chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: White blood cell count increased
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a female patient of unknown age with no pertinent medical history and no drug reactions or allergies. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number and expiry date reported as H015780 and 11-JUN-2014 respectively). There were no concomitant medications. On an unknown date, the patient experienced fever, redness, bruising and swelling at the injection site after receiving PNEUMOVAX23. The patient also complained of feeling bad and as sick as she had ever been after the vaccination. The patient sought medical attention (two office visits to physician). It was unspecified if any treatment was given or if any lab tests were performed. The patient was recovering from the events at the time of reporting. The relatedness for events was unknown for PNEUMOVAX23. Pharmacist requested a lot check for PNEUMOVAX23. Additional information has been requested.
Age: 0.79
Sex: M
Vaccine: HEP, IPV
Symptoms: Autism, Condition aggravated, Oropharyngeal pain, Speech disorder developmental
Clinical narrative: Sore throat for  2 to 3 weeks. Loss of language and pointing.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Basal cell carcinoma, Biopsy skin abnormal
Clinical narrative: Diagnosis of basal cell carcinoma L upper arm x2; patient believes they are at sites of prior vaccine administaration.  All flu vaccines from 2010, 2011, and 2012 flu seasons were administered in L deltoid area.  One of her 2 basal cell carcinomas was at a site that could have been site vaccine was administered; second is lower on her arm and likely does not correlate.  Patient requests that this be reported as an adverse event due to flu shot.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vomiting
Clinical narrative: Syncope s/p HPV vaccine, pt was sitting post vaccine administration when she became faint, also had 1 episode of emesis, VS were stable. Pt was advised to lay down, did not have breakfast, once stable, started hydration. Recovered in 15 min.
Age: 35.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Cardiomyopathy, Echocardiogram abnormal, Electrocardiogram abnormal, Troponin normal
Clinical narrative: This study case was received from the investigator in the trial on 29 May 2013. A 35-year-old male subject was found to have other primary cardiomyopathies 12 days after receiving the following vaccines on 10 April 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM Vi (lot number, route and site of administration not reported) and anthrax (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included normal troponin, abnormal ECG and abnormal echocardiogram on 17 April 2013. Treatments were not reported. Past medical history included high blood pressure and palpitations/pounding heart without exercise. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 1.32
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 30 May 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 4 doses of PENTACEL on 18 February 2010, 21 April 2010, 07 July 2010, and 13 April 2011 (lot numbers, routes and sites of administration not reported). The subject developed a cough on 06 May 2013, approximately 2 years after the last dose, and a paroxysmal cough without a whoop on 06 May 2013. The subject also developed cold like symptoms on 05 May 2013 and post tussive vomiting and apnea (start dates not reported). Laboratory testing included positive PCR on 08 May 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 11 May 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 22 May 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.32
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting
Clinical narrative: Initial report received on 30 May 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 4 doses of PENTACEL on 18 February 2010, 21 April 2010, 07 July 2010, and 13 April 2011 (lot numbers, routes and sites of administration not reported). The subject developed a cough on 06 May 2013, approximately 2 years after the last dose, and a paroxysmal cough without a whoop on 06 May 2013. The subject also developed cold like symptoms on 05 May 2013 and post tussive vomiting and apnea (start dates not reported). Laboratory testing included positive PCR on 08 May 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 11 May 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 22 May 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.04
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse and a health care worker refers to a 12 month old patient of unknown gender. On 11-APR-2013, the patient who was supposed to get PREVENAR 13 was inadvertently vaccinated with a dose of PNEUMOVAX23, 0.5 milliliter (ml), intramuscularly. No adverse effect reported. Reason why it occurred was unknown. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 18-DEC-2012, the patient was vaccinated with a first dose of GARDASIL and on 08-JUN-2013 the patient was vaccinated with a second dose of GARDASIL (Lot number, expiry date, route and dose were not reported) and no adverse event reported. Additional information is not expected.
