chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician via company representative refers to a 31 year old female patient. It was reported that the patient had no pertinent medical history. On 13-JAN-2015, the patient who was 27 weeks gestation was mistakenly vaccinated with a dose of with GARDASIL (dose, dose number, lot/batch number and expiration date were not reported) instead of unknown other vaccine, possible TDAP. There was no concomitant medication. The patient became pregnant with Last Menstrual Period of 08-JUL-2014 (estimated based on 27 weeks gestation on 13-JAN-2015) and Estimated Date of Delivery (EDD) of 14-APR-2015 (estimated based on 27 weeks gestation on 13-JAN-2015). No adverse effects were noted. It was reported that the medication error was not related to packaging. The patient sought medical attention by visiting the physician's office on 13-JAN-2015. At the time of the report the pregnancy outcome was pending. Follow up information has been received from the physician on 05-JUN-2015. The female patient was a non smoker or drug/alcohol user. The patient's medical history included one female delivery, 39 weeks from LMP. The GARDASIL vaccine had lot # J013324 with an expiration date on 12-FEB-2016. Concomitant medications included unspecified prenatal vitamins. The LMP was reported as 04-JUL-2014, estimated date of conception: 18-JUL-2014 and the EDD was reported as 03-APR-2015. 39 weeks from LMP, the patient delivered a normal male infant weighing 4235 gms via caesarean section with no complications during the delivery. The pregnancy outcome was live birth without congenital anomalies or neonatal problems, his head was 15 cm circumference and length of 21.5". The infant's APGAR score was 8 at one minute and was 9 at five minutes. At the time of the report, the outcome of caesarean section was unknown and the outcome of exposure during pregnancy was recovered. Laboratories test showed: On 06-JAN-2012, ABO/RH: A (-). On 10-MAR-2015, ultrasound showed 35 weeks pregnant with normal growth. On 13-APR-2015, glucose resulted 142 (units not provided). Upon internal review the event of caesarean section was considered to be medically significant. Additional information is not expected as all follow up attempts had been received.
Age: 31.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood glucose normal, Caesarean section, Exposure during pregnancy, No adverse event, Rhesus antibodies negative
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician via company representative refers to a 31 year old female patient. It was reported that the patient had no pertinent medical history. On 13-JAN-2015, the patient who was 27 weeks gestation was mistakenly vaccinated with a dose of with GARDASIL (dose, dose number, lot/batch number and expiration date were not reported) instead of unknown other vaccine, possible TDAP. There was no concomitant medication. The patient became pregnant with Last Menstrual Period of 08-JUL-2014 (estimated based on 27 weeks gestation on 13-JAN-2015) and Estimated Date of Delivery (EDD) of 14-APR-2015 (estimated based on 27 weeks gestation on 13-JAN-2015). No adverse effects were noted. It was reported that the medication error was not related to packaging. The patient sought medical attention by visiting the physician's office on 13-JAN-2015. At the time of the report the pregnancy outcome was pending. Follow up information has been received from the physician on 05-JUN-2015. The female patient was a non smoker or drug/alcohol user. The patient's medical history included one female delivery, 39 weeks from LMP. The GARDASIL vaccine had lot # J013324 with an expiration date on 12-FEB-2016. Concomitant medications included unspecified prenatal vitamins. The LMP was reported as 04-JUL-2014, estimated date of conception: 18-JUL-2014 and the EDD was reported as 03-APR-2015. 39 weeks from LMP, the patient delivered a normal male infant weighing 4235 gms via caesarean section with no complications during the delivery. The pregnancy outcome was live birth without congenital anomalies or neonatal problems, his head was 15 cm circumference and length of 21.5". The infant's APGAR score was 8 at one minute and was 9 at five minutes. At the time of the report, the outcome of caesarean section was unknown and the outcome of exposure during pregnancy was recovered. Laboratories test showed: On 06-JAN-2012, ABO/RH: A (-). On 10-MAR-2015, ultrasound showed 35 weeks pregnant with normal growth. On 13-APR-2015, glucose resulted 142 (units not provided). Upon internal review the event of caesarean section was considered to be medically significant. Additional information is not expected as all follow up attempts had been received.
