due to lack of information on dosing and serological marker.; Sender's Comments: The company assessed the event as non-serious. The event is not immunologically confirmed due to lack of information on dosing and serological marker.
More
|
||||||||
| 2857729 | F | TX | 09/10/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Fatigue, Pyrexia
Fatigue, Pyrexia
|
Fatigue; Low grade fever; This non-serious case was reported by a consumer via call center represent...
Fatigue; Low grade fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Additional patient notes included prior vaccines She usually reacts to vaccines. She did not mention any specific examples but did mention she is due for a flu shot and a covid-19 shot.. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fatigue (Verbatim: Fatigue) and low grade fever (Verbatim: Low grade fever). The outcome of the fatigue and low grade fever were resolved. It was unknown if the reporter considered the fatigue and low grade fever to be related to Shingrix. It was unknown if the company considered the fatigue and low grade fever to be related to Shingrix. Additional Information: GSK Receipt Date: 04-SEP-2025 The patient reported that she received Shingrix shot one a couple of months ago. She said with the first dose, she did feel pretty bad. She usually do kind of react to shots, it wasn't an allergic reaction or anything. She indicated that she did not report this to her doctor because she usually reacts to vaccines and did not think it was unusual. She read that side effects could be expected/typical. To elaborate on felt pretty bad, she said that it was mostly fatigue and maybe a low-grade fever the evening of the vaccine and maybe the next morning, but it was not high enough that she took her temperature.
More
|
|||||||
| 2857730 | 09/10/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
|
received first Shingrix shot in January; This non-serious case was reported by a consumer via call c...
received first Shingrix shot in January; 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 received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix in Jan 2025). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: received first Shingrix shot in January). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 31-AUG-2025 The patient received first Shingrix shot in Jan 2025. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
More
|
|||||||||
| 2857731 | F | NJ | 09/10/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
|
never completed the series, now wants the third dose; This non-serious case was reported by a pharma...
never completed the series, now wants the third dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (first dose of Twinrix in Sep 2022 (4F3YY expiry date 01 Jan 2023),) and Twinrix (second dose in Oct 2022). On an unknown date, the patient received the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: never completed the series, now wants the third 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: 22-AUG-2025 Pharmacist called to report that patient got first dose of Twinrix in Sep 2022 and the second dose in Oct 2022 but never received the third dose. Now the patient wants the third dose. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination.
More
|
|||||||
| 2857732 | 22 | F | GA | 09/10/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
|
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
received the first dose of Twinrix on 28 Feb 2025 and the second dose was given 01 Jun 2025; This no...
received the first dose of Twinrix on 28 Feb 2025 and the second dose was given 01 Jun 2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 22-year-old female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received the first dose of Twinrix on 28 Feb 2025). On 01-JUN-2025, the patient received the 2nd dose of Twinrix. On 01-JUN-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: received the first dose of Twinrix on 28 Feb 2025 and the second dose was given 01 Jun 2025). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 25-AUG-2025 Pharmacist reported that a patient received the first dose of Twinrix on 28 Feb 2025 and the second dose was given 01 Jun 2025 which led to Drug dose administration interval too long.
More
|
||||||
| 2857733 | 85 | M | 09/10/2025 |
COVID19-2 |
MODERNA |
AS7140C |
Immunodeficiency, White blood cell count
Immunodeficiency, White blood cell count
|
unsure if his low immune system was pre-existing since they just started checking it a year ago; Thi...
