chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: HEPAB, MNQ
Symptoms: Extraocular muscle paresis, Induration, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Initial unsolicited report received from a nurse on 21 September 2015. This case involves a 54-year-old female patient who was vaccinated with a first dose MENACTRA (batch number: U5049AA, expiration date: 19 August 2016, dose was not reported) intramuscularly in right deltoid and a dose of TWINRIX (batch number: HZ9Z9, expiration date, dose were not reported) intramuscularly in left deltoid on 17 August 2015. Previously in January 2015 and February 2015, the patient received a dose of TWINRIX. The patient did not receive MENACTRA previously. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions reported as no known drug allergies (NKDA), Chronic low back pain, hypertension, numbness in feet, borderline diabetes, cardiac murmur, allergic rhinitis, sciatica. The patient's illness at time of vaccination reported as chronic low back pain, chills. Concomitant medication was not reported. On 18 August 2015 (Friday) in evening, one day following the vaccination, the patient experienced pain and swelling in right upper arm. On same Friday night patient scratched the site, with some "pus" coming out. Had pain in right throat, right shoulder and right chest which started on 18 August 2015 (Friday) night. On 19 August 2015 (Saturday) and 20 August 2015 (Sunday), the patient had a fever. On an unspecified date, the patient had 16 cm long, 10 cm wide warm, red, hard area at injection site, on her right upper arm pain causing weakness of her right arm. The patient had some hard lumps on both arms and left leg and her fingers. The patient had joint pain in all her joints. Felt low energy, has muscle weakness to her legs and arms, dizziness, eye weakness and dizziness when she stands up suddenly. The patient had required ER or doctor visit. The patient had normal blood pressure limits. Other laboratory investigation and corrective treatment were not reported. On an unspecified date, the patient recovered from hard lumps on both arms and left leg and fingers except on her right upper arm was not recovered. The patient had joint pain in all her joints, all resolved except in her elbows. The patient not recovered from pain in right throat, right shoulder and right chest. The outcome of the events eye weakness, low energy, weakness of her right arm, muscle weakness to her legs, pain and swelling in her right upper arm starting, 16 cm long, 10 cm wide warm, red at injection site on her right upper arm, scratched the site, with some pus, lumps right upper arm, fever, dizziness, hard area at injection site on her right upper arm were unknown. Upon internal review, company assessed the event of eye weakness as serious and important medical event. List of documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: HEPAB, MNQ
Symptoms: Injection site pain, Injection site pustule, Injection site swelling, Injection site warmth, Lower extremity mass
Clinical narrative: Initial unsolicited report received from a nurse on 21 September 2015. This case involves a 54-year-old female patient who was vaccinated with a first dose MENACTRA (batch number: U5049AA, expiration date: 19 August 2016, dose was not reported) intramuscularly in right deltoid and a dose of TWINRIX (batch number: HZ9Z9, expiration date, dose were not reported) intramuscularly in left deltoid on 17 August 2015. Previously in January 2015 and February 2015, the patient received a dose of TWINRIX. The patient did not receive MENACTRA previously. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions reported as no known drug allergies (NKDA), Chronic low back pain, hypertension, numbness in feet, borderline diabetes, cardiac murmur, allergic rhinitis, sciatica. The patient's illness at time of vaccination reported as chronic low back pain, chills. Concomitant medication was not reported. On 18 August 2015 (Friday) in evening, one day following the vaccination, the patient experienced pain and swelling in right upper arm. On same Friday night patient scratched the site, with some "pus" coming out. Had pain in right throat, right shoulder and right chest which started on 18 August 2015 (Friday) night. On 19 August 2015 (Saturday) and 20 August 2015 (Sunday), the patient had a fever. On an unspecified date, the patient had 16 cm long, 10 cm wide warm, red, hard area at injection site, on her right upper arm pain causing weakness of her right arm. The patient had some hard lumps on both arms and left leg and her fingers. The patient had joint pain in all her joints. Felt low energy, has muscle weakness to her legs and arms, dizziness, eye weakness and