chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, Exposure during pregnancy, Laboratory test normal, No adverse event, Prenatal screening test
Clinical narrative: This initial non-serious spontaneous case, was received on 21-Sep-2017 from other health professional (nurse), concerning a 20-year-old (explicitly reported as 21 years) adult pregnant female patient. Patient's last menstrual period was on 04-Jun-2017. The patient did not use any contraceptives and had no previous pregnancies, miscarriage/still birth, congenital anomaly, relevant maternal/ paternal medical history. The prenatal test showed no defect. Concomitant medications included prenatal vitamins for unknown indication. On 19-Sep-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, batch number: 179002 (as reported), expiry date: May-2018, anatomical location: not reported). It was reported that FLUAD was administered to a pregnant patient aged less than 65 years (explicitly coded to inappropriate age at vaccine administration and vaccine exposure during pregnancy). It was reported that the patient had not experienced any adverse event. The EDD (estimated date of delivery) was reported as 11-Mar-2018. At the time of this report, the outcome of the event was not reported. The reporter assessed the event as non-serious. Follow-up report received on 28-Sep-2017: It was reported that the patient had not experienced any adverse event (no adverse event). Follow-up report received on 13-Oct-2017: The reporter confirmed the LMP (last menstrual period-04-Mar-2017) and EDD (estimated date of delivery-11-Mar-2018). It was reported that the patient did not use any contraceptives and had no previous pregnancies, miscarriage/still birth, congenital anomaly, relevant maternal/ paternal medical history. The prenatal test showed no defect. Narrative amended accordingly.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: CSF protein increased, Eye swelling, Guillain-Barre syndrome, Headache, Hypoaesthesia
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 15-Oct-2017, concerning a 23-year-old, adult, female patient. The patient's historical conditions included chronic constipation, lower back pain and no report of loose stools in the recent past. The patient's concomitant medication included AMITIZA for an unknown indication. The patient had no viral infection 3-4 weeks prior to the vaccination/onset of GBS (Guillain-Barre syndrome). On 02-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: XT59305 (as reported), expiry date: 17-May-2018). On the same day, within three hours after receiving the vaccine, the patient had headache. 20 hrs later, the patient experienced vertigo and swelling at the eyes. Then the patient experienced loss of feeling in legs which led to hospital admission on 09-Oct-2017. The patient underwent lab investigations included lumbar puncture which showed positive protein for GBS (Guillain-Barre syndrome) and MRI was performed, results were not reported. On 10-Oct-2017, after 9 days of vaccination, the patient was diagnosed with GBS. It was reported that, the patient was in the hospital for 5 days and was treated with intravenous immunoglobulin (IVIG). On an unspecified date, after 1 week of physical therapy, the patient was ambulating independently and no other symptoms of GBS. On 09-Nov-2017, the patient recovered from the event (after receiving intravenous immunoglobulin (IVIG) as reported). The reporter assessed the event as serious (hospitalization). Follow-up received from the reporter on 24-Oct-2017: The patient's lab result (lumbar puncture), final diagnosis and the outcome of the event were updated. Narrative amended accordingly. Follow-up received from the reporter on 10-Nov-2017: Added the event onset date (10-Oct-2017) and the event outcome was changed from recovering to recovered. Event stop date was updated as 09-Nov-2017. It was reported that, the patient had no viral infection 3-4 weeks prior to the vaccination/onset of GBS. There was no information regarding whether vertigo and facial swelling at eyes were due to. Narrative amended accordingly. Follow-up received from the reporter on 27-Nov-2017: The patient had no reports of loose stools in recent past. It was reported that, the patient recovered from the event after receiving intravenous immunoglobulin (IVIG). Amended narrative accordingly.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Nuclear magnetic resonance imaging, Vertigo