unsure if his low immune system was pre-existing since they just started checking it a year ago; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (unsure if his low immune system was pre-existing since they just started checking it a year ago) in an 85-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7140C and 065H22A) for COVID-19 prophylaxis. Concurrent medical conditions included Chronic leukemia and Breathing difficult. On 09-Sep-2022, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 20-Apr-2023, received seventh dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced IMMUNODEFICIENCY (unsure if his low immune system was pre-existing since they just started checking it a year ago) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (unsure if his low immune system was pre-existing since they just started checking it a year ago) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: white count being so high (over 100,000) for 20 years. No concomitant medication was reported. Patient previously received Moderna vaccines on 01-Jan-2021 (lot#025L20A), 13-Jan-2021 (lot#025L20A), 10-Feb-2021 (lot#024M20A), 27-Sep-2021 (lot#041B21A) and 07-Feb-2022 (lot#007J21-2A). The patient received every Moderna vaccine that had come out since it was all started and the last one, he had was September 2024. The patient's doctor told him he needed to get another COVID vaccine this year. His health problems - breathing problems and chronic leukemia were pre-existing before receiving the COVID vaccines but was unsure if his low immune system was preexisting since they just started checking it a year ago. The patient needed infusions to bring his hemoglobin and IgG back up every 3 months. The patient's most of the problems were on account of his chronic leukemia and his white count being so high (over 100,000) for 20 years. The patient was never had any ill effects from any of his vaccines. This case was linked to MOD-2025-789056 (Patient Link).; Reporter's Comments: Patients Chronic leukemia is a strong confounder for the event immunodeficiency. The benefit-risk relationship of product is not affected by this report.
More
|
|||||||
| 2857734 | F | 09/10/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Chills, Pyrexia
Chills, Pyrexia
|
received 5 covid vaccine pretty much had the same side effects/experienced chills and slight fever; ...
received 5 covid vaccine pretty much had the same side effects/experienced chills and slight fever; received 5 covid vaccine pretty much had the same side effects/experienced chills and slight fever; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 (BNT162B2 NOS), 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: CHILLS (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "received 5 covid vaccine pretty much had the same side effects/experienced chills and slight fever". Additional information: A consumer inquired whether the COMIRNATY (2025-2026 Formula) includes the new variant Stratus or the current variant. Another inquiry was made regarding the difference between the 2024-2025 and 2025-2026 formulations. Additionally, the consumer reported having received five prior COVID-19 vaccines with similar side effects, including chills and slight fever, and asked whether the current 2025-2026 formulation would cause the same side effects. In a separate inquiry, the consumer asked whether individuals aged 5 through 64 years who work as privacy are eligible to receive the vaccine or if a doctor's prescription is required. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500177331 same patient, different doses;US-PFIZER INC-202500177332 same patient, different doses;US-PFIZER INC-202500177333 same patient, different doses;US-PFIZER INC-202500177334 same patient, different doses;
More
|
||||||||
| 2857735 | 09/10/2025 |
COVID19 COVID19 |
MODERNA PFIZER\BIONTECH |
|
Malaise, Pain, Pyrexia; Malaise, Pain, Pyrexia
Malaise, Pain, Pyrexia; Malaise, Pain, Pyrexia
|
soreness; malaise; fever; This is a spontaneous report received from a Consumer or other non HCP. Ot...
soreness; malaise; fever; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-788935 (Moderna). A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 2 (initial pfizer dose), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose 1, single for covid-19 immunisation. The patient's relevant medical history included: "immunosuppression NOS" (ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "recovered", described as "soreness"; MALAISE (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "fever". Therapeutic measures were taken as a result of pain, malaise, pyrexia. Additional information: This spontaneous case was reported by a consumer and describes the occurrence of pain in extremity (experienced a little soreness in the arm), pain (soreness), malaise (malaise) and pyrexia (fever) in a patient who received Spikevax NOS (Spikevax NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. Concurrent medical condition included immunosuppression NOS. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and second dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced pain in extremity (experienced a little soreness in the arm), pain (soreness), malaise (malaise) and pyrexia (fever). The patient was treated with Acetylsalicylic acid (Aspirin) at an unspecified dose and frequency. At the time of the report, pain in extremity (experienced a little soreness in the arm), pain (soreness), malaise (malaise) and pyrexia (fever) had resolved. No concomitant medication was reported. The patient had less side effects with Moderna (COVID19) vaccine. The patient had both Moderna and Pfizer. With Pfizer, the patient had the second dose and everything else had been with Moderna. Also mentioned that had heard on the news that Moderna was more effective than Pfizer in the older population and that had less side effects with the Moderna vaccination. It was reported that with Moderna COVID19 vaccine, the patient experienced a little soreness in the arm for 2 days. In terms of the Pfizer vaccine, stated it had been a while either 2022 or 2023 when received the vaccine, but experienced a mild fever, soreness, malaise which aspirin cured after the 2nd day. The patient was at that age where immunity was marginal at best and that continued with wearing a mask in public places. It was unknown if the patient experienced any additional symptoms or events. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
More
|
|||||||||
| 2857751 | 51 | F | AZ | 09/10/2025 |
PNC20 |
PFIZER\WYETH |
LX4484 |
Injection site erythema
Injection site erythema
|
soon after vaccine patient had redness at injection site. By monday she called me at pharmacy. I s...
