| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2850870 | 38 | M | IA | 07/23/2025 |
FLU3 |
SEQIRUS, INC. |
388471 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Aged 38 yr old rec'd the Adjuvanted flu vaccine intended for over 65yr. Recipient picked up t...
Aged 38 yr old rec'd the Adjuvanted flu vaccine intended for over 65yr. Recipient picked up the wrong form, certified pharmacy technician /vaccinator did not check the age at top of form.
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| 2850871 | 53 | M | IA | 07/23/2025 |
FLU3 |
SEQIRUS, INC. |
388471 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
recipient was under 65yr, inadvertently rec'd Adjuvanted flu vaccine. Patient selected wrong f...
recipient was under 65yr, inadvertently rec'd Adjuvanted flu vaccine. Patient selected wrong form. Certified Pharm Tech/Vaccinator administered shot without noticing age <65yr.
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| 2850872 | 61 | M | IA | 07/23/2025 |
FLU3 |
SEQIRUS, INC. |
388471 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Recipient was administered Flu vaccine intended for >65yr. Recipient was under 65 yr old. Wrong ...
Recipient was administered Flu vaccine intended for >65yr. Recipient was under 65 yr old. Wrong form was completed, Certified Pharm Tech/Vaccinator did not notice patient age.
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| 2850873 | 0.33 | M | CO | 07/23/2025 |
DTPPVHBHPB PNC20 RV1 |
MSP VACCINE COMPANY PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
U8313AA MF0416 3Z34X |
Diarrhoea, Haematochezia, Mucous stools; Diarrhoea, Haematochezia, Mucous stools...
Diarrhoea, Haematochezia, Mucous stools; Diarrhoea, Haematochezia, Mucous stools; Diarrhoea, Haematochezia, Mucous stools
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Patient was in for his well check 1 week ago. Parents report that he developed diarrhea that evening...
Patient was in for his well check 1 week ago. Parents report that he developed diarrhea that evening (Tuesday) that continued through Saturday w/5-6 episodes of diarrhea daily. He had a small amount of blood and mucus in 1 stool each day on Friday and Saturday. He had no associated symptoms including fever. There was no change in his diet through this time. He is breastfeeding and Mom reports no change to her diet either. His stools, mood, and appetite have been normal since Saturday. Discussed potential sources of diarrhea and bloody stools, not likely milk protein allergy with spontaneous resolution and unchanged diet. Discussed that this may be due to Rotarix vaccine. There are postmarketing reports of hematochezia, no recommendation noted for subsequent doses.
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| 2850874 | 43 | M | IA | 07/23/2025 |
FLU3 |
SEQIRUS, INC. |
388471 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Patient was under 65yr old but rec'd vaccine intended for >65yr. Wrong form was completed a...
Patient was under 65yr old but rec'd vaccine intended for >65yr. Wrong form was completed and Certified Pharm Tech/Vaccinator did not notice age<65yr.
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| 2850875 | 13 | F | PA | 07/23/2025 |
FLU3 |
SEQIRUS, INC. |
|
Complex regional pain syndrome, Joint injury, Ligament rupture
Complex regional pain syndrome, Joint injury, Ligament rupture
|
crps developed from minor ankle fix and ligament tear. no period for 8 months after injury. had regu...
crps developed from minor ankle fix and ligament tear. no period for 8 months after injury. had regular periods prior. pain did not match injury that should have healed and went onto a pain free life.
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| 2850876 | 1 | M | CO | 07/23/2025 |
HIBV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y015929 Z003767 |
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
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These vaccines were given too soon. The mother of the child stated there was no adverse reaction. Th...
These vaccines were given too soon. The mother of the child stated there was no adverse reaction. The mother is advised to seek medical care if the child experiences any adverse reactions. She was also advised to return to the clinic for these vaccines at an appropriate time frame.
