chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.67
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Influenza virus test negative, Respiratory syncytial virus test negative, Tremor, Urine analysis normal
Clinical narrative: Mom reports temp at 9:00pm on 12/8/16 was 99.9 and she gave TYLENOL by wt. At 4:00am eyes rolled back and began shaking. Called 911. When paramedics arrived temp. was 105 degrees and cold clothes applied. In ER temp was 103.9 degrees rectally and Ibuprofen given. Discharged on cefdinir. Dx febrile seizure.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Dizziness, Fatigue, Swollen tongue
Clinical narrative: Patient's first flu shot: experienced dizziness, swollen tongue, fatigue, temperature of 99 degrees F. Took BENADRYL and ZYRTEC and felt a bit of relief. Made arrangements to check in with practitioner.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Fever 102 F x 2 days. Redness to injection site.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Lymphadenopathy
Clinical narrative: 5 days after the GARDASIL shot she complained of severe pain and swelling of the left upper chest near the axilla, there was a lump - ultrasound showed enlarge lymph nodes - cannot raise her hands. It took 2 weeks before the symptoms resolved. She was initially on AUGMENTIN which was stopped in 4 days.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Chest pain, Full blood count normal, Lymphadenopathy, Mass, Metabolic function test normal
Clinical narrative: 5 days after the GARDASIL shot she complained of severe pain and swelling of the left upper chest near the axilla, there was a lump - ultrasound showed enlarge lymph nodes - cannot raise her hands. It took 2 weeks before the symptoms resolved. She was initially on AUGMENTIN which was stopped in 4 days.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Mobility decreased, Red blood cell sedimentation rate normal, Swelling, Ultrasound chest
Clinical narrative: 5 days after the GARDASIL shot she complained of severe pain and swelling of the left upper chest near the axilla, there was a lump - ultrasound showed enlarge lymph nodes - cannot raise her hands. It took 2 weeks before the symptoms resolved. She was initially on AUGMENTIN which was stopped in 4 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Swelling, redness, slight itch, mild warmth, approx. 3.0 x 7.0 cm.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a nurse via a company representative, referring to her son, a male patient (age 11 or 12 years). Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. In 2016, the patient was vaccinated with his 1st dose of GARDASIL 9, intramuscularly, on his thigh (not specify if on his right or left leg) (lot # and expiration date were not provided) for prophylaxis. Other suspect therapies included meningococcal acyw conj vaccine (crm197) (MENVEO) which was administered on the same date and on the same leg to the patient. On an unknown date (reported as "after hours after the first dose of GARDASIL 9, the patient experienced a extremely swollen thigh, that was red and warm to touch (injection site reaction). Due to the events, the patient was seen in the local emergency room, nevertheless he was not admitted to the hospital. The reporter stated, that on an unknown date (reported as "weeks later"), the patient recovered form the injection site reaction. It was unknown which treatment was provided for the patient. The reporter was going to taker son for his 2nd dose of GARDASIL 9. Furthermore, no product quality issue was involved. The reporter did not provide for a causality between the adverse event and vaccination with GARDASIL 9. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA009737:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unspecified gender and age. On unknown dates, the unspecified number of improperly stored doses of the GARDASIL 9 lot # L037554, expiration date 25-DEC-2017, lot# M013636, expiration date 15-FEB-2018, lot # M034780 expiration date 15-APR-2019 (formulation, dose, frequency, route of administration and indication were not reported) were administered to the patients. On unknown dates, the doses were stored in the temperatures between 32 degrees Fahrenheit and 35 degrees Fahrenheit for 284 hours. Data logger was involved. There was no previous excursion reported. No adverse effects were reported. Additional information is not expected as there is no correspondence contact information.; Sender's Comments:  US-009507513-1703USA009116:
Age: 0.33
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to an unspecified 4 month old patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 07-MAR-2017, the patient was vaccinated with GARDASIL 9 (dose and route of administration were not reported) (lot # reported as M041990 and expiration date 28-JUN-2019) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with the improperly stored doses of VARIVAX (lot # M033905 and expiration date 20-JUL-2018) for prophylaxis. Two of the patients received 0.5 ml of vaccine subcutaneously. There were no adverse effects reported. Administered doses of vaccines experienced defrost cycles and the temperature excursion of 16.4 degrees Fahrenheit for 50 minutes and another temperature excursion greater than 15 degrees Fahrenheit but less than 46 degrees Fahrenheit for 1 hour. Data logger was involved. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a pharmacy technician concerning a patient of unknown age and gender. It was reported that on 09-MAR-2017, an expired dose of M-M-R II (lot # K021950, expiration date 10-NOV-2016) was administered to an unspecified patient (dosage and route of administration not provided). No adverse effects. No further information was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, referring to patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 13-MAR-2017, the patient was vaccinated with improperly stored dose VARIVAX which had Lot number M033905 with expiry date on 20-JUL-2018 (strength and route were not reported) for prophylaxis, however no adverse effects were reported.  