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 15-Oct-2017, concerning a 23-year-old, adult, female patient. The patient's historical conditions included chronic constipation, lower back pain and no report of loose stools in the recent past. The patient's concomitant medication included AMITIZA for an unknown indication. The patient had no viral infection 3-4 weeks prior to the vaccination/onset of GBS (Guillain-Barre syndrome). On 02-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: XT59305 (as reported), expiry date: 17-May-2018). On the same day, within three hours after receiving the vaccine, the patient had headache. 20 hrs later, the patient experienced vertigo and swelling at the eyes. Then the patient experienced loss of feeling in legs which led to hospital admission on 09-Oct-2017. The patient underwent lab investigations included lumbar puncture which showed positive protein for GBS (Guillain-Barre syndrome) and MRI was performed, results were not reported. On 10-Oct-2017, after 9 days of vaccination, the patient was diagnosed with GBS. It was reported that, the patient was in the hospital for 5 days and was treated with intravenous immunoglobulin (IVIG). On an unspecified date, after 1 week of physical therapy, the patient was ambulating independently and no other symptoms of GBS. On 09-Nov-2017, the patient recovered from the event (after receiving intravenous immunoglobulin (IVIG) as reported). The reporter assessed the event as serious (hospitalization). Follow-up received from the reporter on 24-Oct-2017: The patient's lab result (lumbar puncture), final diagnosis and the outcome of the event were updated. Narrative amended accordingly. Follow-up received from the reporter on 10-Nov-2017: Added the event onset date (10-Oct-2017) and the event outcome was changed from recovering to recovered. Event stop date was updated as 09-Nov-2017. It was reported that, the patient had no viral infection 3-4 weeks prior to the vaccination/onset of GBS. There was no information regarding whether vertigo and facial swelling at eyes were due to. Narrative amended accordingly. Follow-up received from the reporter on 27-Nov-2017: The patient had no reports of loose stools in recent past. It was reported that, the patient recovered from the event after receiving intravenous immunoglobulin (IVIG). Amended narrative accordingly.
Age: 67.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: This initial spontaneous case was received from pharmacist on 11-Oct-2017, concerning a 67-year-old elderly female patient. The patient's medical history included hypertension, hypothyroidism and arthritis since and unspecified date. The patient's concomitant medications included anti-inflammatory (unspecified), blood pressure and thyroid medications. On 06-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, batch number: 179401 (as reported), route of administration: intramuscular, expiry date: Jun-2018 and anatomical location: deltoid). On the same day (in the evening), after the vaccination, the patient had excruciating pain around the injection site. After 5 days, the patient had difficulty to move her arm, which was continued and was treated with ibuprofen. The outcome of the events was recovered. The reporter assessed the causality of the event injection site pain as related. The reporter assessed the report as non-serious. Follow-up report received on 28-Nov-2017: Outcome of the events was updated as recovered. It was reported that, the patient had pain around the injection site. Reporter's causality was added. Amended narrative accordingly.
Age: 67.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Asthenia, Mobility decreased, Pain in extremity, Tenderness
Clinical narrative: This initial spontaneous case was received from pharmacist on 11-Oct-2017, concerning a 67-year-old elderly female patient. The patient's medical history included hypertension, hypothyroidism and arthritis since and unspecified date. The patient's concomitant medications included anti-inflammatory (unspecified), blood pressure and thyroid medications. On 06-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, batch number: 179401 (as reported), route of administration: intramuscular, expiry date: Jun-2018 and anatomical location: deltoid). On the same day (in the evening), after the vaccination, the patient had excruciating pain around the injection site. After 5 days, the patient had difficulty to move her arm, which was continued and was treated with ibuprofen. The outcome of the events was recovered. The reporter assessed the causality of the event injection site pain as related. The reporter assessed the report as non-serious. Follow-up report received on 28-Nov-2017: Outcome of the events was updated as recovered. It was reported that, the patient had pain around the injection site. Reporter's causality was added. Amended narrative accordingly.
