| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2836808 | 04/18/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Burning sensation, Herpes zoster, Inappropriate schedule of product administrati...
Burning sensation, Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
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Suspected vaccination failure; had shingles in one arm; 2 doses in Oct; This serious case was report...
Suspected vaccination failure; had shingles in one arm; 2 doses in Oct; 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. In OCT-2024, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In OCT-2024, an unknown time after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced drug dose administration interval too short (Verbatim: 2 doses in Oct). In FEB-2025, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles in one arm). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the drug dose administration interval too short was not applicable. 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: 13-APR-2025 This case was reported by a patient via interactive digital media. The patient stated that he/she was vaccinated, 2 doses in October. At the time of reporting patient have had shingles in one arm for 2 months now. The patient stated that it was intense burning, slowly spreading up to underarm. No rash were reported. The patient stated it took a while to diagnose it. All internal and guess mild compared to most because patient did. The patient suggested to get the vaccine, patient had encouraged everybody to get it. The patient received 2nd dose of Shingrix,?earlier than the recommended interval, which led to shortening of vaccinations schedule. This case was considered as suspected vaccination failure as laboratory test regarding shingles was 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2).
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| 2836809 | 04/18/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
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redness and swelling at the injection site; redness and swelling at the injection site; This non-ser...
redness and swelling at the injection site; redness and swelling at the injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 11-APR-2025, the patient received Shingrix. In APR-2025, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: redness and swelling at the injection site) and injection site swelling (Verbatim: redness and swelling at the injection site). The outcome of the injection site erythema was not reported and the outcome of the injection site swelling was not resolved. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix. It was unknown if the company considered the injection site erythema and injection site swelling to be related to Shingrix. Additional Information: GSK Receipt Date : 12-APR-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine the day before reporting and had redness and swelling at the injection site. The reporter asked if he/she could take Motrin or Benadryl to help with the swelling.; Sender's Comments: US-GSK-US2025AMR046242:same reporter US-GSK-US2025AMR046252:same reporter US-GSK-US2025AMR046239:same reporter US-GSK-US2025AMR046250:same reporter US-GSK-US2025AMR046237:same reporter
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| 2836810 | 04/18/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Herpes zoster, Hypoacusis, Ophthalmic herpes zoster, Vaccination failure; Herpes...
Herpes zoster, Hypoacusis, Ophthalmic herpes zoster, Vaccination failure; Herpes zoster, Hypoacusis, Ophthalmic herpes zoster, Vaccination failure
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Suspected Vaccination failure; got shingles in my eye; got shingles in my scalp, face last fall; Hea...
Suspected Vaccination failure; got shingles in my eye; got shingles in my scalp, face last fall; Hearing has been affected; 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 (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, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: got shingles in my eye) (serious criteria GSK medically significant), facial herpes zoster (Verbatim: got shingles in my scalp, face last fall) and hearing impaired (Verbatim: Hearing has been affected). The outcome of the vaccination failure, ophthalmic herpes zoster, facial herpes zoster and hearing impaired were not reported. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, facial herpes zoster and hearing impaired to be related to Shingrix and Shingrix. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the facial herpes zoster and hearing impaired to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 12-APR-2025 This case was reported by a patient via interactive digital media. The patient got both Shingrix vaccinations and just got shingles in his/her eye, scalp, face last fall and the hearing had been affected and it had been awful. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of 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 completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1& 2). Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix (Dose 1& 2).
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| 2836811 | TX | 04/18/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
UNK |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Pharmacy shared they vaccinated patients over the age of 55; This non-serious case was reported by a...
Pharmacy shared they vaccinated patients over the age of 55; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Pharmacy shared they vaccinated patients over the age of 55). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK Receipt Date: 09-APR-2025 Pharmacy shared they vaccinated patients over the age of 55 that have compromised immune system and the claims were denied which led to Inappropriate age at vaccine administration.
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| 2836812 | 04/18/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Pain in extremity
Pain in extremity
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my arm hurt but better than this; This non-serious case was reported by a consumer via interactive ...
my arm hurt but better than this; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On 14-APR-2025, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: my arm hurt but better than this). The outcome of the pain in arm was not reported. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK receipt Date: 15-APR-2025 This case was reported by a patient via interactive digital media. The patient said that get the shot. The patient received Shingles vaccine and before one day of reporting the arm was hurt but better than this.
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| 2836813 | 04/18/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; I had the vaccines and still got a severe case of them; This serious ...
Suspected vaccination failure; I had the vaccines and still got a severe case of them; 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. 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 herpes zoster (Verbatim: I had the vaccines and still got a severe case of them). The outcome of the vaccination failure and herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingles vaccine. The company considered the vaccination failure and herpes zoster to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 13-APR-2025 This case was reported by a patient via interactive digital media. The patient received Shingles vaccines and still got a severe case of them. The pain was unreal. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine."
