| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2854866 | 08/20/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Loss of consciousness
Loss of consciousness
|
I was knocked out for 2 days; This serious case was reported by a consumer via interactive digital m...
I was knocked out for 2 days; This serious case was reported by a consumer via interactive digital media and described the occurrence of loss of consciousness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced loss of consciousness (Verbatim: I was knocked out for 2 days) (serious criteria GSK medically significant). The outcome of the loss of consciousness was resolved (duration 2 days). It was unknown if the reporter considered the loss of consciousness to be related to Shingles vaccine. The company considered the loss of consciousness to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 08-AUG-2025 This case was reported by a patient via interactive digital media. The patient got the 1st shot on Tuesday and it kicked patient's butt. The patient was knocked out for 2 days and would definitely take off from work for the 2nd shot.; Sender's Comments: A case of Loss of consciousness, unknown time after receiving Shingles vaccine in a patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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| 2854868 | F | AZ | 08/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
5Y4TL |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
received a dose of Shingrix more than one year later from the first dose; This non-serious case was ...
received a dose of Shingrix more than one year later from the first 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 adult female patient who received Herpes zoster (Shingrix) (batch number 5Y4TL, expiry date 31-JAN-2027) for prophylaxis. Previously administered products included Shingrix (received first dose in March 2024). On 14-AUG-2025, the patient received the 2nd dose of Shingrix. On 14-AUG-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received a dose of Shingrix more than one year later from the first dose). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 14-AUG-2025 The patient received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. The reporter asked that the patient need to restart the series.
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| 2854869 | 08/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Rash, Rash erythematous, Rash papular
Rash, Rash erythematous, Rash papular
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noticed about 15 raised red areas on right shoulder opposite of side of where I received my vaccine;...
noticed about 15 raised red areas on right shoulder opposite of side of where I received my vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 23-JUL-2025 16:30, the patient received Shingrix (left arm). On 23-JUL-2025 21:00, 270 min after receiving Shingrix, the patient experienced erythema (Verbatim: noticed about 15 raised red areas on right shoulder opposite of side of where I received my vaccine). The outcome of the erythema was not reported. It was unknown if the reporter considered the erythema to be related to Shingrix. It was unknown if the company considered the erythema to be related to Shingrix. Additional Information: GSK Receipt Date: 24-JUL-2025 This case was reported by a patient via (shingrix GSK chatbot) interactive digital media. The patient received Shingrix vaccine one day prior to the reporting day at 4:30pm and by 10:00 pm noticed about 15 raised red areas on right shoulder opposite of side of where received had vaccine.
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| 2854870 | 08/20/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
|
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interacti...
Suspected vaccination failure; Shingles; This serious case was reported by a consumer 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. The patient's past medical history included shingles (patient had in 2022) and pain (first time was the worst pain patient ever had and last at least 6 months). On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In JUN-2025, more than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 3 weeks). 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: 08-AUG-2025 This case was reported by a patient via interactive digital media. Patient got shingles and got the 2 shot vaccine after a year. Patient stated that he/she just got them (shingles) again, but they were not as bad as the first time, so it did help to get the vaccine. The first time was the worst pain patient ever had and last at least 6 months. Patient thanked that this time was not bad only last about 3 weeks in 2025. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2).
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| 2854872 | 12 | F | MI | 08/20/2025 |
DTAP |
SANOFI PASTEUR |
3CA55C1 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
NONE
NONE
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| 2854873 | 1.08 | M | OH | 08/20/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
34MF9 |
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, no treatment needed, no negative outcome. mother states child is in same healt...
no adverse reactions, no treatment needed, no negative outcome. mother states child is in same health as before. this vaccine given was the same dose and medication that was ordered, subtracting the HIB.
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| 2854874 | 11 | F | TX | 08/20/2025 |
HPV9 |
MERCK & CO. INC. |
Y013407 |
Syncope
Syncope
|
FAINTED APPROXIMATELY 5 MIN AFTER ADMINISTRATION OF THE VACCINE
FAINTED APPROXIMATELY 5 MIN AFTER ADMINISTRATION OF THE VACCINE
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| 2854875 | 08/20/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected Vaccination failure; Shingles worse; This serious case was reported by a consumer via inte...
