chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HIBV, HIBV
Symptoms: Injection site pruritus, Injection site swelling, Mechanical urticaria, Ultrasound Doppler abnormal
Clinical narrative: This spontaneous report as received from a other health professional refers to a female patient of unknown age with prophylaxis. On 06-MAR-2014 the patient was vaccinated with LIQUID PEDVAXHIB lot # J009714 dose 1, intramuscular for prophylaxis. Other suspect therapies included PEDVAXHIB. On 2015 the patient experienced injection site pruritus and injection site mass. On OCT-2015 the patient experienced limb mass. On DEC-2016 the patient experienced rash. On an unknown date the patient experienced cyst, urticaria and product quality issue. The outcome of injection site mass, rash, urticaria, injection site pruritus, limb mass and cyst was reported as not recovered/not resolved. The outcome of product quality issue is unknown.
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HIBV, HIBV
Symptoms: Cyst, Injection site mass, Injection site pruritus, Limb mass, Product quality issue
Clinical narrative: This spontaneous report as received from a other health professional refers to a female patient of unknown age with prophylaxis. On 06-MAR-2014 the patient was vaccinated with LIQUID PEDVAXHIB lot # J009714 dose 1, intramuscular for prophylaxis. Other suspect therapies included PEDVAXHIB. On 2015 the patient experienced injection site pruritus and injection site mass. On OCT-2015 the patient experienced limb mass. On DEC-2016 the patient experienced rash. On an unknown date the patient experienced cyst, urticaria and product quality issue. The outcome of injection site mass, rash, urticaria, injection site pruritus, limb mass and cyst was reported as not recovered/not resolved. The outcome of product quality issue is unknown.
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HIBV, HIBV
Symptoms: Rash, Urticaria
Clinical narrative: This spontaneous report as received from a other health professional refers to a female patient of unknown age with prophylaxis. On 06-MAR-2014 the patient was vaccinated with LIQUID PEDVAXHIB lot # J009714 dose 1, intramuscular for prophylaxis. Other suspect therapies included PEDVAXHIB. On 2015 the patient experienced injection site pruritus and injection site mass. On OCT-2015 the patient experienced limb mass. On DEC-2016 the patient experienced rash. On an unknown date the patient experienced cyst, urticaria and product quality issue. The outcome of injection site mass, rash, urticaria, injection site pruritus, limb mass and cyst was reported as not recovered/not resolved. The outcome of product quality issue is unknown.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Loss of consciousness, Pain in extremity, Peripheral swelling, Syncope
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 19 year old female patient. The patient had no pertinent medical history and drug reactions or allergies. She did not abuse drugs and alcohol. The patient was vaccinated with a first dose of TRUMENBA on 07-JUL-2016. She had no adverse events following prior vaccinations. On 15-MAY-2017, the patient was intramuscularly vaccinated with a third dose of GARDASIL in the left deltoid, lot#N000326, expiration date 14-OCT-2019 (dose was not reported) for prophylaxis. Other suspect therapies included a second dose of TRUMENBA administered intramuscularly in the left arm, in left deltoid, lot# R56659 on the same day at 10:30 am. On 15-MAY-2017 at 10:30 am, right after TRUMENBA was given, the patient fainted. The patient was not admitted to hospital. She did not require a visit to Emergency Room or Physician's Office. No treatment was required. The patient recovered from the event on 15-MAY-2017. The relatedness between the event of syncope and the suspect drugs was not reported.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Loss of consciousness, Syncope
