chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nerve compression, Neuralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 61-year-old male patient who received  for prophylaxis. Concurrent medical conditions included pinched nerve (in the C3 area of the neck. No pain due to physical therapy and the use of gabapentin). Concomitant products included gabapentin. On 24th July 2018 15:00, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In July 2018, 13 hrs after receiving SHINGRIX, the patient experienced neck pain, movement disorder, injection site tenderness and pinched nerve. On an unknown date, the outcome of the neck pain, movement disorder, injection site tenderness and pinched nerve were unknown. It was unknown if the reporter considered the neck pain, movement disorder, injection site tenderness and pinched nerve to be related to SHINGRIX. Additional details reported as follows: With physical therapy and the use of gabapentin, the patient did not have any issues with the pinched nerve for a while at the time of reporting. The patient received SHINGRIX on right deltoid. At 4 am in the morning, the patient woke up to severe pain due to the pinched nerve. This pain was on the left side of his neck right before the neck reaches the clavicle. He reports that it was difficult to move his head due to the pain. Less than a week after vaccination, the patient had tenderness at the injection site. The reporter gave permission for his physician to be contacted. The reporter was unable to provide additional information.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Movement disorder, Neck pain, Nerve compression
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 61-year-old male patient who received  for prophylaxis. Concurrent medical conditions included pinched nerve (in the C3 area of the neck. No pain due to physical therapy and the use of gabapentin). Concomitant products included gabapentin. On 24th July 2018 15:00, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In July 2018, 13 hrs after receiving SHINGRIX, the patient experienced neck pain, movement disorder, injection site tenderness and pinched nerve. On an unknown date, the outcome of the neck pain, movement disorder, injection site tenderness and pinched nerve were unknown. It was unknown if the reporter considered the neck pain, movement disorder, injection site tenderness and pinched nerve to be related to SHINGRIX. Additional details reported as follows: With physical therapy and the use of gabapentin, the patient did not have any issues with the pinched nerve for a while at the time of reporting. The patient received SHINGRIX on right deltoid. At 4 am in the morning, the patient woke up to severe pain due to the pinched nerve. This pain was on the left side of his neck right before the neck reaches the clavicle. He reports that it was difficult to move his head due to the pain. Less than a week after vaccination, the patient had tenderness at the injection site. The reporter gave permission for his physician to be contacted. The reporter was unable to provide additional information.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Administration site reaction, Administration site swelling, Erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 23rd July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 23rd July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site itching, injection site swelling and injection site lump. On 24th July 2018, the patient experienced stiff neck, diarrhea and fever. On 25th July 2018, the patient experienced headache. On an unknown date, the outcome of the injection site erythema, injection site itching, stiff neck, injection site swelling, injection site lump, fever and headache were unknown and the outcome of the diarrhea was recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site itching, stiff neck, injection site swelling, injection site lump, diarrhea, fever and headache to be related to SHINGRIX. Additional details were provided as follows: At 13:00 hours, the patient received SHINGRIX on the left arm. The patient experienced swelling, lump, itching and redness about the size of 2.5 inches by 2.5 inches at the injection site. She experienced diarrhea the second day. She also had fever and stiff neck. Two days after vaccination, the patient experienced headache. The patient had denied permission to contact their physician. The patient was referred to follow up with her health care provider. No further details were provided.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 23rd July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 23rd July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site itching, injection site swelling and injection site lump. On 24th July 2018, the patient experienced stiff neck, diarrhea and fever. On 25th July 2018, the patient experienced headache. On an unknown date, the outcome of the injection site erythema, injection site itching, stiff neck, injection site swelling, injection site lump, fever and headache were unknown and the outcome of the diarrhea was recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site itching, stiff neck, injection site swelling, injection site lump, diarrhea, fever and headache to be related to SHINGRIX. Additional details were provided as follows: At 13:00 hours, the patient received SHINGRIX on the left arm. The patient experienced swelling, lump, itching and redness about the size of 2.5 inches by 2.5 inches at the injection site. She experienced diarrhea the second day. She also had fever and stiff neck. Two days after vaccination, the patient experienced headache. The patient had denied permission to contact their physician. The patient was referred to follow up with her health care provider. No further details were provided.