soon after vaccine patient had redness at injection site. By monday she called me at pharmacy. I said common unless it starts to get bigger and is warm---then could be cellulitis concern. She showed me on Tuesday and I recommended to get seen for potential cellulitis and antibiotic. She filled it that evening 9/9/2025.
More
|
||||||
| 2857752 | 54 | M | CA | 09/10/2025 |
FLU3 |
SANOFI PASTEUR |
U8830AA |
Incorrect dose administered
Incorrect dose administered
|
Pt received Flu zone High Dose rather than Standard Flu Zone by vaccine center staff:
Pt received Flu zone High Dose rather than Standard Flu Zone by vaccine center staff:
|
||||||
| 2857753 | 37 | M | VA | 09/10/2025 |
COVID19 |
MODERNA |
|
Mass, Swelling
Mass, Swelling
|
Small lump at 0150 time. Diarrhea at time 0156 mild
Small lump at 0150 time. Diarrhea at time 0156 mild
|
||||||
| 2857757 | M | 09/10/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Death
Death
|
that poison killed my brother-in-law; This serious case was reported by a consumer via interactive d...
that poison killed my brother-in-law; This serious case was reported by a consumer via interactive digital media and described the occurrence of death in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced death (Verbatim: that poison killed my brother-in-law) (serious criteria death and GSK medically significant). The reported cause of death was death. The reporter considered the death to be related to RSV vaccine. The company considered the death to be unrelated to RSV vaccine. Additional Information: GSK receipt date: 04-SEP-2025 This case was reported by a patient's relative via interactive digital media. The reporter indicated that, this poison killed reporter's brother-in-law so reporter stated that do not tell them that it was safe and effective because it was not, also indicated that it was designed to take lives not save lives. This case is linked with US2025AMR114224, reported by same reporter.; Sender's Comments: A case of death, unknown time after receiving RSV vaccine, in a male patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. US-GLAXOSMITHKLINE INC-US2025AMR114224:Case for father-in-law; Reported Cause(s) of Death: Death
More
|
โ | |||||||
| 2857758 | F | 09/10/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Expired product administered
Expired product administered
|
administered a dose of Arexvy on Aug 22, 2025, that had expired July 2025; This non-serious case was...
administered a dose of Arexvy on Aug 22, 2025, that had expired July 2025; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of expired vaccine used in a female patient who received RSVPreF3 adjuvanted (Arexvy) (expiry date 31-JUL-2025) for prophylaxis. On 22-AUG-2025, the patient received the 1st dose of Arexvy (unknown deltoid). On 22-AUG-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: administered a dose of Arexvy on Aug 22, 2025, that had expired July 2025). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 22-Aug-2025 No patient details provided by reporter.
More
|
||||||||
| 2857759 | F | TN | 09/10/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Malaise, Vaccine positive rechallenge
Malaise, Vaccine positive rechallenge
|
not feeling well for about 12 hours after each dose; This non-serious case was reported by a consume...
