chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site pain, Injection site swelling, Malaise
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of allergic reaction in a 17-year-old female patient who received BEXSERO (batch number 157501, expiry date 31st August 2017. The patient's past medical history included attention deficit/hyperactivity disorder (experienced in July 2014). Concomitant products included amfetamine aspartate + amfetamine sulfate + dexamfetamine sulfate +dexotroamphetamine saccharate (ADDERALL) and ethinyloestradiol + levonorgestrel (SEASONIQUE). On 20th July 2016, the patient received the 1st dose of BEXSERO .5 ml. In July 2016, less than a week after receiving BEXSERO, the patient experienced injection site swelling. On 20th July 2016, the patient experienced allergic reaction, injection site lump, injection sit induration, injection site pain, injection site warmth. On an unknown date, the outcome of the allergic reaction, injection site warmth and injection site swelling were unknown and the outcome of the injection site lump and injection site duration were not recovered/not resolved and the outcome of the injection site pain was recovering/resolving. The reporter considered the allergic reaction, injection site lump, injection site induration, injection site pain, injection site warmth and injection site swelling to be related to BEXSERO. Additional details were provided as follows: This case was not previously reported to anyone. The patient experienced an allergic reaction at the injection site (left deltoid) including a hard knot that was painful and sore, hot to touch and looked similar to a shoulder pad. In the night, several hours after the vaccination, the patient started to feel pain then the swelling started. At the time of reporting, pain was not as bad but hard knot was still huge.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Site of shot in left arm and one hour after receiving the shot she has had moderate/severe pain in shoulder and left arm.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest pain, Dyspnoea
Clinical narrative: MPC following SPV. Pain, chest NEC, Shortness of breath.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Enema administration, Haematochezia, Hypophagia, Intussusception, Irritability
Clinical narrative: Decreased feedings, stiffening up, blood in stool, fussy, vomiting. Went to ER initially, transferred to hospital. Diagnosis of Intussusception. Therapeutic enema x 3 attempts, surgical intervention required to reduce intussusception.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Musculoskeletal stiffness, Surgery, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Decreased feedings, stiffening up, blood in stool, fussy, vomiting. Went to ER initially, transferred to hospital. Diagnosis of Intussusception. Therapeutic enema x 3 attempts, surgical intervention required to reduce intussusception.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Incorrect product storage
Clinical narrative: Pt received IDV, DTAP and MMRII on 7/22/16 frig temp were out of range. 33 degrees being the low. According to S.P. IPV was not stable. Pt will get IPV in Sept 2016 with Flu.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Chills, Headache, Nausea
Clinical narrative: Pt felt suddenly weak, chills, headache, nausea.  Unable to function for about 2 hrs and then symptoms suddenly subsided.  No residual symptoms noted.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Incorrect product storage
Clinical narrative: There was a frig temp discrepancy. VFC frig's min. went down to 31. No illness or injury. Pt does need to be revaccinated. Appt 8/15/16.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain in extremity, Skin warm
Clinical narrative: Pain, redness Left arm axilla to elbow proximally - with redness, warmth - approx (L) 6 in (W) 3 in,  increasing in size appears as cellulitis, Advised f/u with ED if symptoms increase.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Body temperature increased, Full blood count, Iron deficiency anaemia, White blood cell count normal
Clinical narrative: 7/29/16 Mother called the office in am w/concerns about possible side effects from vaccine. T=102.4 and started the evening prior. Mother was told to give ADVIL and reassured. She called back and T=105.8 at 2 pm. She came in for eval. Exam was benign. CBC done. WBC normal - incidental finding of Fe def. anemia.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The pertinent medical history and concomitant therapy was not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # L043213, expiration date: 28-AUG-2017; lot # M004116, expiration date: 12-OCT-2017) (dose and route unspecified). This is one of sever reports received from the same source. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Sciatica, Therapeutic response unexpected
