chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.27
Sex: M
Vaccine: DTAP, HEP
Symptoms: Pyrexia, Skin warm, Staring, Vomiting
Clinical narrative: Got the DTaP and Heb B shots around 10:00 AM, son had a mild cold with no fever. Later in the afternoon to early evening my son was very irritable and felt slightly warm. I gave him Tylenol around 5 pm. We went to bed around 8 pm. I woke around 2 am because my son's body was so hot it woke me up. Our thermometer is very unreliable but he got more Tylenol and husband went to store for a new thermometer. About 1 hour after Tylenol his temperature was 101. In the morning my son was not his usual happy self. He usually greets anyone (especially cashiers) with a giant smile. Instead he just stared lethargically. He was very irritable and clingy all day. Fever present at all times, temp depended on how recently he got Tylenol or Motrin and how much he managed to spit out. It is now 6:30 am on 12/18/2014 and he's puked a tiny bit this morning, still has a raging fever and is absolutely miserable. He cries any time we aren't laying down in bed together, with my breast out and available to him if he needs to nurse and/or cuddle.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Hyperhidrosis, Hypersensitivity, Nausea
Clinical narrative: Nausea feeling, tired followed by chills, sweats and shivering.  Followed by itchy palms of both hands, feet and thighs.  Eventually my whole body itched.  With hives.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Nausea feeling, tired followed by chills, sweats and shivering.  Followed by itchy palms of both hands, feet and thighs.  Eventually my whole body itched.  With hives.
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: Redness with 60mm induration, tenderness.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Ear swelling, Heart rate increased, Sinus disorder, Swelling face
Clinical narrative: Fast heartbeat, swelling inside right sinus and ear, extreme swelling right side if face, from ear to jaw center and some difficulty breathing.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Blindness, Dysgeusia, Dyspnoea, Erythema, Gastric disorder
Clinical narrative: Stomach drop, metallic taste, loss of vision, difficulty breathing, and redness.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Acute hepatic failure, Alanine aminotransferase increased, Ammonia increased, Analgesic drug level therapeutic, Aspartate aminotransferase increased
Clinical narrative: Acute jaundice and signs of acute liver failure. Now listed for liver transplant.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Coagulopathy, Cytomegalovirus test positive, Epstein-Barr virus test negative, Hepatic necrosis, Hepatitis B test negative
Clinical narrative: Acute jaundice and signs of acute liver failure. Now listed for liver transplant.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Hepatitis viral test negative, Jaundice, Toxicologic test normal, Varicella virus test negative, Viral load decreased
Clinical narrative: Acute jaundice and signs of acute liver failure. Now listed for liver transplant.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Eye discharge, Eye irritation, Headache, Ocular hyperaemia
Clinical narrative: Coughing and extreme red burning eyes, with discharge, until about 8 pm.  Still have ore throat and headache. This may have been the onset of a cold, but I haven't had the burning eyes before.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain
Clinical narrative: Coughing and extreme red burning eyes, with discharge, until about 8 pm.  Still have ore throat and headache. This may have been the onset of a cold, but I haven't had the burning eyes before.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: CSF protein increased, Guillain-Barre syndrome, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: Influenza vaccine administered on 11/13/15. Guillain-Barre Syndrome began Dec. 1st 2015. Hospitalized x 2 12/6-12/8 and 12/10 - present.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Abnormal behaviour, Crying, Injection site swelling, Irritability, Lethargy
Clinical narrative: Not acting like usual self, lethargic, irritable, inconsolable crying, swelling at injection site, high fever.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Not acting like usual self, lethargic, irritable, inconsolable crying, swelling at injection site, high fever.
Age: 5.0
Sex: M
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Injection site pain, Irritability, Pyrexia
Clinical narrative: Sore arm and fever and irritability.
Age: 48.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Erythema of eyelid, Eye swelling, Fatigue, Headache
Clinical narrative: 12:45 PM: Severe fatigue, dizziness, eyelids turning red, tunnel vision, headache. 2:00 PM: increased Redness and Swelling around eyes, increased fatigue, headache increasing, small hives breaking out across stomach/torso. Difficulty seeing/blurring vision.
Age: 48.0
Sex: F
Vaccine: HEPAB
Symptoms: Tunnel vision, Urticaria, Vision blurred
Clinical narrative: 12:45 PM: Severe fatigue, dizziness, eyelids turning red, tunnel vision, headache. 2:00 PM: increased Redness and Swelling around eyes, increased fatigue, headache increasing, small hives breaking out across stomach/torso. Difficulty seeing/blurring vision.
Age: 44.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Chest pain, Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal chest pain
Clinical narrative: Swelling, warmth, pain upper L arm progressively worse over next few d and inducing pain and tenderness in proximal thorax and shoulder girdle.  Lasting over 10 d.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: No adverse effects noted.
Age: 1.27
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Seizure
Clinical narrative: 2 active seizures, one lasting 30 minutes in length.
