| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2825446 | 79 | F | TX | 02/07/2025 |
FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. |
|
Arthralgia, Feeling cold, Gait disturbance, Hypoaesthesia, Pain in extremity; Pe...
Arthralgia, Feeling cold, Gait disturbance, Hypoaesthesia, Pain in extremity; Peripheral swelling
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I have swelling in my legs & my arms when I lay down. I feel real cold. I feel achey in my heel ...
I have swelling in my legs & my arms when I lay down. I feel real cold. I feel achey in my heel the right heel. My shoulders are still hurting. I feel numb in my right leg can't walk to good.
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| 2824813 | 19 | F | CA | 02/06/2025 |
MEN |
UNKNOWN MANUFACTURER |
U8194AA |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
19 year old patient who received her MENQUADFI dose mistakenly. She received it 2 1/2 years after he...
19 year old patient who received her MENQUADFI dose mistakenly. She received it 2 1/2 years after her 2nd dose with no reported adverse event; Initial information received on 03-Feb-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 19 years old female patient who received her MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] dose mistakenly she received it 2 1/2 years after her 2nd dose with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Jan-2025, the patient received a dose 3 of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE dose 0.5 ml 1x(once) Solution for injection (strength standard) lot U8194AA expiry-30-Sep-2027 via intramuscular route in the right deltoid for Immunization mistakenly. she received it 2 1/2 years after her 2nd dose with no reported adverse event (extra dose administered) (latency same day). Action taken: not applicable. It was not reported if the patient received a corrective treatment for the event (19 year old patient who received her MENQUADFI dose mistakenly. She received it 2 1/2 years after her 2nd dose with no reported adverse event). At time of reporting, the outcome was Unknown for the event. 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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| 2824833 | 4 | M | NY | 02/06/2025 |
MMRV |
MERCK & CO. INC. |
X019301 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
No adverse side effects were reported. No additional information available at this time.; HCP called...
No adverse side effects were reported. No additional information available at this time.; HCP called regarding an PROQUAD vaccine that expired 1/14/2025 and was administered to a patient on 2/1/2025; This spontaneous report was received from a medical assistant referring to a 4-year-old male patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported. On 01-FEB-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) injection (lot#: X019301, expiration date: 14-JAN-2025; strength, dose, and route of administration were not reported) by a healthcare professional for prophylaxis (expired product administered). No adverse event occurred.
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| 2824834 | U | 02/06/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Expired product administered
Expired product administered
|
Expired product administered; This non-serious case was reported by a other health professional via ...
Expired product administered; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) for prophylaxis. On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired product administered). The outcome of the expired vaccine used was unknown. Additional Information: GSK Receipt Date: 03-FEB-2025 The health care professional reported that a patient received expired dose of Havrix vaccine, which led to expired vaccine used.
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| 2824835 | M | FL | 02/06/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration
More
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Shingles happened in the 3 year span; Drug dose administration interval too long; This non-serious c...
Shingles happened in the 3 year span; Drug dose administration interval too long; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles happened in the 3 year span) and drug dose administration interval too long (Verbatim: Drug dose administration interval too long). The outcome of the shingles and drug dose administration interval too long were unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 09-JAN-2025 Consumer was the reporter. The patient stated that he had his first dose of Shingrix about 3 years ago. The patient recently had his second dose of Shingrix administered late dose. The patient stated that he believed he has a few cases of shingles in those three years lack of effect. All cases of shingles happened in the 3 year span prior to having his second dose of Shingrix administered. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
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| 2824836 | M | TX | 02/06/2025 |
HIBV |
GLAXOSMITHKLINE BIOLOGICALS |
|
Product preparation issue
Product preparation issue
|
may have administered the diluent only; may have administered the diluent only; This non-serious cas...