Suspected Vaccination failure; Shingles worse; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles worse). 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. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 10-AUG-2025 This case was reported by a patient via interactive digital media. The patient got Shingles worse after the shingles shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding 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, regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
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| 2854876 | 32 | F | MI | 08/20/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
7NX57 |
Exposure during pregnancy, Underdose
Exposure during pregnancy, Underdose
|
Pt is 18 weeks 2 days pregnant. EDD 01/19/2026. Age 32, current weight 158.2 Hepatitis B non Immu...
Pt is 18 weeks 2 days pregnant. EDD 01/19/2026. Age 32, current weight 158.2 Hepatitis B non Immune. Offered and accepted Hepatitis B 3 dose series. Pt was inadvertently given the Pediatric dose of Hepatitis B 10 mcg/0.5 ml instead of the adult dose of 20 mcg/0.5 ml. No adverse advent occured
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| 2854877 | 73 | F | FL | 08/20/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
7523J 7523J |
Chills, Fall, Pyrexia, Sensory loss, Sleep disorder; Walking aid user
Chills, Fall, Pyrexia, Sensory loss, Sleep disorder; Walking aid user
|
PATIENT HAD THE VACCINE IN THE EARLY AFTERNOON. SHE WENT TO BED FEELING FINE BUT WOKE UP AT 10:00PM ...
PATIENT HAD THE VACCINE IN THE EARLY AFTERNOON. SHE WENT TO BED FEELING FINE BUT WOKE UP AT 10:00PM DUE TO CHILLS AND HIGH FEVER. AFTER GOING TO THE BATHROOM, SHE LOST SENSATION OF HER LEGS AND FELL DOWN. SHE ENDED UP GOING TO THE ER AND BEEN ON THE WALKER EVER SINCE.
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| 2854878 | 12 | M | IA | 08/20/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
Y97n7 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
No adverse events occurred. Clinic Director immediately notified. Proper process initiated to determ...
No adverse events occurred. Clinic Director immediately notified. Proper process initiated to determine further action, if needed. Notified by Department of Public Health Nurse that the dose was sufficient. Patient's mother notified per protocol.
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| 2854879 | 7 | F | NC | 08/20/2025 |
HEP HEPA HPV9 IPV MMRV MNQ TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. SANOFI PASTEUR MERCK & CO. INC. SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
7NX57 J4K4X Y013407 Y1A201M Y019175 U8375AA 9JT4S |
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; Inappropriate schedule of product administration; Inappropriate schedule of product administration
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Wrong date of birth entered in database. When patient came in room was asked if dob was xxxx she nod...
Wrong date of birth entered in database. When patient came in room was asked if dob was xxxx she nodded, vaccines given and mother then stated the child was 7 years old and that dob xxxx. Patient received HPV and menquadfi too early.
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| 2854880 | 15 | F | IA | 08/20/2025 |
HEP HEPA HPV9 IPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. SANOFI PASTEUR MERCK & CO. INC. |
47XP4 G79C4 Y015760 X1D141m Z008502 |
Product administered to patient of inappropriate age; Product administered to pa...
Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
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Patient came into clinic to update Vaccinations. The only Vaccine to was not Accurate was the Pro qu...
Patient came into clinic to update Vaccinations. The only Vaccine to was not Accurate was the Pro quad, as it was for younger age group than the patient's current age.
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| 2854881 | 20 | F | NJ | 08/20/2025 |
MENB MENB |
PFIZER\WYETH PFIZER\WYETH |
LX2636 LX2636 |
Abdominal pain upper, Injection site erythema, Injection site induration, Inject...
Abdominal pain upper, Injection site erythema, Injection site induration, Injection site pain, Nausea; Pain, Pyrexia, Vomiting
More
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The evening after the vaccine felt feverish. Had body aches, nausea, vomited, stomach pain. Left arm...
The evening after the vaccine felt feverish. Had body aches, nausea, vomited, stomach pain. Left arm red and tender at injection site. 3cm red induration at site. Saw by pediatrician the following day. Zofran prescribed. 2 days later feeling better.