Age: 31.0
Sex: F
Vaccine: SMALL
Symptoms: Chest pain
Clinical narrative: This study case was received from the investigator in a trial on 29 May 2013. A 31-year-old female subject was found to have chest pain, unspecified 11 days after receiving an injection of ACAM2000 (lot number, route and site of administration not reported) on 06 February 2013. Treatments were not reported. Troponin I, ECG and echocardiogram were not available. Past medical history included eczema and headaches. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Tonic clonic movements, Vomiting
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 17 year old female patient. On 01-APR-2013, the patient was vaccinated with first dose of 0.5 ml GARDASIL, (lot # 672193/1524AA expiry date 23-AUG-2014, route was intramuscular). On 10-JUN-2013, the patient was vaccinated with second dose of 0.5 ml GARDASIL, (lot # 672193/1524AA expiry date 23-AUG-2014, route was intramuscular). Concomitant therapies included SPRINTEC. On 01-APR-2013, the patient experienced tonic clonic movements and syncope after the first dose of GARDASIL. On 10-JUN-2013, the patient experienced worsening of tonic clonic movements and syncope after the second dose of GARDASIL vomiting. There was no treatment rendered for the events. The outcome of the reported events were unknown. The patient sought medical attention. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: ANTH, FLUN3, SMALL, TYP
Symptoms: Acute myocardial infarction, Echocardiogram abnormal, Electrocardiogram abnormal, Troponin I increased
Clinical narrative: This study case was received from the investigator in the trial on 29 May 2013. A 41-year-old female subject was found to have acute myocardial infarction, unspecified site 6 days after receiving the following vaccines on 06 October 2009: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM Vi (lot number, route and site of administration not reported), anthrax (manufacturer, lot number, route and site of administration not reporter) and INFLUENZA live intranasal (manufacturer, lot number and site of administration not reported). Relevant laboratory data included an abnormal troponin I of 52.04 on 14 October 2009, an abnormal echocardiogram on 13 October 2009 and an abnormal ECG on 03 November 2009. Treatments were not reported. Past medical history high blood pressure. Additional information will be requested from the investigator. The subject's outcome was not reported. Follow-up information was received from the investigator on 03 June 2013. The investigator provided the units for the Troponin I lab value from 14 October 2009, which was 52.04 ng/mL (abnormal). No other information was provided. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pyrexia
Clinical narrative: This spontaneous report was received from a female registered nurse of unknown age regarding herself. Approximately on an unknown date in 1993 (20 years ago), her arm (affected) was broken. On 03-JUN-2013, the patient was vaccinated with a 0.5 milliliter (ml) of PNEUMOVAX23 (lot number and expiry date unspecified), subcutaneously. No concomitant medications were reported. On 03-JUN-2013 (reported as that day), at supper time, pain at the injection site began. She stated that the pain increased and became severe. She stated that she lost mobility in her arm as a result of the pain. She also developed a fever at that time. There was no visible swelling or redness at injection site. She did not seek any medical attention. No lab tests were performed. She took unspecified anti-inflammatory drugs and unspecified antihistamines which improved her pain and arm function. On 10-JUN-2013, the patient recovered from the events. The relatedness for the events was unknown for PNEUMOVAX23. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 29-MAY-2013, the patient was vaccinated with a second dose of expired GARDASIL (Lot number was reported as 0523U, expiry date was 09-FEB-2010), 0.5 milliliter (ml), intramuscularly. The first dose of GARDASIL was administered on 29-MAR-2013. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a female patient of unknown age. On 28-MAR-2012 the patient was vaccinated with GARDASIL dose 1. The patient received her second dose of GARDASIL on 30-MAY-2012 and will be receiving her third dose of GARDASIL today, 28-MAY-2013. Dosing information, route of administration and lot numbers were not provided. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Antibody test positive
Clinical narrative: This spontaneous report as received from a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of MMR II (Lot number, expiry date, route and dose were not reported) as a child. On an unknown date, the patient's titers tested positive after receiving MMR II. The outcome of titers tested positive was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a mother regarding her child of unknown age and gender. No medical history was reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL dose 1, intramuscularly. The patient's mother reported that her child did not receive the GARDASIL dosage as scheduled after dose 1. No concomitant medications were reported. She was referred to her clinician, on the misuse. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 29-MAY-2013 the patient was vaccinated with an expired dose of GARDASIL lot # 668261/1397AA, expiry date 09-APR-2013. Dosing information and route of administration were not provided. No symptoms were reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to 4 patients of unknown age and gender. On 01-APR-2013 the patients were vaccinated with GARDASIL (lot number H021608, expiration date 13-AUG-2015, route not reported). The physician noted that GARDASIL was shipped on 27-MAR-2013 and did not arrive at the office until 01-APR-2013 and the GARDASIL was in the shipper the entire time. The physician's office could not determine the exact temperature the GARDASIL was exposed to while in the shipment from 27-MAr-2013 to 01-ARP-2013. No patient contact details available. No further information was available. Follow up information was received. The receptionist stated that she spoke with the nurse and she was not aware of the situation and she also stated that the physician would call back. Follow up document included information about 13 year old female patient who on 01-APR-2013 (at 10:31 AM) was vaccinated in left arm with GARDASIL (lot number H021608, expiration date 13-AUG-2015, route and dose not reported). There was none adverse event. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a patient of unknown age and gender. No medical history was reported. On an unknown date in 2008, the patient was vaccinated with dose 1 of GARDASIL (lot #, expiry not reported) intramuscularly. On 10-JUN-2013, the patient was vaccinated with dose 2 GARDASIL (lot #, expiry not reported) intramuscularly. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right deltoid area with redness, swelling and warmth to touch.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 16 cm x 13.5 cm cellulitis reaction to right thigh. Area red, warm to touch with central induration.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to 4 patients of unknown age and gender. On 01-APR-2013 the patients were vaccinated with GARDASIL (lot number H021608, expiration date 13-AUG-2015, route not reported). The physician noted that GARDASIL was shipped on 27-MAR-2013 and did not arrive at the office until 01-APR-2013 and the GARDASIL was in the shipper the entire time. The physician's office could not determine the exact temperature the GARDASIL was exposed to while in the shipment from 27-MAR-2013 to 01-APR-2013. No patient contact details available. No further information was available. Follow up information was received. The receptionist stated that she spoke with the nurse and she was not aware of the situation and she also stated that the physician would call back. Follow up document included information about 18 year old male patient who on 01-APR-2013 (at 13:34) was vaccinated in left arm with a third dose of GARDASIL (lot number H021608, expiration date 13-AUG-2015, route and dose not reported). There was none adverse event. This is one of several reports from the same source. Additional information is not expected.
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Cyanosis, Death, Hypotonia, Resuscitation
Clinical narrative: Infant found blue and limp in bassinet with twin (who was crying to be fed). 911 called. Ambulance crew could not resuscitate infant.
Sex: F
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 female patient of unknown age. On 03-DEC-2009 the patient received her first dose of GARDASIL. The patient received her second dose of GARDASIL on 14-MAR-2012 and her third dose of GARDASIL on 14-MAY-2013. Dosing information, route of administration and lot numbers were not provided. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician refers to a two patient's of unknown age. No current conditions and medical history were reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and frequency not reported) (lot# and exp. Date not reported) for shingles prevention. No co suspects or concomitant medications were reported. The physician reported to the representative that the patient developed a rash after getting ZOSTAVAX. The patient's developed a rash that was no painful to the touch. This is one of the several reports of the same source. The outcome of rash that was no painful to the touch was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to 4 patients of unknown age and gender. On 01-APR-2013 the patients were vaccinated with GARDASIL (lot number H021608, expiration date 13-AUG-2015, route not reported). The physician noted that GARDASIL was shipped on 27-MAR-2013 and did not arrive at the office until 01-APR-2013 and the GARDASIL was in the shipper the entire time. The physician's office could not determine the exact temperature the GARDASIL was exposed to while in the shipment from 27-MAR-2013 to 01-APR-2013. No patient contact details available. No further information was available. Follow up information was received. The receptionist stated that she spoke with the nurse and she was not aware of the situation and she also stated that the physician would call back. Follow up document included information about 11 year old male patient who on 01-APR-2013 (at 11:22 am) was vaccinated in left arm with the first dose of GARDASIL (lot number H021608, expiration date 13-AUG-2015, route and dose not reported). There was none adverse event. This is one of several reports from the same source. Additional information is not expected.
