chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Hypoaesthesia, Paraesthesia, X-ray
Clinical narrative: Initial case was received from a healthcare professional on 27 January 2014. A 23 year old female patient whose history and concomitant medication was not reported had received an intramuscular FLUZONE (batch number, dose not reported) on left deltoid on 01 November 2013. The patient did not have illness at the time of vaccination and no know allergies (NKA). On 05 November 2013, the patient developed intermittent tingling and numbness from arm down to fingers. The doctor told the patient to go to the emergency room and was with medication. On 20 January 2013, she went to another internist who told them that they shot may have pinched a nerve. She was unable to type. She went from an X-ray. The patient feels better now, and the numbness and tingling was gone. The corrective treatment was not reported.  The list of documents held by sender: none.   Follow-up information received from a healthcare professional on 18 April 2014. No additional information was provided.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphonia, Eye discharge, Swelling, Throat tightness
Clinical narrative: Initial report received from a healthcare professional on 05 November 2013. A 49 year old female patient received dose of FLUZONE (lot# and expiration date was unknown) intramuscular at left deltoid on 03-Nov-2013. On the same day, patient experienced cough, throat tightness, hoarseness, and swollen, draining eyes after 2 hours of vaccination. Events were lasted for 24 hour and resolved. Documents held by sender: none.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Heart rate increased, Hyperthyroidism, Myalgia, Pyrexia
Clinical narrative: Initial information was received from a consumer on 03 February 2014. A 57-year-old male patient had medical history of allergic to sulfa, with no concomitant medication were reported had received a dose of FLUZONE in left deltoid on 26 December 2013 (Route, dose and batch number not reported) It was reported that after 3 weeks later patient experienced chills, fever, muscle aches and increased heart rate. Patient told that when he was running he was getting muscle pain. He also had itching 3 weeks after the vaccine. His thyroid function test was done showed hyperthyroid. No corrective treatment was reported. At the time of report outcome of the event was unknown. List of documents held by sender: None.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Thyroid function test abnormal
Clinical narrative: Initial information was received from a consumer on 03 February 2014. A 57-year-old male patient had medical history of allergic to sulfa, with no concomitant medication were reported had received a dose of FLUZONE in left deltoid on 26 December 2013 (Route, dose and batch number not reported) It was reported that after 3 weeks later patient experienced chills, fever, muscle aches and increased heart rate. Patient told that when he was running he was getting muscle pain. He also had itching 3 weeks after the vaccine. His thyroid function test was done showed hyperthyroid. No corrective treatment was reported. At the time of report outcome of the event was unknown. List of documents held by sender: None.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Sudden death
Clinical narrative: This spontaneous report has been received from social media refers to a 12 year old female patient. On an unknown date the patient was vaccinated with GARDASIL (dose, route and frequency were not reported, lot# was unknown). The patient suddenly died just hours after receiving the GARDASIL vaccine. The reason of the death was unknown however it was reported that the patient died from GARDASIL. It was unknown if autopsy was performed. This is one of the several reports from the same social media. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Loss of consciousness, Neck pain, Pyrexia, Vision blurred
Clinical narrative: 8/20/14 4pm - got first HPV shot. Approximately 5pm patient said he has a headache, gave TYLENOL. He had a fever at 6am - next morning when I went to check on him. These were "possible side effects", so we kept out of state drive plans at 2pm. He passed out asleep in car. 6pm called nurse hotline to ask if still "normal" - she said give till the morning. His fever and headache were constant, and then 6am on 8-22-14 he was leaning against wall, saying I have to throw up, my neck hurts, and my eyes are blurry. Called nurse hotline again - and told her symptoms, and she said not normal, you need to take him to ER. So we went to hospital. In Emergency room, getting spinal tap ASAP. Then approx 10 hours later admitted until 8-26-14 at 5 or 6 pm.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: 8/20/14 4pm - got first HPV shot. Approximately 5pm patient said he has a headache, gave TYLENOL. He had a fever at 6am - next morning when I went to check on him. These were "possible side effects", so we kept out of state drive plans at 2pm. He passed out asleep in car. 6pm called nurse hotline to ask if still "normal" - she said give till the morning. His fever and headache were constant, and then 6am on 8-22-14 he was leaning against wall, saying I have to throw up, my neck hurts, and my eyes are blurry. Called nurse hotline again - and told her symptoms, and she said not normal, you need to take him to ER. So we went to hospital. In Emergency room, getting spinal tap ASAP. Then approx 10 hours later admitted until 8-26-14 at 5 or 6 pm.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Abasia, Nausea, Vomiting