Age: 1.02
Sex: F
Vaccine: MMR
Symptoms: Nasopharyngitis, Pyrexia, Rash, Roseola
Clinical narrative: Cold Symptoms that lead to Roseola.
Age: 7.0
Sex: M
Vaccine: FLUN4, IPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: NO Adverse event occurred.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report as received from a consumer refers to a 12 year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were not reported. The reporter stated that he had seen a video on the website about a year ago, saying that a patient was vaccinated with a dose of GARDASIL (formulation, strength, dose, lot number and expiry date were not reported) (date of vaccination was not reported). On an unknown date, a week after vaccination (reported as a week after) the patient died. Product quality complaint (PQC) was not involved. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: On the evening of the 9th, patient reports feeling numbness in her left leg. Since then, the numbness and tingling had spread up her leg and has since moved to her right leg as well. The feeling has not abated. Patient has gone to the ER, her primary care physician and an endocrinologist. No testing was ordered, and told the patient to return if there is a loss of sensation or an impact on mobility.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain, Peripheral coldness
Clinical narrative: Not sure about onset, patient was not clear. Called in Monday 12/14/15 and complained of pain/numbness, and cold fingers. Suggested ibuprofen.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Back pain, Injection site bruising, Injection site pain, Injection site swelling, Pain
Clinical narrative: Initial sting, then swollen, painful, area around shot sites; bruise evident at shots site (had both flu and pneumonia shots); applied Arnica salve; unable to sleep on left side that night; on morning of 12/16, still swollen, painful and bruised at shots site; applied Arnica salve; achy all over, but especially lower back; took 3 aspirin at 8 AM; spent most of the day in bed with hot pack on lower back; better as day progressed; on morning of 12/17, woke up with lower back an shots site still hurting; applied Arnica and took 3 more aspirin; better as day progressed; on 12/18, still achy but better; did not take aspirin.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Sleep disorder
Clinical narrative: Initial sting, then swollen, painful, area around shot sites; bruise evident at shots site (had both flu and pneumonia shots); applied Arnica salve; unable to sleep on left side that night; on morning of 12/16, still swollen, painful and bruised at shots site; applied Arnica salve; achy all over, but especially lower back; took 3 aspirin at 8 AM; spent most of the day in bed with hot pack on lower back; better as day progressed; on morning of 12/17, woke up with lower back an shots site still hurting; applied Arnica and took 3 more aspirin; better as day progressed; on 12/18, still achy but better; did not take aspirin.
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Computerised tomogram, Dysphagia, Feeling abnormal, Injection site erythema
Clinical narrative: This is a spontaneous report from a non-contactable consumer received via a Pfizer sales representative. This female patient in her 30s received a single dose of PREVNAR 13, via an unspecified route of administration in arm on 10Dec2015 and prednisone (manufacturer unknown), via an unspecified route of administration from 10Dec2015 to 11Dec2015 at 1x/day for back disorder. Medical history included ongoing asthma. The patient took an unspecified asthma medication. Concomitant medications were not reported. The patient experienced abscess thyroid, she was having trouble swallowing, she had swelling at injection site, soreness and redness at injection site, lump the size of a walnut on her thyroid; thyroid function came back not normal, she woke up and felt awful, all on 11Dec2015 with outcome of unknown. Clinical course was reported as follows: The patient received PREVNAR 13 on 10Dec2015. She woke up and had a lump the size of a walnut on her thyroid on 11Dec2015. She went back to her primary care doctor and felt awful on 11Dec2015. She woke up on 11Dec2015 and was having trouble swallowing. She contacted her PCP who sent her for the CT and then went to the surgeon who started her on antibiotics (SEPTRA) and she went back to the surgeon on 14Dec2015. Blood work on 11Dec2015 was done by the surgeon and some of her thyroid labs came back not normal. A bunch of different panels were run with unknown results. White blood cell count was normal. The patient had also swelling at injection site, it was also sore and red. The patient stopped taking the steroids on 11Dec2015 because she was afraid to take it with an infection.
Sex: F
Vaccine: PNC13
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Thyroid function test abnormal, Thyroid gland abscess
Clinical narrative: This is a spontaneous report from a non-contactable consumer received via a Pfizer sales representative. This female patient in her 30s received a single dose of PREVNAR 13, via an unspecified route of administration in arm on 10Dec2015 and prednisone (manufacturer unknown), via an unspecified route of administration from 10Dec2015 to 11Dec2015 at 1x/day for back disorder. Medical history included ongoing asthma. The patient took an unspecified asthma medication. Concomitant medications were not reported. The patient experienced abscess thyroid, she was having trouble swallowing, she had swelling at injection site, soreness and redness at injection site, lump the size of a walnut on her thyroid; thyroid function came back not normal, she woke up and felt awful, all on 11Dec2015 with outcome of unknown. Clinical course was reported as follows: The patient received PREVNAR 13 on 10Dec2015. She woke up and had a lump the size of a walnut on her thyroid on 11Dec2015. She went back to her primary care doctor and felt awful on 11Dec2015. She woke up on 11Dec2015 and was having trouble swallowing. She contacted her PCP who sent her for the CT and then went to the surgeon who started her on antibiotics (SEPTRA) and she went back to the surgeon on 14Dec2015. Blood work on 11Dec2015 was done by the surgeon and some of her thyroid labs came back not normal. A bunch of different panels were run with unknown results. White blood cell count was normal. The patient had also swelling at injection site, it was also sore and red. The patient stopped taking the steroids on 11Dec2015 because she was afraid to take it with an infection.