It was reported that the vaccine was exposed to a temperature as follows: >14 farenheit grade but < 46 farenheit grade for 40 minutes; >14 farenheit grade but < 46 farenheit grade for 40 minutes; >14 farenheit grade but < 46 farenheit grade for 50 minutes and had a previous excursion recorded by a data logger of >14farenheit grade  but < 46 farenheit grade  for "5.3 hours" and >14 farenheit grade but < 46 farenheit grade for 50 minutes. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA008241: US-009507513-1703USA008242: US-009507513-1703USA008243:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, referring to patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patient was vaccinated with improperly stored dose VARIVAX which had Lot number M033905 with expiry date on 20-JUL-2018 (strength and route were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccine was exposed to a temperature as follows: >14 farenheit grade but < 46 farenheit grade for 40 minutes; >14 farenheit grade but < 46 farenheit grade for 40 minutes; >14 farenheit grade but < 46 farenheit grade for 50 minutes and had a previous excursion recorded by a data logger of >14farenheit grade  but < 46 farenheit grade  for "5.3 hours" and >14 farenheit grade but < 46 farenheit grade for 50 minutes. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA008241: US-009507513-1703USA008236: US-009507513-1703USA008242:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This solicited report was received from a physician, referring to a 15 year old female patient, who was enrolled in a Market Research.  The patient did not have concurrent condition and concomitant therapies. The patient's medical history was not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (subcutaneous; lot#, expiration date and dose unknown) for prophylaxis. On an unknown date in 2000 or 2010, the patient was fainted, and it was considered as an expected and common side effect.  No diagnostic test was carried out. The outcome of event was reported as recovered with sequelae. It was reported that the event did not re-appear after re-vaccinating GARDASIL. The causality between event  "fainted" and GARDASIL was reported as related. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical mssistant refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided. On an unknown date, the patient was vaccinated with dose of GARDASIL (dose, formulation and route of administration were not provided, lot number K011325, expiration date 08-APR-2017) for prophylaxis. According to a digital data logger measurements, the vaccine was improperly stored in the temperature of 35 degrees Fahrenheit on 16-FEB-2017 for 9 hours, on 21-FEB-2017 for 7 hours, and on 23 February (year unspecified) for 7 hours 30 minutes. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Exposure to vaccinated person, Secondary transmission, Varicella
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative, concerning an 11 months-old child of an unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. The 11 months old child was babysited by a female who has a 61 weeks old son. Her son was vaccinated with VARIVAX (Lot #, expiration date, strength, dose, frequency and anatomical location were not provided) on 30-JAN-2017 for prophylaxis. It was reported that the 11 months old patient broke out which chickenpox within 24 hours of being exposed to the vaccinated 61 weeks old male patient (secondary transmission and chickenpox). At the reporting time, the outcome of the events was not reported. The causal relationship between the VARIVAX and the events was not provided. No product quality complain (PQC) was involved. This is one of several reports received from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1703USA009916: US-009507513-1703USA006978:
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Exposure to vaccinated person
Clinical narrative: This prospective pregnancy report was received from a nurse practitioner via a company representative, concerning a pregnant female patient of an unknown age. The patient's medical history included chickenpox. Her concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On an unspecified date, while the patient was pregnant (unspecified duration), she was exposed to her vaccinated son with VARIVAX (lot #, expiration date, strength, dose, frequency and anatomical location of the injection were not reported) (Exposure to vaccinated person). The patient last menstrual period (LMP), pregnancy due date, trimester of exposure and pregnancy outcome were not reported. The reporter stated that there was a concern for the pregnant patient and the unborn fetus, but the mother's obstetrician and gynecologists (ob-gyn) provider stated that both the mother and the unborn fetus should be fine, since the mother has already had the chickenpox before (unspecified date). No other information was provided on this matter. No product quality complain (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA006978: US-009507513-1703USA009915:
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse (other health professional) refers to a patient of unknown age. Pertinent medical histories and concomitant medications were not reported. On an unknown date in November 2016, the patient was vaccinated with GARDASIL 9 (dosage regimen not reported) dose 1 for prophylaxis. On 08-MAR-2017, the patient was vaccinated with GARDASIL 9 (dosage regimen not reported) lot # M034195 and expiry date 14-APR-2019 dose 3 for prophylaxis (inappropriate schedule of drug administration). No adverse effects reported (no adverse event). No further information to report. Additional information has been requested.