Age: 24.0
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 24 year old patient. On 28-MAY-2013 the patient was vaccinated with GARDASIL dose 2. Dosing information, route of administration and lot number were not provided. The patient received the 1st dose (dosing information, route of administration and lot number not provided) of GARDASIL approximately in 2003 (at the age of 14). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Tenderness
Clinical narrative: This spontaneous report as received from a physician refers to a two patients of unknown age. No current conditions and medical history were reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and frequency not reported) (lot# and exp. date not reported). No co suspects or concomitant medications were reported. The physician reported to the representative that two patients developed a rash after getting ZOSTAVAX. The patients developed a rash that was painful to the touch. This is one of the several report of the same source. The outcome of rash that was painful to the touch was unknown. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Balance disorder, Guillain-Barre syndrome, Hypoaesthesia, Laboratory test
Clinical narrative: Pt. traveled to a foreign country on 2/8/13 for a 2 week vacation. When he returned, received Pneumococcal vaccine in (L) deltoid on 3/1/13. On 3/4/13 began feeling bilateral "hand numbness" and "balance problems". Pt. admitted to hospital on 3/9/13 with "Guillain Barre" diagnosis.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Acoustic stimulation tests, Balance disorder, Brain stem auditory evoked response, Demyelination, Dizziness
Clinical narrative: Vertigo, dizziness, continual since 30NOV12. Symptoms called MS, demyelination syndrome, Lyme's disease and just giddiness. Unable to work balance is disrupted. Visual and hearing disturbances.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Electronystagmogram, Hearing impaired, Impaired work ability, Laboratory test, Lyme disease
Clinical narrative: Vertigo, dizziness, continual since 30NOV12. Symptoms called MS, demyelination syndrome, Lyme's disease and just giddiness. Unable to work balance is disrupted. Visual and hearing disturbances.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Multiple sclerosis, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Vertigo, Visual evoked potentials
Clinical narrative: Vertigo, dizziness, continual since 30NOV12. Symptoms called MS, demyelination syndrome, Lyme's disease and just giddiness. Unable to work balance is disrupted. Visual and hearing disturbances.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Visual impairment
Clinical narrative: Vertigo, dizziness, continual since 30NOV12. Symptoms called MS, demyelination syndrome, Lyme's disease and just giddiness. Unable to work balance is disrupted. Visual and hearing disturbances.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Cold sweat, Convulsion, Feeling cold, Headache
Clinical narrative: Extreme chills; fitful, restless sleep; body aches, headache, hot-cold sweats, shaking from cold. No swelling no redness at injection site.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Pain, Poor quality sleep, Tremor
Clinical narrative: Extreme chills; fitful, restless sleep; body aches, headache, hot-cold sweats, shaking from cold. No swelling no redness at injection site.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: MCV->Erythema and induration at injection site.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: MCV & Tdap both-> Erythema and induration at both injection sites.
Age: 47.0
Sex: F
Vaccine: TYP
Symptoms: Headache, Oropharyngeal pain, Pain, Swelling face
Clinical narrative: Per patient, she started having throat pain and soreness, headache, and right face swelling in the night. She feels it is getting worse.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site urticaria, Rash, Urticaria
Clinical narrative: Broke out in hives at injection site then spread to rest of body, rash started at 1100 next day, resolving about 24h after onset oral Benadryl and topical cortisone, no breathing problems.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Red, swollen, itchy arm.  Redness and swelling wrapping around arm.
Age: 69.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Influenza, Pneumonia
Clinical narrative: ON TRIP CAUGHT FLU. BY 12/25/09 I HAD PNEUMONIA AND TREATED WITH ZITHROMAX. MY MEDICAL HISTORY WILL SHOW IN 69 YEARS I NEVER HAD CHEST OR LUNG ISSUES. I BELIEVE THE VACCINATION WEAKENED MY IMMUNE SYSTEM. I HAVE NOW HAD PNEUMONIA 3 TIMES LASTLY APRIL 6 2013.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Pain, Pruritus, Pyrexia, Urticaria
Clinical narrative: CHILD BROKE OUT IN WHELPS (PAINFUL AND ITCHING) STARTING THE DAY AFTER IMMUNIZATION. WHELPS MOSTLY ON ARM OF IMMUNIZATION, BUT ALSO ON OTHER ARM AND BACK. CHILD ALSO HAD LOW GRADE FEVER.