may have administered the diluent only; may have administered the diluent only; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 2-month-old male patient who received Hib (Hiberix) for prophylaxis. On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: may have administered the diluent only) and inappropriate dose of vaccine administered (Verbatim: may have administered the diluent only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 09-JAN-2025 Pharmacist stated that she was contacted by a clinic staff member who was concerned that they may have administered the diluent only portion of Hiberix to a patient within the past 1-2 months. The staff was not sure if this happened and did not know which patient it was, but they narrowed down to 5 patients, of which one of them could have received diluent only. It was possible that the 5 patients may all be given another dose, but at the time of reporting this decision was not made. The reporter did not have the lot number of the product at the time of reporting. The patient received only diluent of Hiberix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is 1 of the 5 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025002641:Same reporter/Different patient US-GSK-US2025002645:Same reporter/Different Patient US-GSK-US2025002639:Same reporter/Different Patient US-GSK-US2025002647:Same reporter/Different patient
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| 2824837 | 33 | F | IN | 02/06/2025 |
HEP |
UNKNOWN MANUFACTURER |
AHBVB340AA |
Underdose
Underdose
|
patient received a dose of a pediatric presentation of Hepatitis B; patient received a dose of a ped...
patient received a dose of a pediatric presentation of Hepatitis B; patient received a dose of a pediatric presentation of Hepatitis B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 33-year-old female patient who received Hepatitis B vaccine (batch number AHBVB340AA) for prophylaxis. On 21-FEB-2007, the patient received the 3rd dose of Hepatitis B vaccine. On 21-FEB-2007, an unknown time after receiving Hepatitis B vaccine, the patient experienced underdose (Verbatim: patient received a dose of a pediatric presentation of Hepatitis B) and adult use of a child product (Verbatim: patient received a dose of a pediatric presentation of Hepatitis B). The outcome of the underdose and adult use of a child product were unknown. Additional Information: GSK Receipt Date: 03-FEB-2025 The nurse reported that a patient received a dose of a pediatric presentation of Hepatitis B vaccine, which led to underdose and adult use of a child product. The vaccine administration facility was the same as primary reporter.
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| 2824885 | 77 | F | FL | 02/06/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
x357e |
Extra dose administered
Extra dose administered
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duplicate vaccine given outside of guidelines
duplicate vaccine given outside of guidelines
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| 2824886 | 67 | M | NY | 02/06/2025 |
TDAP |
SANOFI PASTEUR |
U8274AA |
Injection site erythema, Injection site pain, Injection site swelling, Pain
Injection site erythema, Injection site pain, Injection site swelling, Pain
|
right upper arm tenderness, swelling and erythema, body aches and fever 24 hours after vaccine; reco...
right upper arm tenderness, swelling and erythema, body aches and fever 24 hours after vaccine; recommended ice to arm and tylenol/ibuprofen prn for fever and body aches
More
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| 2824887 | 0.33 | F | 02/06/2025 |
DTAPHEPBIP HIBV RV5 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
B532G X020942 |
Pyrexia; Pyrexia; Pyrexia
Pyrexia; Pyrexia; Pyrexia
|
patient is having fever of 101.7 within one day of receiving vaccinations as well induration on left...
patient is having fever of 101.7 within one day of receiving vaccinations as well induration on left thigh. Concern with symptoms due to these not being normal reactions for 4-month immunizations.
More
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| 2824888 | 50 | F | NC | 02/06/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EL0142 EL0142 |
Chills, Eyelid disorder, Feeling abnormal, Food allergy, Headache; Hypersomnia, ...
Chills, Eyelid disorder, Feeling abnormal, Food allergy, Headache; Hypersomnia, Lethargy, Memory impairment, Mobility decreased, Pyrexia
More
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Out of the body experience, like a floating sensation. I could not keep my eyes open, headache, feb...
Out of the body experience, like a floating sensation. I could not keep my eyes open, headache, febrile, I could not lift my arms, slept for two days (Lethargy ) severe sweats and chills. I have memory fog episodes after this happened.
