chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 13.25 hours. On 18-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 12.75 hours. On 22-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 5 hours. On 04-JAN-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H016765). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 1.57
Sex: M
Vaccine: FLU3
Symptoms: Abdominal X-ray, Blood creatine phosphokinase increased, C-reactive protein normal, Chest X-ray normal, Crying
Clinical narrative: Patient constantly crying and in some pain, fussy, constantly rubbing his legs, unable to sleep, blue hue on mid chest and abdomen, rash on face.
Age: 1.57
Sex: M
Vaccine: FLU3
Symptoms: Cyanosis, Full blood count normal, Insomnia, Irritability, Limb discomfort
Clinical narrative: Patient constantly crying and in some pain, fussy, constantly rubbing his legs, unable to sleep, blue hue on mid chest and abdomen, rash on face.
Age: 1.57
Sex: M
Vaccine: FLU3
Symptoms: Metabolic function test normal, Pain, Rash, Red blood cell sedimentation rate normal, Skin discolouration
Clinical narrative: Patient constantly crying and in some pain, fussy, constantly rubbing his legs, unable to sleep, blue hue on mid chest and abdomen, rash on face.
Age: 1.88
Sex: M
Vaccine: FLUN4
Symptoms: Pyrexia
Clinical narrative: Patient had fever to a maximum of 105 F.  Controlled with Tylenol, Advil, and cold baths.
Age: 27.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Chills, Vaccination site erythema, Vaccination site pain
Clinical narrative: Rigors, chills, pain at sight of immunization, erythema greater than expected at immunization site.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Abdominal pain upper, Depressed level of consciousness, Syncope, Thirst
Clinical narrative: Child had recieved school entry immunizations total of 4.  Child was sitting on father's lap during procedure. Child was alert and oriented the entire time.  Child did not cry during process. Nurse turned back to clear area. Father related "she fainted". Child was laying on the floor. Child not alert but when touched opened eyes and responded. Child assisted to the clinic table where she started to cry.  No apparent injury to body was noted with exam. Father verbalized he did not think she hit her head. Child wanted water. Only complaint was that of "stomach ache".  Child ambulated from the clinic in hand of father. Father was informed to seek medical attention should child have issues with headache, seizures, hives or shortness of breath. He verbalized understanding.
Age: 63.0
Sex: F
Vaccine: FLUC3
Symptoms: Chills, Ear discomfort, Headache, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Sore throat, ear discomfort, runny nose, chills. Subsequent headache added to symptoms. 4th day now with all symptoms.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: HISTORY OF PRESENT OF ILLNESS: pt with rash after having been given Pneumovax on 1/8/14. She stated it was swollen and itchy yesterday but some better today. never had Pneumovax in past. Pt states area cleaned before shot given. Treatment predniSONE TAB  5MG  TAKE FOUR (4) TABLETS BY MOUTH DAILY FOR 1 DAY THEN TAKE TWO (2) TABLETS BY MOUTH DAILY FOR 1 DAY THEN TAKE ONE (1) TABLET BY MOUTH DAILY FOR 1 DAY TO CONTROL INFLAMMATION. *TAKE WITH FOOD*  Quantity: 7 Days: 6  Refills: 0 *Chronic Med: NO Dispense as Written: NO Indication: Rash and other nonspecific skin eruption.  Outside Med ACETAMINOPHEN TAB  325MG  TAKE TWO (2) TABLETS BY MOUTH Q6H PRN Jan 10, 2014  Outside medication recommended by provider for pain. Outside Med diphenhydrAMINE CAP, ORAL  25MG  TAKE ONE (1) CAPSULE BY MOUTH FOUR TIMES A DAY Jan 10, 2014  Outside medication recommended by provider for itching.
Age: 15.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Electrocardiogram normal, Syncope
Clinical narrative: Syncopal episode, pt came to after 30 seconds.