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| 2850877 | 7 | F | CO | 07/23/2025 |
HEP HEP |
MERCK & CO. INC. MERCK & CO. INC. |
x000179 X002469 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
|
When MA tried to pull immunization information into our system the system did not pull patients vacc...
When MA tried to pull immunization information into our system the system did not pull patients vaccines over. So it made it look like the patient did not have any vaccines done. So, a Hep B was given and then the patient came back on 05/05/2025 and got the 2nd dose. The Mom ended up finding their vaccine records and when we researched it a little more patient had already had all 3 hep B vaccines when she was younger.
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| 2850878 | 76 | F | OR | 07/23/2025 |
COVID19 |
MODERNA |
|
Asthenia, Dizziness, Fatigue
Asthenia, Dizziness, Fatigue
|
fatigue, weakness, decreased energy, dizziness started the following day
fatigue, weakness, decreased energy, dizziness started the following day
|
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| 2850879 | 0.75 | F | 07/23/2025 |
DTAP |
SANOFI PASTEUR |
|
Erythema, Induration, Pain
Erythema, Induration, Pain
|
Local erythema, induration, and pain.
Local erythema, induration, and pain.
|
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| 2850880 | 1 | M | ND | 07/23/2025 |
HIBV MMR PNC20 VARCEL |
SANOFI PASTEUR MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
UK208AA Y008289 MF0415 Y017062 |
Abdominal mass; Abdominal mass; Abdominal mass; Abdominal mass
Abdominal mass; Abdominal mass; Abdominal mass; Abdominal mass
|
1 cm raised round movable lump right groin; 1 cm round flat lump noted in left groin - parents disco...
1 cm raised round movable lump right groin; 1 cm round flat lump noted in left groin - parents discovered lumps today. Vaccination occurred one week ago. Nurse recommended infant be seen by provider in walk in.
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| 2850881 | 13 | M | OH | 07/23/2025 |
MMR MMR |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
90707ORD 90707ORD |
Bronchospasm, Cough, Fatigue, Inflammation, Lymphadenopathy; Mucous stools
Bronchospasm, Cough, Fatigue, Inflammation, Lymphadenopathy; Mucous stools
|
severe lymphadenopathy, fatigue, cough/bronchospasm x 3 weeks. Then developed mucous in the stool/g...
severe lymphadenopathy, fatigue, cough/bronchospasm x 3 weeks. Then developed mucous in the stool/gut inflammation.
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| 2850882 | 53 | F | AL | 07/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
N77J2 |
Erythema, Skin warm, Swelling, Tenderness
Erythema, Skin warm, Swelling, Tenderness
|
Patient experienced ADRs in the form of swelling, redness, warm, and pain to the touch that lasted ...
Patient experienced ADRs in the form of swelling, redness, warm, and pain to the touch that lasted for over 6 weeks. The pain still remains.
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| 2850883 | 16 | M | MI | 07/23/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
k7jy3 57h54 |
Fall, Loss of consciousness; Fall, Loss of consciousness
Fall, Loss of consciousness; Fall, Loss of consciousness
|
patient was given both immunizations while sitting on exam table and right after patient passed out ...
patient was given both immunizations while sitting on exam table and right after patient passed out while sitting down. He fell backwards and slid down wall. Patient was then laid flat with feet elevated and regained consciousness within 30 seconds.
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| 2850884 | 19 | F | MI | 07/23/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
4BX39 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Patient has already completed Hepatitis B vaccination series (3-doses). Additional 4th dose was admi...
Patient has already completed Hepatitis B vaccination series (3-doses). Additional 4th dose was administered by error and was not recommended. Pt has no adverse reaction to Hepatitis B vaccine in the past and no reaction currently experienced by patient. Patient was informed immediately and CDC was contacted to make this report.
