chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Fatigue, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Mild nausea for 1-2 minutes after vaccination in the AM. By afternoon had fatigue and increasing pain in arm surrounding injection site, by evening area became hot to the touch. On exam area is swelling and tenderness distal to injection site over bicep. Fever and lethargy had resolved by next day. By 1/20/2014 swelling/warmth/redness resolved, mild tenderness over bicep persists. 400-600 mg ibuprofen up to 3x daily for pain/fever.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Lethargy, Nausea, Pyrexia
Clinical narrative: Mild nausea for 1-2 minutes after vaccination in the AM. By afternoon had fatigue and increasing pain in arm surrounding injection site, by evening area became hot to the touch. On exam area is swelling and tenderness distal to injection site over bicep. Fever and lethargy had resolved by next day. By 1/20/2014 swelling/warmth/redness resolved, mild tenderness over bicep persists. 400-600 mg ibuprofen up to 3x daily for pain/fever.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 14-JAN-2014 the patient was vaccinated with ZOSTAVAX (lot # J011333, expiry date 13-DEC-2014) 0.65 ml, subcutaneously (dosing regimen and frequency unknown) for vaccination. Other suspect therapies included diphtheria toxoid (+) pertussis whole cell vaccine (+) tetanus toxoid (manufacture unknown) (lot number and expiry date unknown) (dosing regimen and frequency unknown) administered on a different arm than the ZOSTAVAX on 14-JAN-2014. On 16-JAN-2014, the patient experienced a 2 inch rash had developed at the injection site the rash is not bumpy but it is sore. It was reported that the patient sought medical attention and came to see the pharmacist. The outcome of the event was unknown. The action taken with the therapy with ZOSTAVAX and vaccine (+) tetanus toxoid (manufacturer unknown) was unknown. The relatedness of the events to the therapy with ZOSTAVAX and vaccine (+) tetanus toxoid (manufacture unknown) was unknown. 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 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 01-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: 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 was administered dose of GARDASIL (dose and route unknown) on 17-JUL-2013, lot # H011350, expiration date: 21-FEB-2015). No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: This spontaneous report as received from other health professional via company representative refers to a 19 year old female patient. Patient has had no history of allergies to vaccines in the past. On 05-SEP-2013 the patient was vaccinated with GARDASIL (dose number, dose and frequency unknown) lot # J003727 and expiry date 07-NOV-2015), intramuscularly in the left deltoid region. On 06-SEP-2013, in the next morning the patient's arm was very sore and the injection site was red and hot. The patient's mother, who was nurse, instructed the patient to put ice on the injection site. It was reported that patient's reaction lasted 3 to 4 days and nothing else was done for her. The outcome of injection site was red and hot and patients arm was very sore was unknown. No further details were noted. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to an over 60 years old female patient. In November 2013 (approximately 2 months ago) the patient was vaccinated with ZOSTAVAX (dose and route unknown). On an unknown date the patient experienced redness at the injection site. The patient was feeling better now. Causality was not reported. It was unspecified if the patient sought medical attention. Additional information is not expected.
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 (dose and route unknown) on 28-MAR-2013 (lot number, dose, frequency, route and site of administration were not reported). No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist regarding an approximately 61 years old female patient. On 13-JAN-2014 the patient was vaccinated with ZOSTAVAX lot # (J011338, expiry date: 19-DEC-2014) dose; 0.65 ml, subcutaneous in the left arm for vaccination. No concomitant medications were reported. Approximately on an unknown date in January 2014 the patient experienced redness at the injection site of the left arm. Patient sought medical attention: came into pharmacy. No other effects reported. Pharmacist states client will take over the counter BENADRYL if needed. There was no product quality complaint (PQC) involved. The outcome of redness at the injection site of the left arm was reported as not resolved. Causality assessment was not provided. Additional information is not expected.
