| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2854057 | 67 | F | GA | 08/14/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Chills, Extra dose administered, Fatigue, Injection site pain, Nausea; Pyrexia
Chills, Extra dose administered, Fatigue, Injection site pain, Nausea; Pyrexia
|
she got a third shot of Shingrix; Injection site pain/ soreness at injection site; Fever; Tiredness;...
she got a third shot of Shingrix; Injection site pain/ soreness at injection site; Fever; Tiredness; Nausea; Chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 09-FEB-2021 in right arm) and Shingrix (2nd dose received on 08-APR-2021 in right arm). Concurrent medical conditions included fibromyalgia, leukopenia and shoulder tendinitis. Concomitant products included ketorolac tromethamine (Toradol). On 16-JUL-2025, the patient received the 3rd dose of Shingrix (intramuscular, left deltoid) .5 ml. In JUL-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain/ soreness at injection site), fever (Verbatim: Fever), tiredness (Verbatim: Tiredness), nausea (Verbatim: Nausea) and chills (Verbatim: Chills). On 16-JUL-2025, the patient experienced extra dose administered (Verbatim: she got a third shot of Shingrix). The outcome of the injection site pain and tiredness were not resolved and the outcome of the fever, nausea and chills were unknown and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the injection site pain, fever, tiredness, nausea and chills to be related to Shingrix. It was unknown if the company considered the injection site pain, fever, tiredness, nausea and chills to be related to Shingrix. Additional Information: GSK Receipt Date: 17-JUL-2025 The patient self-reported this case for herself. The patient called to inform she got a third shot of Shingrix (day before reporting) on her left shoulder, which led to an extra dose administered. The patient reported she was suffering from tendinitis in the left shoulder and went yesterday (day before reporting) to HCP (health care professional) office to get an injection of Toradol. She was told by HCP that per medical records she was missing the 2nd dose of Shingrix. The patient stated she informed the office that she had completed the series, but the office information stated differently. The reporter stated she was provided with another dose of Shingrix. The patient reported that she reviewed her records and confirmed that both doses of Shingrix were given in 2021. After receiving the 3rd dose, the patient reported tiredness, pain and soreness at the injection site and experienced fever, chills and nausea. The patient described it as feeling terrible. She mentioned she started to have a bad time after the dose was administered, some symptoms overnight and she called earlier today (on the day of reporting) her physician and left a voice message informing the incident but she did not have any call back, then she called the patient assistance line and she was assisted and some information was provided but they gave the medical information number for having professional help directly. Her information was collected, and the call was transferred to the general response center for further assistance for patients. The patient was transferred to the GRC product line for further assistance since medical information was a line for health care providers inquiries.
More
|
||||||
| 2854058 | 68 | F | WI | 08/14/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
324BY |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
Late Second Dose; This non-serious case was reported by a pharmacist via call center representative ...
Late Second Dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old female patient who received HAB (Twinrix) (batch number 324BY, expiry date 28-SEP-2026) for prophylaxis. Previously administered products included Twinrix (First they got was about a year ago). On 04-AUG-2025, the patient received the 2nd dose of Twinrix. On 04-AUG-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late Second Dose). The outcome of the drug dose administration interval too long was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 04-AUG-2025 Other HCP reported that they had a couple that was leaving to go over the Country this December First So, they were looking to do the expedite schedule. The first they got was about a year ago and the second dose, they got it on the day of reporting. Reporter indicated that by looking at the schedule looked like they had to wait at least two weeks between getting dose number 3, but their question was for dose number four, said it had to be a year after the first dose that had already happened. Asked if there a minimum interval between dose number 3 and 4 they would have to wait, or can they just get dose number four when they come back.; Sender's Comments: US-GSK-US2025100211:
More
|
||||||
| 2854059 | 20 | F | 08/14/2025 |
TDAP |
SANOFI PASTEUR |
48420AA |
No adverse event, Product storage error
No adverse event, Product storage error
|
Vaccine fridge had out of range temperature with no reported adverse event; Initial information rece...