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| 2850885 | 16 | M | TX | 07/23/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AH7Z3 |
Headache
Headache
|
frontal headache
frontal headache
|
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| 2850886 | 1 | M | AR | 07/23/2025 |
DTPPVHBHPB DTPPVHBHPB HEPA HEPA MMRV MMRV PNC15 PNC15 |
MSP VACCINE COMPANY MSP VACCINE COMPANY GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
U8313AA U8313AA H3N97 H3N97 Z003311 Z003311 Y010035 Y010035 |
Asthenia, Diarrhoea, Feeling abnormal, Injection site pain, Injection site vesic...
Asthenia, Diarrhoea, Feeling abnormal, Injection site pain, Injection site vesicles; Irritability, Personality change, Pyrexia, Rash, Rash erythematous; Asthenia, Diarrhoea, Feeling abnormal, Injection site pain, Injection site vesicles; Irritability, Personality change, Pyrexia, Rash, Rash erythematous; Asthenia, Diarrhoea, Feeling abnormal, Injection site pain, Injection site vesicles; Irritability, Personality change, Pyrexia, Rash, Rash erythematous; Asthenia, Diarrhoea, Feeling abnormal, Injection site pain, Injection site vesicles; Irritability, Personality change, Pyrexia, Rash, Rash erythematous
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On 7/18/2025, the child developed a blister spot at the site of injection on left thigh, began to ha...
On 7/18/2025, the child developed a blister spot at the site of injection on left thigh, began to have a 103 fever for two days, diarrhea, and red spots developed all over the child's body. The blister spot, diarrhea, and red spots have continued and mother thinks the red spots have continued to spread. Child has been very upset and the site is very tender. Mother reports that the daycare told him that he zones out, no energy, and is not his usual self.
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| 2850887 | 1 | F | MI | 07/23/2025 |
HIBV |
SANOFI PASTEUR |
UK016AC |
Expired product administered
Expired product administered
|
Vaccine was given after expiration date.
Vaccine was given after expiration date.
|
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| 2850888 | 40 | M | FL | 07/23/2025 |
UNK |
UNKNOWN MANUFACTURER |
9429j |
Electrocardiogram, Hypoaesthesia
Electrocardiogram, Hypoaesthesia
|
arm numbness; observation; symptom resolved
arm numbness; observation; symptom resolved
|
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| 2850889 | 12 | F | TN | 07/23/2025 |
HPV9 HPV9 HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y013565 Y013565 Y013565 Y013565 |
Pain in extremity; Pain in extremity; Pain in extremity; Pain in extremity
Pain in extremity; Pain in extremity; Pain in extremity; Pain in extremity
|
Patient has experienced prolong soreness of the arm - Administered on 6/30/2025, Mom called 7/14/20...
Patient has experienced prolong soreness of the arm - Administered on 6/30/2025, Mom called 7/14/2025 to report she is still experiencing pain, advised to treat with Aleve. 7/22/2025 office called to check on patient, patient pain has improved but still present. Due to ongoing pain, MD prescribed Medrol dose pack. Mom to call back if pain is not improved after completion.
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| 2850890 | 1 | F | WA | 07/23/2025 |
HEPA MMRV PNC15 VARCEL |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y018512 Z007210 Z004473 Z003767 |
Extra dose administered, No adverse event, Wrong product administered; Extra dos...
Extra dose administered, No adverse event, Wrong product administered; Extra dose administered, No adverse event, Wrong product administered; Extra dose administered, No adverse event, Wrong product administered; Extra dose administered, No adverse event, Wrong product administered
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No adverse event. Gave the wrong vaccine. Patient was supposed to get an MMR and varicella separatel...
No adverse event. Gave the wrong vaccine. Patient was supposed to get an MMR and varicella separately at 12 mos. Instead received a Proquad and Varicella. They received a double dose of varicella.
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| 2850891 | 4 | M | AZ | 07/23/2025 |
COVID19 |
PFIZER\BIONTECH |
LN6739 |
Product storage error
Product storage error
|
The covid vaccine's 10-week refrigerated use by date was 7/21/25. Vaccine was administered to p...
The covid vaccine's 10-week refrigerated use by date was 7/21/25. Vaccine was administered to patient on 7/22/25.
