chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: HEP
Symptoms: Borrelia test negative, Swelling face, VIIth nerve paralysis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of Bell's Palsy in a 66-year-old male subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). Concurrent medical conditions included allergy to TOPROL XL and ULORIC noted and end stage renal disease for which the subject started chronic dialysis on 09 May 2014. On 06 May 2014, the subject's hepatitis B surface antibodies were found less than 3.5 MIu/ml. On 6 June 2014, the subject received 1st dose of ENGERIX B adult (40 mcg, intramuscular, unknown injection site). On 27 June 2014, less than one month after vaccination with ENGERIX B adult, the subject presented to the reporter's clinic with facial drooping. The subject reported that he had been diagnosed with Bell's Palsy by his primary physician. The healthcare professional considered the events were clinically significant (or requiring intervention). On 21 July 2014, the subject received 2nd dose of ENGERIX B adult (40 mcg, intramuscular, unknown injection site). On 25 July 2014, 4 days after vaccination with ENGERIX B adult, the subject experienced left side of face swollen. The subject was treated with prednisone. At the time of reporting the outcome of the events was unspecified. Follow-up information received on 01 October 2014 from the physician: Some of the patient's details were provided. VAERS details were also provided. In an e-mail correspondence was stated that there is no relationship between the ENGERIX B and Bell's Palsy. The physician and the patient agreed to proceed with the second dose on 21 July 2014 (batch number 35F27, expiry date unknown). On 21st July 2014, the patient received the 2nd dose of ENGERIX B adult (intramuscular) 40 mcg. On 30 July 2014, 9 days after the last vaccination with ENGERIX B adult, the patient experienced swelling face. Rechallenge with ENGERIX B adult was positive. ENGERIX B adult was interrupted and the immunisation serie delayed. At the time of the follow-up reporting, the outcome of the Bell's Palsy, facial droop were not recovered/not resolved and the outcome of the swelling face was recovered/resolved. The reporter considered the Bell's palsy, facial droop and facial swelling to be possibly related to ENGERIX B adult.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Musculoskeletal pain, Pain, Paraesthesia
Clinical narrative: This spontaneous report as received from a 65 year old female patient refers to herself. Patient had drug reaction/allergies to morphine. On unknown date (reported as "about two and a half years ago") patient received dose of ZOSTAVAX (1 injection, dose and route of administration not provided). Concomitant therapy included amlodipine. On 30-SEP-2014 the patient experienced shingles outbreak starting with shoulder blade pain and followed with excruciating pain tingling and extreme tiredness. On 06-OCT-2014 patient felt tingling and saw a blistering rash, which started in the middle of her back and continued to spread to the front side going into her breast area. No lab diagnostic studies were performed. Patient sought medical attention. On 04-OCT-2014 the patient experienced symptoms that mimicked a heart attack, due to those symptoms, patient was hospitalized for 2 days (04-OCT-2014 and 05-OCT-2014). The outcome of the events was reported as not recovered/not resolved. Relatedness between events and vaccination with ZOSTAVAX was not reported. Upon internal review symptoms that mimicked a heart attack were considered to be medically significant. Additional information is not expected. Physician did not wish to be contacted.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a 65 year old female patient refers to herself. Patient had drug reaction/allergies to morphine. On unknown date (reported as "about two and a half years ago") patient received dose of ZOSTAVAX (1 injection, dose and route of administration not provided). Concomitant therapy included amlodipine. On 30-SEP-2014 the patient experienced shingles outbreak starting with shoulder blade pain and followed with excruciating pain tingling and extreme tiredness. On 06-OCT-2014 patient felt tingling and saw a blistering rash, which started in the middle of her back and continued to spread to the front side going into her breast area. No lab diagnostic studies were performed. Patient sought medical attention. On 04-OCT-2014 the patient experienced symptoms that mimicked a heart attack, due to those symptoms, patient was hospitalized for 2 days (04-OCT-2014 and 05-OCT-2014). The outcome of the events was reported as not recovered/not resolved. Relatedness between events and vaccination with ZOSTAVAX was not reported. Upon internal review symptoms that mimicked a heart attack were considered to be medically significant. Additional information is not expected. Physician did not wish to be contacted.
Age: 77.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Severe pain in upper arm near shoulder and radiating down arm, which has gotten worse.  Extremely tired last 3/4 days.
