chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Injection site erythema, Injection site swelling, Mass, Pruritus
Clinical narrative: Called 4-14-15 State red/swollen lt arm - site of injection - c/o sever itching - bruise sm. lump. To clinic 4-15-15 to be check by Dr.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Fatigue, Headache, Nausea, Neck pain
Clinical narrative: Within 24 hours of receiving vaccine developed local at site. On 4/15 she developed neck pain, headache, fatigue, stomachache and nausea. She contacted her pharmacy but did not feel she needed to be seen in office.
Age: 10.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling at injection site, with induration, pruritus and mild stinging. No fever. Given BENADRYL and ibuprofen in office, with Rx for BENADRYL as needed.
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Immediate post-injection reaction, Injection site abscess sterile, Mass
Clinical narrative: Sterile abscess formed in right leg at injection site. Mother reports lump formed right after injection and is coming in today, one week later, to have the lump looked at.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Cough, Eye irritation, Pyrexia, Rash, Rash generalised
Clinical narrative: 4/16 sporadic fever up to 103, irritated eyes. 4/17 sporadic fever up to 103, irritated eyes, coughing. 4/18 sporadic fever up to 103; faint rash on face, coughing. 4/19 faint rash covering entire body, coughing. 4/20 full blown measles rash covering entire body, coughing; visited pediatrician - diagnosed as '99% certain it is a measles like rash caused by an adverse reaction to the MMR vaccine'. 4/21 rash covering entire body, lessened redness, coughing.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: 4/16 sporadic fever up to 103, irritated eyes. 4/17 sporadic fever up to 103, irritated eyes, coughing. 4/18 sporadic fever up to 103; faint rash on face, coughing. 4/19 faint rash covering entire body, coughing. 4/20 full blown measles rash covering entire body, coughing; visited pediatrician - diagnosed as '99% certain it is a measles like rash caused by an adverse reaction to the MMR vaccine'. 4/21 rash covering entire body, lessened redness, coughing.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Chest discomfort, Confusional state, Dizziness, Dyspnoea, Headache
Clinical narrative: Dizziness, headache, nausea, fever, body pain, confusion, swelling of throat and tongue, difficulty breathing, tightness in chest, weakness of arms.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Muscular weakness, Nausea, Pain, Pharyngeal oedema, Pyrexia
Clinical narrative: Dizziness, headache, nausea, fever, body pain, confusion, swelling of throat and tongue, difficulty breathing, tightness in chest, weakness of arms.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Swollen tongue
Clinical narrative: Dizziness, headache, nausea, fever, body pain, confusion, swelling of throat and tongue, difficulty breathing, tightness in chest, weakness of arms.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Arm swelling, itching, redness. Treated with ice packs, rubbing alcohol.
Age: 13.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Rash
Clinical narrative: Vaccine given 2/3/15, broke out in rash on 2/4/15 in the PM. Was taken to Dr's office and was given a DECADRON injection. Rash not at injection site - not papular/macular.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt came down with shingles.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain started in upper arm, it now goes on my shoulder - took physical therapy for 3 mos. and still paying my 800.00 bill off, and pain is no better.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding unknown number of patients of unknown demographics. There was no information about concurrent condition and historical medication. Since 22-JAN-2015, the patients were vaccinated with GARDASIL, lot # J012212 (expiration date-18-FEB-2016), lot # J006236 (expiration date- 25-FEB-2016) and lot # K005881 (expiration date- 14-JAN-2017), intramuscularly which had underwent unsupported temperature excursions (incorrect product storage). No adverse effect was reported. No product quality complaint was involved. No concomitant medication was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (healthcare worker) refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of MMR II, 0.5 ml, subcutaneous, lot # K001231, expiration date 27-JAN-2016; lot # K002816, expiration date 25-FEB-2016 and lot # K011317, expiration date 13-AUG-2016, that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding unknown number of patients of unknown demographics. There was no information about concurrent condition and historical medication. Since 22-JAN-2015, the patients were vaccinated with ROTATEQ, lot # K001935 (expiration date - 18DEC2015) and lot # K006458 (expiration date 24-FEB-2016) orally which had underwent unsupported temperature excursions (incorrect product storage). No adverse effect was reported. No product quality complaint was involved. No concomitant medication was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (healthcare worker) refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of ROTATEQ lot number K010222, expiration date 12-MAY-2016 and lot number K009901, expiration date 08-MAY-2016 (dose not reported, route defaulted to oral), that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 20.0