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Musculoskeletal stiffness, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 23rd July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 23rd July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site itching, injection site swelling and injection site lump. On 24th July 2018, the patient experienced stiff neck, diarrhea and fever. On 25th July 2018, the patient experienced headache. On an unknown date, the outcome of the injection site erythema, injection site itching, stiff neck, injection site swelling, injection site lump, fever and headache were unknown and the outcome of the diarrhea was recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site itching, stiff neck, injection site swelling, injection site lump, diarrhea, fever and headache to be related to SHINGRIX. Additional details were provided as follows: At 13:00 hours, the patient received SHINGRIX on the left arm. The patient experienced swelling, lump, itching and redness about the size of 2.5 inches by 2.5 inches at the injection site. She experienced diarrhea the second day. She also had fever and stiff neck. Two days after vaccination, the patient experienced headache. The patient had denied permission to contact their physician. The patient was referred to follow up with her health care provider. No further details were provided.
Sex: F
Vaccine: MENB, MENB
Symptoms: Arthralgia, Asthenia, Cold sweat, Dizziness, Fatigue
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of vomiting in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced vomiting, presyncope, headache, muscle pain, numbness and nausea. On an unknown date, the outcome of the vomiting, presyncope, headache, muscle pain, numbness and nausea were unknown. It was unknown if the reporter considered the vomiting, presyncope, headache, muscle pain, numbness and nausea to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. This was an after hours voice mail so no additional details were provided. Reporter's Comments: US-CRC-0065796.
Sex: F
Vaccine: MENB, MENB
Symptoms: Haematemesis, Hypoaesthesia, Insomnia, Myalgia, Nausea
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of vomiting in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced vomiting, presyncope, headache, muscle pain, numbness and nausea. On an unknown date, the outcome of the vomiting, presyncope, headache, muscle pain, numbness and nausea were unknown. It was unknown if the reporter considered the vomiting, presyncope, headache, muscle pain, numbness and nausea to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. This was an after hours voice mail so no additional details were provided. Reporter's Comments: US-CRC-0065796.
Sex: F
Vaccine: MENB, MENB
Symptoms: Presyncope, Vomiting
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of vomiting in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced vomiting, presyncope, headache, muscle pain, numbness and nausea. On an unknown date, the outcome of the vomiting, presyncope, headache, muscle pain, numbness and nausea were unknown. It was unknown if the reporter considered the vomiting, presyncope, headache, muscle pain, numbness and nausea to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. This was an after hours voice mail so no additional details were provided. Reporter's Comments: US-CRC-0065796.
Sex: F
Vaccine: MENB, MENB
Symptoms: Headache, Hypoaesthesia, Myalgia, Nausea, Presyncope
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of vomiting in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced vomiting, presyncope, headache, muscle pain, numbness and nausea. On an unknown date, the outcome of the vomiting, presyncope, headache, muscle pain, numbness and nausea were unknown. It was unknown if the reporter considered the vomiting, presyncope, headache, muscle pain, numbness and nausea to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. This was an after hours voice mail so no additional details were provided. Reporter's Comments: US-CRC-0065796.
Sex: F
Vaccine: MENB, MENB
Symptoms: Vomiting
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of vomiting in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced vomiting, presyncope, headache, muscle pain, numbness and nausea. On an unknown date, the outcome of the vomiting, presyncope, headache, muscle pain, numbness and nausea were unknown. It was unknown if the reporter considered the vomiting, presyncope, headache, muscle pain, numbness and nausea to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. This was an after hours voice mail so no additional details were provided. Reporter's Comments: US-CRC-0065796.
