chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via a company representative, referring to a currently 76 year old male patient with hypertension, increased cholesterol, coronary artery disease with coronary artery bypass graft (CABG) and melanoma. On an unknown date, the patient was vaccinated with ZOSTAVAX 19400 plaque forming unit PFU (dose number, dose, rout, lot# and expiration date were not reported) (product use issue). On an unknown date, an unspecified time after receiving ZOSTAVAX, the patient was diagnosed with "shingles". The patient received unspecified treatment. The outcome of "shingles" was not reported. Causality between "shingles" and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of unspecified patients of unknown ages and genders. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date (reported as "starting on or after 20-AUG-2016"), an unknown number of unspecified patients were administered improperly stored doses of PNEUMOVAX 23 (dose and frequency unknown, lot # L031459, expiration date: 30-APR-2017; lot # reported as M022085, expiration date: 19-OCT-2017). The vaccines were stored in 31.5 Fahrenheit degree for 27.5 hours. There was no previous temperature excursion. The call was due to a "data logger". No adverse effect reported. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, IPV, MNQ
Symptoms: Musculoskeletal stiffness, Mydriasis, Unresponsive to stimuli
Clinical narrative: Patient received Hep A and HPV at 1130 am. Patient then went to get labs drawn. Patient returned to clinic and received MENVEO and IPV at 130. 5 min after receiving MENVEO and IPV, patient became very stiff, eyes were dilated and she was not responding verbally when asked questions. Pt was not responsive for about 15 seconds. Her BP was 85/55 HR was 49 and RR was 16. Assessed by MD. Pt stabilized, dc'd home in stable condition.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 65-year-old- patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 12-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # L018503 and expiration date: 16-MAR-2017 )dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 66-year-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions of allergies was provided. On 12-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMVOAX 23 lot # L018503 and expiration date: 16-MAR-2017 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Age: 75.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 75-year-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 21-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # L018503 and expiration date 16-MAR-2017 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Age: 69.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 69-year-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 12-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # L012521 and expiration date 01-FEB-2017 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to 2 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 VARIVAX lot # L017142, expiration date 13-MAY-2017 (exact dose and route of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of -7.1 degrees Celsius (C) for 2 hours 2 minutes on 10-AUG-2016 and -8.1 C for 1 hour 14 minutes on 25-AUG-2016 (cumulative: maximum -7.1 C for 3 hours 16 minutes). There was no prior excursions. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Blood electrolytes normal, Seizure
Clinical narrative: Patient received Hep A #2 and flu injection on 9/7/16, on 9/8/16 patient showed signs of seizure activity. Mom called 911, patient was transported to hospital by ambulance for evaluation.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of GARDASIL 9 (lot # L026602, expiration date 19-OCT-2017; dose and route were not reported). No adverse effects were reported. The vaccines were stored in 33 F for 60 days. The call was made because of the data logger. No previous temperature excursion was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse 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 unknown date, the patient was vaccinated with improperly stored doses ZOSTAVAX lot # M019645, expiration date 18-JUL-2017 (exact dose and route of administration were not reported). No adverse effects were reported. Administered dose of the vaccine experienced the temperature excursion of -7.1 degrees Celsius (C) for 2 hours 2 minutes on 10-AUG-2016 and -8.1 C for 1 hour 14 minutes on 25-AUG-2016 (cumulative: maximum -7.1 C for 3 hours 16 minutes). There was no prior excursions. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
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 a 12-month-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 29-APR-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot #L014429 and expiration date 15-MAR-2018 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 45.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 45 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-MAR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II lot # L007216, expiration date: 03-MAR-2017 (exact dose, route of administration and therapy type were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.33