Sex: U
Vaccine: HEPA
Symptoms: Accidental underdose
Clinical narrative: Information has been received from a registered nurse referring to a 20 year old patient of unknown gender. On 17-APR-2015 the patient was inadvertently administered a pediatric dose of VAQTA (dose, route and lot# were not reported) instead of an adult dose (accidental underdose). No adverse event was reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with GARDASIL inj via gluteal intramuscular administration by unknown HCP. No adverse effects reported. No Product Quality Complaint (PQC) was involved. Follow up information has been received from the certified medical assistant (previously reported as nurse) referring to the 21-year-old female patient. There was no medical history and concurrent condition reported. On 16-DEC-2014 at 11:00, the patient was given the first dose of GARDASIL (lot # J002641, expiration date 10-DEC-2015) (strength and dose not provided) intramuscularly in gluteus, not deltoid (drug administered at inappropriate site). There was no concomitant medication reported. Additional information is not expected because all follow ups requested to complete the case were received. Therapy information, AE term and narrative were updated.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (healthcare worker) refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of GARDASIL (dose and route were not reported) lot # K007264, expiration date 02-MAR-2017 and lot # K007828, expiration date 02-MAR-2017, that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: MMRV
Symptoms: Injection site bruising, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: This spontaneous report was received from a patient's grandmother refers to an approximately 13 month old male patient. No medical history and concomitant therapy was reported. On 30-MAR-2015, the patient was vaccinated with a dose of PROQUAD (Merck) (dose and route not provided) by a local nurse with the local health department. On 06-APR-2015, the patient experienced a fever of 104, a runny nose, a rash and a bruise at the injection site. The patient sought medical attention and visited emergency room. The patient was treated with TYLENOL. The outcome of the events was reported as recovering. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 14-APR-2015, the patient was vaccinated with an expired dose of (Merck) VARIVAX lot reported as J003712, expiration date 27-MAR-2015. Secondary suspects and concomitant therapies were not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a other health professional referring to unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date the unspecified number of patients were vaccinated with improperly stored RECOMBIVAX HB (lot #, expiry dare, dose, route of administration were unknown). Other suspect and concomitant therapies were not reported. No adverse effect reported. No product quality complaint (PQC) involved. Additional information has been requested.
Age: 27.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of 27 year old patients. No relevant medical history was reported. On unspecified dates, these patients started the GARDASIL, (lot number, expiry date, route, dose and frequency were not reported) series at the age of 26 years old. But they did not complete the series until they were 27 years old (inappropriate schedule of drug administration). No adverse experiences reported. 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 unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On unknown dates, the patients were vaccinated with unknown number of doses of improperly stored ROTATEQ (dose, strength, lot # unspecified, orally). No adverse effects reported. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to a patient of unknown age. No current condition and medical history was reported. On 09-APR-2015 the patient was vaccinated with a dose of RECOMBIVAX HB (dose, route and lot# were not reported) (expired on 27-MAR-2015). No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Myalgia, Pyrexia
Clinical narrative: Information has been received from a female patient of unknown age concerning herself. The patient had no pertinent medical history or drug reactions/allergies. On an unknown date the patient was vaccinated with ZOSTAVAX in the left arm (dose, frequency, route and lot# were not reported) because she was over 50. No concomitant medication was given. It was reported that the ZOSTAVAX vaccine gave her high fever, muscle pain, joint pain and no energy for seven days. No treatment was given for the adverse events. No lab diagnostic studies performed. The outcome of the events and causality were not reported. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored GARDASIL (lot # K008931, Exp date 04-MAR-2017, dose and route not reported). No adverse effects was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored LIQUID PEDVAXHIB (lot # K016964, EXP date 17-JUN-2017, dose and route not reported). No adverse effects was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Abnormal behaviour, Blood glucose normal, Chest pain, Crying, Depressed level of consciousness