Vaccine fridge had out of range temperature with no reported adverse event; Initial information received on 06-Aug-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional). This case involves a 20 years old female patient (154.94 cm and 81.82 kg) who received a dose of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] which was exposed to temperature excursion due to vaccine fridge had been out of range temperature with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, lot 48420AA and expiry date 31-Aug-2027 via unknown route in unknown administration site for immunisation which was exposed to temperature excursion because vaccine fridge had been out of range temperature with no reported adverse event (poor quality 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.
More
|
|||||||
| 2854060 | 9 | F | IL | 08/14/2025 |
DTAP |
SANOFI PASTEUR |
3CA55C1 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
9-year old patient was administered Daptacel when she would have been eligible for ADACEL with no re...
9-year old patient was administered Daptacel when she would have been eligible for ADACEL with no reported ae; Initial information received on 11-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 9 years old female patient who was administered Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] when she would have been eligible for Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] 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 Polio Vaccine Inact 3v (Vero) [Ipol Polio Vaccine] for Immunisation. On 29-Jul-2025, the patient received 0.5ml (Dose 5) of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, (once), Strength Standard, lot 3CA55C1 and expiry date 31-Aug-2026 via intramuscular route in the right thigh for immunisation, when she would have been eligible for Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, (unknown strength and expiry date) with no reported adverse events (product administered to patient of inappropriate age) (Latency Same day). Reportedly, Vaccine coordinator explains that they had a 9-year old patient, they were doing catch-up vaccines for her, and the patient received DAPTACEL when she would have been eligible for ADACEL. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
More
|
||||||
| 2854061 | 18 | F | SC | 08/14/2025 |
MENB MENB |
PFIZER\WYETH PFIZER\WYETH |
LF5302 LF5302 |
Blood thyroid stimulating hormone normal, Dysphagia, Full blood count normal, In...
Blood thyroid stimulating hormone normal, Dysphagia, Full blood count normal, Injection site pain, Muscle twitching; Paraesthesia
More
|
Twitching of Left side of Face that progressed to twitching of right side of face too. Pain in Left ...
Twitching of Left side of Face that progressed to twitching of right side of face too. Pain in Left Deltoid & Left upper trapezius. ? Difficulty swallowing. No change in strength. Good Deep Tendon Reflexes. Also had some tingling of hands.
More
|
||||||
| 2854062 | 0.17 | M | AS | 08/14/2025 |
DTAP RV1 |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
3CA20C1 EX434 |
Unresponsive to stimuli; Unresponsive to stimuli
Unresponsive to stimuli; Unresponsive to stimuli
|
The evening of the day baby received vaccines, the baby's owlet monitor went off (never had bef...
The evening of the day baby received vaccines, the baby's owlet monitor went off (never had before) baby was nonresponsive, had to be stroked several times to respond. He nursed after and was fine, (moitor never went off after the event.
More
|
||||||
| 2854063 | 17 | F | VT | 08/14/2025 |
MMRV |
MERCK & CO. INC. |
Y012074 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
MMRV vaccine was given 7/24/25 and the patient was over 13+. Patient had no vaccine reaction. Immuni...
MMRV vaccine was given 7/24/25 and the patient was over 13+. Patient had no vaccine reaction. Immunization designee with department of health was also made aware and advise we use this form to provide data to CDC and vaccine manufactures.
More
|
||||||
| 2854064 | 2.67 | F | TX | 08/14/2025 |
DTAP HEPA HIBV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. SANOFI PASTEUR |
5KR3R Y018512 UK207AA |
Product preparation issue; Product preparation issue; Product preparation issue
Product preparation issue; Product preparation issue; Product preparation issue
|
Pt was given only the solution for the Hib (ActHib) not the actual vaccine.
Pt was given only the solution for the Hib (ActHib) not the actual vaccine.
|
||||||
| 2854065 | 4 | M | CA | 08/14/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
52D72 Y009589 |
Injection site erythema, Injection site swelling, Injection site warmth; Injecti...
Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth
More
|
Lt deltoid had swelling a size of a baseball, redness around the area and warmth around the area (mi...
