chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult was administered a pediatric dose; adult was administered a pediatric dose; 2nd dose was given; adult was administered a pediatric dose; adult was administered a pediatric dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 67-year-old female patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis.   On 06-AUG-2007, the patient received the 3rd dose of Havrix. On 08-JAN-2007, the patient received the 1st dose of Havrix. On 08-JAN-2007, not applicable after receiving Havrix and an unknown time after receiving Havrix, the patient experienced underdose (Verbatim: adult was administered a pediatric dose) and adult use of a child product (Verbatim: adult was administered a pediatric dose). On 06-AUG-2007, the patient experienced underdose (Verbatim: adult was administered a pediatric dose), adult use of a child product (Verbatim: adult was administered a pediatric dose) and extra dose administered (Verbatim: 2nd dose was given). The outcome of the underdose, adult use of a child product, extra dose administered, 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.   Linked case(s) involving the same patient:  US2023AMR047718   Additional Information: GSK receipt date: 29-MAR-2023 A healthcare professional informed that an adult patient had received the two doses of Havrix back in 2007, but that the administered doses were pediatric. The vaccine administration facility was the same as primary reporter. The health care professional (HCP) was not able to provide lot numbers of the products administered. The reporter consented to follow up. An adult patient was administered a dose of pediatrix Havrix, which led to underdose and adult use of child product and also received 3rd dose of pediatrix Havrix, which led to extra dose administered, underdose and adult use of child product.; Sender's Comments:  US-GSK-US2023AMR047718:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Transient acantholytic dermatosis
Clinical narrative: Grover's disease and flare up on skin got worst; This non-serious case was reported by a physician via call center representative and described the occurrence of condition aggravated in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included grover's disease and skin disorder.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced condition aggravated (Verbatim: Grover's disease and flare up on skin got worst). The outcome of the condition aggravated was not resolved.   It was unknown if the reporter considered the condition aggravated to be related to Shingrix.     It was unknown if the company considered the condition aggravated to be related to Shingrix.   Additional Information: GSK receipt date: 29-MAR-2023 The dermatologist reported that after Shingrix first dose, a patient with Grover´s disease got worst. There was a flare up on her skin and got worst. No further details such as lot number or Shingrix administration date had been  provided due HCP was on a rush during the call interaction. The reporter consented to follow up via email.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix given to a 18-month-old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-month-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 14-MAR-2023, the patient received Kinrix. On 14-MAR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix given to a 18-month-old). 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: 29-MAR-2023 CMA stated that a patient was inadvertently administered Kinrix.  She stated she thought the patient should have received the individual components and not the combined. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal. The patient received Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: HEP, HEPA, HEPAB, MENB, TDAP, VARZOS
Symptoms: Product storage error
Clinical narrative: Administered after temperature excursion; 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 numbers of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, HAV (Havrix) for prophylaxis, Herpes zoster (Shingrix) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patients received Bexsero, Twinrix, Boostrix, Havrix, Shingrix and Engerix B. On an unknown date, an unknown time after receiving Bexsero, Twinrix, Boostrix, Havrix, Shingrix and Engerix B, the patient experienced incorrect storage of drug (Verbatim: Administered after temperature excursion). 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: 29-MAR-2023 The clinic supervisor stated Bexsero, Twinrix, Boostrix, Havrix, Shingrix, and Engerix-B vaccines went out of recommended temperature range for 12 days (288 hours) to a maximum temperature of 60 degrees Fahrenheit.   She stated some of the vaccines were administered following this excursion, though she did not had any details on which vaccines, dates of administration, lot numbers, or patient information available at the time of reporting. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patients received Bexsero, Twinrix, Boostrix, Havrix, Shingrix, and Engerix-B vaccines, which were stored at inappropriate temperature, which led to incorrect storage of drug.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix given to a 4-month-old; Kinrix given instead of Pentacel; 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 4-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 29-MAR-2023, the patient received Kinrix. On 29-MAR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix given to a 4-month-old) and wrong vaccine administered (Verbatim: Kinrix given instead of Pentacel). The outcome of the inappropriate age at vaccine administration and wrong 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: 29-MAR-2023 MD stated Kinrix was administered to a 4 month old.  The patient was supposed to get Pentacel. The vaccine administration facility was the same as primary reporter. The HCP did not had the lot number and expiration readily available.  The reporter consented to follow up via postal.  The patient received Kinrix instead of Pentacel, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Received kinrix instead of separate IPV-Dtap; 2.5 YO received Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number 25ZH4, expiry date 27-OCT-2024) for prophylaxis.   