Clinical narrative: This spontaneous report as received from a register nurse refers to a 12 year old patient of unknown gender. Medical history and concurrent conditions were not provided. On 11-NOV-2014, the patient was vaccinated with the third dose of GARDASIL (dose, route, lot number and expiry date were not reported), after that, the patient experienced abasia, vomiting and nausea. None concomitant medication provided. The outcome of abasia, vomiting and nausea was unknown. Relatedness between the therapy with GARDASIL and the events: abasia, vomiting and nausea was not reported. Additional information has been requested.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an approximately, 6 month old female patient. Patient had no history of chicken pox. On 03-SEP-2014, the patient was vaccinated with the third dose of ROTATEQ (lot number J004875, route oral), that was improperly stored. The outcome of administering the improperly stored vaccine was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an approximately, 6 month old female patient. Patient had no history of chicken pox. On 03-SEP-2014, the patient was vaccinated with the third dose of ROTATEQ (lot number J004875, route oral), that was improperly stored. The outcome of administering the improperly stored vaccine was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.41
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an approximately 4 month old male patient. On 30-OCT-2014 the patient was vaccinated with the first dose of ROTATEQ (dose, frequency, not reported, route oral, lot number J013589) that was improperly stored. The outcome of administering the improperly stored vaccine was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.41
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an approximately 4 month old male patient. On 30-OCT-2014 the patient was vaccinated with the first dose of ROTATEQ (dose, frequency, not reported, route oral, lot number J013589) that was improperly stored. The outcome of administering the improperly stored vaccine was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an approximately 9 week old male patient. Patient had no history of chickenpox disease. On 01-OCT-2014, the patient was vaccinated with the first dose of ROTATEQ (dose, frequency not reported, route oral, lot number J013589, expiry date 06-JUN-2015) that was improperly stored. The outcome of administering the improperly stored vaccine was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an approximately 9 week old male patient. Patient had no history of chickenpox disease. On 01-OCT-2014, the patient was vaccinated with the first dose of ROTATEQ (dose, frequency not reported, route oral, lot number J013589, expiry date 06-JUN-2015) that was improperly stored. The outcome of administering the improperly stored vaccine was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an approximately 5 month old male patient. Patient had no history of chickenpox disease. On 11-AUG-2014, the patient was vaccinated with the second dose of ROTATEQ (dose, frequency not reported, route oral, lot number J011342) and third dose on 30-OCT-2014 (lot number J013589, expiry date 06-JUN-2015), that was improperly stored. The outcome of administering the improperly stored vaccine was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an approximately 5 month old male patient. Patient had no history of chickenpox disease. On 11-AUG-2014, the patient was vaccinated with the second dose of ROTATEQ (dose, frequency not reported, route oral, lot number J011342) and third dose on 30-OCT-2014 (lot number J013589, expiry date 06-JUN-2015), that was improperly stored. The outcome of administering the improperly stored vaccine was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.59
Sex: F
Vaccine: RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an approximately 7 month old female patient. Patient had no history of chickenpox disease. On 15-SEP-2014, the patient was vaccinated with the first dose of ROTATEQ (dose, frequency not known, lot number J004875) that was improperly stored. The outcome of administering the improperly stored vaccine was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.59
Sex: F
Vaccine: RV5, RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an approximately 7 month old female patient. Patient had no history of chickenpox disease. On 15-SEP-2014, the patient was vaccinated with the first dose of ROTATEQ (dose, frequency not known, lot number J004875) that was improperly stored. The outcome of administering the improperly stored vaccine was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocation nurse refers to an approximately 9 week old male patient. Patient had no history of chickenpox disease. On 10-SEP-2014, the patient was vaccinated with the first dose ROTATEQ (dose, frequency not reported, lot number J004875, expiry date 17-OCT-2014) and on 11-NOV-2014, with the second dose of ROTATEQ (lot number K001194, expiry date 06-NOV-2015) that was improperly stored. No adverse event was reported. The outcome of administering the improperly stored vaccine was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Incoherent, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocation nurse refers to an approximately 9 week old male patient. Patient had no history of chickenpox disease. On 10-SEP-2014, the patient was vaccinated with the first dose ROTATEQ (dose, frequency not reported, lot number J004875, expiry date 17-OCT-2014) and on 11-NOV-2014, with the second dose of ROTATEQ (lot number K001194, expiry date 06-NOV-2015) that was improperly stored. No adverse event was reported. The outcome of administering the improperly stored vaccine was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bowel movement irregularity, Dysgeusia, Glossodynia, Musculoskeletal stiffness, Rhinorrhoea
Clinical narrative: Within an hour of receiving vaccine-metallic taste in mouth, bumps on tongue, swelling of the tongue for 1 day. Itching on scalp, back, neck.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Within an hour of receiving vaccine-metallic taste in mouth, bumps on tongue, swelling of the tongue for 1 day. Itching on scalp, back, neck.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysgeusia, Pruritus, Swollen tongue, Tongue disorder
Clinical narrative: Within an hour of receiving vaccine-metallic taste in mouth, bumps on tongue, swelling of the tongue for 1 day. Itching on scalp, back, neck.
