chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging normal, Posture abnormal, Pregnancy test negative, Staring
Clinical narrative: Patient is a previously healthy 11 year old female who was admitted from the Emergency Center with a one day history of headache and altered mental status. Per mother, patient was in her usual state of health until yesterday 9/23/15. She received her Tdap and meningitis vaccines and almost immediately after receiving the meningitis vaccine she began to drop her head, feel weak, and was more tired. There was no immediate syncope. Mother next took her to school, however shortly after dropping her off patient experienced a syncopal episode in class. This was reportedly witnessed by a teacher and patient's sister. There was no reported head trauma with the syncope. Patient herself cannot recall the event. Mother then took patient to hospital where initial lab work included CBC, CMP, pregnancy test, and UDS were reportedly negative. Given her history of a new onset of light headache, a CT and MRI scan were performed, both of which were unremarkable. Patient was discharged home after receiving an unknown pain medication. On the way home, patient had her first "dazed" episode where mother states she would stare off into space. There was no deviation of her eyes, movements of her limbs, or loss of bowel/bladder control. Mother states that she could "snap her out of it" by snapping her fingers. The episodes would last approximately one minute and patient would return back to her baseline. Once home that same day, patient's headache continued to worsen and was located primarily behind her eyes. She denies any lacrimation or injection of her eyes. At approximately 20:30 on the evening prior to admission, patient was walking downstairs when mother noted her knees buckled but patient did not fall. At that moment, mother said patient walked from dark, to light, to dark and mother did not notice her pupils reacting the way they were supposed. This prompted mother to return to the ED at which point a physician reportedly also noted that the pupils were not reactive. The was not documented on review of the EC notes. Patient was then transferred to another EC for further evaluation. While en route, she was given IV ketorolac and a bolus of IV fluids which reportedly helped reduced her headache to a 2/10. At the EC, her physical exam was unremarkable. She was admitted for further evaluation and management of her headache and altered mental status spells.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ
Symptoms: Syncope
Clinical narrative: Patient is a previously healthy 11 year old female who was admitted from the Emergency Center with a one day history of headache and altered mental status. Per mother, patient was in her usual state of health until yesterday 9/23/15. She received her Tdap and meningitis vaccines and almost immediately after receiving the meningitis vaccine she began to drop her head, feel weak, and was more tired. There was no immediate syncope. Mother next took her to school, however shortly after dropping her off patient experienced a syncopal episode in class. This was reportedly witnessed by a teacher and patient's sister. There was no reported head trauma with the syncope. Patient herself cannot recall the event. Mother then took patient to hospital where initial lab work included CBC, CMP, pregnancy test, and UDS were reportedly negative. Given her history of a new onset of light headache, a CT and MRI scan were performed, both of which were unremarkable. Patient was discharged home after receiving an unknown pain medication. On the way home, patient had her first "dazed" episode where mother states she would stare off into space. There was no deviation of her eyes, movements of her limbs, or loss of bowel/bladder control. Mother states that she could "snap her out of it" by snapping her fingers. The episodes would last approximately one minute and patient would return back to her baseline. Once home that same day, patient's headache continued to worsen and was located primarily behind her eyes. She denies any lacrimation or injection of her eyes. At approximately 20:30 on the evening prior to admission, patient was walking downstairs when mother noted her knees buckled but patient did not fall. At that moment, mother said patient walked from dark, to light, to dark and mother did not notice her pupils reacting the way they were supposed. This prompted mother to return to the ED at which point a physician reportedly also noted that the pupils were not reactive. The was not documented on review of the EC notes. Patient was then transferred to another EC for further evaluation. While en route, she was given IV ketorolac and a bolus of IV fluids which reportedly helped reduced her headache to a 2/10. At the EC, her physical exam was unremarkable. She was admitted for further evaluation and management of her headache and altered mental status spells.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ
Symptoms: Abasia, Electroencephalogram abnormal, Migraine, Seizure, Staring
Clinical narrative: Patient is a previously healthy 11 year old female who was admitted from the Emergency Center with a one day history of headache and altered mental status. Per mother, patient was in her usual state of health until yesterday 9/23/15. She received her Tdap and meningitis vaccines and almost immediately after receiving the meningitis vaccine she began to drop her head, feel weak, and was more tired. There was no immediate syncope. Mother next took her to school, however shortly after dropping her off patient experienced a syncopal episode in class. This was reportedly witnessed by a teacher and patient's sister. There was no reported head trauma with the syncope. Patient herself cannot recall the event. Mother then took patient to hospital where initial lab work included CBC, CMP, pregnancy test, and UDS were reportedly negative. Given her history of a new onset of light headache, a CT and MRI scan were performed, both of which were unremarkable. Patient was discharged home after receiving an unknown pain medication. On the way home, patient had her first "dazed" episode where mother states she would stare off into space. There was no deviation of her eyes, movements of her limbs, or loss of bowel/bladder control. Mother states that she could "snap her out of it" by snapping her fingers. The episodes would last approximately one minute and patient would return back to her baseline. Once home that same day, patient's headache continued to worsen and was located primarily behind her eyes. She denies any lacrimation or injection of her eyes. At approximately 20:30 on the evening prior to admission, patient was walking downstairs when mother noted her knees buckled but patient did not fall. At that moment, mother said patient walked from dark, to light, to dark and mother did not notice her pupils reacting the way they were supposed. This prompted mother to return to the ED at which point a physician reportedly also noted that the pupils were not reactive. The was not documented on review of the EC notes. Patient was then transferred to another EC for further evaluation. While en route, she was given IV ketorolac and a bolus of IV fluids which reportedly helped reduced her headache to a 2/10. At the EC, her physical exam was unremarkable. She was admitted for further evaluation and management of her headache and altered mental status spells.