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 (dose and route unknown) on 23-AUG-2013, lot # H011350, Expiration Date: 21-FEB-2015). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: 4 cm local reaction around injection site - warm, pierchic red, (R) arm.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 17 yeas old patient. The reporter stated that a shipment of GARDASIL that was shipped from company on 08-JAN-2014 was received at her facility on 13-JAN-2014. One dose of GARDASIL (lot # J012212 exp. date. 18-FEB-2016, dose, route and site of administration not reported) was administered to a patient on 13-JAN-2014 before the status of the shipment was realized. The healthcare worker did not believe that GARDASIL was exposed to temperatures out of the recommended range for longer than 72 hours. No adverse effect had been observed or reported. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Decreased appetite, Erythema, Fatigue
Clinical narrative: Several hundred red spots, some with dark red center, a few with raised "dew drop" center, tired, lack of appetite.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Discomfort, Erythema, Local swelling, Pain
Clinical narrative: Local pain which started at 4 pm and worsened by 6 pm and peaked by 8 pm and was rated as severe. He experienced swelling of the vaccinated right upper extremity by that evening. The swelling is slowly resolving but he has some mild redness. The discomfort is resolving.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Insomnia, Pain, Pyrexia
Clinical narrative: STRONG PAIN KEPT ME AWAKE UNTIL 4AM AND SLEPT UNTIL 7AM. IT BEGAN TO DEVELOP FEVER. TOOK TYLENOL AND FEVER REDUCED TO NORMAL BODY TEMPERATURE.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown demographics. On 16-JAN-2014, the patient was vaccinated with GARDASIL (lot # J011272 expiry date 21-APR-2016) 0.5 ml, intramuscular for an unknown indication. It was reported that the patient received improperly stored GARDASIL. The GARDASIL was stored at a temperature of 29 F for 15 hours. No adverse event were reported. No product quality issue was noted. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discomfort, Injection site haemorrhage
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 12 year old female patient. Pertinent medical history was reported as none. On 10-SEP-2013 the patient was vaccinated with GARDASIL, injection, lot # J007354; expiry: 20-FEB-2016, 0.5 ml, intramuscular in the left arm. Concomitant medications were none. On an unknown date the patient experienced slight bleeding at the injection site and discomfort. There was no treatment given for the event. Patient sought medical attention and called the office. There was no product quality complaint (PQC) involved. It was also reported that the patient's parent recently notified the office by phone after being informed of the GARDASIL recall. The nurse also adds 19 doses of recalled GARDASIL were administered to other unspecified patients on unspecified dates. No adverse effects reported. The outcome of discomfort and slight bleeding at the injection site was reported as resolved on an unknown date. Causality assessment was not provided. Additional information has been requested.
Age: 1.04
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a health professional to a 12 month old patient. On 09-JAN-2014 the patient was vaccinated with a dose of PROQUAD (lot number reported as J008572, expired date 12-JAN-2015) (dosage information and route unspecified) and a dose of VARIVAX (merck) (lot number reported as G17340, expired date 20-JAN-2015) (dosage information and route unspecified), instead of M-M-R II and VARIVAX (merck). The reporter stated that this error was not due to product confusion. No adverse effect had been observed or reported. Additional information has been reported.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Erythema, Pain
Clinical narrative: Dizziness 1st day; followed by upper arm redness/pain.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Full blood count, Injection site erythema, Injection site warmth
Clinical narrative: Extensive redness and warmth on upper arm/possible cellulitis/injection rxn.
Age: 11.0
Sex: F
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: Right arm pink changing to fiery red; swollen next day. Not itchy or painful.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Flu vaccine was given on 11/20/13. Patient c/o's she has experienced upper arm pain where she received the flu vaccine injection since the injection was given.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cough, Headache, Pain, Pyrexia
Clinical narrative: Body aches/fever 101.5 at 11 PM/cough/bad headache/chills. Took one Tylenol PM to get to sleep.  Woke without fever or other symptoms after 9 hours.  (this was only the 2nd vaccine I received since 1968 - received vaccine in Nov 2012 and had no reaction.)
Age: 40.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Rash
Clinical narrative: Patient said rash start showed up two days after the shot then progressed to the whole body after one week.
