| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2836930 | F | IL | 04/21/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Product preparation issue
Product preparation issue
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only diluent administered; only diluent administered; This non-serious case was reported by a pharma...
only diluent administered; only diluent administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received MMR (Priorix) for prophylaxis. On 10-APR-2025, the patient received Priorix. On 10-APR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: only diluent administered) and inappropriate dose of vaccine administered (Verbatim: only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered 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: 14-APR-2025 Other HCP reported that on 10th Apr 2025, a patient received only the diluent component of Priorix, that means, without being reconstituted. The patient received only diluent of Priorix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
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| 2836931 | CT | 04/21/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
No adverse event, Product storage error
No adverse event, Product storage error
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Havrix was administered after a temperature excursion to one patient; This non-serious case was repo...
Havrix was administered after a temperature excursion to one patient; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) for prophylaxis. On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Havrix was administered after a temperature excursion to one patient). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 16-APR-2025 Nurse practitioner reported Havrix was administered after a temperature excursion to one patient, which led to Incorrect storage of drug. Nurse practitioner did not provide patient information or date of administration at the time of the call. No further information provided. No additional adverse event reported.
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| 2836932 | M | IA | 04/21/2025 |
HEP HEPAB |
DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS |
UNK 324BY |
Interchange of vaccine products; Interchange of vaccine products
Interchange of vaccine products; Interchange of vaccine products
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Interchangeability (first dose: TWINRIX, second dose: HEPLISAV).; This non-serious case was reported...
Interchangeability (first dose: TWINRIX, second dose: HEPLISAV).; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a 63-year-old male patient who received HAB (Twinrix) (batch number 324BY, expiry date 28-AUG-2026) for prophylaxis. Co-suspect products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) for prophylaxis. On 11-MAR-2025, the patient received the 1st dose of Twinrix. On 08-APR-2025, the patient received Heplisav b. On an unknown date, an unknown time after receiving Twinrix, the patient experienced interchange of vaccine products (Verbatim: Interchangeability (first dose: TWINRIX, second dose: HEPLISAV).). The outcome of the interchange of vaccine products 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 : 11-APR-2025 Other HCP reported a patient received a first dose of Twinrix, and afterwards received an Heplisav dose, which led to interchange of vaccine products. Reporter asked for any advice in this situation.
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| 2836933 | 1 | M | AZ | 04/21/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
h7rf2 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Twinrix to pediatric patient; This non-serious case was reported by a other health professional via ...
Twinrix to pediatric patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old male patient who received HAB (Twinrix adult) (batch number h7rf2, expiry date 17-JAN-2026) for prophylaxis. On 01-APR-2025, the patient received the 1st dose of Twinrix adult. On 01-APR-2025, an unknown time after receiving Twinrix adult, the patient experienced inappropriate age at vaccine administration (Verbatim: Twinrix to pediatric patient). The outcome of the inappropriate age at vaccine administration 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: 11-APR-2025 Other HCP reported about the administration of Twinrix to a 12 month old male patient, who was given the dose on April 1st, 2025, which led to inappropriate age at vaccine administration. They accepted follow-up.
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| 2836934 | 77 | F | CA | 04/21/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
7NX57 |
Underdose
Underdose
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Underdose; immunization to an adult; This non-serious case was reported by a other health profession...
Underdose; immunization to an adult; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 77-year-old female patient who received HBV (Engerix B 10 mcg) (batch number 7NX57, expiry date 12-DEC-2026) for prophylaxis. On 11-APR-2025, the patient received Engerix B 10 mcg. On 11-APR-2025, an unknown time after receiving Engerix B 10 mcg, the patient experienced underdose (Verbatim: Underdose) and adult use of a child product (Verbatim: immunization to an adult). The outcome of the underdose and adult use of a child product were not applicable. Additional Information: GSK Receipt Date: 11-APR-2025 The reporter reported that gave a hepatitis b pediatrics immunization to an adult and they like to know the recommendations which led to Adult use of a child product and underdose. The Vaccine Administration Facility is the same as Primary Reporter.
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| 2836935 | M | 04/21/2025 |
COVID19 |
MODERNA |
|
Post-acute COVID-19 syndrome
Post-acute COVID-19 syndrome
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I have long covid now; This spontaneous case was reported by a patient and describes the occurrence ...
I have long covid now; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (I have long covid now) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (I have long covid now). At the time of the report, POST-ACUTE COVID-19 SYNDROME (I have long covid now) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. The only time patient had Covid was when he was injected with Moderna shots. He never tested positive. However, he had long covid. It was unknown if the patient experienced any additional symptoms or events. No treatment information was reported.
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| 2836936 | 12 | F | TX | 04/21/2025 |
TD |
SANOFI PASTEUR |
U8492AA |
Injection site reaction, Pain
Injection site reaction, Pain
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patient given tenivac describing that it was like a painful burning sensation while injecting the va...
patient given tenivac describing that it was like a painful burning sensation while injecting the vaccine; Initial information received on 14-Apr-2025 regarding an unsolicited valid non-serious case received from a Nurse. This case was linked with US-SA-2025SA109153 and US-SA-2025SA109935. This case involves a 12 years old female patient where patient was given Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] describing that it was like a painful burning sensation while injecting the vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Polio vaccine for Immunisation. On 14-Apr-2025, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (strength- standard) Suspension for injection lot U8492AA and expiry date- 28-FEB-2027 via intramuscular route in the right arm for immunisation. On 14-APR-2025, the patient given tenivac describing that it was like a painful burning sensation while injecting the vaccine (vaccination site pain) (latency- same day). Action taken- not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event.; Sender's Comments: US-SA-2025SA109153: US-SA-2025SA109935:
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| 2836937 | 13 | F | TX | 04/21/2025 |
TD |
SANOFI PASTEUR |
U8492AA |
Injection site reaction, Pain
Injection site reaction, Pain
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patient given tenivac describing that it was like a painful burning sensation while injecting the va...
