chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Hypotension, Nausea, Pyrexia, Syncope
Clinical narrative: fainted; headache; shivering; nerve pain in right ear; fever spiked; blood pressure dropped; This case was reported by a consumer via call center representative and described the occurrence of fainting in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and nerve pain. Previously administered products included Shingrix (1st dose received in September 2019, 3 months prior to date of reporting).   On 29th December 2019, the patient received the 2nd dose of Shingrix. On 29th December 2019, less than a day after receiving Shingrix, the patient experienced fainting (serious criteria hospitalization and GSK medically significant), headache (serious criteria hospitalization), shivering (serious criteria hospitalization), nerve pain (serious criteria hospitalization), fever (serious criteria hospitalization) and blood pressure decreased (serious criteria hospitalization). The patient was treated with butalbital + caffeine + paracetamol (Fioricet). On 30th December 2019, the outcome of the shivering was recovered/resolved. On 31st December 2019, the outcome of the headache and blood pressure decreased were recovered/resolved. On an unknown date, the outcome of the fainting, nerve pain and fever were unknown.   It was unknown if the reporter considered the fainting, headache, shivering, nerve pain, fever and blood pressure decreased to be related to Shingrix.  Additional details were provided as follows: On Sunday 29 DEC 2019 end of the day, the patient received 2nd dose on that night in bed started getting headache and was shivering in bed. The patient also experienced nerve pain in right ear which came back that night.  Within an hour of waking fever spiked, blood pressure dropped, fainted.  The blood pressure 70/30.  The patient went to Medical Center ER all day in ER, ran tests, tests came back normal. Headache remained all day and diastolic blood pressure was low all day.  The patient was admitted to hospital then headache and low blood pressure continued.  The patient received Fioricet and remained the night and all the next day.  Later, the patient received fluids and blood pressure finally reached 60 (diastolic) and released on 31st December 2019.  The patient requested financial help for hospital bills. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urine analysis normal, Viral test negative
Clinical narrative: fainted; headache; shivering; nerve pain in right ear; fever spiked; blood pressure dropped; This case was reported by a consumer via call center representative and described the occurrence of fainting in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and nerve pain. Previously administered products included Shingrix (1st dose received in September 2019, 3 months prior to date of reporting).   On 29th December 2019, the patient received the 2nd dose of Shingrix. On 29th December 2019, less than a day after receiving Shingrix, the patient experienced fainting (serious criteria hospitalization and GSK medically significant), headache (serious criteria hospitalization), shivering (serious criteria hospitalization), nerve pain (serious criteria hospitalization), fever (serious criteria hospitalization) and blood pressure decreased (serious criteria hospitalization). The patient was treated with butalbital + caffeine + paracetamol (Fioricet). On 30th December 2019, the outcome of the shivering was recovered/resolved. On 31st December 2019, the outcome of the headache and blood pressure decreased were recovered/resolved. On an unknown date, the outcome of the fainting, nerve pain and fever were unknown.   It was unknown if the reporter considered the fainting, headache, shivering, nerve pain, fever and blood pressure decreased to be related to Shingrix.  Additional details were provided as follows: On Sunday 29 DEC 2019 end of the day, the patient received 2nd dose on that night in bed started getting headache and was shivering in bed. The patient also experienced nerve pain in right ear which came back that night.  Within an hour of waking fever spiked, blood pressure dropped, fainted.  The blood pressure 70/30.  The patient went to Medical Center ER all day in ER, ran tests, tests came back normal. Headache remained all day and diastolic blood pressure was low all day.  The patient was admitted to hospital then headache and low blood pressure continued.  The patient received Fioricet and remained the night and all the next day.  Later, the patient received fluids and blood pressure finally reached 60 (diastolic) and released on 31st December 2019.  The patient requested financial help for hospital bills. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure decreased, Blood pressure diastolic decreased, Chills, Headache, Laboratory test normal
