chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 9 week old female patient. The patient has no pertinent medical history and drug reactions/allergies. On 09-JUL-2014 the patient was vaccinated with a dose of RECOMBIVAX HB (lot# J014232, expiration date 29-AUG-2015, dose/frequency reported as directed, intramuscular in the leg as directed). Other suspect therapies included PENTACEL in the same leg. The nurse explained that the office had a patient develop swelling and redness in her leg at the injection site on 09-JUL-2014 after receiving RECOMBIVAX HB. The patient had sought medical attention by office visit. No treatment was given for the events. No lab diagnostics studies were performed. Outcome of the events was reported as recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to 6 unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with VARIVAX (Merck) that were improperly stored outside the proper storage range. No adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unkonwn age and gender. On 14-JUL-2014, the patient received an expired dose of ROTATEQ (lot # J001814, expiration date 05-JUL-2014), 2 ml, oral. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's demographics was unknown. There was no information on pertinent medical history and drug reactions and allergies. "on an unknown date, the patient was vaccinated with VARIVAX (Merck) (dose, frequency, route, product Lot#/Expiry date not reported). The nurse reported that the patient received a dose of VARIVAX (Merck) that was improperly stored and no adverse effects reported. The outcome of the events was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Anaemia, Dyskinesia, Dysstasia, Fall, Fatigue
Clinical narrative: Seizure for 5 minutes.  Loss of muscle control, could not stand up, would fall, couldn't look at mom, no crying during this. Called 24 hour nurse line - told to watch for 2 hours. The next day she called and we told to take to ER if happens again. On 6/24 it happened again same symptoms/type of seizure - lasted 5 minutes. EEG and MRI within normal limits 2 days later. Scheduled to see a neurologist in near future.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Staring, Tremor
Clinical narrative: Seizure for 5 minutes.  Loss of muscle control, could not stand up, would fall, couldn't look at mom, no crying during this. Called 24 hour nurse line - told to watch for 2 hours. The next day she called and we told to take to ER if happens again. On 6/24 it happened again same symptoms/type of seizure - lasted 5 minutes. EEG and MRI within normal limits 2 days later. Scheduled to see a neurologist in near future.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Convulsion, Dyskinesia, Dysstasia, Electroencephalogram normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Seizure for 5 minutes.  Loss of muscle control, could not stand up, would fall, couldn't look at mom, no crying during this. Called 24 hour nurse line - told to watch for 2 hours. The next day she called and we told to take to ER if happens again. On 6/24 it happened again same symptoms/type of seizure - lasted 5 minutes. EEG and MRI within normal limits 2 days later. Scheduled to see a neurologist in near future.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practice nurse refers to a 4 year old patient. Medical history was not reported. On 13-JUN-2014 the patient was vaccinated with a dose of improperly stored of (Oka/Merck) VARIVAX (lot # reported as H015224, Exp date 10-AUG-2014). Concomitant therapy was not reported. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, RVX
Symptoms: Injection site induration, Injection site mass, Lethargy, Pyrexia
Clinical narrative: Very high fever and lethargy lasting 3 days; hard, large lump at injection site.
Age: 0.08
Sex: M
Vaccine: DPP
Symptoms: Unevaluable event
Clinical narrative: The symptoms included growing idiocy and susceptibility to antivax ideology.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Pain in extremity
Clinical narrative: SWELLING AND SORENESS IN ARM.
Age: 16.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Activities of daily living impaired, Back pain, Chills, Erythema, Immediate post-injection reaction
Clinical narrative: Sore immediately after vaccine, swelling by night time.  The next morning, fever, aches, chills, nausea, lower back pain, arm soreness,  She had to stay in bed all day.  She could not go to running practice for school team.  Red hot swelling across her whole upper arm.  Still sore and had back pain and slight nausea even the second day.  Swelling and redness lasted for five days.
Age: 16.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Local swelling, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore immediately after vaccine, swelling by night time.  The next morning, fever, aches, chills, nausea, lower back pain, arm soreness,  She had to stay in bed all day.  She could not go to running practice for school team.  Red hot swelling across her whole upper arm.  Still sore and had back pain and slight nausea even the second day.  Swelling and redness lasted for five days.