Age: 31.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Ultrasound antenatal screen normal, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician via company representative refers to a 31 year old female patient. It was reported that the patient had no pertinent medical history. On 13-JAN-2015, the patient who was 27 weeks gestation was mistakenly vaccinated with a dose of with GARDASIL (dose, dose number, lot/batch number and expiration date were not reported) instead of unknown other vaccine, possible TDAP. There was no concomitant medication. The patient became pregnant with Last Menstrual Period of 08-JUL-2014 (estimated based on 27 weeks gestation on 13-JAN-2015) and Estimated Date of Delivery (EDD) of 14-APR-2015 (estimated based on 27 weeks gestation on 13-JAN-2015). No adverse effects were noted. It was reported that the medication error was not related to packaging. The patient sought medical attention by visiting the physician's office on 13-JAN-2015. At the time of the report the pregnancy outcome was pending. Follow up information has been received from the physician on 05-JUN-2015. The female patient was a non smoker or drug/alcohol user. The patient's medical history included one female delivery, 39 weeks from LMP. The GARDASIL vaccine had lot # J013324 with an expiration date on 12-FEB-2016. Concomitant medications included unspecified prenatal vitamins. The LMP was reported as 04-JUL-2014, estimated date of conception: 18-JUL-2014 and the EDD was reported as 03-APR-2015. 39 weeks from LMP, the patient delivered a normal male infant weighing 4235 gms via caesarean section with no complications during the delivery. The pregnancy outcome was live birth without congenital anomalies or neonatal problems, his head was 15 cm circumference and length of 21.5". The infant's APGAR score was 8 at one minute and was 9 at five minutes. At the time of the report, the outcome of caesarean section was unknown and the outcome of exposure during pregnancy was recovered. Laboratories test showed: On 06-JAN-2012, ABO/RH: A (-). On 10-MAR-2015, ultrasound showed 35 weeks pregnant with normal growth. On 13-APR-2015, glucose resulted 142 (units not provided). Upon internal review the event of caesarean section was considered to be medically significant. Additional information is not expected as all follow up attempts had been received.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Dysarthria, Guillain-Barre syndrome
Clinical narrative: Case number PHHY2015US069269 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 570804) on 09 Jun 2015. This report refers to a 70 year old male patient. His current conditions included polymyalgia rheumatica, gastrooesophageal reflux disease (GERD) and hyperlipidemia. His concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 145624) intramuscularly on 21 Nov 2014. On 22 Nov 2014, he experienced weakness and slurring of speech. He was hospitalized for 30 days and was later found to have Guillain Barre Syndrome. The events outcome was reported as condition unchanged. The events were reported as life threatening. The causality of the events was not reported.
Age: 24.0
Sex: M
Vaccine: FLU3, HEPAB, MNQ, PPV, TDAP, FLU3, HEPAB, MNQ, PPV, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Case number PHHY2015US069654, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 571628) website on 09 Jun 2015. This report refers to a 24 years old male patient. Medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 145605) intramuscularly into right arm on 12 Mar 2015. On the same day, he was also vaccinated with TWINRIX (batch number: 797K7, other manufacturer) into right arm, MENACTRA (batch number: U4686AA, other manufacturer) into left arm, PNEUMOVAX (batch number: K023328, other manufacturer) into left arm and ADACEL (batch number: U4998AB, other manufacturer) into left arm; all intramuscularly. On 13 Mar 2015, the patient experienced cellulitis of about 6 cm distal to the injection site. The patient had an emergency visit due to this event. Outcome of the event was unknown. Case was assessed as non-serious. Causality of the event was not reported. Seriousness assessment of cellulitis at the injection site was upgraded based on the NVS-IMS list.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Pain, Pruritus
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 67 year old female patient. Concurrent conditions and medical history were not reported. Historical drugs included morphine and an unspecified macrolides therapy with which she experienced unknown reactions (dates unknown). On 01-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU vial, (lot # L000450,expiration date: 09-MAR-2016), 0.65 ml, subcutaneous in the right posterior tricep area. Concomitant therapies included prednisone (manufacturer unknown) and hydroxychloroquine sulfate. On 09-MAY-2015, the patient developed a quarter size rashes in a circular pattern, consisting of 5 0r 6 lesions around the injection site (injection site rash). The reporter also indicated that the patient stated that the area was "itchy and hurting" and that the pain was a "palm sized area of