Age: 69.0
Sex: M
Vaccine: TTOX, VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Rash on legs and arms. Itching, red coloration. Cortisone, Benadryl.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Pallor, Presyncope, Speech disorder, Vision blurred
Clinical narrative: Blurred vision, could not talk, pale, hot, near syncope. Gave lollipop, took BP and laid down.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, soreness. Swelling (L) upper arm. Seen in office by M.D. Rx. BENADRYL as needed, MEDROL dose pack, ULTRAVATE cream locally. Pt called on 5/14/13 and said symptoms had resolved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site swelling, Rash, Rash macular, Urticaria
Clinical narrative: Soft tissue swelling at injection site, without redness: Hives to trunk (macular rash).
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hep A - Only vaccine she has ever had. Had yesterday prophylactic from Berry mix she had eaten with family. Today came into clinic with brother because he couldn't come yesterday. Hives under (L) arm in armpit and half way down chest. # 8 hives. Mom doesn't know of any other changes other than the vaccine.
Age: 0.45
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Personality change, Regressive behaviour, Social avoidant behaviour
Clinical narrative: Mother states that post receiving vaccines, pt's attitude changed - she became quiet, withdrawn, shut down, stopped saying "mamas", wouldn't smile. Became more of a baby in the last month post vacc in 3/2013.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Rash, Skin burning sensation
Clinical narrative: Skin has sandpaper or chicken skin rash mostly over back, some on upper thorax. Pt felt burning sensation over back.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count, Injection site erythema, Injection site warmth
Clinical narrative: 2 x 2 inch red hot area around injection site. Very warm to touch.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Moderate - significant swelling and redness at injection site. Fatigue reported.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Pain in extremity, Rash
Clinical narrative: Wrist and hand pain with a rash on legs the next day.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: L upper arm red and swollen.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Hypersensitivity, Oedema peripheral, Pain in extremity
Clinical narrative: Left arm with edema, redness, pain, and warmth extending down to elbow.  Seen for evaluation on 6/11/13 and treated for allergic reaction and cellulitis.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: Left arm with edema, redness, pain, and warmth extending down to elbow.  Seen for evaluation on 6/11/13 and treated for allergic reaction and cellulitis.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Pain, Pyrexia, Urticaria
Clinical narrative: Low grade temp; fatigue; body aches. Next day developed hives (reported on 6/12/13). Was not aware that she had developed hives.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Skin lesion
Clinical narrative: Sores breaking out away from vaccination site (chest). No treatment required.
Age: 51.0
Sex: M
Vaccine: DTAP
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: C/O HEADACHE NAUSEA AND VOMITING.
Age: 2.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Exposure to vaccinated person, Polymerase chain reaction, Skin lesion, Vaccinia test positive
Clinical narrative: Pt developed sore on face after exposure to his father's smallpox vaccine site.
Age: 2.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Orthopoxvirus test positive, Scab, Secondary transmission, Skin lesion, Vaccinia virus infection
Clinical narrative: Pt developed sore on face after exposure to his father's smallpox vaccine site.
Age: 4.0
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Eye swelling, Lip swelling, Urticaria
Clinical narrative: Swollen eyes and lips. Welts all over torso, arms, and legs. ER visit was required.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Myalgia, Paraesthesia, Pyrexia
Clinical narrative: Fever, myalgia, pain, induration on the local injection site, tingling sensation of fingers. Ibuprofen 400 mg every 4 hours.
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Infant received a second dose of Hepatitis B vaccine on the 6th of June around 1500.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Cerebral haemorrhage, Coma, Death, Haematemesis, Injection site bruising
Clinical narrative: On 1/25/2012, as per mother patient developed a black bruise to the left upper arm where vaccines had been administered that covered most of the entire upper arm. On February 1, 2012, he developed a sore throat and fever that lasted a week. On February 7, 2012 at 11 am he reported to hospital. As per mother, patient was non-responsive and was throwing up blood-tinged saliva. He was flown out due to an internal hemorrhage. He was admitted to hospital at around 3 pm. After admission, he remained unresponsive. As per mother, the internal cerebral hemorrhage was too advanced and the patient was not a candidate for surgery so patient eventually became comatose. He passed away on 2/10/2012 at 2 am. Final diagnosis was cerebral hemorrhage and leukemia. As per parent, the client had no previous history of illnesses at the time of vaccination on 1/25/2012.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Leukaemia, Oropharyngeal pain, Pyrexia, Unresponsive to stimuli
Clinical narrative: On 1/25/2012, as per mother patient developed a black bruise to the left upper arm where vaccines had been administered that covered most of the entire upper arm. On February 1, 2012, he developed a sore throat and fever that lasted a week. On February 7, 2012 at 11 am he reported to hospital. As per mother, patient was non-responsive and was throwing up blood-tinged saliva. He was flown out due to an internal hemorrhage. He was admitted to hospital at around 3 pm. After admission, he remained unresponsive. As per mother, the internal cerebral hemorrhage was too advanced and the patient was not a candidate for surgery so patient eventually became comatose. He passed away on 2/10/2012 at 2 am. Final diagnosis was cerebral hemorrhage and leukemia. As per parent, the client had no previous history of illnesses at the time of vaccination on 1/25/2012.