Clinical narrative: Prior to and during vaccine administration, patient was crying and hyperventilating.  After vaccines administered, nursing notified that she was not acting appropriately.  She was sleepy, difficult to arouse. She was starting off, not responding to questions and difficult to keep awake.  Later complaining of chest pain, headache, flank pain, difficulty raising her arm and continues to be slow to answer questioning, not oriented to time or place. Altered mental status of 45 minutes in duration.  Glucose normal, given juice and crackers.  Tylenol for pain.  Admitted to the hospital with neurology consult, and with EKG.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Disorientation, Electrocardiogram normal, Electroencephalogram normal, Flank pain, Headache
Clinical narrative: Prior to and during vaccine administration, patient was crying and hyperventilating.  After vaccines administered, nursing notified that she was not acting appropriately.  She was sleepy, difficult to arouse. She was starting off, not responding to questions and difficult to keep awake.  Later complaining of chest pain, headache, flank pain, difficulty raising her arm and continues to be slow to answer questioning, not oriented to time or place. Altered mental status of 45 minutes in duration.  Glucose normal, given juice and crackers.  Tylenol for pain.  Admitted to the hospital with neurology consult, and with EKG.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Hyperventilation, Mental status changes, Mobility decreased, Slow response to stimuli, Somnolence
Clinical narrative: Prior to and during vaccine administration, patient was crying and hyperventilating.  After vaccines administered, nursing notified that she was not acting appropriately.  She was sleepy, difficult to arouse. She was starting off, not responding to questions and difficult to keep awake.  Later complaining of chest pain, headache, flank pain, difficulty raising her arm and continues to be slow to answer questioning, not oriented to time or place. Altered mental status of 45 minutes in duration.  Glucose normal, given juice and crackers.  Tylenol for pain.  Admitted to the hospital with neurology consult, and with EKG.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Staring, Unresponsive to stimuli
Clinical narrative: Prior to and during vaccine administration, patient was crying and hyperventilating.  After vaccines administered, nursing notified that she was not acting appropriately.  She was sleepy, difficult to arouse. She was starting off, not responding to questions and difficult to keep awake.  Later complaining of chest pain, headache, flank pain, difficulty raising her arm and continues to be slow to answer questioning, not oriented to time or place. Altered mental status of 45 minutes in duration.  Glucose normal, given juice and crackers.  Tylenol for pain.  Admitted to the hospital with neurology consult, and with EKG.
Age: 0.39
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, MMRV, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: 4 month old child was given MMRV (ProQuad) As of time of this report child does not appear to have any adverse reactions.
Age: 9.0
Sex: F
Vaccine: HEP, TDAP, VARCEL
Symptoms: Dizziness, Dyspnoea, Fatigue
Clinical narrative: Dizziness, fatigue, difficulty breathing 24 hours after administration. Now having recurrent episodes of dizziness and shortness of breath daily in last 5 days since vaccines.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Nausea
Clinical narrative: Dizzy, nausea.
Age: 1.7
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-month-old female patient who received KINRIX (batch number 9EA47, expiry date 17th April 2016). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information was provided. RN reports that KINRIX was inadvertently administered to a 19 month old.
Sex: U
Vaccine: RV1
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via GSK/market research programs and described the occurrence of rash in a infant patient who received Rotavirus vaccine. On an unknown date, the patient received Rotavirus vaccine at an unknown dose. On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced rash. The subject was treated with probiotics (nos) (Probiotics). On an unknown date, the outcome of the rash was unknown. The reporter considered the rash to be possibly related to Rotavirus vaccine.
Age: 12.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Induration, Peripheral swelling, Tenderness
Clinical narrative: Received vaccine on 4/16/15 by 4/17/15 arm was red, swollen, tender per mom. Seen in office on 4/18/15 - skin pink, induration, covers all of left upper arm - no cellulitis lines - amount of swelling unchanged in 12 hours per mother.
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received BOOSTRIX. In 2015, the patient received BOOSTRIX (injection). On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to BOOSTRIX. Additional information received: The patient reported that he was given the BOOSTRIX vaccine in a doctor's office and he noticed that the nurse administered the vaccine with a very small needle and he is experiencing soreness in the arm that has continued for 5 weeks. The patient also has denied permission to contact their physician. Patient refused to provide any demographic information or any additional details regarding the adverse event reported.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Influenza, Nausea, Pyrexia, Vomiting
Clinical narrative: Pt's rep called. Pt experiencing signs of "bad" flu. Temp - nausea - fever - diarrhea - vomiting.