Age: 13.0
Sex: F
Vaccine: HPVX, MEN, TDAP
Symptoms: Anaemia, Blood test, Fatigue, Influenza like illness, Malaise
Clinical narrative: Excessive periods. Bleeding lasting 55 days. Blood flow requiring changing of sanitary napkins hourly. As a result of this anemia, fatigue, and overall malice. We first noticed a physical issue fatigue and continual flu like symptoms after being given second HPV shot in January 2011. This was followed by the periods in June.
Age: 13.0
Sex: F
Vaccine: HPVX, MEN, TDAP
Symptoms: Menorrhagia, Ultrasound scan
Clinical narrative: Excessive periods. Bleeding lasting 55 days. Blood flow requiring changing of sanitary napkins hourly. As a result of this anemia, fatigue, and overall malice. We first noticed a physical issue fatigue and continual flu like symptoms after being given second HPV shot in January 2011. This was followed by the periods in June.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swollen red itchy at injection site.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report has been received from the patient's mother via a social media refers to a 17 year old female patient. On an unknown date the patient was vaccinated with GARDASIL (dose, route and frequency were not reported, lot# was unknown). The reporter reported his daughter had a serious adverse reaction to the GARDASIL vaccine and needed urgent care at a local hospital. The outcome of the serious severe adverse reaction was not reported. This is one of the several reports from the same social media. Additional information has been requested.
Age: 0.6
Sex: F
Vaccine: RV5
Symptoms: Death, Extra dose administered, Resuscitation
Clinical narrative: This spontaneous report as received from a patient's father refers to a currently 7 months old female patient. The reporter was not able to confirm the date of the first or second dose of ROTATEQ. In December 2014, when the patient was 6 months, the patient received the third dose of ROTATEQ oral. On 15-JAN-2015, at the age of 7 months, the patient was vaccinated with ROTATEQ dose 4 (due to physician mistake), oral. The reporter stated that the patient was born very ill, with many unspecified complications, which reportedly "even resulting in the death and resuscitation of the patient" on an unspecified date. The cause of death was reported as unspecified complications. It was unknown whether autopsy was performed. Relatedness between the events and vaccination with ROTATEQ was not reported. Upon internal review, the unspecified complication resulting in death and resuscitation was considered as medically significant. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Joint range of motion decreased, Neck pain, Pain in extremity
Clinical narrative: Sore arm-pain is getting worse, sometimes the pain goes into neck and across back and down arm. Unable to lay on side and limited range of motion.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Localized cellulitis to right upper arms with significant redness, swelling, warmth, and tenderness.