Age: 1.14
Sex: F
Vaccine: MMRV
Symptoms: Body temperature increased, Diarrhoea, Hypersomnia, Lethargy
Clinical narrative: Dropped her off at daycare and the provider noted she had a runny bowel movement at 9 AM and then another at 9:25 am. She was very lethargic and her temperature was 100. She slept for about an hour and then I picked her up. She was given Tylenol and took another nap for 1.5 hours. I woke her to eat. She ate very little. Her temperature remained the same although medication had been administered. She slept most of the afternoon/early evening.
Age: 16.0
Sex: F
Vaccine: TYP, YF
Symptoms: Ear pain, Influenza like illness, Lymphadenopathy, Oropharyngeal pain, Pyrexia
Clinical narrative: Flu-like symptoms, fever, ear ache, sore throat, swollen glands....still persisting through to 06/12/2013 patients physician is monitoring.
Age: 1.3
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood test abnormal, Computerised tomogram abnormal, Inflammation, Pyrexia, Secondary transmission
Clinical narrative: 105 fever for a week. Approximately 5 chicken pox blisters. ER visits on 5/23/2013, 5/26/2013, and early AM on 5/28/2013. Last ER visit had us transferred to another and admitted until release in the late afternoon on 5/30/2013. Patients father, who has already had the chicken pox as a child, contracted a single chicken pox blister the day after the vaccination. Patients mother, who also had the chicken pox as a child, contracted shingles in early June.
Age: 1.3
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urine analysis, Varicella post vaccine, X-ray abnormal
Clinical narrative: 105 fever for a week. Approximately 5 chicken pox blisters. ER visits on 5/23/2013, 5/26/2013, and early AM on 5/28/2013. Last ER visit had us transferred to another and admitted until release in the late afternoon on 5/30/2013. Patients father, who has already had the chicken pox as a child, contracted a single chicken pox blister the day after the vaccination. Patients mother, who also had the chicken pox as a child, contracted shingles in early June.
Age: 75.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Pt's husband called and reports: a day or 2 later after PCV13 injection pt developed a red, ring redness to the injection site, warm to the touch, denies fever but now has developed sore rash around it.
Age: 50.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Flushing, Hypoaesthesia, Pain in extremity
Clinical narrative: RAPID ONSET FLUSHED FEELING, LIGHT HEADED, PAIN IN ARM, NUMB FEELING ARM.
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Aphonia, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Extreme nausea, dizziness, headache, low fever, stomach pains, soreness at sight and arm for days. Extreme fatigue first 4 days after vaccine. Still have headaches. Sore throat and upper respiratory infection and loss of voice came about 3 to 4 days after vaccine. Still feel horrible and have headaches. It is June 12th and I am now sick with sore throat and other symptoms mentioned above. My headache comes and goes. Never had headaches ever in my life, until now!
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Injection site pain, Nausea, Oropharyngeal pain, Pain in extremity
Clinical narrative: Extreme nausea, dizziness, headache, low fever, stomach pains, soreness at sight and arm for days. Extreme fatigue first 4 days after vaccine. Still have headaches. Sore throat and upper respiratory infection and loss of voice came about 3 to 4 days after vaccine. Still feel horrible and have headaches. It is June 12th and I am now sick with sore throat and other symptoms mentioned above. My headache comes and goes. Never had headaches ever in my life, until now!