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 a 4-month-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 17-MAY-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # L014429 and expiration date 15-MAR-2018 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. 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 as received from a physician refers to unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of VAQTA (lot # L015460, expiration date 20-JUL-2017; dose and route were not reported). No adverse effects were reported. The vaccines were stored in 33 F for 60 days. The call was made because of the data logger. No previous temperature excursion was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored PROQUAD (lot # L024122 and expiry date: 30-DEC-2016) and VARIVAX (lot # L005301 and expiry date: 17-FEB-2017; lot M012991 and expiry date 14-MAR-2018; lot # L04865 and expiry date: 02-DEC-2017; lot #M014908 and expiry date; 25-MAR-2018). The vaccines were exposed to 10.8 Fahrenheit (F) for 6 hours, back in the range and data logger was reported as yes. No adverse effects were reported. No product quality complaint was reported for the vaccine. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 03-AUG-2016, the patient was vaccinated with improperly stored dose of M-M-R II lot# L029266 (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 01-AUG-2016 the patient was vaccinated with improperly stored doses of (wistar ra 27-3) M-M-R lot # L029266 (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L044475, expiration date 12-MAY-2017; lot # L026602, expiration date 19-OCT-2017, dose and route not reported). The vaccine was improperly stored in 32.4 degree Fahrenheit for unknown time.. Data logger was involved. There was no previous temperature excursion. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of an unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 07-SEP-2016, the patient was inadvertently vaccinated with an expired dose of (Oka-Merck) PROQUAD lot # L007230 with an expiration date 03-SEP-2016 (dose and route of administration were not reported). No adverse effect was reported. Product quality complaint PPQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 03-AUG-2016 the patient was vaccinated with improperly stored doses of (wistar ra 27-3) M-M-R lot # L029266 (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Age: 1.1
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13-month-old patient of unknown gender. The patient's medical history was not reported. On 29-AUG-2016, the patient was inadvertently vaccinated with an expired dose of (wistar ra 27-3) M-M-R II lot # K011189, expiration date 12-AUG-2016, subcutaneous (therapy type was not reported). Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Computerised tomogram, Laboratory test, Mobility decreased, Tremor
Clinical narrative: 1 1/2 hrs after receiving vaccine Pt. developed chills, shakes, vomiting, then could not move. Ambulance was called pt was taken to hospital was given morphine and spent the night pt had a battery of tests. CT scan, xray, felt better in 24 hours.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting, X-ray
Clinical narrative: 1 1/2 hrs after receiving vaccine Pt. developed chills, shakes, vomiting, then could not move. Ambulance was called pt was taken to hospital was given morphine and spent the night pt had a battery of tests. CT scan, xray, felt better in 24 hours.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Peripheral swelling, Pyrexia, Sleep disorder
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 years old female patient with no pertinent medical history, drug reactions  or allergies. The patient was taking multiple unspecified concomitant medications. On 06-SEP-2016, the patient was intramuscularly vaccinated with PNEUMOVAX 23 (dose was not reported, lot# M024673, expiry date on 17-NOV-2017). On 07-SEP-2016, the patient experienced fever, pain at injection site, swollen arm and could not sleep at night. She could not move the arm because of the pain. The patient was treated for the events with MOTRIN and warm compress. She did not have any laboratory test performed. The patient sought medical  attention via calling the pharmacy. The outcome of the events  was reported as not recovered. Causality assessment was not provided. The reporter considered the events of pain at injection site, could not move the arm and could not sleep at night to be disabling. This is one of two reports received from the same reporter. The cases concerned similar events on the same lot# M024673 of PNEUMOVAX 23. Additional information has been requested.
Age: 1.5
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 an 18-month-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 28-MAR-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # L014429 and expiration date 15-MAR-2018 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.25
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 a 3-month-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 15-APR-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # L014429 and expiration date 15-MAR-2018 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Bacterial test negative, CSF cell count normal, CSF protein increased, CSF red blood cell count positive, Electroencephalogram abnormal
Clinical narrative: Developed an encephalitis - presented as seizure and AMS with diffuse slowing on EEG - culture negative (viral and bacterial) with normal imaging - no cells (few RBCs) and elevated CSF protein - started 2 weeks after vaccine administered.
Age: 13.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Encephalitis, Imaging procedure, Laboratory test, Mental status changes, Seizure
Clinical narrative: Developed an encephalitis - presented as seizure and AMS with diffuse slowing on EEG - culture negative (viral and bacterial) with normal imaging - no cells (few RBCs) and elevated CSF protein - started 2 weeks after vaccine administered.
Age: 13.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Viral test negative
Clinical narrative: Developed an encephalitis - presented as seizure and AMS with diffuse slowing on EEG - culture negative (viral and bacterial) with normal imaging - no cells (few RBCs) and elevated CSF protein - started 2 weeks after vaccine administered.