patient given tenivac describing that it was like a painful burning sensation while injecting the vaccine; Initial information received on 14-Apr-2025 regarding an unsolicited valid non-serious case received from a Nurse. This case was linked with US-SA-2025SA109105 and US-SA-2025SA109935. This case involves a 13 years old female patient where patient was given Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] describing that it was like a painful burning sensation while injecting the vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Polio vaccine for Immunisation. On 14-Apr-2025, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (strength- standard) Suspension for injection lot U8492AA and expiry date- 28-FEB-2027 via intramuscular route in the left arm for immunisation. On 14-APR-2025, the patient given tenivac describing that it was like a painful burning sensation while injecting the vaccine (vaccination site pain) (latency- same day). Action taken- not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event.; Sender's Comments: US-SA-2025SA109105: US-SA-2025SA109935:
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| 2836938 | 18 | F | NY | 04/21/2025 |
MEN |
UNKNOWN MANUFACTURER |
U7616AB |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
expired vaccine administration with no reported adverse event; Initial information received on 16-Ap...
expired vaccine administration with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 18 years old female patient who received expired meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included covid-19 vaccine; influenza vaccine; and hepatitis B vaccine, all for Immunisation. On 16-Apr-2025, the patient received 0.5 ml of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection of standard strength once with lot U7616AB and expiry date 11-Apr-2025 via intramuscular route in the right deltoid for immunisation (expired product administered) (Latency same day) Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2836944 | TX | 04/21/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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patient received one dose of of Shingrix and never received the second; This non-serious case was re...
patient received one dose of of Shingrix and never received the second; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (patient received one dose on an unknown date). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received one dose of of Shingrix and never received the second). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 14-APR-2025 The pharmacist reported that the patient received one dose of Shingrix vaccine and never received the second. She did not have any patient demographics. 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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| 2836945 | 04/21/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Pain
Pain
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i did not have a reaction to the shot except a little soreness; This non-serious case was reported b...
i did not have a reaction to the shot except a little soreness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a 85-year-old 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 pain (Verbatim: i did not have a reaction to the shot except a little soreness). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK receipt date: 10-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got his/her single shot at the age of 85 year old and both of his/her sisters get the singles and never got over them, burning stinging for years, his/her older sister singles went inside of her and it hit so many of her nerves the pain was unbearable, he/she honestly think it pushed her over and she passed away, his/her older daughter got singles when she was fairly young so she recovered but his/her other daughter got her shot at 50. The patient mentioned that get single shot, it can be so painful and maybe never go away if they were older. The patient reported that he/she did not had a reaction to the shot except a little soreness.; Sender's Comments: US-GSK-US2025AMR045222:Same reporter /different patient
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| 2836946 | 04/21/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Blood glucose decreased
Blood glucose decreased
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shingle vaccine lower blood sugar; This non-serious case was reported by a consumer via interactive ...
shingle vaccine lower blood sugar; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of blood sugar decreased in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced blood sugar decreased (Verbatim: shingle vaccine lower blood sugar). The outcome of the blood sugar decreased was not reported. The reporter considered the blood sugar decreased to be related to Shingrix. The company considered the blood sugar decreased to be related to Shingrix. Additional Information: GSK Receipt Date: 12-APR-2025 The Shingle vaccine lower blood sugar.; Sender's Comments: US-GSK-US2025AMR046239:same reporter US-GSK-US2025AMR046237:same reporter US-GSK-US2025AMR046252:same reporter US-GSK-US2025AMR046250:same reporter US-GSK-US2025AMR046246:same reporter
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| 2836947 | 10 | F | TX | 04/21/2025 |
TD |
SANOFI PASTEUR |
U8492AA |
Injection site pain
Injection site pain
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patient given tenivac describing that it was like a painful burning sensation while injecting the va...
patient given tenivac describing that it was like a painful burning sensation while injecting the vaccine; Initial information received on 14-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked with US-SA-2025SA109153 and US-SA-2025SA109105. This case involves a 10 years old female patient given tenivac describing that it was like a painful burning sensation while injecting the vaccine after receiving diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Polio vaccine and measles vaccine, mumps vaccine, rubella vaccine (MMR) both for Immunisation. On 14-Apr-2025, the patient received an unknown dose (0.5ml) of suspect receiving diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult; Suspension for injection with unknown strength (lot U8492AA with expiry date 28-FEB-2027) via intramuscular route in the right arm for Immunization. On 14-APR-2025 the patient given tenivac describing that it was like a painful burning sensation while injecting the vaccine (vaccination site pain) (latency: same day). Reportedly: she noticed the change in the color of the TENIVAC box from green to blue. It was the first time they had a complaint from all patients given TENIVAC describing that it was like a painful burning sensation while injecting the vaccine. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event.; Sender's Comments: US-SA-2025SA109105: US-SA-2025SA109153:
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| 2836949 | F | MP | 04/21/2025 |
RSV |
UNKNOWN MANUFACTURER |
AZ24004 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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none
none
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| 2836952 | 7 | M | NJ | 04/21/2025 |
PNC20 |
PFIZER\WYETH |
lk6651 |
Local reaction
Local reaction
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Local reaction 4cm left arm
Local reaction 4cm left arm
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| 2836953 | 62 | F | KY | 04/21/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Injection site erythema, Injection site infection, Injection site scab, Injectio...
Injection site erythema, Injection site infection, Injection site scab, Injection site vesicles
More
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2/15/25 blisters with redness surrounding site 2/25/25 swollen red with white surrounding site. Look...
2/15/25 blisters with redness surrounding site 2/25/25 swollen red with white surrounding site. Looks dark and similar to a burn mark. Measures 1 1/2 x 1 3/8/25 dark red with infection surrounding site 3/23/25 red with a large scab and a dip in the middle of site 3/25/25 referred to a plastic surgeon Have photos if needed
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| 2836954 | 1 | M | OH | 04/21/2025 |
HEPA MMR PNC20 VARCEL |
MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
Y015910 Y015995 LX4484 Y017914 |
Rash; Rash; Rash; Rash
Rash; Rash; Rash; Rash
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Varicella rash (mild)
Varicella rash (mild)
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โ | |||||
| 2837038 | F | 04/21/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Ophthalmic herpes zoster
Ophthalmic herpes zoster
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She got it in her eye; This serious case was reported by a consumer via interactive digital media an...
