chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: MMR, UNK, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: Urine pregnancy test was positive; no additional adverse effects were reported; This spontaneous prospective report was received from a nurse concerning to a female patient. The patient's medical history and concurrent conditions were not provided. Concomitant therapies included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (Tdap), influenza virus vaccine (unspecified) and hepatitis A virus vaccine inactivated (+) hepatitis B virus vaccine rhbsag (yeast) (TWINRIX).  On an unspecified date on January 2020, the patient reported her last menstrual period (LPM).  On 26-FEB-2020, the patient was vaccinated with measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  recombinant Human albumin (rHA) 0.5 milliliter, subcutaneously, once (lot # S013719, expiration date 05-MAY-2021), for routine immunisation and varicella virus vaccine live (oka/merck)(VARIVAX), 0.5 milliliter, once, lot # S005080, expiration date 19-FEB-2021, for prophylaxis (route not provided). Both vaccines were administered using the Merck sterile diluent.  On 09-MAR-2020, the patient was seen by the nurse, and on that day, a urine pregnancy test was positive (vaccine exposure during pregnancy). No additional adverse effects were reported.  At the time of the report, the outcome of the event was not provided.
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient experienced no symptoms; a shipment of Pneumovax23 was due to be delivered on 26-FEB-2020 but was not delivered until 27-FEB-2020. On 05-MAR-2020 a patient was administered a dose of pneumovax23; This initial spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not reported.  On 26-FEB-2020, a shipment of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was due to be delivered, however, it was not delivered until 27-FEB-2020 (product distribution issue).  On 05-MAR-2020, the patient was vaccinated with one dose of the late shipment of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe (strength, dose, route of administration and vaccination scheme were not reported; with lot number reported as S029542 which was confirmed to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent) and expiration date reported and established as 10-JUN-2021) as prophylaxis. It was reported that the patient experienced no symptoms. No further information provided.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress:  manufacturercity: ; manufacturerstate:; manufacturercountry; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2003USA005134: US-009507513-2003USA005469: US-009507513-2003USA005207: US-009507513-2003USA005195: US-009507513-2003USA005188: US-009507513-2003USA004971:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; product storage error; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 08-OCT-2019, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (strength, dose, indication, lot/ batch number and expiry date were not reported) and on 20-FEB-2020, the patient was vaccinated with another dose of rotavirus vaccine, live, oral, pentavalent (therapy type: Digital Data Logger) (ROTATEQ) which was improperly stored for prophylaxis (lot # 1660112, expiration date reported as 18-OCT-2020, strength, dose, route were not reported) (product storage error). There were no adverse effects reported. The administered dose of the vaccine experienced multiple temperature excursions below 2 degree Celsius (1.28 Celsius) for 2 hours and 30 hours as recorded by a data logger. The vaccines had no previous temperature excursion. No product quality complaint was reported.The outcome of product storage error was unknown.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; on 19/02/2020, the patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported.  On 17-OCT-2019, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). On 19-FEB-2020, the patient received subsequent dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) lot # 1660112 and expiry date 18-OCT-2020, 1 dosage form for prophylaxis (strength, anatomical location, route not reported). No additional adverse events reported. Doses of suspect vaccines experienced multiple temperature excursions below 2 degrees Celsius (°C) (1.28C) for 2 hours and 30 minutes. It was reported that there was no previous temperature excursion. Data logger was involved. No product quality compliant was involved in the report.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; received improperly stored ROTATEQ; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.       On 14-JAN-2020, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # and expiry date was not reported) and subsequently on 10-MAR-2020, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # 1660942, expiry date : 06-FEB-2021) orally for prophylaxis.    It was reported that the vaccine experienced a temperature excursion below 2 degrees Celsius (C) (1.28C) for a duration of 2 hours and 30 hours (product storage error). It was reported that there was no previous temperature excursion and this call was due to a digital data logger. The patient had no adverse event. There was no product quality complaint reported.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reports; one male patient was administered improperly stored ROTATEQ; Information has been received from a vaccine coordinator, referring to a 6 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 26-FEB-2020, the patient was administered rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were unknown; lot # 1658255, expiration date 07-FEB-2021) orally for prophylaxis. The vaccine was exposed to temperature excursion below 2 degrees Celsius (0.8 degrees Celsius for 5 hours and 9 minutes on 02-MAR-2020, 0.9 degrees Celsius for 11 hours on 04-MAR-2020 and minus 1.3 degrees Celsius for 9 hours and 29 minutes on 05-MAR-2020) (incorrect product storage).   There was previous temperature excursion at above 9 degrees Celsius (9.3 degrees Celsius) for 3 hours 33 minutes on 25-FEB-2020 and at below 2 degrees Celsius (0.8 degrees Celsius) for 11 hours 39 minutes on 03-MAR-2020. The call was due to digital data logger. No additional adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash, Rash vesicular