pain" at the injection site. Additionally, the pharmacist indicated that the patient was concerned because the events had been ongoing for "3 weeks" (conflicting information). On the other hand, the patient was experiencing recent stressful events and the pharmacist believed that it may be exacerbating the adverse events. The patient had not notified her primary healthcare provider. The reporter sought medical attention through contacting the pharmacist. No treatment was given for the adverse events and no lab diagnostics studies were performed. The outcome of itchy, injection site pain, injection site rash and discomfort was reported as not recovered/not resolved. The relatedness between itchy, injection site pain, injection site rash and discomfort and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 67 year old female patient. Concurrent conditions and medical history were not reported. Historical drugs included morphine and an unspecified macrolides therapy with which she experienced unknown reactions (dates unknown). On 01-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU vial, (lot # L000450,expiration date: 09-MAR-2016), 0.65 ml, subcutaneous in the right posterior tricep area. Concomitant therapies included prednisone (manufacturer unknown) and hydroxychloroquine sulfate. On 09-MAY-2015, the patient developed a quarter size rashes in a circular pattern, consisting of 5 0r 6 lesions around the injection site (injection site rash). The reporter also indicated that the patient stated that the area was "itchy and hurting" and that the pain was a "palm sized area of pain" at the injection site. Additionally, the pharmacist indicated that the patient was concerned because the events had been ongoing for "3 weeks" (conflicting information). On the other hand, the patient was experiencing recent stressful events and the pharmacist believed that it may be exacerbating the adverse events. The patient had not notified her primary healthcare provider. The reporter sought medical attention through contacting the pharmacist. No treatment was given for the adverse events and no lab diagnostics studies were performed. The outcome of itchy, injection site pain, injection site rash and discomfort was reported as not recovered/not resolved. The relatedness between itchy, injection site pain, injection site rash and discomfort and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR, VARZOS
Symptoms: No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 year old patient of unknown gender. No concurrent or historical conditions were reported. On 02-JUN-2015 the patient was inadvertently administered a dose of ZOSTAVAX (strength, dose, route, lot# and expiration date not reported) instead of VARIVAX (Merck). No adverse effect reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant referring to a 4 year old patient of unknown gender. No concurrent or historical conditions were reported. On 02-JUN-2015 the patient was inadvertently administered a dose of ZOSTAVAX (strength, dose, route, lot# and expiration date not reported) instead of VARIVAX (Merck). No adverse effect reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Severe, stabbing pain in head near temple area.  Not sinus pressure like usual with allergies, but stabbing headache.  Very fatigued and achy.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Measles, Pyrexia
Clinical narrative: Fever 102'. 1 week later on 6/6/15 had another fever 100.-102. and has lasted 3 days and on 6/9/15 now has rash on trunk-appears to be measles.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Computerised tomogram, Endometriosis, Exploratory operation, Laboratory test
Clinical narrative: Approximately 6-8 weeks after each Gardasil injection, I was hospitalized with debilitating pelvic pain, ovarian cysts, nausea, vomiting & weight loss. I received IV fluids and pain medications, as well as multiple day stays to stabilize electrolytes. Exploratory surgery was also performed due to extreme pelvic pain brought on by the course of the three (3) HPV shot series, and a diagnosis of Endometriosis was made. No prior history before HPV series of endometriosis, pelvic pain or ovarian cysts.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Nuclear magnetic resonance imaging, Ovarian cyst, Pelvic pain, Ultrasound scan
Clinical narrative: Approximately 6-8 weeks after each Gardasil injection, I was hospitalized with debilitating pelvic pain, ovarian cysts, nausea, vomiting & weight loss. I received IV fluids and pain medications, as well as multiple day stays to stabilize electrolytes. Exploratory surgery was also performed due to extreme pelvic pain brought on by the course of the three (3) HPV shot series, and a diagnosis of Endometriosis was made. No prior history before HPV series of endometriosis, pelvic pain or ovarian cysts.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting, Weight decreased