Age: 0.5
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old patient who received KINRIX (batch number AC20B256AA, expiry date 16th April 2015). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.
Sex: F
Vaccine: RV1
Symptoms: Dermatitis diaper, Frequent bowel movements
Clinical narrative: This case was reported by a consumer via GSK/market research programs and described the occurrence of frequent bowel movements in a infant female patient who received ROTAVIRUS vaccine. On 17th October 2014, the patient received ROTAVIRUS vaccine. On an unknown date, less than a week after receiving ROTAVIRUS vaccine, the patient experienced frequent bowel movements and diaper rash. On an unknown date, the outcome of the frequent bowel movements and diaper rash was unknown. The reporter considered the frequent bowel movements and diaper rash to be possible related to ROTAVIRUS vaccine.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Lt deltoid local reaction from Gardasil vaccine.  Area with swelling, warmth and redness and induration measuring 5 1/2"x 4 1/2".  Child c/o pain to Left deltoid, mom denies fever, temp= 99.1 tym.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site warmth, Local reaction
Clinical narrative: Lt deltoid local reaction from Gardasil vaccine.  Area with swelling, warmth and redness and induration measuring 5 1/2"x 4 1/2".  Child c/o pain to Left deltoid, mom denies fever, temp= 99.1 tym.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Hypersomnia, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient stated that she was very fatigued, went to bed at 8:00 PM on the 17th, slept most of the 18th, and 4 hour nap on the 19th. Upper left arm is red, swollen and warm to touch.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Localised infection
Clinical narrative: Infection on arm.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Chills, Headache, Injected limb mobility decreased, Lymphadenopathy
Clinical narrative: Arm pain/ unable to lift arm, headache, chills, joint pain (lasting 3+ days)swollen gland.  Rash 04/14/2015.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Pain in extremity, Rash, Ultrasound scan
Clinical narrative: Arm pain/ unable to lift arm, headache, chills, joint pain (lasting 3+ days)swollen gland.  Rash 04/14/2015.
Age: 9.0
Sex: M
Vaccine: HPV4
Symptoms: Bladder catheterisation, Dysuria
Clinical narrative: Was taken to Emergency Room because unable to void. Catheterized for 400ml of urine.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Aphasia, Cytogenetic analysis normal, DNA test for fragile X, Decreased appetite, Eccentric fixation
Clinical narrative: Rash within 12 hours of administration.  Fever.  Loss of appetite.  Somnolence.  Took twice to physician asking what was wrong- physician said "viral illness".  Last medical document indicates treatment was "reassurance".  My son did not speak again for 2.5 years.  He stopped eating all but 3 foods.  He started fixating on lights, fans, motorized objects.  Sounds began to hurt him.  All after the vaccine.  He left us and never came fully back.  He has negative tested for fragile X and mitochondrial disease.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Full blood count normal, Hyperacusis, Immediate post-injection reaction, Laboratory test normal, Pyrexia
Clinical narrative: Rash within 12 hours of administration.  Fever.  Loss of appetite.  Somnolence.  Took twice to physician asking what was wrong- physician said "viral illness".  Last medical document indicates treatment was "reassurance".  My son did not speak again for 2.5 years.  He stopped eating all but 3 foods.  He started fixating on lights, fans, motorized objects.  Sounds began to hurt him.  All after the vaccine.  He left us and never came fully back.  He has negative tested for fragile X and mitochondrial disease.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Rash, Somnolence, Viral infection
Clinical narrative: Rash within 12 hours of administration.  Fever.  Loss of appetite.  Somnolence.  Took twice to physician asking what was wrong- physician said "viral illness".  Last medical document indicates treatment was "reassurance".  My son did not speak again for 2.5 years.  He stopped eating all but 3 foods.  He started fixating on lights, fans, motorized objects.  Sounds began to hurt him.  All after the vaccine.  He left us and never came fully back.  He has negative tested for fragile X and mitochondrial disease.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm swollen, 3-4cm indurated, tender and warm to touch. Improving by 2/25/2015, when seen in office.