Sex: F
Vaccine: PNC13
Symptoms: White blood cell count normal
Clinical narrative: This is a spontaneous report from a non-contactable consumer received via a Pfizer sales representative. This female patient in her 30s received a single dose of PREVNAR 13, via an unspecified route of administration in arm on 10Dec2015 and prednisone (manufacturer unknown), via an unspecified route of administration from 10Dec2015 to 11Dec2015 at 1x/day for back disorder. Medical history included ongoing asthma. The patient took an unspecified asthma medication. Concomitant medications were not reported. The patient experienced abscess thyroid, she was having trouble swallowing, she had swelling at injection site, soreness and redness at injection site, lump the size of a walnut on her thyroid; thyroid function came back not normal, she woke up and felt awful, all on 11Dec2015 with outcome of unknown. Clinical course was reported as follows: The patient received PREVNAR 13 on 10Dec2015. She woke up and had a lump the size of a walnut on her thyroid on 11Dec2015. She went back to her primary care doctor and felt awful on 11Dec2015. She woke up on 11Dec2015 and was having trouble swallowing. She contacted her PCP who sent her for the CT and then went to the surgeon who started her on antibiotics (SEPTRA) and she went back to the surgeon on 14Dec2015. Blood work on 11Dec2015 was done by the surgeon and some of her thyroid labs came back not normal. A bunch of different panels were run with unknown results. White blood cell count was normal. The patient had also swelling at injection site, it was also sore and red. The patient stopped taking the steroids on 11Dec2015 because she was afraid to take it with an infection.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Chills, Pain, Rash
Clinical narrative: This initial case was missing the following minimal criteria: no identifiable patient. Upon receipt of follow up information on 06Oct2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported similar events for 7 patients. This is the 3rd of the 7 reports. An 80-year-old female patient (a retired ID Physician) of an unspecified ethnicity received PREVNAR 13 (Lot # J23867, Exp date 31Jan2016) intramuscular at 0.5 ml, single at left arm on 19Nov2014. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced rashes, chills, and pain on unspecified date with outcome of unknown. Two days after receiving vaccine on 21Nov2014 the patient experienced left arm cellulitis not requiring admission to the hospital. The patient was certain this was cellulitis, not a delayed vaccine reaction. The vial was tested for contaminant that comes back negative. The pharmacist considered there was a reasonable possibility that the event left arm cellulitis was related to the PREVNAR 13. Follow-up (02DEC2015): Follow-up attempts are completed. No further information is expected. Follow-up (14Dec2015): This is a follow up spontaneous report from a contactable Pharmacist included: patient occupation; suspect lot #, exp date and vaccination site; left arm cellulitis approximate onset date; patient assessment; pharmacist assessment.
Sex: U
Vaccine: HPV4
Symptoms: Disability
Clinical narrative: This spontaneous report was received from a consumer via Corporate Twitter. The reported tweeted an article. This report refers to a 949 patients of unknown age and gender. On unknown dates, the patients were vaccinated with GARDASIL (dose, route, lot # and expiration date were not provided). On unknown dates, the patients experienced an unspecified disability. At the time of this report, the outcome was unknown. The reporter considered the event as disabled. This is one of several reports received from the same reporter. Additional information is not expected as reporter details were not provided.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a consumer via Corporate Twitter. The reported tweeted an article. This report refers to a unknown number of patients on an unknown age and gender who experienced 4030 unspecified serious adverse events after receiving a dose of GARDASIL (dose, route, lot # and expiration date were not provided). The reporter considered the unspecified events to be medically significant. This is one of several reports received from the same reporter. Additional information is not expected as reporter details were not provided.
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: This non-valid social media spontaneous report as received from an unspecified reporter refers to unspecified number of pregnant female patients of unknown age. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of GARDASIL (dose, frequency, route, lot # and expiration date were not reported). It was reported that GARDASIL caused spontaneous abortion in pregnant women. Estimated delivery date (EDD) and last menstrual period (LMP) were unknown and could not be calculated. The pregnancy outcome was spontaneous abortion. The outcome of the events was unknown. Upon internal review the event of spontaneous abortion was considered to be medically significant. This is one of several reports received from the same reporter. Additional information is not expected as no reporter's contact details were provided.