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| 2850892 | 2 | M | CA | 07/23/2025 |
DTAP DTAP HEPA HEPA HIBV HIBV MMR MMR VARCEL VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
5KR3R 5KR3R H3N97 H3N97 UK229AA UK229AA Y008289 Y008289 Z003767 Z003767 |
Cough, Cyanosis, Erythema, Fatigue, Flushing; Hypotension, Nystagmus, Somnolence...
Cough, Cyanosis, Erythema, Fatigue, Flushing; Hypotension, Nystagmus, Somnolence, Vomiting; Cough, Cyanosis, Erythema, Fatigue, Flushing; Hypotension, Nystagmus, Somnolence, Vomiting; Cough, Cyanosis, Erythema, Fatigue, Flushing; Hypotension, Nystagmus, Somnolence, Vomiting; Cough, Cyanosis, Erythema, Fatigue, Flushing; Hypotension, Nystagmus, Somnolence, Vomiting; Cough, Cyanosis, Erythema, Fatigue, Flushing; Hypotension, Nystagmus, Somnolence, Vomiting
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About 15 min after the family left and had vaccines administered, mother called the office stating t...
About 15 min after the family left and had vaccines administered, mother called the office stating that child was turning bright red, coughing and vomiting, and not acting himself. They were asked to return to the office immediately. Upon entering the office, doctor noticed the child was very flushed - no urticaria was noted and lungs were clear. Oral Benadryl was given in office, 3 ml Only x 1 and within less than 2 minutes , the child is drowsy, he looked tired and non toxic. At 11:06 AM child appeared sleepy, he did take benadryl 3 ml PO and 2 sips of water and was falling asleep. Blood pressure was checked 87/38 continuous O2 sat was put on right big toe and was 91-97 waxing an waning HR 127-144 had peripheral acrocyanosis, remained flushed to face and chest, had perioral cyanosis. EMS arrived within 10 minutes. O2 started non rebreather Sats increased charge given- discussed possible allergic reaction to vaccine (MMR) Vs seizure - possibly post ictal Epinephrine given for weight right thigh by EMS in discussion with this MD- for possible allergic reaction Patient remained without urticaria, or wheezing, but low blood pressure, flushed skin, and falling asleep- wakes up and then with Nystagmus (seemingly Post ictal in examination) non verbal now, whereas prior to vaccines was talkative. Discussed with mother Patient left with EMS and mother on stretcher with car seat at approx. 11:30 AM. Charge nurse at Hospital through transfer center contacted by this MD and charge given with full History of today's events.
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| 2850893 | 54 | M | MT | 07/23/2025 |
PNC20 |
PFIZER\WYETH |
LN4931 |
Injection site erythema, Injection site induration
Injection site erythema, Injection site induration
|
Right deltoid induration and redness. Picture taken and placed in chart 7/23/25. No systemic sympt...
Right deltoid induration and redness. Picture taken and placed in chart 7/23/25. No systemic symptoms.
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| 2850894 | 15 | F | PA | 07/23/2025 |
MMR |
MERCK & CO. INC. |
Y017527 |
Headache, Lymphadenopathy, Oropharyngeal pain, Pyrexia, Rash morbilliform
Headache, Lymphadenopathy, Oropharyngeal pain, Pyrexia, Rash morbilliform
|
Patient's mother reports fever, sore throat, swollen lymph nodes, headache. Measles like rash d...
Patient's mother reports fever, sore throat, swollen lymph nodes, headache. Measles like rash developed 3 days later.
More
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| 2850895 | 8 | M | 07/23/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
47Y5M |
No adverse event, Vaccination error
No adverse event, Vaccination error
|
The patient had no symptoms or reaction. This report is being submitted for documentation of a vacci...