not feeling well for about 12 hours after each dose; This non-serious case was reported by a consumer via sales rep and described the occurrence of feeling unwell in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of malaise (For tolerance of 1st dose refer case US2025AMR105885). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: not feeling well for about 12 hours after each dose). Rechallenge with Shingrix was positive. The outcome of the feeling unwell was resolved (duration 12 hrs). It was unknown if the reporter considered the feeling unwell to be related to Shingrix. It was unknown if the company considered the feeling unwell to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR105885 Additional Information: GSK Receipt Date: 12-AUG-2025 The patient was approximately 55 years old. Patient got both doses of Shingrix as indicated. Patient not felt well for about 12 hours after each dose but recovered the next day.; Sender's Comments: US-GSK-US2025AMR105885:case for 1st dose
More
|
|||||||
| 2857760 | 12 | F | TX | 09/10/2025 |
FLU3 |
SANOFI PASTEUR |
U8527AA |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
administered with an expired fluzone hd vaccine with no reported advesre event; administered with an...
administered with an expired fluzone hd vaccine with no reported advesre event; administered with an expired fluzone hd vaccine with no reported advesre event; Initial information received on 05-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 years old female patient who was administered with an expired influenza USP trival A-B high dose subvirion vaccine [Fluzone High Dose] with no reported advesre event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Sep-2025, the patient received 0.5 ml of dose 1 of an expired influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe with standard strength (expiry date- 30-JUN-2025 and lot U8527AA) once via intramuscular route in unknown administration site for Influenza immunization with no reported adverse event (expired product administered) (product administered to patient of inappropriate age) (latency- same day). Reportedly, List of concomitant vaccines: None. Treatment: No adverse event, no treatment 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
|
||||||
| 2857761 | 1.17 | F | TX | 09/10/2025 |
HIBV |
SANOFI PASTEUR |
UK166AB |
No adverse event, Product preparation error
No adverse event, Product preparation error
|
used sterile water as a diluent instead of the recommended saline with no reported adverse event; In...
used sterile water as a diluent instead of the recommended saline with no reported adverse event; Initial information received on 05-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 14 months old female patient who received HIB (PRP/T) vaccine [ACT-HIB] and used sterile water as a diluent instead of the recommended saline 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 Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Daptacel); and Pneumococcal vaccine conj 7v (CRM197) (Prevnar) as both for Immunisation. On 05-Sep-2025, the patient received 0.5 ml of dose 4 of HIB (PRP/T) vaccine Powder and solvent for solution for injection with standard strength (expiry date- 30-SEP-2025 and lot UK166AB) once via intramuscular route in the left thigh for Immunization and used sterile water as a diluent instead of the recommended saline with no reported adverse event (product preparation error) (latency- same day). Reportedly, reporter was asking if the dose was invalid and needs to be repeated. 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
|
||||||
| 2857856 | 55 | M | NY | 09/10/2025 |
COVID19 |
MODERNA |
|
Laboratory test normal, Skin hypopigmentation, Vitiligo
Laboratory test normal, Skin hypopigmentation, Vitiligo
|
Within a few days of receiving my 2nd injection, I started to notice pigmentation changes in various...
Within a few days of receiving my 2nd injection, I started to notice pigmentation changes in various locations on my body. I made an appointment for May 27, 2021 with a dermatologist who determined that the spots were Vitiligo, triggered by an overactive immune system. As time went on, the number white spots increased and grew larger. The doctor told me this was irreversible and permanent. I have checked the box on this form for "Disability or permanent damage" becauseI was told it is permanent, however I do not consider it a disability, although it is a cause for emotional discomfort because I have relatively dark skin.
More
|
โ | |||||
| 2857857 | 44 | M | MA | 09/10/2025 |
COVID19 |
PFIZER\BIONTECH |
EW0172 |
Pyrexia
Pyrexia
|
Persistent fever over 102๏ฟฝ for over three weeks
Persistent fever over 102๏ฟฝ for over three weeks
|
||||||
| 2857858 | 1.5 | F | KY | 09/10/2025 |
HEPA HEPA |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Blood test normal, Dermatitis diaper, Exfoliative rash, Food intolerance, Inflam...
Blood test normal, Dermatitis diaper, Exfoliative rash, Food intolerance, Inflammation; Perfume sensitivity, Rash, Rash erythematous, Rash papular, Rash pruritic
More
|
constant diaper rash and sensitivity to foods, anything with a scent, and extreme inflammation. At ...
constant diaper rash and sensitivity to foods, anything with a scent, and extreme inflammation. At one point a whole body rash which consisted of raised red bumps that were itchy and scaly.