Lt deltoid had swelling a size of a baseball, redness around the area and warmth around the area (minimal) denied pain around the area c/w local reaction on injection site of KINRIX vaccine. Treatment - ice pack, Benadryl 5 ml and Hydrocortisone cream 1% 3x a day, symptoms resolved after 2 days
More
|
||||||
| 2854108 | 55 | M | PA | 08/14/2025 |
PNC20 PNC20 PNC20 VARZOS VARZOS VARZOS |
PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
LN4930 LN4930 LN4930 35A77 35A77 35A77 |
Chills, Chromaturia, Headache, Injection site erythema, Injection site infection...
Chills, Chromaturia, Headache, Injection site erythema, Injection site infection; Injection site swelling, Muscle spasms, Nausea, Pain, Pyrexia; Sleep disorder; Chills, Chromaturia, Headache, Injection site erythema, Injection site infection; Injection site swelling, Muscle spasms, Nausea, Pain, Pyrexia; Sleep disorder
More
|
Went to urgent care due to spreading red tendrils, to rule out cellulitis from injection site infect...
Went to urgent care due to spreading red tendrils, to rule out cellulitis from injection site infection... plus dark yellow urine, full body pain, "feels like glass all over my body", pain, headache, slight chills/fever, muscle cramping, etc... Patient First described it as "angry" and prescribed 10 day course of Augmentin for prophylactic cellulitis care. Started at 8pm Saturday night, 7/19/25 injections ~10:45am fri 7/18 full body fatigue and muscle pain onset by ~3pm Fri pain overnight - disturbed sleep, nausea (no vomiting) etc expanding circle of redness and swelling Sat 7/19 expanding red tendrils reaching toward lymph nodes so... urgent care at ~5pm Saturday antibiotics started ~7:30pm Sat slower spread through Sunday evening stabilized arm by Monday morning urine color clearing up by Mon morning
More
|
||||||
| 2854109 | 4 | M | OH | 08/14/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
5g23d z002986 |
Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration
More
|
patient well appearing, I gave kinrix and Proquad to the L quad. Provider went in to talk to family ...
patient well appearing, I gave kinrix and Proquad to the L quad. Provider went in to talk to family and make them aware of the incident.
More
|
||||||
| 2854110 | 11 | M | OH | 08/14/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
Y007322 537LH 9Y4BG |
Loss of consciousness, Syncope; Loss of consciousness, Syncope; Loss of consciou...
Loss of consciousness, Syncope; Loss of consciousness, Syncope; Loss of consciousness, Syncope
More
|
Child had syncope after receiving all 3 vaccines. Child briefly lost consciousness and and regained ...
Child had syncope after receiving all 3 vaccines. Child briefly lost consciousness and and regained consciousness a few seconds later with no specific intervention. Child was already sitting and remained seated until after he recovered. RN offered water, juice and snack. Child drank water and took more water and a snack for the ride home. Child walked out to car accompanied by his father.
More
|
||||||
| 2854112 | 44 | F | MI | 08/14/2025 |
DTAP |
SANOFI PASTEUR |
|
No adverse event
No adverse event
|
Patient reported no adverse effects from vaccine
Patient reported no adverse effects from vaccine
|
||||||
| 2854113 | 33 | M | OH | 08/14/2025 |
ANTH |
EMERGENT BIOSOLUTIONS |
300216A |
Wrong product administered
Wrong product administered
|
I was working with an IBT in training and Anthrax was drawn up and given instead of Tuberculin by mi...
I was working with an IBT in training and Anthrax was drawn up and given instead of Tuberculin by mistake. I documented the administration. Correct vile administration should have been verified. Redness and white papules noted at the site 48 hours upon return for the PPD reading. Patient examined by Dr
More
|
||||||
| 2854114 | 81 | F | PA | 08/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7523J |
Headache, Pyrexia, Rash pruritic, Scab
Headache, Pyrexia, Rash pruritic, Scab
|
Patient began experiencing headache and fever of over 101F morning of 8/10/2025. Over the next 4 day...
Patient began experiencing headache and fever of over 101F morning of 8/10/2025. Over the next 4 days, the patient began developing crusty, itchy rashes on the scalp, hands, ears, and the waistline of the back. Pain from the rash began affect daily living which led to the patient seeking medical assistance on 8/14/2025
More
|
||||||
| 2854115 | 12 | M | TX | 08/14/2025 |
TDAP |
SANOFI PASTEUR |
U8564AA |
Headache
Headache
|
Parent called this morning (8-14-25) stating that her child got his shots yesterday morning, Last ni...