Age: 20.0
Sex: F
Vaccine: FLU3, MMR, MNQ, TDAP, VARCEL
Symptoms: Arthralgia, Fatigue, Headache, Pain
Clinical narrative: Vaccine administered 5:45 pm, 10/15 no problems - patient left clinic feeling fine. 3 am awoke with joint pain in wrist and headache. Took MOTRIN one at 7:30 am, feeling tired and pain 6 out of 10. Injection sites no redness/swelling.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Developed hives a few hours after having immunization.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warm to touch and painful at injection site 3-4 inches circ. Advised MOTRIN - cool compress.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red, swollen and painful at injection site. 3 inches. Advised Motrin-cool compress.
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, swolle, warm and painful at injection site - 3-4 in" in diameter - x 24 hrs. Motrin-cool compress to site x 24 hrs.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warm to touch at injection site 3-4 inches in circ. Advised Motrin-cool compress.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warm to touch at injection site, 3-4 inches in circ. Advised Motrin-cool compress.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warm to touch - painful at injection site 3 inches in cir. Advised Motrin-cool compress.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warm to touch. Painful at injection site . 2-3 inches in circ. Advised Motrin-cool compress.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Area 1" redness, swelling, warmthto touch at injection site. Area painful. Resolved 10-15-15. Pain axilla 10-16-15.
Age: 61.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Erythema, Pain, Pain in extremity, Pyrexia
Clinical narrative: Next day he felt drowsy. He was weak, had a fever, aches. His arm became very red, very sore and painful. Patient is still weak two weeks later.
Age: 61.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Somnolence
Clinical narrative: Next day he felt drowsy. He was weak, had a fever, aches. His arm became very red, very sore and painful. Patient is still weak two weeks later.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hypoaesthesia, Pain in extremity
Clinical narrative: Left arm, sore arm, chills, numbness. She says the shot was given higher than usual and maybe hit the bone.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: Patient's mom stated patient had a fever of 103 the night of 10/12/15. Patient came in for triage - temperature of 99.1. PA-C recommended BENADRYL as needed. Patient has redness and induration to right arm.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Lacrimation increased, Rhinorrhoea
Clinical narrative: The next evening after receiving the FLUMIST began having sxs cough runny nose, watery eyes.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: PCV 23 and FLUZONE given on 10/14/15 right deltoid. Redness 40x60cm. Hot to the touch.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: Rash and rash and swelling of entire right arm.
Age: 23.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling in his left deltoid.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria pruritus. Diphenhydramine 50 mg once.