Clinical narrative: Approximately 6-8 weeks after each Gardasil injection, I was hospitalized with debilitating pelvic pain, ovarian cysts, nausea, vomiting & weight loss. I received IV fluids and pain medications, as well as multiple day stays to stabilize electrolytes. Exploratory surgery was also performed due to extreme pelvic pain brought on by the course of the three (3) HPV shot series, and a diagnosis of Endometriosis was made. No prior history before HPV series of endometriosis, pelvic pain or ovarian cysts.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On an unknown date the patients were vaccinated with improperly stored GARDASIL (dose strength, Dose number, route unspecified). No adverse events were reported. The outcome of events reported was unknown. No product quality complaint was involved. This case is linked to the cases 1506USA004940, 1506USA004987, 1506USA004985 via same reporter link. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Balance disorder, Chromaturia, Fatigue, Haematuria, Myalgia
Clinical narrative: Within 90 min of receiving the vaccine patient developed myalgias, lassitude and a fever with a temperature max of 104F within 24 hrs. Her fever persisted (101-102 degrees F) and was associated with dark urine, nausea ans a sense of being off balance for 4.5 days.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pyrexia
Clinical narrative: Within 90 min of receiving the vaccine patient developed myalgias, lassitude and a fever with a temperature max of 104F within 24 hrs. Her fever persisted (101-102 degrees F) and was associated with dark urine, nausea ans a sense of being off balance for 4.5 days.
Age: 1.26
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Crying, Pharyngitis, Pyrexia
Clinical narrative: June 3rd vaccines, June 5th pt ret to clinic c/o high fever and uncontrollable crying x2 days. (20 min after vaccine). Upon examination pt also found to have pharyngitis. SHe recovered within 12 hours- RTB given as well.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Ageusia, Malaise, Pain, Pyrexia
Clinical narrative: Patient had severe pain along "her torso to neck" with malaise, fever 101 (less than 24th duration) loss of taste sensation but returned. No rash or edema or redness at sight of injection.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: HER ARM BECAME RED AND SLIGHTLY SWOLLEN. NOTICED PROXIMAL UPPER ARM TO HAVE AN APPROXIMATELY 1.25" RED SLIGHTLY SWOLLEN CIRCLE WHICH WAS WARM TO THE TOUCH. DONOR HAD GOOD PMS AND DID NOT HAVE ANY FURTHER SIGNS/SYMPTOMS.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (lot # K009953, expiration date 03-APR-2016) (dose, strength, frequency and route were not reported). Concomitant mediation was not reported. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This prospective report has been received from a nurse referring to a 23 year old female patient. Medication history and drug allergy were not reported. On 22-APR-2015 the patient was vaccinated with the third dose of GARDASIL (dose and route were not reported, lot # K009482, expire date 06-MAR-2017) while she was 20 weeks pregnant (second trimester). Concomitant drug was not reported. Her last menstrual period (LMP) was 03-DEC-2014 and estimated date of delivery (EDD) was 09-SEP-2015. No adverse effects were reported. No treatment was given. At the time of reporting, the pregnancy outcome was pending. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning unspecified patients of unknown demographics. Pertinent medical history and drug reactions/allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored COMVAX (dose, route, lot number and expiration date unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender. On 26-MAY-2015 the patient was inadvertently vaccinated with an expired dose of M-M-R II (lot # J006185, expiry date: 24-MAY-2015, dose and route were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On an unknown date the patients were vaccinated with improperly stored VAQTA (dose strength, dose number, route unspecified). No adverse events were reported. The outcome of events reported was unknown. No product quality complaint was involved. This case is linked to the cases 1506USA004940, 1506USA004986, 1506USA004985 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (dose strength, dose number, route unspecified). No adverse events were reported. The outcome of events reported was unknown. No product quality complaint was involved. This case is linked to the cases 1506USA004940, 1506USA004986, 1506USA004987 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified patients of unkonwn age and gender. No information about medical history, concurrent conditions were reported for the patients. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) (dose strength, dose number, route unsepcified). No adverse events were reported. The outcome of events reported was unknown. No product quality complaint was involved. This case is linked to the cases 1506USA004985, 1506USA004986, 1506USA004987 via same reporter link. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 15 year old female patient. Not current conditions and medical history were provided. On 10-MAY-2011 the patient was vaccinated with one dose of CERVARIX, (dose, lot number, expiration date and route of administration were not provided); on 11-JUN-2012 the patient was vaccinated with another dose of CERVARIX (dose, lot number, expiration date and route of administration were not provided) and then on 03-JUN-2015 the patient was vaccinated with a dose of GARDASIL, (dose, lot number, expiration date and route of administration were not provided); which was considered an interchanged of vaccine products. The patient had not reported or demonstrated an adverse effect. Additional information has been requested.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from the registered nurse concerning to an approximately 66 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 03-DEC-2014, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (lot number: K007824 with expiration date of 05-NOV-2015) (dose, route and frequency unspecified). Concomitant medications were not reported. No adverse event was reported. The outcome of the event was unknown. The causality of the events with PNEUMOVAX 23 was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to a unspecified number of unspecified patients of unknown age and gender. No medical history and concomitant medications were reported. On an unknown dates, the patients received improperly stored doses of PROQUAD (Lot# K023364, expiry: 20-MAY-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from the registered nurse concerning to an approximately 67 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 17-MAR-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (lot number: K005402 with unknown expiration date) (dose, route and frequency unspecified). Concomitant medications were not reported. No adverse event was reported. The outcome of the event was unknown. The causality of the events with PNEUMOVAX 23 was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site reaction, Pruritus, Rash erythematous, Rash generalised, Urticaria
Clinical narrative: Fairly sudden onset red rash that had appearance of hive, red outside with white inside, itchy.  Sites were on feet, lower legs, around waist, lower back and ears.
Sex: M
Vaccine: FLU3, HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event reporting related to given Fluvirin 0.5ml dose in error.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Cough, Malaise
Clinical narrative: Pt called office on 6/9/15 at 6:41pm. Says has cough and malaise and feels side effect from TDAP vaccine received on 6/4/15.
Age: 1.32
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Vomiting
Clinical narrative: Small amount clear emesis x1 in evening 6-8-15. Small amount clear emesis x1 in AM 6-9-15.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Rash, Rash macular
Clinical narrative: Erythematous macular rash noted to BUE and BLE occurring approx 24 hrs after administration. Treated with 10 day tapered course prednisone and antihistamines/calamine lotion PRN.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to a unspecified number of unspecified patients of unknown age and gender. No medical history and concomitant medications were reported. On an unknown dates, the patients received improperly stored doses of VARIVAX (Merck) (lot # K021932, expiry: 10-NOV-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from the registered nurse concerning to an approximately 61 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 12-DEC-2014, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (lot number: K005402 with unknown expiration date) (dose, route and frequency unspecified). Concomitant medications were not reported. No adverse event was reported. The outcome of the event was unknown. The causality of the events with PNEUMOVAX 23 was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from the registered nurse concerning to an approximately 66 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 18-DEC-2014, the patient was vaccinated with improperly stored dose of PNEUMOVAX23 (lot number: K005402 with unknown expiration date) (dose, route and frequency unspecified). Concomitant medications were not reported. No adverse event was reported. The outcome of the event was unknown. The causality of the events with PNEUMOVAX23 was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Corneal abrasion, Herpes zoster, Ophthalmic herpes zoster, Optic nerve disorder, Pain
Clinical narrative: Information has been received from an approximately 62 year old patient via company reprehensible referring to himself/herself. Patient's concurrent conditions, concomitant medication and medical history were not provided. In approximately June 2011, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route and frequency were not provided). Six months later, in early December 2011, the patient  suffered an outbreak of the herpes zoster virus. The rash started at the top of his/her head at the hairline and extended into his/her left eye. The pain could only be described as if a knife were driven into the eye, easily the worse pain the patient had ever experienced in his/her life. The patient's doctor told him/her that the outbreak would have been worse if he/she didn't have the vaccine. At the time of the report, the patient still took Gabapentin 400 mg three times a day for the post Shingles neuralgia(onset date unspecified) and four types of eye drops. Because of the affect to his/her eye the patient suffered corneal abrasions and was on a course of heavy steroids for a year. His/her optic nerve had deteriorated(onset date unspecified) in the affected eye but his/her vision was still intact. At 66 years old(at reporting time) the patient expect his/her treatment would continue for life, with no guarantee he/she wouldn't suffer another outbreak. No product quality complaint (PQC) was reported. The patient also provided feedback on the ZOSTAVAX commercials, and suggested they should contain information regarding the potential dangers of the shingles virus to the eye. The outcome of the events was considered as not recovered. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: Information has been received from an approximately 62 year old patient via company reprehensible referring to himself/herself. Patient's concurrent conditions, concomitant medication and medical history were not provided. In approximately June 2011, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route and frequency were not provided). Six months later, in early December 2011, the patient  suffered an outbreak of the herpes zoster virus. The rash started at the top of his/her head at the hairline and extended into his/her left eye. The pain could only be described as if a knife were driven into the eye, easily the worse pain the patient had ever experienced in his/her life. The patient's doctor told him/her that the outbreak would have been worse if he/she didn't have the vaccine. At the time of the report, the patient still took Gabapentin 400 mg three times a day for the post Shingles neuralgia(onset date unspecified) and four types of eye drops. Because of the affect to his/her eye the patient suffered corneal abrasions and was on a course of heavy steroids for a year. His/her optic nerve had deteriorated(onset date unspecified) in the affected eye but his/her vision was still intact. At 66 years old(at reporting time) the patient expect his/her treatment would continue for life, with no guarantee he/she wouldn't suffer another outbreak. No product quality complaint (PQC) was reported. The patient also provided feedback on the ZOSTAVAX commercials, and suggested they should contain information regarding the potential dangers of the shingles virus to the eye. The outcome of the events was considered as not recovered. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Corneal abrasion, Eye pain, Herpes zoster, Ophthalmic herpes zoster, Optic nerve disorder
Clinical narrative: Information has been received from an approximately 62 year old patient via company reprehensible referring to himself/herself. Patient's concurrent conditions, concomitant medication and medical history were not provided. In approximately June 2011, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route and frequency were not provided). Six months later, in early December 2011, the patient  suffered an outbreak of the herpes zoster virus. The rash started at the top of his/her head at the hairline and extended into his/her left eye. The pain could only be described as if a knife were driven into the eye, easily the worse pain the patient had ever experienced in his/her life. The patient's doctor told him/her that the outbreak would have been worse if he/she didn't have the vaccine. At the time of the report, the patient still took Gabapentin 400 mg three times a day for the post Shingles neuralgia(onset date unspecified) and four types of eye drops. Because of the affect to his/her eye the patient suffered corneal abrasions and was on a course of heavy steroids for a year. His/her optic nerve had deteriorated(onset date unspecified) in the affected eye but his/her vision was still intact. At 66 years old(at reporting time) the patient expect his/her treatment would continue for life, with no guarantee he/she wouldn't suffer another outbreak. No product quality complaint (PQC) was reported. The patient also provided feedback on the ZOSTAVAX commercials, and suggested they should contain information regarding the potential dangers of the shingles virus to the eye. The outcome of the events was considered as not recovered. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site mass, Injection site pain
Clinical narrative: IM vaccination of BOOSTRIX TDAP on 6/3/15 adverse reaction reported by pt on 6/10/15. Pt states arm sore hard lump on deltoid area of LA. No redness or sign of inf. NSAIDS and ice and f/u if does not resolved or worsens.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Peripheral swelling
Clinical narrative: Erythematous, swollen warm area surrounding injection site. Pain with movement of arm. Swollen arm 8 x 12".
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site swelling, Pyrexia
Clinical narrative: Fever-arm swollen at site, fatigue.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Seizure
Clinical narrative: Pt had brief seizure with convulsions which lasted approximately 30-40 seconds immediately following administration of 2nd dose of GARDASIL vaccine in our office today.