Age: 1.03
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash, Rash maculo-papular
Clinical narrative: MOTHER'S REPORT STATED RASH AND BUMPS ON NECK, BACK, RIGHT LEG, AND BEHIND EAR. MD REPORTS: possibly d/t MMR or VZV vaccines given 11 days prior. Maculopapular rash known to occur within 1st 3 weeks after these live vaccines given. No vesicular rash, papules all blanch.
Age: 43.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Impaired work ability, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Around 9am, client noticed pain, redness and swelling on R arm; is a daycare provider so it has been difficult to work, experiencing pain while caring for the children; around 1pm, noticed fever. Temp (o) 102. States took 200mg of Tylenol. Now calling HD; latest temp 100 taken around 3pm.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Petechiae
Clinical narrative: Developed a petechial eruption in face. Not itchy. He was instructed to visit PCP.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site rash, Pruritus
Clinical narrative: Rash on left upper arm started Friday, 4/10/15. Seen at Emergency Room on 4/12/15 with continued itching.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site rash, Pruritus
Clinical narrative: Patient has a 4 inch rash around the injection site and has been experiencing burning and itching along her arm and back.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Feeling abnormal, Headache, Injection site pain, Injection site swelling
Clinical narrative: Sore arm/swollen injection site lasting 6 days headache lasting one day. Fever the next day lasting one day. SOB lasting two days. Sense of unease lasting 6 days.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Sore arm/swollen injection site lasting 6 days headache lasting one day. Fever the next day lasting one day. SOB lasting two days. Sense of unease lasting 6 days.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Diet refusal, Enema administration, Intussusception, Pyloric stenosis, Ultrasound abdomen abnormal
Clinical narrative: Refusal to eat and vomiting, taken to ER. Later transferred to another hospital where she was diagnosed with intussusception that was reduced by air contrast enema.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: Refusal to eat and vomiting, taken to ER. Later transferred to another hospital where she was diagnosed with intussusception that was reduced by air contrast enema.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Mosquito like bumps to right side of neck and right arm.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Blood glucose increased, Decreased appetite, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Redness, heat, and pain at injection site in left upper arm about 2 inch circumference, and pain at injection site requiring Tylenol every 4-6 hours.  Body aches, feverish, fatigue, blood sugar higher than usual, palpitations and decrease in appetite.  Symptoms continued through 4/18. 4/19 and 4/20 symptoms improving.  Still some redness (more diffuse) at injection site, but much better.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Pain, Palpitations, Pyrexia
Clinical narrative: Redness, heat, and pain at injection site in left upper arm about 2 inch circumference, and pain at injection site requiring Tylenol every 4-6 hours.  Body aches, feverish, fatigue, blood sugar higher than usual, palpitations and decrease in appetite.  Symptoms continued through 4/18. 4/19 and 4/20 symptoms improving.  Still some redness (more diffuse) at injection site, but much better.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Abdominal pain, Abortion spontaneous, Amniotic cavity infection, Exposure during pregnancy, Foetal death
Clinical narrative: In the morning, I had leg cramps. Later in the afternoon, I had abdominal pain. By 8PM, I was in pre-term labor. I had extremely high blood pressure and rapid heart rate upon entrance to the ER. I was in labor for at least 6 hours, giving birth to a stillborn 16-weeks-gestation baby just after 2AM.  Later determined to be chorioamnionitis of the placenta and pneumonia in the baby, resulting in fetal death.  I had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection.  The vaccine was administered immediately after the ultrasound on 11/07/2014.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Foetal disorder, Heart rate increased, Hypertension, Laboratory test abnormal, Muscle spasms
Clinical narrative: In the morning, I had leg cramps. Later in the afternoon, I had abdominal pain. By 8PM, I was in pre-term labor. I had extremely high blood pressure and rapid heart rate upon entrance to the ER. I was in labor for at least 6 hours, giving birth to a stillborn 16-weeks-gestation baby just after 2AM.  Later determined to be chorioamnionitis of the placenta and pneumonia in the baby, resulting in fetal death.  I had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection.  The vaccine was administered immediately after the ultrasound on 11/07/2014.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Pathology test, Premature labour, Stillbirth