Clinical narrative: This spontaneous report was received from a physician assistant, a 63 year old male patient reporting on himself. The patient's concurrent condition included sciatic nerve pain since a year. The patient did not had any drug reactions/allergies. On approximately 26-MAY-2015 (reported as began 6 weeks ago), the patient began to experience "sciatic nerve pain" which he was experiencing now. On 29-JUN-2016, the patient was vaccinated with ZOSTAVAX 19400 plague forming unit (PFU), (dose, lot # and expiration date unknown) subcutaneously in the left upper arm. There was no concomitant medication. In approximately 2016, the patient's sciatic nerve pain had improved after receiving ZOSTAVAX (Therapeutic response unexpected). On approximately 05-JUL-2016 (reported as two days ago), the patient's sciatic  nerve pain became worse after standing on his feet for nine hours. No laboratory tests were performed. The patient did not sought medical attention from his physician and was taking over the counter ibuprofen, naproxen and was also using heat. The outcome of the events was unknown. Causality was not provided by the reporter. Additional information is not expected as consent to contact was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as medical assistant) refers to a patient of unknown age. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with one dose of improperly stored ZOSTAVAX 9400 PFU (dosing details were not reported) (lot # M010472, expiry date 01-JUN-2017) which was stored at a temperature of -6.6 degree centigrade for 1 hour and 32 minutes, previous excursion of a max of -6.6 degree centigrade for 8 hours and 51 minutes and a max of -9.5 degree centigrade for 23 hours and 55 minutes. Data logger was reported as no (frig tag 2 in use). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In approximately 2016 (since 08-FEB-2016), the patients were vaccinated with improperly stored doses of LIQUID PEXVAXHIB (lot # L042257, expiration date 17-AUG-2018; lot # L042259, expiration date 18-AUG-2018; lot # L051123, expiration date 13-OCT-2018; lot # reported as M001811, expiration date 11-APR-2018 (dose and route of administration were not reported). There was no effect reported. Administered doses of vaccine experienced the temperature excursion of 9 degrees Celsius for 9 hours, 0.3 degree Celsius for 837 hours and 30 degrees Fahrenheit for 542 hours. Data logger was involved. There was no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-JUN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M004116, expiration date 12-OCT-2017 (dose and route of administration were not reported) in the immunization series. There was no adverse effects reported. Administered dose of vaccine, in the worst case, experienced the temperature excursion of 31.1 degrees Fahrenheit for 8 days 3 hours 15 minutes (cumulative excursion). Data logger was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates since 27-JUL-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L037554, expiration date 25-DEC-2017 (dose and route of administration were not reported). There was no adverse effect reported. The outcome was reported as supported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. In approximately 2016, (since 08-FEB-2016), the patients were vaccinated with improperly stored doses of ROTATEQ lot # L027067, expiration date 06-APR-2017; lot # L029617, expiration date 19-MAY-2017; lot L027076, expiration date 25-MAY-2017; lot # L033545, expiration date 30-MAY-2017; lot # M004508, expiration date 29-JUN-2017; lot # M014318, expiration date 30-SEP-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 9 degrees Celsius for 9 hours, 0.3 degrees Celsius for 837 hours and 30 degrees Fahrenheit for 542 hours. This is one of several reports received from the same reporter. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In approximately 2016 (since 08-FEB-2016), the patients were vaccinated with improperly stored doses of VARIVAX (lot # L040421, expiration date 15-OCT-2017; lot # 043624, expiration date 03-NOV-2017; lot # L049532, expiration date 08-DEC-2017; lot # M002063, expiration date 12-JAN-2018; lot # M006156, expiration date 05-FEB-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of -13 degrees Celsius for 65 hours. Data logger was involved. There were no previous  excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist who was called by an unspecified physician's office refers to a patient of  unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date in 2016, the patient was vaccinated with an expired dose of ZOSTAVAX 19400 plague forming units (PFU) injection, subcutaneously, expiry date 25-MAY-2016 (dose, lot # and anatomical location were not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided.  In approximately 2016 (since 08-FEB-2016), the patients were vaccinated with improperly stored doses of M-M-R II (lot # L020189, expiration date 03-JUN-2017; lot # L026551, expiration date 16-JUL-2017, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 9 degree Celsius for 9 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse (medical assistant) via company representative refers to a 30 year old female patient. with Crohn's disease. It was unknown if the patient had any allergies or drug reactions. On 25-JUL-2016, the patient was vaccinated with one unspecified dose of ZOSTAVAX. Concomitant therapies included HUMIRA (also reported as HUMARA), REMICADE and METHOTREXATE. The patient was vaccinated at age of 30 years old. NO treatment was given for adverse event. Lab diagnostic studies were not performed. The patient did not seek medical attention. The patient current status was unknown. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Cranial nerve disorder, Electroencephalogram, Encephalitis
Clinical narrative: 2013-2016 (present) multiple Cranial Neuropathies, Encephalitis, Encephalomyelitis, Parsonage-Turner syndrome, Headaches (chronic).