Parent called this morning (8-14-25) stating that her child got his shots yesterday morning, Last night he complained of a slight headache. No fever. This morning he woke up and the headache was worse. She stated she didn't know if it was related to the shots. I told her probably not, but go ahead and take him to the ER to be checked out.
More
|
||||||
| 2854116 | 21 | F | NY | 08/14/2025 |
VARCEL |
MERCK & CO. INC. |
Z008195 |
Injection site reaction, Rash pruritic
Injection site reaction, Rash pruritic
|
itchy rash localized around vaccine site.
itchy rash localized around vaccine site.
|
||||||
| 2854117 | 12 | M | VA | 08/14/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
X022735 U8113BA 37R35 |
Extra dose administered; Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered; Extra dose administered
|
School nurse brought student to onsite school clinic stating he needed his vaccines. Name given on r...
School nurse brought student to onsite school clinic stating he needed his vaccines. Name given on registration was entered transposed. First name was entered as last and last name as first. When the PHN attempted to look up vaccine record to ensure child needed vaccines no record was found. Another PHN proceeded to give him a Tdap, MCV4-Quad and HPV9 but on return to office it was discovered that he had received Tdap and MCV4-Quad 2 weeks prior on 7/28/25.
More
|
||||||
| 2854118 | 62 | M | FL | 08/14/2025 |
PNC20 |
PFIZER\WYETH |
ln4927 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
patient received prevnar20 2nd time when guidelines didnt require it. states has had no adverse rea...
patient received prevnar20 2nd time when guidelines didnt require it. states has had no adverse reaction to it.
More
|
||||||
| 2854119 | 74 | F | FL | 08/14/2025 |
FLU3 VARZOS |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
u8764db 35a77 |
Injection site erythema, Injection site pain, Injection site reaction, Injection...
Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth; Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
More
|
patient experiencing injection site reaction below the injection area. redness and warmth with some ...
patient experiencing injection site reaction below the injection area. redness and warmth with some soreness
More
|
||||||
| 2854120 | 55 | F | CO | 08/14/2025 |
RSV |
PFIZER\WYETH |
LL8396 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
Patient was erroneously administered Beyfortus and Abrysvo in the same visit. Beyfortus is not indi...
Patient was erroneously administered Beyfortus and Abrysvo in the same visit. Beyfortus is not indicated for patient's age, thus creating a medication error. Patient had no adverse event, reaction, or outcome while in clinic. Upon follow-up 24 hours post administration, patient denied any adverse event and outcome, stating "I'm fine." Upon follow-up after 7 days, patient continued to deny any adverse event or outcome, stating "I haven't had any trouble. I'm still fine."
More
|
||||||
| 2854121 | 25 | M | GA | 08/14/2025 |
MMR TDAP |
MERCK & CO. INC. SANOFI PASTEUR |
Y013132 U8503AA |
Urticaria; Urticaria
Urticaria; Urticaria
|
Dermatology History Onset: 08/13/2025 Timing: new-onset MMR, Tdap on 8/11 Location: hives - chest...
Dermatology History Onset: 08/13/2025 Timing: new-onset MMR, Tdap on 8/11 Location: hives - chest, abdomen, upper extremities, hand(s), and lower extremities Number of lesions: several Size of lesions: polymorphous Distribution/Pattern: scattered Hives Pruritis: Moderate Systemic features:: No wheezing, No throat swelling/tightness, No oropharyngeal swelling, No hoarseness, No shortness of breath, No orthostasis, No abdominal complaints, and No sense of distress/danger. Additional history:: + new exposures. No history of prior urticaria, No new Rx or OTC medications, No new herbals or supplements, No history of environmental allergies, and No history of asthma.
