chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: MEN
Symptoms: Full blood count normal, Laboratory test normal, Metabolic function test normal, Muscular weakness, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Subjective weakness in legs with inability to ambulate and burning sensation in upper legs and shoulders.
Age: 13.0
Sex: F
Vaccine: MEN
Symptoms: Nuclear magnetic resonance imaging spinal normal, Nuclear magnetic resonance imaging thoracic normal, Red blood cell sedimentation rate normal, Vitamin B12 normal, Vitamin D
Clinical narrative: Subjective weakness in legs with inability to ambulate and burning sensation in upper legs and shoulders.
Age: 12.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Delirium, Fatigue, Pyrexia, Syncope, Urticaria
Clinical narrative: Day 2 Fever and syncope, IV and Benadryl at ER. Day 3 hives and delirium treated with fluids and Benadryl at home. Day 4 fatigue and gradual resolution.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Antisocial behaviour, Aphasia, Autism spectrum disorder, Decreased activity, Developmental delay
Clinical narrative: Fever which passed after a day or two, but over the next few months my son completely stopped speaking, stopped playing with toys typically, stopped interacting with myself or others as he had done before the vaccination. And he stopped reaching typical developmental milestones according to his physician, myself, and others observations.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever which passed after a day or two, but over the next few months my son completely stopped speaking, stopped playing with toys typically, stopped interacting with myself or others as he had done before the vaccination. And he stopped reaching typical developmental milestones according to his physician, myself, and others observations.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain, Muscular weakness, Weight bearing difficulty
Clinical narrative: Extreme pain at injection site and entire upper arm. Weakness in arm. Unable to support weight climbing a ladder.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chest pain, Erythema, Pruritus
Clinical narrative: Redness on L arm, and chest. Itchy on torso. Possible hives interior L arm. Pain in chest and L hip. Patient was admitted to hospital and received a prescription for a steroid. Patient picked up steroid approx. 0800 08/15/2016.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # L038018 with expiration date 13-SEP-201; lot # M006708 with expiration date 02-JUN-2018; lot # M010671 with expiration date 02-JUN-2018, lot # L030581 with expiration date 26-JUN-2017, strength, dose, frequency and route were not reported). No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age. The medical history, concurrent condition and concomitant medications were not reported.  On 01-JUL-2016, the patient was vaccinated with ZOSTAVAX (lot # L046897, 0.65 ml, subcutaneous. On 03-JUL-2016, the patient developed itchiness on both arms and bot legs two days after receiving ZOSTAVAX. No treatment was rendered. The outcome of the event was reported as not recovered/not resolved. The patient sought medical attention on 27-JUL-2016. 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 medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient ws vaccinated with improperly stored dose of ROTSTEQ (which had the lot # M019706, expiry date: 24-OCT-2017)(route, dose and anatomical place of vaccination were not provided). No adverse effects were reported. The vaccine was exposed to temperature of 34.2 Fahrenheit 24 hours and 34.5 Fahrenheit 12 hours. No previous temperature excursion was reported. The temperature excursions were detected by a data logger. No product quality complaint (PQC) involved and no further information provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed vocational nurse (LVN) nurse concerning an unspecified number of unspecified patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not provided. On unspecified dates the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (strength, dose, frequency and route unknown, lot # K026666, expiration date 22-OCT-2017, lot # L044707, expiration date 06-OCT-2018). No adverse event was reported. No product quality complaint (PQC) was involved. 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 a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with improperly stored dose of RECOMBIVAX HB (which had the lot # L039660, expiry date 04-FEB-2018, route, dose and anatomical place of vaccination were not provided). No adverse effects were reported. The vaccine was exposed to temperatures of 34.2 Fahrenheit 24 hours and 34.5 Fahrenheit 12 hours. No previous temperature excursion was reported. The temperature excursions were detected by a data logger. No product quality complaint (PQC) involved and no further information provided.  Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Dyschromatopsia, Visual impairment
