chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.08
Sex: M
Vaccine: HIBV, IPV, MMR, PPV, RV5, TDAP, VARCEL
Symptoms: Abdominal pain, Asthma, Concussion, Cough, Diarrhoea
Clinical narrative: swelling in his legs; his legs turned hard and red; his legs turned hard and red; concussion; involved in a car crash; vaccine had been expired; did not have any pneumoccal pneumonia titers; the patient was instead given pneumococcal pneumonia in July 2009; This spontaneous report was received from the patient's mother referring to an approximately 1 month old male patient. Concomitant vaccins included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid, polio vaccine and hib vaccine. In 2009, the patient received diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL). After being vaccinated with diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL), the patient experienced abdominal pain, diarrhea, an asthma attack, coughing, reflux, fever, waking up in bouts of sweat, projectile vomiting, rashes and was screaming for no reason as a baby. Historical drugs included montelukast sodium (SINGULAIR), ranitidine, fluticasone propionate (FLONASE), loratadine (CLARLTIN), and salbutamol sulfate and other over-the-counter drug medicines. the patient's historical condition also included shortness of breath. The patient was allergy to diphenhydramine hydrochloride (BENADRYL).  In July 2009, the patient was instead given individual shots rotavirus vaccine, live, oral, pentavalent (ROTATEQ), varicella virus vaccine live (oka/merck) (VARIVAX), pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, lot #, and expiration date of all therapies were not reported, route of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was oral, route of other vaccines was not reported) for prophylaxis.   In 2012 the patient did not have any pneumococcal pneumonia titers so a second pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) shot was given. After the vaccination, the patient experienced swelling in his legs and his legs turned hard and red. On 05-AUG-2016, the patient received his first shot of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: recombinant human albumin (RHA)) (one shot; strength, dose detail, route, were not reported; lot # K000997 and expiration date 22-JAN-2016) for prophylaxis (expired vaccine used). In 2019, the patient was involved in a car crash, magnetic resonance imaging (MRI) and x-ray in stomach was performed without result provided. In 2020 he received a concussion.   The outcome of all events was not provided.  Causality assessment was not provided.
Age: 0.08
Sex: M
Vaccine: HIBV, IPV, MMR, PPV, RV5, TDAP, VARCEL
Symptoms: Erythema, Expired product administered, Gastrooesophageal reflux disease, Induration, Night sweats
Clinical narrative: swelling in his legs; his legs turned hard and red; his legs turned hard and red; concussion; involved in a car crash; vaccine had been expired; did not have any pneumoccal pneumonia titers; the patient was instead given pneumococcal pneumonia in July 2009; This spontaneous report was received from the patient's mother referring to an approximately 1 month old male patient. Concomitant vaccins included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid, polio vaccine and hib vaccine. In 2009, the patient received diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL). After being vaccinated with diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL), the patient experienced abdominal pain, diarrhea, an asthma attack, coughing, reflux, fever, waking up in bouts of sweat, projectile vomiting, rashes and was screaming for no reason as a baby. Historical drugs included montelukast sodium (SINGULAIR), ranitidine, fluticasone propionate (FLONASE), loratadine (CLARLTIN), and salbutamol sulfate and other over-the-counter drug medicines. the patient's historical condition also included shortness of breath. The patient was allergy to diphenhydramine hydrochloride (BENADRYL).  In July 2009, the patient was instead given individual shots rotavirus vaccine, live, oral, pentavalent (ROTATEQ), varicella virus vaccine live (oka/merck) (VARIVAX), pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, lot #, and expiration date of all therapies were not reported, route of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was oral, route of other vaccines was not reported) for prophylaxis.   In 2012 the patient did not have any pneumococcal pneumonia titers so a second pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) shot was given. After the vaccination, the patient experienced swelling in his legs and his legs turned hard and red. On 05-AUG-2016, the patient received his first shot of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: recombinant human albumin (RHA)) (one shot; strength, dose detail, route, were not reported; lot # K000997 and expiration date 22-JAN-2016) for prophylaxis (expired vaccine used). In 2019, the patient was involved in a car crash, magnetic resonance imaging (MRI) and x-ray in stomach was performed without result provided. In 2020 he received a concussion.   The outcome of all events was not provided.  Causality assessment was not provided.