Sex: M
Vaccine: HEPA, TYP
Symptoms: Lumbar puncture normal, Nuclear magnetic resonance imaging normal, Seizure
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of convulsion in a 25-year-old male patient who received HAVRIX for prophylaxis. Co-suspect products included Typhoid vaccine for prophylaxis. On 10th July 2018, the patient received HAVRIX 1 ml and Typhoid vaccine .5 ml. On 21st July 2018, 11 days after receiving HAVRIX and Typhoid vaccine, the patient experienced convulsion (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the convulsion was recovered/resolved. It was unknown if the reporter considered the convulsion to be related to HAVRIX and Typhoid vaccine. Additional details were provided as follows: The patient was 25 years old at the time of reporting. The age at vaccination was not reported. However, it could be 24 or 25 years old. On 21st July 2018, the patient was admitted to hospital with convulsions the novo. The physician reported that (convulsions the novo) after various tests like spinal puncture, Magnetic resonance imaging (MRI) and there were no findings by the reporting date. The patient was well and with no other episodes of convulsions. The reporter agreed to be followed up. Lab Comments: the patient underwent spinal puncture and Nuclear magnetic resonance imagin (MRI) and there were no findings by the date of reporting.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions and allergies was provided. On an unknown date, the patient received an unspecified dose of improperly stored ROTATEQ (lot # R003534, expiration date 31-AUG-2019), orally for prophylaxis. It was reported that the vaccine was stored in temperature of 35.29 Fahrenheit degrees for 26 minutes (date unspecified). There were no previous temperature excursions recorded. A Digital Data Logger was involved. No adverse effects were reported.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 23-year-old female patient. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 09-JAN-2018, the patient was vaccinated with the first dose of GARDASIL 9 (dose, strength, route of administration, lot # and expiration date were not provided) for vaccination. On 18-JUL-2018, the patient was vaccinated with the second dose of GARDASIL 9 (dose, strength, route of administration, lot # and expiration date were not provided) for vaccination. On 18-JUL-2018, the patient was feeling lightheaded. The outcome of feeling lightheaded was unknown. The relatedness between GARDASIL 9 and feeling lightheaded was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse concerning a 31 weeks and 2 days pregnant female patient (unknown date of conception) of unknown age, with an estimated last menstrual period (LMP) of 16-DEC-2017. The patient's historical condition, concurrent condition, concomitant therapy, historical drugs or allergies were unknown. On 19-JUL-2018, the patient was vaccinated with GARDASIL 9 intramuscularly, provided lot # N003703,  expiry date 29-OCT-2019 (laterality, strength and dose were not reported) for prophylaxis. The patient's initial exposure was at 30 weeks in the third trimester and the pregnancy outcome was pending. It was unknown if any laboratory diagnostics-studies were performed or if the patient required treatment. No adverse effects were reported.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Fatigue, Joint swelling, Measles antibody negative
Clinical narrative: This spontaneous report was received from the patient's mother, concerning a 2 year old female patient. The patient did not have any medical history to report. Her concurrent conditions included allergy to dairy and egg. The patient did not have any concomitant medications to report. On 12-DEC-1997, the patient was vaccinated with the first dose of M-M-R II subcutaneously for prophylaxis lot #0015E (strength, dose, frequency and expiration date were not reported). On the same date, 3 hours after receiving the vaccination with M-M-R II, the patient began to experiencing a severe reaction including joint swelling, fatigue and generalized weakness. The patient sought for medical attention and was treated with prednisolone sodium phosphate (PEDIAPRED) liquid and a 6 day steroid regimen. On an unknown date, the patient recovered from joint swelling. On an unknown date in March 2001, the patient received a second "graduated dose style" of M-M-R II subcutaneously for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported). The patient did not have any reaction following this administration. On 06-JUL-2018, when the patient was 22 year old, the patient had a measles titer test performed and it was failed, there was no immunity. On an unknown date, approximately in 2018, the patient died. It was unknown if an autopsy was performed. At the time of reporting, the outcome of fatigue, generalized weakness, measles titer failed and no immunity was unknown. The causal relationship between the vaccination with M-M-R II and the events was not provided by the reporter.; Reported Cause(s) of Death: Did the patient died: yes.