Age: 1.12
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Blister, Injection site vesicles, Onychomadesis, Skin discolouration, Skin exfoliation
Clinical narrative: Vesicles, initially at site of administration, then spread to rest of skin. Dusky fingers, sloughing off skin, nail loss of big toe. Lasted about 2 weeks. Did not report symptoms to provider.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Influenza like illness, Lymph node pain, Mobility decreased
Clinical narrative: Stiff neck, severe head ache. Enlarged painful lymph nodes entire neck both sides, mouth sores flu like symptoms, pain joints, muscles in bed about 3 weeks, first time out of house was to friends for Thanksgiving dinner.  Problems continue at some point developing neuropathy in feet, painful joints hands, etc.  Rheumatology ruled out psoriatic arthritis and Sjogrens syndrome.  Rh said "sounds bacterial".  Some days feel okay do things around house or run errand then out of blue next day or several days I'm in bed again it keeps kicking my ass. Illness continues with no diagnosis.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Myalgia, Neuropathy peripheral, Stomatitis
Clinical narrative: Stiff neck, severe head ache. Enlarged painful lymph nodes entire neck both sides, mouth sores flu like symptoms, pain joints, muscles in bed about 3 weeks, first time out of house was to friends for Thanksgiving dinner.  Problems continue at some point developing neuropathy in feet, painful joints hands, etc.  Rheumatology ruled out psoriatic arthritis and Sjogrens syndrome.  Rh said "sounds bacterial".  Some days feel okay do things around house or run errand then out of blue next day or several days I'm in bed again it keeps kicking my ass. Illness continues with no diagnosis.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Abasia, Asthenia, Demyelinating polyneuropathy, Electromyogram abnormal, Hypoaesthesia
Clinical narrative: Numbness, weakness, inability to walk over 2-3 wks.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Feeling abnormal, Nasal congestion, Nausea
Clinical narrative: Initial unsolicited report received from a consumer on 13 January 2015. A 70-year-old female patient had received a second intramuscular dose of FLUZONE (lot number, site of administration not reported) on 02 January 2015. The patient reported that she had pre-existing allergies to corn, molds and flu vaccine. Illness at time of vaccination was reported as none and she had no major medical illnesses. She did not receive any other vaccinations within 4 weeks of vaccination received on 02 January 2015. On 03 January 2015, "one day or so" after she received the vaccine, the patient stated that she started to feel bad. She experienced stuffy nose, nausea, blurred vision, diarrhea and dizziness. She also felt very nervous. She did not consult her doctor at the time of the report but said she will. She reported that "her daughter was sick last week with stomach issues so she was not thinking much about it". It was also mentioned that "years ago, she had received a flu shot after which she experienced arm swelling and fever". She was told not to receive another flu vaccine but her doctor told her "it's changed a lot since then and she had it last year no problem". Outcome was reported as unknown. Documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Nervousness, Vision blurred
Clinical narrative: Initial unsolicited report received from a consumer on 13 January 2015. A 70-year-old female patient had received a second intramuscular dose of FLUZONE (lot number, site of administration not reported) on 02 January 2015. The patient reported that she had pre-existing allergies to corn, molds and flu vaccine. Illness at time of vaccination was reported as none and she had no major medical illnesses. She did not receive any other vaccinations within 4 weeks of vaccination received on 02 January 2015. On 03 January 2015, "one day or so" after she received the vaccine, the patient stated that she started to feel bad. She experienced stuffy nose, nausea, blurred vision, diarrhea and dizziness. She also felt very nervous. She did not consult her doctor at the time of the report but said she will. She reported that "her daughter was sick last week with stomach issues so she was not thinking much about it". It was also mentioned that "years ago, she had received a flu shot after which she experienced arm swelling and fever". She was told not to receive another flu vaccine but her doctor told her "it's changed a lot since then and she had it last year no problem". Outcome was reported as unknown. Documents held by sender: none.
Age: 1.35
Sex: F
Vaccine: MMR, TYP, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting and fever.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Impaired work ability, Injected limb mobility decreased, Injection site injury
Clinical narrative: While receiving TDAP adult booster vaccine, felt the needle aim too high up into shoulder.  Felt a rupture in shoulder towards the end of the injection.  Immediate onset of severe pain, inability to lift right arm.  Severe, tearing pain has persisted for 5 days so far.  Unable to lift arm, attend work or sleep due to unbearable pain.  Contacted the administering nurse practitioner.  Have not heard back yet for treatment options.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site pain, Insomnia
Clinical narrative: While receiving TDAP adult booster vaccine, felt the needle aim too high up into shoulder.  Felt a rupture in shoulder towards the end of the injection.  Immediate onset of severe pain, inability to lift right arm.  Severe, tearing pain has persisted for 5 days so far.  Unable to lift arm, attend work or sleep due to unbearable pain.  Contacted the administering nurse practitioner.  Have not heard back yet for treatment options.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Immediate post-injection reaction, Impaired work ability, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: While receiving TDAP adult booster vaccine, felt the needle aim too high up into shoulder.  Felt a rupture in shoulder towards the end of the injection.  Immediate onset of severe pain, inability to lift right arm.  Severe, tearing pain has persisted for 5 days so far.  Unable to lift arm, attend work or sleep due to unbearable pain.  Contacted the administering nurse practitioner.  Have not heard back yet for treatment options.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Electrocardiogram, Exposure during pregnancy, Ultrasound antenatal screen, X-ray
Clinical narrative: Two (2) hours after AFLURIA administered, patient began to experience shortness of breath. Patient went to hospital for treatment. Patient was given steroids. EKG, Xray and ultrasound of unborn baby performed. Discharged with prescriptions for VENTOLIN and prednisone.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Electrocardiogram, Exposure during pregnancy, Obstructive airways disorder
Clinical narrative: Two (2) hours after AFLURIA administered, patient began to experience shortness of breath. Patient went to hospital for treatment. Patient was given steroids. EKG, Xray and ultrasound of unborn baby performed. Discharged with prescriptions for VENTOLIN and prednisone.