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 19 year old female patient. The patient had no pertinent medical history and drug reactions or allergies. She did not abuse drugs and alcohol. The patient was vaccinated with a first dose of TRUMENBA on 07-JUL-2016. She had no adverse events following prior vaccinations. On 15-MAY-2017, the patient was intramuscularly vaccinated with a third dose of GARDASIL in the left deltoid, lot#N000326, expiration date 14-OCT-2019 (dose was not reported) for prophylaxis. Other suspect therapies included a second dose of TRUMENBA administered intramuscularly in the left arm, in left deltoid, lot# R56659 on the same day at 10:30 am. On 15-MAY-2017 at 10:30 am, right after TRUMENBA was given, the patient fainted. The patient was not admitted to hospital. She did not require a visit to Emergency Room or Physician's Office. No treatment was required. The patient recovered from the event on 15-MAY-2017. The relatedness between the event of syncope and the suspect drugs was not reported.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Limb discomfort, Loss of consciousness, Pain in extremity, Peripheral swelling, Syncope
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 19 year old female patient. The patient had no pertinent medical history and drug reactions or allergies. She did not abuse drugs and alcohol. The patient was vaccinated with a first dose of TRUMENBA on 07-JUL-2016. She had no adverse events following prior vaccinations. On 15-MAY-2017, the patient was intramuscularly vaccinated with a third dose of GARDASIL in the left deltoid, lot#N000326, expiration date 14-OCT-2019 (dose was not reported) for prophylaxis. Other suspect therapies included a second dose of TRUMENBA administered intramuscularly in the left arm, in left deltoid, lot# R56659 on the same day at 10:30 am. On 15-MAY-2017 at 10:30 am, right after TRUMENBA was given, the patient fainted. The patient was not admitted to hospital. She did not require a visit to Emergency Room or Physician's Office. No treatment was required. The patient recovered from the event on 15-MAY-2017. The relatedness between the event of syncope and the suspect drugs was not reported.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 19 year old female patient. The patient had no pertinent medical history and drug reactions or allergies. She did not abuse drugs and alcohol. The patient was vaccinated with a first dose of TRUMENBA on 07-JUL-2016. She had no adverse events following prior vaccinations. On 15-MAY-2017, the patient was intramuscularly vaccinated with a third dose of GARDASIL in the left deltoid, lot#N000326, expiration date 14-OCT-2019 (dose was not reported) for prophylaxis. Other suspect therapies included a second dose of TRUMENBA administered intramuscularly in the left arm, in left deltoid, lot# R56659 on the same day at 10:30 am. On 15-MAY-2017 at 10:30 am, right after TRUMENBA was given, the patient fainted. The patient was not admitted to hospital. She did not require a visit to Emergency Room or Physician's Office. No treatment was required. The patient recovered from the event on 15-MAY-2017. The relatedness between the event of syncope and the suspect drugs was not reported.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 19 year old female patient. The patient had no pertinent medical history and drug reactions or allergies. She did not abuse drugs and alcohol. The patient was vaccinated with a first dose of TRUMENBA on 07-JUL-2016. She had no adverse events following prior vaccinations. On 15-MAY-2017, the patient was intramuscularly vaccinated with a third dose of GARDASIL in the left deltoid, lot#N000326, expiration date 14-OCT-2019 (dose was not reported) for prophylaxis. Other suspect therapies included a second dose of TRUMENBA administered intramuscularly in the left arm, in left deltoid, lot# R56659 on the same day at 10:30 am. On 15-MAY-2017 at 10:30 am, right after TRUMENBA was given, the patient fainted. The patient was not admitted to hospital. She did not require a visit to Emergency Room or Physician's Office. No treatment was required. The patient recovered from the event on 15-MAY-2017. The relatedness between the event of syncope and the suspect drugs was not reported.