Age: 23.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Pruritic isolated vesicular lesions on left arm and left leg.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Rash
Clinical narrative: Patient complained of a rash that showed up about one week after the administration of the vaccine.  He also complained of some numbness on his arm.  Called the manufacter and let them know and they did not send me a copy of VAERS statement.  Phone number on file is not getting any return call backs so unable to contact patient.
Age: 63.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Cold sweat, Dizziness, Hyperhidrosis, Injection site pain
Clinical narrative: Upper left arm very sore; could not sleep on left side.  1/18/14 - (8:30 AM) body aching; muscle weakness. Symptoms progressively got worse.  By noon time extreme nausea, chills, shivering; fever began and body pain intensifying.  Fever up to 100.5 @ 4:30 pm. Migraine began. Did not medicate due to extreme nausea. Took Phenergan & 500 mg Aspirin.  By 10:00 PM body pain worsening and nausea intensifying.  Sun 1 AM 1/19/14 (1) phenergan & 500 mg more aspirin.  Fever still 100.5.  Fever broke during night with severe sweating. 1:10 PM 500 mg Aspirin & (1) Phenergan; 3:30 pm fever back up to 100.4; took (2) Pepto-Bismol caplets. 7:15 pm Body pain excruciating; 600 mg. Ibuprofen. 8:30 pm severe vertigo/dizziness occurred. Unable to move; broke out in cold, clammy sweat; duration - 5 mins. Mon 1:50 am 400 mg Ibuprofen and (1) Phenergan. Fever broke again during night. 10:55 AM Mon 1/20/14 400 mg. Ibuprofen. Severe muscle pain subsided.
Age: 63.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Mobility decreased, Muscular weakness, Myalgia, Nasopharyngitis, Nausea
Clinical narrative: Upper left arm very sore; could not sleep on left side.  1/18/14 - (8:30 AM) body aching; muscle weakness. Symptoms progressively got worse.  By noon time extreme nausea, chills, shivering; fever began and body pain intensifying.  Fever up to 100.5 @ 4:30 pm. Migraine began. Did not medicate due to extreme nausea. Took Phenergan & 500 mg Aspirin.  By 10:00 PM body pain worsening and nausea intensifying.  Sun 1 AM 1/19/14 (1) phenergan & 500 mg more aspirin.  Fever still 100.5.  Fever broke during night with severe sweating. 1:10 PM 500 mg Aspirin & (1) Phenergan; 3:30 pm fever back up to 100.4; took (2) Pepto-Bismol caplets. 7:15 pm Body pain excruciating; 600 mg. Ibuprofen. 8:30 pm severe vertigo/dizziness occurred. Unable to move; broke out in cold, clammy sweat; duration - 5 mins. Mon 1:50 am 400 mg Ibuprofen and (1) Phenergan. Fever broke again during night. 10:55 AM Mon 1/20/14 400 mg. Ibuprofen. Severe muscle pain subsided.
Age: 63.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain, Pyrexia, Sleep disorder, Vertigo
Clinical narrative: Upper left arm very sore; could not sleep on left side.  1/18/14 - (8:30 AM) body aching; muscle weakness. Symptoms progressively got worse.  By noon time extreme nausea, chills, shivering; fever began and body pain intensifying.  Fever up to 100.5 @ 4:30 pm. Migraine began. Did not medicate due to extreme nausea. Took Phenergan & 500 mg Aspirin.  By 10:00 PM body pain worsening and nausea intensifying.  Sun 1 AM 1/19/14 (1) phenergan & 500 mg more aspirin.  Fever still 100.5.  Fever broke during night with severe sweating. 1:10 PM 500 mg Aspirin & (1) Phenergan; 3:30 pm fever back up to 100.4; took (2) Pepto-Bismol caplets. 7:15 pm Body pain excruciating; 600 mg. Ibuprofen. 8:30 pm severe vertigo/dizziness occurred. Unable to move; broke out in cold, clammy sweat; duration - 5 mins. Mon 1:50 am 400 mg Ibuprofen and (1) Phenergan. Fever broke again during night. 10:55 AM Mon 1/20/14 400 mg. Ibuprofen. Severe muscle pain subsided.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site induration, Injection site warmth, Swelling
Clinical narrative: PATIENT STATED SHE USUALLY EXPERIENCES REDNESS AND SWELLING AFTER THE FLU VACCINE IS ADMINISTERED. THIS YEAR, SHE REPORTED ON 1/21/2014, IN PERSON, THAT THE REDNESS AND SWELLING ARE STILL PRESENT. SHE ALSO SAID THE AREA IS HARD AND WARM TO THE TOUCH. SHE DID NOT SEEK ANY MEDICAL ATTENTION BUT I ADVISED HER TO SCHEDULE AN APPT TO BE SEEN.SHE IS CURRENTLY APPLYING ICE PACKS TO RELIEVE SOME OF THE SWELLING. SINCE IT HAS BEEN OVER A MONTH SINCE HER VACCINE, I ENCOURAGED HER TO BE SEEN.