She got it in her eye; This serious case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a female 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 ophthalmic herpes zoster (Verbatim: She got it in her eye) (serious criteria GSK medically significant). The outcome of the ophthalmic herpes zoster was not reported. It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingles vaccine. The company considered the ophthalmic herpes zoster to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 14-APR-2025 This case was reported by a patient via interactive digital media. Reporter's friend did not receive the second shot. She got it in her eye, which required transportation to a university hospital. The issue lasted for 4 months and returned months later in the eye again, just missing the optic nerve.; Sender's Comments: Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
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| 2837039 | M | MA | 04/21/2025 |
RVX RVX |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Biopsy rectum abnormal, Colonoscopy abnormal, Diverticulum intestinal, Endoscopy...
Biopsy rectum abnormal, Colonoscopy abnormal, Diverticulum intestinal, Endoscopy abnormal, Intestinal obstruction; Large intestine polyp, Lymphadenopathy, Mantle cell lymphoma, Positron emission tomogram abnormal
More
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Advanced Mantle Cell Lymphoma/ multi-station LAD consistent with stage IV disease; This serious case...
Advanced Mantle Cell Lymphoma/ multi-station LAD consistent with stage IV disease; This serious case was reported in a literature article and described the occurrence of mantle cell lymphoma stage iv in a 72-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Literature Reference. Concurrent medical conditions included colon cancer, lymphadenopathy cervical and weight loss (with lifestyle modifications). Additional patient notes included On the day of endoscopy, patient denied recent changes in patient health. Patient denied fevers, chills, abdominal pain, melena, or hematochezia. On an unknown date, the patient received RSV vaccine. On an unknown date, between 1 and 2 months after receiving RSV vaccine, the patient experienced mantle cell lymphoma stage iv (Verbatim: Advanced Mantle Cell Lymphoma/ multi-station LAD consistent with stage IV disease) (serious criteria GSK medically significant). The patient was treated with bendamustine hydrochloride (Bendamustine) and rituximab. The outcome of the mantle cell lymphoma stage iv was resolving. The reporter considered the mantle cell lymphoma stage iv to be possibly related to RSV vaccine. The company considered the mantle cell lymphoma stage iv to be unrelated to RSV vaccine. Additional Information: GSK receipt date: 14-APR-2025 Author reported a 72-year-old male patient was referred for routine colonoscopy. Patient began routine colonoscopies for colon cancer surveillance starting at age 50. Prior findings included a hyperplastic polyp and sigmoid diverticulosis. On the day of endoscopy, patient denied recent changes in patient health but noted cervical LD (Cervical Lymphadenopathy) in the preceding year that improved on serial ultrasounds. Patient denied fevers, chills, abdominal pain, melena, or hematochezia, but reported intentional weight loss of 40 pounds with lifestyle modifications. Patient also reported enrollment in a new adult RSV vaccine trial. On physical exam, there was no abdominal tenderness or organomegaly. Colonoscopy identified multiple polyps including a large 20 mm ileocecal polyp obstructing access to terminal ileum (top left) and diffuse nodular mucosa in the rectum. Biopsies obtained from the ileocecal valve, rectum and ileum showed extensive lymphoid aggregates that were CD201, CD51, CD10-, BCL6-, and CCND11, consistent with multifocal lymphomatous polyposis 20 to MCL. Oncology referral was placed, and urgent PET scan revealed multi-station LAD (Lymphadenopathy) consistent with stage IV disease. The patient completed 3 cycles of bendamustine and rituximab; repeat PET scan showed near resolution of disease at all sites (bottom). Author presented anatypical case of MCL affecting the colon. the patient received RSV trial vaccine 1-2 months prior to initial LD. The RSV vaccines have been linked to intense B-cells activation, and thus acceleration of low-grade or atypical disease course in older adults with MCL was possible.; Sender's Comments: Mantle cell lymphoma stage IV are unlisted event which is considered unrelated to GSK vaccine RSV vaccine
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| 2837040 | 73 | F | OK | 04/21/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Asthenia, Chills, Diarrhoea, Vomiting
Asthenia, Chills, Diarrhoea, Vomiting
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vomiting; Diarrhea; Chills; Weakness; This non-serious case was reported by a consumer via call cent...
vomiting; Diarrhea; Chills; Weakness; This non-serious case was reported by a consumer via call center representative and described the occurrence of vomiting in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 10-APR-2025, the patient received the 1st dose of Shingrix. On 11-APR-2025, 1 days after receiving Shingrix, the patient experienced vomiting (Verbatim: vomiting), diarrhea (Verbatim: Diarrhea), chills (Verbatim: Chills) and weakness (Verbatim: Weakness). The outcome of the vomiting, diarrhea, chills and weakness were not resolved. It was unknown if the reporter considered the vomiting, diarrhea, chills and weakness to be related to Shingrix. It was unknown if the company considered the vomiting, diarrhea, chills and weakness to be related to Shingrix. Additional Information: GSK Receipt Date: 11-APR-2025 The husband of the patient reports she received dose of Shingrix and next morning she woke up with chills, vomiting, diarrhea and weakness.
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| 2837041 | 66 | F | IL | 04/21/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Facial discomfort, Facial pain, Head discomfort, Headache, Paraesthesia; Swellin...
Facial discomfort, Facial pain, Head discomfort, Headache, Paraesthesia; Swelling face, Trigeminal neuralgia
More
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Facial neuralgia; Facial pressure sensation; Facial pain; Head pain/feels like a pressure headache; ...