More
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| 2854882 | 25 | M | IN | 08/20/2025 |
HEP IPV MMR TDAP VARCEL |
DYNAVAX TECHNOLOGIES CORPORATION SANOFI PASTEUR MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
945665 X1C891M Y004115 LX494 Y013347 |
Blood glucose, Eye movement disorder, Fall, Urinary incontinence; Blood glucose,...
Blood glucose, Eye movement disorder, Fall, Urinary incontinence; Blood glucose, Eye movement disorder, Fall, Urinary incontinence; Blood glucose, Eye movement disorder, Fall, Urinary incontinence; Blood glucose, Eye movement disorder, Fall, Urinary incontinence; Blood glucose, Eye movement disorder, Fall, Urinary incontinence
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Unknown if pt had adverse effect from vaccines but pt was administered 5 vaccines and from there pt ...
Unknown if pt had adverse effect from vaccines but pt was administered 5 vaccines and from there pt was alert and oriented but after receiving the last vaccine, pt then fell back on to the exam table. Nurse offered water to pt. Pt accepted. From there, he drank and was still lying down for a few minutes. He then got up from the exam table and sat on chair and from there, his eyes rolled and fell onto the floor out of the chair. He was then propped up against the wall and nurse ran to get help. Once nurse returned, he was able to stand. Other staff members arrived to assist. Pt then wanted to go to the bathroom (realized he had an accident on himself). He was still able to stand after event.
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| 2854883 | 14 | M | VA | 08/20/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
Lm2212 Lm2212 |
Blood glucose increased, Glucose urine present, Lethargy, Pollakiuria, Thirst; W...
Blood glucose increased, Glucose urine present, Lethargy, Pollakiuria, Thirst; Weight decreased
More
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We collectively obtained the COVID vaccine in preparation of travel from (withheld) to (withheld) on...
We collectively obtained the COVID vaccine in preparation of travel from (withheld) to (withheld) on 11/3. During travel around 11/6-11/7 patient began presenting symptoms of extreme thirst and frequent urination and was very lethargic and began losing weight. Unbeknownst to us these are classic signs of diabetes for someone who is in a state of diabetic ketoacidosis. U
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โ | โ | โ | |||
| 2854884 | 60 | F | FL | 08/20/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
XN575 |
Extra dose administered
Extra dose administered
|
Patient was given Boostrix 8/19/25 and afterwards it was discovered she also received it on 2/5/25
Patient was given Boostrix 8/19/25 and afterwards it was discovered she also received it on 2/5/25
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| 2854885 | 55 | M | MD | 08/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
23AH3 |
Myalgia
Myalgia
|
leg muscles sore
leg muscles sore
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| 2854886 | 17 | F | GA | 08/20/2025 |
MENB |
PFIZER\WYETH |
GP8617 |
Erythema, Induration, Pain, Swelling
Erythema, Induration, Pain, Swelling
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Patient had a large area of induration that was erythematous, painful and swollen 3 inches round. No...
Patient had a large area of induration that was erythematous, painful and swollen 3 inches round. No drainage or puss.
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| 2854887 | 13 | F | NH | 08/20/2025 |
HPV9 |
MERCK & CO. INC. |
Y015179 |
Fall, Head injury, Loss of consciousness
Fall, Head injury, Loss of consciousness
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Code Blue called overhead for a patient that passed out in the second-floor elevator. She was accomp...
Code Blue called overhead for a patient that passed out in the second-floor elevator. She was accompanied by her mother Patient had just received vaccinations and had not eaten any breakfast. Patient was pale with a BP of 80/64. BP increased to 98/70, and patient was transported to an exam room for further evaluation. Patient was given ice for complaints of hitting head when falling. Patient was released to her mother, with the understanding that if there are symptoms that are worrisome to go to the emergency department.
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| 2854888 | 60 | F | AZ | 08/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Hypoaesthesia, Neuropathy peripheral
Hypoaesthesia, Neuropathy peripheral
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I had 2 that day. 1 was Tetanus vaccine the 2nd was Shingles Vaccine both in the upper left arm/sho...