Age: 0.08
Sex: M
Vaccine: HIBV, IPV, MMR, PPV, RV5, TDAP, VARCEL
Symptoms: Peripheral swelling, Pyrexia, Rash, Road traffic accident, Screaming
Clinical narrative: swelling in his legs; his legs turned hard and red; his legs turned hard and red; concussion; involved in a car crash; vaccine had been expired; did not have any pneumoccal pneumonia titers; the patient was instead given pneumococcal pneumonia in July 2009; This spontaneous report was received from the patient's mother referring to an approximately 1 month old male patient. Concomitant vaccins included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid, polio vaccine and hib vaccine. In 2009, the patient received diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL). After being vaccinated with diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL), the patient experienced abdominal pain, diarrhea, an asthma attack, coughing, reflux, fever, waking up in bouts of sweat, projectile vomiting, rashes and was screaming for no reason as a baby. Historical drugs included montelukast sodium (SINGULAIR), ranitidine, fluticasone propionate (FLONASE), loratadine (CLARLTIN), and salbutamol sulfate and other over-the-counter drug medicines. the patient's historical condition also included shortness of breath. The patient was allergy to diphenhydramine hydrochloride (BENADRYL).  In July 2009, the patient was instead given individual shots rotavirus vaccine, live, oral, pentavalent (ROTATEQ), varicella virus vaccine live (oka/merck) (VARIVAX), pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, lot #, and expiration date of all therapies were not reported, route of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was oral, route of other vaccines was not reported) for prophylaxis.   In 2012 the patient did not have any pneumococcal pneumonia titers so a second pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) shot was given. After the vaccination, the patient experienced swelling in his legs and his legs turned hard and red. On 05-AUG-2016, the patient received his first shot of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: recombinant human albumin (RHA)) (one shot; strength, dose detail, route, were not reported; lot # K000997 and expiration date 22-JAN-2016) for prophylaxis (expired vaccine used). In 2019, the patient was involved in a car crash, magnetic resonance imaging (MRI) and x-ray in stomach was performed without result provided. In 2020 he received a concussion.   The outcome of all events was not provided.  Causality assessment was not provided.
Age: 0.08
Sex: M
Vaccine: HIBV, IPV, MMR, PPV, RV5, TDAP, VARCEL
Symptoms: Viral titre, Vomiting projectile, Wrong product administered
Clinical narrative: swelling in his legs; his legs turned hard and red; his legs turned hard and red; concussion; involved in a car crash; vaccine had been expired; did not have any pneumoccal pneumonia titers; the patient was instead given pneumococcal pneumonia in July 2009; This spontaneous report was received from the patient's mother referring to an approximately 1 month old male patient. Concomitant vaccins included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid, polio vaccine and hib vaccine. In 2009, the patient received diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL). After being vaccinated with diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL), the patient experienced abdominal pain, diarrhea, an asthma attack, coughing, reflux, fever, waking up in bouts of sweat, projectile vomiting, rashes and was screaming for no reason as a baby. Historical drugs included montelukast sodium (SINGULAIR), ranitidine, fluticasone propionate (FLONASE), loratadine (CLARLTIN), and salbutamol sulfate and other over-the-counter drug medicines. the patient's historical condition also included shortness of breath. The patient was allergy to diphenhydramine hydrochloride (BENADRYL).  In July 2009, the patient was instead given individual shots rotavirus vaccine, live, oral, pentavalent (ROTATEQ), varicella virus vaccine live (oka/merck) (VARIVAX), pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, lot #, and expiration date of all therapies were not reported, route of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was oral, route of other vaccines was not reported) for prophylaxis.   In 2012 the patient did not have any pneumococcal pneumonia titers so a second pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) shot was given. After the vaccination, the patient experienced swelling in his legs and his legs turned hard and red. On 05-AUG-2016, the patient received his first shot of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: recombinant human albumin (RHA)) (one shot; strength, dose detail, route, were not reported; lot # K000997 and expiration date 22-JAN-2016) for prophylaxis (expired vaccine used). In 2019, the patient was involved in a car crash, magnetic resonance imaging (MRI) and x-ray in stomach was performed without result provided. In 2020 he received a concussion.   The outcome of all events was not provided.  Causality assessment was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; A medical assistant called to report a temperature excursion involving administered PROQUAD vaccines; This spontaneous report has been received from medical assistant referring to a patient of unreported age and gender. No information was provided about the patient's concurrent conditions, pertinent medical history, concomitant therapies, drug and/or allergies reactions.    On 21-DEC-2021, the patient was vaccinated with  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Lot number#: U022726. expiration date: 16-JAN-2023) (dose, vaccination scheme, frequency, route of administration and anatomical site of vaccination were not reported) for prophylaxis which was involved in temperature excursion. (Product storage error)  No additional adverse events reported.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Limb discomfort, Muscular weakness, Pain in extremity
