chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Chills, Headache, Myalgia, Nausea
Clinical narrative: Headache; abdominal pain near transverse colon; Nausea; Shivering; This case was reported by a nurse via sales rep and described the occurrence of headache in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th April 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced headache, abdominal pain, nausea and shivering. On an unknown date, the outcome of the headache, abdominal pain, nausea and shivering were recovered/resolved.   It was unknown if the reporter considered the headache, abdominal pain, nausea and shivering to be related to Shingrix.  Additional details were provided as follows: The patient had headache, abdominal pain near transverse colon, nausea and shivering which were lasted 12 to 24 hours.  No fever, rash or redness at the injection site.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Chills, Headache, Nausea
Clinical narrative: Headache; abdominal pain near transverse colon; Nausea; Shivering; This case was reported by a nurse via sales rep and described the occurrence of headache in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th April 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced headache, abdominal pain, nausea and shivering. On an unknown date, the outcome of the headache, abdominal pain, nausea and shivering were recovered/resolved.   It was unknown if the reporter considered the headache, abdominal pain, nausea and shivering to be related to Shingrix.  Additional details were provided as follows: The patient had headache, abdominal pain near transverse colon, nausea and shivering which were lasted 12 to 24 hours.  No fever, rash or redness at the injection site.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Rash, Rash erythematous
Clinical narrative: rash; This spontaneous report was received from a medical assistant and refers to a 7-month-old male patient. It was reported that the patient did not have any pertinent medical history, allergies or drug reactions. The patient had no concomitant medications.  On 07-MAY-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ)orally, lot # R016791, expiration date 16-APR-2020 (reported as 31-JAN-2020) (dose was no provided) for prophylaxis. It was reported that during the same office visit, the patient was administered with hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (PENTACEL) (dose, indication, route of administration, lot # and expiration date were not reported) and pneumococcal 13v conj vaccine (crm197)(PREVENAR 13) (dose, indication, route of administration, lot # and expiration date were not reported). The reporter informed that 5-10 minutes after administration of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), the patient developed rash "on his upper mid back and chest". No treatment was given for the event and the patient had no lab diagnostic performed. When the event occurred, the patient was in the physician's office. It was reported that later that day (07-MAY-2019), the rash resolved. The causality assessment was not provided by the reporter.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Rash
Clinical narrative: rash; This spontaneous report was received from a medical assistant and refers to a 7-month-old male patient. It was reported that the patient did not have any pertinent medical history, allergies or drug reactions. The patient had no concomitant medications.  On 07-MAY-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ)orally, lot # R016791, expiration date 16-APR-2020 (reported as 31-JAN-2020) (dose was no provided) for prophylaxis. It was reported that during the same office visit, the patient was administered with hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (PENTACEL) (dose, indication, route of administration, lot # and expiration date were not reported) and pneumococcal 13v conj vaccine (crm197)(PREVENAR 13) (dose, indication, route of administration, lot # and expiration date were not reported). The reporter informed that 5-10 minutes after administration of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), the patient developed rash "on his upper mid back and chest". No treatment was given for the event and the patient had no lab diagnostic performed. When the event occurred, the patient was in the physician's office. It was reported that later that day (07-MAY-2019), the rash resolved. The causality assessment was not provided by the reporter.
Age: 1.0
Sex: U
Vaccine: HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13
Symptoms: Apnoea, Cyanosis, Electrocardiogram, Electroencephalogram, Resuscitation
Clinical narrative: Information has been received from a nurse via a field employee referring to a 1-year old patient of unknown gender. Information about medical history and concurrent conditions was unknown by the reporter. Concomitant therapies included PREVNAR and HAVRIX. On 15-MAY-2019 at approximately 10:00, the patient was vaccinated with one dose each of LIQUID PEDVAXHIB (lot number R027320, expiration date 08-JUL-2021; strength and route were not provided) and M-M-R II (lot number R028004, expiration date 01-OCT-2020; strength and route were not provided) for disease prevention. On that day at approximately 14:00, the patient's father called the doctor's office to report that he was in an ambulance on his way to the hospital with the patient, who had "stopped breathing several times and had had seizures". The patient's father reported that he had performed cardiopulmonary resuscitation (CPR) on the patient when the patient stopped breathing. The patient was admitted to the medical center and the patient would be fine. It was unknown if there were any lab diagnostics or studies. The outcome of the events was not reported. The causality between the events and all the vaccines were not provided. Upon internal review, the events "stopped breathing several times and had had seizures" were determined to be medically significant. The event "stopped breathing several times" was considered to be life-threatening by the reporter.
