chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Drug screen negative, Immediate post-injection reaction, Laboratory test normal, Panic attack
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 682874) under the Freedom of Information Act on 10-MAY-2017 and refers to a 14 year old female patient. Information regarding concomitant therapies, concurrent conditions and medical history was not reported. On 10-FEB-2017, the patient was vaccinated a dose of with GARDASIL 9 1.0 (units not reported) intramuscularly in the right arm, which had a lot # M034780 (concentration, expiration date and indication were not provided). On 13-FEB-2017, the patient became dizzy and lightheaded immediately after her 1st and 2nd GARDASIL 9 vaccine. She was observed x 30 minutes in the office then went home. Reports dizziness without other disability or symptoms x 24 hours. 3 days after GARDASIL 9 #2, she had a panic attack after a stressful volleyball practice. Lab data All labs and PEX normal in ED; Tox screen urine (-) negative. Other Medications None known. Current Illnesses None known. History Hx of anxiety; No panic attacks. Prior Vaccinations Dizzy HPV (no brand name) 1-13.00 Patient. At the time of reporting, the patient recovered from dizziness, panic attack, laboratory test normal, immediate post-injection reaction and drug screen negative. The reporter did not provide a causality assessment between GARDASIL 9, and the events. Additional information is not expected, as no further information could be obtain from the Agency.
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Dizziness, Loss of consciousness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act and refers to a 16 year old male patient. The patient did not have concurrent conditions and medical history. His concomitant therapy was unknown. On 16-FEB-2017, at a public health/hospital, the patient was vaccinated with GARDASIL 9 (lot # M017983-valid, dose 1, intramuscular in the right arm) (expiration date unknown) for prophylaxis. On the same day, the patient also received vaccination with BOOSTRIX (lot # 9GE5D, dose 1, intramuscular in the left arm) and MENACTRA (lot # U5462AA, dose 1, intramuscular in the right arm) for prophylaxis. On the same day, after receiving the 3 vaccines, the patient sat in the office for another 15 minutes. Patient was then taken to checkout and then left the clinic. It was reported that while the patient was leaving the building, the patient became dizzy and passed out. The patient's father caught him. Patient did not hit head and was put in a chair. Paramedics were called and clinic nurses checked on patient. The patient was alert and feeling better. The patient stated that he did not feel dizzy anymore and was feeling much better. Paramedics assessed the patient. His blood pressure and blood sugar were checked and within normal limits. Patient did not go to hospital. Patient was assisted and left with no complications. The outcome of blood glucose normal, loss of consciousness and dizziness was reported as recovered/resolved. Additional information is not expected, as the case is from agency and we are unable to do follow-up.
Age: 18.0
Sex: M
Vaccine: HEP, HPV9, MMR, MNQ, TDAP, VARCEL, HEP, HPV9, MMR, MNQ, TDAP, VARCEL
Symptoms: Blood glucose normal, Hyperhidrosis, Pallor, Presyncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 682975) on 10-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 18 year old male patient with prophylaxis. The patient did not have any medical history, current illness or no reported reactions prior to immunization. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # M028323, intramuscular in the left arm for prophylaxis. Other suspect therapies included VARIVAX (lot # M034583, subcutaneous), RECOMBIVAX HB (lot # M033334,intramuscular), ADACEL (lot # U5533AA, intramuscular), MENVEO (lot # M16013, intramuscular) and M-M-R II (M016233, subcutaneous, right arm) for prophylaxis. On an unknown date, he experienced blood glucose normal, presyncope, pallor and hyperhidrosis. On an unknown date, the patient had possible vasovagal episode/ vs vaccine reaction while having his own blood drawn in the lab. He was found sitting in the lab chair pale, diaphoretic-responsive and without loss of consciousness. He was monitored for 15 minutes in the provider's office after administration of the vaccine and had not displayed weakness, hives or dizziness. On an unknown date, at 09:45 a.m, his blood pressure (BP) was 96/68, heart rate (HR) was 46, oxygen saturation was 98 % and blood sugar (BS) was 82 (after administration of 4 Oz of OJ). There was no rash, hives or wheezing. At 09:55 a.m, BP was 92/62, HR was 67 and BS was 84. Patient A plus O was thrice and OJ 4 OZ was given. Patient was stabilized and was transferred via wheelchair to family medicine department for further monitoring. He was monitored for 1 hour. There was still no rash, wheezing, hives or respiratory distress. He was noted as vasovagal stable during departure. It was considered as vasovagal response to blood draw.  The outcome of blood glucose normal and hyperhidrosis was reported as recovered/resolved. The causality was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: TYP, TYP
Symptoms: Pyrexia
Clinical narrative: Mother states temp of up to 103 degrees  for 2 days after taking 1st VIVOTIF.