Age: 0.17
Sex: M
Vaccine: DTPIHI, RVX
Symptoms: Vomiting
Clinical narrative: Vomiting for 7 days, may not be related.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient started vomiting about midnight the night she received the vaccine (approx 8 hours later) and had a fever that continued to climb through the night, peaking at 106 the next morning (11/8/13) at 8 a.m.  She was ill and feverish for approx 3 days after before recovering.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient called 12/11/2013 to complain of redness, swelling, and heat at injection site; I advised to use Hydrocortisone and ice at injection site.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Injection site rash
Clinical narrative: A few hours after the administration of the vaccine mom noted a rash at the site of the injection.  It has spread over the last week on the entire anterior surface of the left thigh.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Dizziness, Dysgeusia, Headache, Nausea
Clinical narrative: Nausea, dizzy, headache, body ache, metal taste in mouth, feel like I have diarrhea. No treatment yet. Called family dr to report symptoms.
Age: 47.0
Sex: M
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Nausea, dizzy, headache, body ache, metal taste in mouth, feel like I have diarrhea. No treatment yet. Called family dr to report symptoms.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Muscle pain soreness, fever, fatigue, redness/pain at injection site (started 6-8 hrs after injection).
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Insomnia, Musculoskeletal stiffness, Pain
Clinical narrative: Patient had arm stiffness that lasted two weeks. She is having a hard time sleeping due to the pain. And she does not have full movement of left arm.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Patient got FLUZONE Intradermal shot on 1-20-14. Instead of typical welt, an red area about diameter of soda can appeared. At 11 AM 1-21-14 you could not see injection site, just a light reddish circle.
Age: 39.0
Sex: F
Vaccine: HEP, TDAP, VARCEL
Symptoms: Hot flush, Hyperhidrosis, Vertigo
Clinical narrative: Client was given 3 vaccines the last Hep B in (R) delt. Client stated she felt a hot flash come over her then 30 seconds later the room was spinning. Client was checked for pulse and BP, she was told to put head between legs, 1 min client was laid on floor and was diaphoretic, BP 97/63, felt better after 5 min with cold paper towel.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Rash
Clinical narrative: 12/5/13 10:00 AM received TC from client. Sxs rash on abd x 1 day after taken (1) dose oral typhoid vaccine on 12/4/13. Instructed to not take any more of the Typhoid, and offered the inj. Typhoid vaccine.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea
Clinical narrative: Patient said after 20 -30 min of vaccination, headache, chill, nausea mild symptoms.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Pt reported soreness in her arm that hasn't gone away since the vaccine was administered. Pt wasn't going to ask her physician and hasn't let us know how she is feeling.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Arthralgia, Cellulitis, Joint swelling, Pain
Clinical narrative: Pain, swelling of elbow - pt could not raise arm without pain. Severe cellulitis per MD in elbow.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Arthralgia, Cellulitis, Joint swelling, Mobility decreased, Pain
Clinical narrative: Pain, swelling of elbow - pt could not raise arm without pain. Severe cellulitis per MD in elbow.