Age: 1.0
Sex: U
Vaccine: HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13
Symptoms: Seizure
Clinical narrative: Information has been received from a nurse via a field employee referring to a 1-year old patient of unknown gender. Information about medical history and concurrent conditions was unknown by the reporter. Concomitant therapies included PREVNAR and HAVRIX. On 15-MAY-2019 at approximately 10:00, the patient was vaccinated with one dose each of LIQUID PEDVAXHIB (lot number R027320, expiration date 08-JUL-2021; strength and route were not provided) and M-M-R II (lot number R028004, expiration date 01-OCT-2020; strength and route were not provided) for disease prevention. On that day at approximately 14:00, the patient's father called the doctor's office to report that he was in an ambulance on his way to the hospital with the patient, who had "stopped breathing several times and had had seizures". The patient's father reported that he had performed cardiopulmonary resuscitation (CPR) on the patient when the patient stopped breathing. The patient was admitted to the medical center and the patient would be fine. It was unknown if there were any lab diagnostics or studies. The outcome of the events was not reported. The causality between the events and all the vaccines were not provided. Upon internal review, the events "stopped breathing several times and had had seizures" were determined to be medically significant. The event "stopped breathing several times" was considered to be life-threatening by the reporter.
Age: 1.0
Sex: U
Vaccine: HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13
Symptoms: Respiratory arrest, Resuscitation, Seizure
Clinical narrative: Information has been received from a nurse via a field employee referring to a 1-year old patient of unknown gender. Information about medical history and concurrent conditions was unknown by the reporter. Concomitant therapies included PREVNAR and HAVRIX. On 15-MAY-2019 at approximately 10:00, the patient was vaccinated with one dose each of LIQUID PEDVAXHIB (lot number R027320, expiration date 08-JUL-2021; strength and route were not provided) and M-M-R II (lot number R028004, expiration date 01-OCT-2020; strength and route were not provided) for disease prevention. On that day at approximately 14:00, the patient's father called the doctor's office to report that he was in an ambulance on his way to the hospital with the patient, who had "stopped breathing several times and had had seizures". The patient's father reported that he had performed cardiopulmonary resuscitation (CPR) on the patient when the patient stopped breathing. The patient was admitted to the medical center and the patient would be fine. It was unknown if there were any lab diagnostics or studies. The outcome of the events was not reported. The causality between the events and all the vaccines were not provided. Upon internal review, the events "stopped breathing several times and had had seizures" were determined to be medically significant. The event "stopped breathing several times" was considered to be life-threatening by the reporter.
Age: 1.0
Sex: U
Vaccine: HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13
Symptoms: Pyrexia, Respiratory arrest, Resuscitation, Seizure
Clinical narrative: Information has been received from a nurse via a field employee referring to a 1-year old patient of unknown gender. Information about medical history and concurrent conditions was unknown by the reporter. Concomitant therapies included PREVNAR and HAVRIX. On 15-MAY-2019 at approximately 10:00, the patient was vaccinated with one dose each of LIQUID PEDVAXHIB (lot number R027320, expiration date 08-JUL-2021; strength and route were not provided) and M-M-R II (lot number R028004, expiration date 01-OCT-2020; strength and route were not provided) for disease prevention. On that day at approximately 14:00, the patient's father called the doctor's office to report that he was in an ambulance on his way to the hospital with the patient, who had "stopped breathing several times and had had seizures". The patient's father reported that he had performed cardiopulmonary resuscitation (CPR) on the patient when the patient stopped breathing. The patient was admitted to the medical center and the patient would be fine. It was unknown if there were any lab diagnostics or studies. The outcome of the events was not reported. The causality between the events and all the vaccines were not provided. Upon internal review, the events "stopped breathing several times and had had seizures" were determined to be medically significant. The event "stopped breathing several times" was considered to be life-threatening by the reporter.