Clinical narrative: postherpetic neuralgia; shingles; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 15-JUL-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered from an acute onset of painful vesicular rash on the right side and was diagnosed with shingles and postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences 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 patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient 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 of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events shingles and postherpetic neuralgia were considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events shingles and postherpetic neuralgia to be disability.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On 07-APR-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles. On 25-APR-2011, the patient presented with complaints of a painful rash and was diagnosed with shingles by her primary care physician. The patient's shingles outbreak lasted several weeks causing severe pain and suffering. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences 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 patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient 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 of zoster vaccine live (ZOSTAVAX), the patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of zoster vaccine live (ZOSTAVAX). The outcome of the events shingles was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events shingles to be disability.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA007100:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Rash
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication were not reported.     In or around October 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, strength, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles.         In or around June 2018 the patient presented to his dermatologist with a painful rash located near his left flank. The patient was diagnosed with shingles and prescribed medication to treat the condition. The patient's shingles outbreak lasted for several weeks causing severe pain and suffering. The patient continued to have nerve pain in the area of the rash and was required to take medication to treat the pain. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Merck's wrongful conduct, the patient 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 of Defendants' conduct, the patient have incurred and will continue to incur medical expenses and other economic harm as a direct result of zoster vaccine live (ZOSTAVAX). The outcome of herpes zoster was not resolved. The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).     The event herpes zoster was considered to be serious due to disability.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effect reported; patient was administered a dose of properly stored but expired PNEUMOV AX 23 which expired on 3/1/2020; This spontaneous report as received from a other health professional refers to a patient of unknown age.    On 16-MAR-2020 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R007721, intramuscular for prophylaxis.  lot number R007721 which had already expired on 01-MAR-2020. No additional adverse effect reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported.; patient received unspecified dose of either a VARIVAX or a PROQUAD dose that was improperly stored.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 06-FEB-2020, the patient received unspecified dose of either a varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route were unknown; lot # S025610, expiration date 18-AUG-2021) or measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose and route were unknown; lot # S0l7250, expiration date 01-DEC-2020) for prophylaxis, that was improperly stored. sterile diluent was properly stored. The vaccine was exposed to temperature excursion at 7.5 degrees Fahrenheit for 15 minutes (incorrect product storage). There was no previous temperature excursion. The call was due to digital data logger. No symptoms were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. On or about 25-JUL-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) at a Pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2015, the patient was treated by a physician, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular, Vaccination failure
Clinical narrative: post-herpetic neuralgia; The vaccine did not prevent shingles as intended; shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. In 2011, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) at a Pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 15-DEC-2011, the patient was treated by a physician, for the onset of a severe vesicular rash, which was diagnosed as shingles. The patient was prescribed amitriptyline (ELAVIL) for management of her painful symptoms and chronic pain. On or about 31-JAN-2012, the patient sought subsequent from the physician, for the diagnosis of post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. The patient was prescribed amitriptyline pregabalin (LYRICA) for management of her painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events post-herpetic neuralgia, herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) at a Pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2015 the patient was treated by a physician, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. On or about 18-FEB-2008, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) at a medical center, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 19-MAR-2013, the patient was treated by a physician, for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) at a Pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by a physician, for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On 07-APR-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles. On 25-APR-2011, the patient presented with complaints of a painful rash and was diagnosed with shingles by her primary care physician. The patient's shingles outbreak lasted several weeks causing severe pain and suffering. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences 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 patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient 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 of zoster vaccine live (ZOSTAVAX), the patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of zoster vaccine live (ZOSTAVAX). The outcome of the events shingles was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events shingles to be disability.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA006636:
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Heart rate decreased, Hypotension, Immediate post-injection reaction, Muscle twitching, Pallor
Clinical narrative: complex syncope episode immediately after injection,  patient was pale, twitching. BP low, HR low. VS stable after about 20 minutes, bottle of water, and snacks.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: complex syncope episode immediately after injection,  patient was pale, twitching. BP low, HR low. VS stable after about 20 minutes, bottle of water, and snacks.
