| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2843731 | 68 | F | AZ | 06/03/2025 |
COVID19 COVID19 UNK UNK |
PFIZER\BIONTECH PFIZER\BIONTECH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
MD3414 MD3414 2553X 2553X |
Balance disorder, Blood pressure decreased, Dizziness, Dysstasia, Loss of consci...
Balance disorder, Blood pressure decreased, Dizziness, Dysstasia, Loss of consciousness; Tremor; Balance disorder, Blood pressure decreased, Dizziness, Dysstasia, Loss of consciousness; Tremor
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(Rph) gave 2 vaccines to a patient today, 1 is covid booster and 1 is Twinrix (2nd dose). After givi...
(Rph) gave 2 vaccines to a patient today, 1 is covid booster and 1 is Twinrix (2nd dose). After giving the Twinrix vaccine, she had a reaction with it. She felt like a little dizziness, shaking her hand and lost her balance about 30 seconds, she lost her conscious for 5- 10 seconds. She did not have short of breath, no muscle weakness, no fever. She had that symptom for about a min and then talk back to me like normal. But then she still could not stand up and the symptom came back again. I checked her BP 118/88 and her oxygen was 97%. We called 911 and they checked her Bp again saying her bp is pretty low but not too low. They decided to admit her to the hospital after that for more investigation on which cause. I asked her before giving vaccines if she had any reaction to any vaccines but she said she did not. She also filled out on the paperwork too. After the ambulance arrived, I asked her friend coming with her if she experience any reaction like this before, and she said the patient did not feel well 2-3 days after the 1st Twinrix but she was doing okay after that so they think it was just a slight reaction. Pt is not taking any seizure medication and this is the first time happened to her. incident report filed. I will follow up with the patient before we close.
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| 2843732 | 0.33 | F | AL | 06/03/2025 |
RV5 |
MERCK & CO. INC. |
Y015019 |
Escherichia test positive, Intussusception, Rotavirus test positive, Salmonella ...
Escherichia test positive, Intussusception, Rotavirus test positive, Salmonella test positive
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Pt diagnosed with intussusception 6/1/25.
Pt diagnosed with intussusception 6/1/25.
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| 2843733 | 44 | F | TN | 06/03/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
Z2ZPB |
Extra dose administered
Extra dose administered
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Patient was given additional dose of Hepatitis A Vaccine. Patient had already completed 2 dose serie...
Patient was given additional dose of Hepatitis A Vaccine. Patient had already completed 2 dose series in January of 2025. Patient did not react to vaccine today, tolerated well.
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| 2843734 | 64 | F | 06/03/2025 |
RSV |
PFIZER\WYETH |
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Extra dose administered
Extra dose administered
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Duplicate dose received
Duplicate dose received
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| 2843735 | 06/03/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected Vaccination failure; have the shingles in my right side of head; This serious case was rep...
Suspected Vaccination failure; have the shingles in my right side of head; 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: have the shingles in my right side of head). The patient was treated with valacyclovir. 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: 31-MAY-2025 This case was reported by a patient via interactive digital media. The patient took the shot but just found out that he/she had the shingles in his/her ride side of head so guess the shot didn't work, the doctor put the patient on valacyclovir for 7 days and hoped since he/she had the shot will have a mild case 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2843736 | 32 | F | IL | 06/03/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
342RC |
Therapy non-responder
Therapy non-responder
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no sero conversion rate on a patient; This non-serious case was reported by a physician via call cen...
no sero conversion rate on a patient; This non-serious case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a 33-year-old female patient who received MMR (Priorix) (batch number 342RC, expiry date 01-MAY-2025) for prophylaxis. This case was associated with a product complaint. On 05-FEB-2025, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced therapy non-responder (Verbatim: no sero conversion rate on a patient). The outcome of the therapy non-responder 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: 27-MAY-2025 The physician wanted to know what was the likely hood of no sero conversion rate on a patient. The physician was not sure if the vaccine was administer at the same zip code. No further information was obtained in this call. Suspect product was now expired. Consented to follow up.
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| 2843737 | M | MN | 06/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3AF9E |
Fatigue, Musculoskeletal discomfort, Pain in extremity, Skin lesion
Fatigue, Musculoskeletal discomfort, Pain in extremity, Skin lesion
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uncomfortable sensation in the groin area, which they first attributed to a tick bite, appearing as ...
uncomfortable sensation in the groin area, which they first attributed to a tick bite, appearing as a cluster lesion; drug dose interval too short; fatigue; pain in injection arm; This non-serious case was reported by a physician via call center representative and described the occurrence of fatigue in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 3AF9E) for prophylaxis. Previously administered products included Shingrix (received first dose on 07-MAY-2018 with batch number LT533 For tolerance of first dose refer case US2025AMR068322). On 07-JUN-2018, the patient received the 2nd dose of Shingrix. On 07-JUN-2018, less than a day after receiving Shingrix, the patient experienced fatigue (Verbatim: fatigue), pain in arm (Verbatim: pain in injection arm) and drug dose administration interval too short (Verbatim: drug dose interval too short). On an unknown date, the patient experienced skin lesion (Verbatim: uncomfortable sensation in the groin area, which they first attributed to a tick bite, appearing as a cluster lesion). The patient was treated with valaciclovir hydrochloride (Valacyclovir) and pheniramine aminosalicylate (Avil). Rechallenge with Shingrix was positive. The outcome of the fatigue and pain in arm were unknown and the outcome of the skin lesion was not reported and the outcome of the drug dose administration interval too short was not applicable. It was unknown if the reporter considered the fatigue, pain in arm and skin lesion to be related to Shingrix. It was unknown if the company considered the fatigue, pain in arm and skin lesion to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR068322 Additional Information: GSK Receipt Date: 30-MAY-2025 Physician called in to request data about the recommendation of booster doses of Shingrix after the initial series, then inquiring about the incidence of postherpetic neuralgia after Shingrix, how many doses are needed to reduce the incidence of postherpetic neuralgia and how many cases of shingles were present after vaccination with Shingrix. This stemmed after the physician stated that whilst hiking, they started to feel an uncomfortable sensation in the groin area, which they first attributed to a tick bite, appearing as a cluster lesion but after this, they went to a physician's office and a PCR swab test was done (identified as Diasorin Molecular Symplexa VZ direct assay) which came back as abnormal and the patient started with valacyclovir, 1000 mg every 8 hours and Aliv. They stated that the after the second doses, they had pain, with an accentuated fatigue.; Sender's Comments: US-GSK-US2025AMR068322:For 1st dose shingrix
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| 2843738 | 0.17 | F | 06/03/2025 |
DTAPHEPBIP DTAPHEPBIP DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
AC21B115CB |
Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration
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tested for HepB titers and the test showed she was not vaccinated; The dates of administration were ...
tested for HepB titers and the test showed she was not vaccinated; The dates of administration were the following 12/Jul/2007, 14/Sep/2007, 2/Nov/2007; This non-serious case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number AC21B115CB) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis and DTPa-HBV-IPV (Pediarix) for prophylaxis. On 02-NOV-2007, the patient received the 3rd dose of Pediarix. On 14-SEP-2007, the patient received the 2nd dose of Pediarix. On 12-JUL-2007, the patient received the 1st dose of Pediarix. On 02-NOV-2007, an unknown time after receiving Pediarix, not applicable after receiving Pediarix and Pediarix and not applicable after receiving Pediarix and Pediarix, the patient experienced drug dose administration interval too short (Verbatim: The dates of administration were the following 12/Jul/2007, 14/Sep/2007, 2/Nov/2007). On an unknown date, the patient experienced therapy non-responder (Verbatim: tested for HepB titers and the test showed she was not vaccinated). The outcome of the therapy non-responder and drug dose administration interval too short 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: 02-JUN-2025 The patient received Pediarix when she was her last shot, it was given early, she was told that she was not vaccinated correctly, which led shortening of vaccination schedule. The reporter mentioned that they had tested for Hepatitis B titers, and the test showed she was not vaccinated, which led therapy non responder.