Clinical narrative: In the morning, I had leg cramps. Later in the afternoon, I had abdominal pain. By 8PM, I was in pre-term labor. I had extremely high blood pressure and rapid heart rate upon entrance to the ER. I was in labor for at least 6 hours, giving birth to a stillborn 16-weeks-gestation baby just after 2AM.  Later determined to be chorioamnionitis of the placenta and pneumonia in the baby, resulting in fetal death.  I had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection.  The vaccine was administered immediately after the ultrasound on 11/07/2014.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Abdominal pain, Abortion spontaneous, Amniotic cavity infection, Foetal death, Heart rate increased
Clinical narrative: In the morning, I had leg cramps. Later in the afternoon, I had abdominal pain. By 8PM, I was in pre-term labor. I had extremely high blood pressure and rapid heart rate upon entrance to the ER. I was in labor for at least 6 hours, giving birth to a stillborn 16-weeks-gestation baby just after 2AM.  Later determined to be chorioamnionitis of the placenta and pneumonia in the baby, resulting in fetal death.  I had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection.  The vaccine was administered immediately after the ultrasound on 11/07/2014.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Hypertension, Laboratory test abnormal, Muscle spasms, Pathology test, Pneumonia
Clinical narrative: In the morning, I had leg cramps. Later in the afternoon, I had abdominal pain. By 8PM, I was in pre-term labor. I had extremely high blood pressure and rapid heart rate upon entrance to the ER. I was in labor for at least 6 hours, giving birth to a stillborn 16-weeks-gestation baby just after 2AM.  Later determined to be chorioamnionitis of the placenta and pneumonia in the baby, resulting in fetal death.  I had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection.  The vaccine was administered immediately after the ultrasound on 11/07/2014.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Premature labour, Stillbirth
Clinical narrative: In the morning, I had leg cramps. Later in the afternoon, I had abdominal pain. By 8PM, I was in pre-term labor. I had extremely high blood pressure and rapid heart rate upon entrance to the ER. I was in labor for at least 6 hours, giving birth to a stillborn 16-weeks-gestation baby just after 2AM.  Later determined to be chorioamnionitis of the placenta and pneumonia in the baby, resulting in fetal death.  I had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection.  The vaccine was administered immediately after the ultrasound on 11/07/2014.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Abdominal pain, Amniotic cavity infection, Delivery, Foetal death, Heart rate increased
Clinical narrative: In the morning, I had leg cramps. Later in the afternoon, I had abdominal pain. By 8PM, I was in pre-term labor. I had extremely high blood pressure and rapid heart rate upon entrance to the ER. I was in labor for at least 6 hours, giving birth to a stillborn 16-weeks-gestation baby just after 2AM.  Later determined to be chorioamnionitis of the placenta and pneumonia in the baby, resulting in fetal death.  I had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection.  The vaccine was administered immediately after the ultrasound on 11/07/2014.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Hypertension, Muscle spasms, Pneumonia, Premature labour, Stillbirth
Clinical narrative: In the morning, I had leg cramps. Later in the afternoon, I had abdominal pain. By 8PM, I was in pre-term labor. I had extremely high blood pressure and rapid heart rate upon entrance to the ER. I was in labor for at least 6 hours, giving birth to a stillborn 16-weeks-gestation baby just after 2AM.  Later determined to be chorioamnionitis of the placenta and pneumonia in the baby, resulting in fetal death.  I had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection.  The vaccine was administered immediately after the ultrasound on 11/07/2014.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Foetal exposure during pregnancy, Pathology test, Pneumonia, Premature baby death, Stillbirth
Clinical narrative: In the morning, I had leg cramps. Later in the afternoon, I had abdominal pain. By 8PM, I was in pre-term labor. I had extremely high blood pressure and rapid heart rate upon entrance to the ER. I was in labor for at least 6 hours, giving birth to a stillborn 16-weeks-gestation baby just after 2AM.  Later determined to be chorioamnionitis of the placenta and pneumonia in the baby, resulting in fetal death.  I had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection.  The vaccine was administered immediately after the ultrasound on 11/07/2014.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Abdominal pain, Abortion spontaneous, Amniotic cavity infection, Exposure during pregnancy, Foetal disorder