On 29-MAR-2023, the patient received Kinrix. On 29-MAR-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Received kinrix instead of separate IPV-Dtap) and inappropriate age at vaccine administration (Verbatim: 2.5 YO received Kinrix). The outcome of the wrong vaccine administered 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: 29-MAR-2023 A reporter called to report the administration of Kinrix to a 2.5 years old patient.  She mentioned that according to the patient´s vaccine record, it was the third IPV and DTap dose and the patient should have received an IPV and Dtap vaccine separately but by mistaken they administered Kinrix. The reporter asked for safety information and recommendations about patient vaccination. The reporter consented to follow up. A reporter called to report the administration of Kinrix to a 2.5 years old male patient, which led to inappropriate age at vaccine administration. The reporter mentioned that according to the patient´s vaccine record, it was the third IPV and DTap dose and the patient should have received an IPV and Dtap vaccine separately but by mistaken they administered Kinrix, which led to wrong vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2021, 2nd dose not given; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2021 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: 1st dose in 2021, 2nd dose not given). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-MAR-2023 The reporter was the patient. The patient did not want to give any demographics. She stated that she had not yet gotten the second vaccine of Shingrix. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose before pandemic, 2nd dose not given; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown time before the pandemic).   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: 1st dose before pandemic, 2nd dose not given). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-MAR-2023 The reporter reported that a patient had not yet received the 2nd dose of Shingrix. Adverse event report contained all reported information.  The patient information, LOT number, expiration date and date of administration unavailable for this patient per healthcare professional.  The reporter gave consent for safety team follow up.  Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case had been linked to US2023048008, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023048008:same reporter
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the diluent; Administered only the diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA764A, expiry date 30-SEP-2024) for prophylaxis.   On 28-MAR-2023, the patient received Menveo. On 28-MAR-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Administered only the diluent) and inappropriate dose of vaccine administered (Verbatim: Administered only the diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-MAR-2023 The reporter called to inquire to know if any information on how to proceed an what to look for with patient. The reporter reported that they inadvertently administered the Menveo diluent component without the Menveo lyophilized component to a patient. The reporter did not consent to follow-up. The reporter reported that they inadvertently administered the Menveo diluent component without the Menveo lyophilized component to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: Administered after temperature excursion; 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 a child male patient who received DTPa-IPV (Kinrix) (batch number 25ZH4, expiry date 27-OCT-2024) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced incorrect storage of drug (Verbatim: Administered after temperature excursion). 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: 30-MAR-2023 The reporter reported that the Kinrix vaccine exposed to -24.6 degree F and was administered to a patient. The reporter asked how to proceed with the patient vaccination. The reporter consented to follow up. The reporter reported that the Kinrix vaccine exposed to -24.6 degree F was administered to a patient, which led to incorrect storage of vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose before pandemic, 2nd not received; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown time before the pandemic).   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: 1st dose before pandemic, 2nd not received). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-MAR-2023 The reporter reported that a patient had not yet received the 2nd dose of Shingrix. Adverse event report contained all reported information.  The patient information, LOT number, expiration date and date of administration unavailable for this patient as per healthcare professional.  The reporter gave consent for safety team follow up.  Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case had been linked to US2023048004, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023048004:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given 1 month after the 1st; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose given 1 month after the 1st). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 30-MAR-2023 The reporter inquired about a patient that received the 2nd dose of Shingrix 1 month after the first dose of Shingrix. The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Ear infection
Clinical narrative: Right Otitis; This spontaneous case was reported by an other health care professional and describes the occurrence of EAR INFECTION (Right Otitis) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AR9237B) for COVID-19 prophylaxis.     The patient had never been diagnosed with/ tested positive for COVID-19. The patient had no Chronic or long-standing health conditions.    On 31-Aug-2022 at 2:04 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Sep-2022 at 2:20 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 18-Jan-2023, the patient experienced EAR INFECTION (Right Otitis). On 28-Jan-2023, EAR INFECTION (Right Otitis) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and/ or at the time of adverse vent were reported as none.  No treatment medications were reported.   This case was linked to MOD-2023-713286 (Patient Link).