Clinical narrative: Information has been received from a nurse via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with one dose of GARDASIL 9 (lot #, expiration date, strength, dose, frequency and route unknown). On an unknown date (after receiving GARDASIL 9), the patient stated that he saw orange out of one eye. The outcome of the event "saw orange out of one eye" was unknown. No product quality complaint (PQC) was involved. The causal relationship between the event and GARDASIL 9 was unknown. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Bruising and tenderness to arm where shot was given. No treatment provided.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with improperly stored dose of M-M-R II (which had the lot # L020188, expiry date: 03-JUN-2017, route, dose and anatomical place of vaccination were not provided). No adverse effects were reported. The vaccine was exposed to temperature of 34.2 Fahrenheit 24 hours and 34.5 Fahrenheit 12 hours. No previous temperature excursion was reported. The temperature excursions were detected by a data logger. No product quality complaint (PQC) involved and no further information provided. 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 medical assistant refers to a patient of unknown age and gender. The patient's medical history concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with improperly stored dose of VAQTA which had the lot # M017982, expiry date: 13-SEP-2017 (route, dose and anatomical place of vaccination were not provided). No adverse effects were reported. The vaccine was exposed to temperature of 34.2 Fahrenheit 24 hours and 34.5 Fahrenheit 12 hours. No previous temperature excursion was reported. The temperature excursions were detected by a data logger. No product quality complaint (PQC) involved and no further information provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On unknown dates in 2016 (reported as starting on or after 06-JUL-2016), the patients were vaccinated with doses of improperly stored PROQUAD (lot# reported as L013600 with expiration date 18-FEB-2017; lot# M006104 with expiration date 01-AUG-2017, dose and route were not reported). The vaccines had been stored under the temperature of 9 Fahrenheit degree for 9 hours. There was no previous temperature excursion. Digital data logger involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site urticaria
Clinical narrative: Patient developed a "Hive" approx. 1 by 3 inches at the injection site on her left arm  Described it as being reddened, hard and itchy.   At reporting time of 10:15 on 8/15/2016 stated it was not as hard, red or itchy.
Age: 1.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Decreased appetite, Febrile convulsion, Full blood count normal, Generalised tonic-clonic seizure, Laboratory test normal
Clinical narrative: 6/2 received multiple immunizations. On 6/3, decrease appetite/activity. 4pm spiked fever 103 and given Tylenol. 7pm had tonic-colic seizure lasting approx. 1 min. some postictal lethargy. Parents took to ER for eval. in ER is alert, oriented and acting normally. No other sx. CBC/chemistries normal. Observed for several hours. No tx.d/c'd to home. Simple febrile convulsion. Return to ER if another seizure o/w, follow up with PCP .
Age: 1.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Lethargy, Metabolic function test, Postictal state, Pyrexia
Clinical narrative: 6/2 received multiple immunizations. On 6/3, decrease appetite/activity. 4pm spiked fever 103 and given Tylenol. 7pm had tonic-colic seizure lasting approx. 1 min. some postictal lethargy. Parents took to ER for eval. in ER is alert, oriented and acting normally. No other sx. CBC/chemistries normal. Observed for several hours. No tx.d/c'd to home. Simple febrile convulsion. Return to ER if another seizure o/w, follow up with PCP .
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Patient had syncope at 10:00 AM, family health clinic called EMS, arrived at 10:20 AM. Brought to emergency room.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had local redness, swelling and site hot to the touch.
Age: 33.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Fatigue, Headache, Nausea
Clinical narrative: Stomach pain, nausea, extremely fatigue, headache.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On unknown dates, the patients were vaccinated with doses of GARDASIL 9 (lot # L000610 with expiration date 31-JAN-2017; lot # L013429 with expiration date 21-JUL-2017; lot# L026602 with expiration date 19-OCT-2017, strength, dose, frequency route were not reported). No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ (lot # M004883 with expiration date 02-OCT-2017; lot # M014318 with expiration date 30-SEP-2017, strength, dose, frequency and route were not reported). No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unknown number of unspecified patients. The patients' medical history, concurrent condition and concomitant medication were unknown. On 05-AUG-2016 and 08-AUG-2016, the patients were vaccinated with improperly stored doses of ROTATEQ orally (dose and frequency unknown, lot # L048854, expiration date: 31-AUG-2017). Vaccines were stored in 53.4F for two hours. There was no previous temperature excursion. This report is for data logger. No adverse event was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Oral disorder, Skin lesion
