| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2855831 | 1.5 | F | ID | 08/27/2025 |
DTAP |
SANOFI PASTEUR |
3CA55C1 |
Hypersensitivity, Urticaria
Hypersensitivity, Urticaria
|
Urtica/hives to body from face, trunk, arms, and legs - Allergic reaction
Urtica/hives to body from face, trunk, arms, and legs - Allergic reaction
|
||||||
| 2855832 | 53 | F | OR | 08/27/2025 |
PNC20 TDAP |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
LC5484 XN575 |
Arthralgia, Injection site pain, Musculoskeletal discomfort; Arthralgia, Injecti...
Arthralgia, Injection site pain, Musculoskeletal discomfort; Arthralgia, Injection site pain, Musculoskeletal discomfort
More
|
Patient presents on 8/27/2025 to report muscle soreness at injection site after DOS. Approximately 1...
Patient presents on 8/27/2025 to report muscle soreness at injection site after DOS. Approximately 1 week later, muscle pain had resolved but pain in joint was more pronounced. Reports joint discomfort was concurrent w/ muscle pain since injection date. Pt was advised to take 200-400 mg of Ibuprofen nightly and was referred to physical therapy.
More
|
||||||
| 2855839 | 70 | M | CA | 08/27/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
5683MF012 |
Arthritis
Arthritis
|
Mild inflammation on his knee after having the Novavax vaccine; This non-serious initial spontaneous...
Mild inflammation on his knee after having the Novavax vaccine; This non-serious initial spontaneous report was reported by a consumer or other non-health professional via contact center (No. NOV25-00632) and concerns an elderly Male who experienced "MILD INFLAMMATION ON HIS KNEE AFTER HAVING THE NOVAVAX VACCINE" after receiving COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) on 23-Oct-2023. At the time of the report, the outcome of the event Arthritis was Recovered/Resolved. A few discrepancies were identified in the source document. Patient's age group was reported as "Adult" but was captured as "Elderly" according to the reported date of birth. The Novavax vaccination information reported for the 'Body Site Location' of the product administration was provided as "Left". Left arm was conservatively selected and will be confirmed with the query sent to the consumer.; Sender's Comments: This Male of an unspecified age experienced Arthritis after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula). The event Arthritis was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Arthritis is considered Possible.
More
|
||||||
| 2855840 | 4 | M | OR | 08/27/2025 |
MMRV |
MERCK & CO. INC. |
Z008219 |
Extra dose administered
Extra dose administered
|
Additional dose of MMRV given to patient as a new patient 4 year old child at 4 year well child chec...
Additional dose of MMRV given to patient as a new patient 4 year old child at 4 year well child check. Patient had already received 2n dose in another state at the age of 3.
More
|
||||||
| 2855841 | 0.5 | F | AZ | 08/27/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U8314AA |
Injection site bruising, Injection site mass
Injection site bruising, Injection site mass
|
Lump on thigh. Bruising still apparent after 2 months
Lump on thigh. Bruising still apparent after 2 months
|
||||||
| 2855842 | 2 | M | MT | 08/27/2025 |
VARCEL |
MERCK & CO. INC. |
x001000 |
Expired product administered
Expired product administered
|
Expired vaccine given by accident
Expired vaccine given by accident
|
||||||
| 2855843 | 60 | F | CO | 08/27/2025 |
PNC21 |
MERCK & CO. INC. |
|
Pain, Pyrexia, Somnolence
Pain, Pyrexia, Somnolence
|
Fever up to 102 achy and sleepy
Fever up to 102 achy and sleepy
|
||||||
| 2855849 | 21 | F | WI | 08/27/2025 |
FLU3 HEP TDAP |
SEQIRUS, INC. DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS |
406984 948203 H4K3S |
Blood glucose normal, Dizziness, Seizure, Urinary incontinence; Blood glucose no...
Blood glucose normal, Dizziness, Seizure, Urinary incontinence; Blood glucose normal, Dizziness, Seizure, Urinary incontinence; Blood glucose normal, Dizziness, Seizure, Urinary incontinence
More
|
Patient stated she had a history of dizziness after vaccines. After vaccines were administered, she...
Patient stated she had a history of dizziness after vaccines. After vaccines were administered, she was asked to sit in a chair in our waiting room for observation. When she tried to stand up after waiting approximately 5 minutes she started to feel dizzy, sat back down in chair, had a small seizure and lost bladder control. 911 was called and patient was evaluated by them - her blood pressure, oxygen and glucose were all within normal range. She declined paramedics taking her to the hospital.