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 5 years old patient received 3rd dose of Daptacel 3 weeks too early with no reported adverse event; Initial information received on 05-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old female patient who received 3rd dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel]  3 weeks too early with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On 05-Apr-2023, the patient received 0.5 mL dose 3 of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (strength, - standard, frequency - once, lot - C5893AA, expiry date - 21-Jun-2023) via intramuscular route in the left arm for immunization, 3 weeks too early with no reported adverse event (inappropriate schedule of product administration) (latency: same day).   Reportedly, patient was supposed to receive the 3rd dose of Daptacel on 27Apr2023, but she received the third dose of Daptacel today (05Apr2023).  Action taken:  not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 29.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Alanine aminotransferase, Blood chloride, Blood creatinine, Blood electrolytes, Blood glucose
Clinical narrative: Flu like symptoms that lasted a couple of days following days after vaccination. Now dealing with Pericarditis that started April 5th which caused me to miss work and I am prescribed steroid treatment and Naproxen to reduce inflammation. Still feeling consistent symptoms until this day.
Age: 29.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Blood potassium, Blood sodium, Brain natriuretic peptide, C-reactive protein, Carbon dioxide
Clinical narrative: Flu like symptoms that lasted a couple of days following days after vaccination. Now dealing with Pericarditis that started April 5th which caused me to miss work and I am prescribed steroid treatment and Naproxen to reduce inflammation. Still feeling consistent symptoms until this day.
Age: 29.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Chest X-ray, Culture urine, Differential white blood cell count, Electrocardiogram, Fibrin D dimer
Clinical narrative: Flu like symptoms that lasted a couple of days following days after vaccination. Now dealing with Pericarditis that started April 5th which caused me to miss work and I am prescribed steroid treatment and Naproxen to reduce inflammation. Still feeling consistent symptoms until this day.
Age: 29.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Full blood count, Impaired work ability, Inflammation, Influenza like illness, Pericarditis
Clinical narrative: Flu like symptoms that lasted a couple of days following days after vaccination. Now dealing with Pericarditis that started April 5th which caused me to miss work and I am prescribed steroid treatment and Naproxen to reduce inflammation. Still feeling consistent symptoms until this day.
Age: 29.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Red blood cell sedimentation rate increased, SARS-CoV-2 test, Troponin I, Urine analysis
Clinical narrative: Flu like symptoms that lasted a couple of days following days after vaccination. Now dealing with Pericarditis that started April 5th which caused me to miss work and I am prescribed steroid treatment and Naproxen to reduce inflammation. Still feeling consistent symptoms until this day.