Clinical narrative: fainted; headache; shivering; nerve pain in right ear; fever spiked; blood pressure dropped; This case was reported by a consumer via call center representative and described the occurrence of fainting in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and nerve pain. Previously administered products included Shingrix (1st dose received in September 2019, 3 months prior to date of reporting).   On 29th December 2019, the patient received the 2nd dose of Shingrix. On 29th December 2019, less than a day after receiving Shingrix, the patient experienced fainting (serious criteria hospitalization and GSK medically significant), headache (serious criteria hospitalization), shivering (serious criteria hospitalization), nerve pain (serious criteria hospitalization), fever (serious criteria hospitalization) and blood pressure decreased (serious criteria hospitalization). The patient was treated with butalbital + caffeine + paracetamol (Fioricet). On 30th December 2019, the outcome of the shivering was recovered/resolved. On 31st December 2019, the outcome of the headache and blood pressure decreased were recovered/resolved. On an unknown date, the outcome of the fainting, nerve pain and fever were unknown.   It was unknown if the reporter considered the fainting, headache, shivering, nerve pain, fever and blood pressure decreased to be related to Shingrix.  Additional details were provided as follows: On Sunday 29 DEC 2019 end of the day, the patient received 2nd dose on that night in bed started getting headache and was shivering in bed. The patient also experienced nerve pain in right ear which came back that night.  Within an hour of waking fever spiked, blood pressure dropped, fainted.  The blood pressure 70/30.  The patient went to Medical Center ER all day in ER, ran tests, tests came back normal. Headache remained all day and diastolic blood pressure was low all day.  The patient was admitted to hospital then headache and low blood pressure continued.  The patient received Fioricet and remained the night and all the next day.  Later, the patient received fluids and blood pressure finally reached 60 (diastolic) and released on 31st December 2019.  The patient requested financial help for hospital bills. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia, Pyrexia, Syncope
Clinical narrative: fainted; headache; shivering; nerve pain in right ear; fever spiked; blood pressure dropped; This case was reported by a consumer via call center representative and described the occurrence of fainting in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and nerve pain. Previously administered products included Shingrix (1st dose received in September 2019, 3 months prior to date of reporting).   On 29th December 2019, the patient received the 2nd dose of Shingrix. On 29th December 2019, less than a day after receiving Shingrix, the patient experienced fainting (serious criteria hospitalization and GSK medically significant), headache (serious criteria hospitalization), shivering (serious criteria hospitalization), nerve pain (serious criteria hospitalization), fever (serious criteria hospitalization) and blood pressure decreased (serious criteria hospitalization). The patient was treated with butalbital + caffeine + paracetamol (Fioricet). On 30th December 2019, the outcome of the shivering was recovered/resolved. On 31st December 2019, the outcome of the headache and blood pressure decreased were recovered/resolved. On an unknown date, the outcome of the fainting, nerve pain and fever were unknown.   It was unknown if the reporter considered the fainting, headache, shivering, nerve pain, fever and blood pressure decreased to be related to Shingrix.  Additional details were provided as follows: On Sunday 29 DEC 2019 end of the day, the patient received 2nd dose on that night in bed started getting headache and was shivering in bed. The patient also experienced nerve pain in right ear which came back that night.  Within an hour of waking fever spiked, blood pressure dropped, fainted.  The blood pressure 70/30.  The patient went to Medical Center ER all day in ER, ran tests, tests came back normal. Headache remained all day and diastolic blood pressure was low all day.  The patient was admitted to hospital then headache and low blood pressure continued.  The patient received Fioricet and remained the night and all the next day.  Later, the patient received fluids and blood pressure finally reached 60 (diastolic) and released on 31st December 2019.  The patient requested financial help for hospital bills. The reporter consented to follow up.