More
|
||||||
| 2857859 | 53 | F | MA | 09/10/2025 |
TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Limb mass, Muscle spasms, Myalgia, Skin irritation, Suture insertion; Tenderness
Limb mass, Muscle spasms, Myalgia, Skin irritation, Suture insertion; Tenderness
|
I got a tdap last July 2024 after I had stitches put in and over a year later I still have a lump in...
I got a tdap last July 2024 after I had stitches put in and over a year later I still have a lump in my arm that is sensitive to touch, nothing major or anything and its not black and blue or gaudy just a lump that sometimes clothes irritates it and sometimes the muscle there hurts and sometimes spasms as well, how do I get rid of it after over a year.
More
|
||||||
| 2857860 | 12 | F | 09/10/2025 |
HPV9 |
MERCK & CO. INC. |
Y013818 |
Fall, Head injury, Loss of consciousness, Pallor, Presyncope
Fall, Head injury, Loss of consciousness, Pallor, Presyncope
|
Passed out fell hit head on floor Pale vasovagal response
Passed out fell hit head on floor Pale vasovagal response
|
|||||||
| 2857861 | 10 | F | 09/10/2025 |
HPV9 |
MERCK & CO. INC. |
Y013818 |
Hyperhidrosis, Pallor, Presyncope
Hyperhidrosis, Pallor, Presyncope
|
Patient had a vasovagal episode pale diaphoretic sugar given rest ice to neck
Patient had a vasovagal episode pale diaphoretic sugar given rest ice to neck
|
|||||||
| 2857862 | 14 | M | MD | 09/10/2025 |
FLU3 |
SEQIRUS, INC. |
406985 |
Hyperhidrosis, Loss of consciousness, Syncope
Hyperhidrosis, Loss of consciousness, Syncope
|
The patient fainted in the chair right after receiving the flu vaccine. He regained consciousness i...
The patient fainted in the chair right after receiving the flu vaccine. He regained consciousness immediately and was sweating profusely. He didn't know what happened, just suddenly blacked out. The patient sat in the chair for about 10-15 minutes drinking juice and felt better before walking around in the store and then going home.
More
|
||||||
| 2857863 | 56 | F | GA | 09/10/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
L227A |
Chest pain, Pruritus
Chest pain, Pruritus
|
Zoster (Shingrix) vaccine was given at 11:57 am and at 11:59 patient reported that she was itching o...
Zoster (Shingrix) vaccine was given at 11:57 am and at 11:59 patient reported that she was itching on her arms, legs, and hair. Zyrtec 5mg (2 tablets for a total of 10mg) was given to patient in clinic and patient monitored for over 30 minutes. 911 was called at 12:18pm to further assess patient. 12:28pm patient reported having chest pain. EMS arrived at 12:32 and took over care. Patient declined going to the hospital for futher evaluation and walked out of clinic on her own. Patient declined further care at hospital because she reported that she is her mother's caregiver.
More
|
||||||
| 2857864 | 71 | M | VA | 09/10/2025 |
PNC21 |
MERCK & CO. INC. |
Z004302 |
Asthenia, Blood test, Injection site cellulitis, Pyrexia
Asthenia, Blood test, Injection site cellulitis, Pyrexia
|
Injection resulted to developing Cellulitis, treatment of antibiotics Cefuroxime Axetil 500mg prescr...
Injection resulted to developing Cellulitis, treatment of antibiotics Cefuroxime Axetil 500mg prescribed by Dr (withheld). Patient still feeling weak, with low fever
More
|
||||||
| 2857865 | 27 | F | NC | 09/10/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
F4A7R |
Cough, Erythema, Throat irritation, Visual impairment
Cough, Erythema, Throat irritation, Visual impairment
|
Patient received flu vaccine at today's visit. Patient screened negative for past reactions to ...
