| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2849757 | 12 | M | CA | 07/15/2025 |
TDAP |
SANOFI PASTEUR |
U8274AA |
Myelitis transverse
Myelitis transverse
|
diffuse myelitis C3-lumbar spine
diffuse myelitis C3-lumbar spine
|
โ | |||||
| 2849758 | 18 | M | SC | 07/15/2025 |
MENB |
PFIZER\WYETH |
LP6524 |
Injection site reaction
Injection site reaction
|
The following day he developed a large local reaction at the site of injection.
The following day he developed a large local reaction at the site of injection.
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| 2849759 | 8 | M | 07/15/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
P2443 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Child here for HepA and HepB vaccines. Child given adult Twinrix. Child tolerated well and left clin...
Child here for HepA and HepB vaccines. Child given adult Twinrix. Child tolerated well and left clinic. Supervisor made aware. Consult with states nurse who states to advise parent of possible increased local reactions. Per vaccine website, Twinrix may be used in children for rapid catch-up schedule, however, this clinics standing order is for 18 years and older.
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| 2849760 | 46 | F | CA | 07/15/2025 |
TD |
SANOFI PASTEUR |
U7927AA |
Arthralgia, Moaning, Myalgia, Pain in extremity, Paraesthesia
Arthralgia, Moaning, Myalgia, Pain in extremity, Paraesthesia
|
About 2 to 3 weeks after the vaccine administration, the patient reported symptoms consisting of pro...
About 2 to 3 weeks after the vaccine administration, the patient reported symptoms consisting of progressively worsening right shoulder, deltoid and humerus pain. It started out as a mild soreness, but then evolved into much more severe pain with reduced range of motion, and paresthesias radiating distally into the wrist and hand. She also reported some pain in the parascapular region on the right side. She denied any bruising or swelling or direct trauma to the area and also there was no history of heavy exertion surrounding the time of the development of her symptoms. There were no fevers, chills or night sweats. Initial laboratory findings did not demonstrate any signs of inflammatory markers. She was referred to pain management and diagnoses of brachial neuritis and possible Parsonage-Turner syndrome were entertained. She was referred to physical therapy and acupuncture, which has helped to some degree. She continues with treatment, and also experiences persistent symptoms and functional impairment in the right upper extremity.
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| 2849761 | 1.5 | M | SC | 07/15/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
Y97N7 |
Cellulitis
Cellulitis
|
Patient went to ER and diagnosed with cellulitis was given antibiotics for treatment and will follow...
Patient went to ER and diagnosed with cellulitis was given antibiotics for treatment and will follow up in clinic.
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| 2849762 | 1 | F | FL | 07/15/2025 |
MMR MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
Y013171 Z007214 |
No adverse event, Wrong product administered; No adverse event, Wrong product ad...
No adverse event, Wrong product administered; No adverse event, Wrong product administered
More
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MD order placed for MMR & Varicella separate. MMR & PROQUAD given instead.
MD order placed for MMR & Varicella separate. MMR & PROQUAD given instead.
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| 2849763 | 12 | F | WI | 07/15/2025 |
HPV9 |
MERCK & CO. INC. |
Y013565 |
Retching, Syncope
Retching, Syncope
|
Pt was stressed prior to receiving vaccine. Upon receiving vaccine pt fainted for a moment. Pt was c...
Pt was stressed prior to receiving vaccine. Upon receiving vaccine pt fainted for a moment. Pt was caught by pt's mom, no injuries sustained. While laying down pt started gagging. Sat pt up and she threw up, minimal to moderate amount. Pt received glass of water to rinse mouth and family stated this wasn't an unexpected reaction. Pt started feeling fine and after an assessment from provider she was cleared to leave. Pt walked out on her own.
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| 2849765 | 6 | F | CA | 07/15/2025 |
VARCEL |
MERCK & CO. INC. |
Y017063 |
Pyrexia
Pyrexia
|
Received Varicella vaccine on 7/2/25. Developed fever at nighttime on 7/9/25, mom unsure if numbers ...
Received Varicella vaccine on 7/2/25. Developed fever at nighttime on 7/9/25, mom unsure if numbers were accurate as the temporal thermometer was ranging between 101-105 however, patient did not show symptoms of high fever such as lethargy. She was able to drink fluids and urinate normally. The fever lasted 48 hours. Mom denies any other symptoms including chills, body aches, cough, congestion. Overall, she was just tired and napping which she doesn't normally. All symptoms have resolved currently
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| 2849766 | 63 | F | CA | 07/15/2025 |
PNC21 |
MERCK & CO. INC. |
Z004302 |
Circumstance or information capable of leading to medication error, Underdose
Circumstance or information capable of leading to medication error, Underdose
|
During vaccine administration, patient jerked and withdrew her arm triggering vaccine administrator ...