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Adverse event, Disability
Clinical narrative: This spontaneous report was received from a consumer via Corporate Twitter. The reported tweeted an article. Patient's mother claimed that her daughter, a female patient of an unknown age, received a dose of GARDASIL (dose, route, lot # and expiration date were not provided) on an unknown date. On an unknown date, the patient needed permanent care. At the time of this report, the outcome of adverse event was reported as unknown. The event was considered to be disabled. This is one of several reports received from the same reporter. Additional information is not expected as reporter details were not provided.
Sex: U
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report was received from a consumer. The reported an article. This report refers to a 149 patients of unknown age and gender. On unknown dates, the patients were vaccinated with GARDASIL (dose, route, lot # and expiration date were not provided). On unknown dates, the patients died. The cause of death was not provided. It was unknown whether the autopsies were performed or not. This is one of several reports received from the same reporter. Additional information is not expected as reporter details were not provided.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a consumer via Corporate Twitter. The reported tweeted an article. This report refers to 561 patients of an unknown age and gender. On unknown dates, the patients were vaccinated with GARDASIL (dose, route, lot # and expiration date were not provided). On unknown dates, the patients experienced unspecified events which were reported as a life threatening events. At the time of this report, the outcome of the unspecified adverse events was unknown. This is one of several reports received from the same reporter. Additional information is not expected as reporter details were not provided.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Arthralgia, Asthenia, Decreased appetite, Depression
Clinical narrative: This spontaneous report was received from the patient's mother referring to her daughter a 19 year old female patient with a history of drug reaction to unspecified steroids and VICODIN, other concurrent conditions and medical history were not provided. On 23-NOV-2011, 30-MAR-2012 and 15-AUG-2012, the patient was vaccinated respectively with first, second and third dose of GARDASIL (dose, route, concentration, site of vaccination and lot number were not provided).  Concomitant therapies included unspecified birth control therapy, AMBIEN and omeprazole (manufacturer unknown). On an unspecified date in 2012, (reported as 3 years ago) and soon after the completion of the series of GARDASIL, the patient experienced fatigue, headache, disturbance in attention, insomnia, nausea, arthralgia (joint, hips and knees pain) and myalgia. On an unspecified date in 2015 in the past six months, the reporter stated that arthralgia, headache, and insomnia got worse and the patient experienced pain (full body pain), movement disorder (difficulty moving her hands), peripheral swelling, swelling face, joint stiffness, depression, anxiety, vertigo, dizziness, tremor, asthenia, retching, dyspepsia, decreased appetite, severe muscle spasms (cramps in hands and legs) and paraesthesia (hands falls asleep). In December 2015, the patient experienced diplegia (couldn't move her legs). On an unspecified date, the patient sought for medical attention. On an unknown date, the patient received treatment for the adverse events that included Amoxicillin (500 mg, bid), Doxycycline (Tablet, oral, 1 DF, bid), Cefuroxime (Tablet, 1 DF, bid) and Gabapentin (Tablet, 1 DF, tid). At the time of the report, the outcome of fatigue, movement disorder, peripheral swelling, swelling face, depression, anxiety, vertigo, dizziness, tremor, asthenia, retching, dyspepsia, decreased appetite, muscle spasms, paraesthesia, pain, headache, disturbance in attention, insomnia, nausea, arthralgia and myalgia was reported as not recovered, otherwise the outcome of diplegia was reported as recovered after 30 minutes and the outcome of joint stiffness was reported as recovering. Upon internal review diplegia was considered as medically significant. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Diplegia, Disturbance in attention, Dizziness, Dyspepsia, Fatigue
Clinical narrative: This spontaneous report was received from the patient's mother referring to her daughter a 19 year old female patient with a history of drug reaction to unspecified steroids and VICODIN, other concurrent conditions and medical history were not provided. On 23-NOV-2011, 30-MAR-2012 and 15-AUG-2012, the patient was vaccinated respectively with first, second and third dose of GARDASIL (dose, route, concentration, site of vaccination and lot number were not provided).  