The patient had no symptoms or reaction. This report is being submitted for documentation of a vaccine administration error, which is appropriate under VAERS guidelines
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| 2850896 | 66 | F | AZ | 07/23/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
K4JH7 |
No adverse event, Underdose
No adverse event, Underdose
|
Hep B pediatric/adolescent 0.5 ml was administered, adult dose is 1 ml, a second dose of Hep B 0.5 ...
Hep B pediatric/adolescent 0.5 ml was administered, adult dose is 1 ml, a second dose of Hep B 0.5 ml was administered to = 1 ml. adult dose, Pt. had no adverse reactions/events
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| 2850897 | 6 | M | MT | 07/23/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U8313AA |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
Pt was inadvertently given a Vaxelis vs just the DTap. No reaction / side effects noted.
Pt was inadvertently given a Vaxelis vs just the DTap. No reaction / side effects noted.
|
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| 2850898 | 13 | M | GA | 07/23/2025 |
HEPA VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
A3X2K YO13348 |
Pruritus, Skin discolouration, Swelling, Swelling face, Urticaria; Pruritus, Ski...
Pruritus, Skin discolouration, Swelling, Swelling face, Urticaria; Pruritus, Skin discolouration, Swelling, Swelling face, Urticaria
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SPOKE WITH MOTHER ON 7/23/2025 SHE REPORTED THAT SON HAD REACTION ON 07/16/2025 THAT EVENING AT HOME...
SPOKE WITH MOTHER ON 7/23/2025 SHE REPORTED THAT SON HAD REACTION ON 07/16/2025 THAT EVENING AT HOME. REACTION CONSISTED OF ITCHING, HIVES, LUMPS AND DISCOLORATION ON FACE AND BACK. MOTHER STATED HER SISTER IN LAW IS A PEDIATRICIAN SHE GAVE HIM SOME MEDICATION THAT CLEARED IT UP, MOTHER STATES SHE DOES NOT RECALL THE NAME OF MEDICATION.
More
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| 2850899 | 4 | M | GA | 07/23/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
SKB3RT93 MSDY005000 |
Injection site erythema, Injection site swelling; Injection site erythema, Injec...
Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling
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|
------------------------------------------------------------------------------------- PATIENT IN CLI...
------------------------------------------------------------------------------------- PATIENT IN CLINIC FOR REDNESS AND SWELLING OF LEFT DELTOID WHERE KINRIX WAS GIVEN. MOM STATES THEY NOTICED IT MONDAY NIGHT, NO FEVER NOTICED. PATIENT IS ALLERGIC TO TYLENOL AND ZYRTEC AND MOTRIN GIVEN LAST NIGHT AND TODAY. LEFT DELTOID MEASUREMENT IS 9 INCHES, RIGHT (NON-SWOLLEN ARM FOR REFERENCE) IS 8 INCHES. DISTRICT PROGRAM MANAGER CONSULTED AND RECOMMENDS VAERS TO BE DONE AS WELL AS COLD COMPRESS. IF WORSENS, SEE PCP.
More
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| 2850900 | 56 | F | OH | 07/23/2025 |
HEP HEP MMR MMR |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
|
Blood test, Dizziness, Dyspnoea, Headache, Lymphadenopathy; Pyrexia, X-ray; Bloo...
Blood test, Dizziness, Dyspnoea, Headache, Lymphadenopathy; Pyrexia, X-ray; Blood test, Dizziness, Dyspnoea, Headache, Lymphadenopathy; Pyrexia, X-ray
More
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Fever, trouble breathing, dizzy, headache, swollen glands
Fever, trouble breathing, dizzy, headache, swollen glands
|
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| 2850901 | 75 | F | OR | 07/23/2025 |
PNC20 |
PFIZER\WYETH |
MF0425 |
Rash, Skin warm
Rash, Skin warm
|
Patient came into doctors office with rash hot to touch that patient stated started on the evening o...
Patient came into doctors office with rash hot to touch that patient stated started on the evening of Sunday 07/20/2025.
More
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| 2850902 | 61 | F | 07/23/2025 |
HEPAB HEPAB |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
B9279 B9279 |
Hyperhidrosis, Hypoaesthesia, Nasopharyngitis, Neck pain, Pain in extremity; Som...