Age: 16.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Skin warm, Swelling
Clinical narrative: Sore immediately after vaccine, swelling by night time.  The next morning, fever, aches, chills, nausea, lower back pain, arm soreness,  She had to stay in bed all day.  She could not go to running practice for school team.  Red hot swelling across her whole upper arm.  Still sore and had back pain and slight nausea even the second day.  Swelling and redness lasted for five days.
Age: 1.26
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Muscle tightness, Muscle twitching, Pyrexia, Rash erythematous, Tremor
Clinical narrative: 07/15/2014  Fever 101.8.  Tremors (twitches, tighten up, shake head) 07/19/2014 lacy, pinkish/red rash.
Age: 1.51
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Autopsy, Death
Clinical narrative: Child found dead the next morning by family member.
Age: 52.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report as received from nurse refers to approximately 52 year old male patient. The patients pertinent medical history included diabetes. The reporter stated that the patient developed unspecified rash approximately on an unknown date in 2014, after the patient was vaccinated with (Oka/Merck) VARIVAX lot J006807, expiration date 30-MAY-2015, dose called doctors office and left message for the doctor on 16-JUL-2014 to inform them of the unspecified rash. The outcome of rash was reported as not recovered/not resolved. No product quality complaint was involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Grand mal convulsion, Immediate post-injection reaction, Syncope, Urinary incontinence
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 13 year old female patient. On 14-JUL-2014 the patient was vaccinated with the first dose of GARDASIL (dose 1, 0.5 ml, intramuscular in the right arm, lot # and expiration date not reported). Concomitant medications, pertinent medical history and drug reactions/allergies were not reported. The reporter stated that the patient was nervous about getting her first dose of GARDASIL and was breathing heavy. On 14-JUL-2014, 30 seconds after being vaccinated, the patient fainted, and then 5 seconds after the patient had Tonic-clonic seizure. The patient also passed urine (elapsed time reported as immediately thereafter). The outcome of the adverse events was unknown. Causality assessment was not provided by the reporter. Upon internal review, tonic-clonic seizure was considered as medically significant. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Loss of consciousness, Respiratory rate increased, Tonic clonic movements, Urinary incontinence
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 13 year old female patient. On 14-JUL-2014 the patient was vaccinated with the first dose of GARDASIL (dose 1, 0.5 ml, intramuscular in the right arm, lot # and expiration date not reported). Concomitant medications, pertinent medical history and drug reactions/allergies were not reported. The reporter stated that the patient was nervous about getting her first dose of GARDASIL and was breathing heavy. On 14-JUL-2014, 30 seconds after being vaccinated, the patient fainted, and then 5 seconds after the patient had Tonic-clonic seizure. The patient also passed urine (elapsed time reported as immediately thereafter). The outcome of the adverse events was unknown. Causality assessment was not provided by the reporter. Upon internal review, tonic-clonic seizure was considered as medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to unknown number of patients of unknown age. On unknown dates, the unknown number of patients were vaccinated with (Oka/Merck) PROQUAD (lot #, expiration date, dose, frequency, route not reported), that were stored outside of the temperature ranges indicated in the prescribing information.  No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to unknown number of patients of unknown age. On unknown dates, time unknown number of patients were vaccinated with VAQTA (lot#, expiration date, dose, frequency, route not reported), that were stored outside of the temperature ranges indicated in the prescribing information. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to unknown number of patients of unknown age. On unknown dates, the unknown number of patients were vaccinated with GARDASIL (lot #, expiration date, dose, frequency, route not reported), that were stored outside of the temperature ranges indicated in the prescribing information. No adverse affect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to unknown number of patients of unknown age. On unknown dates, the unknown number of patients were vaccinated with RECOMBIVAX HB (lot#, expiration date, dose, frequency, route not reported), that were stored outside of the temperature ranges indicated in the prescribing information. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to unknown number of patients of unknown age. On unknown dates, the unknown number of patients were vaccinated with (Oka/Merck) VARIVAX (lot#, expiration date, dose, frequency, route not reported), that were stored outside of the temperature ranges indicated in the prescribing information. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Muscle rigidity, Musculoskeletal stiffness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a "either 12 or 13 years old" male patient. The patient did not have pertinent medical history. On an unknown date the patient was vaccinated with a dose of GARDASIL. Lot #, dose # and administration route were unspecified. On the same date, after the GARDASIL was administered, the patient became "rigid and stiff for 30 seconds". The patient recovered after those 30 seconds. No lab test was done. Patient was seen by a physician assistant. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, Drug administration error, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 8 month old patient of unknown gender. On 09-JUL-2014 (reported as "today") the 8 month old patient was vaccinated intramuscularly with a dose of VAQTA (24/0.5, 0.5 ml, lot # and expiration date were not reported). No adverse effect was reported. The reporter stated that this event was related to staff error, but that the boxes for the prefilled syringes looked similar. SR was sent to the Quality department for review. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a nurse (reported as health care worker) refers to a 67 year old female patient with drug allergies SERZONE and penicillin. The patients pertinent medical history included severe pulmonary hypotension and restrict airway disease. On an unknown date in 2003, the patient was vaccinated with PNEUMOVAX23 (dose and frequency were not reported). Concomitant medications were not reported. On an unknown date in 2003 the patient had a local injection site reaction after being administered PNEUMOVAX23. It was unspecified whether the patient sought medical attention or not. The outcome of local injection site reaction was unknown. The causality of local injection site was not reported. No product quality complaint was filed for PNEUMOVAX23. Additional information is not expected.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 year old female patient with no drug allergies. The patients pertinent medical history was none. On 15-JUL-2014 the patient was vaccinated with ZOSTAVAX (Dose/Frequency: single dose, Therapy route: subcutaneous (SQ), Lot # and expiry date were not reported). Concomitant medications were none. On 16-JUL-2014, the patient developed redness, tenderness, warmth and itching at injection site. The patient sought medical attention (reported as came in to pharmacy) and was self treated with BENADRYL. Lab tests were none. The outcome of redness, tenderness, warmth, and itching at injection site was reported as not recovered. No product quality complaint (PQC) was reported for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II (dose and lot # not reported). The pharmacist reports that the patient developed a "full body" rash and fever when she was a "child" after receiving MMR on an unspecified date "years ago". The outcome of a "full body" rash and fever was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history was provided. The reporting pharmacist believed that on 27-DEC-2007, an improperly stored doses of GARDASIL were administered to an unspecified number of patients. However, he stated that more dates are involved (unspecified what the other dates were) and multiple patients were involved (unspecified number). He did not have patient information. No symptoms were reported. This is one of several reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise
Clinical narrative: This spontaneous report as received from a pharmacist via a field representative refers to a female patient of unknown age. The patient's pertinent medical history included fibromyalgia. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, strength, dose and route not reported). The patient developed "flu-like" symptoms "within 24 hours". The reporter stated that the patient saw her unspecified primary care provider on an unspecified date but no treatment was given. At the time of reporting, the patient "still feeling under the weather". Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose ZOSTAVAX (lot #, expiration date, dose, indication, route not reported) "every year" since an unspecified date. No adverse effect reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unknown number of patients of unknown age and gender. On 16-JUL-2014, improperly stored (Oka/Merck) VARIVAX (strength, formulation, lot#, dose, dose number, route and duration were unspecified) were administered to the unknown number of patients. No adverse symptoms reported. No further information provided. The outcome was unknown. This is one of the two reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unknown number of patients of unknown age and gender. On 16-JUL-2014, improperly stored PROQUAD (injection, strength, lot #, dose, dose number, route and duration were unspecified) were administered to the unknown number of patients. No adverse symptoms reported. No further information provided. The outcome was unknown. This is one of the two reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse practitioner referring to multiple unspecified patients of unknown age. No pertinent medical history and concurrent conditions reported. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX, subcutaneously (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warm to touch (RD). Swollen, slightly red.