Age: 40.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Rash generalised
Clinical narrative: Patient said rash start showed up two days after the shot then progressed to the whole body after one week.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, Apnoea, Apparent life threatening event, Blood immunoglobulin E normal, Crying
Clinical narrative: My daughter began having explosive diarrhea and severe screaming and crying episodes.  This progressed and the next day she was pulling her knees up and screaming. She had a mild fever of 100.4.  Her stool began to look mucousy and bloody like jelly.  We were seen by her pediatrician, and her stool tested positive for blood and they immediately sent us to Hospital.  They suspected intussuseption from the rotavirus vaccine.  They did an abdominal xray which they did not like what they saw on it so they did an ultrasound.  They determined it must have "resolved itself and popped back out on its own" she was given iv's.  A week or so later she then had an apnea episode that lasted longer than 20 seconds several times and her physician sent us to hospital again. They admitted us to the hospital and did testing such as an echocardiogram, etc.  They dx her with ALTE and said they could not say if it was related to her reaction to the vaccine or not.  Her physician even had her immune levels tested such as IgE etc which were all normal.  Her stool tested postive for rotavirus as well they said.  She was very ill for several weeks and had lost significant amount of weight from the diarhea.  I was breast feeding and from the stress my milk almost dried up. I was lucky that it came back with lots of HARD WORK and power pumping.  Many sleepless nights filled with worry went on for months after her reaction to the vaccine.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Echocardiogram normal, Haematochezia, Immunology test normal, Intussusception
Clinical narrative: My daughter began having explosive diarrhea and severe screaming and crying episodes.  This progressed and the next day she was pulling her knees up and screaming. She had a mild fever of 100.4.  Her stool began to look mucousy and bloody like jelly.  We were seen by her pediatrician, and her stool tested positive for blood and they immediately sent us to Hospital.  They suspected intussuseption from the rotavirus vaccine.  They did an abdominal xray which they did not like what they saw on it so they did an ultrasound.  They determined it must have "resolved itself and popped back out on its own" she was given iv's.  A week or so later she then had an apnea episode that lasted longer than 20 seconds several times and her physician sent us to hospital again. They admitted us to the hospital and did testing such as an echocardiogram, etc.  They dx her with ALTE and said they could not say if it was related to her reaction to the vaccine or not.  Her physician even had her immune levels tested such as IgE etc which were all normal.  Her stool tested postive for rotavirus as well they said.  She was very ill for several weeks and had lost significant amount of weight from the diarhea.  I was breast feeding and from the stress my milk almost dried up. I was lucky that it came back with lots of HARD WORK and power pumping.  Many sleepless nights filled with worry went on for months after her reaction to the vaccine.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Mucous stools, Occult blood positive, Pyrexia, Rotavirus test positive, Screaming
Clinical narrative: My daughter began having explosive diarrhea and severe screaming and crying episodes.  This progressed and the next day she was pulling her knees up and screaming. She had a mild fever of 100.4.  Her stool began to look mucousy and bloody like jelly.  We were seen by her pediatrician, and her stool tested positive for blood and they immediately sent us to Hospital.  They suspected intussuseption from the rotavirus vaccine.  They did an abdominal xray which they did not like what they saw on it so they did an ultrasound.  They determined it must have "resolved itself and popped back out on its own" she was given iv's.  A week or so later she then had an apnea episode that lasted longer than 20 seconds several times and her physician sent us to hospital again. They admitted us to the hospital and did testing such as an echocardiogram, etc.  They dx her with ALTE and said they could not say if it was related to her reaction to the vaccine or not.  Her physician even had her immune levels tested such as IgE etc which were all normal.  Her stool tested postive for rotavirus as well they said.  She was very ill for several weeks and had lost significant amount of weight from the diarhea.  I was breast feeding and from the stress my milk almost dried up. I was lucky that it came back with lots of HARD WORK and power pumping.  Many sleepless nights filled with worry went on for months after her reaction to the vaccine.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Ultrasound abdomen normal, Weight decreased, X-ray abnormal
Clinical narrative: My daughter began having explosive diarrhea and severe screaming and crying episodes.  This progressed and the next day she was pulling her knees up and screaming. She had a mild fever of 100.4.  Her stool began to look mucousy and bloody like jelly.  We were seen by her pediatrician, and her stool tested positive for blood and they immediately sent us to Hospital.  They suspected intussuseption from the rotavirus vaccine.  They did an abdominal xray which they did not like what they saw on it so they did an ultrasound.  They determined it must have "resolved itself and popped back out on its own" she was given iv's.  A week or so later she then had an apnea episode that lasted longer than 20 seconds several times and her physician sent us to hospital again. They admitted us to the hospital and did testing such as an echocardiogram, etc.  They dx her with ALTE and said they could not say if it was related to her reaction to the vaccine or not.  Her physician even had her immune levels tested such as IgE etc which were all normal.  Her stool tested postive for rotavirus as well they said.  She was very ill for several weeks and had lost significant amount of weight from the diarhea.  I was breast feeding and from the stress my milk almost dried up. I was lucky that it came back with lots of HARD WORK and power pumping.  Many sleepless nights filled with worry went on for months after her reaction to the vaccine.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Fatigue, Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: Extreme redness and swelling at injection site. Patient was fatigued and had diarrhea and vomiting x 3 days.