Age: 77.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Drug administered at inappropriate site, Injection site pain, X-ray
Clinical narrative: Severe pain in upper arm near shoulder and radiating down arm, which has gotten worse.  Extremely tired last 3/4 days.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: In patient's words: 2-3 inches below injection site there was swelling, hard as a rock, hot, palm size area with redness and itching. Experienced headache all day long.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: In patient's words: 2-3 inches below injection site there was swelling, hard as a rock, hot, palm size area with redness and itching. Experienced headache all day long.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site bruising, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt developed redness and bruising to left bicep muscle and surrounding area around 8:00pm the day after vaccination. Significant swelling noted to the area. Pt also developed a high fever of approximately 102 degrees around 9:00pm. Next day patient was seen in our office, fever resolved. Pt was given a 5 day course of Cephalexin 500mg Cap to take Q12hr for cellulitis.
Age: 64.0
Sex: F
Vaccine: MMRV
Symptoms: Arthralgia, Local swelling
Clinical narrative: Received call this morning; 10/16/14 and informed she has severe joint pain in fingers, wrists, hands, elbows, knees: R>L. Bilateral hands swollen R>L. Pain not relieved by Aleve. Referred to PCP. Agreed to follow up with our office after evaluation/treatment from PCP.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RVX
Symptoms: Constipation, Diarrhoea, Faeces discoloured, Gastrointestinal disorder, Wheezing
Clinical narrative: Wheezy before leaving doctors office.  ER visit for wheezing.    Lasted several weeks.  GI problems that consisted of diarrhea that was green foamy/watery at every diaper change 10 or more times a day.  Diarrhea turned into chronic constipation that lasted for nine months.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Soreness, pain throughout arm. Difficult to raise arm over head. Been going on for a few weeks. Very painful. Feels like a pulled muscle.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Body temperature increased, Chills, Feeling cold
Clinical narrative: Symptoms started approximately 6 hours after immunization. Donor experienced chills, uncontrollable shivering, felt cold and weak with a temperature of 103.1 degrees F. Donor took Extra Strength Tylenol and temperature was 102 at approximately 10:30 PM.  Applied cold compresses to her head and arms.  Donor awake at 6:00 AM on 10/09/2014.  Stated she still felt weak.  Temperature was approximately 101 degrees F at approximately 10:30 AM. All symptoms resolved by morning of 10/10/2014.
Age: 1.34
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Aphasia, Attention deficit/hyperactivity disorder, Autism spectrum disorder, Clostridial infection, Communication disorder
Clinical narrative: Child received the MMR vaccine on 1/20/2012.  He woke up with severe full measles rash covered from head to toe.  103 degree fever.  Lethargic.  Loss of speech, loss of all communication, noticable nervous system problems, eyes rolling into the back of his head, crying inconsolably.  After measles rash healed he stopped getting the symptoms of illness and his immune system was never the same.
Age: 1.34
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Crying, Dyspepsia, Eye movement disorder, Fungal infection, Immune system disorder
Clinical narrative: Child received the MMR vaccine on 1/20/2012.  He woke up with severe full measles rash covered from head to toe.  103 degree fever.  Lethargic.  Loss of speech, loss of all communication, noticable nervous system problems, eyes rolling into the back of his head, crying inconsolably.  After measles rash healed he stopped getting the symptoms of illness and his immune system was never the same.
Age: 1.34
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Lethargy, Measles post vaccine, Nervous system disorder, Pyrexia, Rash generalised
Clinical narrative: Child received the MMR vaccine on 1/20/2012.  He woke up with severe full measles rash covered from head to toe.  103 degree fever.  Lethargic.  Loss of speech, loss of all communication, noticable nervous system problems, eyes rolling into the back of his head, crying inconsolably.  After measles rash healed he stopped getting the symptoms of illness and his immune system was never the same.