Age: 8.0
Sex: F
Vaccine: MMR, TD
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swollen.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Altered state of consciousness, Syncope
Clinical narrative: Patient experienced syncope with alterations in consciousness for approx. 6 minutes. Fruit juice and animal crackers administered. Vital signs remained stable.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient reported erythema, warmth, the day after, at the injection site measuring 1 1/2" x 3" patient reported this at 7-11-14 visit with dr.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Cough, Dyspnoea, Ocular hyperaemia, Throat irritation
Clinical narrative: 6 hours after vaccine, began coughing, trouble breathing, itchy throat, red eyes. Symptoms worsened so went to ER. Epinephrine given with relief. No fever. No rash.
Age: 0.66
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: This is one case out of a cumulative total of 229 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 14 July 2014. These 229 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 14 July 2014 from the investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 10 month old female subject (initials not reported) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three total doses of vaccine: one dose of DAPTACEL (lot number C4431AA) on 25 September 2013 and two doses of PENTACEL, on 18 December 2013 (lot number C4577AA) and 13 March 2014 (lot number C4660AB). Routes and sites of administration were not reported. The subject developed a cough and catarrhal illness on 15 June 2014, approximately 3 months after the last dose. She also experienced paroxysmal cough beginning 18 June 2014, pertussive vomiting, and sleep disturbance. Laboratory testing included positive PCR on 20 June 2014. Chest x-ray was negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 21 June 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 08 July 2014, the subject's cough had resolved. The duration of the subject's cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Upon internal review on 17 July 2014, doses 1 and 2 of DAPTACEL (administered 25 September 2013 and PENTACEL, administered 18 December 2013) were moved from suspect to product history. No new information was added to the case. Documents held by sender: None.
Age: 0.66
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 229 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 14 July 2014. These 229 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 14 July 2014 from the investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 10 month old female subject (initials not reported) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three total doses of vaccine: one dose of DAPTACEL (lot number C4431AA) on 25 September 2013 and two doses of PENTACEL, on 18 December 2013 (lot number C4577AA) and 13 March 2014 (lot number C4660AB). Routes and sites of administration were not reported. The subject developed a cough and catarrhal illness on 15 June 2014, approximately 3 months after the last dose. She also experienced paroxysmal cough beginning 18 June 2014, pertussive vomiting, and sleep disturbance. Laboratory testing included positive PCR on 20 June 2014. Chest x-ray was negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 21 June 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 08 July 2014, the subject's cough had resolved. The duration of the subject's cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Upon internal review on 17 July 2014, doses 1 and 2 of DAPTACEL (administered 25 September 2013 and PENTACEL, administered 18 December 2013) were moved from suspect to product history. No new information was added to the case. Documents held by sender: None.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Local swelling, Pain in extremity, Pruritus
Clinical narrative: She was give TDAP on 7/9/14. On 7/11/14 she developed a painful, red, swollen arm. She also had chills. Dr advised MOTRIN, BENADRYL and was given dicloxacillin for possible cellulitis. She also had itching.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Chest discomfort, Dyspnoea, Injection site swelling, Local swelling, Nausea
Clinical narrative: Pt. was at a pool and c/o SOB, tightness in chest, nausea and (L) arm swollen. Presented to office and lungs clear/no resp distress. Golf size swelling on (L) deltoid, 25 mg BENADRYL given.