Sex: M
Vaccine: MNQ
Symptoms: Product complaint, Underdose
Clinical narrative: she was only able to draw up 0.2 ml of a Menveo vaccine after reconstitution; Product Complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA759A, expiry date 30-NOV-2023) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Menveo .2 ml. On an unknown date, an unknown time after receiving Menveo, the patient experienced underdose (Verbatim: she was only able to draw up 0.2 ml of a Menveo vaccine after reconstitution) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the underdose and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date- 27-MAR-2023 The reporter was a Medical Assistant.  The reporter called to report low fill of Menveo. She did administer this to a patient. No credit or replacement had been ordered, as their vaccines were provided by the local Health Department. The vaccine administration facility was the same as primary reporter. The reporter was consented to follow up via email
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 2019, 2nd 2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (1st dose was received in 2019).  On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 2019, 2nd 2023). The outcome of the drug dose administration interval too long was unknown.  Additional Information: GSK Receipt Date: 31-MAR-2023 The patient got the second dose of Shingrix this year (2023).  The healthcare professional had asked if these 2 doses were valid or if the patient had to restart the vaccine series.  The reporter did not shared information regarding the two Shingrix doses (Lot number, expiry date, date of administration). The reporter had consented to follow up. The patient had received the second dose later than the recommended interval, which had led to lengthening of vaccination schedule.
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Adult dose given to pediatric patient; 1year received adult dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 1-year-old female patient who received HAV (Havrix 1440 adult) (batch number 5%M72, expiry date 13-DEC-2024) for prophylaxis.   On 29-MAR-2023, the patient received the 1st dose of Havrix 1440 adult. On 29-MAR-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced accidental overdose (Verbatim: Adult dose given to pediatric patient) and adult product administered to child (Verbatim: 1year received adult dose). The outcome of the accidental overdose and adult product administered to child 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: 31-MAR-2023 The reporter was a medical assistant. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. The pediatric patient was accidentally administered with Havrix 1440 adult vaccine, which led to accidental overdose and adult product administered to child. The case is linked with case US2023048543, reported by same reporter.; Sender's Comments:  US-GSK-US2023048543:Same report/other patient
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Blood test, Gait disturbance, Laboratory test
Clinical narrative: LEGS STARTED GIVING HIM PROBLEMS, HIS FEET; ALMOST CRIPPLED; CAN BARELY WALK DOWNSTAIRS; PAIN IN HIS FEET, SHINS, CALVES; PAIN IN AREA BEHIND HIS KNEES, PAIN IN HIS KNEES WHERE MENISCUS IS, SHOULDERS ARE ACHING WITH THAT SAME PAIN; This spontaneous report received from a patient concerned an 81 year old male. The patient's weight was 170 pounds, and height was 72 inches. The patient's past medical history included: polymyalgia rheumatica (10 years ago given prednisone), broken ankle (About 15-20 years ago), cellulitis in right arm (About 10 years ago), and blood pressure (given lisinopril), and concurrent conditions included: alcohol user (Patient had cut down quite a bit. Drinks beer with low alcohol content level.), and non smoker, and other pre-existing medical conditions included: The patient was a healthy person, had no known allergies and no drug abuse or illicit drug usage. The patient was previously treated with prednisone for polymyalgia rheumatica, influenza vaccine for prophylactic vaccination, and lisinopril for blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A or 4 expiry: UNKNOWN) dose was not reported, administered on 22-APR-2022 for covid-19 prophylaxis. Provide the reason why sample is not available. Other Specify Other Sample Reason. Not asked. Age at time of vaccination 80 years old. Concomitant medications included origanum minutiflorum oil for covid vaccine, and tocopherol. On AUG-2022, the patient experienced legs started giving him problems, his feet, almost crippled, can barely walk downstairs, pain in his feet, shins, calves, and pain in area behind his knees, pain in his knees where meniscus is, shoulders are aching with that same pain. Laboratory data (dates unspecified) included: Blood pressure normal, Blood test Compromised immune system, normal, and Laboratory test Normal. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from legs started giving him problems, his feet, almost crippled, can barely walk downstairs, pain in his feet, shins, calves, and pain in area behind his knees, pain in his knees where meniscus is, shoulders are aching with that same pain. This report was non-serious. This case, from the same reporter is linked.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Pain in extremity, Physical disability