Hyperhidrosis, Hypoaesthesia, Nasopharyngitis, Neck pain, Pain in extremity; Somnolence
More
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I got a funny pain, and all of sudden i started feeling a travel pain and the pain spread up. It wen...
I got a funny pain, and all of sudden i started feeling a travel pain and the pain spread up. It went up the arm and back down the arm. And it went all the way to neck and it was numbing out. And it was painful but it was numb after. It went across the side of my face and whole side of my face was numb. It was just a bad reaction that the nurse checked to see if i had a stroke at the same moment and the whole area reacted. But the face numbing i have never had happen from any other vaccine i have ever had in my life. I think that it spread with my blood as the vaccine was going throughout my body, It took 2 days for the side effects to leave. Now on the injection site there was no swelling no redness no nothing you could not even see that i had an injection and the injection site did not even bleed. Just the side of my bottom was numb but not my leg just the upper body. On the 21st i broke into a heart sweat, every inch of my was wet including my scalp. I went and took and shower and when i went to the bathroom the toilet seat was wet, I was very careful in the shower i was in there for no more then 10 mins. I do not know if that was from the shot or from the weather. I have been more sleepy. It is possible that i have a cold, but i am just not sure if this came from the shot or not.
More
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| 2850903 | 68 | F | NV | 07/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
n9k4g |
Back pain, Injection site pain, Neck pain, Pain, Product administered at inappro...
Back pain, Injection site pain, Neck pain, Pain, Product administered at inappropriate site
More
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Pt reported extreme radiating pain from site of shot given upwards toward neck and upper back. Pt st...
Pt reported extreme radiating pain from site of shot given upwards toward neck and upper back. Pt stated she went to her personal physician and was told that a nerve was likely struck with the needle during administration, and that the shot was likely given too deeply. Pt stated she is of smaller size and the needle was very long.
More
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| 2850904 | 07/23/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
|
covid vac did not work; covid vac did not work; This is a spontaneous report received from a Consume...
covid vac did not work; covid vac did not work; 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 "covid vac did not work". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2850906 | 11 | M | NJ | 07/23/2025 |
TDAP |
SANOFI PASTEUR |
2CA69C1 |
Expired product administered
Expired product administered
|
administration of an expired ADACEL with no reported adverse event; Initial information received on ...
administration of an expired ADACEL with no reported adverse event; Initial information received on 21-Jul-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 11 years old male patient who was administered of an expired diphtheria-2/tetanus/5 ac pertussis vaccine 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 Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) and HPV vaccine VLP rL1 9v (yeast) (Gardasil 9) both for prophylactic vaccination (Immunisation). On 21-Jul-2025, the patient received an unknown dose of expired suspect diphtheria-2/tetanus/5 ac pertussis vaccine, Suspension for injection (lot 2CA69C1, expiry date: 20-Jul-2025, strength: standard and frequency: once) via intramuscular route in the left deltoid for immunization with no reported adverse event (expired product administered) (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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| 2850907 | 63 | M | TX | 07/23/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
p2443 |
Blood glucose decreased
Blood glucose decreased
|
patient states that about an hour and a half after receiving the Twinrx vaccine his sugar dropped dr...
patient states that about an hour and a half after receiving the Twinrx vaccine his sugar dropped drastically.
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| 2850908 | 0.17 | F | VA | 07/23/2025 |
DTPPVHBHPB DTPPVHBHPB RV5 RV5 |
MSP VACCINE COMPANY MSP VACCINE COMPANY MERCK & CO. INC. MERCK & CO. INC. |
U7788AA U7788AA 2081735 2081735 |
Crying, Dyskinesia, Infant irritability, Muscle twitching, Myoclonus; Tremor; Cr...