During vaccine administration, patient jerked and withdrew her arm triggering vaccine administrator to withdraw needle to prevent injury, some of the vaccine content from the syringe leaked and dripped down patient's arm. A full dose of vaccine was not delivered to the patient. No other adverse events reported. Primary care physician was contacted, prescriber does not want patient to repeat the dose immediately, patient to repeat the dose in a year per prescriber's instruction.
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| 2849767 | 56 | F | FL | 07/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
H97H2 |
Injection site inflammation, Injection site pruritus
Injection site inflammation, Injection site pruritus
|
experienced itching and inflammation in the site of administration; experienced itching and inflamma...
experienced itching and inflammation in the site of administration; experienced itching and inflammation in the site of administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a female patient who received Herpes zoster (Shingrix) (batch number H97H2, expiry date 28-FEB-2027) for prophylaxis. On 20-MAY-2025, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site itching (Verbatim: experienced itching and inflammation in the site of administration) and injection site inflammation (Verbatim: experienced itching and inflammation in the site of administration). The outcome of the injection site itching and injection site inflammation were unknown. It was unknown if the reporter considered the injection site itching and injection site inflammation to be related to Shingrix. It was unknown if the company considered the injection site itching and injection site inflammation to be related to Shingrix. Additional Information: GSK receipt date: 30-JUN-2025 Other HCP needed guidance after a 56-year-old female patient that received the first dose of Shingrix on 20 May 2025, experienced itching and inflammation in the site of administration of the vaccine for a couple of weeks. She wanted to know how to proceed and if the scheduled second dose could be administered. Also, the health care provider mentioned that the patient received simultaneously the same day another vaccine whose name was not known, and she does not know which vaccine triggered the reaction.
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| 2849768 | 68 | F | CO | 07/15/2025 |
COVID19 |
MODERNA |
|
Arthralgia, Injection site pain, Muscular weakness
Arthralgia, Injection site pain, Muscular weakness
|
About November 7, noticed pain in arm at area of injection. Pain continued to spread and is now fel...
About November 7, noticed pain in arm at area of injection. Pain continued to spread and is now felt from the top of my shoulder to my wrist. Result is continual pain whether using the arm or not, weakness
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| 2849769 | 80 | M | 07/15/2025 |
COVID19 RSV |
MODERNA GLAXOSMITHKLINE BIOLOGICALS |
|
Cerebrovascular accident, Death; Cerebrovascular accident, Death
Cerebrovascular accident, Death; Cerebrovascular accident, Death
|
Death, suspected stroke
Death, suspected stroke
|
โ | ||||||
| 2849770 | 27 | F | NC | 07/15/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
Antibody test positive, Biopsy skin abnormal, Blood test, Delivery, Erythema mul...
Antibody test positive, Biopsy skin abnormal, Blood test, Delivery, Erythema multiforme; Exposure during pregnancy, Neonatal disorder, Rash
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mother (reporter) states that her daughter was born. She was diagnosed 2 heart murmurs. She had hyp...
mother (reporter) states that her daughter was born. She was diagnosed 2 heart murmurs. She had hypertrophic cardiomyopathy that is genetic from her biological grandfather. The mother herself then developed a rash all of her body. She saw multiple doctors. She ended up having to have a biopsy performed by Dr. and diagnosed with Erythema multiforme. They also found an antibody in her blood and may have either APS or a blood clot disorder. At this time she is waiting for blood results to confirm diagnosis.
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โ | โ | ||||
| 2849771 | 58 | F | CO | 07/15/2025 |
MMR MMR VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Arthralgia, Asthenia, Condition aggravated, Fibromyalgia, Mobility decreased; Pa...
Arthralgia, Asthenia, Condition aggravated, Fibromyalgia, Mobility decreased; Pain; Arthralgia, Asthenia, Condition aggravated, Fibromyalgia, Mobility decreased; Pain
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Worsening of fibromyalgia and all -over body and joint pain. Patient states she could not get out of...
Worsening of fibromyalgia and all -over body and joint pain. Patient states she could not get out of bed for a week. Very weak. Patient went to PCP one month later and is still experiencing symptoms.