Age: 1.5
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Wrong product administered
Clinical narrative: A 18 month old patient inadvertently received a dose of GARD A SIL 9; This spontaneous report has been received from a medical assistant concerning an 18-month-old patient of unknown gender. No information regarding the patient's concurrent condition, past medical history, concomitant medications, and drug reactions or allergies was provided.  On 17-JAN-2020, the 18-month-old patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 1 dosage form as prophylaxis (product administered to patient of inappropriate age) (lot number 1621934 has been verified to be a valid lot number, expiration date reported and validated as 29-JAN-2022) (concentration, frequency of vaccination scheme, route and anatomical location of vaccination were not reported).   The patient's outcome from the event was not reported.
Age: 1.5
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 18 month old patient inadvertently received a dose of GARD A SIL 9; This spontaneous report has been received from a medical assistant concerning an 18-month-old patient of unknown gender. No information regarding the patient's concurrent condition, past medical history, concomitant medications, and drug reactions or allergies was provided.  On 17-JAN-2020, the 18-month-old patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 1 dosage form as prophylaxis (product administered to patient of inappropriate age) (lot number 1621934 has been verified to be a valid lot number, expiration date reported and validated as 29-JAN-2022) (concentration, frequency of vaccination scheme, route and anatomical location of vaccination were not reported).   The patient's outcome from the event was not reported.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Myalgia, Peripheral swelling
Clinical narrative: Patient reported extreme pain and swelling in upper arm area. He reported that he moved his arm around. The reaction lasted about 10 days and his arm still tingles. Still some tingling.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Patient reported extreme pain and swelling in upper arm area. He reported that he moved his arm around. The reaction lasted about 10 days and his arm still tingles. Still some tingling.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Skin lesion, Squamous cell carcinoma
Clinical narrative: Squamous cell carcinoma at the injection site.  There was a small raised bump that looked like a small pox vaccine site with a blister about the size of the end of your little finger that was first noticed 12/1/2019. Patient states there was no bump present prior to the injection.  Treated with doxycycline and mupiricin ointment for an infection.  Medications did not help.  Saw Dr. 12/31/19 and area was resected.  Path showed squamous cell carcinoma.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site reaction, Injection site swelling, Injection site vesicles, Skin lesion removal, Squamous cell carcinoma
Clinical narrative: Squamous cell carcinoma at the injection site.  There was a small raised bump that looked like a small pox vaccine site with a blister about the size of the end of your little finger that was first noticed 12/1/2019. Patient states there was no bump present prior to the injection.  Treated with doxycycline and mupiricin ointment for an infection.  Medications did not help.  Saw Dr. 12/31/19 and area was resected.  Path showed squamous cell carcinoma.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Papilloma viral infection
Clinical narrative: Hpv infection; This spontaneous report has been received from a nurse, referring to a 30-year-old female patient. The patient had no medical history, no concomitant medication and no drug reaction/allergy  On an unknown dates, the patient was vaccinated with the Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb (GARDASIL) (lot# with expiration date unknown by reporter; strength, dose, frequency not reported) series intramuscularly for prophylaxis when she was 14 or 15 years old.  In November 2019 (reported as two months ago), the patient was diagnosed with human papillomavirus (HPV) infection. The patient had sought medical attention. On an unspecified date, the patient was treated with a colposcopy. The outcome of event was reported as not recovered. The causality assessment was not provided by the reporter.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored PROQUAD were administered to 10 patients; No additional adverse symptoms reported; This spontaneous report was received from an office manager concerning a patient of unknown age and gender.   The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) lot # S013712 and expiration date 01-NOV-2020 (dose and route were not provided), reconstituted in sterile diluent (STERILE DILUENT), for prophylaxis. It was unknown if the sterile diluent (STERILE DILUENT) used to reconstitute the vaccine was stored at proper temperature. No additional adverse events symptoms were reported. The temperature excursions were reported as follows:  measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) (Lot # S013712, expiration date 01-NOV-2020)  Temperature  Total time in the range 6 degrees Fahrenheit (F) to 14 F (-14 degrees Celcius (C) to -l0 C) for 30 minutes Total time in the range 15 F to 46 F (-9 C to 8 C) for 7 hours;  Total time in the range 47 F to 77 F (9 C to 25 C) for 9 hours  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA008160: US-009507513-2001USA008161: US-009507513-2001USA008163: US-009507513-2001USA008164: US-009507513-2001USA008165: US-009507513-2001USA008159: US-009507513-2001USA008158: US-009507513-2001USA008157: US-009507513-2001USA008162:
Age: 36.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: No additional adverse effects reported; When the Medical Assistant drew back on the syringe there was blood in the syringe so the needle was removed from the Patient's arm; This spontaneous report has been received from a medical assistant via a company representative, concerning a 36-year-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant medication were not reported.      On 14-JAN-2020, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number 1637642 has been verified to be a valid lot number, expiration date reported and validated as 28-MAY-2022) 1 dosage form on her left deltoid as prophylaxis (concentration, dose number, frequency of vaccination scheme, and route of administration were not reported).    On the same day, when a medical assistant drew back on the syringe containing the f HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), there was blood in the syringe (wrong technique in product usage process) therefore, the needle was removed from the patient's arm and it was set aside. On the same day, a new vial of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was drawn up and the patient was vaccinated in her right deltoid.   No additional effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received 3 doses ofGARDASIL 9, on unspecified dates, that were all outside of the recommended schedule; No additional adverse event reported; This spontaneous report was received from a pharmacy intern and refers to an unspecified patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On an unknown dates, the patient received 3 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis, which were all outside of the recommended schedule of the prescribing information. No additional adverse event was reported.
Sex: U
Vaccine: MMRV, UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient may have been administrated PROQUAD, who was over the age of 12 years old; This spontaneous report has been received from an office manager via a company representative, concerning a patient over the age of 12-year-old, of unknown gender. Information about the patient's pertinent medical history, concurrent conditions, previously drug reactions and or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with one measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection, as prophylaxis (concentration, formulation, dose, dose number, frequency, anatomical location were not reported; route of administration, lot number, and expiration date unknown by the reporter, however it was reporter that the patient was over the age of 12-year-old (product administered to patient of inappropriate age). A sterile diluent was used.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; a patient was administered an improperly stored dose of PNEUMOVAX23; This spontaneous report was received from a nurse concerning to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On 03-JUL-2019, the patient was vaccinated with an improperly stored dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX 23) lot number R033079 with expiration date on 06-JUN-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis.  Administered doses of vaccine experienced temperature excursion of unknown temperature or time frame. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; Information has been received from a lawyer referring to a male patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 16-JAN-2014, 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 a severe painful rash on his back and was diagnosed as shingles. 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 his 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 event shingles was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event shingles to be disability.
Sex: M
Vaccine: VARZOS
Symptoms: Aortic aneurysm, Hypoaesthesia, Ischaemic stroke, Paraesthesia, Vision blurred
Clinical narrative: acute ischemic stroke; thoracic aortic aneurysm without rupture; bilateral blurry vision; Information has been received from a lawyer referring to a male patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 19-OCT-2017, 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 a sudden onset of blurry vision and chronic numbness and tingling in his legs. The patient was diagnosed with an acute ischemic stroke, thoracic aortic aneurysm without rupture and bilateral blurry vision. 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 his 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 was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered acute ischemic stroke, thoracic aortic aneurysm without rupture and bilateral blurry vision to be disability.   Upon internal review, acute ischemic stroke was determined to be medically significant.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Cellulitis