Age: 1.34
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Sensory disturbance, Viral infection
Clinical narrative: Child received the MMR vaccine on 1/20/2012.  He woke up with severe full measles rash covered from head to toe.  103 degree fever.  Lethargic.  Loss of speech, loss of all communication, noticable nervous system problems, eyes rolling into the back of his head, crying inconsolably.  After measles rash healed he stopped getting the symptoms of illness and his immune system was never the same.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pruritus, Injection site swelling, Nasopharyngitis, Respiratory tract congestion
Clinical narrative: Patient had dull headache for 2 days, then more intense headache for several days along with onset of cold symptoms and congestion.  She also had local injection site reaction that became itchy and raised on day 4 post-vaccine and continued for several days in this manner.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Cardiac monitoring, Cardiac stress test normal, Dyspnoea, Electrocardiogram
Clinical narrative: Whenever I had prior flu shots I experienced flu-like symptoms within hours of the shot. This time I experienced shortness of breath around 6:00 - 6:30 p.m. I could not catch my breath so my husband took me to Urgent Care. When I got to Urgent Care a doctor advised me that he thought I could have a blood clot, possible heart issues, or a reaction to the flu shot I had a couple of hours earlier. He recommended that I go to hospital as the hospital could do tests and provide faster test/lab results. My husband drove me to ER. They too thought I had a blood clot or a heart attack. They noted my HD FLUZONE vaccination received earlier that day as a reaction to that shot was also a possibility. They ran numerous EKGs, blood work (D-dimer; Troponin) gave me a heparin via IV, gave me a nitroglycerin). They monitored my blood pressure, I wore a heart monitor, and they monitored low oxygen levels. The ER doctor admitted me to the hospital. At 3:30 a.m. Dr. came to my room to examine me. At 6:00 a.m. a nurse took blood, and performed vitals. They scheduled me for an 8:15 a.m. nuclear stress test which took 3 hours. After 2:30 p.m. or so the cardiologist who read my stress test posted results online so Dr stopped by to tell me the results and to discharge me on 10-3-14. The heart attack and/or blood clot issues were ruled out, leaving the possibility of an adverse reaction to the flu shot.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Fibrin D dimer, Influenza like illness, Oxygen saturation decreased, Troponin, Vaccination complication
Clinical narrative: Whenever I had prior flu shots I experienced flu-like symptoms within hours of the shot. This time I experienced shortness of breath around 6:00 - 6:30 p.m. I could not catch my breath so my husband took me to Urgent Care. When I got to Urgent Care a doctor advised me that he thought I could have a blood clot, possible heart issues, or a reaction to the flu shot I had a couple of hours earlier. He recommended that I go to hospital as the hospital could do tests and provide faster test/lab results. My husband drove me to ER. They too thought I had a blood clot or a heart attack. They noted my HD FLUZONE vaccination received earlier that day as a reaction to that shot was also a possibility. They ran numerous EKGs, blood work (D-dimer; Troponin) gave me a heparin via IV, gave me a nitroglycerin). They monitored my blood pressure, I wore a heart monitor, and they monitored low oxygen levels. The ER doctor admitted me to the hospital. At 3:30 a.m. Dr. came to my room to examine me. At 6:00 a.m. a nurse took blood, and performed vitals. They scheduled me for an 8:15 a.m. nuclear stress test which took 3 hours. After 2:30 p.m. or so the cardiologist who read my stress test posted results online so Dr stopped by to tell me the results and to discharge me on 10-3-14. The heart attack and/or blood clot issues were ruled out, leaving the possibility of an adverse reaction to the flu shot.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Myocarditis, Nuclear magnetic resonance imaging normal, Pericardial disease
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 06 October 2014. A 20 year-old male subject with no significant past medical history was found to have acute myocarditis other, acute myocarditis and unspecified disease of pericardium 14, 14 and 20 days respectively after the subject had received the following vaccines on 09 January 2014: an injection of ACAM2000 (lot number and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). On 23 January 2014, the subject had a normal ECG. On 29 January 2014, Troponin I result was abnormal with highest record value of 04.30 ng/mL and a normal echocardiogram. On 31 January 2014, the subject had a normal MRI (heart). A lumbar puncture, MRI of brain and spinal cord were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Troponin I increased
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 06 October 2014. A 20 year-old male subject with no significant past medical history was found to have acute myocarditis other, acute myocarditis and unspecified disease of pericardium 14, 14 and 20 days respectively after the subject had received the following vaccines on 09 January 2014: an injection of ACAM2000 (lot number and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). On 23 January 2014, the subject had a normal ECG. On 29 January 2014, Troponin I result was abnormal with highest record value of 04.30 ng/mL and a normal echocardiogram. On 31 January 2014, the subject had a normal MRI (heart). A lumbar puncture, MRI of brain and spinal cord were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Benign intracranial hypertension
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 12 year old female patient. No concurrent conditions or medical history were provided. It was stated the patient received all three doses of GARDASIL injection (strength, dose, route of administration, indication, lot# and expiry date not reported) on unspecified dates. No concomitant medications were reported. The physician reported that the patient developed pseudotumor cerebri while using GARDASIL (date unknown). The patient sought unspecified medical attention and was hospitalized on an unknown date. The outcome of pseudotumor cerebri was unspecified by reporter. The relatedness between the event and GARDASIL was not reported. The reporting physician provided contact information to other physicians who should be contacted as they were the patient's doctors at the hospital. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient stated her arm felt sore on10/15/2014. When she went to take a shower she noticed it was red and slightly swollen at the site of injection. On 10/16/2014 it continues sore and red. She saw CRNP and showed her her arm and reported her symptoms to her (CRNP is employed here also) and was instructed to take Advil, which she took 400mg at 10AM on 10/16/2014. She has been instructed to report additional symptoms or/and worsening of symptoms.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Pyrexia, Tremor, Vomiting
Clinical narrative: Chills, I could not stop shaking, joint pain in shoulders, knees, wrist. Followed by fever and vomiting.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Large area of bright redness at site of injection.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Local swelling
Clinical narrative: Red warm and swollen left deltoid and axilla. Recommended antiinflammatory and Benadryl. Call back if worse for possible antibiotic.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Red warm and swollen left deltoid and axilla. Recommended antiinflammatory and Benadryl. Call back if worse for possible antibiotic.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Cold sweat, Cyanosis, Erythema, Fatigue, Infection
Clinical narrative: A hive like place on left fore arm with swelling, redness, and surrounded by a blue ring. Severe cold sweats lasting for three or more hours. An infection in my entire left arm. Mild fevers with severe fatigue.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site infection, Local swelling, Pyrexia, Urticaria
Clinical narrative: A hive like place on left fore arm with swelling, redness, and surrounded by a blue ring. Severe cold sweats lasting for three or more hours. An infection in my entire left arm. Mild fevers with severe fatigue.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Painful respiration
Clinical narrative: Pain in middle of back (both side affected), becomes more intense when inhaling deeply.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Feeling hot, Injection site pain, Insomnia, Pyrexia
Clinical narrative: Sore left shoulder at point of vaccination; trouble sleeping; felt chills then hot.  Temperature of 100.2. Called nurse hot line to report symptoms.  Told to monitor fever and call back if it gets worse.  Listened to recording of treatment advice.