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| 2849772 | 0.42 | M | RI | 07/15/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
|
Fatigue, Pyrexia
Fatigue, Pyrexia
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also got prevenar vaccine same day, developed fever that lasted for 5 days, up to 101, and he was ve...
also got prevenar vaccine same day, developed fever that lasted for 5 days, up to 101, and he was very tired x 5 days, just concerned about length of fever, no other viral symptoms at that time
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| 2849773 | 41 | M | WA | 07/15/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
JANSSEN JANSSEN JANSSEN JANSSEN JANSSEN JANSSEN |
211A21A 211A21A 211A21A 211A21A 211A21A 211A21A |
CSF shunt operation, Cardiovascular symptom, Cerebral bypass surgery, Cerebral e...
CSF shunt operation, Cardiovascular symptom, Cerebral bypass surgery, Cerebral endovascular aneurysm repair, Cerebral haemorrhage; Chest X-ray normal, Chest discomfort, Colposcopy normal, Computerised tomogram head abnormal, Craniotomy; Dysphagia, Dyspnoea, Eye pain, Fall, Glial scar; Headache, Impaired work ability, Intracranial aneurysm, Intracranial pressure increased, Magnetic resonance imaging head abnormal; Mental impairment, Panic attack, Rectal haemorrhage, Rectal prolapse, Scan with contrast normal; Seizure, Sensory disturbance, Shunt malfunction, Somnolence
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My employer in Sept 2021, even though the CDC came out and stated the shots were not effective, they...
My employer in Sept 2021, even though the CDC came out and stated the shots were not effective, they still gave us a vaccination mandate, My employer threated our jobs if we did not get that vaccination, I put on the consent form that i did not consent, they made me a copy and gave me the shot. That night i woke up to a feeling of something coming up my legs going into my liver to my spline and all the way up to my chest and my chest got tight and it got hard to breathe and hard to swallow and by 6:30 in the morning it was settled in to the back of my left eye. at 8:30 the pain was so intense in my head that i went and took a nap on the couch and i didnt wake up till 4:30 in the afternoon and i never do that. My wife woke me up and asked me if i wanted to go out or stay home and rest, the headache was still there but it was not as bad. So i got up and started to get ready around 5:40 the pain in my head was gone. On April 7th 2 years later, i was working on a project at the house and i told my wife i was gonna do one more thing and then start cleaning up my tools, something popped in my head and i told my wife something is not right. I laid on the floor, i went into a seizure, my wife called 911 and had my son roll me on my side, took me to hospital, did a CT scan and said nothing was wrong in my head but they would order an MRI in the morning, The MRI showed all the blood in my head and they gave me a couple options for hospitals i could go to. I saw Dr., they looked at the artery in my forearm and they were not big enough, so they took the artery out of my leg to do the bypass surgery. They doctor that Dr wanted on the team was gone for a week so he wanted to wait till the Dr was back. A Dr. drilled a hole in my skull and drained some of the fluid out. The surgery was done April 15, They did another Ct Scan April 16th they found another aniersm in my brain , they went into my left thigh and put coils in the aneurism so it would not bother me. May 28-29 they asked me how i was doing with motor skills and speech, my motor skills were fine but sometimes i would be talking to my wife and my mind would go completely blank on the next work that i wanted to say. Because of all the scaring in my brain wasn't using all the fluid that it needed and it was building up and causing pressure. So they on June 13th they had to do a surgery to place a shunt to relieve that. The shunt malfunctioned and i had to go to the ER they had to air lift me to the hospital and they removed the shunt and they put a new shunt June 18th 2024, I was then dealing with all of the side effects of neuro surgery, I was having panic attacks at work and was falling backwards a coworker caught me. the fire department came to my job and began assessing me, and a conversation my nurse had with my wife states that the side effects were normal from brain surgery i was off work from Nov - Jan. I went back to work feeling like i was mentally back to being my old self. About a month later , i began having heart attack symptoms, i had this happen about 4-5 times that last about 15-20 mins, the last one i had, my wife and i were outside planting some plants. I had another one happen at work and i left work and went to the ER, they did a chest Xray and did a CT with contrast to check to see if i was developing an anerisum in my brain , they all came back clear. They doctors didnt know why i was dealing with what i was dealing with in my heart. June 22 i had another episode its lasted for an hour and 5 min i went to the ER at 8:10 in the morning, they ran all the test and they all came back normal, I was recommended to cardiologist and they are scheduled out till 2026 and to get a referral to a different cardiologist. They gave me a new referral and i called them to make an appointment and they did not have anyone to run the machine for a stress test on the heart, and told me to get a referral to another one outside of the area. I am currently waiting for them to review the referral. On May 15 my rectum is now hanging out , i went to use the restroom , and it felt like there was still something that needed to come out and so i pushed something crowned but did not come out i kept pushing but nothing would drop, so i wiped to knocked out whatever it was, and my right hand was covered with blood. So google hemorrhoids on my phone and i knew that , that wasn't it so i knew i had to take a picture of what was going on, and i googled it , and it stated it was a prolapsed rectum. It took me an hour to get it back in i washed my hands and informed my coworker that i needed to leave and needed to go to ER, I went to the ER they took care of things and he gave me a referral they told me that i could have a tumor in there and it is pushing and i needed a colposcopy, I had that done July 1st 2025 and it came back clear and i need to get my prostate checked and i am waiting on a referral from my doctor.