Facial neuralgia; Facial pressure sensation; Facial pain; Head pain/feels like a pressure headache; Swelling face; Tingling; This non-serious case was reported by a consumer via call center representative and described the occurrence of facial neuralgia in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included benign meningioma. Concomitant products included ezetimibe (Zetia), zolpidem and escitalopram. On 05-JUN-2024, the patient received Shingrix (intramuscular, unknown deltoid). On 05-JUN-2024, less than a day after receiving Shingrix, the patient experienced facial neuralgia (Verbatim: Facial neuralgia), facial pressure sensation (Verbatim: Facial pressure sensation), facial pain (Verbatim: Facial pain), headache (Verbatim: Head pain/feels like a pressure headache), facial swelling (Verbatim: Swelling face) and tingling (Verbatim: Tingling). The outcome of the facial neuralgia, facial pressure sensation, facial pain, headache, facial swelling and tingling were not resolved. The reporter considered the facial neuralgia, facial pressure sensation, facial pain, headache, facial swelling and tingling to be related to Shingrix. The company considered the facial neuralgia, facial pressure sensation, facial pain, headache, facial swelling and tingling to be related to Shingrix. Additional Information: GSK Receipt Date: 11-APR-2025 The reporter reported that she began experiencing facial pressure, pain, tingling, headache, swelling. She reported that these sensations appear on the following points of her face/head on right cheek, right temple up into her head, right side of face above cheek, trigeminal nerve to the ear in the back, into neck and down front of neck, stating it was primarily on the right cheek almost to the nose, all the way to the lip area. She stated that when the pain travels up to her temple/head area it felt like a pressure headache. Her right cheek felt like she was hit in the face with a baseball. She reported that the intensity of the pain, tingling and pressure were increased just as it was beginning to subside. These symptoms occur intermittently, daily. She reported that she had an MRI which revealed a meningioma, which, according the neurologist, was unrelated to the current symptoms.
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| 2837042 | 51 | F | 04/21/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Lip swelling
Lip swelling
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Swelling of lips; This non-serious case was reported by a consumer and described the occurrence of l...
Swelling of lips; This non-serious case was reported by a consumer and described the occurrence of lip swelling in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 16-JAN-2022, the patient received Shingrix. On 16-JAN-2022, less than a day after receiving Shingrix, the patient experienced lip swelling (Verbatim: Swelling of lips). On 16-JAN-2022, the outcome of the lip swelling was resolved. It was unknown if the reporter considered the lip swelling to be related to Shingrix. It was unknown if the company considered the lip swelling to be related to Shingrix. Additional Information: GSK Receipt Date: 13-APR-2025 Reporter wanted to know what the ingredients are in vaccine, so they can check future vaccines. Patient had swelling of lips and it was treated.
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| 2837043 | 04/21/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; got the vaccine still got shingles; This serious case was reported by...
Suspected vaccination failure; got the vaccine still got 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. 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: got the vaccine still got 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 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: 14-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that the patient got the vaccine still got shingles and still recommended that crap lol. Not everyone gets that shingles, gets them bad. The vaccines was crap and have even given people shingles. 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. This case was linked with US2025AMR046321, reported by same reporter.; 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 vaccine Shingles vaccine US-GSK-US2025AMR046321:Same reporter
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| 2837044 | 04/21/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Pain
Pain
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shot hurts; This non-serious case was reported by a consumer via interactive digital media and descr...
shot hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis. Family history included trigeminal neuropathy and facial pain (Screaming pain in face, it felt like walking into fire with acid in her ears). In FEB-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: shot hurts). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingrix. It was unknown if the company considered the pain to be related to Shingrix. Additional Information: GSK Receipt Date: 11-APR-2025 The patient's family member who ended up with trigeminal neuropathy, had screaming pain in her face and said that it felt like walking into fire with acid in her ears. The patient got first shot two months ago and that shot did hurt. The patient was fighting with self to go for second shot.; Sender's Comments: US-GSK-US2025AMR046345:Same reporter
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| 2837045 | 56 | F | IL | 04/21/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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inappropriate vaccine schedule/2nd dose taken on 03 FEB 2025; This non-serious case was reported by ...
inappropriate vaccine schedule/2nd dose taken on 03 FEB 2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix on 17 FEB 2023). On 03-FEB-2025, the patient received the 2nd dose of Shingrix. On 03-FEB-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: inappropriate vaccine schedule/2nd dose taken on 03 FEB 2025). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 14-APR-2025 The patient received first dose on 17 Feb 2023 and second dose on 03 Feb 2025. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
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| 2837046 | 04/21/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Malaise; Malaise
Malaise; Malaise
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I felt like crap; This non-serious case was reported by a consumer via interactive digital media and...
I felt like crap; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced feeling abnormal (Verbatim: I felt like crap). The outcome of the feeling abnormal was not reported (duration 2 days). It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the feeling abnormal to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 14-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she had it 2 times not too happy about it received the new shots . Both times he/she felt like crap for 2 days after he/she got the shot, hope fully it works.
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| 2837047 | M | 04/21/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster oticus, Vaccination failure
Herpes zoster oticus, Vaccination failure
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Suspected Vaccination failure; bad cases of shingles inside his ear; This serious case was reported ...
Suspected Vaccination failure; bad cases of shingles inside his ear; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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 otitis externa (Verbatim: bad cases of shingles inside his ear) (serious criteria GSK medically significant). The outcome of the vaccination failure and herpes zoster otitis externa were not reported. It was unknown if the reporter considered the vaccination failure and herpes zoster otitis externa to be related to Shingles vaccine. The company considered the vaccination failure and herpes zoster otitis externa to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 16-APR-2025 This case was reported by a consumer via interactive digital media. The reporter know friend vaccinated and still had bad cases of shingles. He had them inside his ear. 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. This case is linked with US2025AMR046801, reported by same reporter.; 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. Herpes zoster oticus is an unlisted event which is considered unrelated to GSK Shingles vaccine. US-GSK-US2025AMR046801:same reporter different patient
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| 2837048 | 04/21/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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got the 3rd vaccine in 5 months; This non-serious case was reported by a consumer via interactive di...
got the 3rd vaccine in 5 months; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received HBV (Engerix B) for prophylaxis. On an unknown date, the patient received the 3rd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too short (Verbatim: got the 3rd vaccine in 5 months). The outcome of the drug dose administration interval too short was not applicable. Additional Information: GSK Receipt Date: 15-APR-2025 The patient self reported this case for himself/herself This case was reported by a patient via interactive digital media. Patient was taking the series of Hepatitis B (Recombinant) Engerix-B vaccine. He/she had gotten the third vaccine in 5 months, which led to shortening of vaccination schedule.