Age: 34.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Throat tightness, Ultrasound antenatal screen, X-ray
Clinical narrative: Two (2) hours after AFLURIA administered, patient began to experience shortness of breath. Patient went to hospital for treatment. Patient was given steroids. EKG, Xray and ultrasound of unborn baby performed. Discharged with prescriptions for VENTOLIN and prednisone.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Upper left arm tender, swollen and red.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: Large red area at injections site.
Age: 17.0
Sex: M
Vaccine: FLUN4, HEPA, HPV4
Symptoms: Rash
Clinical narrative: Rash on both arms and neck. Rash disappeared within 15 mins. without treatment. Pt. was given a prescription for BENADRYL.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Patient states throat closed about 2 hours after vaccine administered, couldn't take deep breath. Went to ER - treated her for flu.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Circumstance or information capable of leading to medication error, Mobility decreased, Muscle disorder, X-ray
Clinical narrative: On 11/13/14, went to pharmacy and wanted to get flu shot. Pharmacist gave me the shot. While given me the shot, she stated "oh your muscle rolled, I must have hit a nerve". I knew it smarted extra bad. When done, I went to put coat on, my arm would not raise all the way.
Age: 11.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site swelling, Pain, Swelling, Syncope
Clinical narrative: Swelling at injection site 5 hrs. after flu injection. Syncope episode 5 hrs post immunization. Pain with swelling. Rx ibuprofen and an antihistamine.
Age: 11.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Muscle swelling
Clinical narrative: Swelling at injection site 5 hrs. after flu injection. Syncope episode 5 hrs post immunization. Pain with swelling. Rx ibuprofen and an antihistamine.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Swollen hand. I was told by son he was taking her to ER. I am not sure if they actually went or not. Pt failed to tell us that she had gotten pneumo last year.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Alopecia
Clinical narrative: Describes hair thinning/falling out.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Paraesthesia
Clinical narrative: Tingling in finger tips. Flushed feeling. BP 138/88. F/U with primary care MD reported no action needed at time. Continued to monitor. Retake BP -> 128/80. F/U with patient at 15:00. Denies any needs. Reports no symptoms. F/U on 10/16/14 -rpt no symptoms.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Eyelid ptosis, Pain, VIIth nerve paralysis
Clinical narrative: Rec'd flu vaccine 11/5/14. 12/31/14 - routine prenatal visit - Rt facial palsy began 12/30/14. Retroviral pain, rt eyelid droop, can't smile rt side mouth. 1/5/15 needs meds for pain -> steroidal course.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Pain in extremity
Clinical narrative: Influenza vaccine administered 11/4/14. He has since experienced near constant severe pain in the arm while impairs his normal daily activities. Pain increased with time.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Persistent arm pain 2 months after flu vaccine.
Age: 47.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Back pain, Hypoaesthesia, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Pain and numbness in arm, neck, shoulder, and back continuing for weeks after the shot was given.
Age: 47.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Hypoaesthesia, Joint range of motion decreased, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Pain and numbness in arm, neck, shoulder, and back continuing for weeks after the shot was given.
Age: 47.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Paraesthesia
Clinical narrative: Pain and numbness in arm, neck, shoulder, and back continuing for weeks after the shot was given.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Flushing, Rash pruritic, Urticaria
Clinical narrative: Itchy rash, hives. Flush face. Erythema to back and arms. TX - steroid shot in office. OTC BENADRYL.
Age: 89.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: RED, SWOLLEN, ITCHY AREA 2" X 3" AT SITE OF INJECTION LEFT DELTOID.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Dizziness, Formication, Pain in extremity
Clinical narrative: Pain in right arm, worsened over next two days.  Also developed dizziness and lightheadedness and felt like "crawling out of skin".