I had 2 that day. 1 was Tetanus vaccine the 2nd was Shingles Vaccine both in the upper left arm/shoulder I got the Shingles vaccine on May 12, 2025 and immediately started having numbness in both legs and feet. It is 3 months later and it has not gotten better at all. It is called neuropathy and the Doctor has just brushed it off as old age? I am 60 My Doctor immediately turned me over to a FNP-C
More
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| 2854889 | 16 | F | GA | 08/20/2025 |
MENB MNQ |
PFIZER\WYETH SANOFI PASTEUR |
GP8617 U8256BA |
Feeling abnormal, Headache, Nausea, Pain, Pyrexia; Feeling abnormal, Headache, N...
Feeling abnormal, Headache, Nausea, Pain, Pyrexia; Feeling abnormal, Headache, Nausea, Pain, Pyrexia
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Pt reported she felt terrible the next afternoon with terrible headache, nausea, body aches, and fev...
Pt reported she felt terrible the next afternoon with terrible headache, nausea, body aches, and feverish. Symptoms lasted 3 days.
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| 2854890 | 59 | M | PA | 08/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Fatigue, Headache, Impaired work ability, Pain
Fatigue, Headache, Impaired work ability, Pain
|
Body aches; tired; severe headache lasting 1.5 days; missed one day of work due to symptoms
Body aches; tired; severe headache lasting 1.5 days; missed one day of work due to symptoms
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| 2854891 | 16 | F | MA | 08/20/2025 |
MNQ MNQ |
SANOFI PASTEUR SANOFI PASTEUR |
U8508AA U8508AA |
Arthralgia, Back pain, Injection site swelling, Musculoskeletal chest pain, Musc...
Arthralgia, Back pain, Injection site swelling, Musculoskeletal chest pain, Musculoskeletal stiffness; Pain in extremity
More
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Day of vaccination, no symptoms. One day after (8/15/25), moderate swelling of the left deltoid regi...
Day of vaccination, no symptoms. One day after (8/15/25), moderate swelling of the left deltoid region, without erythema. Reported shoulder stiffness and pain in the left side of her back, shoulder, arm and rib cage, which lasted all day. She applied ice and took ibuprofen and acetaminophen. When she woke up the next day (8/16/25) the pain and swelling had resolved
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| 2854892 | 1 | M | IA | 08/20/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
EB499 |
Wrong product administered
Wrong product administered
|
received a tdap (Boostrix) vaccine instead of a dtap (Infanrix) vaccine; This non-serious case was r...
received a tdap (Boostrix) vaccine instead of a dtap (Infanrix) vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number EB499) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis. Previously administered products included Vaxelis (received 3 doses of Vaxelis), Vaxelis (2nd) and Vaxelis (3 rd). On 17-JUL-2025, the patient received Boostrix.The patient did not receive Infanrix. On 17-JUL-2025, an unknown time after receiving Boostrix and not applicable after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: received a tdap (Boostrix) vaccine instead of a dtap (Infanrix) vaccine). The outcome of the wrong vaccine administered 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: 31-JUL-2025 and 01-AUG-2025 The CMA (certified medical assistant) called and reported because they had a patient here in their office, 2 weeks ago (from the date of reporting), he was 15 months of age, and he received a tdap (Boostrix) vaccine instead of a dtap (Infanrix) vaccine, which led to wrong vaccine administered. The vaccine administration facility was the same as primary reporter. The HCP informed that the Boostrix was received as the 4th dose in the DTaP series instead of Infanrix, this because in the past, the patient received 3 doses of Vaxelis.
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| 2854893 | 5 | F | AR | 08/20/2025 |
DTAPHEPBIP HEPA MMRV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
9P329 J4K4X Z003311 |
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; Inappropriate schedule of product administration, No adverse event
More
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INCORRECT INTERVAL OF HEP B/HEP A. No adverse reactions noted or reported by mother.
INCORRECT INTERVAL OF HEP B/HEP A. No adverse reactions noted or reported by mother.
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| 2854894 | 11 | M | CA | 08/20/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
Y012921 U8494AA U8353BA |
Injection site cellulitis, Injection site haematoma; Injection site cellulitis, ...