Age: 4.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories and concomitant therapies were not reported. On unknown dates, the patients received two doses of improperly stored VAQTA (lot # M017982, expiration date: 13-SEP-2017) (dose and route of administration were not provided). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 0.25
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 a 3-month-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 17-MAY-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # L014429 and expiration date 15-MAR-2018 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 3 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-JAN-1997, the patient was vaccinated with a dose of M-M-R II (dose, route of administration, lot # and expiration date were not reported). On 07-SEP-1999, 23 days before his 4th birthday, the patient was inadvertently vaccinated with another dose of M-M-R II. No adverse effects were reported. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Injection site haemorrhage, Ophthalmological examination, Somnolence
Clinical narrative: Major drowsiness following vaccine, I treated it with a nap. Drop of blood at injection site. Treated with a band aid.
Age: 72.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Abdominal discomfort, Feeling of body temperature change, Headache, Pyrexia
Clinical narrative: 4 pm freezing (fever) then hot, upset stomach, headache. Went to ER 2AM. Fever 104.6. Stayed overnight, released next day.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 16 year old patient of unknown gender. On 21-JAN-2016, the patient was vaccinated with an improperly stored dose of the GARDASIL 9 (dose, anatomical location and route of administration were not provided, lot # L016429 with expiration date 09-AUG-2017). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Muscular weakness
Clinical narrative: Complains of muscle weakness of legs bilaterally, onset 6-8 hours after vaccination, symptoms continued. E.R. visits on 8/25 and 9/2/16.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site urticaria
Clinical narrative: Patient developed hive like rash around TDAP injection site Right deltoid.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Throat tightness
Clinical narrative: My throat felt as if it was closing so, I took a BENADRYL at 3:30 am and went back to sleep. Later that morning 9:30 am a rash started on my face and arms. I phoned my doctor who advised me to come in ASAP. He prescribed: "Prednisone and Famotidine" the itching continued for more than 1 weeks, but I have since recovered.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site reaction, Skin lesion, Varicella post vaccine
Clinical narrative: Patient began to get chicken pox lesions down her leg and on her back and arm. Patient complained of itching at the site of the lesions. Lesion onset the day after vaccine given. No s/s of fever.
Age: 80.0
Sex: M
Vaccine: TDAP
Symptoms: Antinuclear antibody negative, Blood creatine phosphokinase normal, Full blood count, Laboratory test, Pain in extremity
Clinical narrative: 4/14/16 called clinic c/o soreness (R) arm. 4/26/16 clinic apt for (R) arm soreness. 6/18/16 physical therapy. 07/13/2016 Right shoulder xray. 07/13/16- Labs. 07/15/16 Labs. 08/04/16 Allergy clinic appt.
Age: 80.0
Sex: M
Vaccine: TDAP
Symptoms: Red blood cell sedimentation rate increased, Rheumatoid factor negative, X-ray limb
Clinical narrative: 4/14/16 called clinic c/o soreness (R) arm. 4/26/16 clinic apt for (R) arm soreness. 6/18/16 physical therapy. 07/13/2016 Right shoulder xray. 07/13/16- Labs. 07/15/16 Labs. 08/04/16 Allergy clinic appt.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus
Clinical narrative: Received Flu immunization at 0900am. At about 0930am employee reported itching and itching  noted on both upper extremities, neck, and (L) side of face. Given BENADRYL 25mg by mouth. Redness also noted to all areas mentioned.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Back pain, Headache, Injection site pain, Injection site swelling, Musculoskeletal pain
Clinical narrative: the day following vaccine administration she reported swelling and pain at injection site, diffuse body aches especially neck, shoulders, and back, as well as headache and low grade fever. Symptoms did improve after 24 hrs.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Neck pain, Pain, Pyrexia
Clinical narrative: the day following vaccine administration she reported swelling and pain at injection site, diffuse body aches especially neck, shoulders, and back, as well as headache and low grade fever. Symptoms did improve after 24 hrs.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Pain, Petechiae, Pruritus, Screaming
Clinical narrative: Patient developed petechial rash around neck and on face within 15 minutes of vaccine administration. He was straining, struggling, and screaming. Mother had her hands on his shoulders and he was scratching at his neck.