Age: 10.0
Sex: M
Vaccine: FLUN4, TDAP
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic, Swelling
Clinical narrative: Child noted red, bumpy rash and swelling.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Swollen tongue
Clinical narrative: Woke up with swollen tongue, area under tongue, and throat.  Took Claritin and inhaler and monitored.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and redness with itching at site of injection after employee flu vaccination.  Employee took Zyrtec and ibuprofen for 2 days post immunization for symptoms.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Dyspnoea, Gastrooesophageal reflux disease, Headache, Influenza like illness
Clinical narrative: Patient reported flu-like symptoms. He complained of nausea/arthralgia/pain/headache and acid reflux. He aslo complained of problems breathing and was admitted to the emergency room approximately 4 hours after receiving the vaccine.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pain
Clinical narrative: Patient reported flu-like symptoms. He complained of nausea/arthralgia/pain/headache and acid reflux. He aslo complained of problems breathing and was admitted to the emergency room approximately 4 hours after receiving the vaccine.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Headache, Local swelling, Somnolence
Clinical narrative: Mom informed our office on 10/15/14 that patient's arm was swollen w/large red, raised after receiving Menveo on 8/20/14 and c/o headache the following day, 8/21, that increased in severity by the end school.  Mother stated the patient slept more than normal that afternoon/evening after receiving injection waking with sever headache periodically.  Patient still c/o headache the next day, 8/22, but not as severe abd was able to go to school.  Sx improved by 8/23.
Age: 1.72
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Dyskinesia, Irritability, Pyrexia, Staring, Vomiting
Clinical narrative: PARENTS REPORT IRRITABILITY, FEVER AND PROLONGED STARING SPELL WHILE PATIENT WAS SITTING UP.  HER NECK HAD ABNORMAL MOVEMENTS - DESCRIBED AS SMALL AND INVOLUNTARY AND JERKING BY HER PARENTS.  VOMITED THE MORNING ON 10/16/2014.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pain in extremity
Clinical narrative: Patient called and said she had been fine for several hours after the vaccination, but around 4:00 PM she had an onset of severe pain that radiated down her right arm and the next day it began to swell. The pain was quite severe and by the next day the pain was subsiding a bit.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Altered state of consciousness, Dizziness, Ear discomfort, Fatigue, Somnolence
Clinical narrative: Extreme fatigue; intermittent dizziness and feeling of imminent loss of consciousness; popping in ears as if from sudden change in air pressure; need for inordinate amount of sleep.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Influenza like illness, Pain in extremity, Vaccination complication, Vaccination site rash, Vaccination site swelling
Clinical narrative: Swelling of left arm where vaccine was administered, rash where vaccine given, pain in arm, flu-like aches and symptoms.
Age: 22.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Member began to have erythema and edema to location of injection.  Site is now warm to touch and extends 4-5cm in width and 3-4cm in height. Treatment: Per overseeing provider - use of Tylenol or Motrin and Benadryl at night before sleep to alleviate symptoms.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Death, Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. Current conditions and medical history was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, 1 injection via unknown route. Concomitant medications were not reported. On an unknown date, 7 days after onset of therapy, the patient experienced shingles without rash. The patient also had lot of pain. On an unknown date the patient died. The outcome of shingles without rash and lot of pain was unknown. Causality assessment was not reported. Product quality complaint was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. Current conditions and medical history was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, 1 injection via unknown route. Concomitant medications were not reported. On an unknown date, 7 days after onset of therapy, the patient experienced shingles without rash. The patient also had lot of pain. On an unknown date the patient died. The outcome of shingles without rash and lot of pain was unknown. Causality assessment was not reported. Product quality complaint was not reported. Additional information has been requested.