Age: 77.0
Sex: M
Vaccine: FLUA3
Symptoms: Computerised tomogram head normal, Computerised tomogram thorax normal, Electrocardiogram normal, Electroencephalogram normal, Full blood count normal
Clinical narrative: This initial spontaneous case, was received from a Pharmacist on 20-Oct-2017, concerns a 77-year-old, elderly male patient. The subject's historical condition included Sjogren's syndrome and epilepsy (well controlled- without episodes for 2 years). Concomitant medication included hydroxychloroquine, levothyroxine, RESTASIS eye drops, multi vitamin (OTC), coenzyme (OTC), levetiracetam and Autologous human corneal epithelial cells (reported as autologous eye drops tear solution produced from blood serum). On 13-Oct-2017, at 14:00 hours, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch no: 179101 and expiry date: May-2018). On 14-Oct-2017, the patient visited the emergency department. On 15-Oct-2017, 2 days after vaccine administration, the patient was diagnosed with transient global amnesia. On an unspecified date, the patient underwent EEG (electroencephalogram), EKG (electrocardiography), full blood work, urinalysis and physical exam which displayed normal responses except for memory. CT (computed tomography) was also performed: no cardiac or intracranial issue noted. It was reported that, "memory of period of time for last 72 h is coming back" and the patient was fully "cognizant" of what was going on around him. By 20-Oct-2017, there were no ongoing issues. On 20-Oct-2017, the patient recovered from the event. The reporter assessed this report as non-serious. Follow up received from the reporter (patient's spouse) on 26-Oct-2017: Updated onset date of the event from 14-Oct-2017 to 15-Oct-2017.
Age: 77.0
Sex: M
Vaccine: FLUA3
Symptoms: Transient global amnesia, Urine analysis normal
Clinical narrative: This initial spontaneous case, was received from a Pharmacist on 20-Oct-2017, concerns a 77-year-old, elderly male patient. The subject's historical condition included Sjogren's syndrome and epilepsy (well controlled- without episodes for 2 years). Concomitant medication included hydroxychloroquine, levothyroxine, RESTASIS eye drops, multi vitamin (OTC), coenzyme (OTC), levetiracetam and Autologous human corneal epithelial cells (reported as autologous eye drops tear solution produced from blood serum). On 13-Oct-2017, at 14:00 hours, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch no: 179101 and expiry date: May-2018). On 14-Oct-2017, the patient visited the emergency department. On 15-Oct-2017, 2 days after vaccine administration, the patient was diagnosed with transient global amnesia. On an unspecified date, the patient underwent EEG (electroencephalogram), EKG (electrocardiography), full blood work, urinalysis and physical exam which displayed normal responses except for memory. CT (computed tomography) was also performed: no cardiac or intracranial issue noted. It was reported that, "memory of period of time for last 72 h is coming back" and the patient was fully "cognizant" of what was going on around him. By 20-Oct-2017, there were no ongoing issues. On 20-Oct-2017, the patient recovered from the event. The reporter assessed this report as non-serious. Follow up received from the reporter (patient's spouse) on 26-Oct-2017: Updated onset date of the event from 14-Oct-2017 to 15-Oct-2017.
Age: 37.0
Sex: F
Vaccine: FLU4, MMRV
Symptoms: Computerised tomogram, Injected limb mobility decreased, Injection site cellulitis, Injection site erythema, Injection site mass
Clinical narrative: Cellulitis at injection site on back of right arm, mass developed, red, hot, edema, sore arm, cannot move arm without popping sound, chronic throbbing in my shoulder, MRI confirmed Mild supraspinatus and infraspinatus tendinosis and mild degeneration of the right shoulder. MRI also confirmed Type 1 distal acromial morphology on right shoulder.