Clinical narrative: Patient developed cellulitis after being administered a dose of PROQUAD; This spontaneous report was received from a certified medical assistant via company representative regarding a 4 years old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were reported as unknown. On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), (lot #, expiry date, dose and anatomical location were unspecified) subcutaneously for routine vaccination. Co-suspect therapy included sterile diluent. On an unknown date, the patient experienced cellulitis on unspecified area of the body after being administered the dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). On unspecified date, the patient's mother contacted the physician's office and the physician instructed the mother to take the patient to the hospital. It was unknown, whether the patient was admitted to the hospital or discharged on the same day. There was no information about the treatment drugs that were provided to the patient at the hospital. It was reported that the patient was going to the physician's office sometime soon for follow-up. The outcome of the event was reported as recovered. The causality of the event was not reported.  Upon internal review, the event cellulitis was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional adverse events reported; The vaccine coordinator is reporting the patient was administered a dose of VARIVAX on 1/13/2020 , that had been improperly stored.; This spontaneous report has been received from a vaccine coordinator (also reported as office manager), referring to a patient of unknown age and gender. The patient's historical condition and concurrent condition were not reported.  On-13-JAN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot# S021926 with expiration date: 15-JUL-2021; dose, strength, frequency and route unknown) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT).  The vaccine was stored under 1.2 Celsius (C) for 3 hours and 9 minutes. There was no previous temperature excursion. The digital data logger was involved.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Human papilloma virus test positive
Clinical narrative: the patient had an unspecified test which was positive for HPV after being vaccinated for HPV; This spontaneous report was received from a physician assistant via field representative and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, drug reactions, allergies, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, dose number, lot #, expiration date and route of administration were not reported) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, dose number, lot #, expiration date and route of administration were not reported) for prophylaxis, it was unable to determinate which vaccine was given to the patient.  On an unspecified date, after human papillomavirus (HPV) vaccination, the patient had an unspecified test for human papillomavirus (HPV), and the result was positive. The outcome of the event was unknown. Causality assessment was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Herpes zoster, Hypoacusis, Post herpetic neuralgia
Clinical narrative: Shingles; postherpetic neuralgia; Hearing problems; Balance problems; Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or around 28-SEP-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX), (lot #, administration route, anatomical location and expiration date were  unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered shingles, postherpetic neuralgia, hearing and balance problems. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, patient symptoms have resulted in physical limitations not present prior to using of the vaccine. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. Patient sustained severe and permanent personal injuries. 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. The aforementioned events were considered as disability.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Deafness unilateral, Sudden hearing loss, Tinnitus
Clinical narrative: Asymetrical sensorineural hearing loss; Sudden hearing loss of the left ear; Tinnitus of the left ear; Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or around 09-FEB-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX), (lot #, administration route, anatomical location and expiration date were  unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the zoster vaccine live (ZOSTAVAX) vaccine, the patient was diagnosed with asymmetrical sensorineural hearing loss, tinnitus of the left ear and sudden hearing loss of the left ear. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, patient symptoms have resulted in physical limitations not present prior to using of the vaccine. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. Patient sustained severe and permanent personal injuries. 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. The aforementioned events were consider as serious due to disability. Upon internal review the deafness neurosensory and sudden hearing loss were considered as medically significant events.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: a dose of improperly stored PROQUAD was administered to a patient; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies.  On 15-JAN-2020, a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 milliliter, with lot # S013712 and expiration date on 01-NOV-2020, for prophylaxis (dose number, route of administration and anatomical injection site were not reported) was administered to the patient. The sterile diluent used to reconstitute the vaccine was properly stored.  It was reported that on an unknown date, the vaccines were exposed to a temperature excursion below 12.2 Celsius (C) degrees for 25 minutes. There were no previous temperature excursions. The call was placed because of a Digital Data logger report.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects were reported; The patient received improperly stored PNEUMOVAX 23; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding medical history, concurrent conditions or concomitant medication was not provided.  