dizziness when she stands up suddenly. The patient had required ER or doctor visit. The patient had normal blood pressure limits. Other laboratory investigation and corrective treatment were not reported. On an unspecified date, the patient recovered from hard lumps on both arms and left leg and fingers except on her right upper arm was not recovered. The patient had joint pain in all her joints, all resolved except in her elbows. The patient not recovered from pain in right throat, right shoulder and right chest. The outcome of the events eye weakness, low energy, weakness of her right arm, muscle weakness to her legs, pain and swelling in her right upper arm starting, 16 cm long, 10 cm wide warm, red at injection site on her right upper arm, scratched the site, with some pus, lumps right upper arm, fever, dizziness, hard area at injection site on her right upper arm were unknown. Upon internal review, company assessed the event of eye weakness as serious and important medical event. List of documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: HEPAB, MNQ
Symptoms: Muscular weakness, Oropharyngeal pain, Pyrexia, Upper extremity mass
Clinical narrative: Initial unsolicited report received from a nurse on 21 September 2015. This case involves a 54-year-old female patient who was vaccinated with a first dose MENACTRA (batch number: U5049AA, expiration date: 19 August 2016, dose was not reported) intramuscularly in right deltoid and a dose of TWINRIX (batch number: HZ9Z9, expiration date, dose were not reported) intramuscularly in left deltoid on 17 August 2015. Previously in January 2015 and February 2015, the patient received a dose of TWINRIX. The patient did not receive MENACTRA previously. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions reported as no known drug allergies (NKDA), Chronic low back pain, hypertension, numbness in feet, borderline diabetes, cardiac murmur, allergic rhinitis, sciatica. The patient's illness at time of vaccination reported as chronic low back pain, chills. Concomitant medication was not reported. On 18 August 2015 (Friday) in evening, one day following the vaccination, the patient experienced pain and swelling in right upper arm. On same Friday night patient scratched the site, with some "pus" coming out. Had pain in right throat, right shoulder and right chest which started on 18 August 2015 (Friday) night. On 19 August 2015 (Saturday) and 20 August 2015 (Sunday), the patient had a fever. On an unspecified date, the patient had 16 cm long, 10 cm wide warm, red, hard area at injection site, on her right upper arm pain causing weakness of her right arm. The patient had some hard lumps on both arms and left leg and her fingers. The patient had joint pain in all her joints. Felt low energy, has muscle weakness to her legs and arms, dizziness, eye weakness and dizziness when she stands up suddenly. The patient had required ER or doctor visit. The patient had normal blood pressure limits. Other laboratory investigation and corrective treatment were not reported. On an unspecified date, the patient recovered from hard lumps on both arms and left leg and fingers except on her right upper arm was not recovered. The patient had joint pain in all her joints, all resolved except in her elbows. The patient not recovered from pain in right throat, right shoulder and right chest. The outcome of the events eye weakness, low energy, weakness of her right arm, muscle weakness to her legs, pain and swelling in her right upper arm starting, 16 cm long, 10 cm wide warm, red at injection site on her right upper arm, scratched the site, with some pus, lumps right upper arm, fever, dizziness, hard area at injection site on her right upper arm were unknown. Upon internal review, company assessed the event of eye weakness as serious and important medical event. List of documents held by sender: none.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Erythema in upper outside and inside arm.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Muscle spasms, Nausea, Pain
Clinical narrative: Body chills and shivering and cramping that wouldn't let up until I got in hot bath. Fever overnight 102.6°-103° Nausea, headache and body ache, and a little vomiting. Fever finally breaking this morning.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Body chills and shivering and cramping that wouldn't let up until I got in hot bath. Fever overnight 102.6°-103° Nausea, headache and body ache, and a little vomiting. Fever finally breaking this morning.
Age: 0.59
Sex: M
Vaccine: IPV, PNC13
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Several red raised spots on both legs on knee and below. No difficulty breathing, swelling, or itching noted.