Age: 37.0
Sex: F
Vaccine: FLU4, MMRV
Symptoms: Injection site oedema, Injection site pain, Injection site reaction, Injection site warmth, Joint crepitation
Clinical narrative: Cellulitis at injection site on back of right arm, mass developed, red, hot, edema, sore arm, cannot move arm without popping sound, chronic throbbing in my shoulder, MRI confirmed Mild supraspinatus and infraspinatus tendinosis and mild degeneration of the right shoulder. MRI also confirmed Type 1 distal acromial morphology on right shoulder.
Age: 37.0
Sex: F
Vaccine: FLU4, MMRV
Symptoms: Nuclear magnetic resonance imaging abnormal, Osteoarthritis, Pain, Pain in extremity, Pneumonia
Clinical narrative: Cellulitis at injection site on back of right arm, mass developed, red, hot, edema, sore arm, cannot move arm without popping sound, chronic throbbing in my shoulder, MRI confirmed Mild supraspinatus and infraspinatus tendinosis and mild degeneration of the right shoulder. MRI also confirmed Type 1 distal acromial morphology on right shoulder.
Age: 37.0
Sex: F
Vaccine: FLU4, MMRV
Symptoms: Pyrexia, Tendon disorder, Tendonitis
Clinical narrative: Cellulitis at injection site on back of right arm, mass developed, red, hot, edema, sore arm, cannot move arm without popping sound, chronic throbbing in my shoulder, MRI confirmed Mild supraspinatus and infraspinatus tendinosis and mild degeneration of the right shoulder. MRI also confirmed Type 1 distal acromial morphology on right shoulder.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 4 year old patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, also reported as age 1 year old, the patient was vaccinated with the first dose of VARIVAX for prophylaxis (strength, dose, route, lot # and expiration date were not reported). Then, on an unspecified date, also reported as at 2 year old, the patient received the second dose of VARIVAX. subsequently, on 06-DEC-2017, also reported as at 4 year old, an extra dose of PROQUAD lot # reported as N020619, expiration date on 22-JAN-2019, for prophylaxis (strength, dose and route of administration were not reported) was given to the patient. No adverse effects were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 07-DEC-2017, the patient was vaccinated with PROQUAD lot # M041082, expiration date 04-APR-2018 (strength, dose and frequency were not reported) for prophylaxis, and on the same date , the patient received a dose of VARIVAX, lot# M035688, expiration date 10-AUG-2018, (strength, dose, and frequency were not reported) for prophylaxis. Concomitant therapies included sterile diluent(MERCK STERILE DILUENT). No adverse effects reported.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This literature marketed report was received from the authors of the published literature article. The authors performed a retrospective chart review to assess hepatitis B titers in children with celiac disease and whether baseline titers were affected by the presence of other autoimmune diseases, gender or vitamin D levels. 67 children that had a baseline hepatitis B titer after the primary vaccine series for hepatitis B were involved. The average age of diagnosis of celiac disease was 6.74 years. The majority (60/67) were diagnosed via endoscopic biopsy while 10.4% (7/67) were diagnosed via serology based on Society of Pediatric Gastroenterology, Hepatology and Nutrition (SPGHAN) guidelines. Thirty-six (53.7%) were male and 31 (46.3%) were female. 60.6% of children (40/66) had normal vitamin D-25 levels. Of the 67 children, 25 (37.3%) had positive hepatitis B surface antibody levels and 42 (62.7%) had negative hepatitis B surface antibody levels. There was no difference in response to the initial primary hepatitis B vaccine (recombinant) (manufacturer unknown) series based on gender. Twenty-three percent of children (6/26) with vitamin D levels <30 ng/mL (considered as low) and 45% of children (18/40) with vitamin D levels greater or equal to 30 ng/mL (normal level), had positive hepatitis titers (p=0.07). Twenty-one percent of children (3/14) with an additional autoimmune disease and 42% in children (22/53) without presence of an additional autoimmune disease, demonstrated hepatitis B immunity following primary vaccination (p=0.22). This literature report refers to 22 children of unknown gender (exact age was not provided) with celiac disease. On unknown dates, the patients were vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) series (dose, route of administration, therapy type, lot# and expiration date were not reported) for prophylaxis. On unknown dates, the patients had negative hepatitis B surface antibody levels. They were not revaccinated due to lack of pediatrician awareness for need of vaccine as child already completed primary vaccine series, parents not making an appointment to get vaccine, and recent awareness of hepatitis B titer status. The outcome of the event was not reported. The authors considered the event to be related to hepatitis B vaccine (recombinant) (manufacturer unknown). This is one of two reports received from the same literature article (cross referenced cases: MARRS #1801USA003203). Sender's Comments: US-009507513-1801USA003203.