Clinical narrative: LEGS STARTED GIVING HIM PROBLEMS, HIS FEET; ALMOST CRIPPLED; CAN BARELY WALK DOWNSTAIRS; PAIN IN HIS FEET, SHINS, CALVES; PAIN IN AREA BEHIND HIS KNEES, PAIN IN HIS KNEES WHERE MENISCUS IS, SHOULDERS ARE ACHING WITH THAT SAME PAIN; This spontaneous report received from a patient concerned an 81 year old male. The patient's weight was 170 pounds, and height was 72 inches. The patient's past medical history included: polymyalgia rheumatica (10 years ago given prednisone), broken ankle (About 15-20 years ago), cellulitis in right arm (About 10 years ago), and blood pressure (given lisinopril), and concurrent conditions included: alcohol user (Patient had cut down quite a bit. Drinks beer with low alcohol content level.), and non smoker, and other pre-existing medical conditions included: The patient was a healthy person, had no known allergies and no drug abuse or illicit drug usage. The patient was previously treated with prednisone for polymyalgia rheumatica, influenza vaccine for prophylactic vaccination, and lisinopril for blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A or 4 expiry: UNKNOWN) dose was not reported, administered on 22-APR-2022 for covid-19 prophylaxis. Provide the reason why sample is not available. Other Specify Other Sample Reason. Not asked. Age at time of vaccination 80 years old. Concomitant medications included origanum minutiflorum oil for covid vaccine, and tocopherol. On AUG-2022, the patient experienced legs started giving him problems, his feet, almost crippled, can barely walk downstairs, pain in his feet, shins, calves, and pain in area behind his knees, pain in his knees where meniscus is, shoulders are aching with that same pain. Laboratory data (dates unspecified) included: Blood pressure normal, Blood test Compromised immune system, normal, and Laboratory test Normal. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from legs started giving him problems, his feet, almost crippled, can barely walk downstairs, pain in his feet, shins, calves, and pain in area behind his knees, pain in his knees where meniscus is, shoulders are aching with that same pain. This report was non-serious. This case, from the same reporter is linked.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Lack of effect; Patient received a Moderna dose (2nd booster shot) and had Covid, contracted it in Nov-2022 and tested positive for 17 days; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION FAILURE (Lack of effect) and COVID-19 (Patient received a Moderna dose (2nd booster shot) and had Covid, contracted it in Nov-2022 and tested positive for 17 days) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In November 2022, the patient experienced VACCINATION FAILURE (Lack of effect) and COVID-19 (Patient received a Moderna dose (2nd booster shot) and had Covid, contracted it in Nov-2022 and tested positive for 17 days). At the time of the report, VACCINATION FAILURE (Lack of effect) and COVID-19 (Patient received a Moderna dose (2nd booster shot) and had Covid, contracted it in Nov-2022 and tested positive for 17 days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2022, SARS-CoV-2 test: (Positive) for 17 days.         No concomitant product was reported. No treatment information was reported.  Company comment: This spontaneous case concerns an adult female patient with no reported medical history, who experienced the unexpected non serious event of COVID-19, unknown days after receiving a dose of mRNA-1273.222 bivalent vaccine (reported as second booster shot). Additionally, Vaccination failure (lack of effect) was reported. SARS-CoV-2 test was positive. No information on primary vaccination schedule, time to onset from the last dose of vaccine, signs and symptoms of COVID 19, other relevant investigations, treatment was available in the report. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Injection site swelling, Pain, Pain in extremity
Clinical narrative: left arm with pain, redness, hot to touch, swelling near injection site, fevers, body aches lasting 3-4 days
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: left arm with pain, redness, hot to touch, swelling near injection site, fevers, body aches lasting 3-4 days
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Inbound call from HCP reporting that an MMR-II which was expired was inadvertently administered to a patient. HCP stated product had not experienced any temp excursions and patient had not reported any symptomatic side effect. No additional AE detail; This spontaneous report as received from a nurse refers to an identifiable patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 31-MAY-2022, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status: rHA; 0.5 milliliter,  lot # T018669 expiration date 29-MAY-2023) for prophylaxis.  The product had not experienced any temperature excursion and the patient had not reported any adverse event.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Vaccination failure