More
|
||||||
| 2855850 | 53 | F | CA | 08/27/2025 |
PPV |
MERCK & CO. INC. |
|
Unevaluable event
Unevaluable event
|
Patient will have to go the pharmacy to get another dose of pneumovax 23
Patient will have to go the pharmacy to get another dose of pneumovax 23
|
||||||
| 2855851 | 16 | F | AZ | 08/27/2025 |
MNQ TDAP |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
U8194AA 9JT4S |
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
|
Mom provided vaccination record and according to system, child was due for TDAP and MCV4. It wasn...
Mom provided vaccination record and according to system, child was due for TDAP and MCV4. It wasn't until after these 2 vaccines were administered did mom provided a different vaccination record and asked for it to be updated. IT was then noted that TDAP and MCV had been given already. There was no adverse reaction while child was in the clinic. Mom was made aware child did not need the vaccines that were administered and asked that she always provide any records she may have to ensure accuracy.
More
|
||||||
| 2855852 | 83 | M | FL | 08/27/2025 |
PNC20 |
PFIZER\WYETH |
LP4947 |
Extra dose administered
Extra dose administered
|
Duplicate vaccine had received a Prevnar 20 on 8/17/2024 was not recorded in state Shots
Duplicate vaccine had received a Prevnar 20 on 8/17/2024 was not recorded in state Shots
|
||||||
| 2855853 | 69 | F | 08/27/2025 |
FLU3 |
SANOFI PASTEUR |
u8800ba |
Injection site erythema, Injection site warmth, Oral herpes
Injection site erythema, Injection site warmth, Oral herpes
|
pt experienced redness and skin that was warm to the touch below the left deltoid and extending down...
pt experienced redness and skin that was warm to the touch below the left deltoid and extending down towards the elbow covering 2/3 of the arm. symptoms started approximately 12 hours after immunization and lasted for nearly 3 days. no treatments administered. pt stated the reaction resolved on its own and all symptoms have disappeared. she also reported the development of a fever blister on her upper lip that appeared on 8/22 that she believes may be connected.
More
|
|||||||
| 2855855 | 66 | M | FL | 08/27/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
F4AC3 |
Chills, Extra dose administered, Fatigue, Influenza like illness, Myalgia
Chills, Extra dose administered, Fatigue, Influenza like illness, Myalgia
|
Patient had already received this vaccine in October of 2023, and received the vaccine again in erro...
Patient had already received this vaccine in October of 2023, and received the vaccine again in error on 8/25/25. Patient reported feeling okay on 8/27/25, but patient did report experiencing chills, muscle aches and fatigue (similar to flu-like symptoms) on 8/26/25.
More
|
||||||
| 1262688 | 64 | F | VA | 08/26/2025 |
COVID19 COVID19 |
JANSSEN JANSSEN |
|
Unevaluable event; Impaired driving ability, Retinal artery occlusion, Thrombosi...
Unevaluable event; Impaired driving ability, Retinal artery occlusion, Thrombosis, Vision blurred
More
|
* Reported to H.D. Nurse on May 14 ? 12th 2021
* Reported to H.D. Nurse on May 14 ? 12th 2021
|
โ | |||||
| 2855540 | IL | 08/26/2025 |
MMR |
MERCK & CO. INC. |
Y008289 |
No adverse event, Product storage error
No adverse event, Product storage error
|
No additional AE case reported; MMR II was inadvertently administered during a T/E; This spontaneous...
No additional AE case reported; MMR II was inadvertently administered during a T/E; This spontaneous report was received from a medical assistant 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 26-Jul-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), 0.5 mL, lot #Y008289, expiration date: 24-Apr-2026, administered by unknown route as prophylaxis. The vaccine was reconstituted with sterile diluent (no administration details provided). The suspect vaccine was inadvertently administered during a temperature excursion: 9.69 C for 0 hours 15 minutes 0 seconds (Product storage error). No additional AE was reported. At the reporting time, the outcome of the event was unknown. The action taken with the suspect vaccine was not reported, but established as not applicable. This is one of three cases received from the same reporter.
More
|
||||||||
| 2855541 | CA | 08/26/2025 |
HPV9 |
MERCK & CO. INC. |
Y012508 |
No adverse event, Product storage error
No adverse event, Product storage error
|
No additional AE; Medical assistant calling to report administering doses of GARDASIL 9 after a temp...
No additional AE; Medical assistant calling to report administering doses of GARDASIL 9 after a temperature excursion.; This spontaneous report was received from a medical assistant on 12-Aug-2025 and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 11-AUG-2025, the patient was vaccinated with an improperly storage dose of) with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), prefilled syringe (lot #Y012508, expiration date not reported, but upon internal validation established as 01-Jan-2027), frequency: total after temperature excursion for Prophylaxis (Product storage error). The administered dose of the vaccine experienced a temperature excursion 2.9 grade Fahrenheit for 5 minutes. No additional adverse event reported. This is one of several reports received from the same reporter (case # 2319351).