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| 2837049 | F | OK | 04/21/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
XX9N4 |
Underdose
Underdose
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the majority of the vaccine was injected but some leaked to the table; This non-serious case was rep...
the majority of the vaccine was injected but some leaked to the table; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete dose administered in a 13-month-old female patient who received MMR (Priorix) (batch number XX9N4, expiry date 01-JUN-2026) for prophylaxis. On 10-APR-2025, the patient received Priorix. On 10-APR-2025, an unknown time after receiving Priorix, the patient experienced incomplete dose administered (Verbatim: the majority of the vaccine was injected but some leaked to the table). The outcome of the incomplete dose 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 Physician reported that a patient moved during the administration of Priorix, the majority of the vaccine was injected but some leaked to the table which led to incomplete dose administered.
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| 2837050 | 0.08 | M | PA | 04/21/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
EP724 |
Expired product administered
Expired product administered
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expired dose of Engerix-B pediatric that was administered to a patient; This non-serious case was re...
expired dose of Engerix-B pediatric that was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-month-old male patient who received HBV (Engerix B pediatric) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis. On 08-APR-2025, the patient received Engerix B pediatric. On 08-APR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced expired vaccine used (Verbatim: expired dose of Engerix-B pediatric that was administered to a patient). The outcome of the expired vaccine used 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: 11-APR-2025 The nurse reported that an expired dose of Engerix-B that was administered to a patient which led to, expired vaccine used.
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| 2837051 | WV | 04/21/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
PX7E2 |
Wrong product administered
Wrong product administered
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potential wrong vaccine; This non-serious case was reported by a nurse via call center representativ...
potential wrong vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old patient who received Men B NVS (Bexsero) (batch number PX7E2) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine) for prophylaxis. On 31-DEC-2024, the patient received Bexsero. On an unknown date, the patient did not receive Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine. On 31-DEC-2024, an unknown time after receiving Bexsero and not applicable after receiving Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine, the patient experienced wrong vaccine administered (Verbatim: potential wrong 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: 11-APR-2025 Nurse mentioned that a 17 year old patient required by the school to get a meningococcal vaccine for types A, C, W, and Y. In their chart it states that they already received a Meningococcal b vaccine on December 31st 2024 that is Bexsero. The caller was unclear as to whether Bexsero was mistakenly administered instead of the required meningococcal vaccine for types A, C, W, and Y (potential wrong vaccine), or whether Bexsero was a different vaccine administered regardless of school requirements. Patient received Bexsero instead of meningococcal vaccine for types A, C, W, and Y, which led to wrong vaccine administered.
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| 2837052 | 63 | M | CO | 04/21/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
223Y9 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Infanrix administered to an adult patient; This non-serious case was reported by a other health prof...
Infanrix administered to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 63-year-old male patient who received DTPa (Infanrix) (batch number 223Y9, expiry date 07-SEP-2026) for prophylaxis. On 11-APR-2025, the patient received Infanrix. On 11-APR-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Infanrix administered to an adult patient). The outcome of the inappropriate age at vaccine administration 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: 11-APR-2025 A medical assistant called to report the administration of Infanrix to a 63 year-old patient which led to inappropriate age at vaccine administration. The HCP asked for guidance on this situation
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| 2837053 | F | FL | 04/21/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
4BX39 |
Extra dose administered
Extra dose administered
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stated they had to receive and extra dose; This non-serious case was reported by a physician via cal...
stated they had to receive and extra dose; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 50-year-old female patient who received HBV (Engerix B adult) (batch number 4BX39) for prophylaxis. On 11-APR-2025, the patient received Engerix B adult. On 11-APR-2025, an unknown time after receiving Engerix B adult, the patient experienced extra dose administered (Verbatim: stated they had to receive and extra dose). The outcome of the extra dose 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 : 11-APR-2025 A physician reported that about the administration of Engerix-B to a patient who previously completed a dose but was stated they had to receive and extra dose, even though they had titers present which led to extra dose administered. They also stated that the patient would probably get Heplisav and requested recommendations.
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| 2837054 | F | IL | 04/21/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMA8030A |
Product preparation issue
Product preparation issue
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Menveo after only the diluent portion; Menveo after only the diluent portion; This non-serious case ...
Menveo after only the diluent portion; Menveo after only the diluent portion; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMA8030A, expiry date 30-APR-2025) for prophylaxis. In JAN-2025, the patient received Menveo. In JAN-2025, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo after only the diluent portion) and inappropriate dose of vaccine administered (Verbatim: Menveo after only the diluent portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 14-APR-2025 The nurse reported that how to proceed and the validity of a dose of Menveo after only the diluent portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter.
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| 2837055 | M | IL | 04/21/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
AZ453 |
Underdose
Underdose
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zero point five milliliter instead of one milliliter; This non-serious case was reported by a pharma...
zero point five milliliter instead of one milliliter; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 48-year-old male patient who received HBV (Engerix B) (batch number AZ453, expiry date 12-FEB-2027) for prophylaxis. Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b). On 14-APR-2025, the patient received the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced underdose (Verbatim: zero point five milliliter instead of one milliliter). The outcome of the underdose 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: 15-APR-2025 The pharmacist called to report an adult patient that was administered half the dose that is 0.5 milliliter instead of 1 milliliter, which led to underdose. It had been 24 hours since the maladministered dose. The Vaccine Administration Facility is the same as Primary Reporter. 1st dose vaccination date was March 16th 2025 and 2nd dose vaccination date on April 14th 2025.