On 20-JAN-2020, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 milliliter, once, lot # reported as S033516, expiration date: 29-JUN-2021, (route and anatomical site of administration were not reported) for prophylaxis. No additional adverse effects were reported.   It was also reported the highest temperature was above  47°F/9°C (47.1F). Time frame: 15 minutes. There was no previous temperature excursion. Data logger was involved.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient was administered an expired MMR II vaccine; This spontaneous report was received from an Office administrator via company representative regarding a 01-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent. On 21-JAN-2020, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) with a lot # R000555 and expiry date was reported as 08-JAN-2020 (expired product administered) (strength, dose and route were not reported) for prophylaxis. No additional adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: The nurse reports that the patient received an improperly stored dose of ROTATEQ; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 20-JAN-2020 the patient received an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (2 ml, batch/lot number 1658254; expiration date 17-NOV-2020, strength and route were not provided) for prophylaxis (incorrect product storage). The administered doses experienced a temperature excursion of 0.06 degree Celsius below zero for 4 hour and 59 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Musculoskeletal disorder
Clinical narrative: difficulty using arm, where PNEUMOVAX 23 was injected; injection site pain and swelling; injection site pain and swelling; This spontaneous report was received from a medical assistant regarding a 69 year old male patient. The patient's concurrent condition included diabetes. Approximately in 2019, reported as "1 year ago", the patient was vaccinated with pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13). The patient's concomitant therapies included diclofenac, metformin, triamcinolone acetonide and cetirizine hydrochloride (ZYRTEC). The patient did not have any drug reactions/ allergies. On 17-JAN-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S028601, expiration date: 02-JUN-2021 (strength, dose, route of administration and anatomical location unknown) in the arm for prophylaxis. On the same day, the patient had injection site pain and swelling (injection site swelling) and difficulty using the arm where pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was injected (injected limb mobility decreased). On 18-JAN-2020 and on 21-JAN-2020, the patient was seen in the office. The patient did not receive any treatment for the events and no lab diagnostics or studies were performed. The outcome of injected limb mobility decreased, injection site swelling and injection site pain was reported as not recovered. The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported. No product quality complaints were involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; Patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 17-JAN-2020, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) of lot # S004399 with expiry date 06-NOV-2020 via oral route (frequency unknown) for prophylaxis (product storage error). On an unknown date, the vaccine was exposed to the temperature below 36 degree Fahrenheit (16 F) for 2 hours and 30 minutes and below 24 Fahrenheit (16.7 F) for 1 hour and 30 minutes, 1 cycle. There was no previous temperature excursion reported. Digital data logger was involved. No adverse effect reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored dose of proquad; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy details were not reported.       On 23-DEC-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) at a dose of 0.5 milliliter, lot # s013712, expiry date 01-NOV-2020, via unknown route for prophylaxis (product storage error). The vaccine was reconstituted with well stored sterile diluent. The vaccine was exposed to a temperature of -12.2 degree Celsius at a time frame of 25 minutes. No previous temperature excursion was reported. The call was due to digital data logger. No additional information was reported.
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored PROQUAD were administered to 10 patients; No additional adverse symptoms reported; This spontaneous report was received from an office manager concerning a patient of unknown age and gender.   The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) lot # S013712 and expiration date 01-NOV-2020 (dose and route were not provided), reconstituted in sterile diluent (STERILE DILUENT), for prophylaxis. It was unknown if the sterile diluent (STERILE DILUENT) used to reconstitute the vaccine was stored at proper temperature. No additional adverse events symptoms were reported. The temperature excursions were reported as follows:  measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD)(Lot # S013712, expiration date 01-NOV-2020)  Temperature  Total time in the range 6 degrees Fahrenheit (F) to 14 F (-14 degrees Celcius (C) to -l0 C) for 30 minutes Total time in the range 15 F to 46 F (-9 C to 8 C) for 7 hours;  Total time in the range 47 F to 77 F (9 C to 25 C) for 9 hours  This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA005479:
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Improperly stored PROQUAD were administered to 10 patients; No additional adverse symptoms reported; This spontaneous report was received from an office manager concerning a patient of unknown age and gender.   The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) lot # S013712 and expiration date 01-NOV-2020 (dose and route were not provided), reconstituted in sterile diluent (STERILE DILUENT), for prophylaxis. It was unknown if the sterile diluent (STERILE DILUENT) used to reconstitute the vaccine was stored at proper temperature. No additional adverse events symptoms were reported. The temperature excursions were reported as follows:  measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) (Lot #S013712, expiration date 01-NOV-2020)  Temperature  Total time in the range 6 degrees Fahrenheit (F) to 14 F (-14 degrees Celcius (C) to -l0 C) for 30 minutes Total time in the range 15 F to 46 F (-9 C to 8 C) for 7 hours;  Total time in the range 47 F to 77 F (9 C to 25 C) for 9 hours  This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA005479:
Sex: U
Vaccine: MMRV, UNK
Symptoms: Product storage error
Clinical narrative: Improperly stored PROQUAD were administered to 10 patients; No additional adverse symptoms reported; This spontaneous report was received from an office manager concerning a patient of unknown age and gender.   The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) lot # S013712 and expiration date 01-NOV-2020 (dose and route were not provided), reconstituted in sterile diluent (STERILE DILUENT), for prophylaxis. It was unknown if the sterile diluent (STERILE DILUENT) used to reconstitute the vaccine was stored at proper temperature. No additional adverse events symptoms were reported. The temperature excursions were reported as follows:  measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) (Lot # S013712, expiration date 01-NOV-2020)  Temperature  Total time in the range 6 degrees Fahrenheit (F) to 14 F (-14 degrees Celcius (C) to -l0 C) for 30 minutes Total time in the range 15 F to 46 F (-9 C to 8 C) for 7 hours;  Total time in the range 47 F to 77 F (9 C to 25 C) for 9 hours  This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA005479:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Improperly stored PROQUAD were administered to 10 patients; No additional adverse symptoms reported; This spontaneous report was received from an office manager concerning a patient of unknown age and gender.   The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) lot # S013712 and expiration date 01-NOV-2020 (dose and route were not provided), reconstituted in sterile diluent (STERILE DILUENT), for prophylaxis. It was unknown if the sterile diluent (STERILE DILUENT) used to reconstitute the vaccine was stored at proper temperature. No additional adverse events symptoms were reported. The temperature excursions were reported as follows:  measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) (Lot # S013712, expiration date 01-NOV-2020)  Temperature  Total time in the range 6 degrees Fahrenheit (F) to 14 F (-14 degrees Celcius (C) to -l0 C) for 30 minutes Total time in the range 15 F to 46 F (-9 C to 8 C) for 7 hours;  Total time in the range 47 F to 77 F (9 C to 25 C) for 9 hours  This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA005479:
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient experienced no symptoms; The patient was administered an unspecified hepatitis A vaccine on an unspecified date in 2017. The pharmacist reports that the patient received a dose of VAQTA on 9/25/2019; This spontaneous information has been received from a pharmacist, concerning an adult patient of unknown gender. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.  On an unspecified date in 2017, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (manufacturer unknown) (strength, route of administration, anatomical location, indication, lot number and expiration date were not reported).  On 25-SEP-2019, the patient received a dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection as prophylaxis (strength and anatomical location were not reported; lot number and expiration date were unknown by the reporter) (inappropriate schedule of drug administration).  The patient experienced no symptoms.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known adverse effects; a 17 year old patient received a dose of PROQUAD; This spontaneous report was received from a medical assistant referring to a 17-year-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 03-JAN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin (rHA), lot number S021617 with expiration date on 09-JAN-2021 (dosage schedule, route of administration and anatomical location were not reported), for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional adverse symptoms reported; an expired dose od M-M-R-II was administered to patient; 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 therapies were not provided.      On 22-JAN-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose and administration route were not provided) lot # N034002 expiration date 02-DEC-2019, for prophylaxis. No additional adverse symptoms were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect; Patient was inadvertently administered a dose of MMR II that was expired; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reaction/ allergies were not reported. Concomitant medications included sterile diluent. On 21-JAN-2020, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) lot number N032427 and expiry date 16-NOV-2019 (route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No adverse events were reported. No product quality complaint (PQC) was reported.