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| 2836814 | F | 04/18/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv...
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 female 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, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). 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 Shingrix and Shingrix. The company considered the vaccination failure and shingles to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 13-APR-2025 This case was reported by a patient via interactive digital media. The patient had the Shingles vaccine year ago in 2024 (from the date of reporting) and when they came out with the advanced Shingrix double injection preventative, her husband and she (patient) both got the shots and guess what not only patient got shingles, the physician said it was the worst case he had ever seen. This case was considered as suspected vaccination failure as details regarding 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 about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingrix vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingrix vaccine.
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| 2836815 | 04/18/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Blister, Erythema, Herpes zoster, Stress, Vaccination failure
Blister, Erythema, Herpes zoster, Stress, Vaccination failure
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Suspected vaccination failure; broke out along the same nerve with red patches with little blisters/...
Suspected vaccination failure; broke out along the same nerve with red patches with little blisters/ it was shingles; Under stress; 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. 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), shingles (Verbatim: broke out along the same nerve with red patches with little blisters/ it was shingles) and stress (Verbatim: Under stress). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure, shingles and stress were not reported. It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingles vaccine. The company considered the vaccination failure, shingles and stress to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 13-APR-2025 This case was reported by a patient via interactive digital media. The patient stated this had happened with him/her also. The patient had the Shingles vaccine and twice, under. Under stress, the patient broke out along the same nerve with red patches with little blisters. The patient's physician both times said it was shingles. Also gave him/her a prescription for Valtrex. The patient was really surprised that it broke through, but fortunately it was just an annoyance not an agony This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster and Stress are unlisted events which are considered unrelated to GSK Shingles vaccine."
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| 2836816 | 04/18/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster
Herpes zoster
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I got shingles between the first and second shot; This non-serious case was reported by a consumer v...
I got shingles between the first and second shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles 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 shingles (Verbatim: I got shingles between the first and second shot). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Linked case(s) involving the same patient: US2019AMR229096 Additional Information: GSK Receipt Date: 12-APR-2025 This case was reported by a patient via interactive digital media. The reporter got shingles between the first and second shot. It was a very mild case.
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| 2836817 | 04/18/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected Vaccination failure; but got Shingles anyway; This serious case was reported by a consumer...
Suspected Vaccination failure; but got Shingles anyway; 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. 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: but got Shingles anyway). 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 : 13-APR-2025 This case was reported by a patient via interactive digital media. He/she had the Shingles shot but got Shingles anyway. 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 about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2836818 | 11 | F | TX | 04/18/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
223Y9 |
Wrong product administered
Wrong product administered
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Administration instead of Boostrix; This non-serious case was reported by a nurse via call center re...
Administration instead of Boostrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) (batch number 223Y9, expiry date 07-SEP-2026) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 07-APR-2025, the patient received Infanrix. On an unknown date, the patient received Boostrix. On 07-APR-2025, an unknown time after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Administration instead of Boostrix). 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: 08-APR-2025 The patient was received a Dtap (Infanrix) vaccine that was an error, because they should have gotten the Tdap (Boostrix), which led wrong vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
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| 2836819 | 20 | F | PA | 04/18/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
9K74F |
Underdose
Underdose
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Pediatric dose to an adult patient; Pediatric dose to an adult patient; This non-serious case was re...
Pediatric dose to an adult patient; Pediatric dose to an adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number 9K74F, expiry date 27-OCT-2025) for prophylaxis. On 06-MAR-2025, the patient received Engerix B pediatric. On 06-MAR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Pediatric dose to an adult patient) and underdose (Verbatim: Pediatric dose to an adult patient). The outcome of the adult use of a child product and underdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 09-APR-2025 A 20-year-old patient was given Engerix B, the birth to 19 year old Engerix-B. The Vaccine Administration Facility is the same as Primary Reporter The healthcare professional confirmed that it was the Engerix-B vaccine, and that the patient received the pediatric dose which led to adult use of a child product and underdose.
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| 2836820 | 04/18/2025 |
DTAP DTAPHEPBIP DTAPIPV HEP HEPA TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Product storage error; Product storage error; Product storage error; Product sto...
Product storage error; Product storage error; Product storage error; Product storage error; Product storage error; Product storage error
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Inappropriate Storage Error; This non-serious case was reported by a physician via call center repre...
Inappropriate Storage Error; This non-serious case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Infanrix) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 16-JAN-2025, the patient received Infanrix, Pediarix, Kinrix, Havrix, Engerix B and Boostrix. On 16-JAN-2025, an unknown time after receiving Infanrix, Pediarix, Kinrix, Havrix, Engerix B and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Inappropriate Storage Error). The outcome of the incorrect storage of drug 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: 09-APR-2025 The physician reported that he had submitted his continuous thermometer readings for review by the VFC program, and was told had a temperature excursions at 0.91 degree Celcius and the total time out of range is 20 minutes. Reporter believed it was an error, as 20 min prior the temperature was 4.92 degree Celcius on 16 January 2025 at 11:42 am 20 minutes, the next temperature was taken at 12:02 pm where it registered 0.43 degree Celsius. There was a patient Involvement, which led to incorrect storage of drug.
