chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
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 was not reported. On 05-MAR-2018, the patient was vaccinated with an improperly stored ROTATEQ lot # N016457, expiration date 16-DEC-2018, oral for prophylaxis. The vaccine underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 28 hours. There was a previous temperature excursion of 47 to 77 degrees Fahrenheit for 3 hours. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA010707: US-009507513-1803USA010708.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-FEB-2015, the patient was inoculated with ZOSTAVAX at a medical office as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended. In or about May 2016, the patient was treated at a hospital and was diagnosed with herpes zoster, or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
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 was not reported. On 15-MAR-2018, the patient was vaccinated with an improperly stored ROTATEQ lot # N016457, expiration date 16-DEC-2018, oral for prophylaxis. The vaccine underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 28 hours. There was a previous temperature excursion of 47 to 77 degrees Fahrenheit for 3 hours. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA010708: US-009507513-1803USA008738.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
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 was not reported. On 16-MAR-2018, the patient was vaccinated with an improperly stored ROTATEQ lot # N016457, expiration date 16-DEC-2018, oral for prophylaxis. The vaccine underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 28 hours. There was a previous temperature excursion of 47 to 77 degrees Fahrenheit for 3 hours. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA008738: US-009507513-1803USA010707.
Age: 19.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Borrelia test negative, CSF lymphocyte count normal, CSF test abnormal, CSF white blood cell count increased, Culture negative
Clinical narrative: Headache, facial and (R) ipsilateral extremity weakness, short-course. Symptoms consistent with neuro-encephalitis with (-) MRI, LP c/w pleocytosis of CSF. All cultures and tests viral illness negative. Self resolved and no residual. Possible HaNDL syndrome.
Age: 19.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Encephalitis, Facial paresis, Full blood count, HIV test negative, Headache
Clinical narrative: Headache, facial and (R) ipsilateral extremity weakness, short-course. Symptoms consistent with neuro-encephalitis with (-) MRI, LP c/w pleocytosis of CSF. All cultures and tests viral illness negative. Self resolved and no residual. Possible HaNDL syndrome.
Age: 19.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Hemiparesis, Herpes simplex test negative, Lumbar puncture abnormal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Headache, facial and (R) ipsilateral extremity weakness, short-course. Symptoms consistent with neuro-encephalitis with (-) MRI, LP c/w pleocytosis of CSF. All cultures and tests viral illness negative. Self resolved and no residual. Possible HaNDL syndrome.
Age: 19.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Pleocytosis, Treponema test negative
Clinical narrative: Headache, facial and (R) ipsilateral extremity weakness, short-course. Symptoms consistent with neuro-encephalitis with (-) MRI, LP c/w pleocytosis of CSF. All cultures and tests viral illness negative. Self resolved and no residual. Possible HaNDL syndrome.
Age: 33.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Pt received HAVRIX, TYPHIM, BOOSTRIX on 3/11/18. Right after his vaccines, patient complained of dizziness, sat down and lost consciousness. Patient was lowered to the floor. Paramedics were called. Pt regained consciousness about a minute later before paramedics arrived. Vitals were normal and pt walked out by himself.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Arthralgia, Carbon dioxide decreased, Culture urine negative, Decreased appetite
Clinical narrative: Patient developed fever, joint pains, stomach aches, decreased appetite and was seen on 3/15/18 and felt to have a viral syndrome but this progressed such that on 3/20/18 she was evaluated again.  She had had two episodes of emesis, no more fever but severely decreased appetite, some stomach aches vs. dysuria and was dehydrated requiring ER evaluation and hospital admission for IV fluids.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Dehydration, Dysuria, Full blood count normal, Pyrexia, Urine analysis normal
Clinical narrative: Patient developed fever, joint pains, stomach aches, decreased appetite and was seen on 3/15/18 and felt to have a viral syndrome but this progressed such that on 3/20/18 she was evaluated again.  She had had two episodes of emesis, no more fever but severely decreased appetite, some stomach aches vs. dysuria and was dehydrated requiring ER evaluation and hospital admission for IV fluids.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Viral infection, Vomiting
Clinical narrative: Patient developed fever, joint pains, stomach aches, decreased appetite and was seen on 3/15/18 and felt to have a viral syndrome but this progressed such that on 3/20/18 she was evaluated again.  She had had two episodes of emesis, no more fever but severely decreased appetite, some stomach aches vs. dysuria and was dehydrated requiring ER evaluation and hospital admission for IV fluids.
Age: 22.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Patient blacked out roughly 1 minute after standing up post vaccines being given. Pt was caught and lowered to the floor without injury. BP was monitored and ammonia administered under the nose. Within 4-5 seconds patient returned to consciousness, stated he didn't know what happened. Pt was alert and oriented, was finally able to sit up in a chair while BP continued to be monitored. After 20 minutes or so- patient was walked to this lobby where wife was explained what happened and patient was able to leave under the supervision of his wife.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13
Symptoms: Extra dose administered
Clinical narrative: Child was given PENTACEL and ACTHIB on the same day. She received a double dose of Hib.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Rash pruritic
Clinical narrative: PATIENT REPORTED WITHIN 24 HOURS STARTING HAVING TERRIBLE HEADACHE, FELT WEAK AND THEN 10 DAYS AFTER SHOT DEVELOPED ITCHY RASH.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Blood pressure increased, Injection site rash, Injection site swelling, Stress
Clinical narrative: Patient states she had joint pain, upper extremity rash, and swelling near injection site, blood pressure elevated since injection, patient stressed out as a result.
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Coma, Intensive care, Status epilepticus
Clinical narrative: Status epilepticus, prolonged, picu, coma. Parents concerned about present development.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fatigue, Nausea, Pain, Somnolence
Clinical narrative: Soreness, Tired/sleepiness/Nausea/cramp-stomach.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Deafness unilateral, Uveitis
Clinical narrative: Pt states he had temporary hearing loss left ear and a flair up of his Uveitis the day after receiving the vaccine.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Induration, Mobility decreased, Pain in extremity
Clinical narrative: Sore arm and hard to the touch. Not warm or red and could not lift arm. Symptoms improving and able to lift arm 3-26-2018 but not fully yet.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Mobility decreased, Pain in extremity
Clinical narrative: Sore arm and hard to the touch. Not warm or red and could not lift arm. Symptoms improving and able to lift arm 3-26-2018 but not fully yet.
Age: 27.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Blood pressure decreased, Syncope
Clinical narrative: Patient fainted. They were moved to a flat bed where their legs were elevated and they quickly became alert. Their BP was down from baseline (103/78 vs 137/78). They were given juice and a snack and returned to baseline status within 10 minutes.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Anaphylactic shock
Clinical narrative: Patient had anaphylactic shock and was needed to be hospitalized. He is now complete with treatment and ok.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site induration
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a 55 year old female patient. No information regarding her pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On approximately 06-FEB-2018, reported as "approximately a month ago", the patient was vaccinated with a dose of PNEUMOVAX 23 injection, intramuscular route of administration (exact dose, lot # and expiration date were not reported). On the same date, "immediately" after vaccination, she developed "extreme induration at the injection site" to the point she "could not move her arm". The patient sought medical attention by contacting her "primary physician" (unspecified), who prescribed her an "extended prednisone treatment" to take as a treatment for the event. No product quality complaint (PQC) was involved. The outcome of the events was reported as recovered. The relatedness between the events and PNEUMOVAX 23 was not reported.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Conjunctivitis, Hypertension
Clinical narrative: This spontaneous report was received from a 65-year-old female patient referring to herself. No medical history, concurrent conditions, concomitant medications or past drugs were reported. On 12-MAR-2018, the patient was vaccinated with a dose of PNEUMOVAX 23, via intramuscular route (exact dose, lot# and expiry date were not reported) as a vaccine for pneumonia. On 15-MAR-2018, the patient experienced high blood pressure and was diagnosed with pink eye. The patient received Lisinopril (manufacturer unknown) as a treatment for high blood pressure. No treatment was given for pink eye. Diagnostic and laboratory tests were not provided. The outcome of both events was reported as not recovered. The causality assessment between the events and PNEUMOVAX was not provided.
Sex: F
Vaccine: HPVX
Symptoms: Adverse event, Seizure
Clinical narrative: This spontaneous report was received from a dementia specialist (a non-licensed healthcare worker) refers to a 14-year-old female patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy was unknown. On an unknown date the patient was vaccinated with a dose of GARDASIL (strength, dose, frequency, lot # and expiry date was not reported) or GARDASIL 9 (strength, dose, frequency, lot # and expiry date was not reported) for prophylaxis. On an unknown date the patient experienced seizures and other (unspecified) side effects. The patient sought medical attention for the events and the patient's doctor gave her antiseizure medications (details unspecified). The action taken with the therapy with GARDASIL and GARDASIL 9 was unknown. The outcome of the events seizures and adverse event was unknown. The relationship between the event seizure and adverse event to the therapy with GARDASIL and GARDASIL 9 was not provided by the reporter. There was no product quality complaint (PQC) reported. Upon internal review, the event seizure was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-NOV-2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended. On or about 20-APR-2016, the patient was treated by a physician for the onset of a severe rash, which was diagnosed as herpes zoster, or shingles with complications (unspecified). As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care the treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 04-JAN-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended. During 2016 (specific date unknown), the patient was treated at an urgent care and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care the treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received on 23-MAR-2018 from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 17-SEP-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 01-MAY-2017, the patient was treated by a physician for the onset of a severe rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the 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: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received on 23-MAR-2018 from a lawyer and a consumer of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications are unknown. During July 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 01-MAY-2016, the patient was treated at a medical center for the onset of a rash that was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 06-JUN-2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster.  On or about 25-MAY-2016, the patient was treated by a Registered Nurse and diagnosed with herpes zoster, or shingles.  As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2014, the patient was inoculated (by an unspecified person) at a medical clinic with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended. On or about 29-APR-2016, the female patient was treated (by an unspecified healthcare professional) at the hospital for the blistering outbreak and decreased immune symptoms which was then diagnosed as perineal shingles. On or about 02-MAY-2016, the patient sought subsequent treatment at the hospital for the diagnosis of vaginal shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-NOV-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In or about May 2016, the patient was treated at a medical center and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. During 2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended. In or about May 2016, the patient was treated at a hospital and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. During 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about April 2016, the patient was treated at a medical center and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Loss of personal independence in daily activities, Musculoskeletal pain, Pain in extremity
Clinical narrative: Left upper arm started hurting at the time of the vaccination and the pain never went away or lessened in severity. The pain is also in my shoulder. Sometimes it hurts so bad, I'm unable to lift my arm to do certain things. It's been over 2 months, and the pain shows no signs of going away. My arm feels the same as it did the day I got vaccinated.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Autism spectrum disorder, Computerised tomogram, Constipation, Developmental delay, Electroencephalogram
Clinical narrative: Seizure, diagnosis of epilepsy (complex partial), autism spectrum disorder, developmental delay, chronic constipation (functional).
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Epilepsy, Nuclear magnetic resonance imaging, Seizure
Clinical narrative: Seizure, diagnosis of epilepsy (complex partial), autism spectrum disorder, developmental delay, chronic constipation (functional).
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Influenza like illness, Lymphadenopathy, Pyrexia, Swelling
Clinical narrative: Patient developed swollen lymph nodes on her neck/throat the day after receiving SHINGRIX. She was so uncomfortable due to the swelling that she was not able to go to work that day. Patient reported feeling feverish and experiencing flu-like symptoms.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Crying, Discomfort, Fatigue, Pain, Screaming
Clinical narrative: Baby fell asleep and slept for 4 hours shortly after vaccinations. Woke around 10 PM screaming and crying. Mother could not comfort child. Gave TYLENOL, but child continued to scream and cry for approximately one to two hours until he finally exhausted and fell back asleep.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Intense shivering through the night post-inoculation with slight fever; soreness and tired the following day such that I didn't go in to work.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a 21 year old female patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 13-APR-2017, the patient was vaccinated with first dose of GARDASIL 9 for prophylaxis (route, anatomical location, lot # and expiration date were not provided) and received the second dose on 14-MAR-2018. No adverse effects were reported. Sender's Comments: US-009507513-1803USA009618.
Sex: F
Vaccine: HPV4
Symptoms: Juvenile idiopathic arthritis, Laboratory test
Clinical narrative: This spontaneous report was received from nurse practitioner via a field representative regarding a 15 year old female patient (friend of the reporter's daughter). The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. In approximately 2015 (reported as approximately three years ago), the patient was vaccinated with one dose of GARDASIL (route, lot # and expiry date unknown) for prevention of human papilloma virus (HPV). On an unknown date, the patient developed juvenile rheumatoid arthritis after being vaccinated with GARDASIL. The patient sought medical attention with a physician. Treatment administered for the event was unknown. The patient underwent multiple unspecified tests on unknown dates for which the results were unknown. At the time of the report, the patient had not recovered from the event. Causality assessment was not provided by the reporter. Upon internal review, the event of juvenile rheumatoid arthritis was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: Information was received on 23-MAR-2018 from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. On or about 05-MAR-2015, the patient was inoculated at a hospital with ZOSTAVAX (lot number, dosage, and route of administration not provided) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 05-JAN-2017, the patient was diagnosed with shingles and neuropathic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has 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
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. During 2015 (specific date not provided), the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended. On or about 01-MAY-2016, the patient was treated at a medical facility and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. During 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 01-MAY-2016, the patient was treated by a physician and was diagnosed with herpes zoster or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 23-MAR-2018 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-OCT-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 01-MAY-2016, the patient was treated at a medical center, and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. During 2015 (specific date not provided), the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended. On or about May 2016, the patient was treated at a hospital/clinic and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. During 2015, the patient was inoculated with ZOSTAVAX at a medical center as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In or about May 2016, the patient was treated by a physician and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. During 2015 (specific date not provided), the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about May 2016, the patient was treated at a clinic and was diagnosed with severe herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. During 2013, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended.  On or about 30-MAY-2016, the patient was treated by the same physician and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 06-FEB-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about May 2016, the patient was treated and diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. During 2015 (specific date not provided), the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about May 2016, the patient was treated at an emergency room and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 01-SEP-2011, the patient was inoculated (by an unspecified person) at a pharmacy with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended. On or about 01-MAY-2016, the female patient was treated by a physician at a clinic for a blistering vesicular outbreak, which was diagnosed as Herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Asthenia, Confusional state, Dizziness, Fall, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This 78-year-old patient of an unspecified ethnicity and gender received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a severe allergic reaction left arm very painful and bright red from the injection site to the elbow, headache, fatigue, dizziness, weakness, confused thinking, had the first fall, this resulted in an injury to a leg. The outcome for all events was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Headache, Hypersensitivity, Injection site erythema, Injection site pain, Limb injury
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This 78-year-old patient of an unspecified ethnicity and gender received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a severe allergic reaction left arm very painful and bright red from the injection site to the elbow, headache, fatigue, dizziness, weakness, confused thinking, had the first fall, this resulted in an injury to a leg. The outcome for all events was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at 0.5 ml, single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced small bump at injection site on an unspecified date with outcome of unknown. The information on the batch number has been requested.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Allergy test, Antibody test negative, Extra dose administered
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 67-years-old male patient received when 66 years old PREVNAR 13, (Lot Number: 539564, Expiry date: 30Sep2018), via an unspecified route of administration at 0.5 ml single in left arm on 21Sep2017 for immunisation. Medical history was none. There were no concomitant medications. Since that vaccination, the patient had to go and do allergy testing for another reason. The wife wasn't specific about what test they did, maybe pulling testing for antibodies. The report came back that he was eligible to get a pneumococcal vaccination and the patient had no antibodies.
Sex: F
Vaccine: MENB
Symptoms: Mobility decreased, Myalgia, Paraesthesia
Clinical narrative: This is a spontaneous report obtained from a contactable physician (Pediatrician) through a Pfizer sales representative. A female patient of an unspecified age, race and ethnicity received the first dose of TRUMENBA on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced muscle pain and pins and needles. The patient stated she was feeling as if she was unable to move arms and legs for 4 days, like she couldn't walk or move. Physician stated she was in fact able to move and walk but she had muscle pain. The patient refused second dose on 20Mar2018. Clinical outcome was unknown at time of this report.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of an unspecified age (reported as Age: 65; Units: Unknown) and ethnicity started to receive PREVNAR 13 via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain at the injection site for a few days. The event took place after use of pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein). Outcome of the event was unknown. Information on batch and lot numbers has been requested.
Age: 61.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Computerised tomogram, Headache, Myalgia, Neck pain, Nuclear magnetic resonance imaging
Clinical narrative: Patient received Pneumonia and Flu on 10/15/16 in the same facility. On March 21, 2017 received a testosterone cypionate treatment. Between this day and October/November 2017 that 2 episodes sores and hives and also muscle pain on left arm when bending or lifting. Not sure if problems are due to the vaccines received or testosterone treatment. Went to clinic and was seen by various providers over time. One time the doctor prescribed something over the counter for the soreness. Last month went back to doctor because started experiencing headaches and still had pain in the arm and neck; doctor prescribed 800 mg of Ibuprofen and other prescription pain medication that was not filled. Doctor got approval for further testing including MRI, CT scan and head X-ray. Doctor provided referral to neurologist; appointment on April 5th. Still taking TYLENOL-Extra Strength, 1-2 day and up to 4 a day.
Age: 61.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pain, Pain in extremity, Skin ulcer, Skull X-ray, Urticaria
Clinical narrative: Patient received Pneumonia and Flu on 10/15/16 in the same facility. On March 21, 2017 received a testosterone cypionate treatment. Between this day and October/November 2017 that 2 episodes sores and hives and also muscle pain on left arm when bending or lifting. Not sure if problems are due to the vaccines received or testosterone treatment. Went to clinic and was seen by various providers over time. One time the doctor prescribed something over the counter for the soreness. Last month went back to doctor because started experiencing headaches and still had pain in the arm and neck; doctor prescribed 800 mg of Ibuprofen and other prescription pain medication that was not filled. Doctor got approval for further testing including MRI, CT scan and head X-ray. Doctor provided referral to neurologist; appointment on April 5th. Still taking TYLENOL-Extra Strength, 1-2 day and up to 4 a day.
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity started to receive PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fatigue, and also some myalgia, some muscle pain on an unspecified date. She said she got the shot on the night and she said it seems like it was getting worst. She guess, muscle and joint pain actually. The outcome was not recovered.