Age: 17.0
Sex: M
Vaccine: FLU3, MEN
Symptoms: Dyspnoea, Pallor, Slow response to stimuli
Clinical narrative: C/O unable to breathe and slow to respond color pale.
Age: 1.34
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMR
Symptoms: Chest X-ray normal, Convulsion, Cyanosis, Influenza virus test negative, Pyrexia
Clinical narrative: Patient was sitting in high chair, suddenly slumped over and had onset of full body convulsion and syanosis, family thought she was choking and gave several back blows, EMS was called and she was taken to ER, where she had a fever of 38.4C.  All testing was negative.
Age: 1.34
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMR
Symptoms: Streptococcus test negative, Urine analysis normal
Clinical narrative: Patient was sitting in high chair, suddenly slumped over and had onset of full body convulsion and syanosis, family thought she was choking and gave several back blows, EMS was called and she was taken to ER, where she had a fever of 38.4C.  All testing was negative.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Full blood count normal, Injection site joint movement impairment, Injection site pain, Injection site swelling
Clinical narrative: L shoulder pain, swelling, limited ROM. Still present 3 weeks after shot, so patient was treated with antibiotics and a steroid pack.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Activated partial thromboplastin time normal, Blood electrolytes, Full blood count, Henoch-Schonlein purpura, Prothrombin time
Clinical narrative: Parents state that an hour after receiving vaccines and PPD, that she started developing a rash on buttocks and legs.  I saw her for same rash on 1/21/14 and diagnosed her with Henoch-Schoenlein Purpura (HSP).  Her rash is classic for this.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash, Renal function test, Urine analysis normal
Clinical narrative: Parents state that an hour after receiving vaccines and PPD, that she started developing a rash on buttocks and legs.  I saw her for same rash on 1/21/14 and diagnosed her with Henoch-Schoenlein Purpura (HSP).  Her rash is classic for this.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling face, Urticaria
Clinical narrative: My face was swollen/puffy and red cheeks, face/neck had hives.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Inflammation, Pyrexia
Clinical narrative: Fevers, inflammation, sign of cellulitis.
Age: 1.51
Sex: F
Vaccine: IPV, MMR
Symptoms: Crying, Decreased appetite, Diarrhoea, Erythema, Pyrexia
Clinical narrative: Fever, crying, decreased appetite and loose stools. That night fever became worse but then dissipated by morning. During the day of 01/20/2014 had a low-grade fever, continued decreased appetite and loose stools. The night of 01/20/2014 and early in the morning of 01/21/2014 fever reached 103.1 and vomiting occurred. Treated with Tylenol, cold shower, and cold compress.  Fever subsided then around 9:00 AM of 01/21/2014 noticed rash- small red dots all over back some on legs, and arms and then spreading to face and chest throughout the day. Visited doctor and was told there were some spots in the mouth as well. I was advised to continue Tylenol treatment and wait to see if fever continues or gets worse.
Age: 1.51
Sex: F
Vaccine: IPV, MMR
Symptoms: Rash, Vomiting
Clinical narrative: Fever, crying, decreased appetite and loose stools. That night fever became worse but then dissipated by morning. During the day of 01/20/2014 had a low-grade fever, continued decreased appetite and loose stools. The night of 01/20/2014 and early in the morning of 01/21/2014 fever reached 103.1 and vomiting occurred. Treated with Tylenol, cold shower, and cold compress.  Fever subsided then around 9:00 AM of 01/21/2014 noticed rash- small red dots all over back some on legs, and arms and then spreading to face and chest throughout the day. Visited doctor and was told there were some spots in the mouth as well. I was advised to continue Tylenol treatment and wait to see if fever continues or gets worse.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Mother called with pt experiencing severe stomach cramps and diarrhea.
Age: 1.43
Sex: F
Vaccine: DTAP, HIBV, UNK
Symptoms: Erythema, Fatigue, Lethargy, Pain, Pyrexia
Clinical narrative: Red stripe, almost like cellulitis, fever of 100.4, doesn't want to put pressure on her legs, tired, lethargic, acting like she feels achy.