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โ | |||||
| 2849774 | 75 | M | 07/15/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
DD72H U8361AA |
Death, Pneumonia; Death, Pneumonia
Death, Pneumonia; Death, Pneumonia
|
Patient was hospitalized for pneumonia and died while admitted on 7/9
Patient was hospitalized for pneumonia and died while admitted on 7/9
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โ | ||||||
| 2849775 | 2 | F | 07/15/2025 |
DTAPHEPBIP HIBV PNC20 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH |
|
Extra dose administered; Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered; Extra dose administered
|
MEMBER WAS GIVEN EXTRA DOSES OF VACCINE THAT WERE NOT INDICATED AT THAT TIME.
MEMBER WAS GIVEN EXTRA DOSES OF VACCINE THAT WERE NOT INDICATED AT THAT TIME.
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| 2849776 | 73 | F | MN | 07/15/2025 |
PPV |
MERCK & CO. INC. |
GM9410 |
Injection site pain
Injection site pain
|
The patient has had 2 years of pain in the right deltoid muscle following the PCV vaccine she receiv...
The patient has had 2 years of pain in the right deltoid muscle following the PCV vaccine she received in that location. She states she still feels like the needle is going into her arm in the site of the injection. There are no shoulder joint symptoms.
More
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โ | |||||
| 2849777 | 80 | M | 07/15/2025 |
PNC20 |
PFIZER\WYETH |
LX4484 |
Pruritus
Pruritus
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Patient came in today stating he had itching about a week after he got the Prevnar vaccine. He start...
Patient came in today stating he had itching about a week after he got the Prevnar vaccine. He started itching a bout a week after injection. It was more local initially then spread to the back/trunk etc. He stated it is a better today since he started using cortisone ointment. He will follow up with his doctor to see if he should do anything else
More
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| 2849778 | 12 | M | PA | 07/15/2025 |
HPV9 |
MERCK & CO. INC. |
Y008640 |
Fall, Fatigue, Head injury, Syncope
Fall, Fatigue, Head injury, Syncope
|
Post administration mom and son (patient) were checking out at front desk and patient experienced sy...
Post administration mom and son (patient) were checking out at front desk and patient experienced syncope, fell backwards. Vitals taken immediately (all WNL). Patient stated he hit the back of his head and was feeling "tired". 911 was called for ED evaluation. Mom did state that patient was very anxious about receiving the vaccine and had not eaten or drank anything today.
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| 2849779 | 0.5 | M | AL | 07/15/2025 |
DTAPIPVHIB HEP PNC20 RV5 |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH MERCK & CO. INC. |
UK226AA 5JX2E LN4930 Y015021 |
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; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
More
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Patient was given in office for 6 month well visit. Patient was given Hep B Adult 1ml vs the ordered...
Patient was given in office for 6 month well visit. Patient was given Hep B Adult 1ml vs the ordered Hep B Pediatric 0.5ml dose in error. As soon as staff realized the error she informed the provider and clinic supervisor. We reported immediately to the parents and completed an internal accident/incident report. Mom will monitor and report any infant fever, increased fussiness and/or redness and swelling to injection sight.
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| 2849780 | 65 | F | 07/15/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
|
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Patient unknowingly received 2 Arexvy vaccines (1 on 12/5/23, and another on 7/14/25). The first vac...