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Encephalomyelitis, Headache, Lumbar puncture, Neuralgic amyotrophy, Nuclear magnetic resonance imaging
Clinical narrative: 2013-2016 (present) multiple Cranial Neuropathies, Encephalitis, Encephalomyelitis, Parsonage-Turner syndrome, Headaches (chronic).
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In approximately 2016 (since 08-FEB-2016), the patients were vaccinated with improperly stored doses of VAQTA (lot # L045713, expiration date 14-JAN-2017; lot # L023936, expiration date 15-MAR-2017; lot # M009377, expiration date 17-JUN-2017; lot # L015460, expiration date 20-JUL-2017; lot # M017982, expiration date 13-SEP-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 9 degrees Celsius for 9 hours, 0.3 degrees Celsius for 837 hours and 30 degrees Fahrenheit for 542 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In approximately 2016 (since 08-FEB-2016), the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L019297, expiration date 18-AUG-2017; lot # L043214, expiration date 30-AUG-2017; lot # M003659, expiration date 20-SEP-2017; lot # M005714, expiration date 03-OCT-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered does of vaccine experienced the temperature excursion of 9 degrees Celsius for 9 hours, 0.3 degrees Celsius for 837 hours and 30 degrees Fahrenheit for 542 hours. This is one of several reports received 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 as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. In approximately 2016 (since 08-FEB-2016), the patients were vaccinated with improperly stored doses of PROQUAD lot # L039269, expiration date 05-APR-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of -13 degrees Celsius for 65 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. 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 assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L018351, expiration date: 11-AUG-2017, lot # reported as L037554, expiration date: 25-DEC-2017, lot # reported as M011840, expiration date 01-FEB-2018, intramuscularly (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9.4 degrees Celsius for 1 hour 17 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a 19-year-old female patient who received BEXSERO. On 14th July 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. In July 2016, less than a month after receiving BEXSERO, the patient experienced pain in arm (serious criteria disability) and mobility decreased (serious criteria disability). On an unknown date, the outcome of the pain in arm and mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and mobility decreased to be related to BEXSERO. Additional details were received as follows: The reporter stated to the sales representative that the patient had no issues with previous vaccines. The injection site for BEXSERO was unknown. The patient experienced arm pain and it was hard for the patient to move her arm. Limited information was provided by the sales representative from the physician. The date of onset of the event was unknown.
Age: 12.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Head injury, Loss of consciousness, Scratch
Clinical narrative: Patient  walked about 30 feet away from where vaccines were given and passed out, hitting his head on the wall and scuffing his left knee.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Injection site urticaria, Lip swelling
Clinical narrative: Pt reports hives developed on her left upper arm and trunk,reports upper lip became swollen. Reports taking 1 Benadryl pill and symptoms subsided. Reports hives returned 7/31/16 afternoon. Pt again took 1 dose of Benadryl. Symptoms subsided and have not returned. Denies shortness of breath, syncope, or other symptom.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Throat irritation, Throat tightness
Clinical narrative: Patient stated about five minutes after vaccine that her throat was itchy and tight. Gave patient 50 mg of diphenhydramine. About 5 minutes later, patient stated she was feeling better and left pharmacy.
Age: 14.0
Sex: F
Vaccine: HEP, HEPA, HPV4
Symptoms: Glucose urine absent, Syncope, Urine analysis normal
Clinical narrative: Apparent faint after third vaccine (while standing after no breakfast).
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Erythema, induration, tenderness at vaccine site.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Rash pruritic
Clinical narrative: Itch rash on face, back and arms.
Age: 54.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Benign prostatic hyperplasia, Blood urine present, Chills, Diarrhoea, Dysuria
Clinical narrative: Fever and chills, nausea.  On 03/15/2015 - symptoms continued and worsened, diarhea began.  Took aspirin.  Drank gatorade.  Blood in urine began along with great difficulty in urination.  Onset of UTI.  03/16/2015 - fever broke, continued with aspirin, began taking OTC drug AZO whcih began to aid in the UTI relief after some time.  03/17/2015 - Able to get to URgent Care facility to be seen by Dr.   Urine Test indicated UTI.  Prescribed Doxycycline.  03/20/2015 - Dr.  confirmed UTI, continued on Doxy.  Also discovered BPH.  This may have been aggrevated by vaccines and UTI.  Dr. did not have an answer as to how I contraced UTI.  Gave me the go-ahead for out of country trip.  Doxy was able to keep the UTI at bay but not knock it out.  After returning, another urologist put me on Cipro which did get rid of the UTI.  Also put on Tamsulosin.  Dr.