Age: 0.12
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Screaming
Clinical narrative: 3 hours of continuous high pitched screaming. Treated with TYLENOL PO.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Ear infection, Joint range of motion decreased, Pharyngitis, Pyrexia
Clinical narrative: Fever, dizziness, pharyngitis, ear infection, limited range of motion in arm
Age: 4.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Eye movement disorder, Loss of consciousness
Clinical narrative: Pt. black-out for about 10 seconds, rolling of the eyes, no involuntary movements, loss of tone or postictal sleeping. P/O 100% B/P 69/39 Pulse rate 73-81 Pt. was awake, alert, interactive and walking at the time of leaving the clinic. Pt instructions: water, rest and increase salt intake for today.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown date an unspecified number of patients were vaccinated with GARDASIL (dose, frequency, strength and lot number not provided). Co-suspect or concomitant therapies were not reported. On an unknown date the GARDASIL reached  a temperature as low as 30F for an unspecified amount of hours and most likely had been administered. The reporter thought that the proper storage range for GARDASIL ws 35F to 46F because they had always bene considered in range at 35F at her office. No adverse effect reported. Additional information was received from a nurse practitioner concerning a 12 year old female patient On 03-JUN-2014, the patient was vaccinated with 3 dose of GARDASIL, injection (lot number reported as J008188). No adverse reaction reported. Additional information is not expected.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal rigidity, Bruxism, Trismus
Clinical narrative: Pt received Boostrix vaccine for prevention of tetanus 06.27.14, returned to the ED 07.17.14 with signs/symptoms of tetanus: lock jaw, grinding teeth, abd spasms. Was transferred to Medical Center.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Fall, Head injury, Laceration, Suture insertion, Syncope
Clinical narrative: Patient had one episode of syncope after received HPV#1. Pt fall and hit the ground on his left forehead at waiting area. Pt was referred to hospital for head injury as per Dr. Spoke with pt regarding post ER f/u on 6/26. As per pt, he went to ER for head laceration on 06/25/14. Pt got 5 stitches done and discharged home w/o any medication. ER MD suggested for suture removal on next Monday 06/30/14.  Pt is feeling OK. Denies fever/pain/HA. Advised to keep suture site clean and dry. RTC for MD evaluation if fever or redness around suture site. Pt verbalized understanding. ER f/u appt made with PCP on 06/30/14 2:45pm.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site reaction, Rash papular
Clinical narrative: Erythematous pin point papular rash on lower extremities.
Age: 72.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Reported swelling to entire (R) upper arm of injection site with redness, warm to touch and pain with movement. No rash, fever or chills.
Age: 1.36
Sex: F
Vaccine: VARCEL
Symptoms: Furuncle, Injection site reaction, Pyrexia, Rash vesicular, Staphylococcal infection
Clinical narrative: My daughter ran a fever from 7/5/2014-7/10/2014 of 99.9-100.1. I treated it with tylenol. On 7/12/2014 she began to get a small rash that looked like chicken pox. On 7/18 she got a staph infection and got boils in her diaper area that spread to he inner thighs as well.
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Barium enema, Enema administration, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Intussusception x 2 (1) 5/23/14 (2) 5/24/14 both reduced by barium enemas.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Death, Respiratory arrest, Unresponsive to stimuli
Clinical narrative: Pt was found unresponsive and not breathing by mother approximately 6 hours after receiving vaccinations. Pt was transferred to hospital at 5:30pm via ambulance and was expired at 6:20pm. Unknown at this time cause of death.
Age: 43.0
Sex: F
Vaccine: YF
Symptoms: Chest pain, Fatigue, Pain, Pyrexia
Clinical narrative: Fever, body aches, fatigue, chest pain.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient c/o swelling and pain and redness at injection site. Pt went to his PCP who told him to monitor site and if it did not go away he would put him on antibiotics. It is getting better without antibiotics.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Crying, Decreased appetite, Insomnia, Irritability, Poor quality sleep
Clinical narrative: Started with not wanting to eat, very crabby...7pm started with fever of 103 Motrin given. Saturday fever of 103 not eating, very crabby...Sunday fever continued, crying, interrupted sleep. Monday fever of 103 continued, not eating, crying, not sleeping well (very interrupted by crying spells) break out in chicken pox rash behind ear, on face, inbeteween thighs, on stomach and back. Took to pediatrician 1:20 PM she stated he's having a reaction to chicken pox vaccine. Reaction still ongoing.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Vaccination complication, Varicella post vaccine
Clinical narrative: Started with not wanting to eat, very crabby...7pm started with fever of 103 Motrin given. Saturday fever of 103 not eating, very crabby...Sunday fever continued, crying, interrupted sleep. Monday fever of 103 continued, not eating, crying, not sleeping well (very interrupted by crying spells) break out in chicken pox rash behind ear, on face, inbeteween thighs, on stomach and back. Took to pediatrician 1:20 PM she stated he's having a reaction to chicken pox vaccine. Reaction still ongoing.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Pt showed signs of seizure after HPV vaccination administration.