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericarditis, Troponin I normal
Clinical narrative: Initial solicited report received on 13 March 2017 from an investigator (Defense Health Agency/Immunization Healthcare Branch) in the trial. A 20 year-old male subject with no significant medical history. The subject's concomitant medication was typhoid VI polysaccharide vaccine (TYPHOID VICPs) on 16 September 2016, influenza quadrival A-B vaccine (INFLUENZA INJECTABLE, QUADRAVALENT) on 16 September 2016, and anthrax vaccine (ANTHRAX) on 16 September 2016. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 19 September 2016. On 12 December 2016, 84 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified. The lab data included on 22 September 2016 blood test was performed which showed troponin I normal, on 22 September 2016 ECG was performed which was abnormal, on 23 September 2016 Echocardiogram was normal, magnetic resonance imaging (MRI) (heart, brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The outcome of the event I30.9 acute pericarditis, unspecified was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to investigator: not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a healthy 20-year-old male who developed acute pericarditis 84 days after receiving a dose of ACAM2000 vaccine. Pericarditis is a listed adverse event that may occur within one month following vaccination with live vaccinia virus smallpox vaccines. He also received other vaccines including typhoid, influenza and anthrax vaccine on same day of ACAM2000 vaccination. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis or pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, sponsor assesses this event as not related to study vaccine.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPVX
Symptoms: Crying, Culture urine, Differential white blood cell count, Dizziness, Fall
Clinical narrative: She got her shot at 2:45 pm and the nurse left the room, at 2:26 pm. She was dizzy, she could not hear/see.  She fell over onto me having a seizure at 2:48pm I screamed for a nurse immediately the lady who gave the shot came in and seen it and then a Dr entered the room as she came too.  Dr asked what happend and lady who gave shot said looked like a seizure to her I said it looked like it to me at this point my daughter is holding her ears saying all she cant hear or see that led to her ears buzzing. And a rash starting in her armpit shoulder area. Dr checked eyes, ears, thoat and heart rate.  She said we cant go anywhere for 15 minutes and recommened ER by EMS I didnt want to wait longer than I had to and said I'd drive her it wasn't far from medical office we were at and she agreed that would be fine since I had a 3rd person there to drive.  We went to ER where I explained what happened and gave note from Dr office, they gave her steroids, fluids ext where the ER Dr came to conclusion of severe allergic reaction I told him she got dizzy and couldn't see or hear on first 2 doses and they said it was normal and he said that was allergic reactions and is no way normal that she should not have got 2nd one at that point.  He said now she has to always have an epinephrine pen which he prescribed with more steroids.  She is terrified of needles now and been crying and fidgety most the night.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPVX
Symptoms: Fear of injection, Full blood count, Human chorionic gonadotropin, Hypersensitivity, Hypoacusis
Clinical narrative: She got her shot at 2:45 pm and the nurse left the room, at 2:26 pm. She was dizzy, she could not hear/see.  She fell over onto me having a seizure at 2:48pm I screamed for a nurse immediately the lady who gave the shot came in and seen it and then a Dr entered the room as she came too.  Dr asked what happend and lady who gave shot said looked like a seizure to her I said it looked like it to me at this point my daughter is holding her ears saying all she cant hear or see that led to her ears buzzing. And a rash starting in her armpit shoulder area. Dr checked eyes, ears, thoat and heart rate.  She said we cant go anywhere for 15 minutes and recommened ER by EMS I didnt want to wait longer than I had to and said I'd drive her it wasn't far from medical office we were at and she agreed that would be fine since I had a 3rd person there to drive.  We went to ER where I explained what happened and gave note from Dr office, they gave her steroids, fluids ext where the ER Dr came to conclusion of severe allergic reaction I told him she got dizzy and couldn't see or hear on first 2 doses and they said it was normal and he said that was allergic reactions and is no way normal that she should not have got 2nd one at that point.  He said now she has to always have an epinephrine pen which he prescribed with more steroids.  She is terrified of needles now and been crying and fidgety most the night.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPVX
Symptoms: Hypotension, Metabolic function test, Rash, Restlessness, Seizure