Clinical narrative: severe pain in her whole arm, where she have to pick up her arm to use it; arm "felt heavy"; This spontaneous report as received from a medical assistant refers to a 70-year-old female patient. The patient had no known allergies. No information regarding the patient's pertinent medical history and concomitant therapies was provided.  On 14-DEC-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe, lot # U018309, expiry date 08-JAN-2023, 0.5 milliliter, intramuscularly in the left arm for prophylaxis (reported as immunization).  In the evening of 14-DEC-2021, after the administration of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the patient started to experience severe pain in her whole arm, where she had to pick up her arm to use it (pain in extremity), and her arm also "felt heavy" (limb discomfort). No treatment was given for the adverse events. The patient did not seek a medical attention in regards to the events.  The outcome of pain in extremity and limb discomfort was unknown. The relatedness between the events of pain in extremity and limb discomfort and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2112USA010039: US-009507513-2112USA010305: US-009507513-2112USA010181:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: missed dose of Gardasil 9/they received their second dose of GARDASIL 9 roughly 5 years and 8 months ago; missed dose of Gardasil 9/they received their second dose of GARDASIL 9 roughly 5 years and 8 months ago; No additional AE information; This spontaneous report was received from an unspecified consumer of unknown age reporting on them self. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.  On an unknown date, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, lot# and the expiration date were not reported) for prophylaxis.    On 30-APR-2016 (reported as roughly 5 years and 8 months ago), the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, lot# and the expiration date were not reported) for prophylaxis.   Caller was requiring what the next steps regarding the missed dose (inappropriate schedule of product administration and product dose omission issue). No additional adverse events.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Skin irritation
Clinical narrative: zoster dermatitis; Information has been received from a lawyer, regarding a case in litigation, concerning a female patient (pt) of unknown age . There was no information provided regarding the pt's concurrent conditions, medical history or concomitant medications. On or around 10-JAN-2017, the pt was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, anatomical location, and route of administration were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered itching and irritation and was diagnosed with zoster dermatitis (unclear if by a healthcare professional). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence , pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of zoster dermatitis was considered to be disabling.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; MMR II and VARIVAX were administered to a patient after tenperature excursion; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On 05-JAN-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (Lot# U015846 and expiration date 19-MAY-2023) (exact dose and frequency were not reported) as prophylaxis. The vaccine a temperature excursion and time frame were unknown. There was no previous temperature excursion. The patient also vaccinated on 05-JAN-2022 with improperly stored measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) Lot# T033814 and expiration date 05-OCT-2022) (exact dose and frequency were not reported) as prophylaxis (product storage error). The vaccine underwent a temperature excursion of 47.5 Fahrenheit for 1 hours. There was no previous temperature excursion. No additional adverse event reported.
Age: 0.5
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Nurse accidentally administered GARDASIL 9 to a 6-month-old child; This spontaneous report was received from a physician regarding a 6-month-old male patient. The patient's medical history included premature baby. The patient's concurrent conditions, concomitant medications, and drug reactions and allergies were unknown.   On 06-JAN-2022 at 12:36 hours (reported as 30 minutes before the call), the patient was accidentally vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) syringe, 0.5 milliliter suspension for injection, due to prophylaxis (strength, frequency, route, anatomical location, lot # and expiration date were not provided) (product administered to patient of inappropriate age) by a nurse. It was unknown if treatment was required. By the time of report, the outcome of accidentally vaccinate a 6-month-old male patient was unknown.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE details or PQC; had not yet received their second dose; This spontaneous report as received from a pharmacist refers to a 14-year-old patient of unknown gender.      The patient's concurrent conditions, medical history, and concomitant therapies were not provided.  In January 2020 (reported as 2 years ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, lot#, and expiration date were not reported).         The second dose should had been administered in January 2021. However, at the reporting time, the patient had not yet received it (inappropriate schedule of product administration). No additional adverse event (AE) details or product quality complaint (PQC) were reported.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 21 year old male who had received his first dose of GARDASIL 9 over a year ago; No additional information; This spontaneous report has been received from a pharmacy technician referring to an adult male patient who was 21 years old at the time of the report.    The patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not reported.   On an unspecified date (reported as "over a year ago"), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) (inappropriate schedule of product administration).   The reporter asked if the patient needed to restart the vaccine schedule, and the time frame between the second and the third dose. No additional information was provided (no adverse event).