Age: 17.0
Sex: F
Vaccine: FLUN4, MEN
Symptoms: Abdominal pain upper, Asthenia, Blindness, Dizziness, Hypoaesthesia
Clinical narrative: Patient immediately began to feel sick she said she felt like she was going to faint.  She sat down and began saying that she couldn't see yet her eyes were wide open.  I watched her turn grey and her pupils dilate.  She then said that she could not feel her legs.  She was very weak.  She started getting severe stomach pains.  After about 10 mins we managed to move her to an exam room where she could lie down. At this point her hands locked into claws.   They remained locked for about 15 mins.   The PA gave her a can of ginger ale.  After about 20 mins after she drank it her color returned to her face, she began to feel her legs and her hands unlocked.  Total time from start to finish was approx 1 hour.
Age: 17.0
Sex: F
Vaccine: FLUN4, MEN
Symptoms: Immediate post-injection reaction, Malaise, Muscle contractions involuntary, Mydriasis, Skin discolouration
Clinical narrative: Patient immediately began to feel sick she said she felt like she was going to faint.  She sat down and began saying that she couldn't see yet her eyes were wide open.  I watched her turn grey and her pupils dilate.  She then said that she could not feel her legs.  She was very weak.  She started getting severe stomach pains.  After about 10 mins we managed to move her to an exam room where she could lie down. At this point her hands locked into claws.   They remained locked for about 15 mins.   The PA gave her a can of ginger ale.  After about 20 mins after she drank it her color returned to her face, she began to feel her legs and her hands unlocked.  Total time from start to finish was approx 1 hour.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient developed rash from elbows down on both arms.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Syncope
Clinical narrative: Fainting, Shortness of Breath, Dizziness.
Age: 1.05
Sex: F
Vaccine: HEPA, PPV, VARCEL
Symptoms: Contusion, Erythema, Injection site bruising, Injection site erythema, Swelling
Clinical narrative: Swelling, redness, bruising, red line in the middle of the bruise. Left thigh redness and bruising spread in two days to a little larger than a quarter. ER doctor prescribed antibiotics for possible infection.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Complex regional pain syndrome, Computerised tomogram normal, Dysphonia, Headache, Heart rate increased
Clinical narrative: Received Shingles vaccine on 12/02/2013. Symptoms began to be noticed on 12/04/2013, including headache, faster pulse rate, some hoarseness & wheezing, numbness & tingling 'pins & needles' feeling on right side of head/scalp/neck. Was sent to E.R. on 12/10/2013 to 'rule out' a stroke. CT was negative, and was given Rx for Prednisone steroid.... Am still experiencing the RSD-CRPS pain at this time.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain, Paraesthesia, Wheezing
Clinical narrative: Received Shingles vaccine on 12/02/2013. Symptoms began to be noticed on 12/04/2013, including headache, faster pulse rate, some hoarseness & wheezing, numbness & tingling 'pins & needles' feeling on right side of head/scalp/neck. Was sent to E.R. on 12/10/2013 to 'rule out' a stroke. CT was negative, and was given Rx for Prednisone steroid.... Am still experiencing the RSD-CRPS pain at this time.
Age: 1.61
Sex: F
Vaccine: MMR
Symptoms: Dyskinesia, Irritability, Lymphadenopathy, Muscle twitching, Pyrexia
Clinical narrative: Fevers of 104 degrees Fahrenheit onset 1/11/14. Lasted 3 days. Swollen lymph nodes behind left ear. Twitching jerking motions in sleep. Irritability for 1 week. Raised rash onset tue. Resolved on Thursday with low grade fever. On 1/20/14. Red rash on trunk and back, neck. Appears like a measles rash.