Concomitant therapies included unspecified birth control therapy, AMBIEN and omeprazole (manufacturer unknown). On an unspecified date in 2012, (reported as 3 years ago) and soon after the completion of the series of GARDASIL, the patient experienced fatigue, headache, disturbance in attention, insomnia, nausea, arthralgia (joint, hips and knees pain) and myalgia. On an unspecified date in 2015 in the past six months, the reporter stated that arthralgia, headache, and insomnia got worse and the patient experienced pain (full body pain), movement disorder (difficulty moving her hands), peripheral swelling, swelling face, joint stiffness, depression, anxiety, vertigo, dizziness, tremor, asthenia, retching, dyspepsia, decreased appetite, severe muscle spasms (cramps in hands and legs) and paraesthesia (hands falls asleep). In December 2015, the patient experienced diplegia (couldn't move her legs). On an unspecified date, the patient sought for medical attention. On an unknown date, the patient received treatment for the adverse events that included Amoxicillin (500 mg, bid), Doxycycline (Tablet, oral, 1 DF, bid), Cefuroxime (Tablet, 1 DF, bid) and Gabapentin (Tablet, 1 DF, tid). At the time of the report, the outcome of fatigue, movement disorder, peripheral swelling, swelling face, depression, anxiety, vertigo, dizziness, tremor, asthenia, retching, dyspepsia, decreased appetite, muscle spasms, paraesthesia, pain, headache, disturbance in attention, insomnia, nausea, arthralgia and myalgia was reported as not recovered, otherwise the outcome of diplegia was reported as recovered after 30 minutes and the outcome of joint stiffness was reported as recovering. Upon internal review diplegia was considered as medically significant. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Insomnia, Joint stiffness, Movement disorder, Muscle spasms
Clinical narrative: This spontaneous report was received from the patient's mother referring to her daughter a 19 year old female patient with a history of drug reaction to unspecified steroids and VICODIN, other concurrent conditions and medical history were not provided. On 23-NOV-2011, 30-MAR-2012 and 15-AUG-2012, the patient was vaccinated respectively with first, second and third dose of GARDASIL (dose, route, concentration, site of vaccination and lot number were not provided).  Concomitant therapies included unspecified birth control therapy, AMBIEN and omeprazole (manufacturer unknown). On an unspecified date in 2012, (reported as 3 years ago) and soon after the completion of the series of GARDASIL, the patient experienced fatigue, headache, disturbance in attention, insomnia, nausea, arthralgia (joint, hips and knees pain) and myalgia. On an unspecified date in 2015 in the past six months, the reporter stated that arthralgia, headache, and insomnia got worse and the patient experienced pain (full body pain), movement disorder (difficulty moving her hands), peripheral swelling, swelling face, joint stiffness, depression, anxiety, vertigo, dizziness, tremor, asthenia, retching, dyspepsia, decreased appetite, severe muscle spasms (cramps in hands and legs) and paraesthesia (hands falls asleep). In December 2015, the patient experienced diplegia (couldn't move her legs). On an unspecified date, the patient sought for medical attention. On an unknown date, the patient received treatment for the adverse events that included Amoxicillin (500 mg, bid), Doxycycline (Tablet, oral, 1 DF, bid), Cefuroxime (Tablet, 1 DF, bid) and Gabapentin (Tablet, 1 DF, tid). At the time of the report, the outcome of fatigue, movement disorder, peripheral swelling, swelling face, depression, anxiety, vertigo, dizziness, tremor, asthenia, retching, dyspepsia, decreased appetite, muscle spasms, paraesthesia, pain, headache, disturbance in attention, insomnia, nausea, arthralgia and myalgia was reported as not recovered, otherwise the outcome of diplegia was reported as recovered after 30 minutes and the outcome of joint stiffness was reported as recovering. Upon internal review diplegia was considered as medically significant. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Nausea, Pain, Paraesthesia, Peripheral swelling
Clinical narrative: This spontaneous report was received from the patient's mother referring to her daughter a 19 year old female patient with a history of drug reaction to unspecified steroids and VICODIN, other concurrent conditions and medical history were not provided. On 23-NOV-2011, 30-MAR-2012 and 15-AUG-2012, the patient was vaccinated respectively with first, second and third dose of GARDASIL (dose, route, concentration, site of vaccination and lot number were not provided).  Concomitant therapies included unspecified birth control therapy, AMBIEN and omeprazole (manufacturer unknown). On an unspecified date in 2012, (reported as 3 years ago) and soon after the completion of the series of GARDASIL, the patient experienced fatigue, headache, disturbance in attention, insomnia, nausea, arthralgia (joint, hips and knees pain) and myalgia. On an unspecified date in 2015 in the past six months, the reporter stated that arthralgia, headache, and insomnia got worse and the patient experienced pain (full body pain), movement disorder (difficulty moving her hands), peripheral swelling, swelling face, joint stiffness, depression, anxiety, vertigo, dizziness, tremor, asthenia, retching, dyspepsia, decreased appetite, severe muscle spasms (cramps in hands and legs) and paraesthesia (hands falls asleep). In December 2015, the patient experienced diplegia (couldn't move her legs). On an unspecified date, the patient sought for medical attention. On an unknown date, the patient received treatment for the adverse events that included Amoxicillin (500 mg, bid), Doxycycline (Tablet, oral, 1 DF, bid), Cefuroxime (Tablet, 1 DF, bid) and Gabapentin (Tablet, 1 DF, tid). At the time of the report, the outcome of fatigue, movement disorder, peripheral swelling, swelling face, depression, anxiety, vertigo, dizziness, tremor, asthenia, retching, dyspepsia, decreased appetite, muscle spasms, paraesthesia, pain, headache, disturbance in attention, insomnia, nausea, arthralgia and myalgia was reported as not recovered, otherwise the outcome of diplegia was reported as recovered after 30 minutes and the outcome of joint stiffness was reported as recovering. Upon internal review diplegia was considered as medically significant. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Retching, Swelling face, Tremor, Vertigo