More
|
||||||||
| 2855542 | F | 08/26/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Disease recurrence, Drug ineffective
COVID-19, Disease recurrence, Drug ineffective
|
COVID 2x; COVID 2x; COVID 2x; This is a spontaneous report received from a Consumer or other non HCP...
COVID 2x; COVID 2x; COVID 2x; This is a spontaneous report received from a Consumer or other non HCP. A 62-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: "smoker" (ongoing), notes: long time. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "COVID 2x". Clinical course: The patient had COVID 2x but had only 1 shot. The reporter asked if it is possible to get 2nd, 3rd & booster shots. Also, the patient lives in a personal care home with a lot of disabled folks who always seem to be sick. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
More
|
||||||||
| 2855543 | 08/26/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
|
poor covid performance; poor covid performance; This is a spontaneous report received from a Consume...
poor covid performance; poor covid performance; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "poor covid performance". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
More
|
|||||||||
| 2855544 | F | CO | 08/26/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
|
I have COVID and I wanted to get Paxlovid but I can't afford it; I have COVID and I wanted to g...
I have COVID and I wanted to get Paxlovid but I can't afford it; I have COVID and I wanted to get Paxlovid but I can't afford it; 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)), in Jun2025 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have COVID and I wanted to get Paxlovid but I can't afford it". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
More
|
|||||||
| 2855559 | 0.17 | M | NY | 08/26/2025 |
RV5 |
MERCK & CO. INC. |
|
Blood lactic acid increased, Lactic acidosis, Leukocytosis, Pyrexia, White blood...
Blood lactic acid increased, Lactic acidosis, Leukocytosis, Pyrexia, White blood cell count increased
More
|
Fever, lactic acidosis
Fever, lactic acidosis
|
||||||
| 2855572 | 08/26/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Urticaria
Urticaria
|
broke out in hives; This non-serious case was reported by a consumer via interactive digital media a...
broke out in hives; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of hives in a 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, an unknown time after receiving Shingles vaccine, the patient experienced hives (Verbatim: broke out in hives). The outcome of the hives was not reported. It was unknown if the reporter considered the hives to be related to Shingles vaccine. It was unknown if the company considered the hives to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 18-AUG-2025 This case was reported by a patient via interactive digital media. Patient had his/her first shingle shot and broke out in hives. Now patient was wondering if he/she should take the 2nd shot or not and asked how long he/she had before next shot.
More
|
|||||||||
| 2855573 | 63 | F | TN | 08/26/2025 |
FLU3 |
SEQIRUS, INC. |
|
Vomiting
Vomiting
|
Caused vomiting for one day afterwards. Reporting for safety reasons.
Caused vomiting for one day afterwards. Reporting for safety reasons.
|
||||||
| 2855574 | 12 | M | OH | 08/26/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
47KS7 |
Wrong patient received product, Wrong product administered
Wrong patient received product, Wrong product administered
|
Pt mistakenly got the wrong vaccine at today's visit. Instead of the HPV that was ordered for h...
Pt mistakenly got the wrong vaccine at today's visit. Instead of the HPV that was ordered for him, he received the Bexsero that was intended for his sibling who was also present for his well check and in the room with him. This mistake was noted immediately and the family and pt were told of the incident. I have been in contact w mom and gave her the info and the data that is noted below. She will watch him for any side effects and we will continue to be in contact. We opted to hold off on the HPV until next visit. Info/data as below: Bexsero (meningococcal group B vaccine) has been studied in 12-year-old children. Clinical trials and post-licensure studies have included adolescents aged 10-25 years, which encompasses 12-year-olds, and have demonstrated immunogenicity and safety in this age group. The agency specifically recommended Bexsero for persons aged 10 years and older who are at increased risk for serogroup B meningococcal disease, and immunogenicity and safety data for this age range are presented in their guidelines. Randomized controlled trials and meta-analyses have evaluated immunogenicity and safety in children and adolescents under 18 years, including those aged 12, showing robust immune responses and an acceptable safety profile after the recommended two-dose series for adolescents. The vaccine is licensed for use in this age group in multiple countries, and real-world experience confirms finding from pre-licensure studies. The safety profile remains consistent across different populations and dosing schedules, with no evidence of increased risk in 12-year-olds compared to older adolescents. Continued pharmacovigilance supports the conclusion that Bexsero is generally safe and well tolerated in adolescents, with adverse events predominantly mild and transient. VAERS report done and will cont to communicate w family to follow for any SE. Pt. with no noted or experienced adverse side effects after the dose. Just received the dose accidentally and at age 12 yo.