More
|
||||||
| 2854122 | 76 | F | MN | 08/14/2025 |
COVID19 |
MODERNA |
040A21A |
COVID-19, SARS-CoV-2 test positive
COVID-19, SARS-CoV-2 test positive
|
Hospitalization related to COVID 19 following completion of primary vaccine series
Hospitalization related to COVID 19 following completion of primary vaccine series
|
โ | |||||
| 2854123 | 4 | F | TX | 08/14/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
YN2X2 Z007852 |
Injection site pain, Injection site swelling; Injection site pain, Injection sit...
Injection site pain, Injection site swelling; Injection site pain, Injection site swelling
More
|
Swelling and pain at injection site , right thigh (Kinrix)
Swelling and pain at injection site , right thigh (Kinrix)
|
||||||
| 2854125 | 12 | F | VA | 08/14/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
FH443 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
Pt was administered Men B vaccine at the clinic resulting in pt going to the health department to ge...
Pt was administered Men B vaccine at the clinic resulting in pt going to the health department to get correct vaccine administered. No adverse reactions have been reported.
More
|
||||||
| 2854126 | 65 | F | NC | 08/14/2025 |
PNC21 |
MERCK & CO. INC. |
Y019158 |
Erythema, Pruritus, Swelling
Erythema, Pruritus, Swelling
|
Area red/raised and itching up to a week after vaccine
Area red/raised and itching up to a week after vaccine
|
||||||
| 2854127 | 0.33 | M | FL | 08/14/2025 |
DTPPVHBHPB PNC20 |
MSP VACCINE COMPANY PFIZER\WYETH |
U7788AA LC128 |
Erythema, Nodule; Erythema, Nodule
Erythema, Nodule; Erythema, Nodule
|
Patient developed small subcutaneous nodes bilateral with minimal erythema on the skin. Left greater...
Patient developed small subcutaneous nodes bilateral with minimal erythema on the skin. Left greater than right. By the time Doctor had examined the patient 3 days after the vaccination the m other stated the reaction had improved .
More
|
||||||
| 2854128 | 18 | F | TX | 08/14/2025 |
HEP |
MERCK & CO. INC. |
Y014323 |
No adverse event
No adverse event
|
no adverse reactions reported. Treatment - reaching out to the manufacturer to obtain additional inf...
no adverse reactions reported. Treatment - reaching out to the manufacturer to obtain additional information regarding symptom monitoring, scheduling for next dose, or repeat of another dose
More
|
||||||
| 2854129 | 11 | F | TX | 08/14/2025 |
HEP HEPA IPV MNQ TDAP |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
Y007989 H3N97 X1D141M U8574AA U8564AA |
Erythema, Headache, Peripheral swelling, Skin warm; Erythema, Headache, Peripher...
Erythema, Headache, Peripheral swelling, Skin warm; Erythema, Headache, Peripheral swelling, Skin warm; Erythema, Headache, Peripheral swelling, Skin warm; Erythema, Headache, Peripheral swelling, Skin warm; Erythema, Headache, Peripheral swelling, Skin warm
More
|
Mother called this morning and stated that the child's right arm was swollen, warm to the touch...
Mother called this morning and stated that the child's right arm was swollen, warm to the touch, red, and that the client had a headache. Mother was instructed to take the child to urgent care for evaluation.
More
|
||||||
| 2854130 | 0.33 | M | FL | 08/14/2025 |
DTPPVHBHPB PNC20 RV5 |
MSP VACCINE COMPANY PFIZER\WYETH MERCK & CO. INC. |
U8309AA LN4929 2096662 |
Diarrhoea; Diarrhoea; Diarrhoea
Diarrhoea; Diarrhoea; Diarrhoea
|
on 6/12/2025 mom called the providers office to report to us that patient has had diarrhea since a ...
on 6/12/2025 mom called the providers office to report to us that patient has had diarrhea since a few days after having the Rota vaccine. The appearance is watery and mucous. He has no other symptoms. he has no blood in the stool. he is eating his normal amount , acting normal for his age..
More
|
||||||
| 2854131 | 12 | F | NC | 08/14/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
DX3P7 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Patient had two different accounts. Patient received a Boostrix 8/4/25 although she was not due as s...
Patient had two different accounts. Patient received a Boostrix 8/4/25 although she was not due as she had gotten one at another location on 1/1/25. No adverse reaction known at this time.