Clinical narrative: This spontaneous report was received from the patient's mother referring to her daughter a 19 year old female patient with a history of drug reaction to unspecified steroids and VICODIN, other concurrent conditions and medical history were not provided. On 23-NOV-2011, 30-MAR-2012 and 15-AUG-2012, the patient was vaccinated respectively with first, second and third dose of GARDASIL (dose, route, concentration, site of vaccination and lot number were not provided).  Concomitant therapies included unspecified birth control therapy, AMBIEN and omeprazole (manufacturer unknown). On an unspecified date in 2012, (reported as 3 years ago) and soon after the completion of the series of GARDASIL, the patient experienced fatigue, headache, disturbance in attention, insomnia, nausea, arthralgia (joint, hips and knees pain) and myalgia. On an unspecified date in 2015 in the past six months, the reporter stated that arthralgia, headache, and insomnia got worse and the patient experienced pain (full body pain), movement disorder (difficulty moving her hands), peripheral swelling, swelling face, joint stiffness, depression, anxiety, vertigo, dizziness, tremor, asthenia, retching, dyspepsia, decreased appetite, severe muscle spasms (cramps in hands and legs) and paraesthesia (hands falls asleep). In December 2015, the patient experienced diplegia (couldn't move her legs). On an unspecified date, the patient sought for medical attention. On an unknown date, the patient received treatment for the adverse events that included Amoxicillin (500 mg, bid), Doxycycline (Tablet, oral, 1 DF, bid), Cefuroxime (Tablet, 1 DF, bid) and Gabapentin (Tablet, 1 DF, tid). At the time of the report, the outcome of fatigue, movement disorder, peripheral swelling, swelling face, depression, anxiety, vertigo, dizziness, tremor, asthenia, retching, dyspepsia, decreased appetite, muscle spasms, paraesthesia, pain, headache, disturbance in attention, insomnia, nausea, arthralgia and myalgia was reported as not recovered, otherwise the outcome of diplegia was reported as recovered after 30 minutes and the outcome of joint stiffness was reported as recovering. Upon internal review diplegia was considered as medically significant. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event, Death
Clinical narrative: This non-valid social media spontaneous report as received from an unspecified reporter refers to unspecified number of children patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with GARDASIL (dose, frequency, route, lot # and expiration date were not reported). It was reported that, parents who injected their children with GARDASIL were murdering and maiming them (onset date unknown). The outcome of adverse event was fatal. Upon internal review the event of murdering and maiming was considered to be disabling. This is one of several reports received from the same reporter. Additional information is not expected as no reporter's contact details were provided.
Age: 39.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Pt received influenza and Tdap vaccine on 11/16. Pt arrived to ER on 12/12 and diagnosed with Guillain-Barre Syndrome = DPH notified.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site inflammation, Injection site joint inflammation, Injection site pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Shouder began to ache, motion limited, severe pain at injection site, high on the shoulder. Still painful to move, worse at night, revisited PCP 1 week later after having called a couple day after shot.  Used heat, ice, Naproxen, with no noticeable improvement. Was switched to Meloxicam on 12/15 to combat inflammation noted on MRI (along with rotator tear and arthritis appearing). After following instructions for rotator cuff exercises and taking the NSAID, aching during the day subsided, but still limited motion and night pain now after 3 days of this treatment.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Rotator cuff syndrome
Clinical narrative: Shouder began to ache, motion limited, severe pain at injection site, high on the shoulder. Still painful to move, worse at night, revisited PCP 1 week later after having called a couple day after shot.  Used heat, ice, Naproxen, with no noticeable improvement. Was switched to Meloxicam on 12/15 to combat inflammation noted on MRI (along with rotator tear and arthritis appearing). After following instructions for rotator cuff exercises and taking the NSAID, aching during the day subsided, but still limited motion and night pain now after 3 days of this treatment.
Age: 54.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Fatigue, Malaise, Pain, Pain of skin, Rash
Clinical narrative: Patient described having tender face and scalp three days after Afluria and Prevnar vaccinations. Patient had never had Prevnar before. Patient also experienced malaise/aching/fatigue and rash/skin peeling on forehead starting three days after which lasted for about 7 days.
Age: 54.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Skin exfoliation
Clinical narrative: Patient described having tender face and scalp three days after Afluria and Prevnar vaccinations. Patient had never had Prevnar before. Patient also experienced malaise/aching/fatigue and rash/skin peeling on forehead starting three days after which lasted for about 7 days.