Clinical narrative: Information was received via a company representative from a female patient of unknown age referring to herself. The patient's medical history, concurrent condition and concomitant therapy were unknown. On 15-JUN-2016 the patient was vaccinated with ZOSTAVAX injection, subcutaneously (dose unknown). On 08-JUL-2016, the patient discovered lesions on the inside and the outside of her mouth and on the upper right side of her face and by her lip. The patient was treated with unspecified medications for the events. It was unknown of the patient assessment between the events and ZOSTAVAX was not reported. Additional information is not expected as there is no consent for follow-up.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unspecified dates, unspecified patients were vaccinated with improperly stored of PROQUAD (1 dose of lot #L030587 with expiration date 10-FEB-2017, 3 doses of lot #L040412 with expiration date 13-APR-2017; route unknown). No adverse effects were reported. On 02-AUG-2016, multiple patients were administered improperly stored doses of PROQUAD (lot #L030587 with expiration date 10-FEB-2017, lot #L046506 with expiration date 17-MAY-2017, lot#M006101 with expiration date 01-AUG-2017, lot #L040412 with expiration date 13-APR-2017, lot #L050908 with expiration date 14-JUN-2017; dose and route were not reported). The lot numbers listed were improperly stored at 16.3 degree Fahrenheit (F) for 4.5 hours and then back in range. There was no previous excursion and data logger was not involved. No adverse effects were reported. At the time of the report, the nurse could not confirm which lot numbers were administered. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Headache, Heart rate increased, Nervousness
Clinical narrative: A few hours after the injection, the arm became swollen, red and very warm about 6" from shoulder to 4" above elbow.  All this gradually moved down the upper arm to nearly the elbow on the next day after the injection.  I felt shaky, faster heart beat, and slightly out of breath, and a small headache.  This was not a severe reaction, but very noticeable because I had never had a reaction before.  I didn't know what to expect or if it would get worse, but it seemed to begin feeling better the 2nd day after the injection. I took some ibuprofen, and on the 2nd day after injection I took 1 small dose of Benadryl.  So far I feel the same.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: A few hours after the injection, the arm became swollen, red and very warm about 6" from shoulder to 4" above elbow.  All this gradually moved down the upper arm to nearly the elbow on the next day after the injection.  I felt shaky, faster heart beat, and slightly out of breath, and a small headache.  This was not a severe reaction, but very noticeable because I had never had a reaction before.  I didn't know what to expect or if it would get worse, but it seemed to begin feeling better the 2nd day after the injection. I took some ibuprofen, and on the 2nd day after injection I took 1 small dose of Benadryl.  So far I feel the same.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Local swelling, Malaise, Pyrexia, Swelling face, Throat tightness
Clinical narrative: Approximately by 8 PM patient developed high tactile fever and generally not feeling well. He vomited several times and had neck/facial swelling. He also complained of throat tightness. Mom gave BENADRYL due to the swelling and he fell asleep, by the next day his symptoms had resolved.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: Approximately by 8 PM patient developed high tactile fever and generally not feeling well. He vomited several times and had neck/facial swelling. He also complained of throat tightness. Mom gave BENADRYL due to the swelling and he fell asleep, by the next day his symptoms had resolved.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection site is red and hot to the touch.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness around injection site. Hot to touch.
Age: 21.0
Sex: M
Vaccine: PNC13
Symptoms: Blood ethanol normal, Cold sweat, Computerised tomogram normal, Drug screen negative, Eye movement disorder
Clinical narrative: Patient non-responsive with cool, clammy hands, non responsive to noxious stimuli, eyes rolled back, tolerated oropharyngeal airway briefly while rescue breaths were given for inadequate breathing.  Transferred to community hospital for further eval.