Age: 1.0
Sex: U
Vaccine: HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13, HEPA, HIBV, MMR, PNC13
Symptoms: Pyrexia, Respiratory arrest, Resuscitation
Clinical narrative: Information has been received from a nurse via a field employee referring to a 1-year old patient of unknown gender. Information about medical history and concurrent conditions was unknown by the reporter. Concomitant therapies included PREVNAR and HAVRIX. On 15-MAY-2019 at approximately 10:00, the patient was vaccinated with one dose each of LIQUID PEDVAXHIB (lot number R027320, expiration date 08-JUL-2021; strength and route were not provided) and M-M-R II (lot number R028004, expiration date 01-OCT-2020; strength and route were not provided) for disease prevention. On that day at approximately 14:00, the patient's father called the doctor's office to report that he was in an ambulance on his way to the hospital with the patient, who had "stopped breathing several times and had had seizures". The patient's father reported that he had performed cardiopulmonary resuscitation (CPR) on the patient when the patient stopped breathing. The patient was admitted to the medical center and the patient would be fine. It was unknown if there were any lab diagnostics or studies. The outcome of the events was not reported. The causality between the events and all the vaccines were not provided. Upon internal review, the events "stopped breathing several times and had had seizures" were determined to be medically significant. The event "stopped breathing several times" was considered to be life-threatening by the reporter.
Age: 11.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain in extremity, Peripheral swelling, Product quality issue
Clinical narrative: Swollen and pain on  arm and legs. Reported x2 days after vaccination. patient was seen by Dr. on 05/16/19 . patient c/o redness, and a lot of itching and some pain on the site of infection. Redness is spreading. Patient's mother reports child c/o legs hurts even to seat down.
Age: 11.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen and pain on  arm and legs. Reported x2 days after vaccination. patient was seen by Dr. on 05/16/19 . patient c/o redness, and a lot of itching and some pain on the site of infection. Redness is spreading. Patient's mother reports child c/o legs hurts even to seat down.
Age: 0.17
Sex: F
Vaccine: HEP
Symptoms: Crying, Insomnia, Screaming, Vomiting, Walking aid user
Clinical narrative: Baby started to throw up.  Then we had to hold her and walk her around otherwise she would cry all the time.  Would not sleep.  She kept throwing up.  Then even if we walked her around had a high pitch scream.  This went on for hours.