More
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| 2824889 | 70 | M | IA | 02/06/2025 |
COVID19 |
MODERNA |
AS7173B |
Death
Death
|
Death
Death
|
โ | |||||
| 2824890 | 1.25 | M | NY | 02/06/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
7745R |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
The child received an incorrect vaccine for their age. They should have received Dtap and Polio sepa...
The child received an incorrect vaccine for their age. They should have received Dtap and Polio separately. No treatment or adverse reactions occurred following the vaccination.
More
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| 2824891 | 51 | F | TN | 02/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
K2BB7 |
Headache, Hypoaesthesia oral, Paraesthesia oral
Headache, Hypoaesthesia oral, Paraesthesia oral
|
patient reported headache as well as tingling and numb tongue the morning after. Patient called 2/5/...
patient reported headache as well as tingling and numb tongue the morning after. Patient called 2/5/25 to report tingling/numb tongue morning after vaccine. Advised patient to call primary care doctor. Called patient 2/6/25 to see how she was doing, she said she called her doctor and her doctor advised her not to get the second shingles vaccine.
More
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| 2824892 | 11 | M | CO | 02/06/2025 |
COVID19 |
MODERNA |
3044079 |
Product storage error
Product storage error
|
Patient was given a vaccine that was stored improperly and should have been discarded on 1/7/25. Leg...
Patient was given a vaccine that was stored improperly and should have been discarded on 1/7/25. Legal gaudrian of pateint will be notified that the state reccomends that patient get revaccinated,
More
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| 2824893 | 29 | M | PA | 02/06/2025 |
MENB PNC20 |
NOVARTIS VACCINES AND DIAGNOSTICS PFIZER\WYETH |
ZK9P4 LJ5280 |
Injection site erythema, Injection site pain, Injection site rash, Injection sit...
Injection site erythema, Injection site pain, Injection site rash, Injection site swelling; Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
More
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redness, pain, swelling, rash to left deltoid. Subsided after 6 days.
redness, pain, swelling, rash to left deltoid. Subsided after 6 days.
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| 2824894 | 11 | M | GA | 02/06/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
95NJ4 X4T99 |
Injection site erythema, Injection site swelling, Pyrexia; Injection site erythe...
Injection site erythema, Injection site swelling, Pyrexia; Injection site erythema, Injection site swelling, Pyrexia
More
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PT CALLED INTO OFFICE ON 2/6/2025 STATING HIS ARM WAS RED SWOLLEN AND HOT ON VACCINE SITE. HE ALSO H...
PT CALLED INTO OFFICE ON 2/6/2025 STATING HIS ARM WAS RED SWOLLEN AND HOT ON VACCINE SITE. HE ALSO HAD A FEVER ALL NIGHT PER MOM.
More
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| 2824895 | 68 | F | MO | 02/06/2025 |
RSV |
PFIZER\WYETH |
|
Mobility decreased, Pain in extremity
Mobility decreased, Pain in extremity
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sore arm 1st day, day 2 patient was unable to use her left arm upon awakening with worsening pain a...
sore arm 1st day, day 2 patient was unable to use her left arm upon awakening with worsening pain and immobility
More
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| 2824896 | F | 02/06/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Anaphylactic reaction
Anaphylactic reaction
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Anaphylaxis recorded in chart. No additional information provided about which vaccine, date of admin...
Anaphylaxis recorded in chart. No additional information provided about which vaccine, date of admin, timing of reaction or details pertaining to the reaction.
More
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| 2824897 | 1.5 | F | 02/06/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
M77CC |
Injection site pain, Wrong product administered
Injection site pain, Wrong product administered
|
Patient give wrong vaccine for tetnus. Given Boostrix and it should have been Daptacel. Spoke with m...
Patient give wrong vaccine for tetnus. Given Boostrix and it should have been Daptacel. Spoke with mom, only reaction was soreness of the site for a few days. No treatment needed.
More
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| 2824898 | 4 | F | AL | 02/06/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
JT322 |
Injection site erythema, Injection site induration, Injection site pruritus
Injection site erythema, Injection site induration, Injection site pruritus
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Itchy at first, then hard knot with significantly large red circle at site. Resolved in three days w...