Age: 21.0
Sex: M
Vaccine: PNC13
Symptoms: Respiration abnormal, Unresponsive to stimuli
Clinical narrative: Patient non-responsive with cool, clammy hands, non responsive to noxious stimuli, eyes rolled back, tolerated oropharyngeal airway briefly while rescue breaths were given for inadequate breathing.  Transferred to community hospital for further eval.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was 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 17-NOV-2015 the patient received the 1st dose of the series with RECOMBIVAX HB (dose unknown) intramuscularly. The 2nd dose was administered on 17-DEC-2015. The patient was to receive the 3rd dose of RECOMBIVAX HB (lot # L048229, expired on 31-MAY-2018) at the reporting day, 27-JUL-2016. (product use issue). No adverse effect was reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9, HEPA, HPV9
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Initially after Gardasil 9 patient became nauseated headache and vomited within next 24 hours patient had 7 separate episodes of dizziness, became light headed and nauseated no further emesis.  After 24 hours patient with no symptoms.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9, HEPA, HPV9
Symptoms: Dizziness, Nausea, Pallor, Tunnel vision, Vomiting
Clinical narrative: Initially after Gardasil 9 patient became nauseated headache and vomited within next 24 hours patient had 7 separate episodes of dizziness, became light headed and nauseated no further emesis.  After 24 hours patient with no symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Mother states that child developed hives after receiving the vaccine.  notes dates this as 10 days prior to 29JUN2012 when it was first documented. Provider stated in record "4yo M patient presents with rash starting on his hairline and moving down to his face, neck, chest, and abdomen x 10 days. MOP thought it might just be a heat rash. MOP states that he also has a different rash under his armpits that has been there for a couple months. MOP has not put any creams on him. MOP states that he does not itch very much but he is itchy.  MOP denies associated sx of congestion or fever.  Child has no hx of allergy issues but FOP does.  Reports due to recent TDY child has been exposed to many new things, including a new pet dog.  She reports no one else if the family is having similar issue. She has not tried to treat the issue with anything." Pt was prescribed Benadryl.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Rash/hives started on leg. Has had them on face, arms, legs.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX, (lot # L048466, expiry date 02-DEC-2017, lot # M000761 expiry date 01-JAN-2018, lot # M005974 expiry date 02-FEB-2018, lot # M009764 expiry date 28-FEB-2018, M009768 expiry date 23-FEB-2018. No adverse effects were reported. Temperature -13.3 degrees centigrade, time 10 minutes. There was no previous exposure. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On an unknown date, an unspecified patient was vaccinated with an improperly stored dose of VARIVAX (lot #M006722 with expiration date 08-FEB-2018, 1 dose, route unknown). No adverse effects were reported. On 02-AUG-2016, multiple unspecified patients were administered improperly stored doses of VARIVAX (lot # M006722 with expiration date 08-FEB_2018, lot # M009765 with expiration date 23-FEB-2018, lot # L031069 with 18-AUG-2017, lot L039092 with expiration date 06-OCT-2017, lot #M004330 with expiration date 26-JAN-2018; dose and route were not reported). The lot numbers listed were improperly stored at 16.3 degree Fahrenheit (F) for 4.5 hours and then back in range. There was no previous excursion and data logger was not involved. No adverse effects were reported. At the time of the report, the nurse could not confirm which lot numbers were administered. 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: Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On unknown dates in 2016 (reported as starting on or after 06-JUL-2016), the patients were vaccinated with doses of VARIVAX (lot # L020002 with expiration date 02-JUN-2017, lot # M000757 with expiration date 06-JAN-2018, dose and route were not reported). The vaccine had been stored under the temperature of 9 Fahrenheit degree for 9 hours. There was no previous temperature excursion. Digital data logger involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Fatigue, Headache, Influenza like illness, Musculoskeletal stiffness, Visual impairment
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 35-year-old female patient who received BOOSTRIX (batch number 7RJ9B, expiry date 18th NOVEMBER 2018). Co-suspect products included TWINRIX adult (batch number 2BA47, expiry date 27th SEPTEMBER 2018). On 21st JUNE 2016, the patient received BOOSTRIX (intramuscular) .5 ml and TWINRIX adult (intramuscular) 1 ml. On 21st JUNE 2016, 6 hrs after receiving BOOSTRIX and TWINRIX adult, the patient experienced headache, spots before eyes, influenza-like symptoms, fatigue and stiff neck. On an unknown date, the outcome of the headache, spots before eyes and stiff neck were recovered/resolved and the outcome of the influenza-like symptoms was unknown and the outcome of the fatigue was unchanged. The reporter considered the headache, spots before eyes, influenza-like symptoms , fatigue and stiff neck to be probably related to BOOSTRIX and TWINRIX adult. Additional details were provided as follows: The patient was vaccinated at 8:30 with BOOSTRIX and TWINRIX adult respectively in the left and right deltoid. The call was transferred to medical information. The case was erroneously considered as "Exclude from Pader".