Patient received flu vaccine at today's visit. Patient screened negative for past reactions to flu vaccine prior to administration. After patient received flu vaccine, patient's face turned red and she began coughing, stating that she was seeing spots and her throat was scratchy. This RN informed Drs. who came to the bedside to assess patient. Patient's vitals were obtained and she was provided with water. Patient was asked to remain in room for about 20 minutes for observation and repeat vitals. Vital signs remained stable during this time, patient was provided with a snack, and symptoms and vitals were reassessed every 5 minutes. After observation period, patient stated that symptoms had improved and vital signs had remained stable. Patient was cleared to leave per Dr.
More
|
||||||
| 2857867 | 0.5 | F | NC | 09/10/2025 |
DTAPHEPBIP FLU3 HIBV RSV RV5 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
b532g 7f299 y020468 kc7884 2139673 |
Inappropriate schedule of product administration, No adverse event, Product admi...
Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age; Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age; Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age; Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age; Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
More
|
Abrysvo given to 6-month-old. Pedvax HIB given off schedule. No known harm to patient at this time.
Abrysvo given to 6-month-old. Pedvax HIB given off schedule. No known harm to patient at this time.
|
||||||
| 2857868 | 18 | M | MD | 09/10/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Chest pain, Dyspnoea, Influenza like illness, Nasopharyngitis, Pericarditis
Chest pain, Dyspnoea, Influenza like illness, Nasopharyngitis, Pericarditis
|
The next day there were flu-like symptoms of a head cold, and then chest pain as well as shortness o...
The next day there were flu-like symptoms of a head cold, and then chest pain as well as shortness of breath associated with pericarditis, which was diagnosed by a cardiologist to be pericarditis.
More
|
||||||
| 2857869 | 0.67 | F | MI | 09/10/2025 |
RV5 |
MERCK & CO. INC. |
2124039 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
No adverse events noted. Vaccine given one day over recommended age
No adverse events noted. Vaccine given one day over recommended age
|
||||||
| 2857870 | 69 | M | NY | 09/10/2025 |
PNC21 |
MERCK & CO. INC. |
ZOO3579 |
Rash pruritic, Skin warm
Rash pruritic, Skin warm
|
4 to 6 inches in diameter, non raised rash. warm to the touch and itchy
4 to 6 inches in diameter, non raised rash. warm to the touch and itchy
|
||||||
| 2857871 | 54 | M | AZ | 09/10/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Poikilocytosis, Thalassaemia
Poikilocytosis, Thalassaemia
|
Incurred blood disorder - Thalassemia and Poikilocytosis
Incurred blood disorder - Thalassemia and Poikilocytosis
|
||||||
| 2857872 | 4 | F | SC | 09/10/2025 |
DTAP |
SANOFI PASTEUR |
3CA20C1 |
Injection site cellulitis, Injection site erythema, Injection site swelling
Injection site cellulitis, Injection site erythema, Injection site swelling
|
Patient with erythema, swelling, and redness to left upper thigh at injection site. Patient came in ...
Patient with erythema, swelling, and redness to left upper thigh at injection site. Patient came in office 9/10/25 to have site evaluated. Diagnosed with cellulitis- started on Cephalexin for treatment.
More
|
||||||
| 2857873 | 43 | F | ME | 09/10/2025 |
COVID19 |
MODERNA |
003c21a |
Dry eye, Immediate post-injection reaction, Photophobia, Rheumatoid arthritis, S...
Dry eye, Immediate post-injection reaction, Photophobia, Rheumatoid arthritis, Sicca syndrome
More
|
Felt like I was becoming extremely sensitive to light immediately after injection but brushed it off...
Felt like I was becoming extremely sensitive to light immediately after injection but brushed it off but over the course of a week could not even be outside with the light felt like I was going blind, also felt like the lubrication was being sucked out of my body. Now diagnosed sicca syndrome ans Keratosis sicca plus Rheumatoid Arthritis but suspect the Rheumatoid is related to almost dying from Pertussis vaccine when I was little.