Age: 18.0
Sex: M
Vaccine: HPV9, UNK, UNK
Symptoms: Adverse reaction, Cellulitis, Erythema, Nausea, Pain
Clinical narrative: LEFT ARM, RED, SWOLLEN AND PAINFUL. ALSO C/O BODY ACHES, FEVER, NAUSEA AND VOMITX1.  ADVERSE REACTION VS CELLULITIS.  ADMIN KEFLEX AND BENADRYL IN ER.  SENT WITH RX FOR KEFLEX TIDX10 DAYS
Age: 18.0
Sex: M
Vaccine: HPV9, UNK, UNK
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: LEFT ARM, RED, SWOLLEN AND PAINFUL. ALSO C/O BODY ACHES, FEVER, NAUSEA AND VOMITX1.  ADVERSE REACTION VS CELLULITIS.  ADMIN KEFLEX AND BENADRYL IN ER.  SENT WITH RX FOR KEFLEX TIDX10 DAYS
Age: 50.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Injection site bruising, Tenderness
Clinical narrative: Large bruise surrounding site where MMR was injected (a little larger than a softball in size).  His arm is tender to touch but no nodules present.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Retinal haemorrhage
Clinical narrative: This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 07-JUN-2017, the patient was vaccinated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date in 2017, "shortly after" receiving ZOSTAVAX, the patient experienced acute retinal hemorrhage on her right eye and shingles under her breasts and back. As a direct and proximate result of the defective ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. The outcome of the events was considered as not recovered. The events were considered to be related to ZOSTAVAX. Upon internal review acute retinal hemorrhage was considered to be medically significant.  Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported; inadvertently vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent ((ROTATEQ); This spontaneous report was received from a medical assistant and refers to a 6 months old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On 15-MAY-2019, the patient was inadvertently vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) per oral route for prophylaxis, lot number N034400, expiration date 10-MAY-2019 (strength and dose number were not reported).  No adverse effects were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: Improperly stored proquad or varivax; This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patients medical history, concurrent conditions, drug allergies and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R010468, expiry date 10-APR-2020, R017641, expiry date 20-JUN-2020, R010466, expiry date 10-APR-2020) or measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot# R020814, expiry date 16-JAN-2020, R015738 expiry date 02-DEC-2019) which was reconstituted with properly stored sterile diluent. Temperature: Total time in the range 6 degree Fahrenheit to 14 degree Fahrenheit (8.8 Fahrenheit), time frame: 24 minutes. Previous temperature excursion : total time in the range 6 degree Fahrenheit to 14 degree Fahrenheit (5.9 fahrenheit) for 12 minutes, total time in range 6 degree Fahrenheit to 14 degree Fahrenheit (5.5 fahrenheit) for 6 minutes recommended frozen range minus 58 degree fahenheit to 5 degree Fahrenheit (5.1 fahrenheit) for 6 minutes total time in range 6 degree Fahrenheit to 14 degree Fahrenheit (5.5F)for 12minutes. Data logger was involved.
Sex: F
Vaccine: HEPA
Symptoms: Amenorrhoea
Clinical narrative: "Since January", the patient "has not had her period"; This spontaneous report has been received from the patient's mother concerning to her 16-year-old daughter. There were none pertinent medical history, concurrent conditions or concomitant medications were reported.  On an unknown date in July 2018, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) one dose intramuscularly (frequency, lot number and expiration date were not provided); furthermore, on an unknown date in January 2019, the patient received one booster of hepatitis a vaccine, inactivated (VAQTA) (frequency, lot number and expiration date were not provided) for hepatitis prevention.  Approximately on an unknown date in January 2019 (reported as since January), the patient had not her period (amenorrhea). The patient sought medical attention and called the physician, the patient did not receive any treatment and none laboratories or studies were performed.  Therapy with hepatitis a vaccine, inactivated (VAQTA) was reproted as continued. The outcome of amenorrhea was reported as not resolved. The causal relationship between the adverse event and the therapy was not assessed.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: the patient later found out that she was pregnant at the time of administration; This spontaneous prospective pregnancy report was received from a nurse referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 25-MAR-2019, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported. After the vaccination the patient found out that she was pregnant at the time of the administration (exposure during pregnancy).    The patient estimated date of delivery (EDD) was 16-MAR-2019. Their last menstrual period (LMP), gestational age and trimester of exposure were not provided.  The pregnancy outcome was outcome pending. The outcome of exposure during pregnancy was unknown.