Age: 43.0
Sex: M
Vaccine: JEV1, TDAP
Symptoms: Dizziness, Injection site pain
Clinical narrative: Within 2 min after administering vaccine (IXIARO), pt complained of pain at injection site and dizziness. Blood pressure was measured to be 72/48 and pulse 40 and temp. 97.9. Patient laid on ground and was given water, glucose (INSTA-GLUCOSE) and recovered approximately 30 min later. Follow up BP 103/67, pulse 53.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal, Pain, Periarthritis
Clinical narrative: PCV 13 vaccine administered 5/30/2014 right arm at shoulder level. Immediate pain that increased progressively within hours. Pain severe. Limited ROM. TX NSAIDs, steroid (oral) and Rt shoulder joint injection, physical therapy. MRI showed Rotator Cuff tear. Surgery 4/28/15 on Rt shoulder showed sm tear and frozen shoulder. Still in physical therapy.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Rotator cuff syndrome, Shoulder operation
Clinical narrative: PCV 13 vaccine administered 5/30/2014 right arm at shoulder level. Immediate pain that increased progressively within hours. Pain severe. Limited ROM. TX NSAIDs, steroid (oral) and Rt shoulder joint injection, physical therapy. MRI showed Rotator Cuff tear. Surgery 4/28/15 on Rt shoulder showed sm tear and frozen shoulder. Still in physical therapy.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Pain at site of shot for two (2) weeks.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Haematochezia
Clinical narrative: Initial unsolicited report received from consumer (patient's parent) on 28 May 2015. A 02-month-old male patient had received a first dose of PENTACEL (batch number, expiration date, dose, route and site of administration were not reported) on 17 February 2015. The patient had medical history of lactose intolerance. The reporter doesn't know (at this point), if it is Ig mediated or secondary effect due to other sensitivity/allergy. Concomitant medication was not reported. On 26 February 2015, nine days after vaccination patient had experienced significant blood appeared in stool. The incident was reported to pediatrician. The pediatrician told that this is not related to vaccination; however, it did started week after he got his first vaccine. Laboratory investigation and corrective treatment were not reported. At the time of this report, outcome of the event was unknown. Upon internal review, company assessed the event of significant blood appeared in his stool as serious and important medical event. List of documents held by sender: none.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Fine motor delay, Gross motor delay, Speech disorder developmental
Clinical narrative: Initial unsolicited report received from a physician (pediatrician) on 30 May 2015. A 05-year-old male patient, whose medical history and concomitant medications were not reported, had received a dose of IPOL (batch number, route and site of administration were not reported) on an unspecified date. Illness at the time of the vaccination was not reported. On an unspecified date after vaccination, the patient experienced fine motor, gross and speech development delay. The reporter stated that a mother was trying to find out if the 5 doses of IPV her child received could be related to the events. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the events was unknown. Upon medical review, the case was considered as serious due to important medical events: slow speech development, fine and gross motor delay. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site pain
Clinical narrative: Initial unsolicited report received from a nurse on 01 June 2015. This case is linked to the case 2015SA077114 (same reporter, same suspect). Two female patients had received a intramuscular dose one of ADACEL (batch number- U5030AA, expiration date- 1 May 2017, site of administration was not reported) on an unspecified date. Patients did not have any illness and pre-existing physician diagnosed allergies, birth defects, medical conditions at time of vaccination. The patient did not have any known drug allergy. Patients did not receive concomitant medications. On an unspecified date after vaccination, patients developed pain at the injection site and superficial cellulitis. Patients required ER/doctor visit. Laboratory investigations were reported as none. The patients were treated with antibiotics and steroids. At the time of this report outcome of events were unknown. Upon medical review, the case was considered as serious due to important medical event- cellulitis. Documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Hypersensitivity, Injection site pain
Clinical narrative: Initial unsolicited report received from a nurse on 01 June 2015. This case is linked to the case 2015SA077113 (same reporter, same suspect). A female patients had received a intramuscular dose one of ADACEL (batch number- U5030AA, expiration date- 1 May 2017, site of administration was not reported) on an unspecified date. The patient did not have any illness and pre-existing physician diagnosed allergies, birth defects, medical conditions at time of vaccination. The patient did not have any known drug allergy. Patient did not receive concomitant medications. On an unspecified date after vaccination, the patient developed pain at the injection site and superficial cellulitis and had an allergic reaction. Patients required ER/doctor visit. Laboratory investigations were reported as none. The patient was treated with antibiotics and BENADRYL. At the time of this report all the patient was recovered from the events. Upon medical review, the case was considered as serious due to important medical event- cellulitis. Documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema multiforme
Clinical narrative: Erythema Multiforme.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site vesicles, Injection site warmth
Clinical narrative: Anthrax vaccine given in the Left Deltoid. The next day patient states that entire upper arm was red, hot and itchy. Patient states that the site was hard and she had a small blister at the injection site. Patient states that the symptoms lasted for 6 days. Patient did not got to ER or receive treatment.