More
|
โ | |||||
| 2857874 | 4 | F | MI | 09/10/2025 |
COVID19 |
MODERNA |
3046979 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
none
none
|
||||||
| 2857875 | 0.17 | F | MI | 09/10/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
39KS9 |
Expired product administered
Expired product administered
|
expired by 3 days
expired by 3 days
|
||||||
| 2857876 | 75 | M | CA | 09/10/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052296 U8847BA |
Fatigue, Injection site pain, Pyrexia; Fatigue, Injection site pain, Pyrexia
Fatigue, Injection site pain, Pyrexia; Fatigue, Injection site pain, Pyrexia
|
Fever, fatigue, injection site soreness
Fever, fatigue, injection site soreness
|
||||||
| 2857877 | 12 | F | MA | 09/10/2025 |
HEPA MNQ |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR |
3255P U8574AA |
Immediate post-injection reaction, Syncope; Immediate post-injection reaction, S...
Immediate post-injection reaction, Syncope; Immediate post-injection reaction, Syncope
More
|
Vasovagal syncope occurred immediately after vaccine administration
Vasovagal syncope occurred immediately after vaccine administration
|
||||||
| 2857878 | 85 | F | IN | 09/10/2025 |
FLU3 |
SANOFI PASTEUR |
UJ253AB |
Cutaneous vasculitis
Cutaneous vasculitis
|
Bilateral lower leg cutaneous vasculitis developed 1 week after influenza vaccine. In retrospect, sh...
Bilateral lower leg cutaneous vasculitis developed 1 week after influenza vaccine. In retrospect, she has a similar left lower leg rash approximately one week after her influenza vaccine last year.
More
|
||||||
| 2857879 | 62 | M | FL | 09/10/2025 |
FLU3 RSV TDAP |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
u8823aa bg5j4 kr75k |
Extra dose administered; Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered; Extra dose administered
|
pt received arexvy when they had already gotten the vaccine in december 2020
pt received arexvy when they had already gotten the vaccine in december 2020
|
||||||
| 2857880 | 78 | M | FL | 09/10/2025 |
FLU3 PNC21 |
SANOFI PASTEUR MERCK & CO. INC. |
u8855ca z006889 |
Rash; Rash
Rash; Rash
|
severe rash- no treatment mentioned- 48 hours course
severe rash- no treatment mentioned- 48 hours course
|
||||||
| 2857882 | 48 | M | NY | 09/10/2025 |
COVID19 |
PFIZER\BIONTECH |
EW0170 |
Cerebrovascular accident, Uveitis
Cerebrovascular accident, Uveitis
|
Had uveitis symptoms a couple days after the 2nd Pfizer shot. Never had any eye problems in the past...
Had uveitis symptoms a couple days after the 2nd Pfizer shot. Never had any eye problems in the past. The pain was so severe that I had to go to ER in the middle of the night. Eventually I booked an appointment to see an eye doctor who administered eye drops and the symptoms were stopped. However, a couple months later the same problem recurred. I went to a different doctor and finally cured it. The doctor mentioned it may be related to some autoimmune genes. Worse thing happened a few months later after the 2nd bout of uveitis. On June 22, 2022, I had a stroke.
More
|
โ | โ | โ | |||
| 2857883 | 66 | F | AL | 09/10/2025 |
COVID19 |
PFIZER\BIONTECH |
EL9264 |
Retinal detachment, Visual impairment, Vitrectomy, Vitreous haemorrhage
Retinal detachment, Visual impairment, Vitrectomy, Vitreous haemorrhage
|
Pt experienced vitreous hemorrhage and retinal detachment in left eye; pt had to undergo vitrectomy ...
Pt experienced vitreous hemorrhage and retinal detachment in left eye; pt had to undergo vitrectomy and to repair damage to retina (performed at Outpatient Surgery); pt reports vision was restored to baseline acuity with no significant complications
More
|
||||||
| 2857884 | 72 | F | CA | 09/10/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052296 U8847BA |
Cough, Headache, Injection site pain, Pyrexia, Rhinorrhoea; Cough, Headache, Inj...