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| 2843739 | 33 | F | CO | 06/03/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
279C4 |
Underdose
Underdose
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pediatric dose of Havrix was administered to a 33 year old female; pediatric dose of Havrix was admi...
pediatric dose of Havrix was administered to a 33 year old female; pediatric dose of Havrix was administered to a 33 year old female; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 33-year-old female patient who received HAV (Havrix pediatric) (batch number 279C4, expiry date 20-SEP-2025) for prophylaxis. On 08-MAY-2025, the patient received Havrix pediatric. On 08-MAY-2025, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: pediatric dose of Havrix was administered to a 33 year old female) and underdose (Verbatim: pediatric dose of Havrix was administered to a 33 year old female). 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: 02-JUN-2025 The Vaccine Administration Facility is the same as Primary Reporter A medical assistant called in to report that a pediatric of Havrix was administered to a 33 year old female on May 8th 2025 which led to adult use of a child product and underdose.
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| 2843740 | 45 | F | CA | 06/03/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
7HG2A |
Product preparation issue
Product preparation issue
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Priorix Inappropriate Reconstitution Technique and administration; Priorix Inappropriate Reconstitut...
Priorix Inappropriate Reconstitution Technique and administration; Priorix Inappropriate Reconstitution Technique and administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 45-year-old female patient who received MMR (Priorix) (batch number 7HG2A, expiry date 01-JAN-2026) for prophylaxis. On 28-MAY-2025, the patient received Priorix. On 28-MAY-2025, an unknown time after receiving Priorix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Priorix Inappropriate Reconstitution Technique and administration) and inappropriate dose of vaccine administered (Verbatim: Priorix Inappropriate Reconstitution Technique and administration). The outcome of the wrong solution used in drug reconstitution 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: 02-JUN-2025 Registered Nurse wanted to know if there were any concerns or consequences of given Priorix reconstituted with another diluent (from Merck's measles, mumps, and rubella vaccine) than the one provided in the box, which led wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
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| 2843741 | 61 | F | NY | 06/03/2025 |
COVID19 |
MODERNA |
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Audiogram, Deafness neurosensory, Deafness unilateral
Audiogram, Deafness neurosensory, Deafness unilateral
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Unilateral flat hearing loss; Sudden sensorineural hearing loss; This literature-non-study case was ...
Unilateral flat hearing loss; Sudden sensorineural hearing loss; This literature-non-study case was reported in a literature article and describes the occurrence of DEAFNESS UNILATERAL (Unilateral flat hearing loss) and DEAFNESS NEUROSENSORY (Sudden sensorineural hearing loss) in a 61-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. LITERATURE REFERENCE: No Medical History information was reported. On an unknown date, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS UNILATERAL (Unilateral flat hearing loss) (seriousness criterion medically significant) and DEAFNESS NEUROSENSORY (Sudden sensorineural hearing loss) (seriousness criterion medically significant). At the time of the report, DEAFNESS UNILATERAL (Unilateral flat hearing loss) and DEAFNESS NEUROSENSORY (Sudden sensorineural hearing loss) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Audiogram: audiometric confirmation of hearing loss. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered DEAFNESS UNILATERAL (Unilateral flat hearing loss) and DEAFNESS NEUROSENSORY (Sudden sensorineural hearing loss) to be related. Concomitant medications were not reported. Hearing loss was reported as unilateral flat. The hearing loss was related to vaccine. There was no previous hearing declines unrelated to vaccine. There was no hearing recovery with steroids. The immune-mediated hearing loss (IMHL) patients (comprised of autoimmune inner ear disease (AIED) and sudden sensorineural hearing loss (SSNHL)) may be at higher risk for hearing loss following Coronavirus disease (COVID-19) infection and/or vaccination. This study compared inflammatory cytokine expression in response to SARS-CoV2 spike protein between two groups of patients with IMHL: IMHL patients that temporally demonstrated worsening SNHL following COVID vaccination or infection as compared to IMHL patients with worsening SNHL unrelated to COVID exposure: (IMHL-COVID (?+)) (n?=?11) (IMHL-COVID (-)) (n?=?10). Two groups treated isolated PBMCs with increasing amounts of SARS-CoV-2 spike protein and compared responses to stimulation with positive and negative controls. IMHL-COVID (+) group is further broken down into 6 patients with AIED that experienced prior hearing declines over a several year period prior to COVID-19 exposure and 5 patients with SSNHL temporally related to COVID-19 exposure with no prior history of acute hearing loss. In SSNHL patients, the presence of asymmetric sensorineural hearing loss was used as criteria for inclusion as prior audiometric data was not available. Patients were enrolled at the time of their office visit reporting a decline in hearing, and blood was collected if audiometric confirmation of an asymmetric hearing loss was obtained. All patients were queried as to COVID-19 exposure, COVID-19 vaccination history, and hearing health history of IMHL which included prior diagnoses of SSNHL, AIED or Meniere's Disease. The hearing losses all occurred between 2021 and 2023. All patients had PBMC harvested immediately prior to the institution of corticosteroid therapy. The time interval between the index event of perceived loss and clinical evaluation and enrollment was highly variable, from 1 day to several months, however the perceived hearing change had to have occurred within a two-week period following infection/vaccination to be considered for enrollment. Informed consent was provided by all enrolled patients prior to entering a subject into the study. Peripheral Blood Mononuclear Cells (PBMC) from IMHL-COVID (?+) patients had increased expression and release of both IL-1๏ฟฝ and IL-6 in response to spike protein as compared to IMHL-COVID (-) patients. However, when the IMHL-COVID (?+) group was broken down into AIED patients compared to SSNHL, it became apparent that the greatest responses were from the AIED patients. When reporter broke down the COVID (?+) group to infection versus vaccination, the immune responses in the infection group (N?=?3 AIED, 1 SSNHL) were stronger. SARS-CoV-2 spike protein at 12 ๏ฟฝg/ml concentration showed robust release of IL-6 in infection group (around sixfold) when compared to the vaccination group. SARS-CoV-2 spike protein showed dose-dependent release of IL-1Ra in both groups. Spike protein at 12 ๏ฟฝg/ml concentration showed much greater release of IL-1Ra in infection group when compared to the vaccination group This study concluded that COVID-19 exposure with reported changes in hearing sensitivity in IMHL patients resulted in pro-inflammatory responses in response to spike protein. The inflammatory responses were greatest in AIED patients, and greater following infection rather than vaccination. This case was linked to US-MODERNATX, INC.-MOD-2025-786804 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-786804:61-Year-old Female patient
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| 2843742 | 06/03/2025 |
COVID19 |
MODERNA |
046B21A |
Death
Death
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somebody that died from taking this one; This spontaneous case was reported by a non-health professi...
somebody that died from taking this one; This spontaneous case was reported by a non-health professional and describes the occurrence of DEATH (somebody that died from taking this one) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided Concomitant product use was not provided by the reporter. Treatment information was not provided. This case was linked to US-MODERNATX, INC.-MOD-2025-787032 (E2B Linked Report). Reporter did not allow further contact; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787032:For somebody; Reported Cause(s) of Death: Death
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| 2843743 | M | 06/03/2025 |
COVID19 |
MODERNA |
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Nasopharyngitis
Nasopharyngitis
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had the lightest cold symptoms with Delta; This spontaneous case was reported by a consumer and desc...
had the lightest cold symptoms with Delta; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (had the lightest cold symptoms with Delta) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (had the lightest cold symptoms with Delta). At the time of the report, NASOPHARYNGITIS (had the lightest cold symptoms with Delta) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. The patient had Moderna vaccines several times recommended by the doctor. When his dog had surgery, and brought Delta into the home, he lost his 2 cats but had the lightest cold symptoms with Delta that he especially had ever had. There was bird flu in the tame and in wild flocks, so he was looking forward to receiving that vaccine. HCP recommended to get the mRNA Covid-19 vaccine several times. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. Reporter causality was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787067 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787067:For male patient
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| 2843744 | 75 | F | 06/03/2025 |
COVID19 |
MODERNA |
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Device issue, Immunisation reaction, Incorrect dose administered, Wrong techniqu...