Sex: U
Vaccine: MENB
Symptoms: Injection site paraesthesia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site tingling in a patient who received BEXSERO. In July 2016, the patient received the 1st dose of BEXSERO. In July 2016, less than a month after receiving BEXSERO, the patient experienced injection site tingling. On an unknown date, the outcome of the injection site tingling was recovered/resolved. It was unknown if the reporter considered the injection site tingling to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The sales representative stated that, the nurse told her that the patient experienced tingling in the vaccinated arm for several days after vaccination with BEXSERO. The sales representative did not know the patient details. No further information was provided.
Age: 10.0
Sex: M
Vaccine: FLUN3, VARCEL
Symptoms: Facial pain, Herpes zoster, Polymerase chain reaction positive, Rash vesicular, Varicella virus test positive
Clinical narrative: Patient developed pain and vesicular rash on one side of face, along dermatome from ear to chin. Diagnosed as shingles (herpes zoster). No reported history of shingles or chickenpox infection in patient. Were unable to obtain specimen for strain genotyping (rash now resolved). Vaccine information from parent-held medical records, some information unknown; patient received varicella vaccine on 08/09/00 and 12/18/09. No secondary varicella cases reported among contacts.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 65 year old female patient. The patient had no drug reactions or allergies. The patient's pertinent medical history and concurrent conditions were unknown by the reporter. On 19-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneously, (Anatomical location, lot number and expiration date were not provided). Concomitant therapies included gabapentin, acetaminophen (+) hydrocodone bitartrate,  HYZAAR, ZOCOR and pantoprazole. On an unknown date the patient experienced "breakouts of a rash, around the tailbone region" (rash), since receiving the ZOSTAVAX. The pharmacist was informed by the patient, that the patient's physician informed patient that the event were probably from the ZOSTAVAX. No product quality complaint was involved. The outcome of rash and the reporter causality between the event and the therapy with ZOSTAVAX were unknown. Additional information has been requested.
Age: 0.23
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Laboratory test normal, Seizure
Clinical narrative: History of seizure within 48 hours of vaccines lasted 20 minutes (mZ01, motor).
Age: 56.0
Sex: F
Vaccine: HEPAB
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of vomiting in a 56-year-old female patient who received TWINRIX adult (batch number L5SH5, expiry date 27th SEPTEMBER 2018). On 1st AUGUST 2016, the patient received TWINRIX adult 1ml. On 4th AUGUST 2016, 3 days after receiving TWINRIX adult, the patient experienced vomiting, nausea and fever. On an unknown date, the outcome of the vomiting, nausea and fever were not recovered/not resolved. The reporter considered the vomiting, nausea and fever to be related to TWINRIX adult. Additional details were provided as follows: This case was previously reported to a doctor. The reporter in the case was medical assistant. The reporter stated that, the patient experienced vomiting, nausea and fever after vaccination with TWINRIX adult.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, HPV4
Symptoms: Cough, Headache, Nasal congestion, Pyrexia
Clinical narrative: 24 hours after vaccine administration patient developed subjective fever, headache, nasal congestion and cough.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding to 2 male patients in their 50's (years old). Pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates approximately in 2016, the patients were vaccinated with ZOSTAVAX vial (doses, frequencies and routes were unknown). On an unknown dates in JUNE 2016 reported as in the last month, the patients experienced injection site reactions after receipt of the ZOSTAVAX. The outcome of injection site reactions were reported as recovered/resolved. The reporter did not provide the causality assessment for the adverse event. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Chest discomfort, Dysphonia, Oropharyngeal pain, Throat tightness
Clinical narrative: 5 min after vaccine-throat pain, chest heaviness, airway felt smaller, voice changes-slight improvement with ibuprofen and BENADRYL.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to 2 female patients in their 50's (years old). Pertinent medical histories, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates approximately in 2016, the patients were vaccinated with ZOSTAVAX vial (doses, frequencies and routes were unknown). On an unknown date in JUNE 2016 reported as in the last month, the patients experienced injection site reactions after receipt of the ZOSTAVAX. On an unknown date, the outcome of injection site reactions were reported as recovered/resolved. The reporter did not provide the causality assessment for the adverse event. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Diarrhoea, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Redness, swelling, pain at injection site. Spread from shoulder to elbow. Also had headache, nausea, vomiting, diarrhea, fatigue for 2-3 days following vaccine admin. Pt. recovered at home.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site swelling, Nausea, Vomiting
Clinical narrative: Redness, swelling, pain at injection site. Spread from shoulder to elbow. Also had headache, nausea, vomiting, diarrhea, fatigue for 2-3 days following vaccine admin. Pt. recovered at home.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Ageusia, Arthralgia, Dysarthria, Dysphagia, Eyelid function disorder
Clinical narrative: No sense of taste, tongue numb, fever, severe headaches, tired, ringing in ears, trouble swallowing, chewing, slurred speech, can't sleep, left eye blurry, pain in joints. 1-3 days after vaccine then symptoms got worse the next 2 weeks. Symptoms - eye drooped, mouth slanted, speech slurred, tongue numb, tired, insomnia, trouble swallowing, trouble chewing, pain behind ear, headache, eye wouldn't shut, eye blurry, no sense for taste, fever and chills, pain in joints, couldn't see to drive, missed work (works on computers).