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| 2836821 | F | MN | 04/18/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3334Y |
Exposure via skin contact
Exposure via skin contact
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Splash of prepared vaccine to the skin; This non-serious case was reported by a nurse via call cente...
Splash of prepared vaccine to the skin; This non-serious case was reported by a nurse via call center representative and described the occurrence of occupational exposure via skin contact with product in a 23-year-old female patient who received Herpes zoster (Shingrix) (batch number 3334Y, expiry date 25-MAR-2027) for prophylaxis. On 09-APR-2025, the patient received Shingrix. On 09-APR-2025, an unknown time after receiving Shingrix, the patient experienced occupational exposure via skin contact with product (Verbatim: Splash of prepared vaccine to the skin). The outcome of the occupational exposure via skin contact with product was not applicable. Additional Information: GSK Receipt Date: 09-APR-2025 The nurse reported that the skin exposure to the reconstituted Shingrix vaccine as when they had prepared the dose, a small amount splashed onto their skin. no vaccine was administered as per worded by the health care professional, but the health care professional expressed she was exposed to it because it splashed on her skin. The vaccine administration facility was the same as primary reporter.
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| 2836822 | M | FL | 04/18/2025 |
HEP HEP HEP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
3H3RX 3H3RX 3H3RX |
Hepatitis B antibody negative, Therapeutic response decreased; Hepatitis B antib...
Hepatitis B antibody negative, Therapeutic response decreased; Hepatitis B antibody negative, Therapeutic response decreased; Hepatitis B antibody negative, Therapeutic response decreased
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completed his 3 doses of Engerix-B a year ago but in his blood test showed that he has not enough le...
completed his 3 doses of Engerix-B a year ago but in his blood test showed that he has not enough levels of the vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a 61-year-old male patient who received HBV (Engerix B) (batch number 3H3RX, expiry date 12-JUL-2024) for prophylaxis. Co-suspect products included HBV (Engerix B) (batch number 3H3RX, expiry date 12-JUL-2024) for prophylaxis and HBV (Engerix B) (batch number 3H3RX, expiry date 12-JUL-2024) for prophylaxis. Concurrent medical conditions included immunocompromised. On 04-APR-2024, the patient received the 3rd dose of Engerix B. On an unknown date, the patient received the 2nd dose of Engerix B and the 1st dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapeutic response decreased (Verbatim: completed his 3 doses of Engerix-B a year ago but in his blood test showed that he has not enough levels of the vaccine). The outcome of the therapeutic response decreased 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: 09-APR-2025 The pharmacist reported that the patient completed the 3 dose schedule of Engerix-B and took a blood test and he "didn't had enough levels of the Hepatitis-B vaccine which was Engerix-B, which led to therapeutic response decreased. The reporter asked can he receive a booster dose of Engerix-B because their doctor ordered it and how do they proceed.
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| 2836823 | 04/18/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
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Unevaluable event
Unevaluable event
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Administration of the Menveo 1-vial presentation to patient under 10 years of age; This non-serious ...
Administration of the Menveo 1-vial presentation to patient under 10 years of age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration of the Menveo 1-vial presentation to patient under 10 years of age). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK Receipt Date: 09-APR-2025 Pharmacist states a patient was supposed to get the Menveo 2-vial presentation (patient was under 10 years of age) but received the 1-vial presentation instead, which led inappropriate age at vaccine administration. The health care professional declined that contact information be stored and declined to provide any additional information, therefore did not probe any further. The reporter did not consent to follow-up.
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| 2836824 | 21 | F | FL | 04/18/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
233FT |
Underdose
Underdose
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pediatric dose of Engerix-B to a 21 y/o patient; pediatric dose of Engerix-B to a 21 y/o patient; Th...
pediatric dose of Engerix-B to a 21 y/o patient; pediatric dose of Engerix-B to a 21 y/o patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 21-year-old female patient who received HBV (Engerix B pediatric) (batch number 233FT, expiry date 12-DEC-2025) for prophylaxis. On 09-APR-2025, the patient received Engerix B pediatric. On 09-APR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: pediatric dose of Engerix-B to a 21 y/o patient) and adult use of a child product (Verbatim: pediatric dose of Engerix-B to a 21 y/o patient). The outcome of the underdose and adult use of a child product were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 10-APR-2025 The nurse requested data on the administration of pediatric dose of Engerix b to a 21ear year old patient which led to underdose and adult use of child product.