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, Upper respiratory tract infection
Clinical narrative: Extreme nausea, dizziness, headache, low fever, stomach pains, soreness at sight and arm for days. Extreme fatigue first 4 days after vaccine. Still have headaches. Sore throat and upper respiratory infection and loss of voice came about 3 to 4 days after vaccine. Still feel horrible and have headaches. It is June 12th and I am now sick with sore throat and other symptoms mentioned above. My headache comes and goes. Never had headaches ever in my life, until now!
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Decreased appetite, Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue after vaccine. Headache for at least 4 days after vaccine. Fatigue 3 days after vaccine. Cluster of hives on hip region day after vaccine. Low grade fever and loss of appetite. Complained of stomach hurting.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Fatigue after vaccine. Headache for at least 4 days after vaccine. Fatigue 3 days after vaccine. Cluster of hives on hip region day after vaccine. Low grade fever and loss of appetite. Complained of stomach hurting.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pruritus, Tenderness
Clinical narrative: Elbow and tricep area red and swollen, itchy, and tender to touch.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Dyspnoea, Full blood count abnormal, Hypersensitivity, Lymphadenopathy
Clinical narrative: She experienced swelling of lymph nodes to left side of body, cough, paleness, and shortness of breath. Less than 24 hours after injection. She was seen in ER and it was determined she was having an allergic reaction.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphocyte count increased, Neutrophil count increased, Pallor
Clinical narrative: She experienced swelling of lymph nodes to left side of body, cough, paleness, and shortness of breath. Less than 24 hours after injection. She was seen in ER and it was determined she was having an allergic reaction.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Skin - left upper arm with large red warm area where she had Tdap.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Contusion, Epistaxis, Full blood count, Platelet count decreased, Thrombocytopenia
Clinical narrative: Was seen in office 4/22/13 for: bruises, nose bleeds; CBC done - plts: 6,000; transferred. Dx with Thrombocytopenia was seen in office 5/9/13 - plts: 4,000; transferred.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Headache, Neck pain, Pruritus generalised, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 17 years old female patient with irregular periods. None drug reactions or allergies were reported. on 13-MAR-2013 the patient was vaccinated with the first dose of GARDASIL injection (dose, route and lot number were not reported). There were none concomitant medications. Patient reported to physician, that after receiving her 1st dose of GARDASIL, on 13-MAR-2013, she had "head and neck pain". Physician reported that patient suffered from a severe rash surrounding her neck and shoulders after receiving the first dose of GARDASIL. The following morning, on 14-MAR-2013, the patient had a rash on her leg that "looked like hives" and was itchy all over. The patient self medicated with BENADRYL (manufacturer unspecified) which did not help. The patient reported all her symptoms "went away within the week" in approximately March 2013. At the moment of the report, the 2nd dose of GARDASIL has not bee administered. None lab/diagnostic studies were performed. The patient did not seek medical attention. Additional information has been received from the physician concerning the patient with no illness at time of vaccination, and none pre-existing allergies or medical conditions, who on 13-MAR-2013 at 14:52, was vaccinated in her left arm with GARDASIL (lot # H020002, expiration date 08-AUG-2015). Reporter stated on 13-MAR-2013, patient experienced hives, Itching, and sore in neck and back. Physician reported no treatment was given for the events, the events resolved on own on 21-MAR-2013. None relevant diagnostics test or laboratory data were performed. Patient was not seen for symptoms. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a 17 years old female patient with irregular periods. None drug reactions or allergies were reported. on 13-MAR-2013 the patient was vaccinated with the first dose of GARDASIL injection (dose, route and lot number were not reported). There were none concomitant medications. Patient reported to physician, that after receiving her 1st dose of GARDASIL, on 13-MAR-2013, she had "head and neck pain". Physician reported that patient suffered from a severe rash surrounding her neck and shoulders after receiving the first dose of GARDASIL. The following morning, on 14-MAR-2013, the patient had a rash on her leg that "looked like hives" and was itchy all over. The patient self medicated with BENADRYL (manufacturer unspecified) which did not help. The patient reported all her symptoms "went away within the week" in approximately March 2013. At the moment of the report, the 2nd dose of GARDASIL has not bee administered. None lab/diagnostic studies were performed. The patient did not seek medical attention. Additional information has been received from the physician concerning the patient with no illness at time of vaccination, and none pre-existing allergies or medical conditions, who on 13-MAR-2013 at 14:52, was vaccinated in her left arm with GARDASIL (lot # H020002, expiration date 08-AUG-2015). Reporter stated on 13-MAR-2013, patient experienced hives, Itching, and sore in neck and back. Physician reported no treatment was given for the events, the events resolved on own on 21-MAR-2013. None relevant diagnostics test or laboratory data were performed. Patient was not seen for symptoms. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 29-AUG-2009 the patient was vaccinated with a dose of GARDASIL (dose, route and lot number not provided) dose 1. On 26-SEP-2012, the patient received the second dose of GARDASIL late (dose, route and lot number not provided). On 20-NOV-2012 the patient received the third dose of GARDASIL, too early (dose, route and lot number not provided). No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. On 06-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number reported as 0567AE, dose and route unspecified) that had expired on 04-APR-2013. No concomitant medications were reported. No adverse effect was reported. 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 physician refers to at least five patient of unknown age. On unknown dates in the past year in 2012 at least five patients were vaccinated with GARDASIL injection (lot # not reported) off schedule. The physician reported the typical scenario was that the patient received the first dose at unspecified provider's facility and presented to her office after "about one year" and was administered a second dose at that time. No adverse effects reported from any patients. Physician did not have specific patient information. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash erythematous, Rash pruritic, Rash vesicular, Scab
Clinical narrative: This spontaneous report as received from an office manager and physician refers to a 67 year old female patient with atrial fibrillation, coronary artery disease, diabetes, gastroesophageal reflux disease, hypertension and hyperlipidemia. Drug reactions and allergies were not reported. On 29-APR-2013, the patient was vaccinated with ZOSTAVAX (lot # J000432, expiration date 10-OCT-2014) subcutaneous recommended by physician (dose was not reported). Concomitant therapies included losartan potassium (manufacturer unknown), ZYRTEC, TORPOL XL tablets, ZOCOR, XARELTO, PROTONIX, HUMULIN, ACTOS, NASONEX, vitamin D (unspecified) and aspirin. On 06-MAY-2013 one week after receiving ZOSTAVAX, the patient reported that she had a "rash on her legs and arms that was itchy, it was getting better but it was now getting much worse". The patient also stated she had "scabs and was constantly scratching even in her sleep". At that time, physician referred the patient to dermatologist. On 04-JUN-2013, the patient was seen by the dermatologist. Dermatologist reported the rash was a slight form of chicken pox probably brought on by the vaccine and prescribed clobetasol propionate 0.5% topical cream. On 05-JUN-2013 at 12:45pm, additional information was received from a physician (dermatologist) who reported the patient's adverse reaction "was not a rash or chicken pox, it was more of an allergic reaction". Physician also stated "the patient had red bumps over her legs and arms but no blisters or lesions". No laboratory diagnostics were performed. The outcome of allergic reaction was unknown. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient. Pharmacist reported none medical history, and none drug reactions or allergies. On 05-JUN-2013 the patient was vaccinated with ZOSTAVAX lot # J000447, exp. date 11-APR-2014, 0.65 ml, subcutaneous for physician recommendation. None concomitant medications were reported. On 05-JUN-2013, patient experienced redness on the opposite side of the elbow about 15 minutes after receiving ZOSTAVAX. Pharmacist reports that she instructed the patient to hang around the pharmacy "for a little" so she could monitor the redness. No treatment was given for redness. None lab diagnostics studies were performed. The outcome of redness on the opposite of the elbow was reported as recovering/resolving ("redness is starting to go away"). The relationship between ZOSTAVAX and redness was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Type III immune complex mediated reaction
Clinical narrative: This spontaneous report as received from a physician assistant refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided). On an unknown date, the day after the patient received ZOSTAVAX, the patient developed Arthus reaction to ZOSTAVAX. The patient presented with "arm really swollen" to clinic. The outcome of Arthus reaction was unknown. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Vaccination error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 15 years old patient who on 17-MAY-2013 received a dose of PROQUAD (dose, route and lot number were not reported) due to a human error. Concomitant medications were not reported. No adverse effect reported. The outcome of patient was not reported. Additional information has been requested.