More
|
||||||
| 2855575 | 17 | VA | 08/26/2025 |
MEN |
UNKNOWN MANUFACTURER |
|
Feeling abnormal, Pharyngitis, Streptococcus test negative
Feeling abnormal, Pharyngitis, Streptococcus test negative
|
Illness (pharyngitis) starting 15Aug25
Illness (pharyngitis) starting 15Aug25
|
|||||||
| 2855576 | 76 | F | AK | 08/26/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
MD3414 MD3414 MD3414 MD3414 |
Blood pressure increased, Bradycardia, Brain natriuretic peptide, C-reactive pro...
Blood pressure increased, Bradycardia, Brain natriuretic peptide, C-reactive protein, Cardiac monitoring abnormal; Cardiac stress test normal, Chills, Dyspnoea, Echocardiogram normal, Fatigue; Nausea, Palpitations, Positron emission tomogram, Positron emission tomogram normal, Pulse abnormal; Red blood cell sedimentation rate, Troponin, Ventricular extrasystoles, Ventricular tachycardia
More
|
chills that evening; woke up next AM with EXTREME fatigue & SOB; vitals - Bradycardia (pulse @ 4...
chills that evening; woke up next AM with EXTREME fatigue & SOB; vitals - Bradycardia (pulse @ 40-50 / normally around 100), and elevated blood pressure. (am former RN; own high quality monitoring equipment). Chose not to go to Emerg Rm; couldn't get appt to see own cardiologist. Monitored self for weeks - with abnormal pulse & hypertensive B/P inconsistent, yet persisting; more infrequent as weeks elapsed. Finally saw cardiac NP. Put on Holter monitor; result - nonsustained tachycardia with increased PVC's. Cardiologist ordered labwork, cardiac US, result: increased pulmonary hypertension; Pet CT/Stress Test, result: normal. Rx prescribed: metoprolol. Cardiac MRI to be scheduled. status currently being evaluated. Initial symptoms of reaction to vaccine also included occasional nausea and heart palpitations. This was my 10th COVID vaccine; chose to get it because of CDC recommendations. Symptoms that still persist are fatigue and shortness of breath, but they have improved.
More
|
||||||
| 2855606 | F | PR | 08/26/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Chills, Fatigue, Headache, Injection site erythema, Injection site pain; Injecti...
Chills, Fatigue, Headache, Injection site erythema, Injection site pain; Injection site swelling
More
|
Pain, redness, and swelling at the injection site; Pain, redness, and swelling at the injection site...
Pain, redness, and swelling at the injection site; Pain, redness, and swelling at the injection site Muscle pain Tiredness Headache Shivering; Pain, redness, and swelling at the injection site Muscle pain Tiredness Headache Shivering; Muscle pain; 29-JUL-2025 00:00Pain, redness, and swelling at the injection site Muscle pain Tiredness Headache Shivering; Headache; Shivering; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concomitant products included tirzepatide (Mounjaro). On 29-JUL-2025, the patient received Shingles vaccine. On 29-JUL-2025, less than a day after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: Pain, redness, and swelling at the injection site), injection site erythema (Verbatim: Pain, redness, and swelling at the injection site Muscle pain Tiredness Headache Shivering), injection site swelling (Verbatim: Pain, redness, and swelling at the injection site Muscle pain Tiredness Headache Shivering), muscle pain (Verbatim: Muscle pain), tiredness (Verbatim: 29-JUL-2025 00:00Pain, redness, and swelling at the injection site Muscle pain Tiredness Headache Shivering), headache (Verbatim: Headache) and shivering (Verbatim: Shivering). The outcome of the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache and shivering were not resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache and shivering to be related to Shingles vaccine. It was unknown if the company considered the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache and shivering to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 30-JUL-2025 The patient had pain, redness, and swelling at the injection site, muscle pain, tiredness, headache and shivering from 29 Jul 2025.
More
|
|||||||
| 2855609 | F | KY | 08/26/2025 |
PNC15 PNC15 UNK UNK |
MERCK & CO. INC. MERCK & CO. INC. UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
Y010032 Y010032 |
Bed sharing, Death, Decreased appetite, Infant irritability, Pyrexia; Unresponsi...
Bed sharing, Death, Decreased appetite, Infant irritability, Pyrexia; Unresponsive to stimuli; Bed sharing, Death, Decreased appetite, Infant irritability, Pyrexia; Unresponsive to stimuli
More
|
DEATH; INFANT IRRITABILITY; UNRESPONSIVE TO STIMULI; DECREASED APPETITE; PYREXIA; Information has be...