Age: 13.0
Sex: M
Vaccine: TYP, TYP
Symptoms: Body temperature increased
Clinical narrative: Mother states temp of up to 103 degrees  for 2 days after taking 1st VIVOTIF.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 17-APR-2017, the patient was vaccinated with PROQUAD (lot number M043307, expiration 24-APR-2018) for prophylaxis. The nurse was unable to provide the lot number and expiration date for the sterile diluent used to reconstitute the vaccine. The nurse reported that PROQUAD was not given inadvertently. The patient had no prior history of receiving M-M-R II,  PROQUAD or VARIVAX. No adverse events reported. No additional information available. Lot number M043307 has been verified to be a valid lot number for PROQUAD. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Nodule, Rash
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. The patient was allergic to BENADRYL. The patient did not have any pertinent medical history and did not take any concomitant medications. On approximately 17-APR-2017, the patient was vaccinated with ZOSTAVAX a single dose, subcutaneously, lot # M039453, expiration date: 19-DEC-2017 to prevent shingles. The vaccine was reconstituted in sterile diluent. On 18-APR-2017 (reported as "one day after the injection"), the patient developed a rash on the left arm. On 21-APR-2017 (reported as "three days later"), the patient's rash expanded to a size of a grapefruit and a hardened knot appeared in the center of it. The patient sought medical attention. No treatment was given for the event and no laboratory studies were performed. The outcome of the adverse events was reported as recovering. The causality between the events and suspect therapies was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-MAY-2016, the patient was vaccinated with a dose of M-M-R II for prophylaxis (lot # L011528 , expiration date 16-JUN-2018; dose, dose number, route of administration were not reported). When a dose of PROQUAD may have been ordered by the physician. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On an unspecified date, the patient started therapy with a "low dose steroid" (unspecified), and on an unknown date, while the patient was on this therapy, he/she was vaccinated with a dose of ZOSTAVAX vial 19400 PFU (dose, frequency, route, lot # and expiration date were not reported), for prophylaxis. The ZOSTAVAX dose was reconstituted with sterile diluent (lot # and expiration date were not reported). It was unknown, if the "low dose steroid" (unspecified) caused the patient to be immunocompromised prior to receiving ZOSTAVAX. It was reported that could not be ruled out that an immunocompromised patient was given ZOSTAVAX which was outside of the prescribing information. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product use in unapproved indication
Clinical narrative: This spontaneous report was received from an allergy technician, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On an unspecified date, the patient was vaccinated with a dose of GARDASIL 9 injection (dose, frequency and route were not reported) lot # M016193 with expiration date of 24-APR-2018, to treat current Human Papillomavirus (HPV) infection that patient has. No adverse effects were reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager via a company representative and refers to a 56-year-old female patient. No information concerning patient's concomitant medication, pertinent medical history, drug reactions or allergies was provided. On 15-FEB-2017, the patient was vaccinated with first single dose of ZOSTAVAX, subcutaneous injection (dose, lot number and expiration date were not provided), for prophylaxis. The order was for PNEUMOVAX23 (dose, lot number and expiration date were not reported) and ZOSTAVAX to be given in a 30 day window, but instead, on 22-MAR-2017, the medical assistant gave the patient the second dose of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a reporter of an unspecified role (other) and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 25-APR-2017, the patient was vaccinated with a 0.65 mL dose of ZOSTAVAX injected subcutaneously in the left arm (lot # M038864 with expiration date at 12-DEC-2017), for prophylaxis, which was reconstituted in sterile diluent (STERILE DILUENT) (strength, dose, lot # and expiration date were not reported). On 27-APR-2017 (reported as "on the second day after injection"), the patient developed red, hot, raised, itchy, painful spot (about size of a quarter) on the arm at the injection site. The outcome of red, hot, raised, itchy, painful spot at the injection site was unknown at the time of the report. The causality assessment was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M035693, expiration date 07-NOV-2017 (dose and route of administration were not reported). The ZOSTAVAX was reconstituted with properly stored diluent (lot number and expiration date were unknown). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 40 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA006889:
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Information has been received from a currently 76 year old male patient referring to himself. The patient medical history included joint problems from arthritis and "couple cancers" (unspecified) with no maintenance medications. The patient stated that he had no concomitant medications and that he had drug reactions/allergies to tetracycline and diazepam (VALIUM). On an unknown date (reported as more than ten years ago), the patient was vaccinated with ZOSTAVAX for prevention from shingles (dose, lot number and expiration date were not reported). In November 2015 (reported as about two years ago in November), the patient reported that he had an unspecified "post vaccination episode" on an unspecified arm. The episode "was minor, but annoying and lasted three weeks". The patient did not seek medical attention at the time. At a later unspecified time, the patient showed the affected area on his arm to an unspecified physician and the area was almost healed. The physician could not do a biopsy at that time because the arm was almost healed, therefore a case of shingles, nor any other source of the episode, could be confirmed. At the time of the reporting the patient status was "fine". The causal relationship between the event and therapy with ZOSTAVAX were not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medications. On an unknown date, between May 2016 and December 2016, the patient was vaccinated with improperly stored VARIVAX lot # L021214, expiration date of 10-JUN-2017, for prophylaxis (dose and route of administration were not reported); which was diluted with properly stored sterile diluent (MRK), for prophylaxis ( lot number and expiration date were not reported). No adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 15-46 degrees Fahrenheit (46F) for 12 hours. There were previous excursions of 15-46 degrees Fahrenheit for 29 hours. There was not Data logger involved. No further information provided. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA001693: US-009507513-1705USA001692:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a 26 year-old patient of an unknown gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On 10-MAY-2017, the patient was vaccinated with an expired dose of improperly stored PROQUAD injection (dose, frequency and route were not reported) lot # L045678 with expiration date of 09-MAY-2017. The PROQUAD dose was reconstituted with sterile diluent (lot # and expiration date were not reported). The temperature excursion of the PROQUAD was between 6 °F and 14 °F (6.22 F) for a time frame of 5 minutes. No previous temperature excursion was reported. On an unspecified date in May 2017, the patient received a PROQUAD dose in addition to the one received on 10-MAY-2017. No adverse effects were reported. Data logger was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Death, Genital rash, Herpes zoster, Rash
Clinical narrative: Information had been received on 10-MAY-2017 from a lawyer and the daughter of the deceased female regarding a case in litigation. It was alleged in litigation that a female patient (decedent) of unknown age was inoculated with ZOSTAVAX vaccine (Date, dose, route, site of administration, lot # and expiration date were not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, 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 05-JUL-2016, the patient was treated in the emergency room, and later by urologist (as reported)(also reported as family nurse practitioner (FNP)) for an excruciating rash that spread to the female patient's genitalia and inside her body.  The female was diagnosed with severe shingles. On or about 06-JUL-2016, the female patient was treated at a family medicine facility, by a physician assistant (PA) for an ongoing and exceptionally severe outbreak of shingles. The patient was prescribed gabapentin to manage her symptoms.  On or about 09-JUL-2016, the female died at her home due to unknown causes, which her estate believes was attributable to the unmanageable pain of her atypical shingles outbreak.  At the time of death, the female was actively suffering from an active outbreak of Herpes Zoster on her body.  As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. The event of died at her home due to unknown causes was determined to be a medically significant event. Additional information has been requested.; Reported Cause(s) of Death: died at her home due to unknown causes.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent condition, or concomitant medication. The patient was inoculated with ZOSTAVAX vaccine (lot number not reported) on or about 21-JUN-2014 as  recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-JUN-2016, the patient was treated for a painful vesicular rash that was diagnosed as shingles. On or about 28-JUN-2016, the patient was treated by a physician for worsening symptoms diagnosed as severe shingles. On or about 15-NOV-2016, the patient was treated again by a physician for residual pain which was diagnosed as post herpetic neuralgia, a chronic condition involving residual nerve pain and damage as a result of severe shingles. The patient has been prescribed gabapentin, hydrocodone-acetaminophen, lipoderm patches and valacyclovir (VALTREX), which have done little to manage her persistent and excruciating 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: Information was received on 10-MAY-2017 from a lawyer regarding a case in litigation regarding a female of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 12-AUG-2011 at the Health Department, as recommended for routine adult health maintenance 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 17-JAN-2016, the patient was treated at a medical center for a painful vesicular eruption that was diagnosed as shingles. The patient has been prescribed acyclovir (manufacturer unknown), oxycodone/acetaminophen (PERCOCET), and  acyclovir(ZORIVAX) to manage 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: Herpes zoster, Neuropathy peripheral, Post herpetic neuralgia