Age: 71.0
Sex: F
Vaccine: FLUR4
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Patient received influenza vaccine 1/26/20. She reported to the pharmacy that she was still experiencing pain in her shoulder when she lifted her arm in March. She had not been evaluated by a doctor.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. On or about 03-MAR-2009, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) at a Pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 22-JUL-2014, the patient was treated by a physician, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. In 2009, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) by a physician, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by the physician, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported; patient received unspecified dose of either a VARIVAX or a PROQUAD dose that was improperly stored; Information has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 07-FEB-2020, the patient received unspecified dose of either a varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route were unknown; lot # S025610, expiration date 18-AUG-2021) or measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose and route were unknown; lot # S017250, expiration date 01-DEC-2020) for prophylaxis, that was improperly stored. sterile diluent was properly stored. The vaccine was exposed to temperature excursion at 7.5 degrees Fahrenheit for 15 minutes (incorrect product storage). There was no previous temperature excursion. The call was due to digital data logger. No symptoms were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 24-MAR-2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 02-AUG-2010, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. The patient was was prescribed acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Seizure
Clinical narrative: received a Tdap vaccine 2 years ago and had a seizure immediately after; This case was reported by a nurse via call center representative and described the occurrence of seizure in a elderly female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, immediately after receiving Tdap Vaccine, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown.   It was unknown if the reporter considered the seizure to be related to Tdap Vaccine.  Additional information was received as follows: The age at vaccination was not reported. Two years before the date of reporting, the patient received Tdap vaccine and had seizure immediately. The reporter consented for follow up. This case has been linked to US2020045174, reported by same reporter.
Sex: F
Vaccine: DTAP
Symptoms: Intensive care, Seizure
Clinical narrative: Dtap vaccine was administered she had a seizure; This case was reported by a nurse via call center representative and described the occurrence of seizure in a infant female patient who received DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, an unknown time after receiving DTaP vaccine, the patient experienced seizure (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the seizure was unknown.   It was unknown if the reporter considered the seizure to be related to DTaP vaccine.  Additional details were provided as follows: The age at vaccination was not reported, but reported that the patient received the vaccine when she was baby. The nurse practitioner reported that after vaccination with Dtap vaccine along with other vaccines, the patient had to be placed in the intensive care unit due to seizures. The reporter stated that, they were uncertain which vaccine could have caused the incident. The reporter stated that, the patient received vaccines seperately, but unknown which brand of vaccine did the patient received. No additional details were provided. The reporter consented to follow up. This case has been linked with case US2020045170, reported by same reporter.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: & Swelling of arm
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dry skin, Oral mucosal erythema, Pruritus, Rash
Clinical narrative: On 02/13/2020 client was checked  out at 10:43, her mother was advised to remain 30 minutes after vaccine injection was given. On 03/18/2020 mother called around 3:30 pm and states her child has had a reactions to some vaccines that was given on 02/13/2020. She stated she started having the reactions the next day. She also stated she called 2 days later and did not get an answer but she left a message. I told her the facility is closed on weekends, and I was not given a message of the call, and no calls was on my telephone. She continues and stated she called a Doctor and was told she need to return to the facility that the child received the vaccines.  the mother continued and states she gave the child Benadryl 25mg from over the counter. I ask her if she took the child to the emergency room? she stated no but she called. At this point i ask if the child was still itching, she said yes. I told her to bring child to the Health Department now, and said she could not because she had to go to work but she would bring her the next day when we open. I told her the Health department opens at 8:00am. on 03/19/2020 patient was accompanied by her mother and her brother at 9:15am. No sighs of stress. V/s BP 101/68- P. 69- Resp. 18 Temp: 95.6. I received a statement at this time from the mother. She said the her child started itching  10 minutes after receiving the vaccines, but they left about 10 minutes after receiving the vaccines. I showed her the statement she signed advising her to remain 30 minutes after any injection. She then said I did not say, I did not sign. I said, "I just left around ten minutes after receiving the vaccines". I then told her she could have come back to have the child checked out. She said well I called the next day (02/14-2020) around 4pm or I do not know the exact time. It was when the rash started. She stated the Benadryl was started about four to six hours after she called on 03/14/2020. she stated that Coco butter was applied about a week later because the rash was getting worse and they continued to give the child Benadryl.   On 03-19-2020 here  at the Health District. My finding was patient had a red spot on the inside of her  bottom lip and a dark patchy rash on her right and left thighs with a very dry appearance. She stated it was still itching. Her mother wanted to know if we could give her some sort of cream for the itching. I told her the only advise I could give was to go to the emergency room if the itching continued. Mother also stated patient  was not on any other medications and did not have any allergies.  LPN/ Immunization Coordinator Health District