Crying, Dyskinesia, Infant irritability, Muscle twitching, Myoclonus; Tremor; Crying, Dyskinesia, Infant irritability, Muscle twitching, Myoclonus; Tremor
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Infant with new onset of infantile abnormal movements with upper and lower extremity tremor/jerking ...
Infant with new onset of infantile abnormal movements with upper and lower extremity tremor/jerking movements on day of immunization. she was increasingly irritable. infant was laying on her back, alert and crying/irritable, when she developed dyssynchronous upper extremity tremor/myoclonus. Not symmetric, not rhythmic, does not spread from 1 lateral extremity to the other, infant awake and alert throughout event. Some myoclonic activity/twitching of lower extremities noted as well. Did not seem significantly fatigued following this unusual movement. Has had no further events since day of vaccination.
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| 2850909 | 39 | M | TX | 07/23/2025 |
HEP HEPA |
DYNAVAX TECHNOLOGIES CORPORATION MERCK & CO. INC. |
945664 Y017625 |
Chills, Trismus; Chills, Trismus
Chills, Trismus; Chills, Trismus
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patient came to pick up prescription on 07/23/2025 during counseling he mentioned on 05/16/2025 he g...
patient came to pick up prescription on 07/23/2025 during counseling he mentioned on 05/16/2025 he got HEPLISAV AND VAQUTA . He stated he had locked jaw and severe chills from the vaccine but felt better after 24 hours
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| 2850910 | 16 | F | NM | 07/23/2025 |
MENB |
PFIZER\WYETH |
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Hyperhidrosis, Injection site swelling, Paraesthesia, Pyrexia
Hyperhidrosis, Injection site swelling, Paraesthesia, Pyrexia
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Mother states child developed fever, sweating, prickly sensation in chest and throughout arm on 07/2...
Mother states child developed fever, sweating, prickly sensation in chest and throughout arm on 07/22/2025, swelling to injection site, mother provided ibuprofen and cold pack for patient.
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| 2850927 | 28 | M | MI | 07/23/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
9jt4s |
Asthenia, Dizziness, Pallor, Peripheral coldness, Swelling
Asthenia, Dizziness, Pallor, Peripheral coldness, Swelling
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Extreme paleness, sweating, coldness of hands, light headedness, dizziness and weakness onset within...
Extreme paleness, sweating, coldness of hands, light headedness, dizziness and weakness onset within minutes of vaccination. Patient was told to bring head down to between knees, cool compress applied to forehead. Patient watched under observation for 30 minutes after recovery.
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| 2850928 | 88 | F | CA | 07/23/2025 |
PNC20 |
PFIZER\WYETH |
LN4929 |
Injection site erythema
Injection site erythema
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PT SITE OF INJECTION DEVELOPED RASH THAT WENT DOWN TO HER ELBOWS. PT WAS SEEN AT THE DR TO EVALUATE....
PT SITE OF INJECTION DEVELOPED RASH THAT WENT DOWN TO HER ELBOWS. PT WAS SEEN AT THE DR TO EVALUATE. NO OTHE REACTION
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| 2850929 | 1 | F | CA | 07/23/2025 |
HEPA HIBV MMR PNC20 VARCEL |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH MERCK & CO. INC. |
A3X2K UK230AA YO19905 LJ5282 U7907AA |
Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration
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N/A
N/A
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| 2850930 | 53 | M | CA | 07/23/2025 |
YF |
SANOFI PASTEUR |
UK36AB |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Gave yellow fever vaccine instead of typhoid vaccine. Treatment: Informed travel clinic doctor (Dr.)...
Gave yellow fever vaccine instead of typhoid vaccine. Treatment: Informed travel clinic doctor (Dr.). Informed patient and Supervisor (RN), Cbc with Diff ordered. Patient will return next day for a typhoid vaccine with in 24 hours of receiving yellow fever vaccine as instructed by Dr. Outcome, no adverse reaction per patient at this time.