Age: 3.0
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV
Symptoms: Injection site movement impairment, Injection site pain
Clinical narrative: She could not walk. Both legs were extremely sore and she had to be carried to the bathroom for the rest of the day. The next day there was still some soreness, but she seemed fine by nightfall.
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Two inches below area of injection to half circumference or arm to past top of shoulder rash/redness.  When patient came tell us this area was decreasing in size from the start.  I contacted the patient today at 9/13/16 for follow through.  He stated he did not contact his doctor put on hydrocortisone cream and the rash completely went away yesterday evening.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Diarrhoea, Dizziness, Fatigue, Nausea
Clinical narrative: Face swelling, dizziness, nausea, vomiting, loose stools, tiredness, weakness.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face, Vomiting
Clinical narrative: Face swelling, dizziness, nausea, vomiting, loose stools, tiredness, weakness.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Facial paralysis, Local swelling, Lymphadenopathy, Pyrexia
Clinical narrative: Right sided lymph node swelling, febrile to 100.8F, significant swelling of right side of neck.  By 9/9 progressed to right sided facial paralysis.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Peripheral swelling, Pruritus, Swelling face, Tenderness
Clinical narrative: Swelling on Left arm, pruritis, 3/10 pain upon palpation, swelling spreading to left side of face.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Peroneal nerve palsy, Sensory loss
Clinical narrative: Loss of feeling in both legs from below knees. 2 minutes. One half hour later same symptoms for 1 minute followed by left foot drop. Two hours later loss of feeling in left ankle with foot drop.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hypersomnia, Irritability, Pyrexia
Clinical narrative: Fussy, sleeping more, fever 101.8.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphonia, Malaise, Speech disorder
Clinical narrative: Hoarse throat/ couldn't talk very well; overall feeling of extreme illness; lasted for 3 full days before I was well again.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Headache, Lumbar puncture
Clinical narrative: Headache, recurrent, intermittent, mildly disabling at times. Addressed by neurology, neurosurgery, endocrinology and psychiatry w/o effect.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Myalgia, Nausea, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Severe pain around diameter of upper right arm, swelling - low grade fever - nausea - muscle aches.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site reaction, Rash erythematous
Clinical narrative: Patient appeared to develop an injection site reaction which progressed to a large red rash. Patient went to ER and is being prophylactically treated for cellulitis with antibiotics.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Presyncope
Clinical narrative: Vasovagal syncope post injection approximately 10 secs. Vital signs taken, patient observed 20 mins.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Vertigo
Clinical narrative: Vertigo 3 days after vaccine, lasting 1-2 days self-resolved.
Age: 93.0
Sex: M
Vaccine: PNC13
Symptoms: Atrial fibrillation, Back pain
Clinical narrative: Slept for six hrs. straight night shot was given. Next 3 nights extreme back pain area of back kidneys. ER on 4th day. Was given NORVASC-result-A-Fib.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Swelling and itching in the left arm at 6 inches below the deltoid area. Patient treated with Ibuprofen 600 mg, ice compress, and BENADRYL since 9/3/16. Spoke w/pt on 9-7-16 and said she is getting better.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Eye irritation, Lacrimation increased, Throat tightness
Clinical narrative: Felt like his throat was closing - eyes watering and burning.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient and mother report that teen broke out in hives approximately 2 hours after receiving vaccine. On torso, face, arms and legs. Very, itchy.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Urticaria
Clinical narrative: Patient and mother report that teen broke out in hives approximately 2 hours after receiving vaccine. On torso, face, arms and legs. Very, itchy.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, hot, pink at injection site painful 5/10 on 0-10/10 pain scale - tx: cool compress, TYLENOL po.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Pt. rec'd DTaP #5 at OV on 9/09/16. Seen on 9/12/16 for redness, edema and warmth at site (RT) arm. Reports s/s began am after vaccine given. Tx with PRN Ibuprofen and BENADRYL. (Note: Pt with Dx vaccine RXN to ? PCV-13 after 2 mo. shots in 2010).
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was administered a (2nd second) dose of AFLURIA. No adverse reaction noted as of today. Patient informal to report any abnormal symptoms. Presented to the office for another vaccine at the time.