Age: 53.0
Sex: M
Vaccine: PNC
Symptoms: Dizziness, Heart rate increased
Clinical narrative: Patient woke up from nap feeling dizzy and fast heart rate.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Alanine aminotransferase normal, Antinuclear antibody positive, Arthralgia, Aspartate aminotransferase normal, Asthenia
Clinical narrative: Developed hives, headache, and neck pain on the evening of 8/13/15 which lasted approximately a week.  Did not seek medical care at this time.  On approximately 9/7/15, developed headache, fatigue, dizziness, weakness, joint pains (without redness or swelling), and loss of typical skills (unable to complete dance moves as she could previously), intermittent palpitations.  Seen in office on 9/21/15.  Symptoms are continuing.  Normal cardiology consult.  Neurologist recommends MRI which is pending.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Basophil percentage, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal
Clinical narrative: Developed hives, headache, and neck pain on the evening of 8/13/15 which lasted approximately a week.  Did not seek medical care at this time.  On approximately 9/7/15, developed headache, fatigue, dizziness, weakness, joint pains (without redness or swelling), and loss of typical skills (unable to complete dance moves as she could previously), intermittent palpitations.  Seen in office on 9/21/15.  Symptoms are continuing.  Normal cardiology consult.  Neurologist recommends MRI which is pending.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood iron normal, Blood potassium normal
Clinical narrative: Developed hives, headache, and neck pain on the evening of 8/13/15 which lasted approximately a week.  Did not seek medical care at this time.  On approximately 9/7/15, developed headache, fatigue, dizziness, weakness, joint pains (without redness or swelling), and loss of typical skills (unable to complete dance moves as she could previously), intermittent palpitations.  Seen in office on 9/21/15.  Symptoms are continuing.  Normal cardiology consult.  Neurologist recommends MRI which is pending.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Blood sodium normal, Blood thyroid stimulating hormone normal, Blood urea normal, C-reactive protein normal, Carbon dioxide normal
Clinical narrative: Developed hives, headache, and neck pain on the evening of 8/13/15 which lasted approximately a week.  Did not seek medical care at this time.  On approximately 9/7/15, developed headache, fatigue, dizziness, weakness, joint pains (without redness or swelling), and loss of typical skills (unable to complete dance moves as she could previously), intermittent palpitations.  Seen in office on 9/21/15.  Symptoms are continuing.  Normal cardiology consult.  Neurologist recommends MRI which is pending.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Dizziness, Eosinophil percentage increased, Fatigue, Haematocrit increased, Haemoglobin normal
Clinical narrative: Developed hives, headache, and neck pain on the evening of 8/13/15 which lasted approximately a week.  Did not seek medical care at this time.  On approximately 9/7/15, developed headache, fatigue, dizziness, weakness, joint pains (without redness or swelling), and loss of typical skills (unable to complete dance moves as she could previously), intermittent palpitations.  Seen in office on 9/21/15.  Symptoms are continuing.  Normal cardiology consult.  Neurologist recommends MRI which is pending.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Headache, Iron binding capacity total normal, Lymphocyte percentage, Mean cell volume normal, Mobility decreased
Clinical narrative: Developed hives, headache, and neck pain on the evening of 8/13/15 which lasted approximately a week.  Did not seek medical care at this time.  On approximately 9/7/15, developed headache, fatigue, dizziness, weakness, joint pains (without redness or swelling), and loss of typical skills (unable to complete dance moves as she could previously), intermittent palpitations.  Seen in office on 9/21/15.  Symptoms are continuing.  Normal cardiology consult.  Neurologist recommends MRI which is pending.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Monocyte percentage, Neck pain, Neutrophil percentage decreased, Nuclear magnetic resonance imaging, Palpitations