Age: 1.43
Sex: F
Vaccine: DTAP, HIBV, UNK
Symptoms: Weight bearing difficulty
Clinical narrative: Red stripe, almost like cellulitis, fever of 100.4, doesn't want to put pressure on her legs, tired, lethargic, acting like she feels achy.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash over front and back of body.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 13.25 hours.ON 18-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 12.75 hours. On 22-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 5 hours. On 12-JAN-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H016765). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to an exact T not recorded but noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 25-APR-2013 at 7:35, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14 hours. On 13-JUN-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 27-MAR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 18 OCT-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (Lot # 0468AE, exp date 04-APR-2013) (dose and route administration were not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 08-DEC-2011 at 8:00, ZOSTAVAX (Lot # 671140/1266AA) was exposed to -13 degrees C for an estimated total time out of range of 10.5 hours. On 09-DEC-2011, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671140/1266AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. Thi  is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 27-JUN-2013, the patient was vaccinated with an our of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J001005, Exp. Date: 24-APR-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 08-DEC-2011 at 8:00, ZOSTAVAX, (Lot # 671140/1266AA) was exposed to -13 degrees C for an estimated total time out of range of 10.5 hours. On 28-DEC-2011, the patient was administered an out of range dose of ZOSTAVAX (Lot # 671140/1266AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 08-DEC-2011 at 8:00, ZOSTAVAX (Lot # 671140/1266AA) was exposed to -13 degrees C for an estimated total time out of range of 10.5 hours. On 06-JAN-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671140/1266AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 08-DEC-2011 at 8:00, ZOSTAVAX  (Lot # 671140/1266AA) was exposed to -13 degrees C for an estimated total time out of range of 10.5 hours. On 11-JAN-2012, the patient was administered an out of range dose of ZOSTAVAX (Lot # 671140/1266AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 12-DEC-2012 at 8:00, ZOSTAVAX (Lot # 671140/1266AA) was exposed to -13 C for an estimated total time out of range of 10.5 hours and on 16-JAN-2012 at 7:30, the vaccine was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 16-JAN-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671140/1266AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 0.36
Sex: F
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 09-OCT-2013, the patient was vaccinated with the first dose of ROTATEQ, (lot#, expiration date, dose and route not reported). On 11-DEC-2013 the patient was vaccinated with an expired dose of GARDASIL (dose, route and indication not reported) as the second dose of ROTATEQ. No adverse event reported. It was not reported if the patient had sought medication attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. In May 2011 the patient was vaccinated with the first dose of GARDASIL, injection, (lot #, expiration date, dose and route unspecified). In January 2013 the patient was vaccinated with the second dose of GARDASIL, injection, (lot #, expiration date, dose and route unspecified). No adverse effects reported. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Local swelling
Clinical narrative: Local swelling.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Local swelling, Skin discolouration
Clinical narrative: Patient stated that on 3rd day after receiving PNEUMOVAX vaccine her arm became swollen and discolored (red/purple) (approx 7" x 4" area). gradually swelling and discoloration resolved but small, hard area (approx size of nickel) remains under skin. Site was palpitated and seems to be hardened area under layer of soft tissue - no discoloration, but slightly higher on deltoid than expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 C for an estimated total time out of range of 13.25 hours. On 18-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14 C for an estimated total time out of range of 12.75 hours. On 22-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14 C for an estimated total time out of range of 5 hours. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 C for an estimated total time out of range of 14-25 hours. On 29-JAN-2013, the patient was administered an out of range dose of ZOSTAVAX (dose and route were not reported) (Lot number H016765). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/.1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 02-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot # 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 19-OCT-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (lot # 0468AE, exp date 04-APR-2013) (dose and route of administration were not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 08-DEC-2011 at 8:00, ZOSTAVAX (Lot # 671140/1266AA) was exposed to -13 degrees C for an estimated total time out of range of 10.5 hours. On 13-DEC-2011, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671140/1266AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 C for an estimated total time out of range of 13.25 hours. On 18-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14 C for an estimated total time out of range of 12.75 hours. On 22-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14 C for an estimated total time out of range of 5 hours. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 C for an estimated total time out of range of 14-25 hours. On 28-JAN-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route were not provided) (Lot number H016765). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare worker refers to herself as a 45 year old female patient. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) (lot, dose and route not reported). Concomitant medication was not reported. On an unknown date, the patient experienced vaccinated with a not stored properly VARIVAX (Merck). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/.1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 29-MAR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot # 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to an exact T not recorded but noted a equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estiamted total time out of range of 10.5 hours. On 12-JUN-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 08-DEC-2011 at 8:00, ZOSTAVAX (Lot # 671140/1266AA) was exposed to -13 degrees C for an estimated total time out of range of 10.5 hours. On 12-DEC-2011, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671140/1266AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 26-JUN-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J001005, Exp. Date: 24-APR-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 08-DEC-2011 at 8:00, ZOSTAVAX (Lot # 671140/1266AA) was exposed to - 13 degrees C for an estimated total time out of range of 10.5 hours. On 09-JAN-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671140/1266AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient who on 23-OCT-2012 was administered an out of temperature range dose of ZOSTAVAX, lot # 0468AE, exp date 04-APR-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-MAR-2012 at 11:30, ZOSTAVAX (Lot # 672477/1604AA) was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 28-MAR-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX, lot # 672477/1604AA, expiration date: 13-JAN-2013 (dose and route not reported). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient who on 22-OCT-2012 was administered an out of temperature range dose of ZOSTAVAX, Lot # 0468AE, exp date 04-APR-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 08-DEC-2011 at 8:00, ZOSTAVAX (Lot # 671140/1266AA) was exposed to - 13 degrees C for an estimated total time out of range of 10.5 hours. On 27-DEC-2011, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671140/1266AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HPV4
Symptoms: Disability, Fall, Fatigue, Hypoaesthesia, Insomnia
Clinical narrative: This spontaneous report as received from a consumer refers to the consumer self, a 19 year old patient of unknown gender. On an unknown date the patient was vaccinated with quadrivalent human papillomavirus recomb. vaccine (route, dose and lot number unknown) dose 1. On an unknown date (reported as 2nd shot August) the patient was vaccinated with quadrivalent human papillomavirus recomb. vaccine (route, dose and lot number unknown) dose 2. No other suspect therapy or concomitant medication was reported. On an unknown date the patient reported the following: can not do anything (upon internal review assesses as disability), tired all the time, hospitalized (hospitalization), upper and neck pain in my spine, can not sleep at night with the pain, soak in the tub all the time to stop the aches and fell down the stairs - loss feeling in legs - hands also mostly morning. No treatment information was reported. The outcome of can not do anything (upon internal review assesses as disability), tired all the time, hospitalized (hospitalization), upper and neck pain in my spine, can not sleep at night with the pain, soak in the tub all the time to stop the aches and fell down the stairs - loss feeling in legs - hands also mostly morning is unknown. The reporters relatedness of can not do anything (upon internal review assesses as disability), tired all the time, hospitalized (hospitalization), upper and neck pain in my spine, can not sleep at night with the pain, soak in the tub all the time to stop the aches and fell down the stairs - loss feeling in legs - hands also mostly morning to quadrivalent human papillomavirus recomb. vaccine is unknown. The patient was reporting not to take the 3rd dose. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HPV4
Symptoms: Neck pain, Pain, Sensory loss, Spinal pain