Injection site cellulitis, Injection site haematoma; Injection site cellulitis, Injection site haematoma; Injection site cellulitis, Injection site haematoma
More
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Assessment/Plan: Diagnoses and all orders for this visit: Hematoma Cellulitis of left upper extremit...
Assessment/Plan: Diagnoses and all orders for this visit: Hematoma Cellulitis of left upper extremity - azithromycin (Zithromax) 200 MG/5ML suspension; Take 12.1 mL (484 mg total) by mouth 1 (one) time each day for 5 days.. Plan: See discharge instructions Patient Instructions Patient received a prescription for Zithromax to treat his hematoma/cellulitis from the injection. Mother was advised also to use cold pads and Motrin for the inflammation Follow up if symptoms worsen or fail to improve. Instructions Follow up if symptoms worsen or fail to improve. Patient received a prescription for Zithromax to treat his hematoma/cellulitis from the injection. Mother was advised also to use cold pads and Motrin for the inflammation
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| 2854895 | 15 | F | OH | 08/20/2025 |
HEPA HPV9 MNQ VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. SANOFI PASTEUR MERCK & CO. INC. |
MB8599 Y015560 U8574AA Z006737 |
Dizziness, Tremor; Dizziness, Tremor; Dizziness, Tremor; Dizziness, Tremor
Dizziness, Tremor; Dizziness, Tremor; Dizziness, Tremor; Dizziness, Tremor
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Patient experienced tremors and began to pass out approximately 5 minutes after vaccination.... pati...
Patient experienced tremors and began to pass out approximately 5 minutes after vaccination.... patient then became stable vital signs were obtained and patient was able to leave on their own.
More
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| 2854896 | 67 | F | 08/20/2025 |
PNC21 |
MERCK & CO. INC. |
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Chills, Fatigue, Peripheral swelling, Pruritus
Chills, Fatigue, Peripheral swelling, Pruritus
|
Chills, fatigue, itching and arm swelling
Chills, fatigue, itching and arm swelling
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| 2854897 | 5 | M | NY | 08/20/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Injected limb mobility decreased, Peripheral swelling, Skin warm, Tenderness, Ur...
Injected limb mobility decreased, Peripheral swelling, Skin warm, Tenderness, Urticaria; Injected limb mobility decreased, Peripheral swelling, Skin warm, Tenderness, Urticaria
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Right arm extremely swollen and a large hive, hot to touch, painful to touch. Difficulty using that ...
Right arm extremely swollen and a large hive, hot to touch, painful to touch. Difficulty using that arm, difficulty lifting arm.
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| 2854898 | 28 | M | AZ | 08/20/2025 |
HEP HPV9 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
9K74F Y015760 |
Underdose; Underdose
Underdose; Underdose
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Pediatric Hep B dose mistakenly given to an adult. Appt. made for adult to receive appropriate dos...
Pediatric Hep B dose mistakenly given to an adult. Appt. made for adult to receive appropriate dose (1 cc)
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| 2854899 | 12 | F | MN | 08/20/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Erythema, Feeling hot, Pain, Pruritus, Swelling; Urticaria
Erythema, Feeling hot, Pain, Pruritus, Swelling; Urticaria
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Hives, Itching, Hot, Red, Swelling, Pain
Hives, Itching, Hot, Red, Swelling, Pain
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| 2854900 | 16 | M | TX | 08/20/2025 |
MNP |
PFIZER\WYETH |
LJ0077 |
Back pain, Chills, Headache
Back pain, Chills, Headache
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Patient reported lower back pain, chills and headache that started yesterday evening. Patient's...
Patient reported lower back pain, chills and headache that started yesterday evening. Patient's mother reported that acetaminophen did not help symptoms.
More
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| 2854901 | 65 | M | MD | 08/20/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
946064 |
Facial paresis
Facial paresis
|
left side facial weakness
left side facial weakness
|
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| 2854902 | 0.33 | M | NC | 08/20/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK199AA |
Product preparation error
Product preparation error
|
Box of Pentacel vaccine retrieved from VFC supply refridge. When opened it was noted that there wer...