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Eyelid ptosis, Facial paralysis, Fatigue, Headache, Hypoaesthesia oral
Clinical narrative: No sense of taste, tongue numb, fever, severe headaches, tired, ringing in ears, trouble swallowing, chewing, slurred speech, can't sleep, left eye blurry, pain in joints. 1-3 days after vaccine then symptoms got worse the next 2 weeks. Symptoms - eye drooped, mouth slanted, speech slurred, tongue numb, tired, insomnia, trouble swallowing, trouble chewing, pain behind ear, headache, eye wouldn't shut, eye blurry, no sense for taste, fever and chills, pain in joints, couldn't see to drive, missed work (works on computers).
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Impaired driving ability, Impaired work ability, Insomnia, Mastication disorder, Pain
Clinical narrative: No sense of taste, tongue numb, fever, severe headaches, tired, ringing in ears, trouble swallowing, chewing, slurred speech, can't sleep, left eye blurry, pain in joints. 1-3 days after vaccine then symptoms got worse the next 2 weeks. Symptoms - eye drooped, mouth slanted, speech slurred, tongue numb, tired, insomnia, trouble swallowing, trouble chewing, pain behind ear, headache, eye wouldn't shut, eye blurry, no sense for taste, fever and chills, pain in joints, couldn't see to drive, missed work (works on computers).
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Tinnitus, Vision blurred
Clinical narrative: No sense of taste, tongue numb, fever, severe headaches, tired, ringing in ears, trouble swallowing, chewing, slurred speech, can't sleep, left eye blurry, pain in joints. 1-3 days after vaccine then symptoms got worse the next 2 weeks. Symptoms - eye drooped, mouth slanted, speech slurred, tongue numb, tired, insomnia, trouble swallowing, trouble chewing, pain behind ear, headache, eye wouldn't shut, eye blurry, no sense for taste, fever and chills, pain in joints, couldn't see to drive, missed work (works on computers).
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Pain in extremity, Rash macular
Clinical narrative: Pt complained of arm pain, and claimed skin was "blotchy". Advised pt if she had chills or if symptoms got worse see a physician.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Arm red and warm to touch on Deltoid muscle.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Nausea, Vomiting
Clinical narrative: Patient had nausea and vomiting for approx. 30 hours after vaccine admin. Recovered at home.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Hyperhidrosis, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: 1 minute post HPV vaccine syncope episode noted. B/P before vaccine 104/64-At onset of episode B/P 80/40-pale diaphoretic-1 hour unresponsive 2 minutes post incident 90/60 alert and responsive-5 minutes post incident 106/60. Rest 30 min.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: Arm red and warm to touch 3 days after vaccine.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Syncope
Clinical narrative: Felt dizzy, then fainted x 30 seconds, observed x 1 hour. Patient felt normal after waking up.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site swelling, Lip swelling
Clinical narrative: Patient observed swelling of lower lip 8/4/16 AM- came directly to office for evaluation. Lip continued to swell. (R) upper arm minimally swollen, no rash, redness or swelling - Treated with prednisone taper and OTC antihistamine.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Musculoskeletal disorder, Pain in extremity, Paraesthesia
Clinical narrative: Numbness and tingling in arm for 1 1/2 wks. Also had significant amount of pain for > 1wk. Unable to lift arm.
Age: 67.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Insomnia, Pain in extremity
Clinical narrative: Left deltoid soreness after receiving vaccine, sleeplessness due pain on left arm. Redness and warmth on injection site.