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| 2836825 | 4 | M | CA | 04/18/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
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Wrong product administered
Wrong product administered
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They get the Boostrix vaccine instead of Infanrix; This non-serious case was reported by a nurse vi...
They get the Boostrix vaccine instead of Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis. Previously administered products included Infanrix (Received 1st dose on unknown date), Infanrix (Received 2 nd dose on unknown date) and Infanrix (Received 3 rd dose on unknown date). On 07-APR-2025, the patient received the 1st dose of Boostrix. On an unknown date, the patient received Infanrix. On 07-APR-2025, an unknown time after receiving Boostrix and Infanrix, the patient experienced wrong vaccine administered (Verbatim: They get the Boostrix vaccine instead of Infanrix). 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 10-APR-2025 On 10-Apr-2025 Nurse called and reported they were working on the clinic on Monday 07-Apr-2025, a child came in for his immunization, a 4 year old child and he was supposed to get the Dtap Infanrix vaccine, but the medical assistant accidentally pull the wrong vaccine and didn't verify it. And patient get the T-dap Boostrix vaccine, which led to wrong vaccine administered. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. Health care professional was mentioned to coworker that the patient had 3 prior Dtap vaccines. Health care professional was didn't specify vaccine brand name.
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| 2836826 | M | 04/18/2025 |
COVID19 |
MODERNA |
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Nasal pruritus, Paraesthesia, Rhinorrhoea, Tinnitus
Nasal pruritus, Paraesthesia, Rhinorrhoea, Tinnitus
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he has runny/itchy nose; he has runny/itchy nose; ringing in the ears; pins and needles in legs, fac...
he has runny/itchy nose; he has runny/itchy nose; ringing in the ears; pins and needles in legs, face and head; The customer stated that he has had brain problems going on for a whole year; he had some "breathing problems"/he still has breathing problems; he has swallowing problems which began in 2024; This spontaneous case was reported by a patient and describes the occurrence of CEREBRAL DISORDER (The customer stated that he has had brain problems going on for a whole year), DYSPNOEA (he had some "breathing problems"/he still has breathing problems), DYSPHAGIA (he has swallowing problems which began in 2024), NASAL PRURITUS (he has runny/itchy nose) and RHINORRHOEA (he has runny/itchy nose) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2024, the patient experienced DYSPNOEA (he had some "breathing problems"/he still has breathing problems) and DYSPHAGIA (he has swallowing problems which began in 2024). On an unknown date, the patient experienced CEREBRAL DISORDER (The customer stated that he has had brain problems going on for a whole year), NASAL PRURITUS (he has runny/itchy nose), RHINORRHOEA (he has runny/itchy nose), TINNITUS (ringing in the ears) and PARAESTHESIA (pins and needles in legs, face and head). At the time of the report, CEREBRAL DISORDER (The customer stated that he has had brain problems going on for a whole year), DYSPHAGIA (he has swallowing problems which began in 2024), NASAL PRURITUS (he has runny/itchy nose), RHINORRHOEA (he has runny/itchy nose), TINNITUS (ringing in the ears) and PARAESTHESIA (pins and needles in legs, face and head) outcome was unknown and DYSPNOEA (he had some "breathing problems"/he still has breathing problems) had not resolved. No concomitant medications were reported. It was reported that the patient had received three covid-19 vaccines in 2021. Patient haven't received any other covid vaccines. Patient reported that he had some breathing problems in 2024 but, he also mentioned it could be due to mold in his apartment. Patient reported he had heard that the vaccines cause blood clots, heart problems and stroke. Patient reported that he had difficulty to understand at times. It was unknown if the patient experienced any additional symptoms or events. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2025: Live follow up received contains no new information. On 14-Apr-2025: Live follow-up received contains significant information and added new event of Difficulty breathing, swallowing difficult, Nasal itching, Runny nose, Pins and needles, ringing in ears, reporter details added, Patient demographics added, suspect dosing regimen added, narrative updated, and reference ID added.; Reporter's Comments: Exposure to mold could be a contributor for the event Dyspnoea. The benefit-risk relationship of the product is not affected by this report.
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| 2836827 | 65 | F | 04/18/2025 |
COVID19 |
MODERNA |
3043157 |
Headache, Malaise, Pain, Pyrexia
Headache, Malaise, Pain, Pyrexia
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she was having little headaches; she wanted to report a good side effect that she had from the Spike...