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Cough, Lethargy, Pyrexia, Rash, Wheezing
Clinical narrative: Same day experienced fever, cough, lethargy. Fever continued for 3 days. 8/24/2014 wheezing, saw MD on 8/25/2014 was given breathing treatment, steroid injection and antibiotic injection. Rx for steroid and antibiotics also. Rash on torso 3 weeks after immunization symptoms continue.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: EXTREME PAIN IN RIGHT SHOULDER NEAR SITE OF INJECTION - LIMITED ROM REDUCING FUNCTIONAL CAPACITY WITH CONTINUED PAIN - STILL ONGOING 7+ DAYS.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: Description included via email.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching on the injection site with mild redness and swelling.
Age: 20.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swollen, hot to the touch.
Age: 23.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Headache, Muscular weakness, Neck pain, Pain in extremity
Clinical narrative: Pt felt left upper arm, wrist, forearm pain, as well as neck pain with headache, felt left arm weakness. Pt took penicillin (his own dose) without much relief.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Hypothermia
Clinical narrative: Incessant crying for over 5 hours, hypothermia (35.3°C) checked by rectal way.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Client lost consciousness for about 1 minute in chair and was assisted to floor.  Client's mother was unconcerned and states that she has done this previously with shots/ medical procedures.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Balance disorder, Gait disturbance, Lethargy, Nuclear magnetic resonance imaging, Personality change
Clinical narrative: Personality Change (lethargic); unsteady gait; loss of balance.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Syncope
Clinical narrative: Dizziness, lightheaded and fainting spell in the evening. Extreme fatigue for the next 2 following days. Treatment: rest.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Oropharyngeal swelling, Urticaria
Clinical narrative: 1/11/15 pt went to doctor with hives and headache.  She returned to Dr on 1/13/15 with pharyngeal swelling and was treated with epinephrine, Decadron and Benadryl.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: C-reactive protein normal, Fontanelle bulging, Full blood count normal, Irritability, Metabolic function test normal
Clinical narrative: Irritability and full anterior fontanelle despite fever reducer and pain control.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Ultrasound skull normal
Clinical narrative: Irritability and full anterior fontanelle despite fever reducer and pain control.
Age: 15.0
Sex: F
Vaccine: HEPA, HIBV, IPV, MMR, TDAP
Symptoms: Asthenia, Dizziness, Dyskinesia, Fatigue, Loss of consciousness
Clinical narrative: On January 21, 2015, client, age 15 years, received 5 vaccines including Tdap, IPV, Hepatitis A, Hepatitis B, and MMR. Approximately 1 minute after vaccines were complete, client became extremely pale, lost consciousness and became very rigid with some uncontrolled movements to bilateral arms. This episode lasted approximately 20 seconds, following which, client regained consciousness and was A/O x 3. Client remained very pale, dizzy, nauseous, weak, and tired following the episode. These symptoms gradually improved over the course of 5 minutes while client drank juice. Client was fully recovered after 5 minutes and ambulated to the waiting room, where she remained seated to wait an additional 15 minutes prior to leaving clinic. Clients color was completely restored and all other symptoms were completely resolved at the time client left clinic approximately 15 minutes following the episode.
Age: 15.0
Sex: F
Vaccine: HEPA, HIBV, IPV, MMR, TDAP
Symptoms: Muscle rigidity, Nausea, Pallor
Clinical narrative: On January 21, 2015, client, age 15 years, received 5 vaccines including Tdap, IPV, Hepatitis A, Hepatitis B, and MMR. Approximately 1 minute after vaccines were complete, client became extremely pale, lost consciousness and became very rigid with some uncontrolled movements to bilateral arms. This episode lasted approximately 20 seconds, following which, client regained consciousness and was A/O x 3. Client remained very pale, dizzy, nauseous, weak, and tired following the episode. These symptoms gradually improved over the course of 5 minutes while client drank juice. Client was fully recovered after 5 minutes and ambulated to the waiting room, where she remained seated to wait an additional 15 minutes prior to leaving clinic. Clients color was completely restored and all other symptoms were completely resolved at the time client left clinic approximately 15 minutes following the episode.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction. Her arm had a red warm raised area with a little hard spot in the middle about 4 inches in diameter.
Age: 7.0
Sex: M
Vaccine: VARZOS
Symptoms: Eyelid oedema, Gravitational oedema, Pain in extremity, Peripheral swelling
Clinical narrative: Dependent edema upper eyelids and below eye sockets.  Swollen hands and child states hands hurt.