Age: 15.0
Sex: F
Vaccine: IPV, PNC13
Symptoms: Head injury, Loss of consciousness, Pallor, Presyncope, Skin discolouration
Clinical narrative: Vasovagal Syncope after IPV and PCV-13 vaccination. Nurse administered vaccination and patient looked stable. He left the room and and 1 minute later mom states patient started to look white and green and then the patient passed out. She hit the back of her head on the wall but the nurse and mom were able to prevent her from falling off the exam table. She lost consciousness for 1-2 seconds. Vital signs were taken and the patient was hemodynamically stable and had pulse ox of 100%. We placed a cold wash cloth on forehead and her neck. She laid down for 15-20 minutes. She was given apple juice. We called the sign language interpreter to talk with patient when she was better. She returned to baseline and was sent home.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC, VARCEL
Symptoms: Incorrect route of drug administration
Clinical narrative: Patient was given varicella vaccine IM instead of SC.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Dermatitis diaper, Diarrhoea, Injection site rash, Pyrexia, Rash
Clinical narrative: Fever over 102.6, spots on legs and arms with pimple like protrusions, vomiting, diarrhea.  Bad diaper rash (probably related to diarrhea).
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Fever over 102.6, spots on legs and arms with pimple like protrusions, vomiting, diarrhea.  Bad diaper rash (probably related to diarrhea).
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Chest X-ray, Fatigue, Full blood count, Headache, Lymphadenopathy
Clinical narrative: Left Supraclavicular lymphadenopathy after Tdap in left arm. Headaches, fatigue, low grade fever that lasted one day.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Mononucleosis heterophile test, Pyrexia
Clinical narrative: Left Supraclavicular lymphadenopathy after Tdap in left arm. Headaches, fatigue, low grade fever that lasted one day.
Age: 3.0
Sex: F
Vaccine: HIBV
Symptoms: Irritability, Pyrexia, Somnolence
Clinical narrative: Started with fever irritability within 30 min. Fever 103 degrees. Fussy and slept most of the day. Parents gave alternating TYLENOL and MOTRIN and afebrile in AM but stilkl fussy.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from the Healthcare worker via Company Representative refers to a patient of unknown age and gender. Patient's pertinent medical history and drug reactions/allergies were not specified. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, lot # not reported). Concomitant medication were not specified. On an unknown date the patient experienced shingles. It was not specified if the patient sought medical attention and if the treatment was given for the event or lab diagnostic studies were performed. There was no intervention to prevent serious criteria. The patient recovered from shingles on unknown date. Relatedness between the event and ZOSTAVAX was not specified. Additional information has been requested.
Age: 0.21
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC13, RV5
Symptoms: Abdominal pain, Crying, Decreased appetite, Intussusception, Irritability
Clinical narrative: Severe abdominal pain, prolonged crying, seen in ED 5 days after vaccine w/ fussiness and decreased appetite. (Concern was intussusception - determined not to be).