she was having little headaches; she wanted to report a good side effect that she had from the Spikevax vaccine/ she went from drinking 38-30 bottles of wine in a month, to having 4 bottles in the 2 months after receiving the vaccine; after she had the vaccination, she did not feel well for about 60 hours; after a vaccine, she feels achy and feverish and all that stuff; after a vaccine, she feels achy and feverish and all that stuff; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (after she had the vaccination, she did not feel well for about 60 hours), PAIN (after a vaccine, she feels achy and feverish and all that stuff), PYREXIA (after a vaccine, she feels achy and feverish and all that stuff), HEADACHE (she was having little headaches) and THERAPEUTIC RESPONSE UNEXPECTED (she wanted to report a good side effect that she had from the Spikevax vaccine/ she went from drinking 38-30 bottles of wine in a month, to having 4 bottles in the 2 months after receiving the vaccine) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043157) for COVID-19 prophylaxis. The patient's past medical history included Hives (Allergic to tetanus as she had hives after the tetanus vaccine). Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine in 2021, Moderna COVID-19 Vaccine and Bivalent (Original and Omicron BA.4/BA.5) in 2022; for Product used for unknown indication: Pfizer BioNTech COVID-19 vaccine in 2021 and Tetanus. Past adverse reactions to the above products included Hives with Tetanus; and No adverse effect with Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), Moderna COVID-19 vaccine and Pfizer BioNTech COVID-19 vaccine. Concurrent medical conditions included Blood pressure high, Hypercholesteraemia (High cholesterol) and Allergy to vaccine (Allergic to tetanus). On 22-Nov-2024, the patient received fifth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. In November 2024, the patient experienced MALAISE (after she had the vaccination, she did not feel well for about 60 hours), PAIN (after a vaccine, she feels achy and feverish and all that stuff) and PYREXIA (after a vaccine, she feels achy and feverish and all that stuff). On an unknown date, the patient experienced HEADACHE (she was having little headaches) and THERAPEUTIC RESPONSE UNEXPECTED (she wanted to report a good side effect that she had from the Spikevax vaccine/ she went from drinking 38-30 bottles of wine in a month, to having 4 bottles in the 2 months after receiving the vaccine). The patient was treated with Naltrexone hydrochloride (Naltrexone) at an unspecified dose and frequency. In November 2024, MALAISE (after she had the vaccination, she did not feel well for about 60 hours) had resolved. At the time of the report, PAIN (after a vaccine, she feels achy and feverish and all that stuff), PYREXIA (after a vaccine, she feels achy and feverish and all that stuff), HEADACHE (she was having little headaches) and THERAPEUTIC RESPONSE UNEXPECTED (she wanted to report a good side effect that she had from the Spikevax vaccine/ she went from drinking 38-30 bottles of wine in a month, to having 4 bottles in the 2 months after receiving the vaccine) had resolved. Patient had no other vaccines. Concomitant product use was not provided by the reporter. The reporter had a good side effect that she had from the Spikevax vaccine that she received in November, and she drank wine mostly and that it had been suggested to her that she should probably cut backed. She would typically have about a bottle of wine a day. After she had the vaccination, she felt unwell for about 60 hours. The reporter stated that typically after a vaccine, she felt achy and feverish and all that stuff, nothing real serious for 24-48 hours, however after this vaccine it lasted a little bit longer. But after that, her desire for alcohol decreased a lot. She went for days without having anything (alcohol) and without thinking about having something. In the days that she did drank, she was able to have just one or two glasses of wine, and that was amazing to her. That went on for 2.5 months, where she went from drinking 38-30 bottles of wine in a month, to 4 bottles in the 2 months after receiving the vaccine and there was nothing else that happened in her life or medical history that she could attribute it to except for the vaccine. During the 2-2.5 months when her desire for alcohol was decreased, she had little headaches that were not bothersome, that would last for 15 seconds or so in the top front of her head in both right and left sides. The reporter tried Naltrexone but it did not work for her. After about 2.5 months, when the desire for alcohol came back like it used to be, the headaches were gone and unfortunately, she went back to her normal ways. She always tried to cut backed cause she knew it was not good for her, but it was very hard for anybody with some kind of an addiction. She again started drinking a bottle a day. No other details were provided. It was unknown if the patient experienced any additional symptoms/events.
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| 2836828 | 15 | F | VT | 04/18/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
FA6780 FA6780 |
Anxiety, Dizziness, Headache, Hypotension, Paraesthesia; Paranoia, Visual impair...
Anxiety, Dizziness, Headache, Hypotension, Paraesthesia; Paranoia, Visual impairment
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Severe headache, anxiety, paranoia, visual disturbances, dizziness, low blood pressure, paresthesia....
Severe headache, anxiety, paranoia, visual disturbances, dizziness, low blood pressure, paresthesia. Tylenol was administered prior to vaccine by school nurse who accompanied my child.
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| 2836829 | 48 | M | PA | 04/18/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
T3Z7D |
Injection site pain, Ultrasound scan
Injection site pain, Ultrasound scan
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EE continues to C/O pain in right upper arm since vaccine given on 2/18/25. Was seen at urgent care ...
EE continues to C/O pain in right upper arm since vaccine given on 2/18/25. Was seen at urgent care on 4/14/25. An ultrasound of the right upper extremities was done and Voltaren cream was ordered. Continues to follow up with urgent care.