Age: 54.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Nausea, Pyrexia, Urinary tract infection
Clinical narrative: Fever and chills, nausea.  On 03/15/2015 - symptoms continued and worsened, diarhea began.  Took aspirin.  Drank gatorade.  Blood in urine began along with great difficulty in urination.  Onset of UTI.  03/16/2015 - fever broke, continued with aspirin, began taking OTC drug AZO whcih began to aid in the UTI relief after some time.  03/17/2015 - Able to get to URgent Care facility to be seen by Dr.   Urine Test indicated UTI.  Prescribed Doxycycline.  03/20/2015 - Dr.  confirmed UTI, continued on Doxy.  Also discovered BPH.  This may have been aggrevated by vaccines and UTI.  Dr. did not have an answer as to how I contraced UTI.  Gave me the go-ahead for out of country trip.  Doxy was able to keep the UTI at bay but not knock it out.  After returning, another urologist put me on Cipro which did get rid of the UTI.  Also put on Tamsulosin.  Dr.
Age: 57.0
Sex: F
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Blood test, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in both feet.
Age: 57.0
Sex: F
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Autoimmune disorder, Hypoaesthesia, Inflammation, Laboratory test, Nuclear magnetic resonance imaging
Clinical narrative: Numbness and tingling in both feet.
Age: 57.0
Sex: F
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Paraesthesia
Clinical narrative: Numbness and tingling in both feet.
Age: 57.0
Sex: F
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Autoimmune disorder, Hypoaesthesia, Laboratory test, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Numbness and tingling in both feet.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Burning sensation, Chills, Lymph node pain, Lymphadenopathy
Clinical narrative: Pain and swelling in arm, lymph glands in armpit swollen and sore, raised, burning red rash down arm, nausea, fever up to 102, chills, weakness, sore throat, difficult to stay awake. Lasted 5 days. Took Phenergan for nausea, Advil for fever and pain, and started taking Benadryl for rash on Day 4. Rash still visible on Day 7. Slight burning sensation continues Day 7.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Oropharyngeal pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Pain and swelling in arm, lymph glands in armpit swollen and sore, raised, burning red rash down arm, nausea, fever up to 102, chills, weakness, sore throat, difficult to stay awake. Lasted 5 days. Took Phenergan for nausea, Advil for fever and pain, and started taking Benadryl for rash on Day 4. Rash still visible on Day 7. Slight burning sensation continues Day 7.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Somnolence
Clinical narrative: Pain and swelling in arm, lymph glands in armpit swollen and sore, raised, burning red rash down arm, nausea, fever up to 102, chills, weakness, sore throat, difficult to stay awake. Lasted 5 days. Took Phenergan for nausea, Advil for fever and pain, and started taking Benadryl for rash on Day 4. Rash still visible on Day 7. Slight burning sensation continues Day 7.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, the patients' were vaccinated with improperly stored LIQUID PEDVAXHIB (dose, strength, route, frequency, lot # and indication unknown) (incorrect product storage). The vaccine was exposed to a high of 9.5 degree Celsius temperature for a time frame of 24 hours. No adverse events were reported. Data logger was involved. It was reported that there was no previous temperature excursion. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown dates, the patients' were vaccinated with improperly stored VAQTA (dose, strength, route, frequency, lot # and indication unknown) (incorrect product storage). The vaccine was exposed to high of 9.5 degree Celsius temperature for a time frame of 24 hours. No adverse events were reported. Data logger was involved. It was reported that there was no previous temperature excursion. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of VARIVAX (subcutaneously, lot # L040422, expiration date 15-OCT-2017; dose was not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The pertinent medical history and concomitant therapy were not reported. On an unknown date, the patients were vaccinated with doses of improperly stored GARDASIL (lot # K010215, expiration date: 05-MAY-2017; lot # L035105, expiration date: 04-MAY-2017, lot # L040460, expiration date: 27-MAY-2017 (dose and route unspecified). This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: REDNESS, SORE AND SWELLING AT INJECTION SITE. WOKE UP THE NEXT MORNING TO ARM SWOLLEN ABOUT THE SIZE OF A BASEBALL.