Age: 0.33
Sex: U
Vaccine: PNC13, PPV
Symptoms: Wrong product administered
Clinical narrative: 4 months old patient received PPSV23 instead of Prevnar 13; This spontaneous report was received from a other healthcare professional refers to a 4 month old patient of unknown gender.The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-DEC-2018, the patient was vaccinated with first dose of pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) (lot# not reported)for prophylaxis. On 05-MAR-2019,the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot# not reported) for prophylaxis instead of pneumococcal 13v conj vaccine (crm197)(PREVNAR 13).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; inadvertently administered an expired dose of VARIVAX; This spontaneous report was received from a physician refers to a 4-year-old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 20-MAY-2019, the patient was inadvertently vaccinated with expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # M045205 and expiration date 11-NOV-2018) (dose, route and frequency unknown) for prophylaxis (expired product administered). No adverse effects were reported. PQC (product quality complaint) was not reported.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: rash; This spontaneous report was received from a nurse refers to a 12 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-APR-2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # N020352, expiry date 10-APR-2020 for prophylaxis. On an unknown date, the patient experienced rash. The outcome of the event was unknown.  This is one of the report received from the same reporter.  Lot No. N020352 has been verified to be a valid lot number for [hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)], expiration date not reported, but upon internal validation established as 10-APR-2020.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Myalgia, Nausea
Clinical narrative: very bad headaches; weakness; muscle aches; nausea; shivering; This case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) (batch number 23JK5, expiry date unknown) for prophylaxis.   On 29th April 2019, the patient received the 1st dose of Shingrix. On 29th April 2019, 6 hrs after receiving Shingrix, the patient experienced headache, muscle pain, nausea, shivering and weakness. On an unknown date, the outcome of the headache and weakness were not recovered/not resolved and the outcome of the muscle pain, nausea and shivering were recovered/resolved.   It was unknown if the reporter considered the headache, muscle pain, nausea, shivering and weakness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Six hours after receiving Shingrix, the patient experienced  very bad headaches muscle aches, nausea and shivering which kept the patient in bed. At the time of reporting, the patient was now 48 hours post injection and felt better but still had a mild headache and general weakness. The patient was not sure if the patient should receive the second dose of Shingrix in 2 months' time. The reporter asked what was the antibody response for people who only receive one dose of Shingrix. Add the date of closure in late reason.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Mobility decreased
Clinical narrative: illness/very ill; could not move; This case was reported by a consumer via media and described the occurrence of unwell in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced unwell and mobility decreased. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the unwell and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the unwell and mobility decreased to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported, but the patient received Flu vaccine as a child. The patient was very ill after receiving Flu vaccine the first time and patient had it attacked immune system so bad that the patient could not move. A year on after receiving Flu vaccine, at the time of reporting the patient was still not 100 percent better even after receiving a long course of steroids. The patient requested not to spout the opinions to people who knew for a dammed fact that it was caused by the Flu vaccine as they were different.  It was reported that the patient would never receive the Flu vaccine again and the patient was certainly not an anti anti vaxxer.
Sex: F
Vaccine: FLU4
Symptoms: Apparent death, Asthma, Bronchitis
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of bronchitis in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced bronchitis (serious criteria hospitalization), asthma (serious criteria hospitalization) and near death experience (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the bronchitis, asthma and near death experience were recovered/resolved. It was unknown if the reporter considered the bronchitis, asthma and near death experience to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The patient suffered very much with bronchitis and asthma after taking flu jabs and was admitted into hospital twice and felt nearly died. The patient stated that the Lord showed her it was the flu jabs and she stopped them 7 years ago. The patient had no bronchitis or asthma.
Sex: U
Vaccine: FLU4
Symptoms: Feeling abnormal
Clinical narrative: feeling bad/worse; This case was reported by a consumer via media and described the occurrence of feeling bad in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. It was reported that after receiving Flu vaccine the patient felt worse. Some other people also said the same.
Sex: M
Vaccine: FLU4
Symptoms: Death
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.  It was unknown if the reporter considered the unknown cause of death to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that what adults did not know about vaccines could kill them. Many adults were unaware that vaccines kill. The reporter's friend's dad died from a flu shot.  The reporter's friend's baby died from her 4 month vaccines (unspecified).; Reported Cause(s) of Death: Unknown cause of death.