Age: 1.61
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash erythematous, Rash morbilliform
Clinical narrative: Fevers of 104 degrees Fahrenheit onset 1/11/14. Lasted 3 days. Swollen lymph nodes behind left ear. Twitching jerking motions in sleep. Irritability for 1 week. Raised rash onset tue. Resolved on Thursday with low grade fever. On 1/20/14. Red rash on trunk and back, neck. Appears like a measles rash.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Blood aluminium increased, Blood beryllium increased, Decreased appetite, Dermatitis diaper, Diarrhoea
Clinical narrative: Day 1-5: Fever onset, became "spacy" - would not respond to interaction as previous, diaper rash formed (had never had this before).  Day 6: Fever still at 102, Infant Tylenol administered. Day 6 night: Restlessness - not sleeping through the night any longer. Day 7: Woke up at 4am. Would only nap for about 1/2 hr at a time. VERY fussy. Would scream for 45 minutes. Began to not eat. Day 8: Went to Dr. and explained what happened. Dr. made excuses and tried to talk me out of it. Day 9-10: Double ear infection, Sore throat. Diarrhea. Diaper rash.  Day 11- 18: Not eating well, loss of appetite. Losing weight. Diarrhea and diaper rash continued.  Lot # FF723
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Ear infection, Feeling abnormal, Hyporesponsive to stimuli, Insomnia, Irritability
Clinical narrative: Day 1-5: Fever onset, became "spacy" - would not respond to interaction as previous, diaper rash formed (had never had this before).  Day 6: Fever still at 102, Infant Tylenol administered. Day 6 night: Restlessness - not sleeping through the night any longer. Day 7: Woke up at 4am. Would only nap for about 1/2 hr at a time. VERY fussy. Would scream for 45 minutes. Began to not eat. Day 8: Went to Dr. and explained what happened. Dr. made excuses and tried to talk me out of it. Day 9-10: Double ear infection, Sore throat. Diarrhea. Diaper rash.  Day 11- 18: Not eating well, loss of appetite. Losing weight. Diarrhea and diaper rash continued.  Lot # FF723
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Oropharyngeal pain, Pyrexia, Restlessness, Screaming, Weight decreased
Clinical narrative: Day 1-5: Fever onset, became "spacy" - would not respond to interaction as previous, diaper rash formed (had never had this before).  Day 6: Fever still at 102, Infant Tylenol administered. Day 6 night: Restlessness - not sleeping through the night any longer. Day 7: Woke up at 4am. Would only nap for about 1/2 hr at a time. VERY fussy. Would scream for 45 minutes. Began to not eat. Day 8: Went to Dr. and explained what happened. Dr. made excuses and tried to talk me out of it. Day 9-10: Double ear infection, Sore throat. Diarrhea. Diaper rash.  Day 11- 18: Not eating well, loss of appetite. Losing weight. Diarrhea and diaper rash continued.  Lot # FF723
Age: 12.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Convulsion, Electroencephalogram abnormal
Clinical narrative: Seizure activity occurred 7-9 times per day starting on the 25th.  It had been at least once daily prior to that when awakening, but then became more severe and prolonged daytime events.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever, redness and swelling at injection site, approx 4" diameter upper left forearm.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: I had a patient who I gave flu shot on last Saturday 1/11/2014. Patient came on Thursday 1/16/2014 claiming the position I gave the flu shot was really hurting. Patient said has gone to dr for check up, took pain medication and apply different kind of topical pain relief application but no relief. Patient claim cannot raise the arm up at all. She claimed the position I gave the shot was too high up on her arm. I remember given patient the shot in the position (deltoid muscle) like I have given to many other Patient that had flu shot with us in the past. I asked Patient if there was any relief at all since she had the shot. Patient said yes but was not satisfied with the progress. I told Patient one of the side effect of the flu shot is soreness in the site of action it may take some days to get relief since there is sign of relief that is good but if still not satisfied with the progress should come back and see us in two day time. She called the pharmacy today 1/20/2014 claiming the condition in her arm is gone worse and was recommended to see a specialist.