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician assistant  via a company representative and refers to a 14 or 15-year-old male patient. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On approximately 18-JUL-2018, the patient was vaccinated with a dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not provided) for routine immunization. After receiving GARDASIL 9, the patient fainted. The outcome of the syncope was reported as recovered on an unknown date in July 2018. The relatedness between GARDASIL 9 and syncope was not reported.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a 1 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 14-JUN-2018, the patient was vaccinated with improperly stored doses of M-M-R II, lot No M045401, expiration date on 14-NOV-2018, subcutaneous in the right thigh, VARIVAX, lot No N031937, Expiration date on 13-NOV-2019, subcutaneously in the left thigh, HAVRIX, Lot No Z4543, intramuscularly in the right thigh and the fourth vaccination with PREVNAR lot No TT86T5, intramuscularly in the left thigh. All the vaccines were administered for prophylaxis. The temperature excursion occurred as a result of a reading from a Digital Data Logger (The timeframes and temperatures were not reported). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA006096: US-009507513-1807USA010900.
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician, concerning a 22 year old female patient. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 26-JUL-2018, the patient inadvertently vaccinated by the physician's medical assistant, with a dose of PROQUAD subcutaneously, for prophylaxis, lot #R003295, albumin status rHA, and expiration date 31-JUL-2019 (strength, dose and frequency were not reported). No adverse effects were reported.
Age: 5.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning multiple patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD, lot #N010865, expiration date 01-OCT-2018, albumin status of recombinant human albumin (rHA) (strength, dose, frequency and route of administration were not reported) and with improperly stored doses of VARIVAX, lot #M000997, expiration date 07-JAN-2018 (strength, dose, frequency and route of administration were not reported) for prophylaxis. The vaccines were reconstituted with a properly stored sterile diluent (lot # and expiration date were not reported). The temperature excursion was reported as 15 °F to 46 °F (23.4°F) for a time frame of 2 hours and 57 minutes. Previous temperature excursion was reported as 6 °F to 14 °F (13.4 °F) for 2 hours. Digital data logger was involved to capture the temperature excursions. No product quality complaint (PQC) was involved. Follow-up information was received on 24-JUL-2018. Additional information has been requested. This is non-valid report due to lack of patient identifiers. Follow-up information was received on 24-JUL-2018 from the medical assistant who provided patient identifiers for the reported event. The patient was a 5-year-old male child who on 29-MAY-2018 was vaccinated with improperly stored dose of PROQUAD lot #N010865 with the expiration date of 01-OCT-2018. At the time of the excursion, the vaccine was deemed stable. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA013102: US-009507513-1808USA001953: US-009507513-1807USA012551: US-009507513-1807USA012552: US-009507513-1807USA012554: US-009507513-1807USA012555:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning multiple patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD, lot #N010865, expiration date 01-OCT-2018, albumin status of recombinant human albumin (rHA) (strength, dose, frequency and route of administration were not reported) and with improperly stored doses of VARIVAX, lot #M000997, expiration date 07-JAN-2018 (strength, dose, frequency and route of administration were not reported) for prophylaxis. The vaccines were reconstituted with a properly stored sterile diluent (lot # and expiration date were not reported). The temperature excursion was reported as 15 °F to 46 °F (23.4°F) for a time frame of 2 hours and 57 minutes. Previous temperature excursion was reported as 6 °F to 14 °F (13.4 °F) for 2 hours. Digital data logger was involved to capture the temperature excursions. No product quality complaint (PQC) was involved. Follow-up information was received on 24-JUL-2018. Additional information has been requested. This is non-valid report due to lack of patient identifiers. Follow-up information was received on 24-JUL-2018 from the medical assistant who provided patient identifiers for the reported event. The patient was a 4-year-old male child who on 27-JUN-2018 was vaccinated with improperly stored dose of PROQUAD lot #N010865 with the expiration date of 01-OCT-2018. At the time of the excursion, the vaccine was deemed stable. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA013102: US-009507513-1808USA001953: US-009507513-1807USA012551: US-009507513-1807USA012552: US-009507513-1807USA012553: US-009507513-1807USA012555.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Exposure during pregnancy