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| 2850931 | 17 | M | CA | 07/23/2025 |
HPV9 MNQ |
MERCK & CO. INC. SANOFI PASTEUR |
Y009051 U8438AA |
Blood glucose normal, Chills, Tremor; Blood glucose normal, Chills, Tremor
Blood glucose normal, Chills, Tremor; Blood glucose normal, Chills, Tremor
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Gardasil and MenQuadfi were administered, then labs were drawn. When the patient walked to the front...
Gardasil and MenQuadfi were administered, then labs were drawn. When the patient walked to the front office after the lab draw to check out, the patient started shivering/shaking. NP was notified immediately by MA of patient's condition and NP went immediately to assess the patient. No signs or symptoms of uticaria, swelling, lightheadedness, syncope, or shortness of breath visualized or reported by pateint. Caregivers gave patient Pedialyte and a candy bar, which the patient ingested. The patient was monitored for 15 minutes. Symptoms improved and pateint stated "I'm feeling better." Patient, Father and Aunt were counseled to go to ER if symptoms worsen, and all verbalized understanding. Patient was able to ambulate safely to his personal vehicle with his Father. 07/23/2025 @12:00PM
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| 2850932 | 32 | F | FL | 07/23/2025 |
RSV |
PFIZER\WYETH |
Abrysvo |
Expired product administered, Exposure during pregnancy
Expired product administered, Exposure during pregnancy
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On 7/10/25, the patient was dispensed Abrysvo by facility to take to the provider's office for ...
On 7/10/25, the patient was dispensed Abrysvo by facility to take to the provider's office for administration. The patient was at 36 weeks per confirmation from the provider. On 7/18/25, the provider's office called and said the dose was expired stating 04/2025. Our system shows we entered expiration 6/2028, lot # H765. We assumed the dose had not been administered and were prepared to investigate and reissue another dose. Upon more inquiries, spoke with patient 7/19 and again with the doctor office today 7/23, confirming the administration date was 7/10/25 for the possibly expired dose. Their record shows Lot # HM9854. We do not have the package to confirm the expiration date was 4/2025 or Lot #.
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| 2850933 | 4 | M | CA | 07/23/2025 |
HIBV |
MERCK & CO. INC. |
Y020467 |
Injection site nodule, Rash
Injection site nodule, Rash
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Large Hard nodule at vaccine injection site. And new rash appeared on his right side of chest.
Large Hard nodule at vaccine injection site. And new rash appeared on his right side of chest.
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| 2850628 | 07/22/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; still got it; This serious case was reported by a nurse via interacti...
Suspected vaccination failure; still got it; This serious case was reported by a nurse via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got it). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 14-JUN-2025 This case was reported by a patient via interactive digital media. The patient had been vaccinated twice and still got it/broke out with it. The vaccine may have reduced the severity, it was not 100 percent effective. Also, the patient did not trust any vaccines anymore. As a nurse, the patient used to. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (doses 1 and 2).
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| 2850636 | 0.42 | M | AK | 07/22/2025 |
DTPPVHBHPB HPV9 RV5 |
MSP VACCINE COMPANY MERCK & CO. INC. MERCK & CO. INC. |
U7829AA X024560 2037483 |
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
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5 month old male infant given a dose of Gardisil 9, this is an early dose. No current event besides ...
5 month old male infant given a dose of Gardisil 9, this is an early dose. No current event besides being given an immunization several years before it was due. No signs/symptoms. pt to be observed by family and brought to clinic if any issues.
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| 2850642 | TX | 07/22/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
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Product storage error
Product storage error
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vial was inadvertently put in the freezer overnight and exposed to freezing temperatures; This non-s...
vial was inadvertently put in the freezer overnight and exposed to freezing temperatures; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: vial was inadvertently put in the freezer overnight and exposed to freezing temperatures). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 11-JUL-2025 Registered nurse reported that Menveo 1vial was inadvertently put in the freezer overnight and exposed to freezing temperatures which led to incorrect storage of drug. The normal person who accepted shipments at the clinic was not there and she was not at work. No further details were shared.
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