More
|
||||||
| 2854132 | 21 | F | NC | 08/14/2025 |
PNC20 |
PFIZER\WYETH |
HE6192 |
Expired product administered
Expired product administered
|
The patient listed was given an expired dose of Prevnar 20 by the pharmacist. The dose expired on Ma...
The patient listed was given an expired dose of Prevnar 20 by the pharmacist. The dose expired on March 2025. The patient was called once the mistake was identified. The pharmacist provided an apology to the patient and also told the patient to come back so that they could provide the another vaccine. The patient verbalized understanding and told the pharmacist she would come right back. She called back an hour later to inform the pharmacist that she would not be able to come in today.
More
|
||||||
| 2854134 | 4 | F | 08/14/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
|
No adverse effects noted from Hib being given at wrong interval
No adverse effects noted from Hib being given at wrong interval
|
|||||||
| 2854135 | 65 | F | KY | 08/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Injection site erythema
Injection site erythema
|
PATIENT SAID SHE STARTED HAVING RED PATCHES APPEAR ON HER ARM AT INJECTION SITE AND EXTENDING TO HER...
PATIENT SAID SHE STARTED HAVING RED PATCHES APPEAR ON HER ARM AT INJECTION SITE AND EXTENDING TO HER UPPER SHOULDER AND IT WAS VERY SORE. SHE BEGAN TAKING BENADRYL AND THEN WENT TO THE DOCTOR WHERE SHE RECEIVED A STEROID SHOT. SHE SAID THAT THE REDNESS IS NOW GONE AN SHE IS NOT HAVING ANY FURTHER ISSUES.
More
|
||||||
| 2854136 | 15 | M | MI | 08/14/2025 |
HPV9 |
MERCK & CO. INC. |
y020464 |
Loss of consciousness
Loss of consciousness
|
Vaccine was administered, just a few minutes (3-5) later the patient passed out in his chair while s...
Vaccine was administered, just a few minutes (3-5) later the patient passed out in his chair while seated. Dr, Her MA, and myself went into the room. We turned two fans onto him to blow cool air, gave him some cold water and checked his pulse/ox levels. Once he was feeling steady again, he was able to move to the exam table and finished his wellness visit with Dr. The entire incident took less than minutes and he was feeling back to normal.
More
|
||||||
| 2854137 | 4 | F | 08/14/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
7D2Y4 Y010247 |
Injection site induration, Injection site mass, Injection site swelling; Injecti...
Injection site induration, Injection site mass, Injection site swelling; Injection site induration, Injection site mass, Injection site swelling
More
|
07/31/2025 Guardian reports hard, raised, smooth knot on right thigh where MMRV was given. Estimates...
07/31/2025 Guardian reports hard, raised, smooth knot on right thigh where MMRV was given. Estimates 2 inches in diameter, reports is not hot to the touch nor is child running fever.
More
|
|||||||
| 2854138 | 81 | F | CA | 08/14/2025 |
FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. |
390224 390224 390224 390224 390224 390224 390224 390224 390224 390224 |
Atrial fibrillation, Cardiac failure congestive, Cardioversion, Chest pain, Chro...
Atrial fibrillation, Cardiac failure congestive, Cardioversion, Chest pain, Chronic kidney disease; Coronary arterial stent insertion, Death, Electrocardiogram, Pneumonia; Asthenia, Atrial fibrillation, Cardiac failure congestive, Cardioversion, Chest pain; Coronary arterial stent insertion, Death, Intensive care, Palpitations, Pneumonia; Renal failure, Renal injury; Atrial fibrillation, Cardiac failure congestive, Cardioversion, Chest pain, Chronic kidney disease; Coronary arterial stent insertion, Death, Electrocardiogram, Pneumonia; Asthenia, Atrial fibrillation, Cardiac failure congestive, Cardioversion, Chest pain; Coronary arterial stent insertion, Death, Intensive care, Palpitations, Pneumonia; Renal failure, Renal injury
More
|
1 hour after shot, patient grabbed her chest and gasped for a moment. Then at about 30 hours after t...