Clinical narrative: got shot, Have it/Suspected vaccination failure; Have it; Still burning inside; 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: got shot, Have it/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Have it) and burning sensation (Verbatim: Still burning inside). The outcome of the vaccination failure was unknown and the outcome of the shingles and burning sensation were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and burning sensation to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and burning sensation to be related to Shingles vaccine.   Additional Information: GSK receipt date: 15-MAR-2023 The case was received from the patient interactive digital media. The patient had it and got his/her Shingles shot. The patient still had the burning inside. The patient stated that it was slowly killing him/her. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had Shingles shot but got Shingles/Suspected vaccination failure; Have it right now/have it on my shoulder, chest , left breast and back; pain has been excruciating; 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.   Concurrent medical conditions included shoulder replacement (Recovering from shoulder replacement).   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: had Shingles shot but got Shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Have it right now/have it on my shoulder, chest , left breast and back) and pain (Verbatim: pain has been excruciating). The patient was treated with valaciclovir hydrochloride (Valtrex) and gabapentin. The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 16-MAR-2023 The case was received from the patient interactive digital media. The patient had it right now(at the time of reporting). The pain had been excruciating.  The patient had the Shingles shot but got Shingles anyway. The patient had it on shoulder, chest, left breast and back. The patient was just recovering from a shoulder replacement revision.  The pain started on his/her shoulder and then breast. The patient stated that this was worse than any pain he/she ever had, This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As per narrative, shoulder replacement seems to be patient's current condition and not adverse event, hence captured as current condition.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Surgery, Vaccination failure
Clinical narrative: had all shots and still got it/Suspected vaccination failure; Still got it; Awful pain; Surgery; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had all shots and still got it/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Still got it), pain (Verbatim: Awful pain) and surgery (Verbatim: Surgery). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and surgery were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain and surgery to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and surgery to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 16-MAR-2023 The case was received from the patient interactive digital media. The patient had all the Shingles shots and still got it when he/she run down after surgery. The reporter stated that it was awful pain, but patient thinks it would had been much worse without the shots. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got vaccine, had shingles/Suspected vaccination failure; Had shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patients received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got vaccine, had shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 16-MAR-2023 The case was received from the consumer  interactive digital media. The reporter stated that everyone he/she ever known who had shingles got the vaccination after to try to prevent ever getting them again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Occipital neuralgia, Trigeminal neuralgia, Vaccination failure
Clinical narrative: Got 3 shots, yet get shingles/Suspected vaccination failure; Get shingles, oddl/they are always from myneck up and tend to be mostly on the right side of my Face/Head; Trigeminal neuralgia; Occipital Neuralgia; Got 3 shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got 3 shots, yet get shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Get shingles, oddl/they are always from myneck up and tend to be mostly on the right side of my Face/Head), trigeminal neuralgia (Verbatim: Trigeminal neuralgia), occipital neuralgia (Verbatim: Occipital Neuralgia) and extra dose administered (Verbatim: Got 3 shots). The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was not reported and the outcome of the trigeminal neuralgia and occipital neuralgia were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, trigeminal neuralgia and occipital neuralgia to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, trigeminal neuralgia and occipital neuralgia to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 31-MAR-2023 The case was received from the patient  interactive digital media. The patient had taken a minimum of 3 shots yet he/she continue to randomly get shingles. The patient stated oddly, they were always from his/her neck up and tend to be mostly on the right side of his/her face/head. The patient now had occipital and trigeminal neuralgia which his/her doctor believed came from the shingles. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The patient received 3rd dose of Shingles vaccine, which led to extra dose administered.