Patient unknowingly received 2 Arexvy vaccines (1 on 12/5/23, and another on 7/14/25). The first vaccine did not show up in the vaccine registry . In addition, the patient did not remember receiving the first dose. She is fine and has not experienced any side effects after receiving the second dose, as per our conversation on 7/15/25.
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| 2849781 | 30 | F | MI | 07/15/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
Unknown |
Chills, Fatigue, Myalgia, Pain
Chills, Fatigue, Myalgia, Pain
|
Upper arm muscular pain. Body aches, tiredness, muscle soreness, fatigue, chills, teeth chattering
Upper arm muscular pain. Body aches, tiredness, muscle soreness, fatigue, chills, teeth chattering
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| 2849782 | 41 | F | MO | 07/15/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
U8122AA |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
This was a vaccine error: Dr. ordered Td for patient, but her medical assistant gave Tdap ins...
This was a vaccine error: Dr. ordered Td for patient, but her medical assistant gave Tdap instead. No adverse reactions and the order was changed to Tdap.
More
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| 2849783 | 74 | M | OH | 07/15/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
NDC: 58160-0842 |
Condition aggravated, Tinnitus
Condition aggravated, Tinnitus
|
Severe deterioration of pre-existing tinnitus.
Severe deterioration of pre-existing tinnitus.
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| 2849784 | 10 | M | WA | 07/15/2025 |
HPV9 |
MERCK & CO. INC. |
Y008843 |
Ear pain, Nausea, Oropharyngeal pain, Pruritus, Throat irritation
Ear pain, Nausea, Oropharyngeal pain, Pruritus, Throat irritation
|
Pt experienced itchy, painful throat and ears along with nausea about 30 mins after receiving HPV #1...
Pt experienced itchy, painful throat and ears along with nausea about 30 mins after receiving HPV #1. Noi SOB, rash/hives, swelling or vomiting . Was given Zyrtec 10 mg at home with improvement in sx an hour later.
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| 2849785 | 19 | F | TX | 07/15/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
5JX2E |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Maladministration of Adult Dose on a Pediatric Patient; Maladministration of Adult Dose on a Pediatr...
Maladministration of Adult Dose on a Pediatric Patient; Maladministration of Adult Dose on a Pediatric Patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B adult) (batch number 5JX2E, expiry date 14-DEC-2026) for prophylaxis. On 07-JUL-2025, the patient received the 1st dose of Engerix B adult. On 07-JUL-2025, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: Maladministration of Adult Dose on a Pediatric Patient) and adult product administered to child (Verbatim: Maladministration of Adult Dose on a Pediatric Patient). The outcome of the overdose and adult product administered to child 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: 07-JUL-2025 The patient had administered a twenty microgram (adult dose) on a nineteen year old patient (first and only dose administered) which led to adult product administered to child and overdose. Vaccination date, vaccine detail and patient demographics were obtained in this call. No further information was obtained in this call.
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| 2849786 | 1 | M | MI | 07/15/2025 |
MMR |
MERCK & CO. INC. |
|
Febrile convulsion
Febrile convulsion
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Febrile seizures
Febrile seizures
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| 2849787 | 43 | M | TX | 07/15/2025 |
COVID19 |
MODERNA |
|
Chest pain, Dyspnoea, Hypertension
Chest pain, Dyspnoea, Hypertension
|
After my 2nd dose of the Moderna covid vaccine, after i left the facility and got home i noticed i c...
After my 2nd dose of the Moderna covid vaccine, after i left the facility and got home i noticed i could feel/hear my heart beat in my left ear non stop as well as chest pains (which hasn't gone away). I also experienced shortness of breath which i've NEVER felt ANY of these symptoms ever in my life. After checking my blood pressure level was critical i went to the ER, however after explaining to the nurses i just had my 2nd covid shot i was told NOT to bring that up to the doctor that would be treating me! That it would only confuse the doctor trying to treat me. They did an EKG said it was "the most beautiful EKG the nurse ever seen," A1C was normal & lungs showed fine. They gave me some high blood pressure med to lower it & sent me on my way. However i still to this day have the same symptoms i went to the ER for, & noticed only recently the FDA added warnings to the Pfizer & Moderna of possible heart side effects like swelling of the heart which i believe i have
More
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| 2849788 | 13 | M | TX | 07/15/2025 |
MNQ TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U8375AA U8115AA |
Injection site erythema, Injection site swelling; Injection site erythema, Injec...
Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling
More
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Pt woke up next day with red raised area around vaccine area. Next day it progressed from the shoul...