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unspecified age and gender. Information regarding patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 27-DEC-2017, the patient was inadvertently vaccinated with improperly stored doses of ROTATEQ vial oral route, lot # N011647, expiration date 17-NOV-2018, for prophylaxis (strength, dose and frequency were not reported). The following temperature excursions were reported: temperature below 32°F during 6 hours 9 minutes, 30.8°F during 2 hours 57 minutes and 31.9°F during 3 hours 12 minutes. Temperature excursion was of 32°F to 35°F during 3 hours 4 minutes, multiple excursions were reported. Previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of the multiple reports received from the same reporter.; Sender's Comments: US-009507513-1801USA001528: US-009507513-1712USA013720: US-009507513-1801USA002097: US-009507513-1801USA002100: US-009507513-1801USA002099:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unspecified age and gender. Information regarding patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 21-DEC-2017, the patient was inadvertently vaccinated with improperly stored doses of ROTATEQ vial oral route, lot # N011647, expiration date 17-NOV-2018, for prophylaxis (strength, dose and frequency were not reported). The following temperature excursions were reported: temperature below 32°F during 6 hours 9 minutes, 30.8°F during 2 hours 57 minutes and 31.9°F during 3 hours 12 minutes. Temperature excursion was of 32°F to 35°F during 3 hours 4 minutes, multiple excursions were reported. Previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of the multiple reports received from the same reporter.; Sender's Comments: US-009507513-1801USA001528: US-009507513-1801USA002098: US-009507513-1712USA013720: US-009507513-1801USA002097:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unspecified age and gender. Information regarding patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 21-DEC-2017, the patient was inadvertently vaccinated with improperly stored doses of VAQTA, intramuscular injection, lot # N017094, expiration date 31-AUG-2017, for prophylaxis (strength, dose and frequency were not reported). The following temperature excursions were reported: temperature below 32°F during 6 hours 9 minutes, 30.8°F during 2 hours 57 minutes and 31.9°F during 3 hours 12 minutes. Temperature excursion was of 32°F to 35°F during 3 hours 4 minutes, multiple excursions were reported. Previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of the multiple reports received from the same reporter.; Sender's Comments: US-009507513-1801USA001528: US-009507513-1801USA002098: US-009507513-1712USA013720: US-009507513-1801USA002097:
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 27-OCT-2008 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-SEP-2013 the patient was treated by a physician for sever vesicular rash accompanied by weakened immune system which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed valacyclovir hydrochloride (VALTREX) for management of her painful symptoms. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 05-JUL-2012, the patient was inoculated with ZOSTAVAX, at a pharmacy (by an unspecified healthcare professional), as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-JAN-2016, he was treated by a physician/MD at an unspecified facility for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe Herpes Zoster, or shingles. The male patient has been prescribed oxycodone for management of his painful symptoms. As a direct and proximate result of these malfunctions, 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 was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 29-SEP-2015, the patient was inoculated with ZOSTAVAX, at a store pharmacy (by an unspecified healthcare professional), as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-SEP-2015, she was treated by a physician at an unspecified facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe Herpes Zoster, or shingles. As a direct and proximate result of these malfunctions, 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 was unknown. The lawyer felt the events were related to ZOSTAVAX.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Ophthalmic herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 05-JAN-2018 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 18-NOV-2016, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of severe herpes zoster. On or about 16-DEC-2016, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as HSV Keratouveitos OS, herpes zoster or shingles with ocular interference. The patient has been prescribed acyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, 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. Upon internal review, HSV Keratouveitos OS/herpes zoster or shingles with ocular interference was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Viral keratouveitis
