| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2826140 | U | 02/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; l have just now had shingles; This serious case was reported by a con...
Suspected vaccination failure; l have just now had shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 83-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: l have just now had shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure and shingles to be unrelated to Shingrix. Additional Information: GSK receipt date: 10-FEB-2025 This case was reported by a patient via interactive digital media. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
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| 2826141 | U | 02/13/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
White blood cell count increased
White blood cell count increased
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white blood count is elevated; This non-serious case was reported by a consumer via call center repr...
white blood count is elevated; This non-serious case was reported by a consumer via call center representative and described the occurrence of white blood cell count increased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced white blood cell count increased (Verbatim: white blood count is elevated). The outcome of the white blood cell count increased was unknown. It was unknown if the reporter considered the white blood cell count increased to be related to Shingles vaccine. It was unknown if the company considered the white blood cell count increased to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 12-FEB-2025 The reporter reported that he/she just got first dose shingles vaccine and had a blood test done. The patient white blood count was elevated. The patient asked could the vaccine cause this.
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| 2826142 | U | MN | 02/13/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
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Product preparation error
Product preparation error
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vaccine administered reconstituted with non-approved diluent; vaccine administered reconstituted wit...
vaccine administered reconstituted with non-approved diluent; vaccine administered reconstituted with non-approved diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On 15-JAN-2025, the patient received the 1st dose of Menveo. On 15-JAN-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: vaccine administered reconstituted with non-approved diluent) and inappropriate dose of vaccine administered (Verbatim: vaccine administered reconstituted with non-approved diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 15-JAN-2025 The pharmacy Intern reported that they administered Menveo (2-vial) but the powder was reconstituted with sterile water instead of the liquid component vial, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not had any patient demographics, lot number or expiration date for the vaccine. This was the first dose of Menveo for this patient. The vaccine administration facility was the same as primary reporter.
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| 2826143 | U | FL | 02/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Product storage error
Product storage error
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Shingrixout of recommended storage temperatures for more than 6 hours; This non-serious case was rep...
Shingrixout of recommended storage temperatures for more than 6 hours; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Shingrixout of recommended storage temperatures for more than 6 hours). The outcome of the incorrect storage of drug was unknown. Additional Information: GSK receipt date: 16-JAN-2025 The reporter called to report leaving Shingrix vaccine out of recommended storage temperatures for more than 6 hours which led to, incorrect storage of drug.
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| 2826144 | 45 | F | TX | 02/13/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
A2J35 |
Incorrect route of product administration, Product administered to patient of in...
Incorrect route of product administration, Product administered to patient of inappropriate age
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received a MMR vaccine intramuscularly; 45 years patient received Priorix vaccine; This non-serious ...
received a MMR vaccine intramuscularly; 45 years patient received Priorix vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 45-year-old female patient who received MMR (Priorix) (batch number A2J35, expiry date 01-SEP-2025) for prophylaxis. On 14-JAN-2025, the patient received Priorix (intramuscular, unknown deltoid). On 14-JAN-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: received a MMR vaccine intramuscularly) and inappropriate age at vaccine administration (Verbatim: 45 years patient received Priorix vaccine). The outcome of the subcutaneous injection formulation administered by other route and inappropriate age at vaccine administration were unknown. 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: 16-JAN-2025 The nurse practitioner reported that they had a patient who received a MMR vaccine (Priorix) two days ago and she received that yesterday. The reporter asked it was a live vaccine and was that correct and she received a MMR vaccine intramuscularly and she got it in the deltoid, which led to subcutaneous injection formulation administered by other route The reporter was told that it was not a live vaccine and she received it on the deltoid and was needing her varicella today which she could not give her if she received the MMR two days ago. The reporter asked that something that they need to repeat whether subcutaneously. The reporter asked do she need to wait and what was it that they need to do at that point, since it was administered incorrectly The patient received Priorix at inappropriate age which led to inappropriate age at vaccine administration.
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| 2826145 | U | FL | 02/13/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
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Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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TDap vaccine (Boostrix) was inadvertently given to a newborn baby; This non-serious case was reporte...
TDap vaccine (Boostrix) was inadvertently given to a newborn baby; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a neonate patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 16-JAN-2025, the patient received Boostrix. On 16-JAN-2025, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: TDap vaccine (Boostrix) was inadvertently given to a newborn baby). The outcome of the inappropriate age at vaccine administration was unknown. 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: 16-JAN-2025 The physician reported that on the day of reporting a TDap vaccine (Boostrix) was inadvertently given to a newborn baby which led to, inappropriate age at vaccine administration. According to reporter, the patient was not even one-day old. The reporter did not agree additional details on the patient when asked. The Vaccine Administration Facility was the same as Primary Reporter.
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| 2826146 | 4 | M | TX | 02/13/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
Y498Z |
Extra dose administered
Extra dose administered
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administration of another dose of Kinrix administered on today; This non-serious case was reported b...
administration of another dose of Kinrix administered on today; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number Y498Z, expiry date 17-MAY-2026) for prophylaxis. Concomitant products included Kinrix. On 16-JAN-2025, the patient received the 2nd dose of Kinrix. On 16-JAN-2025, an unknown time after receiving Kinrix, the patient experienced extra dose administered (Verbatim: administration of another dose of Kinrix administered on today). The outcome of the extra dose administered was unknown. 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: 16-JAN-2025 The other health professional reported administration of Kinrix as 5th dose in series and another dose of Kinrix administered on the day of reporting which led to extra dose administered.
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| 2826147 | 20 | F | NJ | 02/13/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
C2Y9B |
Underdose
Underdose
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20-year-old female received an Engerix B Pediatric/Adolescent Vaccine dose; 20-year-old female recei...
20-year-old female received an Engerix B Pediatric/Adolescent Vaccine dose; 20-year-old female received an Engerix B Pediatric/Adolescent Vaccine dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number C2Y9B, expiry date 15-JUL-2026) for prophylaxis. On 08-JAN-2025, the patient received Engerix B pediatric (right arm) .5 ml. On 08-JAN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: 20-year-old female received an Engerix B Pediatric/Adolescent Vaccine dose) and adult use of a child product (Verbatim: 20-year-old female received an Engerix B Pediatric/Adolescent Vaccine dose). The outcome of the underdose and adult use of a child product were unknown. 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: 17-JAN-2025 The other health professional reported that a 20-year-old female patient received an Engerix B Pediatric/Adolescent vaccine dose instead of Engerix B 20 adult dose by error which led to underdose and adult use of child product. The other health professional stated that the vaccine was administered on the right arm. No additional information was provided.