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| 2836830 | 58 | M | CT | 04/18/2025 |
COVID19 |
MODERNA |
036B21A |
Arthritis, Joint swelling, Metastases to spine, Prostate cancer metastatic
Arthritis, Joint swelling, Metastases to spine, Prostate cancer metastatic
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Pt developed L ankle swelling/inflammation 6/4/2021, has intermittently flared up since without clea...
Pt developed L ankle swelling/inflammation 6/4/2021, has intermittently flared up since without clear cause or known trigger. Pt subsequently diagnosed with metastatic prostate cancer on 2/7/2024 in his spine (no evidence of disease in leg or ankle).
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| 2836831 | 10 | F | MI | 04/18/2025 |
COVID19 FLU3 HPV9 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
MD3414 332H7 Y012865 |
Product administered to patient of inappropriate age; Product administered to pa...
Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
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Patient is 10 years old and received Covid Vaccine intended for ages 12 years and older.
Patient is 10 years old and received Covid Vaccine intended for ages 12 years and older.
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| 2836833 | 11 | M | MI | 04/18/2025 |
COVID19 FLU3 HPV9 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
MD3414 332H7 Y012865 |
Product administered to patient of inappropriate age; Product administered to pa...
Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
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Patient is 11 years old and received Covid vaccine intended for ages 12 and older.
Patient is 11 years old and received Covid vaccine intended for ages 12 and older.
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| 2836834 | 1 | F | IL | 04/18/2025 |
HEPA |
MERCK & CO. INC. |
Y017625 |
Incorrect dose administered
Incorrect dose administered
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MA did not follow vaccine protocol and administered adult hep a vaccine to 12 month old
MA did not follow vaccine protocol and administered adult hep a vaccine to 12 month old
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| 2836835 | 76 | M | FL | 04/18/2025 |
PNC20 |
PFIZER\WYETH |
LK6651 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient got one dose of Prevnar 20 on 12/22/2023 and then got another dose of Prevnar 20 on 04/10/20...
Patient got one dose of Prevnar 20 on 12/22/2023 and then got another dose of Prevnar 20 on 04/10/2025. Patient had no adverse reactions.
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| 2836836 | 1 | M | MI | 04/18/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
1005Z J007027 |
Herpes simplex test negative, Herpes zoster, Varicella virus test positive; Herp...
Herpes simplex test negative, Herpes zoster, Varicella virus test positive; Herpes simplex test negative, Herpes zoster, Varicella virus test positive
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Patient with no history of natural chicken pox seen yesterdays with shingles to left arm. VZV conf...
Patient with no history of natural chicken pox seen yesterdays with shingles to left arm. VZV confirmed by PCR. Appears to be vaccine induced shingles years after series.
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| 2836838 | 74 | F | VA | 04/18/2025 |
RSV VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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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
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Red, hot swelling at site of injections up to 3 days after injection
Red, hot swelling at site of injections up to 3 days after injection
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| 2836839 | 52 | F | OR | 04/18/2025 |
PNC20 TYP |
PFIZER\WYETH SANOFI PASTEUR |
LX4482 X1A271M |
Rash; Rash
Rash; Rash
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Rash on abdomen and behind armpit down arms. Rash on thighs slightly more on right side than left an...
Rash on abdomen and behind armpit down arms. Rash on thighs slightly more on right side than left and not below the knee. No itching or other anaphylactic symptoms (swelling, trouble breathing, etc.).
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| 2836840 | 71 | F | MD | 04/18/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
B945F |
Unevaluable event
Unevaluable event
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none
none
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| 2836841 | 52 | M | IL | 04/18/2025 |
TDAP |
SANOFI PASTEUR |
U8115AA |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Shot given before due date. Got tetanus shot back on 9/7/2023 and gave it today 4/18/2025. We told p...
Shot given before due date. Got tetanus shot back on 9/7/2023 and gave it today 4/18/2025. We told patient about the mistake and he was understanding. We told him nothing serious would happen from getting another tetanus shot early.
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| 2836843 | 61 | F | WI | 04/18/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
K4JH7 |
Underdose
Underdose
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Patient was given a pediatric dose of hep b instead of an adult dose.
Patient was given a pediatric dose of hep b instead of an adult dose.
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| 2836844 | 0.5 | F | VA | 04/18/2025 |
RV1 |
GLAXOSMITHKLINE BIOLOGICALS |
GTIN |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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baby got extra half a dose of Rotavirus vaccine. No reaction
baby got extra half a dose of Rotavirus vaccine. No reaction
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| 2836845 | 4 | F | VA | 04/18/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
|
Injection site erythema, Injection site swelling; Injection site erythema, Injec...
Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling
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Injection site reaction with erythrma and swelling
Injection site reaction with erythrma and swelling
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| 2836846 | 41 | F | VA | 04/18/2025 |
COVID19 |
JANSSEN |
|
Guillain-Barre syndrome, Wernicke's encephalopathy
Guillain-Barre syndrome, Wernicke's encephalopathy
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After receiving vaccine my wife was diagnosed with GBS and WE.
After receiving vaccine my wife was diagnosed with GBS and WE.
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โ | |||||
| 2836847 | 62 | F | WY | 04/18/2025 |
TDAP TDAP TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Brain fog, Ear pain, Fatigue, Headache, Herpes zoster; Herpes zoster oticus, Lym...
Brain fog, Ear pain, Fatigue, Headache, Herpes zoster; Herpes zoster oticus, Lymphadenopathy, Oral herpes zoster, Oropharyngeal pain, Pain in jaw; Pruritus, Pustule, Rash, Secretion discharge, Sensory disturbance; Stomatitis
More
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On Wed. within 15 of vaccine administration, I felt like something warm was moving under my skin. I...
On Wed. within 15 of vaccine administration, I felt like something warm was moving under my skin. It reminded me of the contrast solution you received when having a radiological procedure. It proceeded to move up my shoulder to my neck and left side of my face and head. I told my husband what was happening in case I had an anaphylactic response. I woke up the next morning (Thursday) with an extreme headache. It was not relieved by Tylenol, Motrin, Excedrin Migraine, or sleep. The headache continues to this day but has lessened in severity and is helped by Excedrin Migraine. Sunday morning I woke with itchiness and a rash on the left side of my face and jaw. Swollen lymph nodes in my neck with a sore throat. I had stabbing pain in my left ear. On Monday I woke up with oozing pustules, the headache was worsening as was the ear pain. I had jaw pain, mouth sores, and the headache continued along with brain fog. I was extremely tired. On Tuesday I called to make an appointment to see my primary physician. She was not available so I saw her NP, She did an exam and asked questions and called Dr. in to confirm it was shingles in my ear, mouth, and face. I was prescribed Valacyclovir (10 days), Predinose (5 days), and Gabapentin which I used for three weeks. I did have one more office visit on the following friday. I continue to have intermittent ear pain, headaches, brain fog, and fatigue. I will be following up with my physician by the end of April.
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| 2836848 | 1.92 | F | IA | 04/18/2025 |
HEPA HEPA |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
X2233 X2233 |
Injection site erythema, Injection site induration, Injection site mass, Injecti...
Injection site erythema, Injection site induration, Injection site mass, Injection site pallor, Injection site rash; Injection site warmth, Skin warm
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Patient came in was a large rash on left thigh that had formed over the last 2 days, mother of child...
Patient came in was a large rash on left thigh that had formed over the last 2 days, mother of child states its red, blanching, hot to touch, painful, hard lump under injection site. Mother did mention that she felt warm last night but has been giving her Tylenol.
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| 2836850 | 66 | M | WA | 04/18/2025 |
COVID19 FLU3 PNC21 |
MODERNA SANOFI PASTEUR MERCK & CO. INC. |
8081561 U8521AA Y013009 |
Bacterial infection, Injection site swelling, Peripheral swelling; Bacterial inf...
Bacterial infection, Injection site swelling, Peripheral swelling; Bacterial infection, Injection site swelling, Peripheral swelling; Bacterial infection, Injection site swelling, Peripheral swelling
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Patient came to the pharmacy stating that he was hospitalized 3 days after getting 3 vaccines all t...
Patient came to the pharmacy stating that he was hospitalized 3 days after getting 3 vaccines all together on 3/21st. According to the patient, both of his arms become all swollen from up his shoulder down his hands. It was so bad that he needed to call ambulance to transport him to the ER. He was confined to the hospital from March 21st to March 31st, and when he was discharged he will be on hospice thereafter.
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| 2836851 | 18 | M | CO | 04/18/2025 |
COVID19 FLU3 |
MODERNA GLAXOSMITHKLINE BIOLOGICALS |
8079568 CZ47E |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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Accidentally gave flu and covid vaccines, when he already had one of each in this season (Sept 2024)
Accidentally gave flu and covid vaccines, when he already had one of each in this season (Sept 2024)
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| 2836852 | 28 | M | NY | 04/18/2025 |
TDAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
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Abdominal distension, Abdominal pain, Computerised tomogram abdomen abnormal, En...
Abdominal distension, Abdominal pain, Computerised tomogram abdomen abnormal, Endoscopy, Flatulence; Gastric emptying study, Gastritis, Impaired gastric emptying, Regurgitation
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Gastroparesis (Delayed Stomach Emptying). Shorty after receiving a TDAP booster that was recommended...