Clinical narrative: Information has been received on 05-JAN-2018 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 18-NOV-2016, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of severe herpes zoster. On or about 16-DEC-2016, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as HSV Keratouveitos OS, herpes zoster or shingles with ocular interference. The patient has been prescribed acyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, 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. Upon internal review, HSV Keratouveitos OS/herpes zoster or shingles with ocular interference was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 05-JAN-2018 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 29-NOV-2010, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster or shingles. On or about 25-NOV-2015, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. The patient has been prescribed valacyclovir hydrochloride (VALTREX) for management of his painful symptoms. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-SEP-2016, the patient was vaccinated at a physician's office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-OCT-2016, the patient was treated by a physician for onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, 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.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 05-MAR-2015, the patient was vaccinated at a clinic with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-MAR-2016, the patient was treated at a clinic for onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed VALTREX for the management of his painful and persistent symptoms. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: 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 about 15-DEC-2014 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-DEC-2014 the patient was treated at a health center for the onset of severe vesicular rash accompanied by a weakened immune systems, which was diagnosed as severe herpes zoster. As a direct and proximate result of these malfunctions the patient suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 02-APR-2011 the patient was inoculated with ZOSTAVAX, at a pharmacy (by an unspecified healthcare professional), as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-JUL-2015, she was treated by a physician at a clinic for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe Herpes Zoster or shingles. As a direct and proximate result of these malfunctions, 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 was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuralgia, Skin lesion
Clinical narrative: Information has been received on 05-JAN-2018 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 05-NOV-2015, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of atypical herpes zoster. About four days after being vaccinated, the patient begun to breakout in bilateral blistering vesicles on his lower extremities while on vacation. The vesicular outbreaks bread and worsened in severity until lesions had covered nearly his entire body. On or about 02-JAN-2016, upon returning home from travel, the patient was treated by a physician which affirmed the diagnosis of severe herpes zoster or shingles. The patient continues to be afflicted by neuralgia pain from his extensive zoster infections. The patient has been prescribed prednisone and phototherapy for treatment of his painful symptoms. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, Hepatitis B surface antibody negative
Clinical narrative: This literature marketed report was received from the authors of the published literature article. The authors performed a retrospective chart review to assess hepatitis B titters in children with celiac disease and whether baseline titers were affected by the presence of other autoimmune diseases, gender or vitamin D levels. 67 children that had a baseline hepatitis B titer after the primary vaccine series for hepatitis B were involved. The average age of diagnosis of celiac disease was 6.74 years. The majority (60/67) were diagnosed via endoscopic biopsy while 10.4% (7/67) were diagnosed via serology based on Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) guidelines. Thirty-six (53.7%) were male and 31 (46.3%) were female. 60.6% of children (40/66) had normal vitamin D-25 levels. Of the 67 children, 25 (37.3%) had positive hepatitis B surface antibody levels (greater than 12 mIU) and 42 (62.7%) had negative hepatitis B surface antibody levels. There was no difference in response to the initial primary hepatitis B vaccine (recombinant) (manufacturer unknown) series based on gender. Twenty-three percent of children (6/26) with vitamin D levels <30 ng/mL (considered as low) and 45% of children (18/40) with vitamin D levels greater or equal to 30 ng/mL (normal level), had positive hepatitis titers (p=0.07). Twenty-one percent of children (3/14) with an additional autoimmune disease and 42% in children (22/53) without presence of an additional autoimmune disease, demonstrated hepatitis B immunity following primary vaccination (p=0.22). This literature report refers to 20 children of unknown gender (exact age was not provided) with celiac disease. On unknown dates, the patients were vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) series (dose, route of administration, therapy type, lot# and expiration date were not reported) for prophylaxis. On unknown dates, the patients