Clinical narrative: Information was received on 10-MAY-2017 from lawyer regarding a case in litigation concerning a male patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 29-MAR-2011 at the county health, as recommended for routine adult health maintenance 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 04-JUN-2015, the patient was treated by a physician for a painful rash that was diagnosed as severe herpes zoster or shingles. The patient was prescribe valacyclovir (manufacturer unknown), MEDROL, gabapentin (manufacturer unknown) and narcotic analgesics for management of his severe symptoms. On or about 22-JUN-2015, the patient was treated at the hospital for ongoing conditions that were diagnosed with shingles with post herpetic neuralgia. Post herpetic neuralgia is a chronic condition involving residual pain and nerve damage concurrent and after contracting shingles. On or about 14-DEC-2015, the patient was treated by a physician for worsening conditions, which were diagnosed as new shingles outbreaks and neuropathy. The patient was then prescribed PERCOCET 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 expense, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information had been received on 10-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 27-NOV-2012 at a health care facility, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, 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 18-JUN-2016, the male patient was treated at a regional medical center for a painful, rash that was diagnosed as shingles. The male patient has been prescribed acyclovir and NORCO for management of his symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, 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: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Information had been received on 10-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 16-SEP-2014 at a health center, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, 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 08-JAN-2016, the patient was treated by a female person (not specified what type of health care professional) at the medical center for a painful rash that was diagnosed as Herpes Zoster dermatome (shingles) on the legs, neck, ears and chest. The male patient has been prescribed valcyclovir to manage his symptoms and outbreaks.  As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Upon internal review, the event of caused the patient to contract a persistent strain of Herpes Zoster/Herpes Zoster dermatome (shingles) on the legs, neck, ears and chest was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received on 10-MAY-2017 regarding a case in litigation from a lawyer and a consumer concerning a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 16-FEB-2012, as recommended for routine adult health maintenance 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 21-OCT-2014, the patient was treated by a physician for a painful rash that was diagnosed as shingles. The patient has been prescribed Acyclovir to manage her 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: Herpes zoster, Pain, Rash
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient of unknown age. Medical history and concomitant medications were not provided.  On or about 10-OCT-2912, the patient was vaccinated with ZOSTAVAX at a pharmacy as recommended for routine health maintenance for the prevention of shingles (route and lot # 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 07-JUL-2016, the patient was treated at a Family Practice for a rash that was diagnosed as shingles.  He was prescribed valacyclovir to manage his 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, pain and suffering, and other damages.  The outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a female patient of unknown age, who is also a Nurse Practitioner reporting on herself. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. Approximately in 2014 "reported as: "About three years ago"), the patient was vaccinated with a dose of ZOSTAVAX intramuscularly (strength, dose number, lot number and expiration date were not provided) for prophylaxis. It was reported that the dose of ZOSTAVAX reconstituted with sterile diluent(manufacturer unknown). No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On 10-MAY-2017, the patient was vaccinated with an expired dose of GARDASIL injection (dose, frequency and route were not reported) lot # L040459 with expiration date of 06-APR-2017, for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # L037565, expiration date 29-SEP-2017 and lot# M009766, expiration date 23-APR-2018 (dose and route of administration were not reported). The VARIVAX was reconstituted with properly stored diluent (lot number and expiration date were unknown). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 40 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA000874:
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Abasia, Anaemia, Asthenia, Blood test abnormal, Chills
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of unable to walk in a adolescent female patient who received BEXSERO (batch number 166701, expiry date May 2018). Concomitant products included BEXSERO. On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, less than a day after receiving BEXSERO, the patient experienced unable to walk (serious criteria GSK medically significant), chills, tremor, dizziness, pain, headache, weakness generalized and anemia. On an unknown date, the outcome of the unable to walk, chills, tremor, dizziness, pain, headache, weakness generalized and anemia were recovered/resolved. It was unknown if the reporter considered the unable to walk, chills, tremor, dizziness, pain, headache, weakness generalized and anemia to be related to BEXSERO. Additional details were provided as follows: In April 2017, the patient received the 1st dose of BEXSERO one month before the reporting date. In 2017, within 2 hours after receiving 2nd dose of BEXSERO, the patient had chills, shaking, dizziness, pain, headaches, generalized weakness and was unable to walk. The patient was taken to the emergency room (ER) where blood was drawn which revealed that the patient was anemic. In 2017, all symptoms resolved within 30 minutes to an hour after initiating. No further information was reported regarding the event.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Headache, Pain, Tremor