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| 2826148 | M | 02/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Neuralgia, Spinal stenosis
Neuralgia, Spinal stenosis
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has stenosis in his spine and it was caused by the zoster virus/nerve pain; This non-serious case wa...
has stenosis in his spine and it was caused by the zoster virus/nerve pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of spinal stenosis in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (patient received 1st dose in 2020). Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX). On an unknown date, the patient received the 2nd dose of Shingrix. In OCT-2024, an unknown time after receiving Shingrix and SHINGRIX, the patient experienced spinal stenosis (Verbatim: has stenosis in his spine and it was caused by the zoster virus/nerve pain). The outcome of the spinal stenosis was not reported. The reporter considered the spinal stenosis to be related to Shingrix. The company considered the spinal stenosis to be related to Shingrix. Additional Information: GSK receipt date: 16-JAN-2025 The reporter was the patient. Patient stated that he had the complete series of Shingrix administer with the first dose in 2020 and the second dose in 2021. the patient stated he started experiencing nerve pain in October 2024. Also, states his doctor said he had stenosis in his spine and it was caused by the zoster virus. Consumer denied having been diagnosis with shingles. No further information was known including dates of administration of Shingrix, demographics of consumer.
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| 2826149 | F | TX | 02/13/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
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Inappropriate schedule of product administration
Inappropriate schedule of product administration
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received hepatitis B dosing with Heplisav-B in April 2024 and June 2024 and the patient then receive...
received hepatitis B dosing with Heplisav-B in April 2024 and June 2024 and the patient then received Twinrix in August 2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a adult female patient who received HAB (Twinrix) for prophylaxis. Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) and Hepatitis b vaccine rHBsAg (yeast) (Heplisav b). In AUG-2024, the patient received Twinrix. In AUG-2024, an unknown time after receiving Twinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: received hepatitis B dosing with Heplisav-B in April 2024 and June 2024 and the patient then received Twinrix in August 2024). The outcome of the inappropriate schedule of vaccine administered was unknown. 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: 17-JAN-2025 The pharmacy intern reported that the patient that received hepatitis B dosing with Heplisav-B in April 2024 and June 2024 and the patient then received Twinrix, which led to Inappropriate schedule of vaccine administered. The reporter asked how to complete the hepatitis A series for this patient and at the time of call, no additional dosing had been administered. The Vaccine Administration Facility was the same as Primary Reporter
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| 2826150 | M | OH | 02/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
FH9A7 |
Inappropriate schedule of product administration, Product preparation issue
Inappropriate schedule of product administration, Product preparation issue
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2nd dose was given 7 months later, 1 month more than recommended; reconstituted with two vials of th...
2nd dose was given 7 months later, 1 month more than recommended; reconstituted with two vials of the diluent; reconstituted with two vials of the diluent; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) (batch number FH9A7, expiry date 16-JUL-2026) for prophylaxis. Previously administered products included Shingrix (First dose received on 07-June-2024). On 17-JAN-2025, the patient received the 2nd dose of Shingrix. On 17-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose was given 7 months later, 1 month more than recommended), inappropriate preparation of medication (Verbatim: reconstituted with two vials of the diluent) and inappropriate dose of vaccine administered (Verbatim: reconstituted with two vials of the diluent). The outcome of the drug dose administration interval too long, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 17-JAN-2025 The patient was older than 50 years old. The pharmacist had a patient who was getting a shingles vaccine, it was his second dose and had a vial of the powder that was reconstituted with two vials of the diluent and then administered, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter was reported if dose been a little more diluted so, reporter asked if that would be sufficient or there was just kind of manufacturer's guidance or if needed to, recommended him to come back and to get like a third dose to make sure a third dose, a standardized dose. The patient received 2nd dose was given 7 months later, 1 month 10 days more than recommended which led to lengthening of vaccination schedule. Pharmacist was transferred to second line specialist, after which he stated he/she knew during Covid there were patients that missed the interval for Shingrix and had late second doses. No further context or details provided, The reporter did not consent to follow-up. This case was linked with case US2019236811 reported by the same reporter, for different patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2019236811:same reporter
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| 2826151 | 57 | F | AR | 02/13/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
TP2N2 UNK |
Herpes zoster, Incomplete course of vaccination; Herpes zoster, Incomplete cours...
Herpes zoster, Incomplete course of vaccination; Herpes zoster, Incomplete course of vaccination
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patient wanted to get a late second dose.; she ended up getting shingles,; This non-serious case was...
patient wanted to get a late second dose.; she ended up getting shingles,; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) (batch number TP2N2, expiry date 10-FEB-2023) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 05-OCT-2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. In JUL-2024, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: she ended up getting shingles,). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: patient wanted to get a late second dose.). The outcome of the shingles and incomplete course of vaccination were unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 17-JAN-2025 The pharmacist reported that a patient received the first dose of Shingrix and then patient decided she did not want the second dose. About 6 months ago she ended up getting shingles, and now patient wanted to get a late second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2826152 | 31 | M | AZ | 02/13/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
92DJ3 |
Underdose
Underdose
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31-year-old patient received a pediatric dose of Engerix B; underdose; This non-serious case was rep...
31-year-old patient received a pediatric dose of Engerix B; underdose; 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 31-year-old male patient who received HBV (Engerix B pediatric) (batch number 92DJ3, expiry date 03-MAY-2025) for prophylaxis. On 16-JAN-2025, the patient received the 3rd dose of Engerix B pediatric. On 16-JAN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: 31-year-old patient received a pediatric dose of Engerix B) and underdose (Verbatim: underdose). The outcome of the adult use of a child product and underdose were unknown. 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: 17-JAN-2025 Vaccine Coordinator stated a 31-year-old patient received a pediatric dose of Engerix-B, which led to adult use of a child product and underdose.
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| 2826153 | 0.33 | U | TX | 02/13/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
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Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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A 4 months old patient received a dose of Kinrix.; This non-serious case was reported by a pharmacis...
A 4 months old patient received a dose of Kinrix.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis. On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: A 4 months old patient received a dose of Kinrix.). The outcome of the inappropriate age at vaccine administration was unknown. 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: 22-JAN-2025 The pharmacist reported that a patient of an inappropriate age received a dose of Kinrix, which led to inappropriate age at vaccine administration The reporter asked was it harmful for the patient and was there a problem or was just not recommended. The reporter said that he did not had more information about the patient.