Age: 21.0
Sex: F
Vaccine: HEPA, MMR, TDAP, VARZOS
Symptoms: Pyrexia
Clinical narrative: Pt reported fever required admission to hospital for two days.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Fear, Loss of consciousness, Screaming
Clinical narrative: The pt was screaming in fear during the injection and then he passed out. He did not get a fall injury or hit his head but I wanted to report that he passed out in case of a later reaction.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient developed a red, hard swelling at injection site. She did not experience any pain or pruritis at the site. Only notice when dressing the hard spot.  Through the day it increased in size to that of a half dollar. Patient took diphenhydramine to alleviate symptoms.  The symptoms resolved and as of 12/18/15 afternoon the site has nearly returned to normal.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation
Clinical narrative: LOCALIZED INFLAMMATION AT INJECTION SITE.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Asthenia, Biopsy muscle abnormal, Muscle atrophy, Myofascitis, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Patient has developed biopsy-proven MMF (macrophage myofascitis) with diffuse weakness and muscle atrophy causing his to be wheelchair-bound. Another concern is that I am aware of a second case of MMF in a 6 year old diagnosed earlier this year at hospital.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Wheelchair user
Clinical narrative: Patient has developed biopsy-proven MMF (macrophage myofascitis) with diffuse weakness and muscle atrophy causing his to be wheelchair-bound. Another concern is that I am aware of a second case of MMF in a 6 year old diagnosed earlier this year at hospital.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness (>5cm), induration (minimal) at injection site.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection
Clinical narrative: Patient said injection had gotten infected. Got medical treatment and antibiotic.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: Redness, warmth, pain at injection site and throughout lower half of R arm.
Age: 58.0
Sex: M
Vaccine: FLU4, TYP
Symptoms: Injection site swelling
Clinical narrative: LOCALIZED SWELLING AT INJECTION SITE. ASSESSED BY PHYSICIAN, INSTRUCTED TO GO TO ER IF SHORTNESS OF BREATH, CHEST PAINS, OR RASH OCCUR.
Age: 24.0
Sex: F
Vaccine: BCG
Symptoms: Chills, Dizziness, Dry mouth, Dyspnoea, Heart rate increased
Clinical narrative: Shortness of breath, Aching muscles/body, extremely high heart rate, feverish chills, dizziness, painful to swallow, dry mouth and sleeplessness.
Age: 24.0
Sex: F
Vaccine: BCG
Symptoms: Insomnia, Myalgia, Odynophagia, Pain, Pyrexia
Clinical narrative: Shortness of breath, Aching muscles/body, extremely high heart rate, feverish chills, dizziness, painful to swallow, dry mouth and sleeplessness.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Headache, Muscle spasms
Clinical narrative: COMPLAINS OF HEADACHE, FATIGUE AND FEELS LIKE MUSCLES ARE CRAMPING.
Age: 64.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site mass, Nausea, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: NAUSEA, VOMITING, FEVER, SWOLLEN ARM AND LUMP AT INJECTION SITE.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Left arm pain, difficulty lifting arm above head without pain.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: RED, HOT, SWELLING.
Age: 37.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Blood pressure increased, Chills, Dizziness, Influenza, Injection site pain
Clinical narrative: Started with pain on location of injection. Then next day was on the shoulder and neck. Since then I have been having severe migraines, elevated blood pressure, light headed, faint chills, and flu.
Age: 37.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Migraine, Neck pain, Syncope
Clinical narrative: Started with pain on location of injection. Then next day was on the shoulder and neck. Since then I have been having severe migraines, elevated blood pressure, light headed, faint chills, and flu.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: 2" x 1" itchy rash in the injection site only.
Age: 45.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Urticaria
Clinical narrative: Urticaria-like rash over 75% of body, chills.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Per Patient she was advised has developed cellulitis from Tdap injection. Do not have any further details on what she was prescribed.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Inflammation/redness throughout right arm centered primarily at site of injection from lower arm to shoulder.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis
Clinical narrative: Inflammation/redness throughout right arm centered primarily at site of injection from lower arm to shoulder.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Diarrhoea, Immunoglobulin therapy, Insomnia, Kawasaki's disease
Clinical narrative: High fever 104.3 crying lethargic only sleep on someone Tylenol every 4 hours not keeping fever away. Vomiting diarrhea went to 3 ER's before being admitted on 12/29/2015 diagnosed with Kawasakis disease recieved IVIG treatment.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Lethargy, Pyrexia, Vomiting
Clinical narrative: High fever 104.3 crying lethargic only sleep on someone Tylenol every 4 hours not keeping fever away. Vomiting diarrhea went to 3 ER's before being admitted on 12/29/2015 diagnosed with Kawasakis disease recieved IVIG treatment.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Severe left upper arm/shoulder pain especially picking things up.
Age: 40.0
Sex: F
Vaccine: FLUR3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: After receiving the Influenza vaccine in the right deltoid, she had pain,  swelling and redness of the area. PCP saw her and put her on Prednisone, with improvement of symptoms.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: A pneumococcal vaccine was administered on 12/10 right deltoid. A few days ago patient states the area became itchy and the injection site area became red and swollen. Seen at today clinic on 12/17/15 diagnosed with a local reaction 5-6cm. Treatment: triamcinolone cream BID prn.