1 hour after shot, patient grabbed her chest and gasped for a moment. Then at about 30 hours after the vaccine, she started having severe chest pain as if she was having a heart attack. We went to ER and they found nothing significant. We went home, she tried to nap but felt the same severe pain so we went to another ER. She then was in and out of ERs about 10-15 times over the next month, with severe Afib issues, needing to have her heart stopped/restarted to control the Afib. On Dec 1-10 she was put in Hospitol for 10 days for pneumonia and to control the Afib. Had 2 stints put in and by the end of that Hospitol stay, she was labeled as having congestive heart failure and significant kidney damage (within 4 months she was labeled as having Stage 3 kidney failure). She repeatedly was in and out of the hospitol until May 25, 2025 when she passed away.
More
|
โ | โ | โ | |||
| 2854139 | 18 | F | MA | 08/14/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
9N424 (BCHC) |
Arthralgia, Mobility decreased
Arthralgia, Mobility decreased
|
Instant pain in the shoulder join and inability to move the right shoulder. the pain increased to ar...
Instant pain in the shoulder join and inability to move the right shoulder. the pain increased to around the join and 1/2 upper arm
More
|
||||||
| 2854140 | 12 | M | FL | 08/14/2025 |
MNQ |
SANOFI PASTEUR |
U8562AA |
Product storage error
Product storage error
|
The vaccine administered was not viable it was received out of temperature range.
The vaccine administered was not viable it was received out of temperature range.
|
||||||
| 2854141 | 88 | F | FL | 08/14/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
u8764bb u8764bb |
Cold sweat, Dyspnoea, Electric shock sensation, Headache, Immediate post-injecti...
Cold sweat, Dyspnoea, Electric shock sensation, Headache, Immediate post-injection reaction; Injection site pain
More
|
Patient experienced shortness of breath, became clammy and had a headache immediately after vaccine....
Patient experienced shortness of breath, became clammy and had a headache immediately after vaccine. About 5 minutes later, she started to feel better, however, her blood pressure was 207/98. It appeared to be a panic attack. She states that it felt like an electric shock when the vaccine was given. Her son then took her to the ER to be evaluated.
More
|
||||||
| 2854142 | 72 | F | ME | 08/14/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
4JT43 |
Injection site erythema
Injection site erythema
|
Patient caregiver called today to report noticing some redness on the arm around the vaccine site. S...
Patient caregiver called today to report noticing some redness on the arm around the vaccine site. She said the patient, who is nonverbal, is acting a bit excitable/energetic/nervous but otherwise normal. They were at Walmart shopping when the redness was noticed. I recommended some ibuprofen or diphenhydramine when they get back home and to take a photo of the rash to monitor for worsening/improvement. Caregiver states she is "just checking on her, not very concerned" and feels OK to continue monitoring and usual ADLs
More
|
||||||
| 2854143 | 16 | F | VA | 08/14/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
37R35 |
Abnormal behaviour, Eye pruritus, Generalised tonic-clonic seizure, Headache
Abnormal behaviour, Eye pruritus, Generalised tonic-clonic seizure, Headache
|
Patient's guardian reported grand mal seizures the morning after vaccination. Patient was sent...
Patient's guardian reported grand mal seizures the morning after vaccination. Patient was sent EMS to hospital. Guardian reports no side effects the evening after vaccination. Patient participated in a cross-country team run through a corn field that evening. A headache was reported to Guardian, who recommended on Tylenol. Guardian reported early in the morning the patient was acting unusual and patient reported to the guardian that they had taken 5 benadryl for itchy eyes the night before. The patient had grand mal seizure early that morning, witness by Guardian, who is a school nurse. EMS responded and patient was sent to Hospital before being transferred to another hospital. Guardian reports that the hospital MD and PCP agreed that the benadryl was most likely the cause of the seizures. Of note, the biological sister reportedly was hospialized for a seizure two weeks prior to this event. No history of personal or family history of seizure disorders were known of previously. Guardian was present for all DTAP and TDAP given in 2018 and no adverse effects were noticed after those vaccinations. Guardian reports that the patient has recovered back to baseline.