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| 2826154 | 60 | F | PA | 02/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
N77J2 |
Product preparation issue
Product preparation issue
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received Shingrix diluent alone; received Shingrix diluent alone; This non-serious case was reported...
received Shingrix diluent alone; received Shingrix diluent alone; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number N77J2, expiry date 23-OCT-2026) for prophylaxis. On 28-JAN-2024, the patient received the 2nd dose of Shingrix. On 28-JAN-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received Shingrix diluent alone) and inappropriate dose of vaccine administered (Verbatim: received Shingrix diluent alone). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 28-JAN-2025 The office manager reported that a patient received second dose of Shingrix diluent alone without the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter.
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| 2826155 | 74 | M | NV | 02/13/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Coma, Herpes zoster, Incomplete course of vaccination; Coma, Herpes zoster, Inco...
Coma, Herpes zoster, Incomplete course of vaccination; Coma, Herpes zoster, Incomplete course of vaccination
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4 days in a coma; and got SHINGLES 4 years later.; Symptomatic - Did Not Receive the 2nd vaccination...
4 days in a coma; and got SHINGLES 4 years later.; Symptomatic - Did Not Receive the 2nd vaccination; This serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 31-JAN-2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not received the 2nd dose of Shingrix. On 08-JAN-2025, 1438 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: and got SHINGLES 4 years later.) (serious criteria hospitalization). On an unknown date, the patient experienced coma (Verbatim: 4 days in a coma) (serious criteria hospitalization and GSK medically significant) and incomplete course of vaccination (Verbatim: Symptomatic - Did Not Receive the 2nd vaccination). The outcome of the shingles and incomplete course of vaccination were unknown and the outcome of the coma was resolved (duration 4 days). It was unknown if the reporter considered the shingles and coma to be related to Shingrix. The company considered the shingles and coma to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 30-JAN-2025 Consumer stated no one told him he needed a 2nd dose of Shingrix. The patient was proceeded to get SHINGLES 4 years after first dose and was hospitalized for 16 days, 4 days in a coma. Patient would like to be contacted and would like to send pictures and be a spokesperson. Consumer stated he doesn't believe commercial presents itself as to how serious shingles can be and the commercial needs to stated 2 shots are to be given. The reporter Consented to follow up. Till the time of reporting, the patients did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.; Sender's Comments: Herpes zoster and Coma are unlisted events which are considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
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| 2826156 | F | PA | 02/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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a patient received a first dose of Shingrix and has not received the second dose yet; This non-serio...
a patient received a first dose of Shingrix and has not received the second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received in September 2023). On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: a patient received a first dose of Shingrix and has not received the second dose yet). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 31-JAN-2025 The reporter called report in September 2023 a patient received a first dose of Shingrix and has not received the second dose yet. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
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| 2826157 | 53 | F | 02/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Dizziness, Hypersensitivity, Nausea, Pain
Dizziness, Hypersensitivity, Nausea, Pain
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Nausea; Dizziness; Pain; Allergy; This non-serious case was reported by a consumer via call center r...
Nausea; Dizziness; Pain; Allergy; This non-serious case was reported by a consumer via call center representative and described the occurrence of nausea in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 30-JAN-2025, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea), dizziness (Verbatim: Dizziness), pain (Verbatim: Pain) and allergy (Verbatim: Allergy). The outcome of the nausea and dizziness were not resolved and the outcome of the pain and allergy were unknown. It was unknown if the reporter considered the nausea, dizziness, pain and allergy to be related to Shingrix. It was unknown if the company considered the nausea, dizziness, pain and allergy to be related to Shingrix. Additional Information: GSK Receipt Date: 04-FEB-2025 The patient self-reported this case. The patient received her second dose of Shingrix and was still having dizziness and nausea today (on the reporting day). It was not provided when the dizziness or nausea started and she read to take Tylenol and Advil and that these did not help with pain involved with the shot or after effects (no further information provided). It was not clear if the patient took either Tylenol or Advil (unknown product information). The patient reported that her physician told her to come in to note an allergy in her chart after receiving the second dose of Shingrix, but no further information was provided about the potential allergy.
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| 2826158 | 0.5 | M | MI | 02/13/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
Y49BZ |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Kinrix was administered to a 6-month-old patient; Kinrix dose was the second dose overall of Dtap an...
Kinrix was administered to a 6-month-old patient; Kinrix dose was the second dose overall of Dtap and IPV; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis. On 06-FEB-2025, the patient received Kinrix. On 06-FEB-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 6-month-old patient) and inappropriate schedule of vaccine administered (Verbatim: Kinrix dose was the second dose overall of Dtap and IPV). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown. 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: 06-FEB-2025 A nurse called to report Kinrix was administered to a 6-month-old patient. This Kinrix dose was the second dose overall of Dtap and IPV for the patient which led to Inappropriate schedule of vaccine administered. The patient received a dose of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration.
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| 2826159 | 66 | F | NE | 02/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3G5T3 |
Contusion, Injection site pain, Rash erythematous, Rash pruritic
Contusion, Injection site pain, Rash erythematous, Rash pruritic
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itchy red spots; pain at injection site; Bruised arm; This non-serious case was reported by a consum...
itchy red spots; pain at injection site; Bruised arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 3G5T3, expiry date 20-JUL-2026) for prophylaxis. The patient's past medical history included kidney transplant (The patient reports she did receive a kidney transplant 6 years ago and is on anti-rejection medication). On 19-NOV-2024, the patient received the 2nd dose of Shingrix (intramuscular, right arm) .5 ml. On 19-NOV-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site) and bruising of arm (Verbatim: Bruised arm). On 24-NOV-2024, the patient experienced itchy rash (Verbatim: itchy red spots). The outcome of the injection site pain was resolved and the outcome of the bruising of arm and itchy rash were not resolved. It was unknown if the reporter considered the injection site pain, bruising of arm and itchy rash to be related to Shingrix. It was unknown if the company considered the injection site pain, bruising of arm and itchy rash to be related to Shingrix. Additional Information: GSK Receipt Date: 06-FEB-2025 Caller was the patient and reported she received her second Shingrix vaccine in her right arm on November 19. 2024. The pharmacist injected it very low on her upper arm, about 4 "above her elbow, the bruise is still there. Patient reported there was pain at the injection site that has been resolved. Caller reported less than a week after the Shingrix injection she began experiencing an itchy spot mainly from her shoulders up to her head. The red itchy spots are the size of a dime, some a pencil eraser size and one was the size of a 50-cent piece. The Patient reported she went to the health care professional on 12-Apr-2024 and the HCP gave her a steroid cream for the itching. The caller went back to the HCP and the HCP took a biopsy of 50 percent piece size spot on 05-Feb-2025 and the results will take a week. Caller describes the red itchy spots as coming and going but they never resolve. She also had a spot near her panty line. Caller does had pictures to share if needed. The patient reported she did receive a kidney transplant 6 years ago and is on anti-rejection medication. The reporter consented to follow up.