Pt woke up next day with red raised area around vaccine area. Next day it progressed from the shoulder down to the elbow. Mom gave Benadryl BID x 2 days and then it resolved
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| 2849790 | 4 | F | MO | 07/15/2025 |
DTAPIPV MMR VARCEL |
SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
U7838AA Y008592 Z005455 |
Wrong product administered; Wrong product administered; Wrong product administer...
Wrong product administered; Wrong product administered; Wrong product administered
More
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This is a vaccine addition: Doctor ordered MMRV (Proquad), but medical assistant only gave MMR, so ...
This is a vaccine addition: Doctor ordered MMRV (Proquad), but medical assistant only gave MMR, so doctor changed order to MMR and Varicella.
More
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| 2849791 | 37 | F | NJ | 07/15/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
FL3209 FL3209 FL3209 FK9729 FK9729 FK9729 |
Biopsy breast abnormal, Breast cancer female, Fatigue, Full blood count, Haemogl...
Biopsy breast abnormal, Breast cancer female, Fatigue, Full blood count, Haemoglobin decreased; Hypotension, Infection parasitic, Mammogram abnormal, Parasitic test positive, Syncope; Ultrasound scan; Biopsy breast abnormal, Breast cancer female, Fatigue, Full blood count, Haemoglobin decreased; Hypotension, Infection parasitic, Mammogram abnormal, Parasitic test positive, Syncope; Ultrasound scan
More
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Fainting spells, Low hemoglobin tested and shown, Low blood pressure, Blurry vision, Breast cancer, ...
Fainting spells, Low hemoglobin tested and shown, Low blood pressure, Blurry vision, Breast cancer, fatigue, Parasities
More
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โ | |||||
| 2849792 | 11 | M | CA | 07/15/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
Z002580 DL4YY U8252AA |
Head injury, Lip injury, Syncope; Head injury, Lip injury, Syncope; Head injury,...
Head injury, Lip injury, Syncope; Head injury, Lip injury, Syncope; Head injury, Lip injury, Syncope
More
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Patient ad a syncopal episode in the lobby on check out about 2:50pm. He collapsed and hit his chin ...
Patient ad a syncopal episode in the lobby on check out about 2:50pm. He collapsed and hit his chin on the counter resulting in him biting his lower lip. No teeth loose or damaged. No tongue injury. He also thinks he hit his forehead on the counter but no marks, bruises, swelling or deformity on his head exam. He was brought back to an exam room and laid down on exam table. Vitals: BP 119/73, HR 58, O2 sat 97%. He was observed for 15 minutes and repeat vitals: BP 121/69, HR 64, O2 sat 99%. He was awake, alert, oriented and able to converse normal. He was able to sit up and then also stand and walk without further dizziness or syncope. D/c home, mom given instructions to call the clinic prn any new or worsening symptoms.
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| 2849793 | 4 | M | WA | 07/15/2025 |
DTAPIPV |
SANOFI PASTEUR |
U8203CB |
Injection site erythema, Injection site pain, Injection site warmth
Injection site erythema, Injection site pain, Injection site warmth
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Swelling of right quad with pain, erythema, and warmth extending to bilateral sides and distal quad
Swelling of right quad with pain, erythema, and warmth extending to bilateral sides and distal quad
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| 2849794 | 43 | F | NC | 07/15/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
Z27PB |
Wrong product administered
Wrong product administered
|
Patient came in to receive second dose of Hepatitis A. Patient previously had a dose of Twinrix on 0...
Patient came in to receive second dose of Hepatitis A. Patient previously had a dose of Twinrix on 04/24/25. Patient completed Hep B series through final dose of Twinrix, however she needed to complete her Hep A vaccination. Patient traveling and is completing requirements for travel. Patient received Havrix when patient should have received a Twinrix to finish series. Patient received vaccine and walked out of clinic. RN called patient and made her aware that if she begins to have any allergic reactions, to go to her nearest ER. Patient verbalized understanding.
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| 2849795 | 78 | M | MT | 07/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3J2S2 |
Arthralgia, Myalgia, Pain
Arthralgia, Myalgia, Pain
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Sore shoulder, still sore after 11 days, radiating down into bicep
Sore shoulder, still sore after 11 days, radiating down into bicep
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| 2849797 | 1 | M | NC | 07/15/2025 |
HIBV MMRV PNC20 VARCEL |
SANOFI PASTEUR MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
UK193AA Y008281 LN4928 Y014181 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event
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Vaccines were just given today, no adverse events had happened as of yet
Vaccines were just given today, no adverse events had happened as of yet
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| 2849798 | 12 | M | TX | 07/15/2025 |
MNQ TDAP |
NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
2JZ53 3CA30C1 |
Injection site erythema, Injection site induration, Injection site warmth; Injec...