Clinical narrative: This spontaneous report as received from a consumer refers to the consumer self, a 19 year old patient of unknown gender. On an unknown date the patient was vaccinated with quadrivalent human papillomavirus recomb. vaccine (route, dose and lot number unknown) dose 1. On an unknown date (reported as 2nd shot August) the patient was vaccinated with quadrivalent human papillomavirus recomb. vaccine (route, dose and lot number unknown) dose 2. No other suspect therapy or concomitant medication was reported. On an unknown date the patient reported the following: can not do anything (upon internal review assesses as disability), tired all the time, hospitalized (hospitalization), upper and neck pain in my spine, can not sleep at night with the pain, soak in the tub all the time to stop the aches and fell down the stairs - loss feeling in legs - hands also mostly morning. No treatment information was reported. The outcome of can not do anything (upon internal review assesses as disability), tired all the time, hospitalized (hospitalization), upper and neck pain in my spine, can not sleep at night with the pain, soak in the tub all the time to stop the aches and fell down the stairs - loss feeling in legs - hands also mostly morning is unknown. The reporters relatedness of can not do anything (upon internal review assesses as disability), tired all the time, hospitalized (hospitalization), upper and neck pain in my spine, can not sleep at night with the pain, soak in the tub all the time to stop the aches and fell down the stairs - loss feeling in legs - hands also mostly morning to quadrivalent human papillomavirus recomb. vaccine is unknown. The patient was reporting not to take the 3rd dose. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Blood test normal, Chills, Dysstasia, Weight bearing difficulty
Clinical narrative: Initial report received from a consumer who is the patient on 14 January 2014. A 64 year old female patient received FLUZONE on 08 November 2013, lot, route and site of administration were not reported. The patient had unspecified flu vaccines in the past, dates, batch, route and site of administration were not reported. The patient had both knees replaced on an unreported date. Concomitant medications were not reported. Allergies and medical conditions were reported as unknown. Twenty-eight hours after vaccination on 09 November 2013, the patient experienced chills and slight pain in her left knee. Forty-eight hours later, the patient could not bear weight on her left leg. In 58 hours, it went to her right knee and left wrist and then could not stand. She went to the ER, since both knees were replaced, date not reported. Blood work and xrays were done, results not reported. The patient was admitted to hospital for a sepsis workout which was ruled out (date not reported). Treatments were not reported. The patient recovered and has no residual effects. No further details were available at the time of this report. Documents held by sender: None.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: X-ray
Clinical narrative: Initial report received from a consumer who is the patient on 14 January 2014. A 64 year old female patient received FLUZONE on 08 November 2013, lot, route and site of administration were not reported. The patient had unspecified flu vaccines in the past, dates, batch, route and site of administration were not reported. The patient had both knees replaced on an unreported date. Concomitant medications were not reported. Allergies and medical conditions were reported as unknown. Twenty-eight hours after vaccination on 09 November 2013, the patient experienced chills and slight pain in her left knee. Forty-eight hours later, the patient could not bear weight on her left leg. In 58 hours, it went to her right knee and left wrist and then could not stand. She went to the ER, since both knees were replaced, date not reported. Blood work and xrays were done, results not reported. The patient was admitted to hospital for a sepsis workout which was ruled out (date not reported). Treatments were not reported. The patient recovered and has no residual effects. No further details were available at the time of this report. Documents held by sender: None.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Abscess, Bacterial test, Blood test, Cellulitis
Clinical narrative: Initial report received from a consumer who is the patient on 14 January 2014. A 64 year old female patient received FLUZONE on 08 November 2013, lot, route and site of administration were not reported. The patient had unspecified flu vaccines in the past, dates, batch, route and site of administration were not reported. The patient had both knees replaced on an unreported date. Concomitant medications were not reported. Allergies and medical conditions were reported as unknown. Twenty-eight hours after vaccination on 09 November 2013, the patient experienced chills and slight pain in her left knee. Forty-eight hours later, the patient could not bear weight on her left leg. In 58 hours, it went to her right knee and left wrist and then could not stand. She went to the ER, since both knees were replaced, date not reported. Blood work and xrays were done, results not reported. The patient was admitted to hospital for a sepsis workout which was ruled out (date not reported). Treatments were not reported. The patient recovered and has no residual effects. No further details were available at the time of this report. Documents held by sender: None.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest X-ray, Dehydration, Dysstasia, Electrocardiogram, Headache