Sex: F
Vaccine: MMR
Symptoms: Body temperature abnormal, Presyncope
Clinical narrative: She had 104 temperature; she almost loss consciousness at work; This spontaneous report has been received from the patient via Pfizer, regarding herself a female patient of unknown age. Information regarding the patient's pertinent medical history, concomitant medications, concurrent conditions and previous drug reactions or allergies were unknown.  On an unspecified date, the patient was vaccinated with Measles, Mumps, and Rubella (MMR) (manufacturer unknown) as prophylaxis (exact dose, route of administration and anatomical location of vaccination, lot number and expiration date were not reported).  On an unspecified date, the patient stated that she almost lost consciousness at work (presyncope) and had a 104 grades (units not provided) temperature (body temperature abnormal).   The outcome of the events, and the causality assessment between the events and the suspect therapy was not provided.  This is one of two reports referring to the same patient.; Sender's Comments:  US-009507513-2201USA001553:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; Vaccine was administered after expiration; This spontaneous report has been received from a medical assistant and refers to a patient of unspecified age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided. Concomitant therapies included sterile diluent.  On 10-JAN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 milliliter as prophylaxis (route and anatomical location of administration, and vaccine scheme were not provided; lot number T000892 has been verified to be valid lot number, expiration date reported and established as 08-JAN-2022) with the sterile diluent (concomitant therapy) 0.7 ml (lot number S016937 which has been determined to be an invalid lot number for sterile diluent, expiration date reported as 01-FEB-2022). No additional adverse events (AE) were reported.
Age: 1.42
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; expired MMR II and VARIVAX were administered to a patient yesterday (1/10/2022); This spontaneous report was received from a medical assistant, referring to a 17- month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 10-JAN-2022 (also reported as yesterday), the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number S035356, expiration date was reported and validated as 05-NOV-2021) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number S035125, expiration date reported and validated as 04-NOV-2021), both therapies as prophylaxis (expired product administered). No additional adverse events reported.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Vaccination failure
Clinical narrative: had the shingles shot and can't get rid of them/ suspected vaccination failure; had shingles, can't get rid of them.; There is pain day and night; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles for 8 years).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The patient had shingles for 8 years and was taking medication twice a day. The reporter stated that, he/she had the Shingles shot and could not get rid of shingles. There was pain day and night. The reporter suggested to get vaccinated if the person is fifty years or older. 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 would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got vaccinated and still got shingles/ Suspected vaccination failure; Shingles but not as bad; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's sister in law. The age at vaccination was not reported. The reporter stated that, the patient got vaccinated and still got the shingles but not as bad. 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 would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR001918:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Scar, Skin discolouration
Clinical narrative: shingles; super big pink scar on leg; super big pink scar on leg; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 days after receiving Shingles vaccine, the patient experienced shingles, scar and skin discoloration. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the scar and skin discoloration were not recovered/not resolved.   It was unknown if the reporter considered the shingles, scar and skin discoloration to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that, he/she had shingles and did not ever want to get again, so he/she got the shingles shot to be sure, and 6 days later he/she came down with the shingles again. The patient stated this was worse than first case and left super big pink scar all up leg. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain in extremity, Pyrexia
Clinical narrative: arm hurts really bad; low grade fever; knocking the mess out of me; This case was reported by a consumer via  interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 8th January 2022, the patient received the 2nd dose of Shingles vaccine. In January 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm, fever and feeling bad. On an unknown date, the outcome of the pain in arm, fever and feeling bad were unknown.   It was unknown if the reporter considered the pain in arm, fever and feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient just got 2nd Shingles shot on Saturday and it was knocking the mess out of him/her.  The patient arm was hurting really bad and running a low grade fever.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Received Shingrix subcutaneous; This case was reported by a nurse via sales rep and described the occurrence of intramuscular formulation administered by other route in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (subcutaneous) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received Shingrix subcutaneously for 2nd dose, which led to intramuscular formulation administered by other route. The patient did not seek medical attention. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Herpes zoster, Loss of consciousness, Pain, Pyrexia