DEATH; INFANT IRRITABILITY; UNRESPONSIVE TO STIMULI; DECREASED APPETITE; PYREXIA; Information has been received from Food And Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (Agency #2839201-1) on 17-JUL-2025. This spontaneous report and refers to an infant (age reported as 0.75-year-old) female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-APR-2025, the patient was vaccinated with the third dose of pneumococcal 15-valent conjugate vaccine (VAXNEUVANCE) suspension for injection, administered intramuscularly in left leg, lot #Y010032, expiration date was not reported, however upon internal validation determined as 17-FEB-2027, for prophylaxis (exact dose was not reported); on the same day, she was vaccinated with 3rd dose of diphtheria vaccine toxoid (+) HIB vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (MRC 5) (+) tetanus vaccine toxoid) (PENTACEL), administered intramuscularly in right leg, lot #UK196AA, for prophylaxis (exact dose and expiration date were not reported). On 09-APR-2025, in the evening, the child had fever and fussiness; fever resolved on 10-APR-2025 (discrepancy, outcome reported as fatal), however, her fussiness persisted, and child's appetite was poor. Given child's fussiness the evening of 10-APR-2025, her mother reported that the child slept in her parent's bed. Her parents awakened to find her non-responsive on the morning of 11-APR-2025 and they activated Emergency Medical Services (EMS). Child was transported to hospital. She did not survive and was pronounced dead in the hospital (conflicting information, the onset date of the events of infant irritability, decreased appetite, pyrexia, unresponsive to stimuli, and death was reported as 11-APR-2025; she was treated at emergency room and hospitalized due to the events; she was also treated at emergency room/department or urgent care). The patient died because of the events of infant irritability, unresponsive to stimuli, decreased appetite, and pyrexia. It was unknown whether an autopsy was performed. Causality assessment was not provided. Follow up information has been received on 21-AUG-2025. Investigation summary for VAXNEUVANCE, Batch/Lot #Y010032: Reviews performed as a result of this adverse event concluded that no unexpected events arose during the manufacture of V114 0.5ML 1DOSE SYR Batch number 0001759288 material number 2016658 at MSD Carlow which could have impacted on product quality. No deviations were deemed to have an impact on the batch prior to batch disposition. All acceptance criteria were met. All components utilized in the batch underwent QC inspection and release as per applicable quality standards and site procedures prior to use in the batch. Sterility, Bioburden and endotoxin testing were performed as per approved site procedures and results met specification. Release testing conformed to all specifications. A supporting investigation was requested from the drug substance (DS) manufacturing site MSD (Inv-012951). The investigation did not highlight any issues which would compromise the quality, safety, potency or efficacy of any of the Drug Substance batches consumed in Drug product batch 0001759288. The investigation concluded that the Drug Substance batches conform to all release specifications. A supporting investigation was also completed by the MSD packaging site (Inv-012952). Based on their investigation, no systemic packaging inadequacy of package batch Y010032 were identified at the Merck manufacturing facility that could impact the quality attributes of the product. Based on this investigation of the adverse event, no systemic manufacturing inadequacy was identified at the MSD manufacturing facility that could impact the quality attributes of the product. There have been no additional requests for information or additional testing relating to this Adverse Event.; Reported Cause(s) of Death: DECREASED APPETITE; INFANT IRRITABILITY; PYREXIA; UNRESPONSIVE TO STIMULI
More
|
โ | โ | |||||
| 2855610 | 14 | M | OH | 08/26/2025 |
HPV9 HPV9 HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Z004534 Z004534 Z004534 Z004534 |
Blood thyroid stimulating hormone normal, Brain fog, C-reactive protein normal, ...
Blood thyroid stimulating hormone normal, Brain fog, C-reactive protein normal, Differential white blood cell count normal, Eye pain; Feeling abnormal, Feeling hot, Full blood count normal, General physical condition abnormal, Glycosylated haemoglobin; Headache, Mental impairment, Metabolic function test normal, Red blood cell sedimentation rate normal, Respiratory pathogen panel; Thyroxine free abnormal
More
|
Pt reports that 1-2 days after his HPV vaccine on 8/4 he developed some headaches frontal location a...
Pt reports that 1-2 days after his HPV vaccine on 8/4 he developed some headaches frontal location and a sensation of feeling hot inside without a fever or feeling hot to touch and felt unable to cool down. Pt appeared "blah" or fatigued like getting sick to mom but without other symptoms. The most concerning was his complaint of mental fog and inability to think especially worsened by activity. Pt also described feeling disconnected. Symptoms persisted 9 days when presented for evaluation. At that time had also developed left eye pain. Ordered labs to r/o any other cause for symptoms, none found. Mother stated that, as of today symptoms are improving, he is still having headaches.