Itchy at first, then hard knot with significantly large red circle at site. Resolved in three days with Benadryl.
More
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| 2824899 | 12 | M | NJ | 02/06/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
9KB9G |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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The patient is 12 years old and should have received the TdaP vaccine but instead was given DTaP in ...
The patient is 12 years old and should have received the TdaP vaccine but instead was given DTaP in error.
More
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| 2824900 | 45 | F | CA | 02/06/2025 |
MMR MMR VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
X026330 X026330 Y013347 Y013347 |
Bell's palsy, Discomfort, Dysarthria, Dysphagia, Eyelid function disorder; ...
Bell's palsy, Discomfort, Dysarthria, Dysphagia, Eyelid function disorder; Head discomfort, Hypoaesthesia oral, Muscle rigidity; Bell's palsy, Discomfort, Dysarthria, Dysphagia, Eyelid function disorder; Head discomfort, Hypoaesthesia oral, Muscle rigidity
More
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Patient received MMR II and Varivax on 01/27/2025. Patient reported that on Monday 01/27/2025 around...
Patient received MMR II and Varivax on 01/27/2025. Patient reported that on Monday 01/27/2025 around 6:00pm she began to feel her right upper chin region becoming rigid, then on Tuesday 01/28/25 around 5:00PM began to feel numbness to the right side of her tongue . On Wednesday 1/29/25 upon arising patient reported that she was not able to close her right eyelid and could not blink and in the evening around 5pm was having difficulty talking and drinking water. On Saturday 2/1/2025 patient reported that around 7:00PM she began to feel pressure to front right side of head, back right side of head and right side of neck. Patient went to Clinic on Thursday 01/30/2025, was evaluated and told she had Bells Palsy. Patient was prescribed Vitamin B12 tablets and Artificial Tears. Per patient she also was instructed to massage face and do exercise. At time of follow up clinic appointment on Tuesday 02/04/2025, patient reported that she still cannot close her right eye, has numbness to back right side of tongue and in the evenings continues to feel pressure to front right side of head, back right side of head and right side of neck. Health Center was informed of above, evaluated patient and and concurred with PMD diagnoses of Bells Palsy. Dr. informed this nurse that patient needed further medical treatment as soon as possible to prevent permanent facial paralysis and was recommended to seek further medical care and treatment for Bells Palsy. Patient was provided Department of Health Services Hospital List and instructed patient to go immediately to Medical Center or other option Medical Center. This nurse will contacted patient to see if recommendations were followed, however patient did not answer the phone and a message was left.
More
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| 2824901 | 14 | F | 02/06/2025 |
COVID19 HPV9 MNQ |
MODERNA MERCK & CO. INC. SANOFI PASTEUR |
B0005 010656 U8271AB |
Product preparation error; Product preparation error; Product preparation error
Product preparation error; Product preparation error; Product preparation error
|
the Menquadfi vaccine was incorrectly diluted using the merck sterile diluent provided for live viru...
the Menquadfi vaccine was incorrectly diluted using the merck sterile diluent provided for live virus vaccines (Sterile water, diluent lot# 2031279) and administered to patient. Patient was contacted and agreed to re-vaccination
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| 2824902 | 57 | F | CT | 02/06/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
HM7010 HM7010 |
Alanine aminotransferase increased, Aspartate aminotransferase increased, Autoim...
Alanine aminotransferase increased, Aspartate aminotransferase increased, Autoimmune hepatitis, Blood alkaline phosphatase increased, Blood bilirubin increased; Hepatic failure
More
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autoimmune hepatitis, liver failure
autoimmune hepatitis, liver failure
|
โ | โ | ||||
| 2824903 | 10 | M | TX | 02/06/2025 |
COVID19 |
MODERNA |
3043024 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Accidentally given the wrong age range for the covid vaccine
Accidentally given the wrong age range for the covid vaccine
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| 2824904 | 69 | F | MI | 02/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
YZ9CY |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
No adverse events noted. Patient was given a 3rd Shingrix vaccination inadvertently.