Age: 19.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB, HPV4, MENB
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 19 year old female patient. The patient had no pertinent medical history and drug reactions or allergies. She did not abuse drugs and alcohol. The patient was vaccinated with a first dose of TRUMENBA on 07-JUL-2016. She had no adverse events following prior vaccinations. On 15-MAY-2017, the patient was intramuscularly vaccinated with a third dose of GARDASIL in the left deltoid, lot#N000326, expiration date 14-OCT-2019 (dose was not reported) for prophylaxis. Other suspect therapies included a second dose of TRUMENBA administered intramuscularly in the left arm, in left deltoid, lot# R56659 on the same day at 10:30 am. On 15-MAY-2017 at 10:30 am, right after TRUMENBA was given, the patient fainted. The patient was not admitted to hospital. She did not require a visit to Emergency Room or Physician's Office. No treatment was required. The patient recovered from the event on 15-MAY-2017. The relatedness between the event of syncope and the suspect drugs was not reported.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Migraine, Myalgia, Pyrexia, Spinal pain
Clinical narrative: This is a spontaneous report from a contactable consumer, reported for his/her daughter. A 17-year-old female patient received the first dose of TRUMENBA for immunization at single dose, injection to left upper arm/shoulder on 08Aug2017 at about 10 AM. On the same date the patient experienced passed out, felt very lightheaded, low grade fever, headache, swelling at the injection site, pain at the injection site, significant pain all over her body, then later on in the day, the pain progressed and was concentrated in her back. Patient said her back was killing her and it was all the way up through her spine and to her head. On unknown date sleep disorder. Within 2 hours of the injection is when the  symptoms started and persisted for at least 24 hours. The outcome of the events was unknown. The patient received 800 MG of Ibuprofen and 25 MG of diphenhydramine.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Back pain, Dizziness, Headache, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer, reported for his/her daughter. A 17-year-old female patient received the first dose of TRUMENBA for immunization at single dose, injection to left upper arm/shoulder on 08Aug2017 at about 10 AM. On the same date the patient experienced passed out, felt very lightheaded, low grade fever, headache, swelling at the injection site, pain at the injection site, significant pain all over her body, then later on in the day, the pain progressed and was concentrated in her back. Patient said her back was killing her and it was all the way up through her spine and to her head. On unknown date sleep disorder. Within 2 hours of the injection is when the  symptoms started and persisted for at least 24 hours. The outcome of the events was unknown. The patient received 800 MG of Ibuprofen and 25 MG of diphenhydramine.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Loss of consciousness, Pain, Pyrexia, Sleep disorder, Spinal pain
Clinical narrative: This is a spontaneous report from a contactable consumer, reported for his/her daughter. A 17-year-old female patient received the first dose of TRUMENBA for immunization at single dose, injection to left upper arm/shoulder on 08Aug2017 at about 10 AM. On the same date the patient experienced passed out, felt very lightheaded, low grade fever, headache, swelling at the injection site, pain at the injection site, significant pain all over her body, then later on in the day, the pain progressed and was concentrated in her back. Patient said her back was killing her and it was all the way up through her spine and to her head. On unknown date sleep disorder. Within 2 hours of the injection is when the  symptoms started and persisted for at least 24 hours. The outcome of the events was unknown. The patient received 800 MG of Ibuprofen and 25 MG of diphenhydramine.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 18-year-old male patient who received BEXSERO (batch number 16B101, expiry date 28th February 2019). On 8th August 2017, the patient received the 1st dose of BEXSERO (intramuscular). On 9th August 2017, 1 days after receiving BEXSERO, the patient experienced injection site pain and injected limb mobility decreased were unknown. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in left deltoid and experienced pain at the injection site and the pain was severe that he could not move his arms.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 18-year-old male patient who received BEXSERO (batch number 16B101, expiry date 28th February 2019). On 8th August 2017, the patient received the 1st dose of BEXSERO (intramuscular). On 9th August 2017, 1 days after receiving BEXSERO, the patient experienced injection site pain and injected limb mobility decreased were unknown. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in left deltoid and experienced pain at the injection site and the pain was severe that he could not move his arms.
Age: 76.0
Sex: F
Vaccine: DTAP, TTOX
Symptoms: Arthralgia, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: None stated.