Device issue, Immunisation reaction, Incorrect dose administered, Wrong technique in product usage process
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Patient had a bad experience getting the vaccine/a minor side effects after getting vaccinated; plun...
Patient had a bad experience getting the vaccine/a minor side effects after getting vaccinated; plunger did not move; The vaccination did not go well as the nurse noticed that the plunger of the syringe did not move and when the nurse took out the syringe/Patient believed that some of the content went in as she experienced a minor side effect; The vaccination did not go well as the nurse noticed that the plunger of the syringe did not move and when the nurse took out the syringe/Patient believed that some of the content went in as she experienced a minor side effect; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Patient had a bad experience getting the vaccine/a minor side effects after getting vaccinated), DEVICE ISSUE (plunger did not move), INCORRECT DOSE ADMINISTERED (The vaccination did not go well as the nurse noticed that the plunger of the syringe did not move and when the nurse took out the syringe/Patient believed that some of the content went in as she experienced a minor side effect) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (The vaccination did not go well as the nurse noticed that the plunger of the syringe did not move and when the nurse took out the syringe/Patient believed that some of the content went in as she experienced a minor side effect) in a 75-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Patient was getting the Moderna shot since March 2021.) in March 2021, SPIKEVAX 2024-2025 PFS (Dose: 9 and lot number: 3043030) on 17-Oct-2024. Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 Vaccine and SPIKEVAX 2024-2025 PFS. On 24-Apr-2025, the patient received tenth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 24-Apr-2025, the patient experienced DEVICE ISSUE (plunger did not move), INCORRECT DOSE ADMINISTERED (The vaccination did not go well as the nurse noticed that the plunger of the syringe did not move and when the nurse took out the syringe/Patient believed that some of the content went in as she experienced a minor side effect) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (The vaccination did not go well as the nurse noticed that the plunger of the syringe did not move and when the nurse took out the syringe/Patient believed that some of the content went in as she experienced a minor side effect). On an unknown date, the patient experienced IMMUNISATION REACTION (Patient had a bad experience getting the vaccine/a minor side effects after getting vaccinated). At the time of the report, IMMUNISATION REACTION (Patient had a bad experience getting the vaccine/a minor side effects after getting vaccinated), DEVICE ISSUE (plunger did not move), INCORRECT DOSE ADMINISTERED (The vaccination did not go well as the nurse noticed that the plunger of the syringe did not move and when the nurse took out the syringe/Patient believed that some of the content went in as she experienced a minor side effect) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (The vaccination did not go well as the nurse noticed that the plunger of the syringe did not move and when the nurse took out the syringe/Patient believed that some of the content went in as she experienced a minor side effect) outcome was unknown. No concomitant medication was reported. Patient was a senior citizen and was getting the Moderna shot since March 2021 and from then getting the covid shot every other 6 months. It was reported that she recently had a Moderna covid shot at a Clinic last 24-Apr-2025 which she had a bad experience getting the vaccine. It was mentioned that the vaccination did not go well as the nurse noticed that the plunger of the syringe did not move and when the nurse took out the syringe, she immediately placed it on the used needles without investigating further and advising the patient if how much vaccines were left on the syringe. They thought that the nurse had not let the vaccine thaw long enough because of the plunger did not move. Patient believed that some of the content went in as she experienced a minor side effect after getting vaccinated. It was reported that the Clinic nor the nurse did not provide her a vaccination record as they believed no vaccine was used/administered to the patient. Patient tried to look the data of her recent vaccination on her online vaccination record, and it stated that on 24-Apr-2025, did not receive vaccine. It was reported that that she already tried to ask multiple healthcare provider including her personal doctor and was not able to get a valid response. No treatment medication was reported. The device problem code for SPIKEVAX 2024-2025 PFS syringe included FDA code 1670, IMDRF code A23 which included use of device problem. The evaluation /investigation code information for SPIKEVAX 2024-2025 PFS syringe included FDA code 4114, IMDRF Code B17 which included device not returned, FDA code 3221, IMDRF code C20 which included no findings available and FDA code 19, IMDRF Code D11 which concluded cause traced to user. Investigation Summary & Conclusion with Root Cause Details: A patient reported a suspected maladministration during administration of the Moderna Spikevax (2024-2025 Formula) COVID-19 vaccine on at a clinic. The patient reported that the syringe plunger did not move during injection, raised concern that the vaccine was not delivered. The patient reported that the nurse discarded the syringe without confirming whether any volume had been administered, and no vaccination documentation was provided. The patient's electronic immunization record for that date indicated "did not receive vaccine." Following the incident, the patient reported experiencing minor side effects, suggesting the possibility of partial administration. An Adverse Event case was submitted to document this experience. The patient was referred by the call center agent to consult her healthcare provider for medical guidance. However, she indicated that she had already contacted multiple HCPs, including her personal physician, but was unable to obtain a clear or valid response. Providers reportedly stated that "they did not know," leaving the patient uncertain about her immunization status and whether she must wait the full six-month interval for revaccination. This complaint was based primarily on the patient's perception and inability to confirm whether the dose was properly administered, rather than on an identifiable product quality defect. No product sample or photographic evidence was available, and no further information could be retrieved from the administering clinic or providers to support or clarify the event. No trending analysis for the reported defect could be performed since no batch number could be retrieved. Based on the available information, no product quality issue has been confirmed, and the event was assessed as operational and non-systemic in nature. No additional investigation or CAPA was required. The patient was advised to consult regarding any revaccination needs. Most recent FOLLOW-UP information incorporated above includes: On 23-May-2025: Live follow up received which contains non-significant information, reference number was added. On 27-May-2025: Live significant follow-up received which contains PQC closed investigation report: Reporter's email address, QC comment, QC result date in product tab and narrative was updated.
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| 2843745 | 61 | M | WA | 06/03/2025 |
PNC20 |
PFIZER\WYETH |
LY8609 |
Arthralgia, Joint range of motion decreased, Muscle twitching
Arthralgia, Joint range of motion decreased, Muscle twitching
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has limited range of motion in the abduction and he cannot go past 90 degrees abduction; severe musc...
has limited range of motion in the abduction and he cannot go past 90 degrees abduction; severe muscle twitching in his deltoid and forearm region; Shoulder pain; This is a spontaneous report received from an Other HCP from medical information team. A 61-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 14May2025 as dose number unknown, 0.5 ml single (Lot number: LY8609, Expiration Date: 31Aug2026) at the age of 61 years intramuscular, in left deltoid for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ARTHRALGIA (medically significant) with onset May2025, outcome "recovering", described as "Shoulder pain"; MUSCLE TWITCHING (medically significant) with onset May2025, outcome "not recovered", described as "severe muscle twitching in his deltoid and forearm region"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "has limited range of motion in the abduction and he cannot go past 90 degrees abduction". Therapeutic measures were not taken as a result of muscle twitching, arthralgia, joint range of motion decreased. The patient that was given Prevnar 20 vaccine about to two weeks ago in his left deltoid. The patient returned having shoulder pain and having severe muscle twitching in his deltoid and forearm region. He has limited range of motion in the abduction, and he cannot go past 90 degrees abduction. The reporter is calling for advice on treatment and if this has been seen before. The reporter stated while performing passive range of motion on the patient the caller can get the patient's arm to go up to 180 degrees.; Sender's Comments: There is a reasonable possibility that the event arthralgia was related to PREVNAR 20 based on known drug safety profile. Based on the temporal relationship, the association between the event muscle twitching with PREVNAR20 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 2843746 | 65 | F | OH | 06/03/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
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Arthralgia, Influenza like illness, Injected limb mobility decreased, Injection ...