Clinical narrative: She got her shot at 2:45 pm and the nurse left the room, at 2:26 pm. She was dizzy, she could not hear/see.  She fell over onto me having a seizure at 2:48pm I screamed for a nurse immediately the lady who gave the shot came in and seen it and then a Dr entered the room as she came too.  Dr asked what happend and lady who gave shot said looked like a seizure to her I said it looked like it to me at this point my daughter is holding her ears saying all she cant hear or see that led to her ears buzzing. And a rash starting in her armpit shoulder area. Dr checked eyes, ears, thoat and heart rate.  She said we cant go anywhere for 15 minutes and recommened ER by EMS I didnt want to wait longer than I had to and said I'd drive her it wasn't far from medical office we were at and she agreed that would be fine since I had a 3rd person there to drive.  We went to ER where I explained what happened and gave note from Dr office, they gave her steroids, fluids ext where the ER Dr came to conclusion of severe allergic reaction I told him she got dizzy and couldn't see or hear on first 2 doses and they said it was normal and he said that was allergic reactions and is no way normal that she should not have got 2nd one at that point.  He said now she has to always have an epinephrine pen which he prescribed with more steroids.  She is terrified of needles now and been crying and fidgety most the night.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPVX
Symptoms: Syncope, Tinnitus, Visual impairment
Clinical narrative: She got her shot at 2:45 pm and the nurse left the room, at 2:26 pm. She was dizzy, she could not hear/see.  She fell over onto me having a seizure at 2:48pm I screamed for a nurse immediately the lady who gave the shot came in and seen it and then a Dr entered the room as she came too.  Dr asked what happend and lady who gave shot said looked like a seizure to her I said it looked like it to me at this point my daughter is holding her ears saying all she cant hear or see that led to her ears buzzing. And a rash starting in her armpit shoulder area. Dr checked eyes, ears, thoat and heart rate.  She said we cant go anywhere for 15 minutes and recommened ER by EMS I didnt want to wait longer than I had to and said I'd drive her it wasn't far from medical office we were at and she agreed that would be fine since I had a 3rd person there to drive.  We went to ER where I explained what happened and gave note from Dr office, they gave her steroids, fluids ext where the ER Dr came to conclusion of severe allergic reaction I told him she got dizzy and couldn't see or hear on first 2 doses and they said it was normal and he said that was allergic reactions and is no way normal that she should not have got 2nd one at that point.  He said now she has to always have an epinephrine pen which he prescribed with more steroids.  She is terrified of needles now and been crying and fidgety most the night.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPVX
Symptoms: Muscle rigidity, Posture abnormal, Unresponsive to stimuli
Clinical narrative: She got her shot at 2:45 pm and the nurse left the room, at 2:26 pm. She was dizzy, she could not hear/see.  She fell over onto me having a seizure at 2:48pm I screamed for a nurse immediately the lady who gave the shot came in and seen it and then a Dr entered the room as she came too.  Dr asked what happend and lady who gave shot said looked like a seizure to her I said it looked like it to me at this point my daughter is holding her ears saying all she cant hear or see that led to her ears buzzing. And a rash starting in her armpit shoulder area. Dr checked eyes, ears, thoat and heart rate.  She said we cant go anywhere for 15 minutes and recommened ER by EMS I didnt want to wait longer than I had to and said I'd drive her it wasn't far from medical office we were at and she agreed that would be fine since I had a 3rd person there to drive.  We went to ER where I explained what happened and gave note from Dr office, they gave her steroids, fluids ext where the ER Dr came to conclusion of severe allergic reaction I told him she got dizzy and couldn't see or hear on first 2 doses and they said it was normal and he said that was allergic reactions and is no way normal that she should not have got 2nd one at that point.  He said now she has to always have an epinephrine pen which he prescribed with more steroids.  She is terrified of needles now and been crying and fidgety most the night.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPVX
Symptoms: Deafness, Loss of consciousness