Age: 58.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Peripheral swelling, Rash macular, Skin warm
Clinical narrative: (R) arm developed red splotches which are warm to the touch. Arm is swollen.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Breech delivery, Cytogenetic analysis abnormal, Exposure during pregnancy, Metal poisoning, Urine mercury abnormal
Clinical narrative: Received flu vaccine on 10/14/2008 while pregnant. Delivered baby girl (breech). Mother believes her daughter's learning disabilities (autism spectrum, ADHD) are related to mercury in the flu vaccine she received while pregnant. Client states has reports that document both she and daughter were diagnosed with mercury poisoning and client still has mercury in her urine.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Rash
Clinical narrative: Rash to chest and stomach.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Memory impairment
Clinical narrative: Pt. became confused and forgetful approximately 2 days after vaccine. Her daughter took her to hospital where she was admitted for 2 days. She could not remember her daughter's name, for example. Drs were unsure what caused it. She does have liver dysfunction. Her liver doctor asked her if she was exposed to any virus and pt. told him about ZOSTAVAX. He told her that her illness was likely due to exposure to the live vaccine virus.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient called store complaining of redness and itching at injection site.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Cyanosis, Dyspnoea, Wheezing
Clinical narrative: Patient developed difficulty breathing with cyanosis and wheezing within 10 minutes of vaccine. Responded to IM Epinephrine. Transported to ER by ambulance.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Computerised tomogram abdomen abnormal, Intussusception, Small intestine operation
Clinical narrative: Intussusception small bowel. Surgery.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Red swollen area of injection.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Pruritus, Pyrexia, Swelling
Clinical narrative: Soreness, redness, swelling, itching, fever.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Dyskinesia, Fall, Immediate post-injection reaction, Lethargy, Pallor
Clinical narrative: Patient had fainting episode immediately after shots were given. Fell to the floor and jerked for a few seconds. Fell to the floor and jerked for a few seconds. Came to and was pale and lethargic. Vomited one time. Mother took her to the E.R. Has Family History of seizures.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Syncope, Vomiting
Clinical narrative: Patient had fainting episode immediately after shots were given. Fell to the floor and jerked for a few seconds. Fell to the floor and jerked for a few seconds. Came to and was pale and lethargic. Vomited one time. Mother took her to the E.R. Has Family History of seizures.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Pain, Peripheral swelling
Clinical narrative: Patient states that she "Didn't feel right" after few hours after the shot. Woke up next day with a swollen arm, painful to the touch.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient given two FLUZONE High Dose 2016-2017 vaccines, one in each arm. No adverse events reported. No treatment needed.
Sex: U
Vaccine: HEP, RV5
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. Medical history, concomitant therapy and concurrent conditions were not reported. In August 2016 (also reported as 22-AUG-2016 until 30-AUG-2016), the patients were vaccinated with RECOMBIVAX HB (route of administration not reported) and ROTATEQ via oral (Lot number, expiration date, concentration, dose, frequency for both vaccines were not provided), which were improperly stored, this excursion was detected due to a digital data logger. No adverse effect were reported. It was also reported that RECOMBIVAX HB and ROTATEQ were exposed to a temperature of 35 Fahrenheit degrees for 56 hours. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a female consumer (also reported as mother) regarding her husband's coworker daughter of unknown age. The patient's current conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (lot #, expiry date, dose strength, dose number, vaccination site, route not provided). It was reported that, after the vaccination of GARDASIL, the patient began having problems (unspecified adverse event). The outcome of the adverse event was unknown. Causality assessment was not provided. Additional information is not expected since there is no consent for follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pupillary reflex impaired
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a male patient of unknown age. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (dose, dose number, route of administration, injection site, lot number and expiration date were not provided). There were no concomitant medications reported. The pharmacist stated that the unspecified patient was "pulled over by the cops" for an unspecified reason "a couple days after receiving ZOSTAVAX", and upon pulling over, the cops noted that the "pupils would not dilate" in the patient's eyes (date unspecified). The outcome of pupillary reflex impaired was unknown at the time of the report. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified multiple patients of unknown age and gender. The patients' concurrent conditions, pertinent medical history and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L035129, expiration date 14-SEP-2017, lot # M017292, expiration date 07-APR-2018; dose and route were unknown). The vaccines were stored at 7.5 Fahrenheit degree for 2 hours 40 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Immediate post-injection reaction, Injection site discharge, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacy technician regarding a 62 year old female patient. Previously she had cancer. Patient had none drug allergies or reactions. On 25-AUG-2016, the patient was vaccinated with ZOSTAVAX, subcutaneous, lot # M0159826-28-JUN-2017, (reported as vaccine). Concomitant therapies included EVISTA. On 25-AUG-2016, immediately after administration liquid started to come out of the injection site and ran down the patients arm (accidental exposure to product). On an unknown date in August 2016, the patient experienced injection site started itching and swelling. No treatment was given for the adverse event and none laboratory diagnostics were performed. At the time of adverse events the patient was at the office to seek medical attention. No PQC (product quality complaint) was involved. The outcome of the events were unknown. Causality was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 17-DEC-2015, the patient received the first dose of VAQTA 25/0.5 intramuscularly and the second dose was inadvertently given too soon on 20-APR-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. 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 unspecified patients of unknown age and gender. No information on the patients' concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with unspecified doses of improperly stored PROQUAD, lot # L031602, albumin status rHA, expiration date: 18-FEB-2017 and lot # M006106, albumin status rHA, expiration date: 01-AUG-2017 (route of administration was not reported). No adverse reactions were reported. Additional information has been requested.