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| 2826160 | M | MN | 02/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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has not received the second dose of Shingrix vaccine; This non-serious case was reported by a consum...
has not received the second dose of Shingrix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose during April 2024 in left arm). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has not received the second dose of Shingrix vaccine). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 07-FEB-2025 The patient received the 1st dose of Shingrix at a local pharmacy,the lot and expiry were unknown. The patient reports he has not received the second dose of Shingrix vaccine, which led incomplete course of vaccination. It was unknown why the patient did not get the vaccine between 2 to 6 months after the 1st dose. The reporter did not consent to follow-up.
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| 2826161 | 29 | F | FL | 02/13/2025 |
RSV RSV RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
54A7M 54A7M 54a7m 54a7m |
Exposure during pregnancy, Product administered to patient of inappropriate age,...
Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue; Device use issue, Exposure during pregnancy, No adverse event; Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue; Device use issue, Exposure during pregnancy, No adverse event
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A 29 years old pregnant woman received a dose of Arexvy; A 29 years old pregnant woman received a do...
A 29 years old pregnant woman received a dose of Arexvy; A 29 years old pregnant woman received a dose of Arexvy; A 29 years old pregnant woman received a dose of Arexvy instead of a dose of Abrysvo; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 29-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 54A7M, expiry date 30-OCT-2025) for prophylaxis. Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis. On an unknown date, the patient received Arexvy and did not receive Abrysvo. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: A 29 years old pregnant woman received a dose of Arexvy), drug use in unapproved population (Verbatim: A 29 years old pregnant woman received a dose of Arexvy) and wrong vaccine administered (Verbatim: A 29 years old pregnant woman received a dose of Arexvy instead of a dose of Abrysvo). The outcome of the vaccine exposure during pregnancy, drug use in unapproved population and wrong vaccine administered were unknown. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Exposure (Abrysvo): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 10-FEB-2025 Pharmacist called to report that they administered a dose of Arexvy instead of a dose of Abrysvo to a 29 years old pregnant patient, which led to Drug use in unapproved population, Wrong vaccine administered and Vaccine exposure during pregnancy.
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| 2826167 | U | ME | 02/13/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
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Product storage error
Product storage error
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Fluarix vaccine fridge temperatures Total time at 47.5F x 37 days and it was 51.1 for 1 hour at one ...
Fluarix vaccine fridge temperatures Total time at 47.5F x 37 days and it was 51.1 for 1 hour at one point as well; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) for prophylaxis. On an unknown date, the patients received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: Fluarix vaccine fridge temperatures Total time at 47.5F x 37 days and it was 51.1 for 1 hour at one point as well). The outcome of the incorrect storage of drug was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 11-FEB-2025 The reporter reported that the storage fridge temperatures had been ranging 44 to 50 for months and asked was fluarix still good. The fridge temperature for the last 37 days had been 47 to 48 degrees Fahrenheit and the total time at 47.5 Fahrenheit for 37 days and found a graph and it was 51.1 for 1 hour at one point as well and these vaccines (Fluarix vaccines) were used in patients, which led to incorrect storage of drug.
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| 2826168 | F | 02/13/2025 |
COVID19 |
MODERNA |
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Scan, Vision blurred
Scan, Vision blurred
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blurry vision; This spontaneous case was reported by a patient family member or friend and describes...
blurry vision; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VISION BLURRED (blurry vision) in a female 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 VISION BLURRED (blurry vision). At the time of the report, VISION BLURRED (blurry vision) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Scan: eye problems. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient had blurry vision and patient did not had covid-19 before receiving the Moderna covid-19. The scan shows the eye problems and she had thousands of tests because of this and blood work and she was never sick before. Treatment information was not provided. This case was linked to US-MODERNATX, INC.-MOD-2025-782161 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-782161:Patient's father
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| 2826169 | 63 | F | TX | 02/13/2025 |
COVID19 |
MODERNA |
82B22A |
Acoustic stimulation tests, Deafness neurosensory, Hypotension, Otoscopy, Tympan...
Acoustic stimulation tests, Deafness neurosensory, Hypotension, Otoscopy, Tympanometry
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Low blood pressure; tinnitis/hearing loss/dizziness; This spontaneous case was reported by a patient...
Low blood pressure; tinnitis/hearing loss/dizziness; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS NEUROSENSORY (tinnitis/hearing loss/dizziness) in a 63-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 82B22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (Dose 1, Lot number: - 030M20A, expiry date: - 01-Aug-2021.) on 10-Feb-2021, Moderna covid-19 vaccine (Dose 2, Lot number: - 040A21A, expiry date: -24-Aug-2021.) on 10-Mar-2021, Moderna covid-19 vaccine (Dose 3 and Lot number: - 048F21A.) on 08-Nov-2021. Past adverse reactions to the above products included No adverse effect with Moderna covid-19 vaccine, Moderna covid-19 vaccine and Moderna covid-19 vaccine. Family history included Hearing loss. On 27-Aug-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. In 2022, the patient experienced DEAFNESS NEUROSENSORY (tinnitis/hearing loss/dizziness) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPOTENSION (Low blood pressure). At the time of the report, DEAFNESS NEUROSENSORY (tinnitis/hearing loss/dizziness) and HYPOTENSION (Low blood pressure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: Right Ear - Normal-Moderately Severe Sensorineural Sloping Hearing Loss; Left Ear - Normal-Moderately Severe Sensorineural Sloping Hearing Loss. Word Recognition: Right ear - 100% at 60dBHL; Left ear - 100% at 60dBHL. DPOAES revealed 6/12 frequencies present in the RE 2/12 frequencies present in the LE.. On an unknown date, Otoscopy: Clear ear canals, bilaterally. On an unknown date, Tympanometry: Normal TM mobility, middle ear pressure, and ear canal volume, bilaterally. Pure tone testing (Symmetric).. Concomitant product use was not provided by the reporter. Patient reported that she had intermittent symptoms of buzzing, that she initially noticed about two years ago. Patient denied any symptoms of otalgia, otorrhea, and aural fullness while confirming dizziness due to low blood pressure. Patient was seen for an initial audiological evaluation. Patient reported that she was seen about one month prior was not given any details regarding hearing. She noticed that tinnitus symptoms were stronger. He had tinnitus in both ears for years that sounds like high pitch tome feel more prominent in his right ear. Patient confirms his right ear always had some aural fullness and occasional ache. Occasional dizziness that was like blood pressure related. Parents could not hear very well, noise exposure from recreation without the use of hearing protection. Patient otorrhea. Treatment information was not provided. Reporter causality was not reported.; Reporter's Comments: Company comment: Family history of hearing loss could be a risk factor for the event deafness neurosensory. The benefit-risk relationship of product is not affected by this report.