Age: 0.84
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Muscle twitching, Pyrexia, Seizure like phenomena, Tremor
Clinical narrative: Presented to ED with seizure-like activity in the setting of fever and recent vaccination. Mom reported patient "twitching of his arm... body shaking for 4 minutes."  Seizure-like activities resolved before EMS arrival. Patient at baseline, interactive and laughing prior to ED arrival. No history of seizures disorder in the family.
Age: 26.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Erythema, Induration, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient got shot on Friday afternoon. Arm became swollen, red, warm, firm and itchy. Her arm stayed the same way all weekend and she was seen by a provider on Monday.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to a unspecified number of unspecified patients of unknown age and gender. No medical history and concomitant medications were reported. On an unknown dates, the patients received improperly stored doses of M-M-R II (lot # J016235, expiry: 19-DEC-2015 and Lot# K010319, expiry: 22-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMRV
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: No adverse reaction observed or reported by parent. Pt was to receive Hep A vaccine but was vaccinated with an additional Hep B vaccine by inexperienced MA.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling
Clinical narrative: Swelling and itching.
Age: 14.0
Sex: M
Vaccine: TYP, YF
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Ear swelling, Erythema
Clinical narrative: We waited 20 minutes after vaccine was given and no reaction.  About 40-45 minutes later he began coughing a tremendous amount and his skin took on a bright red color that looked like he was sunburned.  His lips and ears swelled and he developed hives.  He was able to breathe but said he felt like he wasn't getting enough oxygen.  All the symptoms happened within minutes wiht the cough starting first.  We took him immediately to the ER.  They gave him an Epi shot, Benadryl, Zantac, Solumedrol (steroid), and a nebulizer treatment.  They monitored him for 5-6 hours.  He recovered nicely. They sent him home with prescriptions for Epi Pens, steroids, Benadryl and Zantac.  His discharge sheets diagnosis said allergic reaction to vaccines.  The ER doctor said he had an anaphylactic response.
Age: 14.0
Sex: M
Vaccine: TYP, YF
Symptoms: Hypersensitivity, Lip swelling, Urticaria
Clinical narrative: We waited 20 minutes after vaccine was given and no reaction.  About 40-45 minutes later he began coughing a tremendous amount and his skin took on a bright red color that looked like he was sunburned.  His lips and ears swelled and he developed hives.  He was able to breathe but said he felt like he wasn't getting enough oxygen.  All the symptoms happened within minutes wiht the cough starting first.  We took him immediately to the ER.  They gave him an Epi shot, Benadryl, Zantac, Solumedrol (steroid), and a nebulizer treatment.  They monitored him for 5-6 hours.  He recovered nicely. They sent him home with prescriptions for Epi Pens, steroids, Benadryl and Zantac.  His discharge sheets diagnosis said allergic reaction to vaccines.  The ER doctor said he had an anaphylactic response.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: Patient experienced migraine after 2nd HPV vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition or medical history reported. On an unknown date in June 2012, the patient was vaccinated with ZOSTAVAX vial (dose and route unspecified). On an unknown date in October 2013, the patient was vaccinated with the second dose (an extra dose) of ZOSTAVAX. No adverse experience reported. No product quality complaint reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report received from a physician refers to a 68 year old female patient enrolled in a Market Research. Concurrent or medical conditions were not reported. Spring 2013, the patient was vaccinated with ZOSTAVAX (dose, strength, route and lot number were not reported). Secondary suspects and concomitant therapies were not reported. Summer 2014, the patient developed shingles after receiving ZOSTAVAX. The patient recovered from shingles in 2014 (14-21 days after onset). The reporter physician considered shingles to be related to ZOSTAVAX. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from the registered nurse concerning to an approximately 62 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 17-FEB-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (lot number: K005402 with unknown expiration date) (dose, route and frequency unspecified). Concomitant medications were not reported. No adverse event was reported. The outcome of the event was unknown. The causality of the events with PNEUMOVAX 23 was not reported. This is one of the several reports from the same reporter. Additional information has been requested.