chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.21
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Appendicectomy, Barium double contrast, Explorative laparotomy, Feeding disorder, Haematochezia
Clinical narrative: 6 days s/p vaccination, patient had bilious emesis and associated with poor feeding and fussiness. Failed outpatient therapy. Was hospitalized where she had currant jelly stool and an US showing intussusception. An ACBE was unsuccessful. Had to have ex lap. with intussusception reduction and appendectomy.
Age: 0.21
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Intussusception, Irritability, Ultrasound abdomen, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: 6 days s/p vaccination, patient had bilious emesis and associated with poor feeding and fussiness. Failed outpatient therapy. Was hospitalized where she had currant jelly stool and an US showing intussusception. An ACBE was unsuccessful. Had to have ex lap. with intussusception reduction and appendectomy.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Dizziness, Urticaria, Vomiting
Clinical narrative: Patient received vaccine on 12/18/13 and that night he started vomiting, lightheaded, diarrhea and hives.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Pain in arm where shot was given, progressing to shoulder and down to elbow area. Getting progressively worse. Had MRI. Have appointment with orthopedic surgeon. Can't move arm without pain. Sometimes pulsating pain without movement at shot area.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Asthenia, Burning sensation, Loss of control of legs, Myasthenia gravis
Clinical narrative: Weakness with activity. Diagnosed with Myasthenia Gravis.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Antiacetylcholine receptor antibody positive, Antibody test abnormal, Asthenia, Myasthenia gravis
Clinical narrative: Weakness with activity. Diagnosed with Myasthenia Gravis.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Patient received Flu vaccine - left with uncle - uncle called 10-15 min later - child having seizure - Seizure lasting about 5 minutes.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 13-JAN-2014, the patient was vaccinated with expired PROQUAD (Merck) injection (lot # H015641, Expiration Date 06-JAN-2014) (dose, units and route unknown) in error. No adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a nurse refers to her 63 year old mother. The patient's medical history included shingles, chickenpox and cataract surgery. On 07-JAN-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous 0.65 ml subcutaneously. On 07-JAN-2014, nurse sent a picture to him of the patient's arm where ZOSTAVAX administered. The patient developed a reaction on arm: "from center of where ZOSTAVAX administered, it is bright red, the size of egg, has swelling then around egg part for 2 to 3 inches is a pink color, very swollen. Patient has a fever of 100.3F and area around ZOSTAVAX administration site is hot, swollen, red. The patient "has had chickenpox in past, and shingles in past". Patient has received TYLENOL since developing reaction at injection site. Nurse states "there is blistering in center that appears to be cellulitis". Nurse states there is an area of redness where the skin will weep but it "does not look like shingles" and nurse confirmed patient has had shingles at an unspecified time in the past. Nurse states patient takes no medication. Nurse states patient had cataract surgery 2 weeks ago but states she is unsure what she medications patient received. Outcome of all events was unknown. Causality was not reported. Additional information has been requested
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Secretion discharge
Clinical narrative: This spontaneous report as received from a nurse refers to her 63 year old mother. The patient's medical history included shingles, chickenpox and cataract surgery. On 07-JAN-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous 0.65 ml subcutaneously. On 07-JAN-2014, nurse sent a picture to him of the patient's arm where ZOSTAVAX administered. The patient developed a reaction on arm: "from center of where ZOSTAVAX administered, it is bright red, the size of egg, has swelling then around egg part for 2 to 3 inches is a pink color, very swollen. Patient has a fever of 100.3F and area around ZOSTAVAX administration site is hot, swollen, red. The patient "has had chickenpox in past, and shingles in past". Patient has received TYLENOL since developing reaction at injection site. Nurse states "there is blistering in center that appears to be cellulitis". Nurse states there is an area of redness where the skin will weep but it "does not look like shingles" and nurse confirmed patient has had shingles at an unspecified time in the past. Nurse states patient takes no medication. Nurse states patient had cataract surgery 2 weeks ago but states she is unsure what she medications patient received. Outcome of all events was unknown. Causality was not reported. Additional information has been requested
Sex: F
Vaccine: MMR
Symptoms: Measles antibody positive, Mumps antibody test negative, Rubella antibody positive
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of MMR II (dosage and lot# unspecified). The physician reported that a patient had serologic testing done in October 2013 (date unspecified) and the results indicated that the patient was positive for measles and rubella but negative for mumps. The physician was unsure if the patient had received MMR II in the past but stated that he believed she had. No further information was provided. No treatment received for the event. The outcome of the event was unknown. Reporter's causality was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to-14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 08-FEB-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspepsia, Syncope
Clinical narrative: Pt w/ h/o receiving flu shot w/o incident, latex allergy and no other known issues. Use latex free form vaccine. Upon receiving vaccine, pt experienced fainting and stomach indigestion. EMS called and took to ER. Mom explained after shot pt experience seizure once before after allergy shot.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 08-DEC-2011 at 8:00, ZOSTAVAX (Lot # 671140/1266AA) was exposed to -13 degrees C for an estimated total time out of range of 10.5 hours, on 16-JAN-2012 at 7:30 and 17-JAN-2014 at 7:30, the vaccine was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 18-JAN-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671140/1266AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Nausea, Pyrexia