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| 2826172 | 41 | F | NV | 02/13/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Taste disorder, Throat tightness; Dysgeusia, Throat tightness; Taste disorder, T...
Taste disorder, Throat tightness; Dysgeusia, Throat tightness; Taste disorder, Throat tightness; Dysgeusia, Throat tightness
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throat almost seized up completely; strange taste in my mouth; This is a spontaneous report received...
throat almost seized up completely; strange taste in my mouth; This is a spontaneous report received from a Consumer or other non HCP. A 41-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 11Jan2025 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "hypogammaglobulonemia" (unspecified if ongoing); "light-chain disease" (unspecified if ongoing); "hemochromatosis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: several plants" (unspecified if ongoing); "Known allergies: oral allergy syndrome for related foods" (unspecified if ongoing), notes: Known allergies: oral allergy syndrome for related foods; "immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT; DOXYCYCLINE. Past drug history included: Codeine, reaction(s): "Known allergies: codeine"; Levaquin, reaction(s): "Known allergies: levaquin". Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN; LOT NUMBER UNKNOWN), for COVID-19 immunization, reaction(s): "strange taste in my mouth", "throat feeling a little tight". The following information was reported: TASTE DISORDER (life threatening) with onset 11Jan2025, outcome "recovered" (11Jan2025), described as "strange taste in my mouth"; THROAT TIGHTNESS (life threatening) with onset 11Jan2025, outcome "recovered" (11Jan2025), described as "throat almost seized up completely". Therapeutic measures were taken as a result of throat tightness, taste disorder. Patient reported that she have previously reacted to this vaccine with her throat feeling a little tight from the moment of injection. She got a strange taste in her mouth immediately and then an uncomfortable tightness that relaxes after about 15 minutes but remains for a few hours to a lesser degree. During this last dose, her throat almost seized up completely. She always carry extra strength Benadryl and an epinephrine auto-injector, which no doubt saved her life that day, but she was writing to try and discover what in this vaccine was causing her to react this way. She was immunocompromised and an asthmatic who would greatly benefit by continuing to take it, but at this point, the reactions have become too dangerous to risk. Patient also mentioned that she have never had COVID before despite being around infected people. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2826174 | M | KS | 02/13/2025 |
COVID19 |
PFIZER\BIONTECH |
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Rash
Rash
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rash; This is a spontaneous report received from a Consumer or other non HCP. A 42-year-old male pa...
rash; This is a spontaneous report received from a Consumer or other non HCP. A 42-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08Feb2025 at 07:00 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Herpes" (unspecified if ongoing); "Drug allergy" (unspecified if ongoing), notes: Name of Drug as Reported: No. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: RASH (non-serious), outcome "recovering". Therapeutic measures were not taken as a result of rash. Additional information: The patient did not received any other vaccines on the same date as the vaccine(s) for which they were reporting. The patient did not received any other vaccines within 4 weeks PRIOR to the vaccine(s) for which they were reporting. The patient was not taking any other medications within 2 weeks of the event starting. Patient had recently seen a rash. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2826175 | F | 02/13/2025 |
COVID19 |
PFIZER\BIONTECH |
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Hypothyroidism
Hypothyroidism
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hypothyroid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A ...
hypothyroid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient in her 50's 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: Bnt162b2 (DOSE 1), for Covid-19 Immunization; Bnt162b2 (DOSE 2), for Covid-19 Immunization. The following information was reported: HYPOTHYROIDISM (medically significant), outcome "unknown", described as "hypothyroid". Therapeutic measures were taken as a result of hypothyroidism. The patient must take medicines for life now. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500016654 Same reporter and product; different patient and events;
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| 2826176 | F | LA | 02/13/2025 |
COVID19 |
PFIZER\BIONTECH |
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Therapeutic response unexpected
Therapeutic response unexpected
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After getting Pfizer Covid Shot Psoriasis was better; This is a spontaneous report received from a C...
After getting Pfizer Covid Shot Psoriasis was better; This is a spontaneous report received from a Consumer or other non HCP. A 68-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in May2021 as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "arthritis in the spine" (unspecified if ongoing), notes: takes medicine for this; "low thyroid" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM oral taken for spinal osteoarthritis (ongoing); SYNTHROID oral taken for hypothyroidism (ongoing). The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "After getting Pfizer Covid Shot Psoriasis was better". Additional information: She clarified the positive feedback as she has and suffered from Psoriasis. When she first got the COVID shots it was the two shots, it was the original one and the one afterwards. She later clarified and confirmed, this report as regarding her as the patient. She is the one with Psoriasis and have the positive feedback. She explained she had Psoriasis and after getting the first shot it was 10-15 percent better. Then got the second shot and it was 30 percent better. She later got the first booster, and it got better. She went recently and got the last booster in November and now cannot tell where she had it on her arm. No one else can see it. Whatever we put in it is working for her psoriasis. She is not on any other medication for psoriasis. She did not see a dermatologist about it. When she got the vaccine, she noticed a big difference with the psoriasis. She got the first shot in 2021. After getting the first one, she did not really notice a difference a whole lot. She was thinking it was due to less stress initially. This comes and goes. The second one, she noticed the benefit more. It was sometime in May 2021 when she got the second shot and noticed this. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2826177 | M | 02/13/2025 |
COVID19 |
PFIZER\BIONTECH |
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Myocarditis
Myocarditis
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myocarditis; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A ...
myocarditis; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient 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. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500017159 Same reporter and product; different patient and events;US-PFIZER INC-202500033364 Same reporter, product and event; different patient;
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| 2826178 | U | 02/13/2025 |
COVID19 |
PFIZER\BIONTECH |
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Diagnostic procedure, Dyspnoea, Electrocardiogram, Hypertrophic cardiomyopathy
Diagnostic procedure, Dyspnoea, Electrocardiogram, Hypertrophic cardiomyopathy
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Hypertrophic cardiomyopathy; shortness of breath; This is a spontaneous report received from a Consu...