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of hives in a male patient who received FLULAVAL. In 2013, the patient received FLULAVAL. On an unknown date, Unknown after receiving FLULAVAL, the patient experienced hives (serious criteria disability and clinically significant/intervention required). On an unknown date, the outcome of the hives was recovered/resolved. It was not reported if the reporter considered the hives to be related to FLULAVAL. Additional details: The patient's previous vaccination went always uncomplicated. No other details were known. This was one of the 3 reports sent by the same reporter.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased
Clinical narrative: Case number PHEH2014US020201, is a combined initial and follow up spontaneous report from a pharmacist received on 07 Oct 2014 and 08 Oct 2014 respectively. This report refers to a 25-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with FLUVIRIN (batch number: 1413301, expiration date: Jun 2015) on 04 Oct 2014. On 05 Oct 2014, next day he had a temperature of 102 which increased to 105 and the patient ended up going to the emergency room. The outcome of the event was unknown. Seriousness and causality were not reported.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal stiffness, Neck pain, Torticollis
Clinical narrative: Patient received Fluvirin/Trivalent Preservative Free given in the Right Arm 0.50ml - Novartis Vaccine- Lot # 145903 Vis date-8/19/14.  On 10/14/2014 with some neck pain before bed.  On 10/15/2014 began having worsening neck stiffness.  She is unsure if she slept on it wrong.  On 10/16/2014 had painful, rightward torticollis and unable to move to midline.  It responded to OMT with moderate increase in mobility and decrease in pain.  She was given Flexeril and steroid burst as an outpatient.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, PPV, FLU3, PPV
Symptoms: Balance disorder, Cellulitis, Chills, Injection site erythema, Injection site streaking
Clinical narrative: Pt stated her arm was very warm, swollen and red with streaks from injection site down to elbow.  She experienced fever, chills and night sweats. She also reported muscle aches and balance problems.  She went to the MD and he gave her antibiotics for cellulitis on 10/13/2014.  She went back and received a steroid injection on 10/14/2014 and reported feeling better on 10/15/2014.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, PPV, FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Night sweats, Pyrexia
Clinical narrative: Pt stated her arm was very warm, swollen and red with streaks from injection site down to elbow.  She experienced fever, chills and night sweats. She also reported muscle aches and balance problems.  She went to the MD and he gave her antibiotics for cellulitis on 10/13/2014.  She went back and received a steroid injection on 10/14/2014 and reported feeling better on 10/15/2014.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, PPV, FLU3, PPV
Symptoms: Balance disorder, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt stated her arm was very warm, swollen and red with streaks from injection site down to elbow.  She experienced fever, chills and night sweats. She also reported muscle aches and balance problems.  She went to the MD and he gave her antibiotics for cellulitis on 10/13/2014.  She went back and received a steroid injection on 10/14/2014 and reported feeling better on 10/15/2014.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, PPV, FLU3, PPV
Symptoms: Muscle disorder, Night sweats, Pyrexia
Clinical narrative: Pt stated her arm was very warm, swollen and red with streaks from injection site down to elbow.  She experienced fever, chills and night sweats. She also reported muscle aches and balance problems.  She went to the MD and he gave her antibiotics for cellulitis on 10/13/2014.  She went back and received a steroid injection on 10/14/2014 and reported feeling better on 10/15/2014.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, PPV, FLU3, PPV
Symptoms: Balance disorder, Cellulitis, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Pt stated her arm was very warm, swollen and red with streaks from injection site down to elbow.  She experienced fever, chills and night sweats. She also reported muscle aches and balance problems.  She went to the MD and he gave her antibiotics for cellulitis on 10/13/2014.  She went back and received a steroid injection on 10/14/2014 and reported feeling better on 10/15/2014.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, PPV, FLU3, PPV
Symptoms: Injection site warmth, Myalgia, Night sweats, Pyrexia
Clinical narrative: Pt stated her arm was very warm, swollen and red with streaks from injection site down to elbow.  She experienced fever, chills and night sweats. She also reported muscle aches and balance problems.  She went to the MD and he gave her antibiotics for cellulitis on 10/13/2014.  She went back and received a steroid injection on 10/14/2014 and reported feeling better on 10/15/2014.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Red, hot, swollen, round area about 2 in in diameter initially, then dispersing into a 2x4 in solid stripe across my upper arm.
Age: 40.0
Sex: M
Vaccine: HEPAB, HPVX
Symptoms: Activities of daily living impaired, Amnesia, Asthenia, Cognitive disorder, Disability
Clinical narrative: Significant cognitive decline, brain loss, memory loss, massive energy decline making getting out of bed a difficult proposition. Major depression. Looked into lawsuit, disability, etc.