Clinical narrative: Suspected vaccination failure/Took second dose, got the virus; Passed out; Got the virus; Aches; Fever; Chills; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), shingles, pain, fever and chills. On an unknown date, the outcome of the vaccination failure, passed out, shingles, pain, fever and chills were unknown.   It was unknown if the reporter considered the vaccination failure, passed out, shingles, pain, fever and chills to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient took 2nd dose and passed out. On an unknown date, the patient had experienced aches, fever, chills to got that virus. The patient stated that just not him/her but he/she sure went through a lot. This case was considered as suspected vaccination failure as details regarding time to onset and  laboratory test confirmation 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
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure/Took second dose, got the virus; Passed out; Got the virus; Aches; Fever; Chills; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), shingles, pain, fever and chills. On an unknown date, the outcome of the vaccination failure, passed out, shingles, pain, fever and chills were unknown.   It was unknown if the reporter considered the vaccination failure, passed out, shingles, pain, fever and chills to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient took 2nd dose and passed out. On an unknown date, the patient had experienced aches, fever, chills to got that virus. The patient stated that just not him/her but he/she sure went through a lot. This case was considered as suspected vaccination failure as details regarding time to onset and  laboratory test confirmation 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: Pain in extremity, Pyrexia
Clinical narrative: Slight fever; Arm sore; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In January 2022, the patient received the 2nd dose of Shingles vaccine. In January 2022, less than a week after receiving Shingles vaccine, the patient experienced fever and pain in arm. On an unknown date, the outcome of the fever and pain in arm were recovered/resolved.   It was unknown if the reporter considered the fever and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated he/she just got the second shot in the week of reporting and ran a slight fever and arm sore for a few days, nothing too major and it was worth it in the long run. The follow-up would not be possible as no contact details were available.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEP
Symptoms: Incorrect dose administered
Clinical narrative: Pediarix and Engerix-B on the same day; This case was reported by a physician via call center representative and described the occurrence of overdose in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) (batch number 25n35, expiry date 16th March 2025) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd January 2022, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device. On 3rd January 2022, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was 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:  US2022002098  Additional details were reported as follows: The reporter was a Pediatrician. The patient was inadvertently administrated Pediarix and Engerix-B on the same day, which led to overdose. The reporter consented to follow up.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, UNK
Symptoms: Dysphonia, Peripheral swelling
Clinical narrative: Hoarseness; swelling in his left leg; This case was reported by a physician via call center representative and described the occurrence of hoarseness in a 6-month-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2021-2022 season) (batch number 2579B, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Hib (Hiberix) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR-13 VACCINE) for prophylaxis.   Concurrent medical conditions included respiratory syncytial virus infection.   On 3rd January 2022, the patient received the 1st dose of FluLaval Tetra 2021-2022 season (intramuscular) .5 ml, Flulaval Tetra Pre-Filled Syringe Device, the 3rd dose of Pediarix (intramuscular) .5 ml, Pediarix Pre-Filled Syringe Device, the 3rd dose of Hiberix (intramuscular) .5 ml and PREVNAR-13 VACCINE (intramuscular). On 3rd January 2022, less than a day after receiving FluLaval Tetra 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced hoarseness and swelling of legs. On an unknown date, the outcome of the hoarseness and swelling of legs were recovered/resolved.   It was unknown if the reporter considered the hoarseness and swelling of legs to be related to FluLaval Tetra 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a pediatrician that was reporting adverse events for 2 different patients who were brothers and received 4 vaccines as part of their 6 month old vaccination series. The patient received his first dose of Flulaval and Pediarix in his right thigh. The patient received his Hiberix and the Prevnar-13 vaccine in his left thigh The reporter did not get the lot number /expiration date for the Pediarix or the Hiberix vaccine administered. The doctor reported that the patient experienced hoarseness within 24 hours of taking the vaccines and she suggested that the Flulaval was the potential suspect vaccine to cause this adverse events since this was the only new vaccine to the patient.  Although, the physician also reported that the patient was recovering from a case of RSV.  The physician reported the patient's mom stated that her son experienced swelling in his left leg. Doctor reported all side effects are currently resolved. The reporter did not get consent because healthcare professional was reporter, not patient. The case has been linked to US2022002798, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022002798:same reporter