Hypertrophic cardiomyopathy; shortness of breath; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for covid-19 immunization. The following information was reported: HYPERTROPHIC CARDIOMYOPATHY (medically significant), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath". The patient underwent the following laboratory tests and procedures: Diagnostic procedure: (unspecified date) Unknown results; (Jul2023) confirmed shortness of breath; Electrocardiogram: (unspecified date) Unknown results; (unspecified date) Unknown results, notes: 2nd EC. Clinical course: During COVID-19, the patient had to get vaccinated because [City] required doses for almost everything. However, the patient did it because of work. The patient had to be vaccinated to attend the patient's players' hockey games. Following COVID-19, when the patient resumed training, the patient felt a slight difference in breathing, not alarming but the patient could see that there was a difference. It was getting worse and worse, but the patient did not pay much attention to it. In Aug2022 the patient left to register the patient's company. Having an apartment in [City], continuing to have a "pied-a-terre" in the city, and continuing training in the patient's daily life. In July2023, doin tests in the city so as not have any problems back since the patient cannot have an insurance policy for protection. At that time, they came back to the patient and confirmed shortness of breath, at the same time they asked the patient to check everything. The patient met a cardiologist and a family doctor in City luckily because they also found this shortness of breath intriguing. The patient had tests and an EC cardiogram, the cardiologist wanted to have the patient have an EC cardiogram every year. So it was at the patient's 2nd EC cardiogram that the patient was screened for this rare disease, Hypertrophic Cardiomyopathy. Breathing was increasingly difficult and above all, the obligation to no longer do high-intensity exercise. The patient stated that all this started from the results of the vaccine, before all that, the patient had no problems. The patient was taking the time to write before starting the procedures because the patient was officially 200% certain that this was caused by the 2 vaccines. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2826179 | U | MT | 02/13/2025 |
COVID19 |
PFIZER\BIONTECH |
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Investigation, Polymyalgia rheumatica
Investigation, Polymyalgia rheumatica
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Polymyalgia rheumatica; This is a spontaneous report received from a Consumer or other non HCP, Prog...
Polymyalgia rheumatica; This is a spontaneous report received from a Consumer or other non HCP, Program ID: . A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 as dose 1, 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: POLYMYALGIA RHEUMATICA (medically significant) with onset 2021, 1 week after the suspect product(s) administration, outcome "unknown". The event "polymyalgia rheumatica" required physician office visit. The patient underwent the following laboratory tests and procedures: tested: (2021) Polymyalgia rheumatica. Therapeutic measures were taken as a result of polymyalgia rheumatica. Clinical course: the patient developed severe hip and shoulder 1 week after Covid shot. Later that year the patient was tested, diagnosed and treated by a Rheumatologist for polymyalgia rheumatica. The patient was still taking prednisone as a treatment. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2826180 | M | 02/13/2025 |
COVID19 |
PFIZER\BIONTECH |
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Death
Death
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My 1st son; 8 months died after vaccine; This is a spontaneous report received from a Consumer or ot...
My 1st son; 8 months died after vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An 8-month-old male patient received BNT162b2 omicron (kp.2) (PFIZER-BIONTECH COVID-19 VACCINE (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. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "My 1st son; 8 months died after vaccine". The date and cause of death for the patient were unknown. Clinical course: The reporter stated that My 1st son; 8 months died after vaccine. I did get all 3 COVID vaccines (Pfizer) & became hypothyroid & must take meds. for life now. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death
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| 2826181 | F | IN | 02/13/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19 pneumonia, Drug ineffective
COVID-19 pneumonia, Drug ineffective
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passed away from pneumonia due to COVID-19; passed away from pneumonia due to COVID-19; This is a sp...
passed away from pneumonia due to COVID-19; passed away from pneumonia due to COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08Nov2024 as dose 1, 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: DRUG INEFFECTIVE (death), COVID-19 PNEUMONIA (death) all with onset Nov2024, outcome "fatal" and all described as "passed away from pneumonia due to COVID-19". The patient date of death was 26Nov2024. Reported cause of death: "passed away from pneumonia due to COVID-19", "pneumonia". It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162B2 OMICRON (KP.2) will be requested and submitted if and when received.; Reported Cause(s) of Death: passed away from pneumonia due to COVID-19; passed away from pneumonia due to COVID-19; pneumonia
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✓ | ||||||
| 2826182 | F | 02/13/2025 |
COVID19 FLUX VARZOS |
PFIZER\BIONTECH UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS |
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Vaccination site pain; Vaccination site pain; Vaccination site pain
Vaccination site pain; Vaccination site pain; Vaccination site pain
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In the same arm and It hurts for a while; This is a spontaneous report received from a Consumer or o...
In the same arm and It hurts for a while; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 62-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), in arm for immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), in arm for immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "In the same arm and It hurts for a while". Additional Information: She made her remember when she got the COVID; Shingles and Flu vaccines at the same time and in the same arm. It hurts for a while. It was unknown whether the reporter consider event as caused by suspect product. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2826183 | F | 02/13/2025 |
COVID19 |
PFIZER\BIONTECH |
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Feeling abnormal, Overdose
Feeling abnormal, Overdose
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She reacted poorly to have two on the same day; She reacted poorly to have two on the same day; This...
She reacted poorly to have two on the same day; She reacted poorly to have two on the same day; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An elderly female patient 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. The following information was reported: FEELING ABNORMAL (non-serious), OVERDOSE (non-serious), outcome "unknown" and all described as "She reacted poorly to have two on the same day". Additional information: It was reported that she still was not sure about so many vaccines she reacted poorly to have two on the same day. It was unknown whether the reporter consider event as caused by suspect product. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2826184 | F | 02/13/2025 |
COVID19 |
PFIZER\BIONTECH |
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Gastrointestinal disorder
Gastrointestinal disorder
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GI issues; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An a...
GI issues; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An adult female patient 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. The following information was reported: GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "GI issues". Additional information: Patient was forced to get the Pfizer Covid vaccine in order to resume normal living. Everyone in my household who got it has had GI issues since. Those who got a different vaccine haven't had GI issues. Patient think the vaccine's side effects hadn't been determined and now don't trust Pfizer any longer. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2826185 | F | 02/13/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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Had taken several Pfizer vacs, but still got Covid / reactions had varied; Had taken several Pfizer ...
Had taken several Pfizer vacs, but still got Covid / reactions had varied; Had taken several Pfizer vacs, but still got Covid / reactions had varied; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An adult female patient received BNT162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had taken several Pfizer vacs, but still got Covid / reactions had varied". Reporter considered event as caused by suspect product(s). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2826186 | U | 02/13/2025 |
FLUX |
UNKNOWN MANUFACTURER |
No batch number |
Influenza
Influenza
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Flu while being vaccinated; This spontaneous case, initially received on 04-Feb-2025, was reported b...