Clinical narrative: She got her shot at 2:45 pm and the nurse left the room, at 2:26 pm. She was dizzy, she could not hear/see.  She fell over onto me having a seizure at 2:48pm I screamed for a nurse immediately the lady who gave the shot came in and seen it and then a Dr entered the room as she came too.  Dr asked what happend and lady who gave shot said looked like a seizure to her I said it looked like it to me at this point my daughter is holding her ears saying all she cant hear or see that led to her ears buzzing. And a rash starting in her armpit shoulder area. Dr checked eyes, ears, thoat and heart rate.  She said we cant go anywhere for 15 minutes and recommened ER by EMS I didnt want to wait longer than I had to and said I'd drive her it wasn't far from medical office we were at and she agreed that would be fine since I had a 3rd person there to drive.  We went to ER where I explained what happened and gave note from Dr office, they gave her steroids, fluids ext where the ER Dr came to conclusion of severe allergic reaction I told him she got dizzy and couldn't see or hear on first 2 doses and they said it was normal and he said that was allergic reactions and is no way normal that she should not have got 2nd one at that point.  He said now she has to always have an epinephrine pen which he prescribed with more steroids.  She is terrified of needles now and been crying and fidgety most the night.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator and refers to five unspecified patients (gender and age unknown). No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unspecified dates, five injectable doses of M-M-R II, that were exposed to light varying from 1 to 6 hours (Incorrect product storage) (strength, dose, frequency, route of administration, anatomical location,  lot # and expiration date were not reported), were administrated to five unspecified patients for prophylaxis. No adverse symptoms were reported. Additional information has been requested.
Age: 0.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an 8 day old patient (gender unknown). No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 13-MAR-2017, the patient was vaccinated with an expired dose of injectable RECOMBIVAX HB (Lot # K018180 and expiration date 17-SEP-2016) for prophylaxis (dose, frequency, route of administration and anatomical location were not reported) (product use issue). There were no adverse effects reported. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient (gender and age unknown). No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 14-MAR-2017, the patient was vaccinated with an expired dose of injectable PNEUMOVAX23 (Lot # L017406 and expiration date 26-FEB-2017) intramuscularly for prophylaxis (dose, frequency and anatomical location were not reported) (product use issue). There were no known adverse effects.  Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: PPV, VARCEL
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a 2-year-old male patient. The patient's concurrent conditions, medical history, known allergies and concomitant therapies were not reported. On 13-MAR-2017, the patient received a dose of VARIVAX injection (dose, lot# and expiration date were not reported). In the night of 13-MAR-2017, the patient developed a red rash at the injection site which was warm to the touch. The patient was taken by the mother to the emergency room. The patient was prescribed diphenhydramine hydrochloride (BENADRYL) to be used every four to six hours and prednisone (manufacturer unknown). At the four or six hours, the rash reappeared after having gone away. The patient's outcome was reported as not recovered. The causality between adverse events and VARIVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored ROTATEQ (lot # M033338 expiration date: 15-APR-2018) orally, for prophylaxis. The vaccines were exposed to 32 degrees F to 35 degrees F (0 degrees C to 1 degrees C) and the cumulative time was 32 hours. A data logger was used. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA007407: US-009507513-1703USA007408: US-009507513-1703USA007409.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored VAQTA (lot # M039202 expiration date: 11-MAR-2018) for prophylaxis. The vaccines were exposed to 32 degrees F to 35 degrees F (0 degrees C to 1 degrees C) and the cumulative time was 32 hours. A data logger was used. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA007407: US-009507513-1703USA007408: US-009507513-1703USA007409.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to multiple unspecified patients of unknown age and gender.  Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored RECOMBIVAX HB (lot # M042322 expiration date: 21-FEB-2019; lot # M039642 expiration date: 03-JUL-2019) for prophylaxis. The vaccines were exposed to 32 degrees F to 35  degrees F (0 degrees C to 1 degrees C) and the cumulative time was 32 hours. A data logger was used. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007407: US-009507513-1703USA007389: US-009507513-1703USA007408:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, referring to patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 13-MAR-2017, the patient was vaccinated with improperly stored dose VARIVAX which had Lot number  M033905 with expiry date on 20-JUL-2018 (strength and route were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccine was exposed to a temperature as follows: >14 Fahrenheit grade but < 46 Fahrenheit grade for 40 minutes; >14 Fahrenheit grade but < 46 Fahrenheit grade for 40 minutes; >14 Fahrenheit grade but < 46 Fahrenheit grade for 50 minutes and had a previous excursion recorded by a data logger of >14 Fahrenheit grade but < 46 Fahrenheit grade for "5.3 hours" and >14 Fahrenheit grade but < 46 Fahrenheit grade for 50 minutes. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA008242: US-009507513-1703USA008243: US-009507513-1703USA008236.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, referring to patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 13-MAR-2017, the patient was vaccinated with improperly stored dose VARIVAX which had Lot number M033905 with expiry date on 20-JUL-2018 (strength and route were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccine was exposed to a temperature as follows: >14 Fahrenheit grade but < 46 Fahrenheit grade for 40 minutes; >14 Fahrenheit grade but < 46 Fahrenheit grade for 40 minutes; >14 Fahrenheit grade but < 46 Fahrenheit grade for 50 minutes and had a previous excursion recorded by a data logger of >14 Fahrenheit grade  but < 46 Fahrenheit grade for "5.3 hours" and >14 Fahrenheit grade but < 46 Fahrenheit grade for 50 minutes. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA008241: US-009507513-1703USA008243: US-009507513-1703USA008236.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Pruritus, Rash
Clinical narrative: This spontaneous report was received from the patient's wife referring to a 71 year old male patient. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. Concomitant medications included an unspecified medication for prevention of diabetes. On 13-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX one time injection, for prevention of shingles (route, lot # and expiration date were not reported). On an unspecified date in November 2012, the patient experienced an itch and a rash. It was stated that the patient sought medical attention and an unspecified treatment was given for the adverse events. Also it was reported that an unspecified blood test was performed (no results reported). The reporter stated that the unspecified diabetes prevention medication that the patient was using at the same time had some indication of similar side effects, but that he was taken off of it early on. At the time of reporting the outcome of the events was reported as not recovered. A product quality complaint was not involved. The causality assessment between the events and ZOSTAVAX was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Chills, Herpes zoster, Hyperaesthesia, Pyrexia
Clinical narrative: This spontaneous report was received from the daughter of a 69 year old female patient. Weight was 170 pounds and height was 61 inches.  The patient had no pertinent medical history and no known allergies.  Concomitant medications included PERCOCET and valacyclovir. On an unspecified date "years ago", the patient received ZOSTAVAX to prevent shingles (route and lot # not provided). The daughter reported that her mother was taken to the Emergency Room (ER) on 22-MAR-2017 because she got the shingles. The patient had a big rash on the waist and had sharp pain in her lower spine inside her body. She also reported her mother has a respiratory infection, chills, fever and sensitive skin. She received treatment for the adverse events. When asked if lab/diagnostic studies were performed, the daughter stated "yes, blood test every year". The outcome of the events was not resolved. The daughter did not provide causality. She stated she was going to reach out to her attorney to take legal action since her mother got the shingles after getting the vaccine. Additional information is not expected as the daughter did not provide consent to contact her mother's physician.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Respiratory tract infection, Spinal pain
Clinical narrative: This spontaneous report was received from the daughter of a 69 year old female patient. Weight was 170 pounds and height was 61 inches.  The patient had no pertinent medical history and no known allergies.  Concomitant medications included PERCOCET and valacyclovir. On an unspecified date "years ago", the patient received ZOSTAVAX to prevent shingles (route and lot # not provided). The daughter reported that her mother was taken to the Emergency Room (ER) on 22-MAR-2017 because she got the shingles. The patient had a big rash on the waist and had sharp pain in her lower spine inside her body. She also reported her mother has a respiratory infection, chills, fever and sensitive skin. She received treatment for the adverse events. When asked if lab/diagnostic studies were performed, the daughter stated "yes, blood test every year". The outcome of the events was not resolved. The daughter did not provide causality. She stated she was going to reach out to her attorney to take legal action since her mother got the shingles after getting the vaccine. Additional information is not expected as the daughter did not provide consent to contact her mother's physician.