Age: 1.17
Sex: F
Vaccine: DTAP, FLU4, HEPA, HIBV, MMRV, PNC13
Symptoms: Febrile convulsion
Clinical narrative: Pt. had a febrile seizure and was evaluated at medical center. Rechecked in our office.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Abdominal pain upper, Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Mother brought patient to clinic today to report vaccine reaction from injection 10-9-15. Reports area was red and swollen for three days and child had fever on 10-12-15 and given TYLENOL. Child also complained of stomach ache during that time period. Today Lt upper anterior leg with induration 10 x 10 cm and slight redness. No fever, denies stomach ache.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Vaccination complication
Clinical narrative: Mother brought patient to clinic today to report vaccine reaction from injection 10-9-15. Reports area was red and swollen for three days and child had fever on 10-12-15 and given TYLENOL. Child also complained of stomach ache during that time period. Today Lt upper anterior leg with induration 10 x 10 cm and slight redness. No fever, denies stomach ache.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Eye movement disorder, Fall, Hyperhidrosis
Clinical narrative: Gave shot, patient moved to other chair, gave brothers shot, then went to give mother's shot and patient clenched fists and feel out of chair. Became cold and clammy and eyes rolled back in head. Lowered head to ground and gave smelling salts. Patient woke and didn't remember what happened, sweaty and dizzy.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle contractions involuntary
Clinical narrative: Gave shot, patient moved to other chair, gave brothers shot, then went to give mother's shot and patient clenched fists and feel out of chair. Became cold and clammy and eyes rolled back in head. Lowered head to ground and gave smelling salts. Patient woke and didn't remember what happened, sweaty and dizzy.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: Whole upper arm swelled up w/in 5 minutes of receiving FLUZONE HD. Put ice on it x 15 minutes and encouraged him to see his doctor.
Sex: U
Vaccine: FLU4
Symptoms: Malaise
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of sickness in a patient who received FLULAVAL. On 2nd October 2015, the patient received FLULAVAL. On 5th October 2015, 3 days after receiving FLULAVAL, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to FLULAVAL season. Additional details were provided as follows: This is one of the 7 cases reported by the same reporter. The reporter indicated that FLULAVAL vaccines were adminsitered to a group of individuals at a company clinic. The sales rep stated that the reporter said six other individuals called out sick (possibly October 5th) after receiving the Flu vaccine but details were unknown and it was not know if related.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Malaise, Pyrexia
Clinical narrative: Patient reports cough,l fever and malaise after receiving the Pneumovax vaccine on 3/17/11. This was reported in a follow-up appt in September.
Age: 0.26
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Muscle contractions involuntary, Screaming, Tremor
Clinical narrative: As reported by mother - during the evening of 5/6/15 infant started to cry and was not consolable. Infant continually cried withe clinched fist at times seemed to shake. Screamed through most of the night. Mother thought of taking baby to ER but did not.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Antiphospholipid antibodies, Fibromyalgia
Clinical narrative: Pt states that she has developed Lupus and fibromyalgia from receiving a Hepatitis B vaccine in 07/2015.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Erythema and pain which radiated across upper arm and shoulder lasting 1-2 weeks.
Age: 24.0
Sex: M
Vaccine: PPV
Symptoms: Palpitations, Peripheral swelling, Pruritus, Tachycardia, Urticaria
Clinical narrative: Telephone call from the emergency room provider Hospital he describes patient as having a very signficant and drug reaction to the pneumococcal vaccination administered yesterday. He is tachycardia has significant swelling in the upper extremity is being treated with IV SOLU-MEDROL and remains in the emergency room at this time. Urticaria, Pruritus and Palpitations.
Age: 24.0
Sex: M
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Telephone call from the emergency room provider Hospital he describes patient as having a very signficant and drug reaction to the pneumococcal vaccination administered yesterday. He is tachycardia has significant swelling in the upper extremity is being treated with IV SOLU-MEDROL and remains in the emergency room at this time. Urticaria, Pruritus and Palpitations.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: REdness and swelling (golf ball size)
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria, Pruritus
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Skin exfoliation
Clinical narrative: Fever, Sloughing
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site rash
Clinical narrative: Rash on thighs only.