Age: 46.0
Sex: F
Vaccine: HPV4
Symptoms: Blood bilirubin increased, Infertility female, Limb injury, Liver operation, Muscle injury
Clinical narrative: This spontaneous report as received from a consumer refers to an approximately 46 year old female patient reporting on herself. In January 2007, a Papanicolaou (PAP) smear and hormones tests were done which resulted normal. In March 2008, a colposcopy and blood tests were done (results were not reported). In March 2008, the patient was vaccinated with GARDASIL dose 1 (route and lot number were not reported) on doctor's recommendation. In late May 2008, the patient was vaccinated with GARDASIL dose 2 (route and lot number were not reported). On an unknown date in 2008, after receiving GARDASIL, the patient's bilirubin became so elevated, that after a certain course of events she was admitted (from approximately May 2008 to July 2008) to the liver transplant ward in a hospital for 2 months. The patient had bilirubin levels measured from November 2007 until August 2012 (results unspecified). In May 2008, the patient signed a stent uninformed consent. On 02-JUN-2008, the patient had a stent placement. On 18-JUL-2008, the patient experienced liver surgery stent removal. The patient reported that her amended preadmission consent was misplaced. On an unknown date, the patient stated that a physician tried to get her to sign a care plan stating that she had ongoing drug, cigarette and alcohol abuse, as well as falsely claiming she had significant psychiatric problems (the patient refused: medico legal). On an unknown date, an in-vitro fertility (IVF) specialist, made light of the patient's fertility issue and egg saving. The patient did not save eggs prior to surgery with risk if death at age 46. On an unknown date in 2013, reported as 2013/2014, the patient experienced accumulative right side muscle and nerve damage post-surgery, spine twist and subsequent damage to right leg. The patient stated that it was a wonderful blessing that she did not die and that she would like to contribute to clinical trials to help perfect GARDASIL, as she had carefully put together reports, blood tests internationally over 20 years from eminent specialists. The outcome of liver surgery stent placement, liver surgery stent removal, damage to right leg, spine twist, accumulative right side muscle and nerve damage post-surgery, fertility issue and bilirubin became so elevated was unknown. Causality was not reported. Upon internal review, stent surgery and liver surgery stent removal were considered as medically significant events. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: HPV4
Symptoms: Nerve injury, Post procedural complication, Spinal disorder, Stent placement
Clinical narrative: This spontaneous report as received from a consumer refers to an approximately 46 year old female patient reporting on herself. In January 2007, a Papanicolaou (PAP) smear and hormones tests were done which resulted normal. In March 2008, a colposcopy and blood tests were done (results were not reported). In March 2008, the patient was vaccinated with GARDASIL dose 1 (route and lot number were not reported) on doctor's recommendation. In late May 2008, the patient was vaccinated with GARDASIL dose 2 (route and lot number were not reported). On an unknown date in 2008, after receiving GARDASIL, the patient's bilirubin became so elevated, that after a certain course of events she was admitted (from approximately May 2008 to July 2008) to the liver transplant ward in a hospital for 2 months. The patient had bilirubin levels measured from November 2007 until August 2012 (results unspecified). In May 2008, the patient signed a stent uninformed consent. On 02-JUN-2008, the patient had a stent placement. On 18-JUL-2008, the patient experienced liver surgery stent removal. The patient reported that her amended preadmission consent was misplaced. On an unknown date, the patient stated that a physician tried to get her to sign a care plan stating that she had ongoing drug, cigarette and alcohol abuse, as well as falsely claiming she had significant psychiatric problems (the patient refused: medico legal). On an unknown date, an in-vitro fertility (IVF) specialist, made light of the patient's fertility issue and egg saving. The patient did not save eggs prior to surgery with risk if death at age 46. On an unknown date in 2013, reported as 2013/2014, the patient experienced accumulative right side muscle and nerve damage post-surgery, spine twist and subsequent damage to right leg. The patient stated that it was a wonderful blessing that she did not die and that she would like to contribute to clinical trials to help perfect GARDASIL, as she had carefully put together reports, blood tests internationally over 20 years from eminent specialists. The outcome of liver surgery stent placement, liver surgery stent removal, damage to right leg, spine twist, accumulative right side muscle and nerve damage post-surgery, fertility issue and bilirubin became so elevated was unknown. Causality was not reported. Upon internal review, stent surgery and liver surgery stent removal were considered as medically significant events. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome, Hemiplegia
Clinical narrative: This spontaneous report was received from a registered nurse via company representative referring to a 14-year-old female patient. The patient's medical history included bad cold 2 months prior (September 2013) to the episode. On an unknown date in November 2012 the patient completed vaccination with the 3rd dose series of GARDASIL (lot # not reported( (dose not reported) to prevent HPV. No other concomitant therapies reported. On an unknown date in November 2013, approximately one year after completing a 3 dose series of GARDASIL the patient developed guillain-barre syndrome (hospitalization, medically significant and disability). The patient was then hospitalized for 2 months. The patient was reported to be still paralysed on her left side. The patient sought medical attention. It was reported that the patient was hospitalized in one hospital and was transferred to another hospital. The causality of the event was unspecified. The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: FLUC3
Symptoms: Blood pressure decreased, Dizziness, Heart rate decreased, Skin discolouration
Clinical narrative: Conscious but dizzy BP/HR dropped. Pt didn't experience sxs until approximately 5 mins after the vaccine was administered. Called for Paramedics. After Paramedics came, BP/HR slowly rose. Normal skin color returned - Heart rhythm was normal. PO2 was normal. He was advised to go home and f/u w/ primary care MD.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site nerve damage
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site nerve damage in a 51-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 18 December 2013 at 11:30 the subject received a dose of BOOSTRIX (.5 ml, unknown, left arm). On an unspecified date within months of vaccination with BOOSTRIX, the subject experienced damaged nerve endings in his arm and cannot lift his hand [unable to move hand]. On 17 January 2014, the pharmacist reported the subject experienced nerve damage in his arm following BOOSTRIX vaccination on 18 December 2013. Per pharmacist the subject saw his healthcare provider who said "the nerve damage was related to the vaccine"; "stated this is a one in a million case". The subject cannot lift his hand due to the nerve damage. It was unknown if the subject only had a doctor's office visit or a hospital visit. This case was assessed as medically serious by GSK. At the time of reporting the injection site nerve damage and unable to move hand were unresolved.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: Red, swollen arm.