Clinical narrative: Information has been received from a nurse, referring to a female patient of unknown age. The patient was pregnant on an unknown date. Information of medical history and concomitant therapy was not provided. On an unknown date, the patient was vaccinated with VARIVAX (lot#, expiration date, strength, dose, frequency and route were not reported) for prophylaxis. On an unknown date, the patient was "not showing immunity levels". The patient visited physician's office. The last menstrual period (LMP) and expected date of delivery (EDD) were unknown and could not be calculated. The pregnancy outcome was outcome pending. The causality assessment was not reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. The patient's medical history, concurrent condition and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored ROTATEQ lot# N010706, expiration date 02-DEC-2018 (exact dose, frequency and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion between 47 degrees Fahrenheit to 77 degrees Fahrenheit (also reported as 54 degrees Fahrenheit) for 19 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse events were reported.
Age: 17.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a physician and refers to a 17-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, reported as "last week", the patient was vaccinated with PROQUAD injection (dose, frequency, route of administration, lot # and expiration date were not reported). The vaccine was reconstituted with sterile diluent. The outcome of event was unknown. No causality assessment was provided.
Sex: M
Vaccine: HEPA
Symptoms: Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Exposure to communicable disease
Clinical narrative: This literature marketed report has been received from authors of a published article, referring to a 65-69 years old (age group also reported as adult) male patient with hepatitis C virus coinfection. The patient's medical history and concomitant medications were not reported. The patient had been received a long-term conservatorship or short-term acute-care psychiatric treatment in the hospital. The patient did not have a record of previous hepatitis A virus (HAV) immunity. On an unknown date in 2017, the patient was vaccinated with a single dose of hepatitis a vaccine, inactivated (manufacturer unknown) (route, lot # and expiration date unknown) for prophylaxis. In 2017 (reported as onset at day 26 from July 2107), the patient had clinical signs and symptoms (vomiting, lethargic, abdominal pain, jaundice) and laboratory results consistent with acute HAV infection. The laboratory results included alanine aminotransferase (ALT): 2419 U/L (highest measure within 1 week of illness); aspartate aminotransferase (AST): 1176 U/L (highest measure within 1 week of illness); bilirubin: 10.1 mg/dL; and the ribonucleic acid (RNA) genotype was 1B. The patient was hospitalized for 2 days for the event. The patient had close contact, shared living quarters and shared a hospital unit restroom with another patient who had immunoglobulin M (IgM) antibodies to HAV. The outcome of the event was unknown. The reporter considered the event to be related to hepatitis a vaccine, inactivated (manufacturer unknown).
Sex: M
Vaccine: HEPA
Symptoms: Hepatitis A, Jaundice, Lethargy, Vomiting
Clinical narrative: This literature marketed report has been received from authors of a published article, referring to a 65-69 years old (age group also reported as adult) male patient with hepatitis C virus coinfection. The patient's medical history and concomitant medications were not reported. The patient had been received a long-term conservatorship or short-term acute-care psychiatric treatment in the hospital. The patient did not have a record of previous hepatitis A virus (HAV) immunity. On an unknown date in 2017, the patient was vaccinated with a single dose of hepatitis a vaccine, inactivated (manufacturer unknown) (route, lot # and expiration date unknown) for prophylaxis. In 2017 (reported as onset at day 26 from July 2107), the patient had clinical signs and symptoms (vomiting, lethargic, abdominal pain, jaundice) and laboratory results consistent with acute HAV infection. The laboratory results included alanine aminotransferase (ALT): 2419 U/L (highest measure within 1 week of illness); aspartate aminotransferase (AST): 1176 U/L (highest measure within 1 week of illness); bilirubin: 10.1 mg/dL; and the ribonucleic acid (RNA) genotype was 1B. The patient was hospitalized for 2 days for the event. The patient had close contact, shared living quarters and shared a hospital unit restroom with another patient who had immunoglobulin M (IgM) antibodies to HAV. The outcome of the event was unknown. The reporter considered the event to be related to hepatitis a vaccine, inactivated (manufacturer unknown).