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (office administrator) refers to an unspecified number of patients of unknown age and gender. On an unknown date, multiple unspecified patients were administered GARDASIL (dose, route # and expiration date were not provided) that was stored improperly. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected because there is no contact permission.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (office administrator) refers to an unspecified number of patients of unknown age and gender. On an unknown date, multiple unspecified patients were administered liquid PEDVAXHIB (dose, route, lot # and expiration date were not provided) that was stored improperly. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected because there is no contact permission.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Healthcare Worker concerning a patient of unknown age and gender. On an unknown date, the patient was administered a dose of (Oka/Merck) VARIVAX that was exposed to temperature outside of the proper storage range (details unspecified). No concomitant therapy was reported. No adverse effects were reported. No Product Quality Complaint (PQC) was filed. The action taken was assessed as not applicable. The outcome of event was not reported. The causality was assessed as not related to the therapy with (Oka/Merck) VARIVAX. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 patient of unknown age and gender. On an unknown date the patients were vaccinated with ROTATEQ (orally, dosage was not reported) lot # H017722 exp date 09-APR-2014. Vaccines were improperly stored for a period from 20-MAR-2014 to 07-MAY-2014. Nurse stated vaccines were exposed to 10.5C for 56.05 hours cumulatively through 07-MAY-2014. No adverse effects reported. It was reported that the nurse was inquiring about temperature excursions that occurred from October 2013 to March 2014. The nurse also stated that they were replacing the refrigerator, freezer, and the data logger and were sending the old data logger for calibration to the health department. The reporter stated that vaccines were improperly stored for a period from 28-AUG-2013 until June 2014 and were received by 5 patients (previously reported from 20-MAR-2014 to 07-MAY-2014). Highest temperature: 9C: number of hours prior to administration: 35H; number of doses administered 1. Highest temperature: 9.5C; number os hours prior to administration: 206H; number of doses administered: 1. Highest temperature: 9.5C; number of hours prior to administration 269H; number of doses administered: 1. Highest temperature: 10C; number of hours prior to administration: 271H; number of doses administered: 1. Highest temperature: 10C; number of hours prior to administration: 277H; number of doses administered: 1. All doses administered before expiration date. This is one of the several report from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Hepatic enzyme increased
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. No relevant medical history of the patient was reported. On 24-MAR-2014, the patient was vaccinated with GARDASIL, dose 1 and on 17-JUN-2014 the patient was vaccinated with the second dose (strength, route of administration, site of administration, lot number and expiration dates were not reported). There were no concomitant medications reported. On 14-JUL-2014, a blood work was done which revealed an increase in liver enzymes. The healthcare worker discussed the report with physician, however, the physician did not want to provide any further information. It was unspecified whether the patient had sought any medical attention. There was no product quality complaint  involved. The outcome of increased in liver enzymes was unknown. The causality of the event increase liver enzymes was unknown. Additional information is not expected.
Sex: U
Vaccine: HEPA, MNQ
Symptoms: Arthralgia, Contusion, Dizziness, Feeling hot, Haemorrhage
Clinical narrative: Immunizations were given. While nurse turned to put the needle down. Patient passed out on floor. Face down and shook. He stated that he felt warm and then he doesn't remember after that. He came to quickly and responded to questions appropriately. Initially pt stated he bit his tongue and his left knee hurt. No obvious injury to tongue noted. (L) knee has small bruise but pain went away within 15 min. Pt was dizzy when sitting up for a few min and returned to lying down. This persisted for an approximate 45 min - 1 hr. BP and pulse was taken frequently and he was monitored constantly. He was finally about to sit and stand without dizziness or upset stomach and returned to lobby where he remained for approximately 15 min. At 9:27 He was given Hep A #1 to (R) deltoid and then MCV4 to (L) deltoid. He passed out for very short time and woke up talking appropriately. Vision clear. BP 140/70. C/o biting tongue but no obvious injury noted.9:35 BP 120/72 Pulse 72 9:45 70/42 P 52 R: 24. When pt was dizzy he was layed down with legs up until dizziness went away and no c/o sick to stomach. He was sit up to see how he felt. This continued until 10:30. He then sat up and stood without complaints. 9:53 BP 94/58 P -66 9:58 BP 102/96 P - 52 c/o (L) side hurting. Noted 2 inch superficial cut to (L) abd. Slight bleeding. Cleaned with antiseptic wipe then antibiotic creme and bandaid applied. No bruising or hematoma noted. 10:10 108/64 P -64 10:13 BP 112/76 Dad was with patient and he stated that he passes out easy.