Clinical narrative: In the morning, I had leg cramps. Later in the afternoon, I had abdominal pain. By 8PM, I was in pre-term labor. I had extremely high blood pressure and rapid heart rate upon entrance to the ER. I was in labor for at least 6 hours, giving birth to a stillborn 16-weeks-gestation baby just after 2AM.  Later determined to be chorioamnionitis of the placenta and pneumonia in the baby, resulting in fetal death.  I had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection.  The vaccine was administered immediately after the ultrasound on 11/07/2014.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Heart rate increased, Hypertension, Laboratory test abnormal, Muscle spasms, Pathology test
Clinical narrative: In the morning, I had leg cramps. Later in the afternoon, I had abdominal pain. By 8PM, I was in pre-term labor. I had extremely high blood pressure and rapid heart rate upon entrance to the ER. I was in labor for at least 6 hours, giving birth to a stillborn 16-weeks-gestation baby just after 2AM.  Later determined to be chorioamnionitis of the placenta and pneumonia in the baby, resulting in fetal death.  I had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection.  The vaccine was administered immediately after the ultrasound on 11/07/2014.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3, FLU3
Symptoms: Premature baby death, Premature labour, Stillbirth
Clinical narrative: In the morning, I had leg cramps. Later in the afternoon, I had abdominal pain. By 8PM, I was in pre-term labor. I had extremely high blood pressure and rapid heart rate upon entrance to the ER. I was in labor for at least 6 hours, giving birth to a stillborn 16-weeks-gestation baby just after 2AM.  Later determined to be chorioamnionitis of the placenta and pneumonia in the baby, resulting in fetal death.  I had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection.  The vaccine was administered immediately after the ultrasound on 11/07/2014.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Impaired driving ability, Muscle tightness, Walking aid user
Clinical narrative: Starting about 15 minutes after receiving shot, patient states that her muscles started tightening up. She had difficulty getting to her car and driving home, then had difficulty walking for the next week and had to use a walker when previously not having to use a walker all the time. She told her doctor about the event but is not sure if it was ever reported, and she received no treatment. She said it was "a few weeks" before she recovered to near normal condition.
Age: 1.08
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Inguinal hernia, Inguinal hernia repair, Ultrasound scan, Urine analysis, X-ray
Clinical narrative: Right sided Inguinal Hernia.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Peripheral swelling, Swelling, Swelling face
Clinical narrative: Swelling of chest area, enlargement of limbs, face swelling.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Flushing, Immediate post-injection reaction, Malaise, Skin tightness
Clinical narrative: Pt complained within seconds of receiving flu shot of not feeling well. Pt states that he felt tightness around nose and flushed but denies shortness of breath. Vitals are 122/70, pulse 63, O2 94% and temp 99.0.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Headache, Injection site reaction, Nausea
Clinical narrative: After shot was administered on 4-14-15 patient had nausea, dizziness, headache, and large on site reaction.
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site nodule, Injection site reaction, Skin exfoliation
Clinical narrative: (L) leg: at site of injection has 1 cm nodule, subdermal, at 2 cm distal to injection site has 1 cm erythematous scaling patch.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Asthenia, Generalised tonic-clonic seizure, Postictal state, Seizure
Clinical narrative: 4/14/15 5:20 pm medical center for seizure which occurred shortly before then. Witnessed by parents. Generalized sx, postictal st, weakness-generalized. Received Hep A, MMR, VARIVAX 4/14/15 at 9:30 am. (Grand mal seizure)
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Donor stated that when she woke up the day after receiving the shot that she noticed her arm was sore and some redness. Upon evaluation: redness present at injection site and is 2 inches in dia. site is warm. Stiff and sore around 2 inch diameter barrier. Donor states her arm is sore w/certain activities. No hx of reactions for herself or any known family members.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Donor stated that when she woke up the day after receiving the shot that she noticed her arm was sore and some redness. Upon evaluation: redness present at injection site and is 2 inches in dia. site is warm. Stiff and sore around 2 inch diameter barrier. Donor states her arm is sore w/certain activities. No hx of reactions for herself or any known family members.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Pt reports pain, heat and swelling at injection site. Body aches Fri and Sat night. Pt called today 4/20/15 to report arm is better but still slightly warm and sore.