No adverse events noted. Patient was given a 3rd Shingrix vaccination inadvertently.
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| 2824905 | 36 | M | WA | 02/06/2025 |
TDAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
3CA32C1 3CA32C1 |
Asthenia, Injected limb mobility decreased, Injection site hypersensitivity, Inj...
Asthenia, Injected limb mobility decreased, Injection site hypersensitivity, Injection site pain, Muscle oedema; Myalgia, Pain, Paraesthesia, Pyrexia
More
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Paresthesia to left arm, edema to deltoid, hypersensitive pain reaction at injection site, muscle pa...
Paresthesia to left arm, edema to deltoid, hypersensitive pain reaction at injection site, muscle pain from neck to arm, decreased strength to left arm, decreased ROM to left arm, generalized body aches and self reported fever.
More
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| 2824906 | 62 | F | TX | 02/06/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Fatigue, Headache, Injection site erythema, Injection site induration, Injection...
Fatigue, Headache, Injection site erythema, Injection site induration, Injection site swelling; Pain, Pain in extremity
More
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Pain in arm, red in surrounding area, swollen hard in surrounding area. General fatigue, severe head...
Pain in arm, red in surrounding area, swollen hard in surrounding area. General fatigue, severe headache, general body aches
More
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| 2824907 | 6 | M | MN | 02/06/2025 |
COVID19 |
PFIZER\BIONTECH |
Fk5127 |
Electrocardiogram, Electroencephalogram, Epilepsy
Electrocardiogram, Electroencephalogram, Epilepsy
|
Patient was diagnosed with Epilepsy after COVID vaccine. No prior history of concern.
Patient was diagnosed with Epilepsy after COVID vaccine. No prior history of concern.
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โ | |||||
| 2824909 | 12 | F | TX | 02/06/2025 |
COVID19 |
MODERNA |
LC4370 |
Discontinued product administered
Discontinued product administered
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State / CDC kept changing the time of when to stop the 23-24 version and start giving the 24-25 vers...
State / CDC kept changing the time of when to stop the 23-24 version and start giving the 24-25 version of the vaccine.
More
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| 2824910 | 68 | F | WI | 02/06/2025 |
COVID19 |
PFIZER\BIONTECH |
3044202 |
Blood glucose increased
Blood glucose increased
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Increased blood sugar after the vaccine and blood sugar increase has continued months later.
Increased blood sugar after the vaccine and blood sugar increase has continued months later.
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| 2824911 | 17 | F | OH | 02/06/2025 |
MNQ |
SANOFI PASTEUR |
U8259AA |
Erythema, Pain in extremity, Skin warm, Sleep disorder, Swelling
Erythema, Pain in extremity, Skin warm, Sleep disorder, Swelling
|
P24 hours later patient reported "very swollen like a very big bump, red, pain on the bump, and...
P24 hours later patient reported "very swollen like a very big bump, red, pain on the bump, and very warm also it?s been making my whole arm hurt with some sharp pain, the pain has been waking me up from my sleep, i can?t sleep cause of the pain"
More
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| 2824912 | 54 | F | MD | 02/06/2025 |
RAB |
NOVARTIS VACCINES AND DIAGNOSTICS |
FDP00613 |
Diarrhoea, Tinnitus
Diarrhoea, Tinnitus
|
c/o diarrhea in afternoon and ringing in ears on and off for about 3 hours.
c/o diarrhea in afternoon and ringing in ears on and off for about 3 hours.
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| 2824913 | 6 | M | PA | 02/06/2025 |
VARCEL |
MERCK & CO. INC. |
Y010373 |
Circumstance or information capable of leading to medication error
Circumstance or information capable of leading to medication error
|
The patient, was receiving the Varicella Vaccine. Upon the initial administration attempt the patien...