Age: 67.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left deltoid soreness after receiving vaccine, sleeplessness due pain on left arm. Redness and warmth on injection site.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Musculoskeletal disorder, Paraesthesia
Clinical narrative: Numbness and tingling in arm for 1 1/2 weeks. Unable to lift arm.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Received Tdap and MCV4 in left deltoid of HPV 9 in right deltoid on 8-2-16. On 8-7-16 noticed on (L) deltoid red circle with induration. Area 2.5 x 2 inch diameter indurated red, sl. swelling on left deltoid. Reports mildly itchy. Office visit 8-8-16 tx with cool compresses and hydrocortisone cream to area.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: BOOSTRIX given to child instead of KINRIX. Advised by CDC to report.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Said shot should have been given subq and not IM. She also had swelling and redness at the injection site.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Grip strength decreased, Hypoaesthesia, Muscle contractions involuntary, Paraesthesia
Clinical narrative: Patient reported numbness, tingling of left arm on 8-5. Stated could not use left hand, could not grip. Follow-up call patient stated hand had drawn up into a fist and was difficult to open.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site rash
Clinical narrative: Rash at administration site.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Joint swelling, Mass, Muscular weakness, Musculoskeletal pain
Clinical narrative: Neck stiffened up. Swollen lump in collar bone. Pain in shoulder radiated down arm. Pain in elbow. Weakening of hand. Swollen knuckles.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Neck stiffened up. Swollen lump in collar bone. Pain in shoulder radiated down arm. Pain in elbow. Weakening of hand. Swollen knuckles.
Age: 1.02
Sex: M
Vaccine: MMRV, PNC13, MMRV, PNC13
Symptoms: Blood culture negative, CSF culture negative, Culture urine negative, Electroencephalogram normal, Febrile convulsion
Clinical narrative: Complex febrile seizure.
Age: 1.02
Sex: M
Vaccine: MMRV, PNC13, MMRV, PNC13
Symptoms: Nuclear magnetic resonance imaging brain normal
Clinical narrative: Complex febrile seizure.
Age: 1.02
Sex: M
Vaccine: MMRV, PNC13, MMRV, PNC13
Symptoms: Blood test, Electroencephalogram, Neurological examination, Nuclear magnetic resonance imaging brain, Seizure
Clinical narrative: Complex febrile seizure.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Redness and pain of arm, fever to 102.5, vomiting, nausea, myalgias.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Redness and pain of arm, fever to 102.5, vomiting, nausea, myalgias.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Glossodynia, Hyperaesthesia, Influenza like illness
Clinical narrative: Woke up tongue felt like I had scalded the edge all around and across back of tongue. Flu like symptoms. Joints hurt, my body ached all over low grade fever, my arm hurt with a swollen red spot larger than silver dollar full of fever.  As day progress symptoms increased with the red spot increasing up to top of arm and down to elbow all underneath with increase pain and severe itching.  Saturday was the same with more swelling and a great deal of pain, and itching. Pain increase to armpit and top of breast.  Sunday area deceased a little with itching increased and area very sensitive to touch or movement.  Monday decreased to ache and itching had deceased.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Pain, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Woke up tongue felt like I had scalded the edge all around and across back of tongue. Flu like symptoms. Joints hurt, my body ached all over low grade fever, my arm hurt with a swollen red spot larger than silver dollar full of fever.  As day progress symptoms increased with the red spot increasing up to top of arm and down to elbow all underneath with increase pain and severe itching.  Saturday was the same with more swelling and a great deal of pain, and itching. Pain increase to armpit and top of breast.  Sunday area deceased a little with itching increased and area very sensitive to touch or movement.  Monday decreased to ache and itching had deceased.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Hypersensitivity
Clinical narrative: Patient had allergic reaction.
Age: 8.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Cough, Dyspnoea, Nausea, Urticaria
Clinical narrative: Patient became short of breath, increased cough, hives on torso, stomach ache and nausea within 15 minutes after receiving MMR vaccine.  She was immediately given Epinephrine 0.3mg IM, followed with 1 albuterol neb, Zyrtec 10mg and 30mg oral prednisolone.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: FROM SHOULDER TO ELBOW, RED, SWOLLEN, PAINFUL LEFT ARM.
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Dizziness, Hyperhidrosis, Pallor, Palpitations, Pyrexia
Clinical narrative: C/O dizziness, feeling faint, pale and diaphoretic, heart palpitations, vomiting, and fever 102.5.
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Vomiting
Clinical narrative: C/O dizziness, feeling faint, pale and diaphoretic, heart palpitations, vomiting, and fever 102.5.