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of unable to walk in a adolescent female patient who received BEXSERO (batch number 166701, expiry date May 2018). Concomitant products included BEXSERO. On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, less than a day after receiving BEXSERO, the patient experienced unable to walk (serious criteria GSK medically significant), chills, tremor, dizziness, pain, headache, weakness generalized and anemia. On an unknown date, the outcome of the unable to walk, chills, tremor, dizziness, pain, headache, weakness generalized and anemia were recovered/resolved. It was unknown if the reporter considered the unable to walk, chills, tremor, dizziness, pain, headache, weakness generalized and anemia to be related to BEXSERO. Additional details were provided as follows: In April 2017, the patient received the 1st dose of BEXSERO one month before the reporting date. In 2017, within 2 hours after receiving 2nd dose of BEXSERO, the patient had chills, shaking, dizziness, pain, headaches, generalized weakness and was unable to walk. The patient was taken to the emergency room (ER) where blood was drawn which revealed that the patient was anemic. In 2017, all symptoms resolved within 30 minutes to an hour after initiating. No further information was reported regarding the event.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistance concerning a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with the first and the second dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). However, on 19-APR-2017, as the third dose of the series, the patient received GARDASIL (lot number M014929) for prophylaxis (dose, route of administration and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose and route of administration were not reported, lot # M014929 with expiration date 27-MAY-2017). Concomitant medications were not reported. The patient received the third dose of in the immunization series three months after the first dose. No adverse effects reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 4 years old patient. Gender, medical history, drug and allergy history and concurrent conditions were not reported. On 04-MAY-2017, the patient was vaccinated with an expired dose of PROQUAD which had a lot # L044056 and an expiration date 02-MAY-2017, (dose, route and anatomical location were not reported) for prophylaxis. The patient's concomitant therapy was not provided. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies. On an unknown dates, an unspecified number of patients were vaccinated with an improperly storage doses at a temperature of 47 °F to 77 °F for 9 hours and 54 minutes of LIQUID PEDVAXHIB (lot # L014429 and expiration date 15-MAR-2018) (lot # M014925 and expiration date 16-FEB-2019) (lot # M036056 and expiration date 18-MAY-2019) for prophylaxis (dose and route of administration were not reported). The vaccine did not have a previous temperature excursion and this information was provided due to the data logger. No adverse effects were reported. There was no product quality (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004700: US-009507513-1704USA010790: US-009507513-1705USA004699:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies. On an unknown dates, an unspecified number of patients were vaccinated with an improperly storage doses at a temperature of 47 °F to 77 °F for 9 hours and 54 minutes of ROTATEQ (lot # L029615 and expiration date 15-MAY-2017) (lot # M019706 and expiration date 24-OCT-2017) (lot # M031807 and expiration date 02-APR-2018) for prophylaxis (dose and route of administration were not reported). The vaccine did not have a previous temperature excursion and this information was provided due to the data logger. No adverse effects were reported. There was no product quality (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA010790: US-009507513-1705USA004700: US-009507513-1705USA004698:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies. On an unknown dates, an unspecified number of patients were vaccinated with an improperly storage doses at a temperature of 47 °F to 77 °F for 9 hours and 54 minutes of PNEUMOVAX23 (lot # M036728 and expiration date 20-MAY-2018) (lot # M039060 and expiration date 22-MAY-2018) for prophylaxis (dose and route of administration were not reported). The vaccine did not have a previous temperature excursion and this information was provided due to the data logger. No adverse effects were reported. There was no product quality (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004699: US-009507513-1704USA010790: US-009507513-1705USA004698:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received on 10-MAY-2017 regarding a case in litigation from a lawyer and a consumer concerning a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 27-JUN-2007 as recommended for routine adult health maintenance 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 16-JUN-2016, the patient was treated for a painful rash that was diagnosed as severe shingles. The patient was prescribed valacyclovir hydrochloride (reported as "Valaciclovir"), NORCO and ciprofloxacin for management of the excruciating 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: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician referring to multiple patients of unknown ages and genders. The patients' medical history or concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L046884, expiration date 23-NOV-2017) dosage information, route and anatomical site of vaccination were not informed, for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown) which was stored in correct range. No adverse effects were reported. There was no product quality complaint involved. It was also reported that the vaccines experienced temperatures from 9° C to 25° C. The time frame was 6.5 hours. There was no previous temperature excursion. The call was because of a "data logger".  Additional information is not expected, since the physician contact details were not provided.