Box of Pentacel vaccine retrieved from VFC supply refridge. When opened it was noted that there were 2 vials of the blue Dtap/IPV component in the box but no corresponding doses of the Green Hib component. There should be equal numbers of the 2 components as they are combined to constitute a dose. The nurse used the Hib component only and used sterile water as a dilutent. The pt only received the Hib component, and the wrong dilutent.
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| 2854903 | 1.67 | F | NC | 08/20/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK199AA |
Product preparation error
Product preparation error
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Box of Pentacel vaccine retrieved from supply refridge. When opened it was noted that there were 2 ...
Box of Pentacel vaccine retrieved from supply refridge. When opened it was noted that there were 2 vials of the blue Dtap/IPV component in the box but no corresponding Green Hib component. There should be equal numbers of the 2 components as they are combined to constitute a dose. The nurse used the Hib component only and put sterile water in as a dilutent. The pt only received the Hib component with the incorrect dilutent.
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| 2854904 | 63 | M | MA | 08/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
J32PB |
Pain
Pain
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He talked about having pain all over his body, mainly in his legs and groin.
He talked about having pain all over his body, mainly in his legs and groin.
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| 2854905 | 71 | F | MI | 08/20/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
7pk53 |
Unevaluable event
Unevaluable event
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None
None
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| 2854906 | VA | 08/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
FT95N |
Product storage error
Product storage error
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Incorrect storage; This non-serious case was reported by a pharmacist via call center representative...
Incorrect storage; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) (batch number FT95N, expiry date 25-APR-2027) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Incorrect storage). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK receipt date: 05-AUG-2025 Reporter recently discovered that a box of Shingrix was put in the freezer instead of the fridge when our order was put away. It was received into the pharmacy on 1st August 2025 and went into the freezer that day. It was discovered on 2nd August 2025. Reporter read that the adjuvant was no longer any good. Is the antigen still able to be used? If be able to purchase adjuvant in order to reconstitute the antigen? If the product was completely unusable, please advise. A very costly error for our pharmacy when technician putting away the order. Thank you. Upon callback to HCP today, Pharmacist stated it was due to lack of being aware.
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| 2854907 | 60 | 08/20/2025 |
RSV |
PFIZER\WYETH |
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Asthma, Condition aggravated
Asthma, Condition aggravated
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4 d after vacc pt had her first asthma flare in several years. Needs 6 visits over 2 mo and aggres...
4 d after vacc pt had her first asthma flare in several years. Needs 6 visits over 2 mo and aggressive med management to control symptoms including weeks of oral steroids. Pt slowly healing but not at baseline.
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| 2854908 | 30 | F | TN | 08/20/2025 |
HEP VARCEL |
DYNAVAX TECHNOLOGIES CORPORATION MERCK & CO. INC. |
946904 z006738 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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Extraneous dose given -no reaction from patient
Extraneous dose given -no reaction from patient
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| 2854909 | 58 | F | CA | 08/20/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LN4929 LN4929 |
Chills, Erythema, Headache, Nausea, Peripheral swelling; Pyrexia
Chills, Erythema, Headache, Nausea, Peripheral swelling; Pyrexia
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Swelling and redness to the entire arm, headache, nausea, chills and fever. Cephalexin 500mg capsu...
Swelling and redness to the entire arm, headache, nausea, chills and fever. Cephalexin 500mg capsules given to the patient.
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| 2854910 | 61 | F | GA | 08/20/2025 |
FLU3 |
SANOFI PASTEUR |
u8790aa |
Injection site erythema, Injection site pain, Injection site pruritus, Pain
Injection site erythema, Injection site pain, Injection site pruritus, Pain
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Patient has redness at injection site and surrounding area about the size of a baseball. Patient st...
Patient has redness at injection site and surrounding area about the size of a baseball. Patient states the area is tender to touch. She is also complaining of itching. She is taking tylenol and motrin with minimal benefit. She is also complaining that it is painful to lift the arm. Consulted patient to take benadryl for the itching and try alternating with warm and cold compresses for pain relief. Also let ptnt know let MD know if pain worsens or is not relieved within 72 hours.