Flu while being vaccinated; This spontaneous case, initially received on 04-Feb-2025, was reported by a non health professional and concerns a patient of unknown age/gender. Administration of company suspect drug: On an unknown date, the patient received INN Flu Vaccine Seasonal for indication not reported, dose, route of administration and anatomical location: not reported. Lot number: No batch number available but will be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Flu while being vaccinated (Medically Significant, outcome: Not Reported). It was reported that, the patient got flu while being vaccinated. It was unknown which influenza vaccine the patient received. INN Flu Vaccine Seasonal action taken: Not Applicable Reporter assessment: the reporter did not provide seriousness and causality assessment for the event.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Furthermore, due to lack of more detailed information (e.g. temporal relationship, patients risk factors, diagnostic reports and brand name of vaccine) causality cannot be excluded.
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| 2826187 | 55 | F | CA | 02/13/2025 |
FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
Z29D3 Z29D3 |
Skin erosion, Vaccination site discomfort, Vaccination site erythema, Vaccinatio...
Skin erosion, Vaccination site discomfort, Vaccination site erythema, Vaccination site reaction, Vaccination site scab; Vaccination site swelling, Wound
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Patient complaint of reaction post vaccination. Patient scheduled with provider visit on 02-04-2025,...
Patient complaint of reaction post vaccination. Patient scheduled with provider visit on 02-04-2025, patient reports she believes staff caused lesion and per patient reports she noted day 1 post vaccination area appeared swollen, beefy raw and reported discomfort. Patient denies previous allergic reaction to vaccines. Upon assessment of affected area, area appeared swollen, moderate erythema surrounding affected area and wound bed appeared discolored/ dry blood (scab like), patient denied fever or drainage to wound and wound measured 1,5inx1.5in. Assessed patient for allergic reaction: high persistent fever, angioedema, pruritus, SOB, hives , swelling or redness to injection site, patient reported only discomfort/ swelling and redness. Wound assessed by provider per provider wound care done, applied triple antibiotic and instructed patient to cover wound. Affected area marked and informed patient if erythema surpasses line, patient to go to ER. Patient verbalized understanding. Patient has been visiting nursing for wound care and monitoring of wound. Wound appears to be healing with 80% improvement, measuring 0.5inx0.5in, no erythema or swelling to affected site and healthy granulation tissue present with no drainage to area at this time. Patient scheduled for wound check in one week with nursing per provider.
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| 2826188 | 64 | F | NY | 02/13/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
HN0477 HN0477 HN0477 HN0477 HN0477 HN0477 HN0477 HN0477 HN0477 |
Antinuclear antibody increased, Antinuclear antibody positive, Balance disorder,...
Antinuclear antibody increased, Antinuclear antibody positive, Balance disorder, Bile duct stone, Biliary dilatation; Biopsy oesophagus normal, Blood pressure increased, C-reactive protein normal, Carbohydrate antigen 19-9 increased, Carcinoembryonic antigen normal; Cardiac stress test normal, Chest X-ray normal, Chest pain, Cholelithiasis, Condition aggravated; Dizziness, Echocardiogram normal, Endoscopic retrograde cholangiopancreatography abnormal, Endoscopic ultrasound abnormal, Endoscopy upper gastrointestinal tract abnormal; Epstein-Barr virus antibody negative, Epstein-Barr virus antibody positive, Full blood count normal, Gastritis, Helicobacter test negative; Hiatus hernia, Impaired work ability, Lipids normal, Loss of personal independence in daily activities, Magnetic resonance cholangiopancreatography; Magnetic resonance imaging abdominal abnormal, Malaise, Mass, Metabolic function test normal, Musculoskeletal chest pain; Nausea, Oesophageal disorder, Red blood cell sedimentation rate normal, SARS-CoV-2 antibody test positive, Spinal X-ray; Ultrasound chest, Ultrasound scan abnormal, Ventricular extrasystoles
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Day of Shot - Loss of balance, dizziness. Continued for several days and worsened. Day 3-4 started w...
Day of Shot - Loss of balance, dizziness. Continued for several days and worsened. Day 3-4 started with PVCs and nausea. BP elevated 200+/100+. Admitted to hospital on 2/25 with chest pain, PVCs, very high blood pressure. It has been almost 1 year of doctor appointments and tests since that shot. I still am not well and have not been able to work or manage my home.
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✓ | ✓ | ||||
| 2826189 | U | 02/13/2025 |
COVID19 |
PFIZER\BIONTECH |
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Arterial thrombosis, Embolism, Thrombosis
Arterial thrombosis, Embolism, Thrombosis
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COVID19 Pfizer BioNTech. Around 3 months after taking the vaccine, I was diagnosed with Blood Clots...
COVID19 Pfizer BioNTech. Around 3 months after taking the vaccine, I was diagnosed with Blood Clots / Embolism without any injury or symptoms. Seveir artery thrombosis caused with almost certainty by the vaccine, and now I'm sentenced for life to take anticoagulants every day, which cost 550 per month.
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✓ | ✓ | ||||||
| 2826198 | 31 | F | CO | 02/13/2025 |
MMR MMR VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
342RC 342RC Y014182 Y014182 |
Eye swelling, Injection site erythema, Injection site pain, Injection site react...
Eye swelling, Injection site erythema, Injection site pain, Injection site reaction, Sensitive skin; Skin irritation; Eye swelling, Injection site erythema, Injection site pain, Injection site reaction, Sensitive skin; Skin irritation
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On 2/12 woke up with L eye swelling, used ice pack for 20 minutes and swelling mostly resolved. at 7...
On 2/12 woke up with L eye swelling, used ice pack for 20 minutes and swelling mostly resolved. at 7pm she noticed site redness with burning/stinging pain, no treatment was applied or taken but traced with blue pen to observe. On 2/13 woke with increased L eye swelling used ice pack to resolve swelling. At 8:50am this nurse met with patient, a new employee, the site in question was the site where her varicella immunization was administered by this nurse. Advised pain relief of acetaminophen or ibuprofen and Benedryl at bedtime, and continue to monitor and report adverse changes as directed by CCO, Dr. At 205pm employee reported increased sensation and irritation extending into L axilla. Redness exceeded pen-drawn boarder slightly. After speaking to Dr. employee was advised to take 400mg up to 800mg of ibuprofen for pain relief. She was also advised to take Benedryl when at home and at bedtime, as she reports drowsiness with Benedryl use. On 2/13 at 807am Employee reports site redness and sensitivity improved. One Benedryl was taken at bedtime, no eye swelling was observed. Employee encouraged to continue pain relief and Benedryl as needed.