The patient, was receiving the Varicella Vaccine. Upon the initial administration attempt the patient flinched in a manner that was greater than expected. When the patient flinched, the mother, who was bracing the child was grazed by the sterile needle. This did not become apparent/noticeable as the child was in a heightened emotional state, so a second successful attempt was made in delivering the entirety of the vaccine. After assessing the child the mother brought to the Nurses attention that she had been grazed by the needle. The mother, who received none of the dosage of the vaccine, did not express any complaint or concern at that time. Supervisors were contacted for guidance. No treatment rendered at the time of the visit. Time frame, Administration time 09:50 am February 6th, 2025.
More
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| 2824914 | 61 | F | NY | 02/06/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA |
043B21A 043B21A 006C21A 006C21A |
Blood test normal, Death, Electromyogram, Magnetic resonance imaging head, Magne...
Blood test normal, Death, Electromyogram, Magnetic resonance imaging head, Magnetic resonance imaging spinal; Motor neurone disease; Blood test normal, Death, Electromyogram, Magnetic resonance imaging head, Magnetic resonance imaging spinal; Motor neurone disease
More
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developed UMN disease-died within 1 year of onset of symptoms
developed UMN disease-died within 1 year of onset of symptoms
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โ | |||||
| 2824915 | 66 | M | WA | 02/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
N35N9 |
Product preparation issue
Product preparation issue
|
When going to document the shingles vaccine given to patient, I realized he was only given the recon...
When going to document the shingles vaccine given to patient, I realized he was only given the reconstitute with adjuvant suspension component liquid. He did not receive the compound with it. As of right now patient has had no reactions. NDC: 58160-829-03 Lot: N35N9 EXP: 11/15/26 0.5mL Adjuvant suspension component Mfd by Glaxosmithline Bio
More
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| 2824916 | 33 | M | NJ | 02/06/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y014868 Y014868 |
Headache, Injection site erythema, Injection site induration, Injection site pai...
Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site paraesthesia; Injection site pruritus
More
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Redness, induration, burning/itching/tingling sensation to injection site associated with headache
Redness, induration, burning/itching/tingling sensation to injection site associated with headache
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| 2824917 | 16 | F | MA | 02/06/2025 |
MMRV |
MERCK & CO. INC. |
Y016876 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
A MMRV was given inadvertently. MMR was intended but MMRV was given along with Varicella vaccinati...
A MMRV was given inadvertently. MMR was intended but MMRV was given along with Varicella vaccination. Dr. was notified of error via phone. Mother of child was notified via phone of error. Education was provided to parent of side effects that may occur ie: chicken pox rash, fever 2-3 weeks after vaccine. Mother stated she understood and has thermometer to monitor for increased temperatures, will also monitor for rashes. Will go to local urgent care if need arises. No ill effects have been reported by child's parents at this time. Health Commissioner, Medical Director and direct supervisors were updated.
More
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| 2824918 | 0.5 | M | NC | 02/06/2025 |
DTAPHEPBIP PNC20 |
GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH |
5YB7L LJ5280 |
Hypersensitivity; Hypersensitivity
Hypersensitivity; Hypersensitivity
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Patient had an allergic reaction to the vaccines given.
Patient had an allergic reaction to the vaccines given.
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| 2824919 | 62 | F | WA | 02/06/2025 |
PNC21 PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Erythema, Fatigue, Lymphadenopathy, Nasopharyngitis, Rash; Rash erythematous, Ra...
Erythema, Fatigue, Lymphadenopathy, Nasopharyngitis, Rash; Rash erythematous, Rash papular, Rash pruritic, Skin warm, Swelling; Ultrasound scan
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pt says later in the day after getting the vaccine, she noticed her lymph nodes were swollen and tha...
pt says later in the day after getting the vaccine, she noticed her lymph nodes were swollen and that under the right side of under the jawbone it was red, swollen and hot to the touch. She had a red raised itchy sore rash on her throat. She used lotion on it and it went away after about four days. She went to Dr in her primacy doctors clinic on 1/30/2025 with cold symptoms where she was ordered an ultrasound. Results were normal. She was instructed to contact her PCP if her lymph nodes did not go back to normal or continued to enlarge. She continues to remain very tired and still has cold symptoms.