Age: 7.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Dtap given and not needed. No adverse outcome.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had a red swollen arm at spot where she had the vaccination.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme
Clinical narrative: Erythema Multiform
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a consumer referring to her child, a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with VARIVAX (dose, frequency, route, lot# and expiration date not reported). On an unknown date the patient experienced a mild case of Chicken Pox (diagnosed by an unspecified physician) after the vaccination. The outcome of the event was unknown. Causality assessment was not reported. Additional information is not expected due to lack of contact information.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. In 2015 these patients were vaccinated with doses of ZOSTAVAX (lot# L000450 with expiration 09-MAR-2016; lot# K020802 with expiration 31-JAN-2016; lot# L015416 with expiration 01-AUG-2016; dose and frequency were not reported), which had been improperly stored since January 2015 (incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. In 2015 these patients were vaccinated with doses of PROQUAD (Merck) (lot # K022446 with expiration 13-MAY-2016; lot# L017140 with expiration 13-NOV-2016; dose, frequency and route were not reported), which had been improperly stored since January 2015. No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. In 2016 these patients were vaccinated with doses of GARDASIL 9 (lot # K026247 with expiration 29-JAN-2017; dose, frequency and route were not reported), which had been improperly stored since January 2015) (incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Information has been received from a physician and Licensed Practical Nurse via field representative referring to a 12 month old male patient. The patient's pertinent medical history and drug reactions or allergies were unspecified. On an unknown date, the patient was vaccinated with one dose of VARIVAX (Merck) (lot number, expiration date and dose were unknown) subcutaneously due to a childhood vaccine recommendation. Other suspect therapies included M-M-R II (lot number, expiration date, dose and route were unknown). COncomitant medications included other unspecified vaccines. On an unknown date, the patient developed a chickenpox rash over 25% of his body (on his leg, groin, face and hands). The patient sought medical attention via office visit. The outcome of the event was unknown. The causality between the event and suspect therapies was unspecified. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age. On 13-OCT-2015 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 lot # J013555 (expiration date 02-MAY-2015). No adverse events were reported. The outcome was unknown. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant to a 12 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL (lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported). No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant to an 11 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL (lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported). No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose and route were not reported; lot # L017997 with expiry date 19-MAY-2017; lot # L004654 with expiry date 11-FEB-2017; lot # L013063 with expiry date 14-APR-2017 and lot # L006383 with expiry date 25-FEB-2017). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown ae and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose and route were not reported; lot # L004006 with expiry date 05-AUG-2016; lot # L009210 with expiry date 17-SEP-2016; lot # L030592 with expiry date 12-FEB-2017 and albumin status of recombinant human albumin (RHA); lot # reported as L0169304 (invalid lot number for PROQUAD (Merck) with expiry date 08-NOV-2016). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant to a 13 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL (lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported). No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician via a field representative referring to her/his 13 year old male son. Information about medical history, concurrent condition and concomitant medication was not reported. On an unspecified date in 2003 (reported as "about 12 years ago") the patient was vaccinated with VARIVAX (Merck) (subcutaneous injection; strength, dosage and frequency unspecified). The patient was immunized with the appropriate doses as indicated on the prescribing information. On an unspecified date in 2015 (reported as "within the past two weeks") the patient had developed chicken pox. The patient sought medical attention as he was the physician's son. The outcome of the event was reported as recovered/resolved on an unspecified date in 2015. Therapy with VARIVAX (Merck) was also reported as continued. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a physician referring to an 18 year old patient of unknown gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 12-OCT-2015 the patient was vaccinated with a dose of PROQUAD (Merck) (lot#, dose, route and dose number were unspecified) when the patient was 18 years of age. No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant to an 11 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported). No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of  unknown age and gender. No concurrent condition or medical history was reported. On 08-OCT-2015 the patient was vaccinated with expired dose of PNEUMOVAX23 (lot # K010016, dose and route of administration not provided). No concomitant therapy was reported. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Thrombosis
Clinical narrative: Information has been received from a new article via an journalist in a website referring to unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with doses of GARDASIL (dose, dose number, lot number, application and route were not reported). According to the research of Centers for Disease Control and Prevention, the researchers looked at problems reported to the Vaccine Adverse Events Reporting System in the 2.5 years since GARDASIL was licensed. There were 0.2 blood clots per 100,000 doses. The outcome of event blood clots was not reported. The causality was unknown. This is one of several reports received from the same source. Additional information is not expected since there was no contact details provided.