Age: 50.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain, Chills, Headache, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Abdominal cramps, pain to injection site, chills, fever, headache, body aches. Next day, redness and swelling spread close to elbow and injection site was hard to touch with limitation of movement.
Age: 50.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Abdominal cramps, pain to injection site, chills, fever, headache, body aches. Next day, redness and swelling spread close to elbow and injection site was hard to touch with limitation of movement.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Pt reported today 1/21/15- she states that she noticed the redness on 1/17/15.  No other symptoms reported.  She said she's fine.
Age: 4.0
Sex: M
Vaccine: FLU4, HEPA, MMRV
Symptoms: Injection site erythema
Clinical narrative: 7x10 cm red erythemic mark on right leg where HepA and Proquad vaccine was administered.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Abasia, Abdominal pain, Back pain, Cold sweat, Dizziness
Clinical narrative: Within 5 mins of receiving the vaccine she fainted, couldn't walk or stand, Cold sweats, headache, dizziness, abdominal pain, nausea,  vomiting, pain in upper back, pale. Was given treatment of putting feet up ice packs on neck. Was give ibuprofen for the head ache. After 1 hour of no improvement was sent from the doctor office to the emergency room for treatment.  At the emergency room they monitored her blood pressure and vitals and gave her food.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Dysstasia, Headache, Nausea, Pallor, Syncope
Clinical narrative: Within 5 mins of receiving the vaccine she fainted, couldn't walk or stand, Cold sweats, headache, dizziness, abdominal pain, nausea,  vomiting, pain in upper back, pale. Was given treatment of putting feet up ice packs on neck. Was give ibuprofen for the head ache. After 1 hour of no improvement was sent from the doctor office to the emergency room for treatment.  At the emergency room they monitored her blood pressure and vitals and gave her food.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Vomiting
Clinical narrative: Within 5 mins of receiving the vaccine she fainted, couldn't walk or stand, Cold sweats, headache, dizziness, abdominal pain, nausea,  vomiting, pain in upper back, pale. Was given treatment of putting feet up ice packs on neck. Was give ibuprofen for the head ache. After 1 hour of no improvement was sent from the doctor office to the emergency room for treatment.  At the emergency room they monitored her blood pressure and vitals and gave her food.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Enema administration, Intussusception, Lethargy, Pain, Pallor
Clinical narrative: Infant vomited x4 and became lethargic, pale, still. 4 more non-bilious emesis preceded by shriek of pain. Taken to Emergency Department at 2 pm. Seen by MD at 7 pm.  Ultrasound revealed intussusception.  Reduced with contrast enema.  Admitted for 24 hours observation.   Additional vomiting during night; repeat ultra-sound was negative.  No additional symptoms or sequelae.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Infant vomited x4 and became lethargic, pale, still. 4 more non-bilious emesis preceded by shriek of pain. Taken to Emergency Department at 2 pm. Seen by MD at 7 pm.  Ultrasound revealed intussusception.  Reduced with contrast enema.  Admitted for 24 hours observation.   Additional vomiting during night; repeat ultra-sound was negative.  No additional symptoms or sequelae.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Redness, itching and hives at injection site. Right deltoid area. Donor denied any other signs or symptoms. Donor advised to follow up with medical attention if symptoms worsen.
Sex: F
Vaccine: HEP
Symptoms: Blood glucose decreased, Blood test, Jaundice, Phototherapy, Yellow skin
Clinical narrative: LOW BLOOD SUGAR AND YELLOW SKIN (JAUNDICE).