Cough, Headache, Injection site pain, Pyrexia, Rhinorrhoea; Cough, Headache, Injection site pain, Pyrexia, Rhinorrhoea
More
|
Fever, runny nose, headache, cough, sore injection site
Fever, runny nose, headache, cough, sore injection site
|
||||||
| 2857885 | 76 | F | NE | 09/10/2025 |
COVID19 |
MODERNA |
3052583 |
Injection site rash, Injection site warmth, Rash erythematous, Rash pruritic
Injection site rash, Injection site warmth, Rash erythematous, Rash pruritic
|
Red almost rash like. Could be a bruise. not raised. at first warm to the touch, no longer warm 3 da...
Red almost rash like. Could be a bruise. not raised. at first warm to the touch, no longer warm 3 days later. Rash is spreading. Covers arm from injection site to elbow and medial Biocept area. Rash has an irregular boarder. starts light from injection site and gets darker towards the elbow. Rash is itchy.
More
|
||||||
| 2857886 | 67 | M | NJ | 09/10/2025 |
FLU3 FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
U8847CA U8847CA U8847CA |
Atrial fibrillation, Balance disorder, Chills, Condition aggravated, Dizziness; ...
Atrial fibrillation, Balance disorder, Chills, Condition aggravated, Dizziness; Dyspnoea, Heart rate increased, Influenza, Injection site pain, Oxygen saturation decreased; Presyncope, Sleep disorder
More
|
pt had severe AFIB (pulse was 114 and normal pulse is around 50-55) later the same day of receiving ...
pt had severe AFIB (pulse was 114 and normal pulse is around 50-55) later the same day of receiving the vaccine. He had soreness at the injection site along with the dizziness, became light headed and had shortness of breath. He called his PCP. He was told to take flecainide 100mg and metoprolol 25mg. The next morning he took these same meds because he was still in AFIB. He also had flu symptoms at this time. He almost passed out and lost consciousness. He called his doctor again. He was told to stop taking the meds but to rest and keep an eye on his pulse. In the middle of the night he woke up with uncontrollable shivering like he was having a seizure. His pulse rate was 35 and pulse ox was 70%. He drank a lot of water, had Pedialyte and Gatorade. A little later the pulse rate was 42 and pulse was 90%. He was comfortable that he was getting better and the shivering had stopped so he took Tylenol and went to bed. He called his doctor again in the morning and was told to go to the ER if he had another episode like that. Over the weekend his pulse and pulse ox was lower than normal. He continued to take Tylenol for the flu like symptoms. He still feels a little bit out of balance but is better. He was told to stay in touch with the doctor and keep his follow up appt.
More
|
โ | |||||
| 2857887 | 45 | F | DE | 09/10/2025 |
PNC21 |
MERCK & CO. INC. |
Y01957 |
Injected limb mobility decreased, Injection site pain, Sleep disorder
Injected limb mobility decreased, Injection site pain, Sleep disorder
|
Severe arm pain at injection site, limiting movement Pain intensity described as unusually severe c...
Severe arm pain at injection site, limiting movement Pain intensity described as unusually severe compared to prior muscular vaccine injections Pain persistent through the night, interfering with sleep Concern about prolonged duration of symptoms - Patient alternating with taking ibuprofen and tylenol.
More
|
||||||
| 2857888 | 56 | F | MS | 09/10/2025 |
FLU3 PNC21 |
SANOFI PASTEUR MERCK & CO. INC. |
u8823ca z006889 |
Rash, Rash erythematous; Rash, Rash erythematous
Rash, Rash erythematous; Rash, Rash erythematous
|
Large red rash on shoulder, warm to the touch. Recommended cold and warm compress. Md is sending i...
Large red rash on shoulder, warm to the touch. Recommended cold and warm compress. Md is sending in a prescription.
More
|
||||||
| 2857889 | 17 | F | KS | 09/10/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
K7JY3 |
Mass, Pain, Shoulder injury related to vaccine administration
Mass, Pain, Shoulder injury related to vaccine administration
|
Severe pain and lump that has continued since receiving injection. Has seen ortho doctor on 8/26/25 ...
Severe pain and lump that has continued since receiving injection. Has seen ortho doctor on 8/26/25 that is calling this a SIRVA. Working with physical therapy
More
|