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received from a news article via a journalist in a website referring to unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with doses of GARDASIL (dose, dose number, lot number, application and route were not reported). According to the research of Centers for Disease Control and Prevention, the researchers looked at problems reported to the Vaccine Adverse Events Reporting System in the 2.5 years since GARDASIL was licensed. Overall, 93.8 percent reported problems were considered non-serious. The exact adverse events were not reported. It was reported that these types of reports could not determine whether adverse events were caused by the vaccine or just a coincidence. This is one of several reports received from the same source. Additional information is not expected since there was no contact details provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. In 2015 these patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot # K021484, expiration 03-NOV-2016; dose, frequency were not reported), which had been improperly stored since January 2015 (incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a new article via an journalist in a website referring to unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with doses of GARDASIL (dose, dose number, lot number, application and route were not reported). According to the research of Centers for Disease Control and Prevention, the researchers looked at problems reported to the Vaccine Adverse Events Reporting System in the 2.5 years since GARDASIL was licensed. There were 8.2 reports of fainting per 100,000 cases. The outcome of event fainting was not reported. The causality was unknown. This is one of several reports received from the same source. Additional information is not expected since there was no contact details provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to unspecified number of patients of unknown age and gender. There was no information about patients pertinent medical histories, concomitant medications and drug reactions or allergies provided. Since 06-OCT-2015, the patients were vaccinated with improperly stored doses of ROTATEQ orally (lot# L008053, expiration date 30-NOV-2016; lot # L000568, expiration date 10-JUL-2016; lot # L008997, expiration date 04-DEC-2016 dose was not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant to a 16 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported). No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant to a 12 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported). No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant to a 14 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported). No adverse experiences were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant to a 15 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported. No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant to an 18 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported. No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 66 year old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 06-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose 0.65 ml, route subcutaneous, lot # L013546, expiration date 17-JUL-2016). On 09-OCT-2015 (reported as next day), the patient experienced a "rash" at the injection site. The rash was "a red circle about 2 inches in diameter" and was also painful and itchy. On 13-OCT-2015, the patient was seen by the pharmacist. The patient did not receive any treatment for the adverse events. There was no lab diagnostics and studies performed. The patient's outcome was not recovered/not resolved. The relatedness between the events and the therapy with ZOSTAVAX was not provided. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant to an 14 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported. No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Impetigo, Rash, Rash maculo-papular, Varicella
Clinical narrative: 8/13/15 ER developed maculopapular rash on trunk, arms and legs. ER stated chicken pox. 8/16/15 ER again now with rash on face, under nose and upper mouth. ER states impetigo. Mom unable to reach by phone or certified letter. Lost to follow up.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Dyskinesia, Fall, Guillain-Barre syndrome, Intensive care, Vaccination complication
Clinical narrative: He got the shot in (18) of September got bad reaction, he couldn't control his body, he fell down 3 times then they take him to Emergency 2 time and now he is inpatient he was in (ICU).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had a very red, swollen area around administration site. Still persisting after a week. Her doctor prescribed VALTREX as treatment.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Confusional state, Fatigue, Hepatitis B antibody, Pain in extremity
Clinical narrative: Patient states no problems initially after receiving vaccine. Denies pain immediately following injection, but 1/2 hr afterward spoke to sister on phone and sister asked her if she was "drunk" - she felt confused, weak and fatigued and took 1/2 nap - That evening went out to eat and didn't give enough money to pay her bill - confusion lasted 1 1/2 - 2 days. Pain in arm started 2 hrs after shot and lasted 1 week.
Age: 57.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant to an 11 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported. No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Pt had swelling at injection site, itchiness that spread throughout body no fever or headache. Went to urgent care - was prescribed KEFLEX, prednisone, ATARAX.
Age: 0.25
Sex: F
Vaccine: HEPA, PPV, HEPA, PPV
Symptoms: Wrong drug administered
Clinical narrative: Pt was seen for a nurse visit, wrong vaccines given, even noticed upon 5 month visit. Merck called.
Age: 0.25
Sex: F
Vaccine: HEPA, PPV, HEPA, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt was seen for a nurse visit, wrong vaccines given, even noticed upon 5 month visit. Merck called.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Dizziness, Injection site erythema, Injection site urticaria
Clinical narrative: Patient received injection on 9/24/15. She came to the pharmacy on 10-6-15 with hives and redness at site of injection approximately 3 inch/2 inch.  Complained of dizziness, diarrhea which I told her is probably unrelated.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: Patient received vaccine on 9/30/15, started to itch and burn the next day, by Saturday 10/3 she had rash that covered entire upper arm.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Decreased appetite, Nausea, Pyrexia, Vaccination site cellulitis
Clinical narrative: Tenderness, swelling, severe cellulitis like reaction from vaccination site to elbow, nausea, loss of appetite, fever 101 - urgent care diagnosed cellulitis - BACTRIM prescribed. Seen 3 times.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Tenderness, swelling, severe cellulitis like reaction from vaccination site to elbow, nausea, loss of appetite, fever 101 - urgent care diagnosed cellulitis - BACTRIM prescribed. Seen 3 times.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant to an 16 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported. No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant to an 12 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported. No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant to an 17 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported. No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant to a 15 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL (lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported). No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant to a 17 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL (lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported). No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant to a 16 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL (lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported). No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Cellulitis
Clinical narrative: Cellulitis (L) arm. Follow up with provider 10/20/15 to re check. Tx with cephalexin 250 mg/5 ml bid x10 days.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX, lot # K021487, expiration date 03-NOV-2016 (dose, route of administration and indication were not reported). Concomitant therapy was not provided. No adverse effects were reported. Additional information has been requested.