Clinical narrative: Initial report received from a consumer who is the patient on 14 January 2014. A 64 year old female patient received FLUZONE on 08 November 2013, lot, route and site of administration were not reported. The patient had unspecified flu vaccines in the past, dates, batch, route and site of administration were not reported. The patient had both knees replaced on an unreported date. Concomitant medications were not reported. Allergies and medical conditions were reported as unknown. Twenty-eight hours after vaccination on 09 November 2013, the patient experienced chills and slight pain in her left knee. Forty-eight hours later, the patient could not bear weight on her left leg. In 58 hours, it went to her right knee and left wrist and then could not stand. She went to the ER, since both knees were replaced, date not reported. Blood work and xrays were done, results not reported. The patient was admitted to hospital for a sepsis workout which was ruled out (date not reported). Treatments were not reported. The patient recovered and has no residual effects. No further details were available at the time of this report. Documents held by sender: None.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immunology test, Influenza like illness, Intensive care, Knee arthroplasty, Laboratory test
Clinical narrative: Initial report received from a consumer who is the patient on 14 January 2014. A 64 year old female patient received FLUZONE on 08 November 2013, lot, route and site of administration were not reported. The patient had unspecified flu vaccines in the past, dates, batch, route and site of administration were not reported. The patient had both knees replaced on an unreported date. Concomitant medications were not reported. Allergies and medical conditions were reported as unknown. Twenty-eight hours after vaccination on 09 November 2013, the patient experienced chills and slight pain in her left knee. Forty-eight hours later, the patient could not bear weight on her left leg. In 58 hours, it went to her right knee and left wrist and then could not stand. She went to the ER, since both knees were replaced, date not reported. Blood work and xrays were done, results not reported. The patient was admitted to hospital for a sepsis workout which was ruled out (date not reported). Treatments were not reported. The patient recovered and has no residual effects. No further details were available at the time of this report. Documents held by sender: None.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Malaise, Respiratory syncytial virus bronchiolitis, Sepsis, Vascular test, Vital capacity decreased
Clinical narrative: Initial report received from a consumer who is the patient on 14 January 2014. A 64 year old female patient received FLUZONE on 08 November 2013, lot, route and site of administration were not reported. The patient had unspecified flu vaccines in the past, dates, batch, route and site of administration were not reported. The patient had both knees replaced on an unreported date. Concomitant medications were not reported. Allergies and medical conditions were reported as unknown. Twenty-eight hours after vaccination on 09 November 2013, the patient experienced chills and slight pain in her left knee. Forty-eight hours later, the patient could not bear weight on her left leg. In 58 hours, it went to her right knee and left wrist and then could not stand. She went to the ER, since both knees were replaced, date not reported. Blood work and xrays were done, results not reported. The patient was admitted to hospital for a sepsis workout which was ruled out (date not reported). Treatments were not reported. The patient recovered and has no residual effects. No further details were available at the time of this report. Documents held by sender: None.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Weight bearing difficulty
Clinical narrative: Initial report received from a consumer who is the patient on 14 January 2014. A 64 year old female patient received FLUZONE on 08 November 2013, lot, route and site of administration were not reported. The patient had unspecified flu vaccines in the past, dates, batch, route and site of administration were not reported. The patient had both knees replaced on an unreported date. Concomitant medications were not reported. Allergies and medical conditions were reported as unknown. Twenty-eight hours after vaccination on 09 November 2013, the patient experienced chills and slight pain in her left knee. Forty-eight hours later, the patient could not bear weight on her left leg. In 58 hours, it went to her right knee and left wrist and then could not stand. She went to the ER, since both knees were replaced, date not reported. Blood work and xrays were done, results not reported. The patient was admitted to hospital for a sepsis workout which was ruled out (date not reported). Treatments were not reported. The patient recovered and has no residual effects. No further details were available at the time of this report. Documents held by sender: None.