Clinical narrative: Extremely tender at injection site with erythema next day after injection; fever and headache, some associated nausea. Temp 101.9 F Tx: Doxycycline hyclate 100 mg BID x 7 days. Warm compresses, rest and fluids.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Axonal neuropathy, Electromyogram abnormal, Paraesthesia, Sensory disturbance
Clinical narrative: Within 24 hrs of receiving flu vaccine, patient developed tingling in his toes - > to his legs and hands without further progression until 21 OCT, when the tingling moved above his waist. Patient sought evaluation and was admitted to his local hospital. (Documentation from ER eval, hospital admission, and follow up outpatient Neurology evaluations enclosed). Patient continues to experience sensory symptoms today with most recent Neurology evaluation at the clinic in DEC 2013. (EMG report enclosed - reveals an axon loss neuropathy). OF NOTE: Patient developed sensory and motor symptoms following vaccines administered in 2009, fall 2011, and OCT 2012. (2 previous initial VAERS reports filed, as well as 1 follow up VAERS report filed).
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 03-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot# 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 04-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Product quality issue, Vaccination error
Clinical narrative: This spontaneous report as received from a consumer concerning his child. On an unknown date the patient was vaccinated with recalled GARDASIL lot # J007354 and expiry date 20-FEB-2016 (dose number and route unknown) and vaccination and no adverse event were reported. The outcome of child received the recalled GARDASIL and no adverse event was unknown. No further information was provided. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Case number PHEH2014US000820 is an initial spontaneous report from the consumer received on 09 Jan 2014. This report refers to a male patient of an unknown age. On 27 Sep 2013, the patient was vaccinated with FLUVIRIN (batch number: 1307601) in the right deltoid muscle. On 03 Jan 2014, the patient was diagnosed with type A flu. The outcome of the event was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 01-JUL-2013 at 07:40, ZOSTAVAX lot # J001005 was exposed to an exact T not recorded but noted as equal to or > 12C for an estimated total time out of range of 44.5 hours. On 01-JUL-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J001005, Exp. Date: 24-APR-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 16-JAN-2012 at 7:30 and on 17-JAN-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 20-JAN-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671141/1267AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 16-JAN-2012 at 7:30 and on 17-JAN-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 30-JAN-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671141/1267AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 08-FEB-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14.25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 11-FEB-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 16-JAN-2012 at 07:30 and on 17-JAN-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 21-FEB-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671141/1267AA, expiration date 05-NOV-2012) (dose and route administration were not provided). No adverse experience was reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 16-JAN-2012 at 7:30 and on 17-JAN-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 22-FEB-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671141/1267AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 17-JAN-2013 at 7:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14.25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 06-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route of administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 05-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from pharmacy student refers to a 37 year old female patient with diabetes and asplenia. Approximately on an unknown date of 2008 the patient was vaccinated with PNEUMOVAX23 injection (dose number, lot number and expiry date and route unknown). It was reported that patient has been administered PNEUMOVAX23 yearly for the last 6 years. No adverse effect was reported. The outcome of has been administered PNEUMOVAX23 yearly for the last 6 years and no adverse event was unknown. No further information provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 13.25 hours. On 18-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 12.75 hours. On 22-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 5 hours. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 14.25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 01-FEB-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H016765). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 16-JAN-2012 at 07:30 and on 17-JAN-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 23-FEB-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot number 671141/1267AA, expiration date 05-NOV-2012) (dose and route administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14.25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 05-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 02-APR-2013 (lot number: H011350; exp date: 21-FEB-2015) (dose, frequency, route and site of administration were not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 13.25 hours. On 18-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 12.75 hours. On 22-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 5 hours. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 14.25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 06-FEB-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H016765). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 03-MAR-2012 at 11:30am, ZOSTAVAX lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 03-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 16-JAN-2012 at 7:30 and on 17-JAN-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 01-MAR-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -14 degrees C for an estimated total time out of range of 10.5 hours and on 03-MAR-2012 at 11:30 it was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 05-MAR-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671141/1267AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Reported by patient husband - on 1/20/14 - pt said flu shot on 10/11/13 "felt different" than other flu shots in past. Injection site was very sore and soreness persists today. Pt reportedly cannot lift arm above head/has trouble lifting. Pt. has not informed primary MD. Pharmacy first informed on 1/20/14.