Age: 40.0
Sex: M
Vaccine: HEPAB, HPVX
Symptoms: Major depression, Nervous system disorder
Clinical narrative: Significant cognitive decline, brain loss, memory loss, massive energy decline making getting out of bed a difficult proposition. Major depression. Looked into lawsuit, disability, etc.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Feeling hot, Immediate post-injection reaction, Pain
Clinical narrative: Itching immediately after.  Below shot redness, swelling, heat. Redness extended down about 4 inches wide and 4 inches long. Pain. Dizziness.  When swallowing it felt like there was a stick in my throat.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Sensation of foreign body, Swelling
Clinical narrative: Itching immediately after.  Below shot redness, swelling, heat. Redness extended down about 4 inches wide and 4 inches long. Pain. Dizziness.  When swallowing it felt like there was a stick in my throat.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Fatigue, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient states that he awoke on 10/12/14 with his right arm "Frozen" and that he felt "achy and tired". As of 10/13/14, his arm was "still sore" and still felt tired. He took one dose of Aleve. As of 10/14/14 he states his arm is "all better".
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Muscular weakness, Nausea
Clinical narrative: Patient returned to nurse 20 minutes post flu vaccination complaining of light-headedness, nausea, and weakness in legs.  Vitals taken by nurse - 126/62, Pulse 68 and respiration 20.  Patient was oriented x3 and color was good.  Patient instructed to sit down, drink water and stay in room with nurse.  After 10 minutes, patient ambulated in hallway.  Returned and said he was feeling much better.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypersensitivity, Local swelling, Skin warm
Clinical narrative: Employee states she woke with a swollen arm, with redness and warmth to the touch.  She presented to Occupational Health Clinic and was referred to her MD who treats her lupus.
Age: 1.08
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMRV
Symptoms: Varicella post vaccine
Clinical narrative: Varicella.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Hypersensitivity, Oropharyngeal pain, Pain in extremity, Swelling
Clinical narrative: Patient called the pharmacy the following day (10/15/14) and also notified her primary doctor of these adverse events: around 7pm on 10/14/14 she started experiencing a sore arm, throat and ears, and swelling. She felt like her throat was closing. When she called her primary doctor he didn't make any recommendations and stated the symptoms should go away. I (pharmacist) recommended using Benadryl for the allergic reaction. Patient took Tylenol for the pain and soreness. Today 10/16/14 I called the patient and she is getting better only soreness in arm.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Patient called the pharmacy the following day (10/15/14) and also notified her primary doctor of these adverse events: around 7pm on 10/14/14 she started experiencing a sore arm, throat and ears, and swelling. She felt like her throat was closing. When she called her primary doctor he didn't make any recommendations and stated the symptoms should go away. I (pharmacist) recommended using Benadryl for the allergic reaction. Patient took Tylenol for the pain and soreness. Today 10/16/14 I called the patient and she is getting better only soreness in arm.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Patient developed a 2 in bruise at site where influenza vaccine was administered.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Itching and rash on torso and scalp.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Patient describes a small red bump about 1 in in diameter, not painful, slightly itchy.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Pain in extremity, Pyrexia, Somnolence, Vision blurred
Clinical narrative: Painful arm (from shoulder to elbow), fever 102.9, extreme drowsiness, blurry vision, puffy eyes.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Diarrhoea, Gastrointestinal disorder, Lethargy, Lymph node pain
Clinical narrative: Fever for 5 days with two days of temps reaching 104-105 degrees, vomited during high fever, rash/itchiness around neck and hairline, sore glands, loss of appetite, lethargic, diarrhea. GI was not back to normal for about 3 weeks.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Pyrexia, Rash, Vomiting
Clinical narrative: Fever for 5 days with two days of temps reaching 104-105 degrees, vomited during high fever, rash/itchiness around neck and hairline, sore glands, loss of appetite, lethargic, diarrhea. GI was not back to normal for about 3 weeks.
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Myalgia, Pain, Pyrexia
Clinical narrative: Body aches, chills, mild fever, joint aches, muscle aches.
Age: 51.0
Sex: F
Vaccine: RAB, TDAP
Symptoms: Arthralgia, Lymphadenopathy, Myalgia
Clinical narrative: Sore Joints, Achy muscles, Swollen lymph node in groin.
Age: 62.0
Sex: F
Vaccine: FLUC3
Symptoms: Cold sweat, Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: SEVERE vomiting, diarrhea, low grade fever, aches, headache, cold sweats over 48 hours. Water & Tylenol - finally able to be taken after 30 hrs. Gatorade & saltine crackers - after 40 hrs.