Gastroparesis (Delayed Stomach Emptying). Shorty after receiving a TDAP booster that was recommended by a PCP as it had been more than 10 years since my last dose, I began experiencing symptoms such as abdominal pain, fullness after only eating a small amount of food, excessive gas and bloating, and regurgitation of food. I went to the hospital once the pain began to increase, where a CT scan was done, I was then referred to a gastroenterologist. I then saw a gastroenterologist who performed a endoscopy and found that bile was throughout my stomach which was causing gastritis and could be due to delayed stomach emptying. A Gastric Emptying study was eventually performed which confirmed that my stomach was emptying slower than normal. I was recommended a diet for gastroparesis. I would like to emphasize that this all began after I received the Tdap Vaccine. I did not have this condition before vaccination.
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| 2836853 | 55 | M | 04/18/2025 |
PNC21 |
MERCK & CO. INC. |
2002626 |
Erythema, Pain, Swelling
Erythema, Pain, Swelling
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swollen, reddened, painful area. no fever
swollen, reddened, painful area. no fever
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| 2836854 | 65 | M | WI | 04/18/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7LC49 |
Fatigue, Nausea, Pain in extremity, Thrombosis
Fatigue, Nausea, Pain in extremity, Thrombosis
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leg pain in both legs ; blood clots, fatigue, nausea, went to hospital, was given Eliquis, hot and c...
leg pain in both legs ; blood clots, fatigue, nausea, went to hospital, was given Eliquis, hot and cold packs on legs
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| 2836855 | 33 | F | 04/18/2025 |
TDAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U8352AA U8352AA |
Injection site erythema, Injection site induration, Injection site inflammation,...
Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Injection site reaction; Injection site warmth, Skin lesion
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Red, tender, inflamed, hard and hot lesion on the right deltoid. Patient was treated with Azithromyc...
Red, tender, inflamed, hard and hot lesion on the right deltoid. Patient was treated with Azithromycin 250mg for 5 days and Prednisone for 1 week. Lesion improved and subsided after treatment.
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| 2836856 | 2 | M | ID | 04/18/2025 |
HIBV |
SANOFI PASTEUR |
UK042AA |
No adverse event
No adverse event
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No adverse reaction at time of visit
No adverse reaction at time of visit
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| 2836857 | 49 | F | MI | 04/18/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LJ5283 LJ5283 |
Chest discomfort, Chills, Dyspnoea, Injection site reaction, Local reaction; Whe...
Chest discomfort, Chills, Dyspnoea, Injection site reaction, Local reaction; Wheezing
More
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SOB/wheezing, chest heaviness, chills, local site reaction
SOB/wheezing, chest heaviness, chills, local site reaction
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| 2836858 | 63 | M | MA | 04/18/2025 |
PNC21 |
MERCK & CO. INC. |
Y019158 |
Arthralgia, Urticaria
Arthralgia, Urticaria
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Date of vaccination was 4/11/25 in am; knee pain at site of prior pain in afternoon 4/11/25; extensi...
Date of vaccination was 4/11/25 in am; knee pain at site of prior pain in afternoon 4/11/25; extensive hives across entire body on evening of 4/14 that continued until 4/16; treated with antihistamines
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| 2836859 | 0.33 | M | MI | 04/18/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
2g273 |
Crying, Decreased appetite, High-pitched crying
Crying, Decreased appetite, High-pitched crying
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high pitched scream for over 6 hours inconsolable and loss of appetite
high pitched scream for over 6 hours inconsolable and loss of appetite
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| 2836860 | 75 | F | CO | 04/18/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Arthralgia, Arthritis, Magnetic resonance imaging abnormal, Magnetic resonance i...
Arthralgia, Arthritis, Magnetic resonance imaging abnormal, Magnetic resonance imaging joint, Pain; Protein total increased, Pruritus, Rotator cuff syndrome
More
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I started to notice the itching on 10/11, I wasnt sure what it was, i thought it could be from the p...
I started to notice the itching on 10/11, I wasnt sure what it was, i thought it could be from the pool or the rec center. The doctors office did not know either, they thought i should just drink more water and buy some cream. At the end of the month i started having issues with my shoulder. On 12/29 they did a MRI of my left shoulder and it showed some tears and arthritis. And i dont remember hurting my arm at all. And at the same time i was having issues with both the top and bottom hurting and i was having trouble with movement, even getting out of bed hurt so bad. So we are still no sure what is going on. Other test are being ordered. The one thing that showed up on my blood test was high protein. I keep having these problems and i can not pin point what is wrong. Its not my diet. I cant do the things i use to normally do before. we are still working on that.
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| 2836861 | 58 | F | MI | 04/18/2025 |
MMRV |
MERCK & CO. INC. |
Y015992 |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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Pt was administered ProQuad today at age 58 instead of receiving a separate dose of varicella and MM...
Pt was administered ProQuad today at age 58 instead of receiving a separate dose of varicella and MMR. Vaccine was verified with a 2nd RN prior to administration. Pt's PCP and nursing supervisor were informed. Local Health Department was contacted for recommendations. Pt was informed of vaccine error and questions were answered.
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