Sex: U
Vaccine: HEPA, MNQ
Symptoms: Laceration, Loss of consciousness, Tongue biting, Tremor
Clinical narrative: Immunizations were given. While nurse turned to put the needle down. Patient passed out on floor. Face down and shook. He stated that he felt warm and then he doesn't remember after that. He came to quickly and responded to questions appropriately. Initially pt stated he bit his tongue and his left knee hurt. No obvious injury to tongue noted. (L) knee has small bruise but pain went away within 15 min. Pt was dizzy when sitting up for a few min and returned to lying down. This persisted for an approximate 45 min - 1 hr. BP and pulse was taken frequently and he was monitored constantly. He was finally about to sit and stand without dizziness or upset stomach and returned to lobby where he remained for approximately 15 min. At 9:27 He was given Hep A #1 to (R) deltoid and then MCV4 to (L) deltoid. He passed out for very short time and woke up talking appropriately. Vision clear. BP 140/70. C/o biting tongue but no obvious injury noted.9:35 BP 120/72 Pulse 72 9:45 70/42 P 52 R: 24. When pt was dizzy he was layed down with legs up until dizziness went away and no c/o sick to stomach. He was sit up to see how he felt. This continued until 10:30. He then sat up and stood without complaints. 9:53 BP 94/58 P -66 9:58 BP 102/96 P - 52 c/o (L) side hurting. Noted 2 inch superficial cut to (L) abd. Slight bleeding. Cleaned with antiseptic wipe then antibiotic creme and bandaid applied. No bruising or hematoma noted. 10:10 108/64 P -64 10:13 BP 112/76 Dad was with patient and he stated that he passes out easy.
Age: 1.38
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse refers to a 16 month old patient of unknown gender. On 10-JUL-2014 the patient was vaccinated with an improperly stored VARIVAX lot # J012376 Expiration date: 03-OCT-2015, 0.5 ml, subcutaneous that was exposed to 13F for two hours. No adverse effects were reported. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site anaesthesia, Injection site pain
Clinical narrative: Pain and movement issues left shoulder decreased sensation in upper arm grasp in normal.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site dryness, Injection site erythema, Injection site pain, Injection site reaction, Muscle rigidity
Clinical narrative: Red, tender, rigid, and dry injection site reaction. Patient was instructed to monitor injection site for about three more days, then return to pharmacy.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Irritability
Clinical narrative: Red, tender, rigid, and dry injection site reaction. Patient was instructed to monitor injection site for about three more days, then return to pharmacy.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous, Rash pruritic
Clinical narrative: Red, warm, smooth, and itchy rash at vaccine injection site.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Irritability
Clinical narrative: Red, warm, smooth, and itchy rash at vaccine injection site.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with RECOMBIVAX HB. Dose, route, lot number and expiration date were not reported. The nurse reported that doses of RECOMBIVAX HB were stored improperly and administered to an unspecified number of patients on unspecified dates. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected since we can not contact physician.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: No adverse reactions. KINRIX given to patient on 7/15/14 - expired on 6/28/14. Patient has upcoming appt to be re-vaccinated.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with ROTATEQ. Dose, route, lot number and expiration date were not reported. The nurse reported that doses of ROTATEQ were stored improperly and administered to an unspecified number of patients on unspecified dates. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected since we can not contact physician.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Area that patient received shot on 7-15-14 is swollen with redness.
Age: 24.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Patient required proof of immunity to varicella for school. Titers done 6/26/14 - not immune. Varicella vaccine administered 7/10/14. 7/21/14 -positive preg test. LMP 6/6/14 per patient. Pt reports she did not know she was pregnant at time of vaccine.
Age: 24.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Patient required proof of immunity to varicella for school. Titers done 6/26/14 - not immune. Varicella vaccine administered 7/10/14. 7/21/14 -positive preg test. LMP 6/6/14 per patient. Pt reports she did not know she was pregnant at time of vaccine.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injected limb mobility decreased, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: 7-9-14 - Arm very painful after injection, 7/10/14 arm continued to be sore, 7-11-14 soreness increased, arm swollen at injection site. 7/12/14 soreness continued, arm red, swollen to about size of orange, hard knot at injection site, pt unable to lift arm above shoulder height.