Age: 19.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Within 5 minutes of receiving vaccines patient became dizzy and briefly lost consciousness. She was helped to the floor by her sister. Within a few minutes she was up sitting in a chair and feeling better. 911 was called and emergency responders were on site with 15 minutes. They put her through an assessment and she checked out ok. Patient refused further treatment and was cleared to go on her way.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Blood glucose decreased, Blood pressure increased, Chest discomfort, Dyspnoea, Ear discomfort
Clinical narrative: After injecting Patient complained about not able to here everything what I was saying to her because of too much pressure in her ear, few seconds later she said having light headache and pressure in her chest or difficulty breathing that is when we called 911. I made Patient to lie down on the floor gave ice pack to put it on her head and started checking blood pressure every 5 minutes. Patient was coherent and conscious all the time and was talking to me she was feeling better every minute after she lied down. Her Bp was 215/118 with pulse rate of 93 for the 1 st time and went down every time since and last one was 120/86 when EMS took her BP. EMS arrived at 12:50 AND SAID EVERYTHING WAS OK AND SHE PROBABLY TOO WORKED UP BECAUSE OF FEAR OF NEEDLES. SUGAR WAS 75. AFTER FEW MINUTES WITH EMS PT. WAS RELEASED TO GO AND GET SOMETHING TO EAT.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Headache
Clinical narrative: After injecting Patient complained about not able to here everything what I was saying to her because of too much pressure in her ear, few seconds later she said having light headache and pressure in her chest or difficulty breathing that is when we called 911. I made Patient to lie down on the floor gave ice pack to put it on her head and started checking blood pressure every 5 minutes. Patient was coherent and conscious all the time and was talking to me she was feeling better every minute after she lied down. Her Bp was 215/118 with pulse rate of 93 for the 1 st time and went down every time since and last one was 120/86 when EMS took her BP. EMS arrived at 12:50 AND SAID EVERYTHING WAS OK AND SHE PROBABLY TOO WORKED UP BECAUSE OF FEAR OF NEEDLES. SUGAR WAS 75. AFTER FEW MINUTES WITH EMS PT. WAS RELEASED TO GO AND GET SOMETHING TO EAT.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Quarter size red spot swollen and hot to the touch. Sore and itchy, or about a week. After 11th day spot is faded.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Received MCV4 IM left Deltoid and TDAP IM (R) Deltoid. At 1125 on 8/5/16. At 1800, patient noticed swelling at injection sites when removed bandaids; warmth, induration. No meds taken to relieve pain/selling. RTC 8/7/16 at 1644 R Deltoid erythema induration 6/5 cm X 7cm Left Deltoid 8cmX7.5cm. Tx with Ibuprofen; cool pack, monitor for adverse effects or increase in size/pain.
Age: 18.0
Sex: M
Vaccine: MENB, TD
Symptoms: Chills, Cough, Pyrexia
Clinical narrative: Chills, fever (no temp reported) day after receiving vaccines. Today symptoms resolved. Has a cough.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Screaming
Clinical narrative: Inconsolable screaming starting 2 hr p vaccine; lasting 5 hrs.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fever, arm swollen and painful.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Fever, arm swollen and painful.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Lymphadenopathy
Clinical narrative: 1 lymph node size of 1" in diameter at the Left Axilla, non tender, mobile no redness.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Ear pain, Eyelid oedema, Ocular hyperaemia, Urticaria
Clinical narrative: 8/12/16 Given #2 VARICELLA. Immediately C/O ears hurting, eyes red and puffy, developed hives on trunk and extremities.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Injected limb mobility decreased, Injection site erythema, Injection site pain, Screaming
Clinical narrative: Non stop screaming and crying, tenderness redness and swelling localized at left thigh vaccination site. Inability to move left leg.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Vaccination site swelling
Clinical narrative: Non stop screaming and crying, tenderness redness and swelling localized at left thigh vaccination site. Inability to move left leg.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Itchiness, erythema and swelling.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Enema administration, Faeces discoloured, Intussusception, Irritability, Lethargy
Clinical narrative: The patient became increasingly fussy on 8/8/2016. This progressed to lethargy on 8/9/16 with bilious emesis and a dark stool. He was admitted on 8/10/16 to the hospital with a RUQ intussusception that was reduced by air contrast enema.