Age: 33.0
Sex: M
Vaccine: MNQ
Symptoms: Fatigue, Headache, Loss of consciousness, Pyrexia
Clinical narrative: Tired at midnight, passed out at 3am on trip to bathroom, headache at 6am, still a little feverish at 10am.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Malaise
Clinical narrative: Fatigue, lack of appetite, general malaise. No site reaction.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a physician via a company representative referring to a male patient of unknown age. Information regarding concomitant medication, medical history and drug reactions/allergies were unknown. On an unknown date in 2014 (reported as 2 years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date and dose were unknown; one time injection; subcutaneous). On an unknown date, the patient showed up with a shingles rash around C2 neck area on left side but no complaints of pain. The patient sought medical attention. No treatment was given for the event. It was unknown if lab diagnostics studies were performed. The outcome of the event was reported as recovering. The causality was not reported. Additional information is not expected as the physician doesn't want to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 27-JUL-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # L012476, expiration date 10-JUL-2016) subcutaneously (strength, dosing details, anatomical location were unknown) (expired product administered). No adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from other health professional (Medical Assistant) refers to multiple unspecified patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates since January 2016 (Onset approximated to 2016), the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (batch/lot# K011562 with an expiry date 18-AUG-2017, lot # K026247 with an expiry date 29-JAN-2017) (doses and frequencies unspecified) intramuscularly. No adverse effects were reported. It was reported that vaccines were not discontinued. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from other health professional (Medical Assistant) refers to multiple unspecified patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates since January 2016 (Onset approximated to 2016), the patients were vaccinated with improperly stored doses of ROTATEQ VIAL (lot # K011948 with an expiry date 07-JUN-2016, lot # L013197 with an expiry date 29-JAN-2016) (doses and frequencies unspecified) intramuscularly. No adverse effects were reported.  It was reported that vaccines were not discontinued. This is one of the several reports received from the same reporter.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from other health professional (Medical Assistant) refers to multiple unspecified patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates since January 2016 (Onset approximated to 2016), the patients were vaccinated with improperly stored doses of GARDASIL injection (lot # K026247 with an expiry date 29-JAN-2017) (doses and frequencies unspecified) intramuscularly. No adverse effects were reported. It was reported that vaccines were not discontinued. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.67
Sex: F
Vaccine: MMR
Symptoms: Measles post vaccine, Morbillivirus test positive, Polymerase chain reaction positive, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a non-pregnant female patient of unknown age. Concomitant medication, pertinent medical history and drug reactions or allergies were unknown by the reporter. On an unknown date, the patient was exposed to measles and subsequently, she was vaccinated with a dose of M-M-R II (dose, lot # and expiration date were not reported) subcutaneously as pot  exposure  prophylaxis. On an unknown date, the patient developed fever and a rash post vaccination with M-M-R II. The patient had polymerase chain reaction (PCR) testing done on an unknown date, post fever and rash, and the patient was positive for measles of an  unknown strain. It was reported that the therapy with M-M-R II was continued. The outcome of the adverse events was unknown. The relatedness between the adverse events and M-M-R II was not reported. Upon internal review, the event of measles were determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates in 2016 (reported as after 20-JUL-2016), the patients were vaccinated with the improperly stored doses of GARDASIL 9 (intramuscularly, lot # reported as L037554, expiration date 25-DEC-2017; dose was not reported). The vaccines had a temperature excursion to 26 F for 90 minutes on 20-JUL-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of improperly stored PNEUMOVAX23 (lot # L033707, expiration date 18-MAY-2017, route unknown). The vaccine had been stored under 50.9 Fahrenheit for 34 minutes. There was no previous exposures. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates in 2016 (reported as after 20-JUL-2016), the patients were vaccinated with the improperly stored doses of ROTATEQ (orally, lot # L029615, expiration date 15-MAY-2017; dose was not reported). The vaccines had a temperature excursion to 26 F for 90 minutes on 20-JUL-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to a patient of unknown age. On 24-JUN-2016, the patient was vaccinated after the temperature excursion with VARIVAX (lot # M000996, expiry date 07-JAN-2018, 0.5 ml, subcutaneous). Temperature was 6 Fahrenheit for 17 hours. No adverse effects were reported. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patient was inadvertently vaccinated with PROQUAD (lot # L046507, expiry date unknown) (dosing regimen and frequency unknown) subcutaneously and VARIVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown) (overdose). No concomitant medications were reported. No adverse effects were reported. The action taken with the suspect therapy was unknown. The outcome of the events was unknown. There was no product quality complaint reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Patient's pertinent medical  history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 27-JUL-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # L012476, expiration date 10-JUL-2016, subcutaneously)(strength, dosing details, anatomical location were unknown)(expired product administered). No adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored VAQTA (lot # M021124, expiration date 02-FEB-2018, route unknown). The vaccine had been stored under 50.9 Fahrenheit for 34 minutes. There was no previous exposures. Digital data logger had been involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (lot # M006708, expiration date 02-JUN-2018, route unknown). The vaccine had been stored under 50.9 Fahrenheit for 34 minutes. There was no previous exposures. Digital data logger had been involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from other health professional (Medical Assistant) refers to multiple unspecified patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates since January 2016 (Onset approximated to 2016), the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # K021444 with an expiry date 17-SEP-2016, lot # L029631 with an expiry date 14-AUG-2017) (doses and frequencies unspecified) intramuscularly. No adverse effects were reported. It was reported that vaccines were not discontinued. This is one of the several reports received from the same reporter.  Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from other health professional (Medical Assistant) refers to multiple unspecified patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates since January 2016 (Onset approximated to 2016), the patients were vaccinated with improperly stored doses of VAQTA (strength 24/0.5 units unspecified) injection (lot # K007791 with an expiry date 22-AUG-2016, lot# K019560 with an expiry date 02-JUN-2017, lot # L007559 with an expiry date 04-NOV-2016)(doses and frequencies unspecified) intramuscularly. No adverse effects were reported. It was reported that vaccines were not discontinued. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 27-JUL-2016, the patient was inadvertently administered an expired VARIVAX (lot # K010339, expiration date 22-JUL-2016, dose and route not reported. No adverse effects wree reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-JUL-2016, the patient was vaccinated with improperly stored dose of GARDASIL (lot # M007764, expiry date: 30-JAN-2018; dose and route not reported). No adverse effects were reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On an unknown date in JAN-2016, the patient was vaccinated with first dose of GARDASIL (strength, dosing details, anatomical location, lot# and expiration date were unknown). On 12-JUL-2016 (also reported as today), the patient received the second dose of GARDASIL (strength, dosing details, anatomical location, lot# and expiration date were unknown). No adverse symptoms reported. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a physician regarding a 4 year old male patient. There was no information about concurrent condition and  historical medication. On 22-MAR-2016, the patient was vaccinated with M-M-R II, .5 ml, subcutaneous in the right thigh. On 20-JUN-2016, the patient was vaccinated with M-M-R II, .5 ml, subcutaneous in the left upper arm (experienced inappropriate schedule of drug administration). Other suspect therapies included KINRIX, 0.5 ml, left thigh, intramuscular. the outcome of event was unknown. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 18 year old male patient. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 11-JUL-2016, the patient was vaccinated with M-M-R II (lot # K008815 and expiration date 19-JUN-2016) subcutaneously (strength, dosing details and anatomical location were unknown). After giving the injection, the reporting nurse later realized that the M-M-R II vaccine had expired on 19-JUN-2016. The reporting nurse stated that, only one injection was given before the expiration of the vaccine was noticed. There has not been any adverse events reported with the patient. No treatment was given for the adverse event. The patient did not sought medical attention for the event. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 14 year old female patient. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown dates, the patient was vaccinated with three doses of GARDASIL (unspecified lot number/expiry date and dosage). On an unspecified date, patient was inadvertently vaccinated with GARDASIL 9 injection as a fourth dose, of GARDASIL vaccination series (unspecified lot number/expiry date and dosage). Additional information is not expected, as there is no consent to contact the reporter.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 18-JAN-2016, patient was vaccinated with first dose of GARDASIL 9 injection (unspecified lot number/expiry date and dosage). On 23-MAR-2016, patient was vaccinated with second dose of GARDASIL 9 injection (unspecified lot number/expiry date and dosage). On 18-JUL-2016, the patient was vaccinated with third dose GARDASIL 9 injection, lot # M004116 (expiry date: 12-OCT-2017) 4 days early (unspecified dosage). All dates of administration were confirmed. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site urticaria, Peripheral swelling
Clinical narrative: Injection site and arm swelling, hives, and redness.
Age: 79.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Urticaria
Clinical narrative: Injection site and arm swelling, hives, and redness.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Dizziness, Facial pain, Fatigue, Flushing
Clinical narrative: Immediately after the shot was administered, I experienced severe muscle pain throughout my whole left arm, I could not touch or move my arm without crippling pain. A few hours after the shot I felt incredibly dizzy and very weak. I felt flushed and experienced a fast heartbeat. That night I woke up to throbbing pain in my face, I looked in the mirror to find out that the left half of my nose had swelled to twice the normal size. Since I have gotten this shot I have experienced headaches and migraines, dizziness and fatigue even until today (almost a week after).