Age: 62.0
Sex: F
Vaccine: FLUC3
Symptoms: Vomiting
Clinical narrative: SEVERE vomiting, diarrhea, low grade fever, aches, headache, cold sweats over 48 hours. Water & Tylenol - finally able to be taken after 30 hrs. Gatorade & saltine crackers - after 40 hrs.
Age: 65.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given Flumist at the age of 65. Not recommended to be given over the age of 49.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Fatigue, Headache, Influenza like illness, Rhinorrhoea
Clinical narrative: Flu like: coughing, heavy mucous, pounding headache, tired.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised
Clinical narrative: TOTAL BODY RASH-WITHIN 10 MINUTES. GETS FLU SHOT EVERY YEAR NO PROBLEM THIS YEAR GOT QUADRAVALENT.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chest pain, Dyspnoea, Heart rate increased
Clinical narrative: DYSPNEA, RAPID HEART RATE, WEAKNESS, CHEST PAIN.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: High fever >102.5, headache, soreness.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Impaired driving ability, Muscular weakness, Syncope
Clinical narrative: Patient stated she had shortness of breath, syncope and weakness in extremities during the night.  Pt called us the next afternoon with mild syncope and weakness in extremities. Pt stated she felt better than last night.  Pt was advised not to drive due to syncope and to seek medical care immediately.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Diabetes insipidus, Diarrhoea, Headache, Meningism
Clinical narrative: Headache, meningitis-like symptoms, hospitalization, jaw and ear inflammation, diarrhea, tinnitus, weight loss, neuropathies, fever, diabetes insipidus, chemical sensitivities, anxiety, panic disorder.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Middle ear inflammation, Multiple chemical sensitivity, Neuropathy peripheral, Osteitis, Panic disorder
Clinical narrative: Headache, meningitis-like symptoms, hospitalization, jaw and ear inflammation, diarrhea, tinnitus, weight loss, neuropathies, fever, diabetes insipidus, chemical sensitivities, anxiety, panic disorder.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Tinnitus, Weight decreased
Clinical narrative: Headache, meningitis-like symptoms, hospitalization, jaw and ear inflammation, diarrhea, tinnitus, weight loss, neuropathies, fever, diabetes insipidus, chemical sensitivities, anxiety, panic disorder.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Vaccination site pruritus
Clinical narrative: Patient developed localized swelling and severe pruritis at site of vaccination. Patient was given NSAIDS and Benadryl with moderate relief.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: Severe muscle pain, radiating down arm to fingers, and up arm into neck, down left leg, range of motion in left arm very limited.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Red area on left arm that is warm to the touch. Patient reports arm was sore 10/15/14 but patient did not notice the red area until later in the evening 10/15. She noticed that it was warm to the touch today. The area is not raised and the soreness has disipated since yesterday but the redness remains.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site rash
Clinical narrative: Patient came in for 3rd HPV on 9/30/14 and explained to nurse that one day after last shot he got a rash about 4 inches wide around injection site. The rash lasted for a few days and went away.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypersensitivity, Pruritus
Clinical narrative: Intense itching neck, face, head; red marks on neck, face; took chewable Benadryl & symptoms resolved (first time I have had an allergic reaction to a flu shot).
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Crying, Dizziness, Immediate post-injection reaction
Clinical narrative: Patient was crying while vaccinations were given. Immediately after vaccinations were finished she explained that she felt dizzy. I laid patient on exam table BP 99/76. She laid there for 5 minutes and she felt good enough to sit up BP 107/63 while sitting up. Patient then stood up and stated she felt fine BP 102/68. I explained to patient and mother if she were to feel that way again to lay down and if condition does not improve, she shall go to emergency room. I walked patient to vehicle.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Flushing, Palpitations
Clinical narrative: Flushing, racing heart, increase blood pressure.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Lacrimation increased, Ocular hyperaemia, Respiratory tract congestion
Clinical narrative: Sudden onset of redness to the eyes with watery drainage, congestion and increase in SOB and congestion.
Age: 0.17
Sex: M
Vaccine: 6VAX-F, IPV, RVX
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red, raised rash at and around injection site, about 25mm in diameter.
Age: 56.0
Sex: F
Vaccine: FLUC3
Symptoms: Back pain, Musculoskeletal stiffness, Swelling face
Clinical narrative: Pain and stiffness in lower back lasting 3+ days; swelling of face; took Advil 200mg for pain; cold compresses to face.
Age: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Blood glucose normal, Chest discomfort, Cyanosis, Dizziness, Eye movement disorder
Clinical narrative: Immediately after administering vaccine patient's face was pale with cyanosis around her mouth.  Medical Assistant noted her arms were stiff and head was shaking with eyes rolled back.  Few seconds later patient was awake with "funny feeling" in her chest and dizziness.  Blood pressure was low at 88/54 and heart rate was in 60's.  Glucose was 145.  After 30 minutes of observation patient felt well and walked out with her parents.