More
|
||||||
| 2855611 | 1.92 | F | MI | 08/26/2025 |
DTAP HEPA |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
JF7DM L4EA4 |
Injection site cellulitis, Injection site erythema, Injection site pain, Injecti...
Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling; Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
More
|
Parent called back to clinic on 08/25/25 to inform staff injection site of Dtap was very red, swolle...
Parent called back to clinic on 08/25/25 to inform staff injection site of Dtap was very red, swollen, and hurting. Mom reported to nursing staff right thigh swelling " as big as my hand" . Advised patient's parent that day to have patient evaluated that day and to report to Urgent care for assessment. Mom called back later and stated leg was twice the size of normal reddish purple discoloration on back side of right leg near knee. Parent again advised needed to take patient to urgent care for immediate assessment. Parent called back later in the evening stating took patient to urgent care and was prescribed an antibiotic for cellulitis. Per Urgent care note patient prescribed Keflex 125mg/5mL every 8 hours x 7 days. Advised to f/u with PCP in 1 week for recheck.
More
|
||||||
| 2855612 | 19 | F | 08/26/2025 |
MENB |
PFIZER\WYETH |
LW8910 |
Pain in extremity, Rash macular, Skin warm
Pain in extremity, Rash macular, Skin warm
|
Patient received Trumenba vaccine during 8/20/25 visit. Patient sent in a provider a message with a ...
Patient received Trumenba vaccine during 8/20/25 visit. Patient sent in a provider a message with a picture showing a large red blotchy area on the patients arm. Patient states that her arm is sore and warm. RN showed message to a provider. Provider recommends patient been seen in clinic. Patient has been informed of recommendation to be seen. Provider has concerns for possible cellulitis.
More
|
|||||||
| 2855613 | 0.33 | M | UT | 08/26/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7776AA |
Refusal of vaccination
Refusal of vaccination
|
Pt mom did not want this full vaccine. It was given by mistake.
Pt mom did not want this full vaccine. It was given by mistake.
|
||||||
| 2855614 | 3 | M | NE | 08/26/2025 |
HEPA |
MERCK & CO. INC. |
Y009094 |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
|
Patient was given 1ml instead of the pediatric dose of 0.5ml. Called and spoke with his mom and she...
Patient was given 1ml instead of the pediatric dose of 0.5ml. Called and spoke with his mom and she stated no adverse effects from the vaccine.
More
|
||||||
| 2855615 | 60 | F | SC | 08/26/2025 |
PNC20 |
PFIZER\WYETH |
|
Injection site cellulitis
Injection site cellulitis
|
develop cellulitis about 1 inch below the injection site
develop cellulitis about 1 inch below the injection site
|
||||||
| 2855616 | 50 | F | OR | 08/26/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
37R35 |
Pyrexia, Rash
Pyrexia, Rash
|
Fever of 101 for two days and rash appeared-starting on their face and head, now moving down their b...
Fever of 101 for two days and rash appeared-starting on their face and head, now moving down their body.
More
|
||||||
| 2855617 | 15 | M | TX | 08/26/2025 |
MMRV |
MERCK & CO. INC. |
Z010383 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
No adverse reaction reported as of 8/26/2025 10:15am.
No adverse reaction reported as of 8/26/2025 10:15am.
|
||||||
| 2855618 | 0.33 | M | MI | 08/26/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
9C295 |
Injection site nodule
Injection site nodule
|
PATIENT RECEIVED A 1 IN X 1 IN NODULE AT THE SITE OF INJECTION.
PATIENT RECEIVED A 1 IN X 1 IN NODULE AT THE SITE OF INJECTION.
|
||||||
| 2855619 | 65 | M | WI | 08/26/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
j32pb |
Death
Death
|
Unknown. Report is made after review of medical record by medical examiner. Unknown if recent vaccin...
Unknown. Report is made after review of medical record by medical examiner. Unknown if recent vaccination had any effect of cause of death which is reported as Atherosclerotic and Hypertensive Cardiovascular Disease with Other significant conditions: diabetes mellitus, hypothyroidism, smoking, and chronic ethanol use. No autopsy was performed.
More
|
โ | |||||
| 2855620 | 17 | F | MA | 08/26/2025 |
MNQ |
SANOFI PASTEUR |
U8562AA |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Patient was scheduled to receive dose # 2 of Meningitis B Vaccine (Bexsero) but was given a third do...
Patient was scheduled to receive dose # 2 of Meningitis B Vaccine (Bexsero) but was given a third dose of Menquadfi accidentally. Pt with no side effects.