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| 2824920 | 18 | M | ME | 02/06/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
2345B |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Pt has administered Adult dose of 1mL instead of 0.5mL pediatric dose. Error reported to state who r...
Pt has administered Adult dose of 1mL instead of 0.5mL pediatric dose. Error reported to state who recommended completing VAERS report. Spoke to patient's parent/guardian and no adverse events to report.
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| 2824921 | 33 | M | PA | 02/06/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
ER8736 ER8736 ER8736 ER8736 |
Asthenia, Brain fog, Cardiac stress test, Chest pain, Clumsiness; Colonoscopy, C...
Asthenia, Brain fog, Cardiac stress test, Chest pain, Clumsiness; Colonoscopy, Crying, Disorientation, Dizziness, Dysphagia; Gastrointestinal disorder, Imaging procedure, Magnetic resonance imaging head, Mental impairment, Migraine; Muscle spasms, Pain in extremity, Palpitations, Thirst
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First night of secound dose. What light headed, disoriented. Walking into walls. Severely thirsty an...
First night of secound dose. What light headed, disoriented. Walking into walls. Severely thirsty and nothing Quenched my thirst. Muscle spasms . Then after that migraines , brain fog . Then heart palpitations and sharp chest pain if tried exercise. Then upper outter leg pain . Both legs crying walking up steps . Then stomach issues and was hard to swallow water. Energy levels weee zero and couldn?t think even.
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| 2824922 | 0.5 | F | 02/06/2025 |
DTAPHEPBIP PNC20 |
GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH |
5YB7L LG5575 |
Infant irritability, Injection site induration; Infant irritability, Injection s...
Infant irritability, Injection site induration; Infant irritability, Injection site induration
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MOP stated that child had an induration on L leg and was fussy for a week.
MOP stated that child had an induration on L leg and was fussy for a week.
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| 2824923 | 79 | F | NM | 02/06/2025 |
PPV |
MERCK & CO. INC. |
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Fatigue, Pyrexia
Fatigue, Pyrexia
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Fecer of 1 degree, fatigue
Fecer of 1 degree, fatigue
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| 2824924 | 32 | F | CA | 02/06/2025 |
RSV |
PFIZER\WYETH |
KD0161 |
Exposure during pregnancy, Extra dose administered, No adverse event
Exposure during pregnancy, Extra dose administered, No adverse event
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Patient is pregnant with EDD of 2/26/2025. She presented for a prenatal visit on 2/5/2025 and the pr...
Patient is pregnant with EDD of 2/26/2025. She presented for a prenatal visit on 2/5/2025 and the provider CNM found the patient had two RSV injections. One was done on 1/3/25 and the other on 1/17/25. Patient didn't report any reaction.
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| 2824925 | 9 | F | NM | 02/06/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
J3952 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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NO ADVERSE REACTIONS/EVENT OCCURRED. I am reporting this for tracking of data from this safety event...
NO ADVERSE REACTIONS/EVENT OCCURRED. I am reporting this for tracking of data from this safety event. Patient's forecast showed she was due for a Hep B vaccine. Verified patient's vaccine history and confirmed with provider patient needed a Hep B vaccine. Verified patient allergies, contraindications, medications list, vitals, and pertinent history. Order for Hep B Peds (Engerix/B) Ped/Adolescent was entered by provider. I verified the order. Hep B is not stocked in the Clinic records. I went to outpatient pharmacy with the patient's label and provided the patient's label to the pharmacist. I verbalized that I was from Clinic and needed a Hep B vaccine for this patient. I was given the adult dose of Hep B vaccine (20 mcg) instead of the pediatric dose of Hep B vaccine (10 mcg). I did not know this was not the correct dose and I administered it to the patient. I went to document the vaccine that was given to provide an immunization record to the guardian but could not find the Lot# J3952 under the pediatric Hep B. I contacted outpatient pharmacy about this and was transferred to the point of contact pharmacist. I let her know I could not find the Lot# for the Hep B vaccine I picked up from the outpatient pharmacy. She assisted me in checking the Lot# and confirmed it was the Lot# for the adult Hep B vaccine. This is when I realized the error. I had been given the adult dose of Hep B (20 mcg) instead of the pediatric dose (10 mcg), and I administered it, unaware this was the adult dose.