Injection site erythema, Injection site induration, Injection site warmth; Injection site erythema, Injection site induration, Injection site warmth
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Induration, with erythema, warmth to touch, no pain to site
Induration, with erythema, warmth to touch, no pain to site
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| 2849799 | 35 | M | FL | 07/15/2025 |
COVID19 COVID19 |
JANSSEN JANSSEN |
1822811 1822811 |
Chemotherapy, Colon cancer stage III, Colon operation, Genetic testing, Imaging ...
Chemotherapy, Colon cancer stage III, Colon operation, Genetic testing, Imaging procedure; Investigation, Iron deficiency anaemia
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I received the Johnson & Johnson COVID-19 vaccine on 10/27/2021. At the time of vaccination, I w...
I received the Johnson & Johnson COVID-19 vaccine on 10/27/2021. At the time of vaccination, I was healthy with no known genetic or familial predisposition for colon cancer. On 8/2/2023, I was diagnosed with iron deficiency anemia. Follow-up screenings led to a diagnosis of Stage 3c colon cancer on 8/22/2024. I have since undergone major surgery, chemotherapy, and multiple imaging scans. Genetic testing has ruled out any hereditary factors. My oncologists have not confirmed a direct link to the vaccine, but also have not ruled it out. This report is filed to document the timeline and establish a potential association between the vaccine and this rare, late-onset diagnosis in an otherwise healthy individual.
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โ | โ | โ | |||
| 2849800 | 51 | M | PA | 07/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3ZX3E |
Expired product administered
Expired product administered
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gave Shingrix vaccine before they realize that have been expired; This non-serious case was reported...
gave Shingrix vaccine before they realize that have been expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 3ZX3E, expiry date 02-JUL-2025) for prophylaxis. On 10-JUL-2025, the patient received the 1st dose of Shingrix. On 10-JUL-2025, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: gave Shingrix vaccine before they realize that have been expired). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 10-JUL-2025 The Vaccine Administration Facility was the same as Primary Reporter A Registered Nurse reported that a dose of the Shingrix vaccine was administered before realizing that the vaccine had expired which led to expire vaccine used.
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| 2849801 | 57 | F | MT | 07/15/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
PJ353 PJ353 |
Erythema, Fatigue, Headache, Malaise, Nausea; Pain in extremity, Peripheral swel...
Erythema, Fatigue, Headache, Malaise, Nausea; Pain in extremity, Peripheral swelling
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About 24 hours after injection, pt reported that her arm became painful, red, and swollen. Urgent C...
About 24 hours after injection, pt reported that her arm became painful, red, and swollen. Urgent Care (within same building) was consulted and recommended ice, Benadryl, NSAID, and watchful waiting vs having pt come in to be seen. Follow up on 7/10 (4 days after injection) pt reported her arm was getting better and improving, however, she reported that the day before (3 days after injection) she had a headache, was nauseous, sick, and tired. It wasn't as bad today, but still feeling sick.
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| 2849802 | 44 | F | CA | 07/15/2025 |
PNC20 |
PFIZER\WYETH |
LN4928 |
Headache, Injection site pain, Injection site swelling
Headache, Injection site pain, Injection site swelling
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Patient stopped by after her lab draw to let us know that she received her PCV 20 vaccine and that a...
Patient stopped by after her lab draw to let us know that she received her PCV 20 vaccine and that after midnight she started feeling soreness at the injection site and headache. She was wondering if that was normal. I reviewed with her the VIS in spanish with her and noted to her that those are know effects after vaccination. To monitor symptoms fro the next 24-48 hours if no improvement to contact us. Injection site was clear of redness or irritation, mild swelling note, ice pack given to patient and advised to ice intermittently on-off every 10-15 minutes for comfort. Patient accepted and understood.
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| 2849803 | 2 | F | MD | 07/15/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
F3Y25 |
Expired product administered
Expired product administered
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Expired dose administered; This non-serious case was reported by a nurse via call center representat...
Expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-year-old female patient who received HAV (Havrix) (batch number F3Y25, expiry date 15-FEB-2025) for prophylaxis. On 10-JUL-2025, the patient received Havrix. On 10-JUL-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used 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: 11-JUL-2025 On 11th July 2025, a nurse practitioner called to report that a medical assistant had used a dose of Havrix which had expired and had been administered to a patient, which led to Expired vaccine used. According to the reporter, the dose had expired on 15th February 2025 and had been administered on 10th July 2025.
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| 2849804 | M | MD | 07/15/2025 |
PNC20 |
PFIZER\WYETH |
LW1951 |
Cerebrovascular accident, Impaired work ability
Cerebrovascular accident, Impaired work ability
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life-threatening stroke; This is a spontaneous report received from a Consumer or other non HCP. A ...
life-threatening stroke; This is a spontaneous report received from a Consumer or other non HCP. A male patient received pneumococcal 20-valent conjugated vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 11Jul2025 as dose number unknown, 0.5ml single (Lot number: LW1951) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (life threatening, medically significant), outcome "recovering", described as "life-threatening stroke". Clinical course: Due to a life-threatening stroke he had and him currently being in recovering he is unable to work.
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| 2849805 | 76 | F | MA | 07/15/2025 |
TD |
SANOFI PASTEUR |
2CA81C1 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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inappropriate use due to administration of an expired vaccine with no reported adverse event; Initia...
inappropriate use due to administration of an expired vaccine with no reported adverse event; Initial information received on 11-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 76-year-old female patient and is reported inappropriate use due to administration of an expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Jul-2025, the patient received a Booster dose 0.5 ml of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection of lot 2CA81C1 and expiry date: 04-Jul-2025 via intramuscular route in the left deltoid for immunization had inappropriate use due to administration of an expired vaccine with no reported adverse event (expired product administered) (latency: on 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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| 2849806 | M | TX | 07/15/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK225AB |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
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received the lyophilized ACTHib component reconstituted with 0.7mL sterile water (MMR diluent) and d...
received the lyophilized ACTHib component reconstituted with 0.7mL sterile water (MMR diluent) and did not receive any of the liquid DTaP/IPV portion, with no reported adverse event; Initial information received on 11-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age male patient who was only received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (VERO)] the lyophilized acthib component reconstituted with 0.7ml sterile water (mmr diluent) and did not receive any of the liquid portion 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 15v (CRM197) (Vaxneuvance) and Rotavirus vaccine live reassort oral 5v (Rotateq) for Immunisation. On 11-Jul-2025, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection, lot UK225AB,expiry date:31-Jul-2026,strength:standard,via unknown route in the left thigh for immunisation,only lyophilized acthib component reconstituted with 0.7ml sterile water (mmr diluent) and did not receive any of the liquid portion, 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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| 2849807 | 0.5 | IL | 07/15/2025 |
HIBV |
SANOFI PASTEUR |
UK3066AA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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administration of expired dose of ACT-HIB with no reported adverse event; Initial information receiv...
administration of expired dose of ACT-HIB with no reported adverse event; Initial information received on 14-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 6 months old and unknown gender patient who was administered expired dose of HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Jul-2025, the patient received an unknown dose of expired suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (lot UK3066AA and expiry date 30-Jun-2025) (strength not reported) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (Latency: same day). Reportedly, There was no extended stability data on Act Hib after expiration. 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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| 2849808 | 1.33 | M | FL | 07/15/2025 |
HIBV |
SANOFI PASTEUR |
UK210AA |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
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administered acthib using sterile water as diluent instead of the acthib diluent with no reported ae...
administered acthib using sterile water as diluent instead of the acthib diluent with no reported ae; Initial information received on 14-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 16 months old male patient who was administered HIB (PRP/T) VACCINE [ACT-HIB] using sterile water as diluent instead of the acthib diluent 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 (Dtap), Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) and Hepatitis a vaccine (Hepa) for prophylactic vaccination (Immunisation). On 14-Jul-2025, the patient received a dose of 0.5 ml (dose 4) of suspect HIB (PRP/T) vaccine using sterile water as diluent instead of the acthib diluent (formulation: Powder and solvent for solution for injection) (lot UK210AA and expiry date 28-Feb-2026) (frequency: once and strength not reported) via unknown route in the left thigh for immunization 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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| 2849810 | 1.25 | M | CO | 07/15/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UK233AC UK093AB |
Wrong product administered; Wrong product administered
Wrong product administered; Wrong product administered
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Gave the patient Pentacel instead of Dtap vaccine.
Gave the patient Pentacel instead of Dtap vaccine.
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