Age: 76.0
Sex: F
Vaccine: DTAP, TTOX
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Aphasia, Blood magnesium normal, Blood phosphorus normal, Confusional state, Excessive eye blinking
Clinical narrative: Patient seen 8/11/17 for MMR vaccination. At that time reported one week ago had dysuria that resolved, one day only. Had fever around that time (brother had fever same day, also only lasted one day). She does occasionally have day and night time urinary accidents, never fully dry. Therefore, urine obtained, but patient unable to give sample. MMR was administered. Patient subsequently was able to bring urine back and showed >100,000 E.coli, started on KEFLEX. Today, comes back to discuss possible seizures since the MMR vaccine. Mother states patient has had a total of 4 episodes starting August 12, the day after her MMR, over a four-day timeframe. Episodes consisted of a sudden stop of conversation, often midsentence, where she seemed nonresponsive with eyes blinking. The eyes did not roll back or have any nystagmus. Episodes lasted about 20 seconds each time. After which she could not remember the sentence that she had started. For the time period immediately following the events she seemed mildly confused and to have word finding difficulty. There was no abnormal movements associated with the events other than the eye blinking, she did not drop with any of the events, no muscle tightness or weakness that they appreciated. She is otherwise been her normal self. Her activity level is normal. She did not have fever at any of the episodes, or otherwise since receiving the MMR. She has had no abdominal pain, nausea, vomiting, diarrhea. She has had no rashes. She has had no joint pains, swelling, redness. She is sleeping normally. Her behavior and mood have been the same as normal. She has had no episodes for the last 2 days.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Full blood count normal, Haemoglobin increased, Memory impairment, Metabolic function test normal, Speech disorder
Clinical narrative: Patient seen 8/11/17 for MMR vaccination. At that time reported one week ago had dysuria that resolved, one day only. Had fever around that time (brother had fever same day, also only lasted one day). She does occasionally have day and night time urinary accidents, never fully dry. Therefore, urine obtained, but patient unable to give sample. MMR was administered. Patient subsequently was able to bring urine back and showed >100,000 E.coli, started on KEFLEX. Today, comes back to discuss possible seizures since the MMR vaccine. Mother states patient has had a total of 4 episodes starting August 12, the day after her MMR, over a four-day timeframe. Episodes consisted of a sudden stop of conversation, often midsentence, where she seemed nonresponsive with eyes blinking. The eyes did not roll back or have any nystagmus. Episodes lasted about 20 seconds each time. After which she could not remember the sentence that she had started. For the time period immediately following the events she seemed mildly confused and to have word finding difficulty. There was no abnormal movements associated with the events other than the eye blinking, she did not drop with any of the events, no muscle tightness or weakness that they appreciated. She is otherwise been her normal self. Her activity level is normal. She did not have fever at any of the episodes, or otherwise since receiving the MMR. She has had no abdominal pain, nausea, vomiting, diarrhea. She has had no rashes. She has had no joint pains, swelling, redness. She is sleeping normally. Her behavior and mood have been the same as normal. She has had no episodes for the last 2 days.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Diarrhoea, Erythema, Injection site erythema, Limb discomfort
Clinical narrative: Patient stated she had diarrhea several hours after vaccination (around 10:00 am). Donor asked to leave work due to not feeling well. On 8/18/17 at 0600, patient was at work and told me that she had been up in the night with diarrhea, chills, and a sore left arm (states she can't move it without pain).  Patient also states she has a "hive" on her left foot which she showed me. It is about the size of a nickel with a raised area and redness. Patient's left arm is slightly red but not swollen. Patient stated she put ice on her arm on 8/17/17.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Malaise, Urticaria
Clinical narrative: Patient stated she had diarrhea several hours after vaccination (around 10:00 am). Donor asked to leave work due to not feeling well. On 8/18/17 at 0600, patient was at work and told me that she had been up in the night with diarrhea, chills, and a sore left arm (states she can't move it without pain).  Patient also states she has a "hive" on her left foot which she showed me. It is about the size of a nickel with a raised area and redness. Patient's left arm is slightly red but not swollen. Patient stated she put ice on her arm on 8/17/17.
Age: 1.25
Sex: M
Vaccine: DTAP, HEP, IPV, RV1
Symptoms: Hypersomnia
Clinical narrative: He slept for 18 hours, which is not typical for him. And this is the exact same thing his brother did at the same age.
Sex: U
Vaccine: MEA, MMR
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report as received from a consumer refers to unspecified number (reported as "some') of children of unknown age and gender. On an unknown date, the patients were vaccinated with either M-M-R II (frequency was not reported) or ATTENUVAX (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patients experienced allergic reaction to vaccine. The outcome of the event was unknown. Event was considered to be related to suspect therapy. Additional information is not expected.