Sex: F
Vaccine: HPV9
Symptoms: Deep vein thrombosis, Injection site swelling, Peripheral swelling, Ultrasound Doppler abnormal, White blood cell count increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act and refers to a female patient of unknown age. The patient had no medical history, current illness and prior vaccinations. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # M036059, (dose provided as 0.0) intramuscular in the left arm (indication not provided). Concomitant therapies included multivitamin (VITAMINS (UNSPECIFIED)). It was reported that patient developed swelling at site of vaccine injection on right arm(vaccination site swelling), swelling on left arm(peripheral swelling) found to have a left brachial vein deep vein thrombosis (DVT), ultrasound doppler abnormal and white blood cell count increased . In Lab test, Duplex of both upper extremities were performed which showed DVT right extremity; WBC 17(units not provided). The patient had emergency room visit and was hospitalized. The outcome of the events deep vein thrombosis, white blood cell count increased, vaccination site swelling, ultrasound doppler abnormal and peripheral swelling was reported as recovered/resolved.  Causality assessement was not provided. The agency considered the events to be serious due to life-threatening. Additional information is not expected because no further details can be obtained from the Agency.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Irritability, Rash, Rash macular, Urticaria
Clinical narrative: Mother states pt. had developed a rash at 6-14 days post-vaccination that resolved. Mother stated pt. developed another 'red, splotchy hive-like rash,' on 05/13/17. Mother denies respiratory issues for pt. or fever, only other complaint is increased, 'fussiness.' RN encouraged mother to receive emergency medical treatment if mother feels pt. is currently having an allergic reaction, which she denies. RN also encouraged mother to follow-up with PCP today for pt.'s rash, mother agreed to this.
Age: 7.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Wrong patient received medication
Clinical narrative: RECEIVED AN UN-NEEDED VACCINE (HBV) DUE TO PARENT ANSWERING TO WRONG NAME - CHILDREN'S NAMES WERE PRONOUNCED THE SAME, BORN SAME MONTH AND YEAR AND NEEDED SIMILAR BUT NOT IDENTICAL VACCINES.  PARENT CHANGED CHILD'S NAME DURING REGISTRATION PROCESS, ALSO.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis, Rash erythematous, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Warm, erythematous rash over vaccine site on left deltoid, evaluated and started on antibiotics for cellulitis 3 days later.
Sex: F
Vaccine: PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist reporting on a female patient of unknown age. There were no patient's concomitant medications, pertinent medical history, drug reactions or allergies provided. In April 2016 (reported as "1 year ago"), the patient was vaccinated with one unspecified dose of PREVNAR, for prophylaxis. On 27-APR-2017, the patient came to the pharmacy to receive a dose of PNEUMOVAX 23 (lot#, expiration date, route of administration were not reported), for prophylaxis. The patient received a second dose of PREVNAR instead, because she told the pharmacist she was due for a dose of that vaccine, and realized she was actually supposed to get PNEUMOVAX 23 only after the pharmacist gave her the second dose of PREVNAR. The pharmacist did not report any adverse effects. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse practitioner (also reporter as nurse prescriber) via a field representative, concerning a 72 years-old male patient. The patient's concurrent conditions included diabetes (unspecified). His medical history, concomitant medications, drug reactions or allergies were unknown by the reporter. On 13-DEC-2013, the patient was vaccinated with ZOSTAVAX lot # J008528 and expiration date on 19-OCT-2014 (strength, route of administration or anatomical location were not provided); one dose was administered for prevention of shingles. On an unspecified date in the fall of 2016, the patient developed shingles. Therefore, he sought medical attention and received an unspecified treatment for the event. It was unknown if laboratory diagnostics studies were performed. The outcome of the event shingles was unknown. The relatedness between the event shingles and the vaccine was not reported. No product quality complaint (PQC) was involved. Additional information is not expected as there was no consent to contact the reporter.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications.   On an unknown date, the patients were vaccinated with improperly stored M-M-R II lot # M029230 with expiration date of 08-JUN-2018, lot# M037096 with expiration date of 23-AUG-2018, lot# M040624 with expiration date of 03-OCT-2018(rHA), lot# M029919 with expiration date of 13-JUN-2018 and lot# M035388 with expiration date of 02-AUG-2018, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47-77 degrees Fahrenheit (°F) for 3 hours. There were not previous excursions. Data logger was involved.  No adverse symptoms were reported. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA001009: US-009507513-1705USA001228: US-009507513-1705USA001229: US-009507513-1705USA001231: US-009507513-1705USA001232: