chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pharyngeal oedema, Platelet count normal, Pyrexia, Rash, Skin lesion
Clinical narrative: This spontaneous report as received from a physician via company representative refers to 2 month old male patient. The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. On 15-AUG-2013 the patient was vaccinated with ROTATEQ dose 1 (dose, frequency, lot# not reported). Concomitant therapies included PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). It was reported that on 15-AUG-2013, along with ROTATEQ vaccine, patient was also vaccinated with PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). After two days (17-AUG-2013), the patient developed a rash, and was admitted to the hospital for 3 days, and diagnosed with erythema multiforme (hospitalization). The patient sought medical attention (went to the hospital). The outcome of erythema multiforme was unknown at the time of the report. The patient is now 8 months old and under the care of an unspecified allergist. No patient contact details available. The reporter considered the event was serious due to hospitalization. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urine analysis, Urticaria, White blood cell count normal
Clinical narrative: This spontaneous report as received from a physician via company representative refers to 2 month old male patient. The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. On 15-AUG-2013 the patient was vaccinated with ROTATEQ dose 1 (dose, frequency, lot# not reported). Concomitant therapies included PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). It was reported that on 15-AUG-2013, along with ROTATEQ vaccine, patient was also vaccinated with PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). After two days (17-AUG-2013), the patient developed a rash, and was admitted to the hospital for 3 days, and diagnosed with erythema multiforme (hospitalization). The patient sought medical attention (went to the hospital). The outcome of erythema multiforme was unknown at the time of the report. The patient is now 8 months old and under the care of an unspecified allergist. No patient contact details available. The reporter considered the event was serious due to hospitalization. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema multiforme, Rash
Clinical narrative: This spontaneous report as received from a physician via company representative refers to 2 month old male patient. The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. On 15-AUG-2013 the patient was vaccinated with ROTATEQ dose 1 (dose, frequency, lot# not reported). Concomitant therapies included PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). It was reported that on 15-AUG-2013, along with ROTATEQ vaccine, patient was also vaccinated with PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). After two days (17-AUG-2013), the patient developed a rash, and was admitted to the hospital for 3 days, and diagnosed with erythema multiforme (hospitalization). The patient sought medical attention (went to the hospital). The outcome of erythema multiforme was unknown at the time of the report. The patient is now 8 months old and under the care of an unspecified allergist. No patient contact details available. The reporter considered the event was serious due to hospitalization. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Band neutrophil count increased, Blood alkaline phosphatase increased, Blood bicarbonate normal, Blood chloride normal, Blood creatinine normal
Clinical narrative: This spontaneous report as received from a physician via company representative refers to 2 month old male patient. The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. On 15-AUG-2013 the patient was vaccinated with ROTATEQ dose 1 (dose, frequency, lot# not reported). Concomitant therapies included PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). It was reported that on 15-AUG-2013, along with ROTATEQ vaccine, patient was also vaccinated with PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). After two days (17-AUG-2013), the patient developed a rash, and was admitted to the hospital for 3 days, and diagnosed with erythema multiforme (hospitalization). The patient sought medical attention (went to the hospital). The outcome of erythema multiforme was unknown at the time of the report. The patient is now 8 months old and under the care of an unspecified allergist. No patient contact details available. The reporter considered the event was serious due to hospitalization. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: CSF culture, Culture urine, Dermatitis contact, Erythema, Erythema multiforme
Clinical narrative: This spontaneous report as received from a physician via company representative refers to 2 month old male patient. The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. On 15-AUG-2013 the patient was vaccinated with ROTATEQ dose 1 (dose, frequency, lot# not reported). Concomitant therapies included PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). It was reported that on 15-AUG-2013, along with ROTATEQ vaccine, patient was also vaccinated with PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). After two days (17-AUG-2013), the patient developed a rash, and was admitted to the hospital for 3 days, and diagnosed with erythema multiforme (hospitalization). The patient sought medical attention (went to the hospital). The outcome of erythema multiforme was unknown at the time of the report. The patient is now 8 months old and under the care of an unspecified allergist. No patient contact details available. The reporter considered the event was serious due to hospitalization. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematocrit decreased, Haemoglobin normal, Lumbar puncture, Neutrophil count increased, Pharyngeal oedema
Clinical narrative: This spontaneous report as received from a physician via company representative refers to 2 month old male patient. The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. On 15-AUG-2013 the patient was vaccinated with ROTATEQ dose 1 (dose, frequency, lot# not reported). Concomitant therapies included PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). It was reported that on 15-AUG-2013, along with ROTATEQ vaccine, patient was also vaccinated with PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). After two days (17-AUG-2013), the patient developed a rash, and was admitted to the hospital for 3 days, and diagnosed with erythema multiforme (hospitalization). The patient sought medical attention (went to the hospital). The outcome of erythema multiforme was unknown at the time of the report. The patient is now 8 months old and under the care of an unspecified allergist. No patient contact details available. The reporter considered the event was serious due to hospitalization. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Platelet count normal, Pyrexia, Rash, Skin lesion, Urine analysis
Clinical narrative: This spontaneous report as received from a physician via company representative refers to 2 month old male patient. The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. On 15-AUG-2013 the patient was vaccinated with ROTATEQ dose 1 (dose, frequency, lot# not reported). Concomitant therapies included PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). It was reported that on 15-AUG-2013, along with ROTATEQ vaccine, patient was also vaccinated with PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). After two days (17-AUG-2013), the patient developed a rash, and was admitted to the hospital for 3 days, and diagnosed with erythema multiforme (hospitalization). The patient sought medical attention (went to the hospital). The outcome of erythema multiforme was unknown at the time of the report. The patient is now 8 months old and under the care of an unspecified allergist. No patient contact details available. The reporter considered the event was serious due to hospitalization. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urticaria, White blood cell count normal
Clinical narrative: This spontaneous report as received from a physician via company representative refers to 2 month old male patient. The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. On 15-AUG-2013 the patient was vaccinated with ROTATEQ dose 1 (dose, frequency, lot# not reported). Concomitant therapies included PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). It was reported that on 15-AUG-2013, along with ROTATEQ vaccine, patient was also vaccinated with PEDIARIX (manufacturer unknown), ACTHIB (manufacturer unknown) and PREVNAR (manufacturer unknown). After two days (17-AUG-2013), the patient developed a rash, and was admitted to the hospital for 3 days, and diagnosed with erythema multiforme (hospitalization). The patient sought medical attention (went to the hospital). The outcome of erythema multiforme was unknown at the time of the report. The patient is now 8 months old and under the care of an unspecified allergist. No patient contact details available. The reporter considered the event was serious due to hospitalization. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report was received from a 56 year old female consumer reporting herself, with allergy to vancomycin and with no pertinent medical history. On 29-JAN-2014 the patient was vaccinated with ZOSTAVAX (dose reported as "directed" and route reported as "injection") (lot number and expiration date were not reported). Concomitant therapy reported as regular regimen of unspecified medications. The patient referred that on 29-JAN-2014, after receiving ZOSTAVAX developed injection site itching, swelling, redness, headache that lasted for a week, bruising, and a feeling of malaise and a "funny feeling in her throat". The patient had an office visit with her primary care physician and is scheduled for an additional follow-up visit tomorrow (12-FEB-2014). At the time of the report the outcome for "headache" was reported as recovered, for the other event the outcome was not recovered. The patient was treated with topical anti-itch creams, ibuprofen (also reported as IB Profin), BENADRYL, and VISTARIL. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a 56 year old female consumer reporting herself, with allergy to vancomycin and with no pertinent medical history. On 29-JAN-2014 the patient was vaccinated with ZOSTAVAX (dose reported as "directed" and route reported as "injection") (lot number and expiration date were not reported). Concomitant therapy reported as regular regimen of unspecified medications. The patient referred that on 29-JAN-2014, after receiving ZOSTAVAX developed injection site itching, swelling, redness, headache that lasted for a week, bruising, and a feeling of malaise and a "funny feeling in her throat". The patient had an office visit with her primary care physician and is scheduled for an additional follow-up visit tomorrow (12-FEB-2014). At the time of the report the outcome for "headache" was reported as recovered, for the other event the outcome was not recovered. The patient was treated with topical anti-itch creams, ibuprofen (also reported as IB Profin), BENADRYL, and VISTARIL. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Oropharyngeal discomfort
Clinical narrative: This spontaneous report was received from a 56 year old female consumer reporting herself, with allergy to vancomycin and with no pertinent medical history. On 29-JAN-2014 the patient was vaccinated with ZOSTAVAX (dose reported as "directed" and route reported as "injection") (lot number and expiration date were not reported). Concomitant therapy reported as regular regimen of unspecified medications. The patient referred that on 29-JAN-2014, after receiving ZOSTAVAX developed injection site itching, swelling, redness, headache that lasted for a week, bruising, and a feeling of malaise and a "funny feeling in her throat". The patient had an office visit with her primary care physician and is scheduled for an additional follow-up visit tomorrow (12-FEB-2014). At the time of the report the outcome for "headache" was reported as recovered, for the other event the outcome was not recovered. The patient was treated with topical anti-itch creams, ibuprofen (also reported as IB Profin), BENADRYL, and VISTARIL. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Dyspnoea, Pruritus generalised, Rash, Urticaria
Clinical narrative: Parent received call from school child with hives and itching.  Approx 15 minutes later parent received call child complaint of "not being able to swallow" - child taken to ER by parent.
Age: 5.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Dysphagia, Pruritus, Rash, Urticaria
Clinical narrative: Parent received call from school child with hives and itching.  Approx 15 minutes later parent received call child complaint of "not being able to swallow" - child taken to ER by parent.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: This spontaneous report as received from a patient and his wife refers to the approximately 87 year old male patient. The patient's pertinent medical history was reported as asthma and he had drug reactions/allergies with Aspirin. On an unknown date of 2006 the patient was vaccinated with ZOSTAVAX (dose, route, lot#, frequency not reported) as recommended by the physician. Concomitant therapies included prednisone (manufacturer unknown), ADVAIR and PROAIR. On an unknown date of June 2011 the patient got Shingles. The rash lasted about 3 weeks. It was reported that the patient was still dealing with the resulting nerve pain. Towards the end of the report, the patient got on the phone and provided with some answers to this report. The patient stated that pain in mostly on his right side near his waistline. He was hospitalized twice for the pain (hospitalized) once on 01-AUG-2011 for three days (03-AUG-2011) and again on 28-SEP-2012. It was reported that the patient sought medical attention (saw the physician). There was no lab diagnostics studies performed. An unspecified medication for the nerve pain was given to the patient in the hospital. The outcome of the event got shingles and rash was reported as recovered at the time of the report. Rest of the events had not resolved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via Public Field Employee refers to a female patient of unknown age. The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. On an unknown date the patient was vaccinated with ZOSTAVAX single administration, injection route of administration (dose, lot#, anatomical site not reported). No concomitant medications were reported. On an unknown date, reported as four weeks later after administration of the vaccine, the patient experienced pain (disability), swelling and a hard lump at the injection site. The pain and discomfort (disability), reportedly limits mobility in the arm area (disability). The patient sought medical attention (returned to the pharmacist). The outcomes of the events were reported as not recovered/not resolved. Upon internal review the events pain and discomfort reportedly limits mobility in the arm was considered as serious due to disability. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist via Public Field Employee refers to a female patient of unknown age. The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. On an unknown date the patient was vaccinated with ZOSTAVAX single administration, injection route of administration (dose, lot#, anatomical site not reported). No concomitant medications were reported. On an unknown date, reported as four weeks later after administration of the vaccine, the patient experienced pain (disability), swelling and a hard lump at the injection site. The pain and discomfort (disability), reportedly limits mobility in the arm area (disability). The patient sought medical attention (returned to the pharmacist). The outcomes of the events were reported as not recovered/not resolved. Upon internal review the events pain and discomfort reportedly limits mobility in the arm was considered as serious due to disability. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a 16 year old male patient. On 04-FEB-2014 the patient was vaccinated with a first dose of GARDASIL (lot #, expiration date and dose was not reported). Other suspect therapies included Hepatitis A vaccine (manufacturer unknown) (lot #, expiration date and dose was not reported) administered on the same day, 04-FEB-2014. Concomitant therapies included MENACTRA received also on 04-FEB-2014. The physician also reported that the patient had not eaten that day. On 04-FEB-2014 the patient experienced a syncope event and passed out. It was stated that patient went to the Emergency Room. The outcome of all adverse events was reported as "client was fine". The relatedness between all the events and suspected therapies was not reported. Upon internal review reported term "passed out" was considered as a medically significant event. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose abnormal, Caesarean section, Complication of pregnancy, Exposure during pregnancy, Haemoglobin decreased
Clinical narrative: Information has been received from a nurse practitioner (N.P.), for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female with herpes simplex virus and no drug reactions or allergies who on 12-SEP-2011 was vaccinated with the first dose of GARDASIL (lot #, dose and route not reported). There was no concomitant medication. The N.P. reported that the patient had positive pregnancy test (by urine) on 04-OCT-2011. The N.P. stated that the patient was a few days pregnant when she received the vaccine. No adverse effects to report. The Last menstrual period (LMP) was 25-AUG-2011 and the Estimated Delivery Date (EDD) was 31-MAY-2012. The patient sought unspecified medical attention. At the time of the report, the outcome of the pregnancy was unknown. Follow up information has been received from the nurse practitioner concerning the 24 year old female patient. A girl baby was born via C-section on 29-MAY-2012 at 39 weeks and 5 days. The gestational blood sugar (GBS) performed positive (+) (also reported as "GBS+"). The patient had a complicated antepartum course with hemorrhage and decreased haemoglobin (HB) to 9.2 but was discharged in good condition on post-partum day 4. As far as she knew the baby was normal and healthy. There were no congenital anomalies or problems with the baby mentioned in the chart. The infant was a baby girl and weighed 4.425 kg. Apgar scores were 8 and 9. The outcome of the C-section was unknown. Upon internal review, C-section was considered as medically significant. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Haemorrhage in pregnancy, Human chorionic gonadotropin positive
Clinical narrative: Information has been received from a nurse practitioner (N.P.), for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female with herpes simplex virus and no drug reactions or allergies who on 12-SEP-2011 was vaccinated with the first dose of GARDASIL (lot #, dose and route not reported). There was no concomitant medication. The N.P. reported that the patient had positive pregnancy test (by urine) on 04-OCT-2011. The N.P. stated that the patient was a few days pregnant when she received the vaccine. No adverse effects to report. The Last menstrual period (LMP) was 25-AUG-2011 and the Estimated Delivery Date (EDD) was 31-MAY-2012. The patient sought unspecified medical attention. At the time of the report, the outcome of the pregnancy was unknown. Follow up information has been received from the nurse practitioner concerning the 24 year old female patient. A girl baby was born via C-section on 29-MAY-2012 at 39 weeks and 5 days. The gestational blood sugar (GBS) performed positive (+) (also reported as "GBS+"). The patient had a complicated antepartum course with hemorrhage and decreased haemoglobin (HB) to 9.2 but was discharged in good condition on post-partum day 4. As far as she knew the baby was normal and healthy. There were no congenital anomalies or problems with the baby mentioned in the chart. The infant was a baby girl and weighed 4.425 kg. Apgar scores were 8 and 9. The outcome of the C-section was unknown. Upon internal review, C-section was considered as medically significant. Additional information is not expected.