Sex: F
Vaccine: RAB
Symptoms: Hypersensitivity
Clinical narrative: severe allergic reaction; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a female patient who received Rabies NVS (Rabies Vaccine) for prophylaxis.   In February 2019, the patient received Rabies Vaccine. On an unknown date, less than a year after receiving Rabies Vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Rabies Vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient was in her 50s or 60s. On 5th February 2019 or 6th February 2019, the patient received an unknown Rabies vaccine. The patient experienced severe allergic reaction. The reporter had no more information and declines to provide any more information or follow up.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Coordination abnormal, Gait disturbance, Injection site pain, Pain in extremity
Clinical narrative: lack of coordination; altered balance/ feels like she is going to fall; sore arm/ injection site pain; hard time walking; This case was reported by a consumer via call center representative and described the occurrence of lack of coordination in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th May 2019, the patient received the 2nd dose of Shingrix. On 7th May 2019, less than a day after receiving Shingrix, the patient experienced lack of coordination, balance disorder, pain in arm and walking difficulty. On an unknown date, the outcome of the lack of coordination and balance disorder were recovering/resolving and the outcome of the pain in arm and walking difficulty were unknown.   It was unknown if the reporter considered the lack of coordination, balance disorder, pain in arm and walking difficulty to be related to Shingrix.  Additional details were provided as follows: Same day of vaccination the patient started noticing a lack of coordination. The patient was having a hard time walking because she lacks balance and the patient feels like she was going to fall off. Patient also reported a sore arm and pain at the injection site. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Seizure, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 20th March 2019) for prophylaxis. Co-suspect products included SHINGRIX (batch number ZY3X4, expiry date 20th April 2019) for prophylaxis. On 8th March 2018, the patient received the 1st dose of SHINGRIX. On 15th May 2018, the patient received the 2nd dose of SHINGRIX. On 8th March 2018, less than a month after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced convulsion (serious criteria GSK medically significant). On 14th April 2019, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles (serious criteria other: ER visit). The patient was treated with Valacyclovir. On 8th March 2018, the outcome of the convulsion was recovered/resolved. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and convulsion to be related to SHINGRIX. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The patient experienced convulsions after receivng 1st dose of SHINGRIX vaccine. The patient experienced shingles after 2nd dose of SHINGRIX. The patient received valacyclovir and shingles resolved. The shingles also reappeared again. The patient went to hospital and was put on valacyclovir again.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Contusion, Induration, Pain, Swelling
Clinical narrative: Bruising; Swelling; Soreness / Pain; Enduration hardness about size of 2 inches by 2 inches; This case was reported by a nurse via call center representative and described the occurrence of contusion in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABX747AA, expiry date 28th February 2020) for prophylaxis.   On 6th May 2019, the patient received Bexsero (intramuscular) .5 ml. On 6th May 2019, less than a day after receiving Bexsero, the patient experienced contusion, swelling, pain and induration. On an unknown date, the outcome of the contusion, swelling, pain and induration were not recovered/not resolved.   It was unknown if the reporter considered the contusion, swelling, pain and induration to be related to Bexsero.  Additional case details were reported as follows: The patient received vaccine in left arm. On the day of vaccination patient experienced bruising, swelling, soreness, pain and enduration hardness about size of 2 inches by 2 inches. The patient still experiencing all the side effects. The reporter reporting adverse events for two patients. This case had been linked to the case US2019086305, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Redness; Warmth; Swelling; This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced localized erythema, feeling of warmth and local swelling. The patient was treated with antibiotics nos. On an unknown date, the outcome of the localized erythema, feeling of warmth and local swelling were recovered/resolved.   It was unknown if the reporter considered the localized erythema, feeling of warmth and local swelling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional reported the patient received the Shingrix dose at a different location and had a pretty severe reaction.  The patient reported severe redness, warmth, and swelling, 4 to 6 inches from the actual injection site.  The patient reported going to the physician and received an antibiotic, which seemed to resolve the issue. The physician felt the reaction was local.  The reporter did not give consent to follow up. The outcome reported for all AES in the structured field of XML is " RECOVERED/RESOLVED WITH SEQUEL" instead of " Recovered/Resolved" (outcome uploaded in database)
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Diarrhoea, Dyspnoea, Influenza, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza in a adult male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, 1 day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced influenza (serious criteria hospitalization), weakness (serious criteria hospitalization), difficulty breathing (serious criteria hospitalization), diarrhea (serious criteria hospitalization) and sleepiness (serious criteria hospitalization). On an unknown date, the outcome of the influenza, weakness, difficulty breathing, diarrhea and sleepiness were recovered/resolved. It was unknown if the reporter considered the influenza, weakness, difficulty breathing, diarrhea and sleepiness to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported but, it could be 60 or 61 years. The patient received the flu shot about 5 years ago before the date of reporting. The patient stated that, the day after he got the flu he was weak, had difficulty breathing, diarrhea and he was sleeping alot. He noted he was in the hospital for 6 days.  The patient has not gotten the flu shot since. The reporter did not consent to follow-up.
Sex: F
Vaccine: HEP, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Menactra was put on the wrong encounter tray and given. wanted to give hepatitis b vaccine/ no AE; Menactra was given to a 2 day old in error/ no AE; Initial information received on 11-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves a 2 days old female patient who was vaccinated with a 0.5 ml  dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Batch number: U6207AB and expiry date: 25-May-2020) in right thigh on 11-Apr-2019, instead of HEPATITIS B VACCINE.   The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant vaccines was received.   It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  It was reported that patient was supposed to get a Hep B vaccine but 2 nurses were drawing up vaccines and the Menactra was put on the wrong encounter tray and given.  The patient followed up in office for a weight check and no reaction symptoms was reported, healthy baby.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Follow up information was received on 15-May-2019 received from a nurse.   As reported updated, no AE added.  Documents held by the sender: none.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: child was administered with an expired Daptacel; Initial information received on 15-May-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case involves a 12 months old female patient who was vaccinated with first dose expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5190AA, expiry date- 24-Apr-2019) vaccine on 10-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) which was received during the same visit.  It is an actual medication error due to expired vaccine used.  It was not reported if the patient experienced any adverse event following vaccination.  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 Directive  and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a five year old male patient who mistakenly received Adacel instead of Daptacel; 5 year old who mistakenly received Adacel instead of Daptacel; Initial information received on 15-May-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case involves a five years old male patient who was mistakenly received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U5875AB via unknown route in unknown administration site on 13-May-2019 instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past vaccination(s) included DTAP on 06-AUG-2015, DTAP on 16-MAY-2014, HEPATITIS B VACCINE on 12-MAR-2014 and IPV on 31-DEC-2013.  The patient's past medical history, medical treatment(s) and family history were not provided.   It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  It was not reported if the patient experienced any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: his first Menactra injection on 12/31/2013, the second injection March 16/ no AE.; Initial information received on 15-May-2019 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves a 12 years old male patient who received his first injection of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Prefilled Syringes) on 31-DEC-2013 (lot: U4556AB; left deltoid) and second injection on 16-March-2016 (lot: U527AA, right deltoid) via intramuscularly.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  ADACEL vaccine was received as concomitant therapy.   It was of actual medication error case due to  extra dose administered. As per Product insert, 4 year interval should be there between two doses.  No adverse event was experienced.  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 Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: baby was administered an expired vaccine; Initial information received on 15-May-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff) via phone.  This case involves a 4 months old male patient who was vaccinated with an 0.5 ml second expired dose of  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Batch number: C5455AA and expiry date: 18-Dec-2018) via intramuscular route on 14-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) on 14-May-2019.  It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 18 month old female patient was inadvertently received a dose of Quadracel; Initial information received on 15-May-2019 regarding an unsolicited valid non-serious case received from an other health care professional.   This case involves a 18 months old female patient who was inadvertently received a 0.5 ml fourth dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot C5532AB, expiry date: 09-Oct-2020 via intramuscular route in the thigh NOS on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HAEMOPHILUS INFLUENZAE TYPE B) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  It was an actual medication error due to inappropriate age at vaccine administration.  It was not reported if the patient experienced any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.