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. In the summer of 2013 the patient was vaccinated with first dose of GARDASIL (lot #, expiration date, dose, route not reported) for vaccination. The patient was observed for 15 minutes and left to go home. 45 minutes after leaving the office, the patient experienced an "out of body experience" and felt faint and woozy. The patient did not seek medical attention. The outcome of the event was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Patient states severe redness, inflammation, extremely painful and warm at the site and around area of injection. Seen by her MD who gave her a steroid cream and BENADRYL. Symptoms resolved after a few days.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Fainted momentarily. But almost immediately consciousness came back.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Papule, Rash, Skin lesion
Clinical narrative: ZOSTAVAX given 1-15-14 - 2 days later developed diffuse rash involving bilateral upper extremities with papules as well as intact vesicles, approximately 50 lesions measuring 2-4 mm.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a other health professional (CMA) refers to a 12 months old male patient who was given VARIVAX (lot # reported as H018786; exp date: 15-OCT-2014), 0.5ml, once, subcutaneously in the left leg, on 27-DEC-2013 and accidentally given included PROQUAD (lot # reported as J000138, exp date: 04-JUL-2014), 0.5ml, once subcutaneously in the right leg on 27-DEC-2013. The patient's relevant medical history included acid reflux and congenital talipes equinovarus. The patient's relevant concomitant medications included amoxicillin, lansoprazole, ADVIL and TYLENOL. The patient had no relevant past drug history. He was given the VARIVAX for routine prevention of a 12 month old and given the included PROQUAD vaccination instead of the intended MMR vaccination, resulting in 2 doses of varicella. There were no adverse events observed. There was no relevant laboratory data. As of 27-DEC-2013, it was unknown if he would continue to take VARIVAX and included PROQUAD. The outcome of the dual varicella vaccination with VARIVAX and included PROQUAD was unknown. Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Within 5 minutes patient developed hive near injection site, on left subcut arm, upper. Pt was given 12.5 mg = 5 mL BENARDRYL, childrens.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Zoster rash left sacroiliac. Eval and treated 01/17/2014.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Pt had bruising and redness at site of injection.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 14-JAN-2014 the patient was vaccinated with an expired dose of M-M-R II (lot # 0012AE, expiration date 16-DEC-2013) 0.5 ml (route, indication not reported). No adverse effects reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Diarrhoea, Erythema, Headache, Local swelling
Clinical narrative: Diarrhea - 1-18-14 last -> 1-18-14. Nausea - 1-17-14 -> 1-19-14. Headache - 1-17-14 -> 1-19-14. Stomach pain 1-19-14. Arm was red, swollen, and warm, sore - 1-18-14 -> 1-19-14.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain in extremity, Skin warm
Clinical narrative: Diarrhea - 1-18-14 last -> 1-18-14. Nausea - 1-17-14 -> 1-19-14. Headache - 1-17-14 -> 1-19-14. Stomach pain 1-19-14. Arm was red, swollen, and warm, sore - 1-18-14 -> 1-19-14.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site anaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Pt had TDAP on 01/14/14 at clinic. Pt states arm did not get sore until 01/17/14. C/O of numbness at site and pain 8-9/10 left upper arm shoulder. Treated on 01/20/14 by chiropractor with cortisone injection and Vicodin. Recommended to follow up with PCP.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient called pharmacy on 1/20/14 complaining of redness, itching, and warmth around injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Reddness and warm ot the right thigh, local reaction. Treatment, cool compresses, Benadryl PO.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Injection site was sore and now extremely red. Soreness and redness is improving and patient does not think he needs to be seen by MD. I encouraged him to seek attention if needed and/or have it looked at by RPh.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Erysipelas, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Swelling, redness, pain, hot to the touch on (R) thigh erysipelas. Amoxicillin TID x 10 days. ROCEPHIN injection 1 gram today in clinic.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site warmth