Age: 25.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Case number PHHY2015US047389 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 563753) website on 21 Apr 2015. This report refers to a 25-year-old male patient. Historical conditions and concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) in the arm on 25 Sep 2014. On 29 Sep 2014, he experienced tonic clonic seizure. Following the event the patient had an emergency room visit. Outcome of the event was reported as not recovered. The seriousness of the event was not reported but the event was upgraded as medically significant based on information available in NVS-IME list. Causality of the event was not reported.
Age: 5.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Cardiac arrest, Cough, Death, Influenza, Life support
Clinical narrative: Case number PHHY2015US047311, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 563861) website on 21 Apr 2015. This report refers to a 5-year-old female patient. Her historical conditions and concomitant medication were not reported. She was vaccinated with seasonal Influenza vaccine (manufacturer and batch number: unknown) on an unknown date. On an unknown date, after vaccination, the patient experienced a cough and fever. The patient was seen in a clinic and prescribed with steroids and a nebulizer. Hours later the patient collapsed and CPR was performed. The patient was found to have Influenza A. Then the patient was hospitalized and placed on life support. The patient had a cardiac arrest. Outcome of the events was condition unchanged. Further on an unknown date, the patient died. Seriousness criteria were reported as fatal, life threatening and hospitalization. Causality of the events was not reported.
Age: 5.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pyrexia, Resuscitation, Syncope
Clinical narrative: Case number PHHY2015US047311, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 563861) website on 21 Apr 2015. This report refers to a 5-year-old female patient. Her historical conditions and concomitant medication were not reported. She was vaccinated with seasonal Influenza vaccine (manufacturer and batch number: unknown) on an unknown date. On an unknown date, after vaccination, the patient experienced a cough and fever. The patient was seen in a clinic and prescribed with steroids and a nebulizer. Hours later the patient collapsed and CPR was performed. The patient was found to have Influenza A. Then the patient was hospitalized and placed on life support. The patient had a cardiac arrest. Outcome of the events was condition unchanged. Further on an unknown date, the patient died. Seriousness criteria were reported as fatal, life threatening and hospitalization. Causality of the events was not reported.
Age: 31.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from 31 year old female patient with no medical history, drug reactions allergies or concurrent conditions. On 06-FEB-2015 the patient was vaccinated with an unspecified varicella virus vaccine live (manufacturer unknown) (dose, frequency, lot number and expiration date were not reported). The consumer reported that she received a dose of an unspecified varicella virus vaccine live (manufacturer unknown) and subsequently, she discovered that she was 6 weeks pregnant. She took a pregnancy test and the results were positive. The patient last menstrual period (LMP) was approximately on 29-DEC-2014, the estimated date of conception and estimated date of delivery were 12-JAN-2015 and 12-JAN-2015 respectively. The patient contacted her physician and made an appointment. Follow up information was received from the registered nurse and physician via the pregnancy risk registry program on 17-APR-2015. Patient demographics were updated. Patient's concurrent conditions included polycystic ovarian syndrome, latent tuberculosis and history of premature delivery in 2007. Patient did not smoke or use alcohol. She had no illness at the time of vaccination. On 22-DEC-2014, patient was tested for varicella antibodies before vaccination with VZV containing vaccine and the result was negative. Patient was vaccinated with VARIVAX with lot no# K007975 subcutaneously in the left arm on 06-FEB-2015. On 08-FEB-2015, a urine pregnancy test was done which was positive (also reported as unknown). Patient's last menstrual period (LMP) was reported to be 30-DEC-2014 and estimated delivery date to be 17-OCT-2015. Lab tests revealed HCG (human chorionic gonadotropin) level to be 32/50 (units unspecified) on 11-FEB-2015. ABO/RH test in February 2015 showed 3 weeks. On 20-FEB-2015, an Ultrasound showed visible pregnancy at 5 weeks. The patient was seen on 26-FEB-2015 and on 04-MAR-2015, for counselling and she finally chose elective termination since her first child was a special needs child. Elective termination was done at greater than 7 weeks from LMP, in approximately March 2015. Causality for elective termination was not provided. Upon internal review, abortion induced was determined to be medically significant. Additional information has been requested. Reporter information, patient demographics, medical history, lab tests, vaccine information, events and narrative have been updated.