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Bradycardia, Diarrhoea, Lip swelling, Nausea, Presyncope
Clinical narrative: I experienced stage 3 reactions during the night,tachycardia,  nausea, vomiting, diarrhea, vasovagal reaction when I got up with bradycardia of 40/min, syncope,  and my face swelling.  It continued to swell including my lips, inside of my cheeks.  I took 12.5 mg of Benedryl to prevent my throat from swelling too.  This am March 19 my mouth isn't as swollen but my face still is.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face, Syncope, Tachycardia, Vomiting
Clinical narrative: I experienced stage 3 reactions during the night,tachycardia,  nausea, vomiting, diarrhea, vasovagal reaction when I got up with bradycardia of 40/min, syncope,  and my face swelling.  It continued to swell including my lips, inside of my cheeks.  I took 12.5 mg of Benedryl to prevent my throat from swelling too.  This am March 19 my mouth isn't as swollen but my face still is.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Fever & Tremor
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse AE information provided; the patient was administered an improperly stored dose ofROTATEQ on 2/21/2020; This spontaneous report was received from nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/ allergies and concomitant medication were unknown.  On 21-FEB-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# R017932, expiration date 01-MAY-2020; dose and frequency were not provided) orally for prophylaxis (product storage error).  Temperature excursion of this vaccine was highest temperature above 47 degrees Fahrenheit (54.5F) for 2 hours 25 minutes. There was no previous temperature excursion. No additional adverse event was reported. Data logger was involved.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: post-herpetic neuralgia; persistent strain of herpes zoster or shingles; The vaccine did not prevent shingles as intended; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 29-OCT-2009, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 23-SEP-2013, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as shingles. The patient was was prescribed tramadol for management of his painful symptoms and chronic pain. On or about 10-OCT-2012, the patient sought subsequent treatment for the diagnosis of post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. The patient was prescribed gabapentin for management of his painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 14-APR-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 04-AUG-2014, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 03-DEC-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended. On or about 02-NOV-2014, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as shingles. She was prescribed acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 10.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient was supposed to have received Adacel and was inadvertently given Daptacel instead intramuscularly in the deltoid/ No AE; Initial information was received on 12-Mar-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 10 years and 11 months old male patient who was supposed to have received DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [ADACEL] (lot number not reported) and was inadvertently given DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead via intramuscular route in the deltoid NOS (unknown if left or right deltoid)  (wrong product administered).  The patient's past vaccination(s) included DAPTACEL with Had four previous doses. Medical history, past medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to wrong vaccine administered.  It was unknown whether the patient had any adverse reactions.  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.  Information on the batch number was requested.
Age: 27.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Deep chills and body aches set in about 11-12 hours after the vaccination, followed by a headache and fever. Symptoms continued until about 3am when the fever broke, but the headache and flu-like body aches continued until through the following day.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal pain, Arthralgia, Asthenia, Chills, Crying
Clinical narrative: Weeklong series of issues starting with chills, weakness, body and joint aches. Progressing to a night of severe abdominal pains followed by strong non stop vomiting over one entire night. Had to lie on floor near toilet. Could barely sit up to vomit, dizzy.  Crying because no relief after vomiting. The abdominal pain would start up right away until the violent vomiting would begin again. Then the watery diarrhea started later near morning. Lost  4 lbs over 2 days.  The following days I was weak, slept a lot. Ocassional cramps. Thankful no vomiting. It was over a week before I was much back to normal. Thank goodness my husband was with me. He also had a similar reaction. Not as prolonged or violent.  I was dizzy and pale post incident.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Diarrhoea, Dizziness, Hypersomnia, Muscle spasms, Pain
Clinical narrative: Weeklong series of issues starting with chills, weakness, body and joint aches. Progressing to a night of severe abdominal pains followed by strong non stop vomiting over one entire night. Had to lie on floor near toilet. Could barely sit up to vomit, dizzy.  Crying because no relief after vomiting. The abdominal pain would start up right away until the violent vomiting would begin again. Then the watery diarrhea started later near morning. Lost  4 lbs over 2 days.  The following days I was weak, slept a lot. Ocassional cramps. Thankful no vomiting. It was over a week before I was much back to normal. Thank goodness my husband was with me. He also had a similar reaction. Not as prolonged or violent.  I was dizzy and pale post incident.