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| 2826199 | 62 | F | SC | 02/13/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
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COVID-19, Echocardiogram abnormal, Illness, Pericarditis, SARS-CoV-2 test positi...
COVID-19, Echocardiogram abnormal, Illness, Pericarditis, SARS-CoV-2 test positive; COVID-19, Echocardiogram abnormal, Illness, Pericarditis, SARS-CoV-2 test positive; COVID-19, Echocardiogram abnormal, Illness, Pericarditis, SARS-CoV-2 test positive
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Illness after each covid-19 vaccination and booster. Covid-19 was a positive diagnosis but the effec...
Illness after each covid-19 vaccination and booster. Covid-19 was a positive diagnosis but the effects were several times worse than normal. My physician advised me not to take any further vaccines after the first booster because of the intensity of my illness resulting from the vaccination.
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✓ | |||||
| 2826200 | 40 | F | TN | 02/13/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Colonoscopy, Endoscopy upper gastrointestinal tract, Gastrointestinal disorder, ...
Colonoscopy, Endoscopy upper gastrointestinal tract, Gastrointestinal disorder, Helicobacter infection; Colonoscopy, Endoscopy upper gastrointestinal tract, Gastrointestinal disorder, Helicobacter infection
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Sever stomach issues....hpylori
Sever stomach issues....hpylori
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| 2826201 | 38 | F | OK | 02/13/2025 |
COVID19 COVID19 |
JANSSEN JANSSEN |
206A21A 206A21A |
Blood test, Cardiac ablation, Cardiac operation, Epstein-Barr virus infection, I...
Blood test, Cardiac ablation, Cardiac operation, Epstein-Barr virus infection, Imaging procedure; Metal poisoning, Post-acute COVID-19 syndrome, Scan, Supraventricular tachycardia
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Chronic EBV, heart surgery, heavy metal poisoning with Lead and Mercury.
Chronic EBV, heart surgery, heavy metal poisoning with Lead and Mercury.
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| 2826202 | 70 | F | MD | 02/13/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Condition aggravated, Death, Dementia Alzheimer's type, Malaise, Mobility d...
Condition aggravated, Death, Dementia Alzheimer's type, Malaise, Mobility decreased
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Covid 19 shot and Flu shot sames time. Got deathly sick. Got down in bed and never got up again. She...
Covid 19 shot and Flu shot sames time. Got deathly sick. Got down in bed and never got up again. She kept getting worse and worse. She died 4.5 weeks later.
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| 2826203 | 59 | F | FL | 02/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7zm55 |
Diarrhoea, Headache, Nausea, Peripheral swelling
Diarrhoea, Headache, Nausea, Peripheral swelling
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swollen arm, severe headache, nausea, diarrhea
swollen arm, severe headache, nausea, diarrhea
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| 2826204 | 78 | F | GA | 02/13/2025 |
RSV |
PFIZER\WYETH |
HM9854 |
Extra dose administered
Extra dose administered
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PATIENT RECEIVED DUPLICATE VACCINE- PATIENT RECEIVED HER RSV VACCINE ( AREXVY) ON 12/23/23 WHICH WAS...
PATIENT RECEIVED DUPLICATE VACCINE- PATIENT RECEIVED HER RSV VACCINE ( AREXVY) ON 12/23/23 WHICH WAS NOT REPORTED TO REGISTRY. PATIENT RECEIVED ABRYSVO ON 2/12/25.
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| 2826205 | 50 | F | WA | 02/13/2025 |
COVID19 COVID19 FLU3 FLU3 HEP HEP MMR MMR PNC21 PNC21 COVID19 COVID19 FLU3 FLU3 MMR MMR PNC20 PNC20 VARZOS VARZOS |
MODERNA MODERNA SEQIRUS, INC. SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MODERNA MODERNA SEQIRUS, INC. SEQIRUS, INC. MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
unknown unknown Unknown Unknown unknown unknown unknown unknown unknown unknown 3043823 3043823 391418 391418 Y003677 Y003677 LG5577 LG5577 2T92N 2T92N |
Arthralgia, Laboratory test, Loss of personal independence in daily activities, ...
Arthralgia, Laboratory test, Loss of personal independence in daily activities, Product administered at inappropriate site, X-ray; Arthralgia, Asthenia, Joint swelling, Mobility decreased, Skin warm; Arthralgia, Laboratory test, Loss of personal independence in daily activities, Product administered at inappropriate site, X-ray; Arthralgia, Asthenia, Joint swelling, Mobility decreased, Skin warm; Arthralgia, Laboratory test, Loss of personal independence in daily activities, Product administered at inappropriate site, X-ray; Arthralgia, Asthenia, Joint swelling, Mobility decreased, Skin warm; Arthralgia, Laboratory test, Loss of personal independence in daily activities, Product administered at inappropriate site, X-ray; Arthralgia, Asthenia, Joint swelling, Mobility decreased, Skin warm; Arthralgia, Laboratory test, Loss of personal independence in daily activities, Product administered at inappropriate site, X-ray; Arthralgia, Asthenia, Joint swelling, Mobility decreased, Skin warm; Arthralgia, Laboratory test, Loss of personal independence in daily activities, Product administered at inappropriate site, X-ray; Arthralgia, Asthenia, Joint swelling, Mobility decreased, Skin warm; Arthralgia, Laboratory test, Loss of personal independence in daily activities, Product administered at inappropriate site, X-ray; Arthralgia, Asthenia, Joint swelling, Mobility decreased, Skin warm; Arthralgia, Laboratory test, Loss of personal independence in daily activities, Product administered at inappropriate site, X-ray; Arthralgia, Asthenia, Joint swelling, Mobility decreased, Skin warm; Arthralgia, Laboratory test, Loss of personal independence in daily activities, Product administered at inappropriate site, X-ray; Arthralgia, Asthenia, Joint swelling, Mobility decreased, Skin warm; Arthralgia, Laboratory test, Loss of personal independence in daily activities, Product administered at inappropriate site, X-ray; Arthralgia, Asthenia, Joint swelling, Mobility decreased, Skin warm
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The pharmacist gave me two shots on each shoulder, and one in my left forearm, on my right shoulder ...
The pharmacist gave me two shots on each shoulder, and one in my left forearm, on my right shoulder he did one too high and I still have pain in that shoulder, he did two in my left shoulder and the pain is unbearable. I had to go to the er a couple days after because they pain was too much. I have been to the er three times since Dec and Feb 5th. This has completely affected every area of my life. The pain has not gotten better and I don?t know where to go from here.
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