More
|
||||||
| 2855621 | 0.17 | M | OH | 08/26/2025 |
PNC15 |
MERCK & CO. INC. |
Y005465 |
Hyporesponsive to stimuli, Pyrexia
Hyporesponsive to stimuli, Pyrexia
|
Pt got a Prevnar vaccine yesterday and got a low grade temp. Around 10 pm temp went to 101.5 and he ...
Pt got a Prevnar vaccine yesterday and got a low grade temp. Around 10 pm temp went to 101.5 and he was fussy and they went to the ER. At the ER it was 101.3 and gave him Tylenol and said to call our office. This morning temp was 102 at 9:30am-10am and mom gave him Tylenol which brought it down to 99.6.
More
|
||||||
| 2855622 | 6 | M | 08/26/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
Y49BZ Z009665 |
Product administered to patient of inappropriate age; Product administered to pa...
Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
More
|
Given at wrong age.
Given at wrong age.
|
|||||||
| 2855623 | 16 | M | TX | 08/26/2025 |
MNQ |
SANOFI PASTEUR |
u8562aa |
Syncope
Syncope
|
Patient fainted shortly after vaccine administration
Patient fainted shortly after vaccine administration
|
||||||
| 2855624 | 2 | M | AZ | 08/26/2025 |
PNC20 |
PFIZER\WYETH |
LJ5282 |
Erythema, Pyrexia, Skin warm, Swelling
Erythema, Pyrexia, Skin warm, Swelling
|
WARM TO THE TOUCH, RED, SWELLING, FEVER. MOM WAS GIVING HIM TYLENOL
WARM TO THE TOUCH, RED, SWELLING, FEVER. MOM WAS GIVING HIM TYLENOL
|
||||||
| 2855625 | 69 | F | CO | 08/26/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
nr4t5 |
Dizziness, Influenza like illness
Dizziness, Influenza like illness
|
pt had severe flu like symptoms and felt like fainting
pt had severe flu like symptoms and felt like fainting
|
||||||
| 2855626 | 59 | M | NC | 08/26/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
FT95N FT95N |
Chest X-ray normal, Chills, Headache, Hyperhidrosis, Malaise; Pain, Productive c...
Chest X-ray normal, Chills, Headache, Hyperhidrosis, Malaise; Pain, Productive cough, Pyrexia, Respiratory pathogen panel, SARS-CoV-2 test negative
More
|
After immunization has been with fever, chills, diaphoresis, headaches, body aches/malaise, producti...
After immunization has been with fever, chills, diaphoresis, headaches, body aches/malaise, productive cough.
More
|
||||||
| 2855627 | 64 | F | IA | 08/26/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
GJ952 |
Injection site erythema, Injection site pruritus, Injection site swelling, Injec...
Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
More
|
GOT RED, HOT, ITCHY BAND (RASH) AROUND HER ARM. 4 INCHES WIDE AND 2 INCHES BELOW INJECTION SITE. STA...
GOT RED, HOT, ITCHY BAND (RASH) AROUND HER ARM. 4 INCHES WIDE AND 2 INCHES BELOW INJECTION SITE. STARTED 6 DAYS AFTER INJECTION. IT WAS LOCATED BELOW THE INJECTION SITE WHERE HER FREESYTLE LIBRE WAS. SHE REPORTED HAVING SOME SWELLING AT THE INJECTION SITE FOR A DAY/TWO AFTER THE INJECTION THAT HAS NOW DISSIPATED.
More
|
||||||
| 2855628 | 0.58 | M | CA | 08/26/2025 |
DTAPIPV |
SANOFI PASTEUR |
U8383AB |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
I gave patient DTap-IPV when I was supposed to give patient Vaxelis. No symptoms, patient waiting in...
I gave patient DTap-IPV when I was supposed to give patient Vaxelis. No symptoms, patient waiting in the room for 15 minutes and there was no reaction to the vaccine.
More
|
||||||
| 2855629 | 53 | M | CA | 08/26/2025 |
FLU3 |
SANOFI PASTEUR |
u8800ca |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
NO ADVERSE REACTION NOTED. PATIENT REQUESTED THE HIGH DOSE FLU VACCINE.
NO ADVERSE REACTION NOTED. PATIENT REQUESTED THE HIGH DOSE FLU VACCINE.
|
||||||
| 2855630 | 4 | F | CA | 08/26/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
5C79N |
Incorrect route of product administration, No adverse event
Incorrect route of product administration, No adverse event
|
no symptoms,no signs, vaccine was placed subcutaneous route instead of intramuscular
no symptoms,no signs, vaccine was placed subcutaneous route instead of intramuscular
|
||||||
| 2855631 | 12 | M | MT | 08/26/2025 |
TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Dizziness, Gait disturbance, Heart rate increased, Malaise, Pallor; Tinnitus, Vi...