Age: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Head titubation, Hypotension, Immediate post-injection reaction, Musculoskeletal stiffness, Pallor
Clinical narrative: Immediately after administering vaccine patient's face was pale with cyanosis around her mouth.  Medical Assistant noted her arms were stiff and head was shaking with eyes rolled back.  Few seconds later patient was awake with "funny feeling" in her chest and dizziness.  Blood pressure was low at 88/54 and heart rate was in 60's.  Glucose was 145.  After 30 minutes of observation patient felt well and walked out with her parents.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Arm is sore, redness and swelling in upper area of arm, between injection and elbow.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PATIENT RECIEVED ANTHRAX VACCINE ON 15 OCT 2014. PATIENT RETURNED TO CLINIC 24HRS LATER WITH REDNESS AND SWELLING AT THE INJECTION SITE, SIZE 8MM BY 9MM. PATIENT WAS TREATED WITH BENADRYL 50MG/MEDROL DOSE PACK/ZANTAC 150MG.
Age: 75.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Patient called the pharmacy reported that she has a red ring around her upper arm and it's swelling. She thinks it's the Pneumovax that she's allergic to.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Arm was red and swollen and very painful for the first 24 hours 72 hours later the swelling and redness has decreased and no more pain.
Age: 72.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient described warm feeling and slight pain around injection site. *pink reddish color*
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Chest pain, Cough, Headache, Oropharyngeal pain
Clinical narrative: Headache, cough, sore throat, chest pain.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Neck pain
Clinical narrative: I received the influenza vaccine at work. The injection seemed to be given high on my right arm. My arm was sore and achy immediately following and worsened over course of next 10 days. On 10/9/2014, I awoke with increased pain in my arm, into right shoulder and neck. On 10/10/14, the pain was much worse and I could barely move my right arm and shoulder. I was seen by an orthopedic surgeon who treated me with a steroid injection in biceps groove for biceps tendonitis and into the capsule of my right shoulder for adhesive capsulitis and placed on pain medication. I saw an orthopedic specialist on 10/13/14, he started me on high dose steroids and a muscle relaxant. I am still recovering from this, followed up with ortho specialist today, 10/16/14. My mobility is improving and was given stretching and ROM exercises to do daily to improve mobility and increase strength. I am on the steroid taper so  time will tell as this is completed and stretching exercises followed to see if I regain complete mobility again.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging spinal, Pain in extremity, Periarthritis, Tendonitis, X-ray limb
Clinical narrative: I received the influenza vaccine at work. The injection seemed to be given high on my right arm. My arm was sore and achy immediately following and worsened over course of next 10 days. On 10/9/2014, I awoke with increased pain in my arm, into right shoulder and neck. On 10/10/14, the pain was much worse and I could barely move my right arm and shoulder. I was seen by an orthopedic surgeon who treated me with a steroid injection in biceps groove for biceps tendonitis and into the capsule of my right shoulder for adhesive capsulitis and placed on pain medication. I saw an orthopedic specialist on 10/13/14, he started me on high dose steroids and a muscle relaxant. I am still recovering from this, followed up with ortho specialist today, 10/16/14. My mobility is improving and was given stretching and ROM exercises to do daily to improve mobility and increase strength. I am on the steroid taper so  time will tell as this is completed and stretching exercises followed to see if I regain complete mobility again.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Swelling at injection site after patient was fiven the Fluzone Quad injection. Swelling was immediate and about a quarter in size.  Cold compress was applied at the injection site for about 15 minutes and patient was advised to take acetaminophen or a non-steroidal anti-inflammatory drug if swelling persisted or pain began. Patient said he had no pain at all at injection site.  Also advised patient that he could apply a cold compress at home if needed.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Anaemia, Blood iron decreased, Blood test normal, Haemoglobin decreased, Malaise
Clinical narrative: After I took the flu shot at 8:00 PM. I got very sick at 03:00 the next morning. I went to the ER where I work and my blood work was normal. Six days later I was very ill and went to the ER and my hemaglobin was 8.4 down the week before from 16.2.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Transfusion
Clinical narrative: After I took the flu shot at 8:00 PM. I got very sick at 03:00 the next morning. I went to the ER where I work and my blood work was normal. Six days later I was very ill and went to the ER and my hemaglobin was 8.4 down the week before from 16.2.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea
Clinical narrative: After leaving pharmacy, patient said she experienced slight trouble breathing and faintness, dizziness and stated that symptoms lasted less than 2 hours and reports feeling fine after that.