Clinical narrative: Swelling, redness, pain, hot to the touch on (R) thigh erysipelas. Amoxicillin TID x 10 days. ROCEPHIN injection 1 gram today in clinic.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Antinuclear antibody, Epstein-Barr virus antibody, Full blood count, Gait disturbance, Muscle spasms
Clinical narrative: Symptoms stated 2 weeks after GARDASIL given and still noted: Muscle cramps in legs, pains in Both legs, left arm seen in office 12/14/2011. Returned to office 12/19/2013 for same complaints and now limping x 4 days.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pain in extremity, Rheumatoid factor, Streptococcus test, Urine analysis, X-ray of pelvis and hip
Clinical narrative: Symptoms stated 2 weeks after GARDASIL given and still noted: Muscle cramps in legs, pains in Both legs, left arm seen in office 12/14/2011. Returned to office 12/19/2013 for same complaints and now limping x 4 days.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: I have pain in shoulders and arms and hands my fingers hurt to move pain 24 hours a day nothing can help.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Infantile spitting up, Injection site erythema, Injection site mass, Irritability, Pyrexia
Clinical narrative: (R) leg inj spot 1 cm (R) lateral thigh, erythema, fussy, spitting up 1/15/14, lump (R) leg, (+) fever.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an immunization program refers an patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored GARDASIL (route, site, dose, strength not reported, lot # H021861, exp. date: 09-OCT-2015). Follow up information received from the nurse. The patient had been revaccinated. No symptoms reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a Company Representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (route, dose, frequency and lot # were unknown) "that was one month expired". No adverse effects reported. 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 was administered dose of GARDASIL (dose and route not reported) on 29-AUG-2013 (lot and expiration date 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: DTAPIPVHIB
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 07-SEP-2013 the patient was vaccinated COMVAX dose 1 for prophylaxis. Lot number, dose, route and frequency were not provided. On 11-JAN-2014, the patient was mistakenly administered PENTACEL, instead of the 2nd dose of COMVAX. No adverse effect was reported. Additional information is not expected.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: General physical health deterioration, Headache, Oropharyngeal pain, Pyrexia, Sputum discoloured
Clinical narrative: Case number PHEH2014US000692 is an initial spontaneous report received from a consumer (patient) on 06 Jan 2014: This report refers to a 49-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with a trivalent seasonal influenza vaccine (manufacturer was reported as Novartis, batch number and trade name: unknown) as a single dose, on 28 Dec 2013. One to two days after vaccination, he developed minor sore throat, headache, fever and severe yellow brown sputum. The reaction turned into a full blown viral infection. It was reported that he was declining in health since the time vaccine was administered. Outcome of the events was reported as unknown. Reporter assessed the events as serious causing disability. No additional information about causality was reported.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Viral infection
Clinical narrative: Case number PHEH2014US000692 is an initial spontaneous report received from a consumer (patient) on 06 Jan 2014: This report refers to a 49-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with a trivalent seasonal influenza vaccine (manufacturer was reported as Novartis, batch number and trade name: unknown) as a single dose, on 28 Dec 2013. One to two days after vaccination, he developed minor sore throat, headache, fever and severe yellow brown sputum. The reaction turned into a full blown viral infection. It was reported that he was declining in health since the time vaccine was administered. Outcome of the events was reported as unknown. Reporter assessed the events as serious causing disability. No additional information about causality was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from pharmacy student refers to a patient of unknown age and gender. On 17-JAN-2014 the patient was vaccinated with MMR II, therapy type unknown (Lot number and dose number unknown) 0.5 ml, subcutaneously for prophylaxis that expired 30-NOV-2013 and no adverse event was reported. The outcome of received expired vaccine was unknown. No further information has been provided. 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 administered dose of GARDASIL on 29-AUG-2013 (lot #H011350 and expiration date 21-FEB-2015). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.