Age: 1.12
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 month old patient of unknown gender. On 10-FEB-2014 the patient was vaccinated with first dose of VAQRIVAX (Merck) (strength, dose unit, route, lot number and expiry date unknown). On the same day patient was vaccinated with first dose of PROQUAD (Merck) (strength, dose unit, route, lot number and expiry date unknown). No adverse event reported. The outcome of 12 month old patient received a first dose of PROQUAD (Merck) and VARIVAX (Merck) on 10-FEB-2014 and no adverse event were unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous report was received from a 64 year old female patient concerning herself. Pertinent medical history: tumor in the ear. Drug reactions/allergies: allergy to codeine and allergy to muscle relaxants. Approximately on an unknown date in January 2014 (also reported as end of January) the patient was vaccinated with M-M-R II (dosing regimen unspecified) (also reported as it was suggested by CDC since patient was going out of the country). Concomitant therapies included steroids (CORTICOSTEROID (UNSPECIFIED)). Approximately on 19-FEB-2014 (also reported as about a week ago) the patient experienced joint pain in both arms (left arm), joint pain in both arms (right arm), tingling in the right fingertips, numbness in the fingertips and pain in the right arm. The consumer reported that the joint pain in the left arm was almost completely gone (approximately on an unknown date in February 2014) but all the other symptoms were still there (not resolved). Causality assessment for the events was not provided. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician via a field employee refers to a patient of unknown age and gender. On an unspecified date in 2014, the patient was vaccinated with a dose of PNEUMOVAX23 (lot #, dose, route and indication not reported). Other suspect therapies included ZOSTAVAX (lot #, expiration, dose and route not reported) on an unspecified. The patient sought medical attention at physician's office on an unspecified date and complained of a red, swollen area between the shoulder and elbow in the arm where ZOSTAVAX was administered. The outcome of the event was unknown. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with vaccination. On 20-FEB-2014 the patient was vaccinated inadvertently with ZOSTAVAX vial (strength, dose number, dose unit unknown) with lot # J000492, subcutaneously that has expired on 19-JAN-2014 for vaccination. No adverse effect was reported. The outcome of she inadvertently administered ZOSTAVAX which expired on 19-JAN-2014 to a patient and no adverse effect was unknown. No further information provided. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: This spontaneous report as received from a pharmacist (also reported as pharmacy student) refers to a 26 year old male patient. Patients medical history, drug reactions and allergies were reported as none. On 12-JUN-2013, the patient was vaccinated with first dose of GARDASIL, intramuscular injection, strength 120 Y, (lot number H015030, expiry date 28-MAR-2015), dose 0.5 ml, intramuscular for vaccination. On 13-DEC-2013, the patient was vaccinated with second dose of GARDASIL, intramuscular injection, strength 120 Y, (lot number H015030, expiry date 28-MAR-2015), dose 0.5 ml, intramuscular for vaccination. Concomitant medication was reported as none. Approximately on an unspecified date and month in 2013, the patient developed genital warts after receiving the first dose of GARDASIL. No product quality complaint was involved. No lab diagnostics studies were performed. On an unknown date in 2013, the patient went to see pharmacist. The outcome of the event genital warts was unknown. The reporters causality assessment for the event genital warts with the therapy of GARDASIL was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 26-FEB-2014 the patient was vaccinated with GARDASIL INJ via intramuscular injection (lot#, dose and dose# unknown) into the gluteal muscle in error. No known adverse effects. The outcome and action taken were not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician assistant refers to a female patient of unknown age. Same time last year, in 2013 the patient was vaccinated with ZOSTAVAX (dose and lot# not reported). In December 2013 the patient was diagnosed with the shingles, after received the therapy of ZOSTAVAX. The outcome of shingles was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: HIV test positive, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to a Human Immunodeficiency Virus (HIV)-positive patient of unknown age and gender. On unspecified date in September 2007 the patient was vaccinated with first dose GARDASIL, on unspecified date in November 2007 patient was administered with second dose of GARDASIL and on unspecified date in January 2009 with third dose, subsequently (doses, lot # and expiration dates for each vaccination not reported). No adverse effect reported. Additional information is not expected.