Sex: M
Vaccine: HPV9
Symptoms: Arthropod bite, Injection site nodule
Clinical narrative: Information has been received from a nurse prescriber via a company representative referring to a 15 year old male patient. The patient's concurrent condition, medical history and concomitant medication were not reported. On an unknown date, the patient was vaccine with GARDASIL 9 (lot number, strength, and dose were not reported) for prevention of human papillomavirus (HPV). On approximately 19-JUL-2017 (reported as 3 weeks ago) recently the patient was seen in the office and had 1cm by 1cm nodule on his arm near the injection site. The reporter believed it was "an insect bite and not related to the vaccine". The outcome of the events was unknown. Action taken with GARDASIL 9 was not applicable. The reporter considered the events to be not related to the vaccine.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a health worker refers to multiple patients of unknown age. On an unknown date those patients were vaccinated with improperly stored ROTATEQ for prophylaxis. No adverse events were reported. Additional information has been requested.
Age: 26.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 26 year old patient of unknown gender. On an unknown date, the patient was inadvertently vaccinated with PROQUAD, albumin status of recombinant human albumin (rHA), lot# reported as N014759 with an expiration date of 30-NOV-2018 (dose, route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, referring to unspecified number of patients of unknown age and gender. From 01-MAY-2017 to 11-AUG-2017, the patients were vaccinated with improperly stored doses of VARIVAX (lot number M009767, expiration date 23-FEB-2018; lot  number M032495, expiration date 05-JUL-2018; lot number M038858, expiration date 14-SEP-2018; lot  number M041080, expiration date 06-OCT-2018; lot number M049126, expiration date 15-DEC-2018; lot number N012134, expiration date 17-APR-2019) for prophylaxis. Concomitant therapies included sterile diluent. The data logger registered a temperature range between minus 9 to 8 grades Celsius (°C) during 88 hours and 45 minutes. There was no previous temperature excursion. No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a father referring to a 18 year old female patient with seasonal allergy. Concomitant therapy included mometasone furoate (NASONEX). On 02-JUL-2017 the patient was vaccinated with a dose of GARDASIL 9 (dose, frequency, lot# and expiration date unspecified) intramuscularly to prevent human papillomavirus (HPV). On an unknown date in July 2017 (reported as "a few days later"), the patient experienced influenza like symptoms. The patient did not sought for medical attention. No treatment was given for the event and no lab diagnostics /studies performed. The outcome of the event was reported as recovered/resolved in 2017. Causality was not reported.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered, Measles antibody positive, Mumps antibody test negative, Rubella antibody positive
Clinical narrative: This spontaneous report was received from a physician refers to an approximately 32 years old male patient. It was reported that the patient did not have any pertinent medical history, drug reactions or allergies and did not take any concomitant medication. On 07-APR-1986 the patient was vaccinated with first dose of M-M-R II (lot, expiry date, dosing regimen and frequency and route were unknown) for the prevention of measles, mumps and rubella. On 09-MAR-1999, the patient was vaccinated with second dose of M-M-R II (lot, expiry date, dosing regimen and frequency and route were unknown), On 24-OCT-2005 the patient was vaccinated with third dose of M-M-R II (lot, expiry date, dosing regimen and frequency and route were unknown) and On 21-SEP-2006, the patient was vaccinated with fourth dose of M-M-R II (lot, expiry date and route were unknown by the reporter) for the prevention of measles, mumps and rubella. Other suspect therapies included sterile diluent. On an unknown date "titers were drawn" after third dose of M-M-R II and the results showed the patient had low titers of measles and rubella. On an unknown date "titers were drawn" after fourth dose of M-M-R II and the results showed the patient now had a low mumps titer, but the antibody titers of measles and rubella are normal. It was reported that the patient sought medical attention by visiting the physician. The outcome of the events were unknown. The causality assessment was not provided by the reporter. No product quality complaint was filed. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to two unspecified patients of unknown age and gender. On 14-AUG-2017, the patients were vaccinated with expired doses of GARDASIL 9, lot number L018351, expiration date 11-AUG-2017, for prophylaxis. No adverse effects were reported.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 18-MAY-2017 the patient was vaccinated with RECOMBIVAX HB lot # L038018 for prophylaxis. Other suspect therapies included ROTATEQ. Concomitant therapies included hib conj vaccine (unspecified carrier), diphtheria toxoid, pertussis acellular vaccine (unspecified), poliovirus vaccine inactivated (unspecified), tetanus toxoid(DIPHTHERIA TOXOID (+) HIB CONJ VACCINE (UNSPECIFIED CARRIER) (+) PERTU) and PREVNAR 13. On 2017 the patient experienced incorrect product storage.  