Age: 1.08
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Measles post vaccine, Rash generalised
Clinical narrative: Client broke out in head to toe rash with raised bumps. Was diagnosed with measles 12-12-15.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site swelling, Local reaction
Clinical narrative: Immediate localized reaction after vaccine administered. Arm swelled at injection site and bruised.
Age: 53.0
Sex: F
Vaccine: FLU4, HEPA, PPV
Symptoms: Chills, Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: Onset 12/17/15 at 16:30: (L) arm redness/swelling 9.5 cm x 10.5 cm; warm to touch, painful (rates "8"/10), complains of chills. Tympanic temperature 37.3 C, BP 124/78, pulse 131.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Decreased appetite, Irritability, White blood cell count increased
Clinical narrative: Patient received 2 month old vaccines at 11 AM 12/17/15. Patient then developed temperature 101.5 that evening, as well as being fussy/decreased appetite. CBC done in clinic 12/18/15 - WBC 18.3.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Right deltoid area with large, warm erythematous patch that surrounds injection site.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Differential white blood cell count, Full blood count, Hypersensitivity
Clinical narrative: Patient was seen at clinic on 12-16-15 for vaccines. Tdap and HPV administered to left arm, and MENVEO to right arm. Patient follow up w/us on 12-18-15 due to possible allergic reaction to vaccines. Warm compresses were apply to affected area by parent. Patient to follow on 12-21-15.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Infection, Peripheral swelling, Skin warm
Clinical narrative: Patient arm swelled the following day after shingle shot (ZOSTAVAX). It was red/hot  and swollen and raised. She took BENADRYL that night. Went to dr next day. They gave her cephalexin and pain meds for infection.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Very red, sore, warm to touch, occurred few hours after vaccines administered.
Age: 67.0
Sex: F
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Upper left arm swollen, erythema, and hot to the touch at injection site.
Age: 14.0
Sex: M
Vaccine: FLU3, HPV9, MNQ
Symptoms: Blood glucose decreased, Dizziness
Clinical narrative: Approx. 10 minutes after receiving HPV #1, youth felt dizzy while sitting down in lab and having blood work drawn. Then, felt dizzy and rolled head and stated he was dizzy. Blood sugar immediately taken via finger stick and glucometer was 56. No food since yesterday 12/18/15 t.c. to mother. No further sx.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Anxiety, Areflexia, Condition aggravated, Guillain-Barre syndrome, Night sweats
Clinical narrative: This spontaneous report was received from a 66 year old male patient regarding himself. The patient's medical history included Raynaud's phenomenon (the patient stated that this was 'stems from Guillain-Barre syndrome'). Patient didn't have any drug allergies or reactions. On 13-OCT-2015, the patient was vaccinated with PNEUMOVAX 23 shot (strength, dose, route and lot number or batch number unspecified). No information on concomitant medication was provided. The patient reported that over a period of two to three days (since an unknown date approximately in October 2015) after receiving PNEUMOVAX 23, his Guillain-Barre syndrome symptoms gradually "revived". These symptoms included severe foot tingling, loss of reflexes, anxiety attacks in the form of a racing heart and night sweats. The patient did not seek any medical attention. The outcome of the event and causality were unknown. No further information was available. No product quality complaint (PQC) was involved. Upon internal review, the event Guillain-Barre syndrome was determined to be medically significant. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Palpitations, Paraesthesia
Clinical narrative: This spontaneous report was received from a 66 year old male patient regarding himself. The patient's medical history included Raynaud's phenomenon (the patient stated that this was 'stems from Guillain-Barre syndrome'). Patient didn't have any drug allergies or reactions. On 13-OCT-2015, the patient was vaccinated with PNEUMOVAX 23 shot (strength, dose, route and lot number or batch number unspecified). No information on concomitant medication was provided. The patient reported that over a period of two to three days (since an unknown date approximately in October 2015) after receiving PNEUMOVAX 23, his Guillain-Barre syndrome symptoms gradually "revived". These symptoms included severe foot tingling, loss of reflexes, anxiety attacks in the form of a racing heart and night sweats. The patient did not seek any medical attention. The outcome of the event and causality were unknown. No further information was available. No product quality complaint (PQC) was involved. Upon internal review, the event Guillain-Barre syndrome was determined to be medically significant. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: TYP, YF
Symptoms: Induration, Local swelling, Pruritus, Tenderness
Clinical narrative: Patient notes local swelling, induration, and pruritus. Some tenderness, full range of motion.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Painful at injection site. Silver dollar sized, hot, thick skin, red.
Age: 1.29
Sex: M
Vaccine: DTAP, FLU3, HIBV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 7.5 x 9.5 erythema and warmth on upper left thigh.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Headache, Pain, Pyrexia, Vision blurred
Clinical narrative: Patient rec'd vaccine 12/17/2015. Experienced blurry vision, headache, fever, body aches, fatigue.