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a 8 week old female patient. No pertinent medical history, no concomitant medication and no drug reactions/allergies with the patient. On 17-FEB-2014 the patient was vaccinated with ROTATEQ (lot# reported as J008739, exp 25-MAR-2015) (dose, route, dose# unknown). Other suspect therapies included RECOMBIVAX HB (lot# reported as J004700, exp 26-DEC-2015) on 17-FEB-2014 (dose, route, dose# unknown). Concomitant therapies included PENTACEL and PREVENAR 13 on 17-FEB-2014 (dose, route, dose# unknown). On 17-FEB-2014, after the administration of the vaccines the patient experienced four watery stools and a fever of 100.1. On 18-FEB-2014 the patient experienced another 3 watery stools. The patient's parents brought her back to the physician's office to be evaluated; the physician diagnosed the patient with "diarrhea of moderate severity" and recommended hydration and probiotics to treat the patient. No labs performed due to the events. The outcome was unknown. Action taken was not provided. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 57 years old male patient. On 08-FEB-2014 the patient was vaccinated with one single injection ZOSTAVAX (strength, dose number, dose unit, lot # and expiry date, route unknown) for prevention of shingles. On an unknown date of February 2014, patient developed a purple bruise at the injection site after receiving the ZOSTAVAX vaccine. Patient did not sought medical attention and no lab Diagnostics Studies were Performed. The outcome of developed a purple bruise at the injection site after receiving the ZOSTAVAX was unknown. No further AE information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unknown date the patient was vaccinated with the first shot of GARDASIL (dose and lot # not reported). It was reported that on an unknown date the patient experienced rash after receiving the first shot of GARDASIL. The outcome of rash was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rash erythematous
Clinical narrative: This spontaneous report as received from a registered nurse other health professional refers to a 19 years old female patient. The patient's historical drug included ZITHROMAX Z-PAK given for an ear infection. The patient's current condition included allergy to amoxicillin. On 21-FEB-2014 the patient was vaccinated intramuscularly in the left deltoid with the first dose of GARDASIL lot # H021346, expiration date: 01-OCT-2015. The nurse reported that on 22-FEB-2014, the day after the vaccination the patient developed a red rash on their neck and chest. The patient's rash spread to the upper back over the next couple of days. The patient tried treatment and he used hydrocortisone cream (OTC) but it didn't help. At this time of this report the patient did not recover. She sought medical attention and she contacted the office. The relatedness between the red rash and the vaccination with GARDASIL was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Foetal exposure during pregnancy, Jaundice neonatal
Clinical narrative: Initial and follow up information have been received from a registered nurse concerning female patient of unknown age. On 07-FEB-2012, the patient's mother was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL (lot number not reported). There was no concomitant medication. The registered nurse reported that on 29-FEB-202 a urine pregnancy test was performed and the patient's mother tested positive. The estimated last menstrual period was on 06-FEB-2012 and the estimated due date (EDD) was on 05-NOV-2012. The patient's mother sought unspecified medical attention. No treatment given for the event. On 02-NOV-2012, the patient's mother delivered a full term baby girl at 39 weeks vaginally. The patient's Apgar scores were 9 and 9. Jaundice was mentioned in a hospital note but otherwise the patient seemed normal and healthy. The physician looked through all routine follow up visits from last year and reported that there was no mention of congenital anomalies. Baby seemed totally healthy. This is one of several reports received from same source, the mother report captured in 1203USA00152. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a 25 year old female consumer reporting on herself, with no pertinent medical history, no drug reactions/allergies, GARDASIL, a Pregnancy Registry product, who on an unspecified date was vaccinated with the third dose of GARDASIL (Lot #, dose and route not reported). There was no concomitant medication. The patient called to report that she got her third GARDASIL shot and later found out she was pregnant. Patient's last menstrual period was reported as approximately 02-AUG-2011. No lab diagnostic studies were performed. Follow up information was received from a physician's assistant concerning a patient with an obstetrical history of two pregnancies and two elective terminations and unknown birth defects or infant complications in previous pregnancies who was vaccinated at another office with the first two doses of GARDASIL, the first dose administered on 23-MAR-2011 (Lot #, dose and route not reported) and the second dose on 24-MAY-2011 (Lot #, dose and route not reported). The patient was vaccinated with the third dose of GARDASIL on 06-SEP-2011 (dose and route not reported) and lot # 670050/1229AA. The patient's last menstrual period was 02-AUG-2011 and estimated delivery date would be 08-MAY-2012. It was reported that all prenatal testing were unknown as of right now. No other medication was used during pregnancy. At the time of the report, the pregnancy outcome was unknown yet, the patient not due until 08-MAY-2012. A consent form was mailed to the patient. Follow up information has been received. The nurse reported that they had no idea about any baby information and also did not know the patient's OBGYN. As of now, the pregnancy outcome remains unknown. No further information is available.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash macular, Rubella antibody negative
Clinical narrative: Possible vaccination induced rubella. Diffuse, macular rash over face, trunk, and back.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report as received form a physician via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX vial (strength, dose number, dose unit, lot# and expiry date, route unkonwn). Other suspect therapies included corticosteroids (unspecified) (manufacture unknown)(strength dose, frequency, lot# and expiry date, route and indication unknown). On an unknown date at the time of ZOSTAVAX administration the patient was taking an unspecified low dose of an unspecified steroid (manufacturer unknown). A couple of years later on an unspecified date, patient developed a severe case of shingles with post herpetic neuralgia. Patient visited physician for medical attention. The outcome of severe shingles, at the time of ZOSTAVAX administration patient was taking an unspecified steroid and shingles with post herpetic neuralgia was unknown. No further information provided. Additional information is not expected.
Age: 0.39
Sex: F
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. On 29-JAN-2014 the patient was vaccinated with a dose of M-M-R II. No adverse effect was reported. Follow up information had been received from a physician 4 month old female patient. The patient do not have any previous medical history and illness during vaccination. On 29-JAN-2014, the patient was vaccinated with a dose of M-M-R II (lot number not specified) for an unknown indication. The 4 month year child was given vaccine mistakenly. It was an inappropriate age to have the vaccine administered. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. No medical history or concurrent conditions were provided. On an unknown date in December 2013, the patients were vaccinated with oral ROTATEQ (dose, route and lot numbers were not provided). No co-suspect or concomitant therapies were reported. The registered nurse reported that the oral ROTATEQ administered to the patients had been improperly stored. The registered nurse was unable to confirm the exact number or identities of the patients involved at the time of the report. No adverse effects were reported. This case is linked to cases MARRS # 1402USA010128 and MARRS # 1402USA010129 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. No medical history or concurrent conditions were provided. On an unknown date in December 2013, the patients were vaccinated with GARDASIL (dose, route and lot numbers were not provided). No co-suspect or concomitant therapies were reported. The registered nurse reported that the GARDASIL administered to the patients had been improperly stored. The registered nurse was unable to confirm the exact number or identities of the patients involved at the time of the report. No adverse effects were reported. This case is linked to cases MARRS # 1402USA009065 and MARRS # 1402USA010129 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unkonwn age and gender. No medical history or concurrent conditions were provided. On an unknown date in December 2013, the patients were vaccinated with M-M-R II (dose, route and lot numbers were not provided). No co-suspect or concomitant therapies were reported. The registered nurse reported that the M-M-R II administered to the patients had been improperly stored. The registered nurse was unable to confirm the exact number or identities of the patients involved at the time of the report. No adverse effects were reported. This case is linked to cases MARRs # 1402USA009065 and MARRS # 1402USA010128 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. In June 2013, reported as about 8 months ago, the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular. The patient was currently at an unspecified clinic to receive their second dose. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age. The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, route, lot number, frequency not reported). No concomitant medications were reported. The physician reported that the patient was later hospitalized at unspecified hospital for pneumonia. The patient sought medical attention (hospitalization). The physician also reported that it was unclear if the patient had recovered at this time. The outcome of pneumonia is unknown. The reporter considered the event as serious due to hospitalization. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 23 cm x 22 cm area of erythema, warmth at injection site. Warm but not tender. No myositis. (Subcutaneous). No limp, muscle tenderness. No fever. Will observe. No specific therapy recommended.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Genital burning sensation, Genital rash, Genitals enlarged
Clinical narrative: This spontaneous report as received from a physician refers to physician's friend a 57 year old female patient with fibromyalgia and none drug reactions or allergies. On 17-FEB-2014 the patient was vaccinated with ZOSTAVAX 0.65 ml injection (lot # J011882, expiration date: 04-JAN-2015) (route not provided). In February 2014 the patient experienced enlarged genitals and bumps with severe burning in her genital area since unspecified date. She called to physician. For treatment of event an VICODIN was given. The outcome of events was reported as not recovered/not resolved. The relatedness between vaccination with ZOSTAVAX and events was not reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain in extremity
Clinical narrative: Nausea and extreme left arm pain within a couple of hours.
Sex: F
Vaccine: HPV4
Symptoms: Lip discolouration
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a female patient of unknown age. It was reported that the patient was not pregnant. On an unknown date the patient was vaccinated with the first dose of GARDASIL (dose and route not provided). Shortly thereafter (unspecified date), the patient returned to the office with a birth mark discoloration on her lip. The patient decided to discontinue the rest of the GARDASIL series of doses. The patient's outcome was unknown. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Administered 2/24/14, red, raised area noted 2/26/14. 2/27/14 Seen by provider. (L) upper arm red, raised, and hot area 4" wide by 7" long. Dx - rash reaction to vaccine. Treatment 1) prednisone, 2) BENADRYL.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Vaccination complication
Clinical narrative: Administered 2/24/14, red, raised area noted 2/26/14. 2/27/14 Seen by provider. (L) upper arm red, raised, and hot area 4" wide by 7" long. Dx - rash reaction to vaccine. Treatment 1) prednisone, 2) BENADRYL.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 2 months old patient of unknown gender. The patient had no drug reactions/allergies. On 24-FEB-2014, about 15 minutes ago, the patient was received with the first dose of ROTATEQ (lot# unspecified) ("suspension2" as reported) (strength, dose unspecified). The nurse reported that the patient spit out some of the dose which then dribbled out of the patient's mouth. The patient's facial skin where the ROTATEQ dribbled on then developed hives. Patient was currently still in the office. At the time of the report, the outcome of the event was not recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student refers to a patient (age and gender unspecified). On 27-MAY-2011 and on 27-JAN-2014, the patient was vaccinated with GARDASIL, strength 120Y (dose and frequency unspecified), intramuscular. Concomitant medication was unspecified. No adverse symptoms reported. No product quality complaint was involved. The outcome of events was unknown. No further information was provided. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report as received from a Nurse refers to a 80 year old female patient. On 22-FEB-2014, the patient was vaccinated with PNEUMOVAX23 (Lot # J014401, expiration date 26-NOV-2014) (dose and route were not reported). Concomitant therapies included terbinafine (manufacturer unknown). On 24-FEB-2014, the patient experienced the injection site reaction. The site of injection presented with erythema, pain and tenderness. The patient did not received treatment for the adverse event. On an unspecified date, the patient sought medical attention. The outcome of the site of injection presented with pain and tenderness and the injection site presented with erythema was unknown. Additional information has been requested.