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 31-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 03-FEB-2010, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a medical office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 17-NOV-2015, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 31-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 14-OCT-2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 12-JUL-2010, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 31-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles.  As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 31-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 23-APR-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a medical center as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 08-AUG-2014, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. The patient was prescribed famciclovir and hydrocodone for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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: U
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The patient previously received one dose of M-M-R, one dose of varicella virus vaccine live (unspecified), 4 doses of diphtheria toxoid pertussis acellular vaccine (unspecified) tetanus toxoid and 3 doses of poliovirus vaccine inactivated (unspecified). On 18-JUN-2018 the patient was vaccinated with PROQUAD from lot R003292 dose 1, subcutaneous in the left arm for prophylaxis. On the same day, the patient was also vaccinated with KINRIX from lot 74G79 dose 1, intramuscular in the right deltoid for prophylaxis. The sterile diluent (manufacturer unknown) (lot# M012716 with expiration date 20-AUG-2018, lot # N030577 with expiration date 19-APR-2019, lot# N027783 with expiration date 17-NOV-2019,lot# M013220 with expiration date 24-SEP-2018, lot# M035268 with expiration date 19-APR-2019; lot # N006322 with expiration date 11-JUL-2019, lot # M012718 with expiration date 10-NOV-2018, lot # N004190 with expiration date 04-JUL-2019, lot # N022038 with expiration date 27-NOV-2019, lot# N030574 with expiration date 05-JUN-2020, lot# N030178 with expiration date 15-JUL-2020) used to reconstitute the vaccines was properly stored. The medical assistant was not sure which sterile diluent (manufacturer unknown) lot numbers were used. The vaccines were exposed to temperature excursion of -14 degree Celsius up to -10 degree Celsius for 5 hours total (including the previous exposure to temperature excursion). Data logger was involved. No product quality complaint (PQC) was involved in this case. No symptoms were reported. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1808USA000454: US-009507513-1808USA000455: US-009507513-1808USA000456: US-009507513-1808USA000457: US-009507513-1808USA000459: US-009507513-1808USA000460: US-009507513-1808USA000461: US-009507513-1808USA000462: US-009507513-1808USA000463: US-009507513-1808USA000464: US-009507513-1808USA000465: US-009507513-1808USA000466: US-009507513-1807USA007589.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a 4 year old male patient. The patient previously received one dose of M-M-R, one dose of varicella virus vaccine live (unspecified), 4 doses of diphtheria toxoid pertussis acellular vaccine (unspecified) tetanus toxoid and 3 doses of poliovirus vaccine inactivated (unspecified). On 25-JUL-2018 the patient was vaccinated with PROQUAD from lot R003292 dose 1, subcutaneous in the left deltoid for prophylaxis.  On the same day, the patient was also vaccinated with KINRIX from lot 95FR9 dose 1, intramuscular in the right deltoid for prophylaxis. The sterile diluent (manufacturer unknown) (lot# M012716 with expiration date 20-AUG-2018, lot # N030577 with expiration date 19-APR-2019, lot# N027783 with expiration date 17-NOV-2019,lot# M013220 with expiration date 24-SEP-2018, lot# M035268 with expiration date 19-APR-2019; lot # N006322 with expiration date 11-JUL-2019, lot # M012718 with expiration date 10-NOV-2018, lot # N004190 with expiration date 04-JUL-2019, lot # N022038 with expiration date 27-NOV-2019, lot# N030574 with expiration date 05-JUN-2020, lot# N030178 with expiration date 15-JUL-2020) used to reconstitute the vaccines was properly stored. The medical assistant was not sure which sterile diluent (manufacturer unknown) lot numbers were used.  The vaccines were exposed to temperature excursion of -14 degree Celsius up to -10 degree Celsius for 5 hours total (including the previous exposure to temperature excursion). Data logger was involved. No product quality complaint (PQC) was involved in this case. No symptoms were reported. This is one of the several reports linked via same reporter link.; Sender's Comments: US-009507513-1807USA007589:
Age: 4.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 4 year old male patient. On 24-JUL-2018 the patient was vaccinated with improperly stored VARIVAX lot # R002051 dose 1, subcutaneous in the left thigh for prophylaxis. Other suspect therapies included VAQTA lot # R002086 dose 1, intramuscular in the right thigh; M-M-R II lot # N027782 dose 1, subcutaneous in the right thigh and PREVNAR 13, dose 4 intramuscular in the left thigh from lot # T94425. Concomitant therapies included sterile diluent. Sender's Comments: US-009507513-1807USA007589.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 5 year old male patient. The patient previously received one dose of M-M-R, one dose of varicella virus vaccine live (unspecified), 4 doses of diphtheria toxoid pertussis acellular vaccine (unspecified) tetanus toxoid and 3 doses of poliovirus vaccine inactivated (unspecified). On 23-JUL-2018 the patient was vaccinated with improperly stored PROQUAD lot # R002935 dose 1, subcutaneous in the left arm for prophylaxis (product storage error). Other suspect therapies included KINRIX. Concomitant therapies included sterile diluent(STERILE DILUENT).; Sender's Comments: US-009507513-1807USA007589:
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 12 month old male patient. On 30-JUL-2018 the patient was vaccinated with improperly stored VARIVAX lot # R002051 dose 1, subcutaneous in the right thigh for prophylaxis. Other suspect therapies included VAQTA lot # R002086 dose 1, intramuscular in the left thigh; M-M-R II lot # N027782 dose 1, subcutaneous in the left thigh and PREVNAR 13, dose 4 intramuscular in the right thigh from lot # T94425. Concomitant therapies included sterile diluent. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1807USA007589.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 31-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-APR-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a medical office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 23-OCT-2016, the patient was treated at an urgent care center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 31-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 27-MAR-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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: U
Vaccine: MMRV
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with PROQUAD injection, intramuscularly lot # N029156, expiration date 16-APR-2019, intramuscularly, for prophylaxis (dose and frequency were not reported). No adverse event reported.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fatigue, Lethargy, Nausea, Night sweats
Clinical narrative: This spontaneous report was received from a mother referring to her daughter, 21 year old female patient. The patient had no concomitant medications and pertinent medical history. The patient was allergic to amoxicillin. In June 2018, the patient was vaccinated with GARDASIL 9 one injection (lot #, expiration date, dose, strength and route of administration were not provided) for HPV prevention. On an unknown date in June or July of 2018 (reported as one day following administration), the patient experienced night sweats, dizziness, lethargy, fatigue and nausea for one month after getting the first dose of GARDASIL 9 vaccination. The patient sought medical attention by speaking with physician. The patient had no laboratory tests performed and no treatment was administered for the events. The outcome of night sweats, nausea, fatigue, lethargy and dizziness was reported as recovered in approximately July 2018. The causal relationship between the events and therapy with GARDASIL 9 was not provided by the reporter.
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old male patient. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 01-AUG-2018, the patient was vaccinated with GARDASIL 9 lot # N032956, expiration date 13-JUL-2020, intramuscularly (dose and frequency were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 01-AUG-2018 the patient inadvertently vaccinated with an expired dose of VAQTA (lot # L017757, expiry date: 08-APR-2018) (dose, frequency and route were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint was involved.