Arthralgia, Influenza like illness, Injected limb mobility decreased, Injection site erythema, Injection site pain; Injection site pruritus, Injection site swelling, Injection site warmth, Musculoskeletal pain, Pain
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it has started to itch; felt warm to touch, felt achy, just kind of like flu type symptoms; Was like...
it has started to itch; felt warm to touch, felt achy, just kind of like flu type symptoms; Was like, odd shape, was long, from under where she got shot, down. Was swollen, hot, really hurting, to point where, she had to like, keep it near, directly next to her body.; Was like, odd shape, was long, from under where she got shot, down. Was swollen, hot, really hurting, to point where, she had to like, keep it near, directly next to her body.; As far redness, seems to be getting a little better.; arm was hurting; This is a spontaneous report received from a Consumer or other non HCP. A 65-year-old female patient received pneumococcal 20-valent conjugated vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 21May2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing). Concomitant medication(s) included: TETANUS VACCINE. Vaccination history included: Pneumovax, for immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22May2025, outcome "not recovered", described as "arm was hurting"; VACCINATION SITE ERYTHEMA (non-serious) with onset 23May2025, outcome "unknown", described as "As far redness, seems to be getting a little better."; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 23May2025, outcome "unknown" and all described as "Was like, odd shape, was long, from under where she got shot, down. Was swollen, hot, really hurting, to point where, she had to like, keep it near, directly next to her body."; INFLUENZA LIKE ILLNESS (non-serious) with onset 23May2025, outcome "unknown", described as "felt warm to touch, felt achy, just kind of like flu type symptoms"; VACCINATION SITE PRURITUS (non-serious) with onset 28May2025, outcome "unknown", described as "it has started to itch". Therapeutic measures were taken as a result of vaccination site pain. Additional information: Caller states, she called before about Prevnar 20, last week. Unfortunately, was driving, could not write down what agent was going to give her. They wanted to ask more questions. Wanted to speak to someone who could tell about reaction. Only had enough time to speak to one person, wanted to find out if she should go to hospital or not. When clarifying what day report was made with Pfizer, caller states, she got injection Wednesday. 99 percent sure she called Friday, 23May2025, was on the way to go watch her granddaughter. Arm hurt: When clarifying reaction caller referring to, that she experienced after Prevnar 20 injection, she states, was a pretty severe reaction. Had injection Wednesday morning, about noon, probably around noon. Then, Thursday, arm, did not pay attention by looking at it but, arm was hurting. Has had tetanus shots that hurt. But this, felt warm to touch, felt achy, just kind of like flu type symptoms. Did not think much of it, took some Advil. Arm swollen: Then, on Friday morning, woke up, arm was swollen, from like, shoulder to elbow. Had huge red, like bright red, probably 4 inches long, looked like someone had smashed her or something. Was like, odd shape, was long, from under where she got shot, down. Was swollen, hot, really hurting, to point where, she had to like, keep it near, directly next to her body. Always gets shots in left because, she is right handed. Hurt to move it, even to get up off couch, was hurting extremely bad. Did not have difficulty breathing. Looked up what they considered to be severe, was not having anaphylactic shock. Thought, will be another day, thought the next day should be better. Woke up Friday morning, was not better, was worse. When she started getting panicky, called Pfizer, talked to girl, told her about this, gave all symptoms, as being described here. Wanted to talk to someone who could tell if this was normal and, if it should be getting worse after 48 hours. The agent could not help, she did not get the information, they were not helpful. Asked how many times they get reports of people saying 48 hours, still have this, getting worse, if they think it should get a little better. This is worse, redder, more swollen, hurts more. Agent was not helpful at all. This was Friday, kept wanting to go to Emergency Room. Then, Monday was holiday. On27May2025, contacted doctor office because, left message with assistant. Has not heard back from doctor. Always worries because, doctor does not have best medical assistant, not as thorough. On 28May2025, has been a week. Just today it has started to itch. A little itchy means, it is getting better. However, arm still in pain. Told them originally, where arm goes up into shoulder, at very top of shoulder, further than were shoulder meets arm, goes probably another 3 inches, that pain still there, that part has not gotten better. As far redness, seems to be getting a little better. Swelling sems to be going down a bit, now itchy and has been scratching. Clarified, 23May2025, Friday was the date she called, clarifying that the pain started that Thursday, 22May2025. Pain was not much but, all ready knew pain was there, was getting red. Friday, 23May2025, was looking really bad. All symptoms described, were getting bad, worse and took pictures every day, of arm, was sending to son, who is paramedic. Patient's son told her to go to Emergency room, did not want to sit in room with bunch of people. When she spoke with Pfizer, they did not talk like it was horrible. Wanted to report it still because, she is still having the pain in arm. Can still see slight redness, can tell is a little swollen but, the pain still there. That is concerning to her, why she is still having pain like this. Now, can move arm around but, it hurts, all the way from elbow, up all the way into above shoulder blade, where it connects to arm. When she moves arm, hurts all the way, about 3 inches up into shoulder. Wanted to make sure that was all on file. Did not know if there was something she can do. Clarified, the pain and swelling being referred to, where she received injection, in left arm. Not like she gets a lot of shots, did get original Covid, the 2 and the booster. That was years ago. Thinks she just got flu shot last year. In past, has had Pneumovax, all the ones they want people to have. Treatment: The only thing, other than Advil is, she has some muscle relaxers that she had, Tizanidine. If she has lower back pain, muscle spasms, can take Tizanidine, does not take it often. The pain so bad, as far as sleeping, did take Tizanidine Friday night, Saturday night, Sunday night. Can't drive if she takes those, so just took the 3 nights. Does not have pain medicine or anything, nothing like that. Causality for "arm was hurting", "was like, odd shape, was long, from under where she got shot, down. was swollen, hot, really hurting, to point where, she had to like, keep it near, directly next to her body.", "as far redness, seems to be getting a little better.", "it has started to itch" and "felt warm to touch, felt achy, just kind of like flu type symptoms" was determined associated to device constituent of pneumococcal 20-valent conjugated vaccine (diphtheria CRM197 protein) (malfunction). The information on the batch/lot number for pneumococcal 20-valent conjugated vaccine (diphtheria CRM197 protein) will be requested and submitted if and when received.
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| 2843747 | 41 | F | TX | 06/03/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Anaemia, Blood iron, Condition aggravated, Goitre, Investigation; Pancreatic cys...
Anaemia, Blood iron, Condition aggravated, Goitre, Investigation; Pancreatic cyst, Pancreatic enlargement, Platelet count, Platelet count decreased, Uterine leiomyoma; Vaginal haemorrhage
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bleeding since got the vaccination. She has been having vaginal bleeding for the two years/Bleeding ...