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: inadvertently given an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 31-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43E4T, expiry date 1st October 2021) for prophylaxis.   On 4th January 2022, the patient received Boostrix. On 4th January 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: On 4th January 2022, the patient was inadvertently given a dose of Boostrix vaccine which was already expired on 1st of October 2021.  The patient had not yet been redosed. The reporter gave consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: two missing vials were given without being reconstituted; two missing vials were given without being reconstituted; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, there were 4 vials of Shingrix antigen in the fridge and 2 vials of adjuvant were found left out on the counter. Two adjuvant vials were missing.  The reporter initially stated that it was possible that the two missing vials were given without being reconstituted, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The situation was still being investigated.  After specialist noted the safety team would be informed of the potential administration of the adjuvant-only, the reporter back-pedaled and stated that it was more likely the box got dropped and the adjuvant vials were lost or discarded.  The specialist was submitting potential event out of an abundance of caution. The reporter did not consent to follow-up.
Age: 41.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of Shingrix 41 y/o patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 41-year-old female patient who received Herpes zoster (Shingrix) (batch number 2737P, expiry date 22nd January 2022) for prophylaxis.   On 1st September 2021, the patient received Shingrix. On 1st September 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: This case was reported by the registered nurse. The reporter stated that, an immunocompetent 41 year old patient was administered with Shingrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, Chest pain, Injection site swelling, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: swelling at injection site; pain left chest; fever; first dose on 1/31/2020, Covid on 30-JUNE-2021; unable to make a fist; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st January 2020, the patient received the 1st dose of Shingrix. In February 2020, 1 day after receiving Shingrix, the patient experienced stiff fingers. On 30th June 2020, the patient experienced covid-19. On an unknown date, the patient experienced injection site swelling, chest pain and fever. On an unknown date, the outcome of the injection site swelling, covid-19, chest pain, fever and stiff fingers were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, covid-19, chest pain, fever and stiff fingers to be related to Shingrix.     Additional details were provided as follows: The patient self-reported this case. The patient experienced pain in her left chest, fever and swelling at the injection site. She also stated that the morning after the dose, she was unable to make a fist with her left hard. The patient received dose of Shingrix vaccine and was diagnosed with Covid. The reporter did not consent to follow-up. For tolerance to the 2nd dose refer case US2022AMR004816.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR004816:Same patient
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: swelling at injection site; pain left chest; fever; first dose on 1/31/2020, Covid on 30-JUNE-2021; unable to make a fist; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st January 2020, the patient received the 1st dose of Shingrix. In February 2020, 1 day after receiving Shingrix, the patient experienced stiff fingers. On 30th June 2020, the patient experienced covid-19. On an unknown date, the patient experienced injection site swelling, chest pain and fever. On an unknown date, the outcome of the injection site swelling, covid-19, chest pain, fever and stiff fingers were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, covid-19, chest pain, fever and stiff fingers to be related to Shingrix.     Additional details were provided as follows: The patient self-reported this case. The patient experienced pain in her left chest, fever and swelling at the injection site. She also stated that the morning after the dose, she was unable to make a fist with her left hard. The patient received dose of Shingrix vaccine and was diagnosed with Covid. The reporter did not consent to follow-up. For tolerance to the 2nd dose refer case US2022AMR004816.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR004816:Same patient
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received DTPa-IPV (Kinrix) (batch number Z9MZ2, expiry date 3rd December 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th January 2022, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 10th January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The medical assistant reported that the patient received expired dose of Kinrix today (day of reporting), which led to expired vaccine used. No further information reported. The reporter consented to follow-up.