Age: 69.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 69-year-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 11-MAR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # L012521 and expiration date 01-FEB-2017 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Age: 52.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Patient came in for office visit 8/29/16. It was decided by both patient and provider to receive flu shot and PNEUMOVAX. Patient was advised to have one injection in each arm. Patient repeatedly refused and insisted on both in left arm. Was seen on 9/1/16 for fever and arm edema. Given KEFLEX after phone call to nurse. Pt is fine now.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients (reported as "1 or 2") of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients received doses of improperly stored ROTATEQ (orally, lot# L033694, expiration date: 16-JUN-2017) (dose was not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients (reported as "1 or 2") of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, unspecified number of patients was vaccinated with PNEUMOVAX 23 lot # M018766 with expiration date 15-NOV-2017 (dose and route of administration were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Axillary pain, Chest pain, Injected limb mobility decreased, Injection site pain, Malaise
Clinical narrative: C/o soreness in left arm, most pain in axillary region, did get MENACTRA and HPV #1 in left arm at wcc on Tuesday, no bruising or swelling this arm, no redness around injection site noted. Not feeling well. Initial injection site sore, then c/o chest hurting on that day, didn't want to go to school, then c/o underarm hurting; not red but sore; not using L arm; high tolerance to pain; has takes some ibuprofen the last 2 nights 10 ml both nights.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Pain in extremity
Clinical narrative: C/o soreness in left arm, most pain in axillary region, did get MENACTRA and HPV #1 in left arm at wcc on Tuesday, no bruising or swelling this arm, no redness around injection site noted. Not feeling well. Initial injection site sore, then c/o chest hurting on that day, didn't want to go to school, then c/o underarm hurting; not red but sore; not using L arm; high tolerance to pain; has takes some ibuprofen the last 2 nights 10 ml both nights.
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Seizure like phenomena
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in the summer (year unspecified), the patient was vaccinated with the first dose of GARDASIL (exact dose, lot # and expiration date were not reported) intramuscularly. On an unknown date (reported as sometime after the vaccination), the patient developed seizure like problems. the patient did not return to the doctor's office but, on an unknown date, she had an magnetic resonance imaging (MRI) at another physician's office, which showed other potential causes for the seizures. No product quality complaint (PQC) was reported. the outcome of seizure like problems was unknown. the relatedness between the event and GARDASIL was not reported. Upon internal review, the event of seizure like problems was considered to be medically significant. Additional information is not expected, the reporter did not wish to be contacted.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: This solicited report was received from a 44 year old female patient enrolled in a Market Research Program. The patient's concurrent condition, historical conditions and concomitant medications were not reported. On an unknown date, the patient received pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (also reported as flu shot). Dose, route, lot #, expiration date and anatomical location were not reported. It was reported that after vaccination the patient had an allergic reaction. The patient stated she did not feel comfortable due to the allergic reaction with that last vaccination. The outcome of the event was unknown. At the time of reporting, the causality assessment between the event and the suspect therapy was not reported. Additional information is not expected as the reporter did not consent for further follow up.