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at 0.5 ml, single on an unspecified date for immunization (protection against pneumococcal pneumonia). The patient medical history and concomitant medications were not reported. A couple of years before this report, the patient experienced a very swollen arm due to vaccination with Prevnar 13. She went to the doctor and the swelling went down and swelling resolved.
Sex: F
Vaccine: MENB
Symptoms: Erythema
Clinical narrative: This is a spontaneous report from a contactable nurse practitioner received via a sales representative. A 18-year-old female patient received the first single dose of TRUMENBA (lot R56652) on an unspecified date, in left deltoid, for immunisation. The patient medical history included sensitive skin. Concomitant medications were not reported. The patient experienced red all the way down her arms after getting the injection on an unspecified date, about 3 days after vaccination, with unknown outcome.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Alopecia, Autoimmune disorder, Cold urticaria, Dermatitis, Oral discomfort
Clinical narrative: Large bald spot on head by hairline appeared, hair has not regrown, diagnosed as Alopecia. Generalised urticaria when cold outside, perioral dermatitis, dermatitis on arm that comes and goes, burning sensation on lips when eating eggs. The alopecia and dermatitis we noticed after about a month. The urticaria we noticed in the early winter when the cold weather came, maybe November 2016. All these symptoms have been diagnosed by a dermatologist February 15, 2017.  Dr Dermatology, Dr said there are few treatments for these conditions/autoimmune disorders.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Large bald spot on head by hairline appeared, hair has not regrown, diagnosed as Alopecia. Generalised urticaria when cold outside, perioral dermatitis, dermatitis on arm that comes and goes, burning sensation on lips when eating eggs. The alopecia and dermatitis we noticed after about a month. The urticaria we noticed in the early winter when the cold weather came, maybe November 2016. All these symptoms have been diagnosed by a dermatologist February 15, 2017.  Dr Dermatology, Dr said there are few treatments for these conditions/autoimmune disorders.
Age: 0.58
Sex: F
Vaccine: DTAPH, HEP
Symptoms: Breath holding, Decreased appetite, Dyskinesia, Fall, Injection site irritation
Clinical narrative: Jerking. Muscle Spasms. Falling over. Briefly holding breath while tense. Swelling of injection site. Irritated injection site. Fussy behavior. Loss of appetite.