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 16-JAN-2012 at 7:30 and on 17-JAN-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 01-MAR-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -14 degrees C for an estimated total time out of range of 10.5 hours and on 03-MAR-2012 at 11:30 it was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 06-MAR-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671141/1267AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from registered nurse. It was reported that GARDASIL vaccine were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered a dose of GARDASIL on 23-JAN-2013 exposed to temperature of 11C (dose, route and lot number not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 11 year old patient of unknown gender. On an unknown date the patient was vaccinated with GARDASIL lot # J007354. Route, dose and frequency were not reported. On an unknown date the patient experienced injection site reaction. The nurse stated that she could vaguely recall a patient reporting an injection site reaction, but this patient was "eleven years old," and multiple vaccines were administered during that same office visit (date not reported). At the time of this call, the nurse did not have access to the patient's information. The patient may have experienced an adverse effect to GARDASIL, lot # J007354. The nurse did not know for certain which vaccine the patient may have experienced an AE with. The outcome of injection site reaction was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot #H019999 was exposed to -14C for an estimated total time out of range of 14.25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 01-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 08-APR-2013 (lot number: H011350; exp date: 21-FEB-2015) (dose, frequency, route and site of administration were not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 16-JAN-2012 at 7:30 and on 17-JAN-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 29-FEB-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671141/1267AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 05-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 16-JAN-2012 at 7:30 and on 17-JAN-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 28-FEB-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671141/1267AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 16-JAN-2012 at 7:30 and on 17-JAN-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to --8 degrees C for an estimated total time out of range of 14 hours. On 01-MAR-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -14 degrees C for an estimated total time out of range of 10.5 hours and on 03-MAR-2012 at 11:30 it was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 07-MAR-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671141/1267AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Severe redness, swelling and tenderness extending to shoulder and neck region in left arm.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-MAR-2013 at 11:30 ZOSTAVAX was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 07-MAR-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 672476/1605AA, expiration date 13-JAN-2013) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody positive, Mumps antibody test negative, Rubella antibody positive
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The patient's medical history and concurrent conditions were not provided. On an unknown date the patient was vaccinated with a dose of MMR II (albumin status unknown). Dose, route and lot number were not provided. No concomitant medications were reported. The pharmacist reported the titer was drawn yesterday (approximately on 14-JAN-2014). The pharmacist stated he was unsure if this client was ever vaccinated with MMR II. No adverse effects were reported. No reporter causality was provided. Additional information is not expected; The pharmacist did not want to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 01-JUL-2013 at 07:40, ZOSTAVAX lot # J001005 was exposed to an exact T not recorded but noted as equal to or > 12C for an estimated total time out of range of 44.5 hours. On 12-JUL-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX  (dose and route administration were not provided) (Lot number J001005, Exp. Date: 24-APR-2014). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 10-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot # 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 16-JAN-2012 at 07:30 and on 17-JAN-2012 at 7:30, ZOSTAVAX (Lot # reported as 0869AA) (Lot # 0869AA is an invalid lot for ZOSTAVAX) was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 01-MAR-2012 at 7:30, ZOSTAVAX (Lot # reported as 0869AA) was exposed to -14 degrees C for an estimated total time out of range of 10.5 hours and on 03-MAR-2012 at 11:30 it was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 07-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # reported as 0869AA) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Erythema, edema, pain to area surrounding site. Prescribed prednisone dose pak and cefuroxime.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 27-DEC-2013 the patient was vaccinated with ZOSTAVAX, injection (strength, route, lot number and expiration date not provided). Other suspect therapies included PNEUMOVAX 23 injection (strength, route, lot number and expiration date not provided). The reporter mentioned that the patient was suppose to receive PNEUMOVAX 23 and a TDAP vaccine (manufacturer unknown) on this day, but it seemed that the ZOSTAVAX was administered instead of TDAP. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 01-JUL-2013 at 07:40, ZOSTAVAX lot # J001005 was exposed to an exact T not recorded but noted as equal to or > 12C for an estimated total time out of range of 44.5 hours. On 11-JUL-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX  (dose and route administration were not provided) (Lot number J001005, Exp. Date: 24-APR-2014). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-MAR-2013 at 11:30 ZOSTAVAX (Lot # 672476/1605AA) was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 07-MAR-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 672476/1605AA, expiration date 13-JAN-2013) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-MAR-2013 at 11:30 ZOSTAVAX was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 09-MAR-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 672476/1605AA, expiration date 13-JAN-2013) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Age: 0.97