had negative hepatitis B surface antibody levels. The patients started a gluten free diet on unknown dates. On unknown dates, the patients were revaccinated with one additional hepatitis B vaccine (recombinant) (manufacturer unknown) vaccine. All of the patients showed a positive titer (greater than 12 mIU) following revaccination on unknown dates. The authors considered the event of negative hepatitis B surface antibody levels to be related to hepatitis B vaccine (recombinant) (manufacturer unknown). This is one of several reports received from the same literature article (cross referenced cases: MARRS # 1712USA010740). Sender's Comments: US-009507513-1712USA010740:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On 05-JAN-2018, the patient was vaccinated with an improperly stored and expired PROQUAD lot # M031566 with an expiration date 24-DEC-2017 for prophylaxis (dose, route of administration and anatomical location were not reported). Concomitant therapies included sterile diluent (STERILE DILUENT) which was properly stored and not expired. No adverse effect was reported. Administered dose of PROQUAD experienced the temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 48 hours. There was previous temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 13 hours. A digital data logger was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-AUG-2012, the patient was vaccinated at a physician's office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. The patient was treated at urgent care for onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles (date not reported). The patient was prescribed gabapentin for the management of his painful and persistent symptoms. As a direct and proximate result of these malfunctions, 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. This corrected report. Case opened to add reporter information. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Neuralgia, Pain, Post herpetic neuralgia
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 26-APR-2016  at a pharmacy, the patient was inoculated (by an unspecified healthcare professional) with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration, lot # and expiration date were not provided). This is conflicting information as the events associated were reported in 2015. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-JUL-2015, the female was treated (by an unspecified healthcare professional) at a medical clinic for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. Between the dates of 05-AUG-2015 and 10-AUG-2015, the female patient was admitted to a medical facility for ongoing and significantly worsening shingles symptoms and pain. On or about 24-AUG-2015, the patient sought subsequent treatment at the same medical clinic (as on or about 28-JUL-2015) for uncontrolled pain and zoster outbreaks that had gotten worse in severity. On or about 31-AUG-2015, the female patient was treated again at the same medical clinic for continued shingles symptoms, nerve pain and scarring from the outbreaks. On or about 02-NOV-2015, the female was treated at the medical clinic for ongoing pain, at which time she was diagnosed with post-herpetic neuralgia, a chronic condition of nerve damage and pain secondary to zoster outbreaks. The female patient has been prescribed NEURONTIN, ZORIVAX (as reported), LYRICA, VALTREX and TYLENOL for management of her painful symptoms. As a direct and proximate result of these malfunctions, 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 was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Scar
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 26-APR-2016  at a pharmacy, the patient was inoculated (by an unspecified healthcare professional) with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration, lot # and expiration date were not provided). This is conflicting information as the events associated were reported in 2015. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-JUL-2015, the female was treated (by an unspecified healthcare professional) at a medical clinic for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. Between the dates of 05-AUG-2015 and 10-AUG-2015, the female patient was admitted to a medical facility for ongoing and significantly worsening shingles symptoms and pain. On or about 24-AUG-2015, the patient sought subsequent treatment at the same medical clinic (as on or about 28-JUL-2015) for uncontrolled pain and zoster outbreaks that had gotten worse in severity. On or about 31-AUG-2015, the female patient was treated again at the same medical clinic for continued shingles symptoms, nerve pain and scarring from the outbreaks. On or about 02-NOV-2015, the female was treated at the medical clinic for ongoing pain, at which time she was diagnosed with post-herpetic neuralgia, a chronic condition of nerve damage and pain secondary to zoster outbreaks. The female patient has been prescribed NEURONTIN, ZORIVAX (as reported), LYRICA, VALTREX and TYLENOL for management of her painful symptoms. As a direct and proximate result of these malfunctions, 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 was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.