Age: 0.58
Sex: F
Vaccine: DTAPH, HEP
Symptoms: Injection site swelling, Irritability, Muscle spasms, Neurological examination, Tension
Clinical narrative: Jerking. Muscle Spasms. Falling over. Briefly holding breath while tense. Swelling of injection site. Irritated injection site. Fussy behavior. Loss of appetite.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac failure, Guillain-Barre syndrome, Paralysis, Pneumothorax
Clinical narrative: Lungs collapsed - heart failure complete paralysis.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Balance disorder, Cellulitis, Erythema, Headache, Hypersensitivity
Clinical narrative: Ct. called to inform Health Dept that she had an allergic reaction after PPSV23 vaccine on 3-1-17, her left arm was sore, swollen and redden. It was hot to touch. Applied ice. On 3-2-17 c/o headache and felt off balance. Walked into her Dr. office. Dr. who examined and gave her a shot which she thinks it was an antibiotic but not sure. Was started on KEFLEX q 6 hours PO. 3/3/17 gotten worse and increased was swollen down to the elbow. She was a direct admit to hospital. Treated for cellulitis. Started on IV vancomycin which she had an allergic reaction with hives and itchiness. Switch to KEFLEX IV. Discharged on 3/5/17.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Ct. called to inform Health Dept that she had an allergic reaction after PPSV23 vaccine on 3-1-17, her left arm was sore, swollen and redden. It was hot to touch. Applied ice. On 3-2-17 c/o headache and felt off balance. Walked into her Dr. office. Dr. who examined and gave her a shot which she thinks it was an antibiotic but not sure. Was started on KEFLEX q 6 hours PO. 3/3/17 gotten worse and increased was swollen down to the elbow. She was a direct admit to hospital. Treated for cellulitis. Started on IV vancomycin which she had an allergic reaction with hives and itchiness. Switch to KEFLEX IV. Discharged on 3/5/17.
Age: 1.33
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Regressive behaviour, Screaming, Speech disorder developmental
Clinical narrative: Within a month of his vaccines, patient quit trying to talk.  Beforehand, he was saying words like "No" when he didn't want something.  He would say "bye bye", "hi" "Mama" "Dada".  After his vaccines, within a month, we noticed he stopped saying most words.  We noticed this especially because he started screaming instead of trying to talk.  This loud high pitched screaming was the only way he would communicate with us.  This lasted until around age 2 1/2.  His doctor was concerned at his 2 year checkup.  Patient could understand what we were saying, he could follow simple directions, but he could not speak for himself.  His doctor believed at his 2 year checkup that he had a speech delay.  There were no other symptoms, as patient was healthy and thriving in every other aspect.  We were told by Dr. to contact a speech therapist, but instead, we worked with him at home.  As of now, he is 3 1/2 and finally speaking.  He started speaking at 3 years old and has slowly progresses since.  Once he starts preschool this fall, I believe he will need speech therapy, as he is still very difficult to understand.  We have not gone back to the doctor since his 2 year appointment.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Seizure
Clinical narrative: Patient had a fever of 103 and generalized seizure lasting less than 15 minutes, unknown exact time.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M012495, expiration date: 09-OCT-2017; dose and route were not provided). The vaccine was exposed to a temperature of 34 degrees Fahrenheit  for total cumulative time frame of 8 hours. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received on 09-MAR-2017 from a female medical assistant (MA), referring to a female patient of unknown age.  The patient's pertinent medical history, concomitant medications and drug allergies were not reported. The medical assistant reported that on an unknown date, the patient was administered a dose of improperly stored VARIVAX (Lot number M024702, expiration date 18-MAY-2018).  The strength, site and route of VARIVAX administration were not reported. The VARIVAX was exposed to temperature: 6 degrees F (Fahrenheit) to 14 degrees F (Fahrenheit) for a time frame of 13 hours.  There was no previous temperature excursion reported. The call was not because of a data logger. No adverse effect reported. There was no product quality complaint involved. On 09-MAR-2017, it was further specified by the medical assistant (primary reporter), that the doses (as reported), which were reported to have been administered to the patient in this case, were exposed to 15 hours in the 6 degrees F (Fahrenheit) to 14 degrees F (Fahrenheit), rather than the 13 hours she originally reported. No additional information was reported. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Colitis ulcerative
Clinical narrative: This spontaneous report was received from the patient's mother via a company representative and refers to a 13-year-old son. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of M-M-R II injection, intramuscularly (IM) (strength dose, frequency, anatomical location, lot number, and expiration date were not provided) for prophylaxis. On an unknown date reported as "one week after" the vaccination, the patient experienced ulcerative colitis. However,  it was reported that the patient continued the therapy. At the reporting time, it was unknown whether the patient recovered from the event of ulcerative colitis. The causal relationship between the therapy with M-M-R II and the event of ulcerative colitis was not provided. There was no product quality complaint involved. Upon internal review, the event of ulcerative colitis was considered to be medically significant. Additional information is not expected as there was no information to contact the physician.