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: PARENT LISTED BIRTHDAY AS 8/1/2012. VACCINES WERE BASED ON THIS BIRTHDAY. NO OTHER IMMUNIZATION RECORDS WERE AVAILABLE. ON 1/22/2014, WHEN REVIEWING RECORD, A SECOND BIRTH DATE WAS NOTED AS 2/1/2013. IT WAS THEN CONFIRMED THAT THE 2/1/2013 BIRTH DATE WAS CORRECT. VACCINES GIVEN ON 1/21/2014 WILL NEED TO BE REPEATED AFTER 2/1/2014.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Muscle spasms
Clinical narrative: Muscle spasms in chest and back; continued several days until actual shingles rash appeared on 01/17/2014; Began treatment on that day for shingles.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Palpitations
Clinical narrative: Patient states that she woke two times during the night with her heart pounding and cold sweats. She reviewed the VIS which listed these symptoms as possible reactions. She took Benadryl and symptoms subsided. No issues since taking the Benadryl.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Slight fever.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and itching started about 15 hours ago. Patient has tried Calamine lotion once about 13 hours ago. Benadryl once about 45 minutes ago. Symptoms have improved with homecares.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site pain, Injection site reaction, Pain, Paraesthesia
Clinical narrative: Initially there was a sharp pain and tingling on injection. Progressed to a deep seated aching pain which impaired her ability to function normally over the course of a week. Patient experiences additional sharp pain upon movement or weight bearing.  Treated with 10 day course of steroids during which time pain subsided, only to return upon completion of therapy. Patient as recommended ibuprofen 800 mg tid but was uneffective. Dr. wants to initiate Neurontin bid.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Weight bearing difficulty
Clinical narrative: Initially there was a sharp pain and tingling on injection. Progressed to a deep seated aching pain which impaired her ability to function normally over the course of a week. Patient experiences additional sharp pain upon movement or weight bearing.  Treated with 10 day course of steroids during which time pain subsided, only to return upon completion of therapy. Patient as recommended ibuprofen 800 mg tid but was uneffective. Dr. wants to initiate Neurontin bid.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills--Fever.  First severe aching waist up--then half hour later entire body.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-MAR-2012 at 11:30 ZOSTAVAX (Lot # 672476/1605AA) was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 12-MAR-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 672476/1605AA, expiration date 13-JAN-2013) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not reported, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 07-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. On 13-JAN-2014 the patient was vaccinated with GARDASIL, .5 ml, intramuscularly. On 13-JAN-2014, the patient's blood test was positive for pregnancy. The patient experienced no adverse effect. The outcome of blood test was positive for pregnancy and no adverse effect is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a male patient of unknown age reporting on himself. On an unknown date the patient was vaccinated with ZOSTAVAX (route, dosage, and lot number unknown). The patient reported that he developed shingles after receiving ZOSTAVAX. The outcome of he developed shingles was unknown. Additional information is not expected.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Laboratory test normal, Pyrexia, X-ray normal
Clinical narrative: MOC reports fever of 104. Patient was taken to ER. Labs and X-rays were done. Results normal. Patient discharged and advised to follow-up the next day.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Swelling in left side of face upon awakening next morning had subsided by 11 AM, no treatment.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Hypoaesthesia, Laboratory test, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Woke up at 7 am on NOV 20 2013 w/ tingling, numbness in arms, legs, hands and feet. Also had a tightness around my midsection, as if a belt was being tightened. Numerous tests were given by doctors.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Woke up at 7 am on NOV 20 2013 w/ tingling, numbness in arms, legs, hands and feet. Also had a tightness around my midsection, as if a belt was being tightened. Numerous tests were given by doctors.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: High fever 103 degrees 2 days.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient fainted briefly after receiving flu vaccine. Her son fainted and she got upset.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving the flu vaccine.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Muscle pain, fever, nausea, 2nd day after vaccine administered and continuing 3 days.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Chest X-ray normal, Culture negative, Dyskinesia, Febrile convulsion, Irritability
Clinical narrative: Patient vaccinated 12/20/2013, later that day developed "jerking movements" fussiness an fever the next morning developed fever to 103 and had febrile seizure and had emergency room evaluation.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: Patient vaccinated 12/20/2013, later that day developed "jerking movements" fussiness an fever the next morning developed fever to 103 and had febrile seizure and had emergency room evaluation.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Insomnia, Neck pain
Clinical narrative: Patient says a week after receiving the vaccine she started feeling pain in the neck and back area and usually occurs at night and having trouble sleeping.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Paraesthesia
Clinical narrative: Injection on Dec 30th, 2013. Photo Jan 11th 2014. This injection is still effecting my vitality! Today the 15th still marking and some shooting spikes like electrical shocks.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Fatigue, Headache, Pruritus, Rash generalised, Rash papular
Clinical narrative: Onset of scalp itching approx. 1 hr. later. About 16 hours after injection patient had onset of pruritic papular rash widespread on body. Also headache and fatigue.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Rash pruritic
Clinical narrative: Onset of scalp itching approx. 1 hr. later. About 16 hours after injection patient had onset of pruritic papular rash widespread on body. Also headache and fatigue.