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| 2854911 | 16 | M | AL | 08/20/2025 |
MMR MNQ VARCEL |
MERCK & CO. INC. SANOFI PASTEUR MERCK & CO. INC. |
Y004117 U8574AA Z003766 |
Loss of consciousness, Syncope; Loss of consciousness, Syncope; Loss of consciou...
Loss of consciousness, Syncope; Loss of consciousness, Syncope; Loss of consciousness, Syncope
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Patient had a syncope episode. Patient did not loose consciousness.
Patient had a syncope episode. Patient did not loose consciousness.
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| 2854912 | 11 | M | TX | 08/20/2025 |
DTPPVHBHPB HPV9 MNQ |
MSP VACCINE COMPANY MERCK & CO. INC. SANOFI PASTEUR |
U8335AA Y018297 U8558BA |
No adverse event, Wrong product administered; No adverse event, Wrong product ad...
No adverse event, Wrong product administered; No adverse event, Wrong product administered; No adverse event, Wrong product administered
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Vaxelis was accidently administered, Patient needed a TDAP. No adverse reactions.
Vaxelis was accidently administered, Patient needed a TDAP. No adverse reactions.
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| 2854913 | NJ | 08/20/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
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Immunodeficiency
Immunodeficiency
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Immunocompromised status after Bexsero 2 doses; This serious case was reported by a physician via ca...
Immunocompromised status after Bexsero 2 doses; This serious case was reported by a physician via call center representative and described the occurrence of immunocompromised in a patient who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced immunocompromised (Verbatim: Immunocompromised status after Bexsero 2 doses) (serious criteria GSK medically significant). The outcome of the immunocompromised was unknown. It was unknown if the reporter considered the immunocompromised to be related to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the immunocompromised to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date :07-AUG-2025 and 08-AUG-2025 Physician reported that a patient had received 2 doses of Bexsero and later became immunocompromised. The reporter wanted to ask should they receive additional dose(s) of Bexsero or not. The reporter consented to follow up.; Sender's Comments: A case of Immunodeficiency, unknown date after Bexsero and Bexsero Pre-Filled Syringe Device, in a patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
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| 2854914 | F | NJ | 08/20/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Intercepted product prescribing error
Intercepted product prescribing error
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Inappropriate age prescription.; This non-serious case was reported by a pharmacist via call center ...
Inappropriate age prescription.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. Concurrent medical conditions included cancer (patient has cancer). On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced intercepted drug prescribing error (Verbatim: Inappropriate age prescription.). The outcome of the intercepted drug prescribing error 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: 08-AUG-2025 Other HCP reported that a patient had cancer, and oncologist wanted the patient to get this vaccine, which led to intercepted drug prescribing error. According to reporter, patient had a prescription for Pediarix. No further details provided.
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| 2854915 | F | KY | 08/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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Shingrix late second dose; This non-serious case was reported by a pharmacist via call center repre...
Shingrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose at the end of the 2024). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: Shingrix late second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 12-AUG-2025 The reporter reported that the patient had a patient who got the first Shingrix shot at the end of last year. The reporter asked did she just need 1 more shot. It had been more than 10 months since her first shot. No further information provided. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2854916 | F | NY | 08/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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did not receive second dose; This non-serious case was reported by a pharmacist via call center repr...
did not receive second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose in October 2022). The patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: did not receive second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 15-AUG-2025 The patient did not receive Hz/su + AS01B was Shingrix. The reporter reported that the patient received the first dose in October 2022 and did not receive the second dose yet. Till the time of reporting, the patients did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
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| 2854917 | M | 08/20/2025 |
COVID19 |
MODERNA |
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Haematological neoplasm
Haematological neoplasm
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blood cancer; This spontaneous case was reported by a consumer and describes the occurrence of HAEMA...
blood cancer; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOLOGICAL NEOPLASM (blood cancer) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 13-Mar-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced HAEMATOLOGICAL NEOPLASM (blood cancer) (seriousness criterion medically significant). At the time of the report, HAEMATOLOGICAL NEOPLASM (blood cancer) had resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. No concomitant medication was reported. It was stated that patient has blood cancer they did not knew when it started or if the vaccine impacted it in any ways. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.
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