Dizziness, Gait disturbance, Heart rate increased, Malaise, Pallor; Tinnitus, Visual impairment
More
|
About 5 minutes after vaccination. White complexion, dizzy, seeing spots and colors, ears ringing, r...
About 5 minutes after vaccination. White complexion, dizzy, seeing spots and colors, ears ringing, rapid heartbeat, not feeling well, trouble walking. We sat him down and the pharmacist had us call EMS just to be safe. EMTs came and checked his vitals. After about 20 minutes he started feeling better and we went home and he just relaxed.
More
|
||||||
| 2855632 | 08/26/2025 |
COVID19 DTPIHI PNC20 RV5 RVX |
MODERNA UNKNOWN MANUFACTURER PFIZER\WYETH MERCK & CO. INC. UNKNOWN MANUFACTURER |
|
Body temperature, Irritability, Pyrexia, Somnolence; Body temperature, Irritabil...
Body temperature, Irritability, Pyrexia, Somnolence; Body temperature, Irritability, Pyrexia, Somnolence; Body temperature, Irritability, Pyrexia, Somnolence; Body temperature, Irritability, Pyrexia, Somnolence; Body temperature, Irritability, Pyrexia, Somnolence
More
|
sleepy; irritable/ cranky; fever; This spontaneous report was received from a Consumer or other non ...
sleepy; irritable/ cranky; fever; This spontaneous report was received from a Consumer or other non health professional and refers to a patient of unknown age and gender. The patient's concurrent conditions and concomitant therapies were not reported. The patient previously had fever and irritability with other symptoms with vaccines at 2 months, 4 months (same as other vaccines received on 11 Jul-2025). On 11-Jul-2025, the was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dosage form administered by oral route (exact dose, lot # and expiration date were not reported) for prophylaxis (indication reported as unknown but by default changed to prophylaxis). On the same day, the patient started therapy with clesrovimab (ENFLONSIA) (reported as RSV vaccine) prefilled syringe, 1 dosage form administered by unknown route for unknown indication (exact dose, lot # and expiration date were not reported). On the same day, he was vaccinated with a dose of COVID-19 vaccine mRNA omicron (KP.2) Moderna (MODERNA COVID-19 VACCINE) dose 1 administered intramuscularly (lot # and expiration date were not reported) for COVID-19; with a dose of Pneumococcal vaccine conj 20v (CRM197) 1 dosage form administered by unknown route for unknown indication (expiration date, and lot # were not reported); and with a dose of Diphtheria vaccine (+) Hepatitis b vaccine (+) HIB vaccine (+) Pertussis vaccine (+) Polio vaccine (+) Tetanus vaccine 1 dosage form administered by unknown route for unknown indication (indication, expiration date, and lot # were not reported). It was reported that the patient received first dose of Moderna Covid vaccine at 6-month checkup along with RSV, rotavirus, and other standard vaccines. The patient received the vaccine at noon. On 11-Jul-2025, the patient experienced somnolence (sleepy). On the same day at 5:00 PM, the patient experienced irritability (irritable/ cranky) and pyrexia (fever). On that day at 5:00 PM, body temperature was 101 F. It was also reported that, post vaccination, the patient developed fever and he was sleepy with irritable symptom which started about two hours after vaccination. He was feverish and cranky until mid-day on 13-Jul-2025. The fever never reached over 101 F. From 11-Jul-2025 to 13-Jul-2025, the patient was treated with paracetamol (TYLENOL) (oral use) at a dose of 2.5 milliliter every four hours. Paracetamol (TYLENOL) significantly improved the symptoms. The patient did not experience any additional symptoms or events. On 12-Jul-2025, somnolence had resolved. On 13-Jul-2025, irritability and pyrexia had resolved. The action taken with COVID-19 vaccine mRNA omicron (KP.2) Moderna (MODERNA COVID-19 VACCINE) was unknown (by default changed to not applicable). The action taken with clesrovimab (ENFLONSIA) was not reported. The action taken with Diphtheria vaccine (+) Hepatitis b vaccine (+) HIB vaccine (+) Pertussis vaccine (+) Polio vaccine (+) Tetanus vaccine, Pneumococcal vaccine conj 20v (CRM197) and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was not applicable. The causal relationship between the reported adverse events and the suspect therapies was not reported.; Sender's Comments: Priority : 4 , Is case serious : No , Index user : , Index date : 2025-07-28 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : MOD-2025-788098 , Central date : 2025-07-28 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
More
|