On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered no adverse event to be not related to RECOMBIVAX HB and ROTATEQ. The reporter considered incorrect product storage to be not related to ROTATEQ and RECOMBIVAX HB. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006507.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 15-AUG-2017 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 19-SEP-2015, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot #, were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-APR-2016, he was treated by a physician at a walk-in clinic for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 17-SEP-2016, the male patient was treated again by the same physician, for ongoing and worsening symptoms of shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, he has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness, Decreased immune responsiveness, Emotional distress, Eye pain, Ophthalmic herpes zoster
Clinical narrative: This initial spontaneous report was received on 15-AUG-2017 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 16-JUN-2008, the patient was inoculated with ZOSTAVAX for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-AUG-2016, he was treated by a physician/MD (at a medical facility for eye care) for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster keratitis, or shingles with involvement in the eyes. The male patient has suffered complications including eye pain and vision loss, and has been prescribed valacyclovir (VALTREX) and "DUERZOL" (as reported)(It is unclear if this medication was difluprednate ophthalmic emulsion (DUREZOL).) for management of his painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Upon internal review, the events of Herpes zoster keratitis and vision loss were determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This initial spontaneous report was received on 15-AUG-2017 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 16-JUN-2008, the patient was inoculated with ZOSTAVAX for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-AUG-2016, he was treated by a physician/MD (at a medical facility for eye care) for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster keratitis, or shingles with involvement in the eyes. The male patient has suffered complications including eye pain and vision loss, and has been prescribed valacyclovir (VALTREX) and "DUERZOL" (as reported)(It is unclear if this medication was difluprednate ophthalmic emulsion (DUREZOL).) for management of his painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Upon internal review, the events of Herpes zoster keratitis and vision loss were determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 15-AUG-2017 regarding a case in litigation from a lawyer and 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 14-MAR-2013 as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after being vaccinated, on or about 25-MAR-2013, the was treated by a nurse practitioner at a healthcare facility for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 15-AUG-2017 regarding a case in litigation from a lawyer and 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 in 2011 at a drugstore as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Throughout the years of 2013 and 2015, the patient was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. Throughout the years of 2013 and 2015, the patient was also treated by another physician at a medical clinic for ongoing and worsening symptoms of shingles. As a direct and proximate result of these malfunctions the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 01-JUN-2017 the patient was vaccinated with GARDASIL 9 lot # M003659 for prophylaxis. Concomitant therapies included BEXSERO. On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006507:
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 31-MAY-2017 the patient was vaccinated with ROTATEQ lot # L048854, oral for prophylaxis. Concomitant therapies included hib conj vaccine (unspecified carrier), diphtheria toxoid, pertussis acellular vaccine (unspecified), poliovirus vaccine inactivated (unspecified), tetanus toxoid(DIPHTHERIA TOXOID (+) HIB CONJ VACCINE (UNSPECIFIED CARRIER) (+) PERTU) and PREVNAR 13. On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006507.
Age: 0.17
Sex: F
Vaccine: HIBV, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 02-JUN-2017 the patient was vaccinated with ROTATEQ lot # L048854 for prophylaxis. Concomitant therapies included PREVNAR 13 and hib conj vaccine (unspecified carrier)(HIB CONJ VACCINE (UNSPECIFIED CARRIER)). On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. This is one of several reports received from the same reporter.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 06-JUN-2017 the patient was vaccinated with ROTATEQ lot # M031802 for prophylaxis. On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006507.
Age: 0.42
Sex: F
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 09-JUN-2017 the patient was vaccinated with ROTATEQ lot # M031802, oral for prophylaxis. Concomitant therapies included HIB CONJ VACCINE (UNSPECIFIED CARRIER). On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006507.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 09-JUN-2017 the patient was vaccinated with VAQTA lot # N005274 for prophylaxis. On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006507.