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| 2837056 | 79 | F | 04/21/2025 |
COVID19 |
MODERNA |
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COVID-19
COVID-19
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Covid/Fever/sick; This spontaneous case was reported by a patient and describes the occurrence of CO...
Covid/Fever/sick; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid/Fever/sick) in a 79-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. In 2024, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2024, the patient experienced COVID-19 (Covid/Fever/sick). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) in 2024 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid/Fever/sick) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2024, Body temperature: 102 Degree. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Patient took any medication before or had fever was reported as not known. The concomitant medication was not reported. It was reported that, patient's voice was kind of a wreck because she got Covid, and her doctors had sent a prescription for Paxlovid. She was working a little slow there because she had a high temperature. Later in the call the patient stated, she had Covid last year and took medicine. She couldn't even think then that she did not have to go through all this after Plaxavil. Also, she didn't take the Pfizer vaccine, she took the Moderna vaccine. Representative clarified that the patient took Paxlovid, the patient stated, she did take that. Patient then mentioned, "she got a 102-degree fever and was really sick."
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| 2837057 | 80 | M | 04/21/2025 |
COVID19 COVID19 |
MODERNA PFIZER\BIONTECH |
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COVID-19; COVID-19
COVID-19; COVID-19
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he brought Covid home from the gym on Friday; This spontaneous case was reported by a patient family...
he brought Covid home from the gym on Friday; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (he brought Covid home from the gym on Friday) in an 80-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Comirnaty) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Tozinameran (Comirnaty) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (he brought Covid home from the gym on Friday). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (he brought Covid home from the gym on Friday) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. The information about off label event was reported as not known. Concomitant medication was not reported. It was reported that, the physician had prescribed Paxlovid a year ago to patient in case they got it but did not get it a year ago. Both patient and his wife had Covid and both were sharing a box and physician called in another Paxlovid prescription for both patient and his wife to take it together. Patient and his wife got a box about a year and a half ago because they were going on vacation and then they didn't use it. Patient came back home from the gym on Friday, and got Covid and on the day before reporting, patient and his wife took the test, and they were both positive, so they shared the beginning of the first box and by next day night, there would be like one sheet left. They were splitting the first box and after dosage use, only one of them would be able to go another day. The area was supposed to have really high instances of Covid then. Later in the call, the reporter stated, neither one of them had ever gotten Covid previously. They had all the vaccines, every single one of them including Pfizer vaccine, and the last one was Moderna vaccine. Patient received Comirnaty 2023-2024 formula vaccine. Paxlovid caused bad taste. This case was linked to US-MODERNATX, INC.-MOD-2025-784935 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-784935:Patient 2 of 2 (Wife case)
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| 2837058 | F | 04/21/2025 |
COVID19 |
MODERNA |
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COVID-19, Pain, Pain in extremity, SARS-CoV-2 test
COVID-19, Pain, Pain in extremity, SARS-CoV-2 test
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everything aches; little sore arm; started to feel sick/Positive for covid; This spontaneous case wa...
everything aches; little sore arm; started to feel sick/Positive for covid; This spontaneous case was reported by a patient and describes the occurrence of PAIN (everything aches), PAIN IN EXTREMITY (little sore arm) and COVID-19 (started to feel sick/Positive for covid) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer vaccine. Past adverse reactions to the above products included No adverse effect with Pfizer vaccine. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (everything aches), PAIN IN EXTREMITY (little sore arm) and COVID-19 (started to feel sick/Positive for covid). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19, at an unspecified dose and frequency. At the time of the report, PAIN (everything aches), PAIN IN EXTREMITY (little sore arm) and COVID-19 (started to feel sick/Positive for covid) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. The information about off label event was reported as not known. It was reported that, the physician had prescribed Paxlovid a year ago to patient in case they got it but did not get it a year ago. Both patient and his wife had Covid and both were sharing a box and physician called in another Paxlovid prescription for both patient and her husband to take it together. Patient and his wife got a box about a year and a half ago because they were going on vacation and then they didn't use it, so patient got Covid home from the gym on Friday and on Saturday, patient started to feel sick and so on the day before reporting, patient and her husband took the Covid test, and they were both positive, so shared the beginning of the first box and so by next day night, there would be like one sheet left. They were splitting the first box and after dosage use, only one of them would be able to go another day. The area was supposed to had really high instances of Covid then. They received all the vaccines, every single one of them, and the last one was Moderna vaccine. Later in the call, the reporter stated, neither one of them had ever gotten Covid. It was the only one vaccine to which the patient had a reaction. It wasn't terrible, and patient woke up feeling like she was hit by a truck, everything ached and that was it. Patient stated it was not like the worst reaction patient ever had to anything which was much worse than a little sore arm. Patient continued to report about the other complaint and everyone was talking about that which was the aftertaste reaction with the Paxlovid, and it was awful. As per the patient, it was like the most bitter thing and nothing made it go away, it was awful but better than being sick. Patient took lot of supplements and alternative things. She did not want to have anything conflicting. The only thing patient was craving for was oranges and oatmeal. This case was linked to US-MODERNATX, INC.-MOD-2025-784934 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-784934:Patient 2 of 2 (Wife case)
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| 2837059 | 78 | F | 04/21/2025 |
COVID19 |
MODERNA |
021B21A |
Cardiac amyloidosis, Epilepsy, Musculoskeletal disorder
Cardiac amyloidosis, Epilepsy, Musculoskeletal disorder
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Patient was diagnosed with 2 small epileptic seizures; currently experiencing multiple symptoms of t...
Patient was diagnosed with 2 small epileptic seizures; currently experiencing multiple symptoms of the attr-cm condition/Patient mentioned that she is still experiencing a discomfort in her chest with a muscular problem on her left arm; Muscular problem on her left arm; This spontaneous case was reported by a patient and describes the occurrence of EPILEPSY (Patient was diagnosed with 2 small epileptic seizures) and CARDIAC AMYLOIDOSIS (currently experiencing multiple symptoms of the attr-cm condition/Patient mentioned that she is still experiencing a discomfort in her chest with a muscular problem on her left arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A, 033C21A and 057M2114) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Kidney stone (had a large kidney stone on the left side (happened before the covid Moderna shot)) and Myocarditis (might had myocarditis (not diagnosed but it was an assumption by PCP) as some of the symptom's correlates to the condition (happened decade ago).). On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 08-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 18-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In February 2024, the patient experienced EPILEPSY (Patient was diagnosed with 2 small epileptic seizures) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced CARDIAC AMYLOIDOSIS (currently experiencing multiple symptoms of the attr-cm condition/Patient mentioned that she is still experiencing a discomfort in her chest with a muscular problem on her left arm) (seriousness criterion medically significant) and MUSCULOSKELETAL DISORDER (Muscular problem on her left arm). The patient was hospitalized on sometime in February 2024 due to EPILEPSY. At the time of the report, EPILEPSY (Patient was diagnosed with 2 small epileptic seizures), CARDIAC AMYLOIDOSIS (currently experiencing multiple symptoms of the attr-cm condition/Patient mentioned that she is still experiencing a discomfort in her chest with a muscular problem on her left arm) and MUSCULOSKELETAL DISORDER (Muscular problem on her left arm) had not resolved. Concomitant medication use information was not provided by reporter. 2 of the symptoms for familial and most the symptoms that she had, which she currently experienced, was coming from the attr-cm wild version. The patient was currently on a medication for anti-seizure. The patient wanted to know if there was a potential connection between the Moderna's side effects and the attr-cm side effects. It was unknown if the patient experienced any additional symptoms/events. The patient did not have any additional medical history, concomitant disease or risk factor.; Reporter's Comments: The event Cardiac amyloidosis, reported as multiple symptoms of the "ATTR-cm condition" and Musculoskeletal disorder are considered as not related to the Moderna vaccine given that Cardiac amyloidosis is a genetic disorder secondary to a mutation or instability of the transirretin protein, and the long latency and clinical context for the Musculoskeletal disorder The benefit-risk relationship of the product is not affected by this report.
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| 2837060 | M | 04/21/2025 |
COVID19 |
MODERNA |
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Abdominal pain, Constipation, Flatulence
Abdominal pain, Constipation, Flatulence
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has gas, bloating, abdominal pain, severe abdominal pain, constipation; has gas, bloating, abdominal...
has gas, bloating, abdominal pain, severe abdominal pain, constipation; has gas, bloating, abdominal pain, severe abdominal pain, constipation; has gas, bloating, abdominal pain, severe abdominal pain, constipation; has gas, bloating, abdominal pain, severe abdominal pain, constipation; This spontaneous case was reported by a patient and describes the occurrence of FLATULENCE (has gas, bloating, abdominal pain, severe abdominal pain, constipation), ABDOMINAL DISTENSION (has gas, bloating, abdominal pain, severe abdominal pain, constipation), ABDOMINAL PAIN (has gas, bloating, abdominal pain, severe abdominal pain, constipation) and CONSTIPATION (has gas, bloating, abdominal pain, severe abdominal pain, constipation) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Coronary artery disease (mild) and Blood pressure high. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced FLATULENCE (has gas, bloating, abdominal pain, severe abdominal pain, constipation), ABDOMINAL DISTENSION (has gas, bloating, abdominal pain, severe abdominal pain, constipation), ABDOMINAL PAIN (has gas, bloating, abdominal pain, severe abdominal pain, constipation) and CONSTIPATION (has gas, bloating, abdominal pain, severe abdominal pain, constipation). At the time of the report, FLATULENCE (has gas, bloating, abdominal pain, severe abdominal pain, constipation), ABDOMINAL DISTENSION (has gas, bloating, abdominal pain, severe abdominal pain, constipation), ABDOMINAL PAIN (has gas, bloating, abdominal pain, severe abdominal pain, constipation) and CONSTIPATION (has gas, bloating, abdominal pain, severe abdominal pain, constipation) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. The patient had gas, bloating, abdominal pain, severe abdominal pain, constipation, but that he had some of those problems a long time, before he took a COVID shot. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. Reporter causality was not reported.
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| 2837073 | 04/21/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Malaise, Pneumonia
Malaise, Pneumonia
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so Sick breathing treatments, Pneumonia maybe mild; This serious case was reported by a consumer via...
so Sick breathing treatments, Pneumonia maybe mild; This serious case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pneumonia (Verbatim: so Sick breathing treatments, Pneumonia maybe mild) (serious criteria GSK medically significant). The outcome of the pneumonia was not reported. It was unknown if the reporter considered the pneumonia to be related to RSV vaccine. The company considered the pneumonia to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 14-APR-2025 This case was reported by the patient via interactive digital media. The patient stated RSV shot was what he/she got, and he/she was so sick breathing treatments, pneumonia might be mild but his/her family were real sick.; Sender's Comments: Pneumonia is an unlisted event which is considered unrelated to GSK RSV vaccine.
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| 2837074 | 04/21/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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suspected vaccination failure; severe shingles out break; This serious case was reported by a consum...
suspected vaccination failure; severe shingles out break; 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. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: severe shingles out break). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 14-APR-2025 This case was reported by a patient via interactive digital media. The patient had both shots for prevention and at the time of reporting the patient had a severe shingles outbreak. 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, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
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| 2837075 | 87 | F | MI | 04/21/2025 |
COVID19 |
MODERNA |
010A21A |
COVID-19, Chronic obstructive pulmonary disease, Condition aggravated, Influenza...
COVID-19, Chronic obstructive pulmonary disease, Condition aggravated, Influenza like illness, SARS-CoV-2 test positive
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Name: Medical Record #: Age: 92 y.o. DOB: 3/XX/1933 Admit date: 4/12/2025 Discharge date: 4/...
Name: Medical Record #: Age: 92 y.o. DOB: 3/XX/1933 Admit date: 4/12/2025 Discharge date: 4/15/2025 Admitting Physician: DO Attending Physician at the Time of Discharge: DO Primary Care Physician: MD Reason for Admission: COVID Infection, COPD exacerbation Brief Summary of Hospital Stay: Patient is a 92 y.o. female with a history of CVA and COPD on 2L NC nightly who presented for flu-like illness since Monday. Of note, her husband was recently diagnosed and hospitalized with COVID-19. On arrival, she was also noted to be positive for COVID-19, complicated further by a COPD exacerbation. She was started on steroids, remdesivir, and other pulmonary hygiene measures. She initially required upwards of 4L nasal cannula. With the aforementioned treatment, she was quickly able to be weaned off supplemental oxygen. She was subsequently requesting discharge. She was sent home with instructions to complete her 5-day course of steroids. She should resume using 2L nasal cannula at night while sleeping. Follow-up with her PCP was scheduled Discharged to Home.
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| 2837076 | 62 | F | MI | 04/21/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
GT2524 GT2524 |
COVID-19 pneumonia, Cough, Decreased appetite, Dyspnoea, Hypernatraemia; Hypokal...
COVID-19 pneumonia, Cough, Decreased appetite, Dyspnoea, Hypernatraemia; Hypokalaemia, SARS-CoV-2 test positive
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Name: Medical Record #: Age: 65 y.o. DOB: 2/XX/1960 Admit date: 4/13/2025 Discharge date: ...
Name: Medical Record #: Age: 65 y.o. DOB: 2/XX/1960 Admit date: 4/13/2025 Discharge date: 04/18/2025 Attending Physician at the Time of Discharge: D.O. Reason for Admission: COVID 19 pneumonia Brief Summary of Hospital Stay: Patient is a 65 y.o. female history of cerebral palsy due to childhood meningitis, non verbal and non ambulatory at baseline presented from facility due to cough and breathing problems. She was found to have COVID 19 and admitted for management of COVID 19 pneumonia. During her stay, she was placed on IV Unasyn and Decadron. She was successfully weaned off of supplemental oxygen. Her stay was complicated by mild hypokalemia and hypernatremia. This was suspected from NS infusion and poor oral intake as well. It was suspected that her intake continued to be poor here as she requires a certain person to feed her. Our staff has tried one-on one feeds but she continues to refused large food intake. I have spoken with her POA/sister and she verifies that she likely will eat better back in facility with (redacted name). BMP ordered in a week to recheck electrolytes. Strict return precautions given. The patient was discharged in stable condition with improvement of symptoms and appropriate follow up planned. Discharged to Home Health Care.
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| 2837077 | 65 | F | MD | 04/21/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Arthralgia, Chills, Fatigue, Migraine, Pain in extremity; Pyrexia
Arthralgia, Chills, Fatigue, Migraine, Pain in extremity; Pyrexia
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Chills, 100๏ฟฝ fever, migraine, arm pain, fatigue, joint pain
Chills, 100๏ฟฝ fever, migraine, arm pain, fatigue, joint pain
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| 2837078 | 2 | M | 04/21/2025 |
HEPA |
MERCK & CO. INC. |
Y013274 |
Injection site rash, Lip swelling, Rash, Urticaria
Injection site rash, Lip swelling, Rash, Urticaria
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day 1 a couple hours after receiving, rash/hives on neck face and chin. Swelling of top lip. Day 3 r...
day 1 a couple hours after receiving, rash/hives on neck face and chin. Swelling of top lip. Day 3 received oral steroid to calm reaction, improved and now rash/hives come and go. Rash at the injection site and on back and belly, move throughout the course of the week. Now on day 7 and have been giving benadryl 5ml every 8 hours and zyrtec 5ml every 24 hours, and doing so since day 3. rash/hives come and go.
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| 2837079 | 47 | M | GA | 04/21/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EN6204 EN6204 EW0183 EW0183 |
Anti-GAD antibody positive, Anti-islet cell antibody negative, Anti-zinc transpo...
Anti-GAD antibody positive, Anti-islet cell antibody negative, Anti-zinc transporter 8 antibody negative, Blood cholesterol normal, Blood triglycerides normal; Glycosylated haemoglobin increased, High density lipoprotein normal, Insulin C-peptide normal, Low density lipoprotein increased, Type 1 diabetes mellitus; Anti-GAD antibody positive, Anti-islet cell antibody negative, Anti-zinc transporter 8 antibody negative, Blood cholesterol normal, Blood triglycerides normal; Glycosylated haemoglobin increased, High density lipoprotein normal, Insulin C-peptide normal, Low density lipoprotein increased, Type 1 diabetes mellitus
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New onset Type 1 Diabetes. GAD65 elevations - control now with carb restricted diet.
New onset Type 1 Diabetes. GAD65 elevations - control now with carb restricted diet.
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| 2837080 | 51 | F | NC | 04/21/2025 |
PNC21 |
MERCK & CO. INC. |
z002626 |
Erythema, Pain, Pruritus, Swelling
Erythema, Pain, Pruritus, Swelling
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patient received immunization on 04/16/2025 in office in left deltoid. sent an office message this m...
patient received immunization on 04/16/2025 in office in left deltoid. sent an office message this morning with photos of swollen, reddened area, painful and itchy. day 5 since administration. Patient did report that it is getting better with Benadryl and Tylenol
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| 2837081 | 74 | M | FL | 04/21/2025 |
PNC20 |
PFIZER\WYETH |
lk6650 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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no adverse event, Prevnar was given due to the fact that shots did not update his records, no indica...
no adverse event, Prevnar was given due to the fact that shots did not update his records, no indication on shots that patient had gotten Prevnar back in 203
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| 2837082 | 69 | F | FL | 04/21/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
x357e |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Vaccine error, given out of CDC recommended schedule
Vaccine error, given out of CDC recommended schedule
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