Age: 1.53
Sex: F
Vaccine: MMR
Symptoms: Immune thrombocytopenic purpura, Immunoglobulin therapy, Platelet count decreased
Clinical narrative: ITP - platelets of 3 1 week after MMR. Hospitalized x 1 d; got IVIG.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the patients was vaccinated orally, with ROTATEQ (strength, dose, dose number and lot # not reported), which was improperly stored. The temperature excursion for Oral, ROTATEQ was supported with in-house stability data. It was reported that there had been two episodes of temperature excursion, after the second excursion, doses of improperly stored vaccines were administered to patients. No adverse symptoms reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker refers to unspecified patients of unknown age and gender. On 16-JAN-2015 the patients were vaccinated with improperly stored ROTATEQ (2 ml, once, oral, lot number was unknown). No adverse events was reported. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Ageusia, Eating disorder, Eyelid ptosis, Fatigue, Lacrimation increased
Clinical narrative: Had the flu shot on Friday, 10-17-14. Went to a dance that evening. Saturday evening, lost sense of taste when eating dinner. The next morning (Sunday) after waking up, ate breakfast and again had loss of taste. Noticed a bit of paralysis on the left side of face. Not severe. About an hour and a half later, since it wasn't getting better he went to the doctor who diagnosed Bell's Palsy. He was put on anti-viral med and anti-inflammatory med. The symptoms got worse before getting better. he had loss of taste, paralysis on the left side of his face, eye drooping and watering, pain behind the ear and difficulty eating and speaking. By Thanksgiving (5-6 weeks) was about 75% recovered. He has somewhat plateaued. Continues to improve and some effects remain although mostly when he is tired. He is about 85% recovered.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Speech disorder, VIIth nerve paralysis
Clinical narrative: Had the flu shot on Friday, 10-17-14. Went to a dance that evening. Saturday evening, lost sense of taste when eating dinner. The next morning (Sunday) after waking up, ate breakfast and again had loss of taste. Noticed a bit of paralysis on the left side of face. Not severe. About an hour and a half later, since it wasn't getting better he went to the doctor who diagnosed Bell's Palsy. He was put on anti-viral med and anti-inflammatory med. The symptoms got worse before getting better. he had loss of taste, paralysis on the left side of his face, eye drooping and watering, pain behind the ear and difficulty eating and speaking. By Thanksgiving (5-6 weeks) was about 75% recovered. He has somewhat plateaued. Continues to improve and some effects remain although mostly when he is tired. He is about 85% recovered.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse concerning unspecified number of patients age and gender not provided. The nurse reported that since 25-SEP-2014 improperly stored oral, ROTATEQ were administered to unspecified patients. No adverse effects were noted. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a doctor on 01 October 2013. The 5 months old patient had received FLUZONE and vaccine was administered to incorrect age of patient. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a pharmacist on 03-October-2013. The patient had received FLUZONE 0.5 ml via subcutaneous route. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: Initial summary report received on 24 September 2013 from a non-health care professional. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported that 6 patients have received the FLUZONE. Patients experienced redness and severe swelling a couple of days after immunization. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 04 November 2013. A 20 months old patient had received expired FLUZONE. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: Initial report received from a consumer on 18 November 2013. A 09-year-old female patient whose medical history and concomitant medications were not reported received FLUZONE (batch number; UH899AD, expiration date: 30 June 2014) in left deltoid on 05 November 2013 (route of addministration unknown). The patient had swelling of approximately 15x22cm and her left arm was measured to be about 1.5 cm larger than her other arm. Pediatrician observed this reaction to the Flu vaccine and indicated that it was red and there was observable swelling but the patient had no observable pain response, no respiratory or fever responses. Pediatrician indicated that a second child within the same family was administered the vaccine from the same lot with neither response nor complaints. Lab investigation and corrective treatments were not reported. The patient's reaction was resolved within 36 hours of the consultation. Documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Influenza, Nodule, Pain in extremity, Upper extremity mass
Clinical narrative: Initial report received from a consumer on 14 November 2013. A female patient whose age at the time of event, medical history and concomitant medication were not reported, had received a dose 2 of FLUZONE (lot number: unknown, route was not reported) in the right deltoid on an unspecified date in 2012. The patient had received dose 1 of FLUZONE (lot number, route was not reported) in the left deltoid on an unspecified date in 2011. On an unspecified date, the patient had got flu with 3x1 inch nodule, hard lump and pain in left deltoid. Laboratory investigation was and corrective treatments were not reported. On an unspecified date, the patient had recovered from events. Documents held by sender: none. Follow-up received from a health care professional on 27 January 2014. The age of the patient was reported as 57 years. It was reported that the patient had received the vaccine in winter 2012, in the right and left upper arm. The event was recovered on its own. The patient does not have any laboratory details, corrective treatment and medical history.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Initial case received from a health care professional on 30 October 2013. A child (gender and age were unknown) patient, received, received an dose of FLUZONE on an unspecified date (Route, site, dose and batch number were not reported). It was reported that on an unspecified date patient developed swelling and redness at injection site and low grade fever. Corrective treatment and concomitant medication were not reported. At the time of report the outcome of event was unknown.