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| 2824926 | 50 | F | CA | 02/06/2025 |
FLU3 FLU3 FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
UT8415JA UT8415JA UT8415JA UT8415JA |
Abdominal pain upper, Aphonia, Constipation, Diarrhoea, Dysphagia; Epistaxis, Fa...
Abdominal pain upper, Aphonia, Constipation, Diarrhoea, Dysphagia; Epistaxis, Fatigue, Headache, Impaired work ability, Influenza; Mucous stools, Musculoskeletal stiffness, Nausea, Pain in extremity, Paraesthesia; Throat irritation, Throat tightness, Upper respiratory tract congestion
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An hour after the shot I felt extreme fatigue/ ?wiped out,? upon waking next morning severe aching p...
An hour after the shot I felt extreme fatigue/ ?wiped out,? upon waking next morning severe aching pain stiffness and tingling in entire left arm, about 24 hours after, I felt like my throat closed up to half its usual width and got scratchy, food was catching, felt like a sinus infection was coming on. The next day my I lost my voice and only squeaks came out for the next 2.5 days. I had flu symptoms and missed two days of work. This segued into severe headache and upper respiratory congestion, stomach pains and nausea with diarrhea, mucous-covered stool and constipation. Two nosebleeds over this time.
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| 2824927 | 61 | F | CA | 02/06/2025 |
VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Bell's palsy, Computerised tomogram head, Facial paralysis, Fatigue, Oral h...
Bell's palsy, Computerised tomogram head, Facial paralysis, Fatigue, Oral herpes; Pyrexia, Rash, Rash erythematous, Skin atrophy, Somnolence; Swelling face, Urticaria
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pt states that she was extremely tired after getting the vaccine. The next day she began running a ...
pt states that she was extremely tired after getting the vaccine. The next day she began running a fever, developed fever blisters on her lips and she slept the entire day. After about 24 hours, the right side of her face became swollen and had fallen. She tried to drink water but it came out of mouth because the entire right side of face was drooping. She went back to bed and slept. The next morning, the right side of her face was still swollen but not as swollen as the day before. A couple of days later, she noticed the right side of her face on her cheeks, she was developing a rash and/or hives. Her chin had dimples in it and her neck looked like chicken skin as her skin was just hanging. She contacted her PCP and was seen right away. She was prescribed Valtrex for the fever blisters. The next morning, her right cheek was still red with rash and was worse. She went back to her PCP. She was prescribed more Valtrex and steroids. She was told if gets any worse to go to the ER. By Feb 3rd she went to ER. They did CT scan. She was diagnosed with Bells Palsy associated with the vaccine. She was told keep using the meds prescribed by PCP and to follow up with PCP next day.
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| 2824928 | 0.67 | M | IL | 02/06/2025 |
DTAPHEPBIP HIBV PNC20 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH |
D252F Y003145 LG5577 |
No adverse event, Off label use; No adverse event, Off label use; No adverse eve...
No adverse event, Off label use; No adverse event, Off label use; No adverse event, Off label use
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Dr. ordered the vaccines for this patient and they were administered in the office as ordered. Dr. ...
Dr. ordered the vaccines for this patient and they were administered in the office as ordered. Dr. discussed with the mother at the time of the visit that he wanted the Rotavirus to be administered in light of patient's many complex medical issues that include gastrointestinal issues. There was no adverse effect.
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