More
|
โ | |||||
| 2854144 | 5 | F | NC | 08/14/2025 |
DTAPIPV MMRV |
SANOFI PASTEUR MERCK & CO. INC. |
z008501 u8009ab |
Head injury, Musculoskeletal stiffness, Seizure like phenomena, Syncope, Unrespo...
Head injury, Musculoskeletal stiffness, Seizure like phenomena, Syncope, Unresponsive to stimuli; Head injury, Musculoskeletal stiffness, Seizure like phenomena, Syncope, Unresponsive to stimuli
More
|
Pt. became unresponsive, collapsed and presented seizure like activity (stiffening of body) for appr...
Pt. became unresponsive, collapsed and presented seizure like activity (stiffening of body) for approx. 2 seconds post vaccination. Pt. had received both vaccines approx. 20 minutes prior to event. Pt sustained a minor head injury ( redness/ swelling ) from fall. Pt. condition stabilized and Emergency room visit declined by mother. Mother advised to closely monitor in case pt condition deteriorates. MOC understands when to seek emergency care.
More
|
||||||
| 2854145 | 53 | F | 08/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Injection site erythema, Injection site mass, Injection site pain, Injection sit...
Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
More
|
patient reported hard knot in arm at injection site, swollen, red, painful to the touch.
patient reported hard knot in arm at injection site, swollen, red, painful to the touch.
|
|||||||
| 2854146 | 4 | M | NM | 08/14/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
52D72 Z005152 |
Injection site rash; Injection site rash
Injection site rash; Injection site rash
|
Mother reports patient developed redness on right thigh since Tuesday 8/12/25. Reports redness sprea...
Mother reports patient developed redness on right thigh since Tuesday 8/12/25. Reports redness spreading since Tuesday. Denies any fever or any other symptom. Normal vital signs in office. Redness on right thigh and injection site measure 11x12cm. Discussed case with provider in clinic and plan was to outline redness with surgical marker and follow up with parents in 48 hours to see if any improvement is noted.
More
|
||||||
| 2854147 | 4 | M | WA | 08/14/2025 |
IPV |
SANOFI PASTEUR |
Y1A212M |
Incorrect route of product administration, No adverse event
Incorrect route of product administration, No adverse event
|
Patient received intramuscular injection of the IPV vaccination. They did not have any signs of an a...
Patient received intramuscular injection of the IPV vaccination. They did not have any signs of an adverse reaction at the time of immunization, and they have not contacted us with any concerns about the vaccine sight.
More
|
||||||
| 2854148 | 16 | M | TX | 08/14/2025 |
MENB |
PFIZER\WYETH |
LF5308 |
Erythema, Headache
Erythema, Headache
|
LOCALIZED ERYTHEMA AND HEADACHE
LOCALIZED ERYTHEMA AND HEADACHE
|
||||||
| 2854149 | 52 | F | 08/14/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Z006076 Z006076 |
Chills, Decreased appetite, Fatigue, Pain, Pyrexia; Urticaria
Chills, Decreased appetite, Fatigue, Pain, Pyrexia; Urticaria
|
She developed, fever, chills, body aches, fatigue, decreased appetite the evening after receiving va...
She developed, fever, chills, body aches, fatigue, decreased appetite the evening after receiving vaccine and this lasted until night of 08/13. On early morning of 08/14 developed full body hives.
More
|
|||||||
| 2854150 | 12 | M | OH | 08/14/2025 |
MNQ TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U8194AA U8352AA |
Hyperhidrosis, Pallor, Syncope; Hyperhidrosis, Pallor, Syncope
Hyperhidrosis, Pallor, Syncope; Hyperhidrosis, Pallor, Syncope
|
Fainting, seemed to be vasovagal syncope, patient turned pale and diaphoretic - happened approximate...
Fainting, seemed to be vasovagal syncope, patient turned pale and diaphoretic - happened approximately 2 minutes after vaccine administration
More
|
||||||
| 2854151 | 9 | F | AL | 08/14/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
3RT93 |
No adverse event
No adverse event
|
no adverse event noted. child received Kinrix at age 9. pt. should have been 6 or younger.
no adverse event noted. child received Kinrix at age 9. pt. should have been 6 or younger.
|