Age: 0.5
Sex: F
Vaccine: HIBV, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 12-JUN-2017 the patient was vaccinated with ROTATEQ lot # M031802, oral for prophylaxis. Concomitant therapies included (HIB CONJ VACCINE (UNSPECIFIED CARRIER) and PREVNAR 13. On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006507.
Age: 0.33
Sex: U
Vaccine: HIBV, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 19-JUN-2017 the patient was vaccinated with ROTATEQ lot # M031802, oral for prophylaxis. Concomitant therapies included PREVNAR 13 and HIB CONJ VACCINE (UNSPECIFIED CARRIER). On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-1707USA006507.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 20-JUN-2017 the patient was vaccinated with ROTATEQ lot # M031802, oral for prophylaxis. Concomitant therapies included PREVNAR 13, (DIPHTHERIA TOXOID (+) HIB CONJ VACCINE (UNSPECIFIED CARRIER) (+) PERTU) and hib conj vaccine (unspecified carrier)(HIB CONJ VACCINE (UNSPECIFIED CARRIER)). On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006507.
Age: 1.08
Sex: F
Vaccine: HEPA, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 21-JUN-2017 the patient was vaccinated with VAQTA lot # N005274 for prophylaxis. Concomitant therapies included PREVNAR 13. On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006507.
Age: 0.33
Sex: F
Vaccine: DTAP, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 23-MAY-2017 the patient was vaccinated with ROTATEQ lot # L048854, oral for prophylaxis. Concomitant therapies included DIPHTHERIA TOXOID (+) PERTUSSIS VACCINE (UNSPECIFIED) (+) TETANUS TOXO and PREVNAR 13. On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006507.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. On 16-AUG-2017, the patient was administered a dose of VAQTA, lot reported as: M016191, expiration date: 26-MAY-2017, for prophylaxis. No adverse effects were reported in the patient. Lot number M016191 has been verified to be a valid lot number for VAQTA.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. On 14-AUG-2017, the patient was inadvertently administered a dose of GARDASIL, lot reported as: L012190, expiration date: 13-APR-2017, for prophylaxis.  No adverse effects were reported in the patient. Lot number: L012190  has been verified to be a valid lot number for GARDASIL.
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Emotional distress, Injury, Pain, Physical disability
Clinical narrative: Information was received on 16-AUG-2017 from a lawyer regarding a female patient of unknown age. On 18-AUG-2015, the patient received a dose of ZOSTAVAX vaccine for its intended purpose: the prevention of shingles. On or about 29-AUG-2015, the patient developed an itchy rash on her trunk and upper extremities. The patient's condition got so bad that she had to be hospitalized on 03-SEP-2015. Subsequently, the patient required various treatments and medications for her condition. In late 2016, the patient was again hospitalized for this condition. The patient continues to experience a recurrent rash. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations from, and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further as a tragic consequence, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct use of ZOSTAVAX. The patient paid for the ZOSTAVAX for the purpose of preventing shingles and the patient has not received the safe and effective vaccine for which she paid. Itchy rash on her trunk and upper extremities and recurrent rash were disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Quality of life decreased, Rash, Rash pruritic
Clinical narrative: Information was received on 16-AUG-2017 from a lawyer regarding a female patient of unknown age. On 18-AUG-2015, the patient received a dose of ZOSTAVAX vaccine for its intended purpose: the prevention of shingles. On or about 29-AUG-2015, the patient developed an itchy rash on her trunk and upper extremities. The patient's condition got so bad that she had to be hospitalized on 03-SEP-2015. Subsequently, the patient required various treatments and medications for her condition. In late 2016, the patient was again hospitalized for this condition. The patient continues to experience a recurrent rash. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations from, and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further as a tragic consequence, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct use of ZOSTAVAX. The patient paid for the ZOSTAVAX for the purpose of preventing shingles and the patient has not received the safe and effective vaccine for which she paid. Itchy rash on her trunk and upper extremities and recurrent rash were disabling. Additional information has been requested.