bleeding since got the vaccination. She has been having vaginal bleeding for the two years/Bleeding has been too many blood clots; After the first vaccination she had the vaginal bleeding. When got the second shot the bleeding was more intense, was throwing pound of blood clot; enlarged pancreas; cyst on pancreas; Enlarged thyroid; Fibroids; anemia/ low iron; low platelet; This is a spontaneous report received from a Consumer or other non HCP. A 41-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 41 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), when the patient was 41 years old, for Covid-19 Immunization, reaction(s): "vaginal bleeding". The following information was reported: VAGINAL HAEMORRHAGE (medically significant), outcome "not recovered", described as "bleeding since got the vaccination. She has been having vaginal bleeding for the two years/Bleeding has been too many blood clots"; CONDITION AGGRAVATED (medically significant), outcome "not recovered", described as "After the first vaccination she had the vaginal bleeding. When got the second shot the bleeding was more intense, was throwing pound of blood clot"; PANCREATIC ENLARGEMENT (non-serious), outcome "not recovered", described as "enlarged pancreas"; PANCREATIC CYST (non-serious), outcome "not recovered", described as "cyst on pancreas"; GOITRE (non-serious), outcome "unknown", described as "Enlarged thyroid"; UTERINE LEIOMYOMA (non-serious), outcome "unknown", described as "Fibroids"; ANAEMIA (non-serious), outcome "unknown", described as "anemia/ low iron"; PLATELET COUNT DECREASED (non-serious), outcome "unknown", described as "low platelet". The events "enlarged pancreas", "cyst on pancreas", "enlarged thyroid", "fibroids", "anemia/ low iron" and "low platelet" required physician office visit. The events "bleeding since got the vaccination. she has been having vaginal bleeding for the two years/bleeding has been too many blood clots" and "after the first vaccination she had the vaginal bleeding. when got the second shot the bleeding was more intense, was throwing pound of blood clot" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood iron: (unspecified date) low; Cyst on Pancreas measured: (2024) had grown a bit more; Platelet count: (unspecified date) low. Therapeutic measures were taken as a result of vaginal haemorrhage, condition aggravated. Clinical course: The reporter was not feeling well, and she was calling to see of can help. The patient received the vaccine 2 years ago. She has an enlarged pancreas, cyst on pancreas, enlarged thyroid, fibroids, and also been bleeding since got the vaccination. She has been having vaginal bleeding for the two years. They were also calling to see if there was any additional information regarding the frequency of this being reported and questions regarding management of symptoms. Agent informed the reporter that she will call her back after speaking with Medical Information with the information she finds out. She will speak with them first and since she is not feeling good will call her back tomorrow. Age of onset reported as like 40 years old. Height: Does not have documentation for accurate estimated, then provided 1.5 (reporter unable to clarify further). It was also reported that she has been seen by several specialist not just one. Already has anemia and low platelet. Event Details: Cyst on Pancreas: Last year they monitored it, measured it. It had grown a bit more. They are going to run analysis and will be sent to surgeon. Enlarged thyroid: Has had many appointments. She lost appointment with specialist. Now she has one for 13Jun. They will run biopsy on her. Referred to their place to get a biopsy. Fibroids: Outcome Unknown and only the Gynecologist can answer if they have improved or not. Vaginal Bleeding: Bleeding has been too many blood clots. She had treatment in the (Withheld), but it did not help. She went to another Gynecologist at the (Withheld) and they gave the same birth control pills that did not help get any better. She had to go to the Emergency Room twice due to bleeding. Now they are sending her to have surgery. She was sent to a blood specialist due to low platelet and iron. Other Conditions: At the time took the vaccination was a very health woman. The patient was not allergic to any previous vaccination, medications, food or other products. Was not taking any medications. The patient did not receive any other vaccines on the same date as the Pfizer vaccine and did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. Confirms she got the second shot. After the second shot did not get the third one. When got the second shot the bleeding was more intense. Confirms had the bleeding with the first vaccination. After the first vaccination she had the vaginal bleeding, but she was not aware why she was going through it. When she got the second shot was throwing pound of blood clot. The vaccination causing bleeding. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500111636 same patient, different dose/event;
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| 2843748 | 84 | F | NJ | 06/03/2025 |
PNC20 |
PFIZER\WYETH |
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Cough
Cough
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Patient indicated that she started coughing occasionally a few hours after receiving vaccine. Cough...
Patient indicated that she started coughing occasionally a few hours after receiving vaccine. Coughing stopped within 24 hours.; This is a spontaneous report received from a Consumer or other non HCP. An 84-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 30May2025 at 16:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 84 years for immunisation. The patient's relevant medical history included: "Shellfish allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset 30May2025 at 20:00, outcome "recovered" (31May2025), described as "Patient indicated that she started coughing occasionally a few hours after receiving vaccine. Coughing stopped within 24 hours.". Therapeutic measures were not taken as a result of cough. Additional information: The patient did not receive any other vaccines on the same date as the vaccine(s). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2843749 | F | 06/03/2025 |
RSV TDAP |
PFIZER\WYETH UNKNOWN MANUFACTURER |
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Vaccination site erythema; Vaccination site erythema
Vaccination site erythema; Vaccination site erythema
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Redness in arm following vaccination; This is a spontaneous report received from a consumer. An adu...
Redness in arm following vaccination; This is a spontaneous report received from a consumer. An adult female patient (pregnant) received RSV Vaccine Prot.Subunit Pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown), in arm for maternal immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), as dose number unknown, single), in arm for maternal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Redness in arm following vaccination". Additional Information: Redness in arm following vaccination. The patient was vaccinated with both TDAP and RSV concomitantly.
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| 2843750 | 06/03/2025 |
COVID19 COVID19 |
MODERNA UNKNOWN MANUFACTURER |
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Nervous system disorder; Nervous system disorder
Nervous system disorder; Nervous system disorder
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neurological complications; This is a literature report for the following literature source(s). A p...
neurological complications; This is a literature report for the following literature source(s). A patient (age and gender not provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NERVOUS SYSTEM DISORDER (medically significant), outcome "unknown", described as "neurological complications". Follow-up(30MAY2025) This is a literature report for the following literature source(s).This a follow-up report based on the receipt of the publication the case has been updated to include additional information identified in the publication.; Sender's Comments: The reasonable possibility that the event is related to BNT162b2 (COVID-19 Vaccine - Manufacturer Unknown) administration cannot be excluded. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
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| 2843751 | 06/03/2025 |
COVID19 |
PFIZER\BIONTECH |
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Illness, Pain
Illness, Pain
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sick; a lot of pain; This is a spontaneous report received from an Other HCP, Program ID. A patient...
sick; a lot of pain; This is a spontaneous report received from an Other HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Primary immunisation series complete, manufacturer unknown), for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; PAIN (non-serious), outcome "unknown", described as "a lot of pain". Additional information: the reporter said there's a long term effect that's getting worse after getting the covid vaccine and booster shot. The reporter mentioned she needed a place to send a patient because the patient was sick and had a lot of pain. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2843752 | 81 | M | 06/03/2025 |
FLUA4 |
SEQIRUS, INC. |
No batch number |
Rhinorrhoea
Rhinorrhoea
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dripping of or from nose; This spontaneous case, initially received on 11-May-2024 and 14-May-2024 (...
dripping of or from nose; This spontaneous case, initially received on 11-May-2024 and 14-May-2024 (being processed together), was reported by a non health professional and concerns an elderly male patient. The patient's medical history was not reported. The patient's concomitant medications included rosuvastatin and losartan. The patient's historical vaccines included plenty of flu vaccines (brand not specified) received on an unknown date for unknown indication, after which the patient has never had this situation. Administration of company suspect drug(s): On 31-Dec-2023, the patient received Fluad Quadrivalent, Indication, Route of administration, Dose, Anatomical location, Lot number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, an unknown amount of time after vaccination, the patient experienced dripping of or from the nose (outcome: not recovered/not resolved). The patient reported there was no decrease in dripping of or from the nose. In a day mostly 3-to-9 time, dripping starts without any reason and sometimes the patient has to keep tissue in that nostril or sometimes both. The patient reported the dripping from the nose became more frequent, up to six times a day. At the time of initial reporting, the patient had not recovered from the event of 'Runny nose'. Non-drug treatment/Other action taken: Fluad Quadrivalent action taken: Not Applicable Reporters assessment: The reporter did not provide a causality assessment and considered the event as non-serious.; Reporter's Comments: Due to lack of information and unclear temporal relationship, causality for the event of 'dripping of or from the nose' is assessed as unassessable.
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| 2843753 | 18 | F | IN | 06/03/2025 |
HPV9 HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y00583 Y00583 Y00583 |
Altered state of consciousness, Bladder dysfunction, Blood lactic acid, Computer...
Altered state of consciousness, Bladder dysfunction, Blood lactic acid, Computerised tomogram head, Electrocardiogram; Electroencephalogram normal, Fall, Full blood count, Magnetic resonance imaging head, Metabolic function test; Sinus tachycardia, Tachycardia, Unresponsive to stimuli
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multiple episodes of altered consciousness, approximately 5 total, over 5 days 5/30-6/3; associated ...
multiple episodes of altered consciousness, approximately 5 total, over 5 days 5/30-6/3; associated with sinus tachycardia to 140+, up to 170; has had an EEG that noted no changes to electrical activity concerning for active epileptic seizure but has had multiple episodes of altered consciousness to the point that she has been unresponsive to sternal rub. Episodes of tachycardia occur at rest, simply while laying in bed, Friday night's episode was associated with a fall, and 1 episode was associated with loss of bladder function.
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| 2843754 | 06/03/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Unevaluable event
Unevaluable event
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None stated.
None stated.
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| 2843762 | 64 | F | OR | 06/03/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
LM2212 LM2212 LM2212 LM2212 LM2212 |
Arthralgia, Arthritis reactive, Aspiration joint, Blood test, Colitis ulcerative...
Arthralgia, Arthritis reactive, Aspiration joint, Blood test, Colitis ulcerative; Condition aggravated, Culture negative, Echocardiogram, Immediate post-injection reaction, Incisional drainage; Joint swelling, Loss of personal independence in daily activities, Muscular weakness, Neck pain, Oropharyngeal pain; Pain in extremity, Paraesthesia, Peripheral swelling, Pharyngeal swelling, Pyrexia; Swelling, Tonsillar hypertrophy, X-ray
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10/13/2024 Vaccination with Immediate left shoulder & hand pain. Within 1 week was experiencing ...
10/13/2024 Vaccination with Immediate left shoulder & hand pain. Within 1 week was experiencing low grade fevers; IBD-UC low-grade flare symptoms. 10/25 & 10/26 Two consecutive ER visits for severe left shoulder pain. 10/27 Admission inpatient hospital; bloodwork, cultures, radiology. 10/28 Surgical I&D left shoulder & L ankle. Home on 10/30 11/3 ER for progression painful swelling hands & wrists R>L. 11/8 seen by PCP & sent to Hosp for admission R hand/wrist painful swelling. 11/9 R wrist tapped for fluid by radiologist. 11/11 Dc'd home. 11/13 seen by Rheumatogist - diagnosis Reactive Arthritis 11/15 seen by PCP. 11/18 stitches removed by ortho-surgeon And Tele-visit with gastroentologist. 12/2 seen by rheumatologist. 12/7 R hand swelling, low-grade fevers; 12/9 gross swelling r hand. 12/13/2024 seen by PCP. 12/20 ER visit for 3 overlapping sites of pain/swelling. 2025: 1/5 - 1/9 hospital admit for multiple sites in pain/swelling: L elbow, L thumb & wrist, R thumb hand & wrist; L side of throat & neck (tonsils), R foot at toe joints; Parathesias in R & L ulnar side of wrists radiating into fingers & forearms. 1/9 Enrolled with Chronic Disease Management RN and meal delivery. 1/11 ER visit R hand. 1/13 Seen by rheumatologist. 1/14 Start Prednisone taper at 60mg. 1/15 Televisit with MD in PCP's office. 2/12 Seen by PCP with Lab work. Ongoing lowgrade flare and parasthesias in both wrists, hands & thumbs. Weakness in grip & difficulty with ADL's
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| 2843763 | 11 | M | AZ | 06/03/2025 |
UNK |
UNKNOWN MANUFACTURER |
2014790 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Child needed 11 yo IZs in addition to Hep B, Hep A and Varicella. Mom decided to get Tdap, MCV and H...
Child needed 11 yo IZs in addition to Hep B, Hep A and Varicella. Mom decided to get Tdap, MCV and Hep B and bring child back for the rest. HPV was given instead of Hep B. Mom notified, she brought child in on Wednesday 7/31/24 for the rest of IZs. No Adverse Effects reported.
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| 2843764 | 0.5 | M | AZ | 06/03/2025 |
RV5 |
MERCK & CO. INC. |
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Extra dose administered
Extra dose administered
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6 month old child came for his 6-month IZs, I noticed that he only had 2 doses of the rotavirus vacc...
6 month old child came for his 6-month IZs, I noticed that he only had 2 doses of the rotavirus vaccine and he was due for # 3 dose, he was within the right age range to complete the series; when looking at database it didn't show that #3 dose was due; I know that there have been glitches in database so I put in today's dose (06/03/25) as a historical vaccine administration and it didn't show that it was an error; I administered Rotateq only to notice after that he had received Rotarix and therefore he did not need a third dose for the rotavirus; it still shows on database that the Rotateq administered is a valid dose
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| 2843766 | 18 | F | AZ | 06/03/2025 |
MNQ |
SANOFI PASTEUR |
U7827AB |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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2 nd MCV on child's record was not added in database- missed when going over needed IZs and gav...
2 nd MCV on child's record was not added in database- missed when going over needed IZs and gave dose when not needed. Mom aware. No adverse effects.
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| 2843767 | 8 | M | AZ | 06/03/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
95BJ9 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Administered Hep B on 2/12/2025 but not due until 2/21/2025. Client returned to clinic on 2/21/25 an...
Administered Hep B on 2/12/2025 but not due until 2/21/2025. Client returned to clinic on 2/21/25 and Hep B was administered. No Adverse effects reported.
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| 2843768 | 60 | F | FL | 06/03/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
5d9h4gk |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient received second tetanus vaccine after receiving a booster on 08/13/24. Patient reported no s...
Patient received second tetanus vaccine after receiving a booster on 08/13/24. Patient reported no side effects
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| 2843769 | 73 | M | CO | 06/03/2025 |
COVID19 |
PFIZER\BIONTECH |
MD3414 |
Muscular weakness, No reaction on previous exposure to drug
Muscular weakness, No reaction on previous exposure to drug
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Patient had the shot on 4/8/25, but the next morning he has muscle weakness of both the left and rig...
Patient had the shot on 4/8/25, but the next morning he has muscle weakness of both the left and right arms. He says it went away after 1 day. He never has any reaction to vaccines before.
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| 2843770 | 54 | F | CO | 06/03/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Y019157 Y019157 |
Angioedema, Decreased appetite, Fatigue, Injection site erythema, Injection site...
Angioedema, Decreased appetite, Fatigue, Injection site erythema, Injection site pain; Injection site reaction, Pain
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Pt stated she received the imz on 5-31-25, however she noticed her arm started redness, pain upon to...
Pt stated she received the imz on 5-31-25, however she noticed her arm started redness, pain upon touch, and muscle hardness today, 6-3-25. It starts at around the injection site and starts about 1 inch wide ffor 2.5 inches and then widens to about 3 inches wide totally goes down her arm about 5 inches. She said it feels warm to the touch and feels like a bruise would feel and her muscle feels hard. Had body aches and a fever and fatigue and no appetite on 6-1-25 and took Tylenol PM. Dr is out of town for a couple of weeks, so we will follow up with another at the clinic. Pt called her doctor's office also and will follow up with them too
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| 2843771 | 1 | M | NY | 06/03/2025 |
MMR |
MERCK & CO. INC. |
X012616 |
Expired product administered
Expired product administered
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They gave my 12 month old vaccine that was expired by a month.
They gave my 12 month old vaccine that was expired by a month.
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| 2843772 | 1 | M | LA | 06/03/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
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Pyrexia, Urticaria
Pyrexia, Urticaria
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High fever 102.3 for two days followed by hives for3 days
High fever 102.3 for two days followed by hives for3 days
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| 2843773 | 64 | M | CA | 06/03/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
80777027310 80777027310 80777027310 |
Back pain, Blood test, Central nervous system lesion, Computerised tomogram, Fat...
Back pain, Blood test, Central nervous system lesion, Computerised tomogram, Fatigue; Gait disturbance, Lumbar puncture, Magnetic resonance imaging, Muscular weakness, Myelitis transverse; Pain, X-ray
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Pain, fatigue, muscle weakness in legs, difficulty walking, back pain, diagnosis of transverse myeli...
Pain, fatigue, muscle weakness in legs, difficulty walking, back pain, diagnosis of transverse myelitis with lesions on the spine
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| 2843780 | 48 | M | TX | 06/03/2025 |
COVID19 FLU3 TDAP |
MODERNA SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
B0001 U8500BA M2G32 |
Expired product administered; Expired product administered; Expired product admi...
Expired product administered; Expired product administered; Expired product administered
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Patient was given a Covid vaccine that was expired. Vaccine expired 5/8/2025 and given 5/13/2025. Pa...
Patient was given a Covid vaccine that was expired. Vaccine expired 5/8/2025 and given 5/13/2025. Patient unable to communicate through phone well but family member states patient has been doing fine.
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| 2843781 | 56 | M | TX | 06/03/2025 |
COVID19 |
MODERNA |
B0001 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Patient was given a Covid vaccine that was expired. Vaccine expired 5/8/2025 and given 5/13/2025. Un...
Patient was given a Covid vaccine that was expired. Vaccine expired 5/8/2025 and given 5/13/2025. Unable to reach patient x 5 times. Per spouse patient has been going to work every day from 4 am with no problems.
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| 2843782 | 59 | M | TX | 06/03/2025 |
COVID19 |
MODERNA |
B0001 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Patient was given a Covid that was expired. Vaccine expired 5/8/25 and was given 5/13/25. Called pat...
Patient was given a Covid that was expired. Vaccine expired 5/8/25 and was given 5/13/25. Called patient was was able to reach patient today states he has been doing fine with no complaints.
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| 2843783 | 48 | F | TX | 06/03/2025 |
COVID19 FLU3 TDAP |
MODERNA SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
B0001 U8500BA M2G32 |
Expired product administered, Injection site pain; Expired product administered,...
Expired product administered, Injection site pain; Expired product administered, Injection site pain; Expired product administered, Injection site pain
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Patient was given a Covid vaccine that was expired. Vaccine expired 5/8/2025 and given 5/13/2025. Pa...
Patient was given a Covid vaccine that was expired. Vaccine expired 5/8/2025 and given 5/13/2025. Patient complained of arm pain at injection site, no other complaints. Per patient doing well.
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| 2843479 | 72 | M | UT | 06/02/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Biopsy, Herpes zoster, Knee arthroplasty, Ligament sprain, Muscle injury; Pain, ...
Biopsy, Herpes zoster, Knee arthroplasty, Ligament sprain, Muscle injury; Pain, Postoperative wound infection, Wound dehiscence
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surgical wound infected; Wound dehiscence Right knee surgical wound opened; Knee replacement surgery...
surgical wound infected; Wound dehiscence Right knee surgical wound opened; Knee replacement surgery right knee; diagnosed with shingles at the same location he hurt his back/shingles spread to his left neck; Pain; back twisted; hurt a muscle; This serious case was reported by a consumer via call center representative and described the occurrence of knee replacement in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included retinal detachment. Concurrent medical conditions included hypertension, indigestion and prostate cancer. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX), gabapentin, aciclovir (Acyclovir), prednisolone, lisinopril, cyanocobalamin (B 12), famotidine, latanoprost and tamsulosin. On 23-DEC-2024, the patient received the 2nd dose of Shingrix (left arm) .5 ml. In DEC-2024, an unknown time after receiving Shingrix, the patient experienced sprained back (Verbatim: back twisted) and muscle injury (Verbatim: hurt a muscle). On 02-JAN-2025, the patient experienced knee replacement (Verbatim: Knee replacement surgery right knee) (serious criteria clinically significant/intervention required). In JAN-2025, the patient experienced shingles (Verbatim: diagnosed with shingles at the same location he hurt his back/shingles spread to his left neck) and pain (Verbatim: Pain). On an unknown date, the patient experienced surgical wound infection (Verbatim: surgical wound infected) and wound dehiscence (Verbatim: Wound dehiscence Right knee surgical wound opened). The patient was treated with clobetasol propionate. The outcome of the knee replacement, surgical wound infection, wound dehiscence, sprained back and muscle injury were not reported and the outcome of the shingles and pain were not resolved. It was unknown if the reporter considered the knee replacement, shingles, pain, surgical wound infection, wound dehiscence, sprained back and muscle injury to be related to Shingrix. The company considered the knee replacement to be unrelated to Shingrix. It was unknown if the company considered the shingles, pain, surgical wound infection, wound dehiscence, sprained back and muscle injury to be related to Shingrix. Additional Information: GSK Receipt Date: 28-MAY-2025 The reporter is the patient who reports that he received both Shingrix doses as recommended in the prescribing information in 2024. The reporter read on social media that he should report any adverse event concerning Shingrix. The reporter stated that he twisted his back in December of 2024 and hurt a muscle in his left back. He stated in the second week of January 2025 he was diagnosed with shingles at the same location he hurt his back in December of 2024. The shingles spread to his left neck and left groin. The shingles were still ongoing.; Sender's Comments: Knee arthroplasty is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
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| 2843480 | 60 | M | UT | 06/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
Y7XG3 |
Rash, Rash pruritic
Rash, Rash pruritic
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he developed an itchy rash on both of his forearms; few dots on his back and back of his calves, but...
he developed an itchy rash on both of his forearms; few dots on his back and back of his calves, but they are not itchy; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number Y7XG3, expiry date 27-MAR-2027) for prophylaxis. On 12-MAY-2025, the patient received the 1st dose of Shingrix (left deltoid) .5 ml. On 19-MAY-2025, 7 days after receiving Shingrix, the patient experienced itchy rash (Verbatim: he developed an itchy rash on both of his forearms) and rash (Verbatim: few dots on his back and back of his calves, but they are not itchy). The outcome of the itchy rash and rash were not resolved. It was unknown if the reporter considered the itchy rash and rash to be related to Shingrix. It was unknown if the company considered the itchy rash and rash to be related to Shingrix. Additional Information: GSK Receipt Date :27-MAY-2025 Reporter reported that patient received his first Shingrix vaccine in the left arm on 12th May 2025. He reported 1 week later on 19th May 2025 he developed an itchy rash on both of his forearms, and it was still ongoing. Reporter also reported a few dots on his back and back of his calves, but they were not itchy. Reporter stated his wife had a prescription medication (unknown name) for itching that he put on the itchy rash a couple times.
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| 2843481 | 38 | M | NY | 06/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
P5F7T |
Product administered to patient of inappropriate age, Product package associated...
Product administered to patient of inappropriate age, Product package associated injury, Skin laceration
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Product complaint; 0.8cm laceration to the pad of his left index finger; glass vial, it shattered in...
Product complaint; 0.8cm laceration to the pad of his left index finger; glass vial, it shattered in the patient's hand suddenly; Inappropriate age at vaccine administration; This non-serious case was reported by a other health professional and described the occurrence of skin laceration in a 38-year-old male patient who received Herpes zoster (Shingrix) (batch number P5F7T, expiry date 27-APR-2027) for prophylaxis. This case was associated with a product complaint. On 28-MAY-2025, the patient received Shingrix. On 28-MAY-2025, less than a day after receiving Shingrix, the patient experienced skin laceration (Verbatim: 0.8cm laceration to the pad of his left index finger), glass ampoule associated injury (Verbatim: glass vial, it shattered in the patient's hand suddenly) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product complaint). On 28-MAY-2025, the outcome of the glass ampoule associated injury was resolved. The outcome of the skin laceration was not reported and the outcome of the inappropriate age at vaccine administration was not applicable and the outcome of the pharmaceutical product complaint was unknown. It was unknown if the reporter considered the skin laceration and glass ampoule associated injury to be related to Shingrix. It was unknown if the company considered the skin laceration and glass ampoule associated injury to be related to Shingrix. Additional Information: GSK Receipt Date: 29-MAY-2025 This report was submitted via the online direct entry reporting system. While preparing to remove the plastic cap from the glass vial, it shattered in the patient's hand suddenly. Patient sustained a 0.8 cm laceration to the pad of his left index finger. First aid was given. The 38 year old patient received dose of Shingrix, which led to inappropriate age at vaccine administration.
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| 2843482 | 06/02/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Underdose
Underdose
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regurgitated dose of Rotarix during or after administration; Accidental underdose; This non-serious ...
regurgitated dose of Rotarix during or after administration; Accidental underdose; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation in a child patient who received Rotavirus vaccine for prophylaxis. On an unknown date, the patient received Rotavirus vaccine (oral). On an unknown date, immediately after receiving Rotavirus vaccine, the patient experienced regurgitation (Verbatim: regurgitated dose of Rotarix during or after administration) and accidental underdose (Verbatim: Accidental underdose). The outcome of the regurgitation was resolved and the outcome of the accidental underdose was not applicable. The reporter considered the regurgitation to be related to Rotavirus vaccine. It was unknown if the reporter considered the regurgitation to be related to Rotarix Unspecified Oral Administation Device. The company considered the regurgitation to be related to Rotavirus vaccine. It was unknown if the company considered the regurgitation to be related to Rotarix Unspecified Oral Administation Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 29-MAY-2025 This report was submitted via the online direct entry reporting system. Healthcare professional (HCP) stated that 3 patients recently have regurgitated dose of Rotarix during or after administration, which led to accidental underdose.
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| 2843483 | 2 | F | NY | 06/02/2025 |
HEP |
UNKNOWN MANUFACTURER |
UNK |
Rash
Rash
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Rash started in back of neck and is now all over body and feet/it is still ongoing; This non-serious...
Rash started in back of neck and is now all over body and feet/it is still ongoing; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 2-year-old female patient who received Hepatitis B vaccine for prophylaxis. In FEB-2025, the patient received Hepatitis B vaccine. In FEB-2025, between 2 and 3 weeks after receiving Hepatitis B vaccine, the patient experienced generalized rash (Verbatim: Rash started in back of neck and is now all over body and feet/it is still ongoing). The outcome of the generalized rash was not resolved. It was unknown if the reporter considered the generalized rash to be related to Hepatitis B vaccine. It was unknown if the company considered the generalized rash to be related to Hepatitis B vaccine. Additional Information: GSK receipt date: 30-MAY-2025 The grandmother of the patient reported the patient received a Hepatitis B vaccine in February 2025 and 2 and a half weeks later she noticed a rash in the back of the neck. The rash later traveled to face and is now all over her body including feet. They took her to several doctors. She did not want to provide heath care professional consent. The reporter would call back with the name of the vaccine.
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| 2843484 | 06/02/2025 |
RVX RVX |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Dyspnoea, Extra dose administered, Respiratory syncytial virus infection, Vaccin...
Dyspnoea, Extra dose administered, Respiratory syncytial virus infection, Vaccination failure; Dyspnoea, Extra dose administered, Respiratory syncytial virus infection, Vaccination failure
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I am vaccinated and had the booster shots but I got it anyway; had the booster shots; Suspected vacc...
I am vaccinated and had the booster shots but I got it anyway; had the booster shots; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine and RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine and RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: I am vaccinated and had the booster shots but I got it anyway) (serious criteria hospitalization) and extra dose administered (Verbatim: had the booster shots). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine and RSV vaccine. The company considered the vaccination failure and respiratory syncytial virus infection to be unrelated to RSV vaccine and RSV vaccine. Additional Information: GSK Receipt Date: 23 -MAY-2025 This case was reported by a patient via interactive digital media. The patient was vaccinated and had the booster shots but he/she got it anyway which led to extra dose administered. And the patient couldn't breathe, he/she had to go to the hospital. This case was considered as suspected vaccination failure as details regarding time to onset for respiratory syncytial virus infection and laboratory confirmation regarding respiratory syncytial virus infection 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 RSV vaccine(Dose 1 & 2) Respiratory syncytial virus infection is an unlisted event which is considered unrelated to GSK RSV vaccine(Dose 1 & 2)
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| 2843485 | 06/02/2025 |
FLUX VARZOS |
UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Chills; Chills
Chills; Chills
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SHIVERING; This non-serious case was reported by a consumer via interactive digital media and descri...
SHIVERING; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shivering in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included influenza vaccine for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix and influenza vaccine. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shivering (Verbatim: SHIVERING). The action taken with influenza vaccine was unknown. The outcome of the shivering was resolved. It was unknown if the reporter considered the shivering to be related to Shingrix. It was unknown if the company considered the shivering to be related to Shingrix. Additional Information: GSK receipt date: 24-MAY-2025 The reporter reported that he/she made the mistake of getting my first Shingrix with my flu shot. Several days under several blankets, shivering.
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| 2843486 | 06/02/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; I had the vaccine 3 years ago and i now have shingles; This serious ...
Suspected vaccination failure; I had the vaccine 3 years ago and i now have 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, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had the vaccine 3 years ago and i now have shingles). 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. 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: 27-MAY-2025 This case was reported by a patient via interactive digital media. Consumer reported that had the vaccine 3 years ago and now have shingles. He /she was in absolute agony. 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2843487 | M | 06/02/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster
Herpes zoster
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he got shingles two weeks later and still has it and he; This non-serious case was reported by a con...
he got shingles two weeks later and still has it and he; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles 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, 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: he got shingles two weeks later and still has it and he). The outcome of the shingles was not resolved. 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. Additional Information: GSK receipt date: 28-MAY-2025 This case was reported by a reporter via interactive digital media. Reporter stated that reporter's husband's uncle four years ago, got the shingles shot and he got shingles two weeks later and still had it and he got it bad.
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| 2843488 | 06/02/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Rash; Rash
Rash; Rash
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mild rash going down my arm; This non-serious case was reported by a consumer via interactive digita...
mild rash going down my arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash 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 rash (Verbatim: mild rash going down my arm). The outcome of the rash was not reported. It was unknown if the reporter considered the rash to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the rash to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 29-MAY-2025 This case was reported by a patient via interactive digital media. The patient got both shots and he/she not sure but had a mild rash going down arm. it was mild he/she glad got the shots.
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| 2843489 | 58 | M | MN | 06/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
LT533 |
Fatigue, Pain in extremity
Fatigue, Pain in extremity
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accentuated fatigue; pain in injection arm; This non-serious case was reported by a physician via ca...
accentuated fatigue; pain in injection arm; This non-serious case was reported by a physician via call center representative and described the occurrence of fatigue aggravated in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number LT533) for prophylaxis. On 07-MAY-2018, the patient received the 1st dose of Shingrix. On 07-MAY-2018, less than a day after receiving Shingrix, the patient experienced fatigue aggravated (Verbatim: accentuated fatigue) and pain in arm (Verbatim: pain in injection arm). The outcome of the fatigue aggravated and pain in arm were unknown. It was unknown if the reporter considered the fatigue aggravated and pain in arm to be related to Shingrix. It was unknown if the company considered the fatigue aggravated and pain in arm to be related to Shingrix. Additional Information: GSK receipt date: 22-MAY-2025 The patient experienced pain in arm, with an accentuated fatigue after the first dose of Shingrix.; Sender's Comments: US-GSK-US2025068287:For 2nd dose shingrix
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