Clinical narrative: Developed hives, headache, and neck pain on the evening of 8/13/15 which lasted approximately a week.  Did not seek medical care at this time.  On approximately 9/7/15, developed headache, fatigue, dizziness, weakness, joint pains (without redness or swelling), and loss of typical skills (unable to complete dance moves as she could previously), intermittent palpitations.  Seen in office on 9/21/15.  Symptoms are continuing.  Normal cardiology consult.  Neurologist recommends MRI which is pending.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Platelet count normal, Protein total normal, Red blood cell sedimentation rate normal, Serum ferritin normal, Thyroxine free decreased
Clinical narrative: Developed hives, headache, and neck pain on the evening of 8/13/15 which lasted approximately a week.  Did not seek medical care at this time.  On approximately 9/7/15, developed headache, fatigue, dizziness, weakness, joint pains (without redness or swelling), and loss of typical skills (unable to complete dance moves as she could previously), intermittent palpitations.  Seen in office on 9/21/15.  Symptoms are continuing.  Normal cardiology consult.  Neurologist recommends MRI which is pending.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Urticaria, Vitamin D, White blood cell count normal
Clinical narrative: Developed hives, headache, and neck pain on the evening of 8/13/15 which lasted approximately a week.  Did not seek medical care at this time.  On approximately 9/7/15, developed headache, fatigue, dizziness, weakness, joint pains (without redness or swelling), and loss of typical skills (unable to complete dance moves as she could previously), intermittent palpitations.  Seen in office on 9/21/15.  Symptoms are continuing.  Normal cardiology consult.  Neurologist recommends MRI which is pending.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Seizure
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 30 September 2015. If applicable: "This case was linked to 2015SA151762". This case involves a female patient (age not reported) who was vaccinated with a dose of Flu vaccine [dose, dose in series, batch number, expiry date, route and site of administration were not reported] on an unknown date (10 years ago). The patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as unknown. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient had experienced convulsions. Laboratory data and corrective treatment were not reported. On an unknown date, the patient was recovered from the event. Upon medical review, the case was considered as serious due to important medical event: convulsions. List of documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Seizure
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 30 September 2015. If applicable: "This case is linked to 2015SA151777". This case involves a female patient (age not reported) who was vaccinated with a dose of Flu vaccine [dose, dose in series, batch number, expiry date, route and site of administration were not reported] on an unknown date (10 years ago). The patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as unknown. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient had experienced convulsions. Laboratory data and corrective treatment were not reported. On an unknown date, the patient was recovered from the event. Upon medical review, the case was considered as serious due to important medical event: convulsions. List of documents held by sender: none.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Chest pain, Cough, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Initial unsolicited case received from a non-healthcare professional on 24-Sep-2015. This case involves a 40-year-old male patient who was vaccinated with a dose of ADACEL (batch number- U5241AA, expiry date: 13-Jan-2018, route and site of administration were not reported) on 10-Sep-2015. Concomitant medications were not reported. Patient had migraine at the time of vaccination and also he had no known allergies. On 11-Sep-2015, one day after vaccination patient developed arm pain and injection site pain and swelling, dry cough and chest pain. On 12-Sep-2015, patient went to ER doctor visit. Lab tests were not reported. On 12-Sep-2015, patient received steroid shot, MEDROL dose pack and cough medicine as corrective treatments. It was reported that patient felt great after steroid shot and outcome of events at the time of report was reported as unknown. Upon medical review, case was considered as serious due to important medical event: chest pain. Documents held by Sender: none.
Age: 19.0
Sex: F
Vaccine: ANTH, JEVX, SMALL, TYP, VARCEL
Symptoms: Angina pectoris, Electrocardiogram abnormal, Troponin I normal
Clinical narrative: Initial solicited report received on 22 September 2015 from an investigator participating in a study. Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This case involves a 19-year-old female subject who developed other and unspecified angina pectoris during the study participation. The subject had a medical history of chest pain and cardiomyopathy. The subject had no other significant medical history. The subject received concomitant therapies with Anthrax on 05 June 2015, Japanese Encephalitis intramuscularly on 05 June 2015 and Typhoid, ViCPs on 05 June 2015 and Varicella on 05 June 2015. On 29 June 2015, 24 days after receiving a first dose of ACAM2000 on 05 June 2015 (route and site of administration and batch number were not reported), the subject developed other and unspecified angina pectoris. The event appeared after visit was not reported. Lab data included Troponin I lab test done on 30 June 2015 and result was normal, electrocardiogram (ECG) done on 29 June 2015 was abnormal, Echocardiogram, MRI (brain, spinal cord, heart) and Lumbar puncture were not performed. The subject's corrective treatment were not reported. The event other and unspecified angina pectoris was considered as important medical event. The outcome of the event other and unspecified angina pectoris was not reported. According to the investigator, the event relation to the concomitant medications given was not reported. Relationship to investigational product according to Company: associated. The information whether the serious adverse event led to the termination of the subject from the study or not, was not reported. List of documents held by sender: none. "Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study."
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received a single dose of PREVNAR 13, via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced a cellulitis reaction on an unspecified date with outcome of unknown.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Pain and soreness at shot site even after 10 days.
Age: 50.0
Sex: F
Vaccine: FLUC3
Symptoms: Eye pain, Eye swelling, Eyelid pain
Clinical narrative: Patient reported that her right eye began to hurt.  The pain became worst as the day went on. The following morning, the right eye was very swollen and painful to even blink.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Full blood count, Liver function test, Metabolic function test, Nausea
Clinical narrative: Patient experienced extreme nausea and lightheadness.  She developed severe vomiting.  She was escorted to the Emergency Room for stabilization.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Renal function test, Vomiting
Clinical narrative: Patient experienced extreme nausea and lightheadness.  She developed severe vomiting.  She was escorted to the Emergency Room for stabilization.
Age: 77.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Chills, Eye irritation, Ocular hyperaemia, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Chills. Congestion in chest. Blood red eyes, bilateral "as if there were sand in my eyes". External throat pain to palpation.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Blood culture, Dyspnoea, Odynophagia, Pharyngeal oedema, Throat irritation
Clinical narrative: Initially felt scratchy throat.  By 4:10, throat started significantly swelling, hard to breathe, painful to swallow.  Drove to emergency room where was given epinephrine, Benadryl, prednisone, and Famotidine.  Observed for 4 1/2 hours then sent home with prescriptions of the above, including and EPI pen.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm swelling, redness from shoulder to about 2 inches from above elbow. No treatment needed.
Age: 19.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain upper, Feeling cold, Nausea, Pyrexia, Vomiting
Clinical narrative: Started to get cold with a stomach ache. Progressed to a mild fever (99) and naseua with vomiting throughout the night.
Age: 74.0
Sex: M
Vaccine: FLUC3, PNC13
Symptoms: Injection site rash, Pain in extremity, Pyrexia
Clinical narrative: Low grade fever; rash below site of injection 6 x 6; soreness in right arm.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Redness around injection site descending down to the elbow.  Fluid filled blisters around the injection site.
Age: 59.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received FLULAVAL QUADRIVALENT. Previously administered products included Influenza vaccine (the patient had never experienced any reaction in the past after vaccination with flu shots). Concurrent medical conditions included knee arthritis. Concomitant products included ALDACTONE, SINGULAIR, progesterone, estradiol and ADVAIR DISKUS. On 22nd September 2015, the patient received FLULAVAL QUADRIVALENT. On 24th September 2015, 2 days after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site pain, stiffness, arthralgia, stiff joint and joint range of motion decreased. On 25th September 2015, the patient experienced pain in hand. On 27th September 2015, the patient experienced shoulder pain. The patient was treated with CELEBREX. On 29th September 2015, the outcome of the injection site pain, stiffness, arthralgia, stiff joint, pain in hand, shoulder pain and joint range of motion decreased were recovered/resolved. It was unknown if the reporter considered the injection site pain, stiffness, arthralgia, stiff joint, pain in hand, shoulder pain and joint range of motion decreased to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The patient was a employee. The reported injection site was right arm. The patient did not experience any adverse reaction following previous vaccination. On 24th September 2015, 2 days after receiving FLULAVAL QIV, the patient experienced pain and stiffness in her right hand and wrist. The pain and stiffness really resulted in a decrease range of motion when performing certain activities. The decreased range of motion was similar to someone who suffered from chronic arthritis. After one day the symptoms started to dissipate with little residual pain. On 25th September 2015, 3 days after vaccination, the patient experienced pain in the left hand and wrist. The pain and stiffness lessened after one day but with residual pain. After almost complete resolution, the pain and stiffness returned to both hands and wrists on 27th September 2015. On 27th September 2015, 5 days after the vaccination, the patient also experienced quite significant pain and stiffness in her left shoulder and was very painful that she was unable to sleep that following night. Throughout the entire course of pain, the patient was taken CELEBREX 200 mg with little relief. She normally takes this medication. The patient also added that she experienced pain in right and left knees, but has a history of arthritis. She noted that pain was more severe than it normally is with just her arthritis. The pain was particularly in the left knee. The patient could not recall when the pain started following the vaccination. The batch number and expiry date of the vaccine were unknown. Medical attention was not required. The patient did not consult a physician regarding the events. The patient was not hospitalised because of the reaction.
Age: 59.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Psoriatic arthropathy, Sleep disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received FLULAVAL QUADRIVALENT. Previously administered products included Influenza vaccine (the patient had never experienced any reaction in the past after vaccination with flu shots). Concurrent medical conditions included knee arthritis. Concomitant products included ALDACTONE, SINGULAIR, progesterone, estradiol and ADVAIR DISKUS. On 22nd September 2015, the patient received FLULAVAL QUADRIVALENT. On 24th September 2015, 2 days after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site pain, stiffness, arthralgia, stiff joint and joint range of motion decreased. On 25th September 2015, the patient experienced pain in hand. On 27th September 2015, the patient experienced shoulder pain. The patient was treated with CELEBREX. On 29th September 2015, the outcome of the injection site pain, stiffness, arthralgia, stiff joint, pain in hand, shoulder pain and joint range of motion decreased were recovered/resolved. It was unknown if the reporter considered the injection site pain, stiffness, arthralgia, stiff joint, pain in hand, shoulder pain and joint range of motion decreased to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The patient was a employee. The reported injection site was right arm. The patient did not experience any adverse reaction following previous vaccination. On 24th September 2015, 2 days after receiving FLULAVAL QIV, the patient experienced pain and stiffness in her right hand and wrist. The pain and stiffness really resulted in a decrease range of motion when performing certain activities. The decreased range of motion was similar to someone who suffered from chronic arthritis. After one day the symptoms started to dissipate with little residual pain. On 25th September 2015, 3 days after vaccination, the patient experienced pain in the left hand and wrist. The pain and stiffness lessened after one day but with residual pain. After almost complete resolution, the pain and stiffness returned to both hands and wrists on 27th September 2015. On 27th September 2015, 5 days after the vaccination, the patient also experienced quite significant pain and stiffness in her left shoulder and was very painful that she was unable to sleep that following night. Throughout the entire course of pain, the patient was taken CELEBREX 200 mg with little relief. She normally takes this medication. The patient also added that she experienced pain in right and left knees, but has a history of arthritis. She noted that pain was more severe than it normally is with just her arthritis. The pain was particularly in the left knee. The patient could not recall when the pain started following the vaccination. The batch number and expiry date of the vaccine were unknown. Medical attention was not required. The patient did not consult a physician regarding the events. The patient was not hospitalised because of the reaction.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Pain, burning and itching at injection site rash, swelling at site and adjacent to site.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Rash at injection site. Patient states that it seem to be subsiding.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain down arm.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Blister, Chills, Induration, Pain, Peripheral swelling
Clinical narrative: Arm swelling, pain, sensation of hardness, blisters, itch. Body aches and chills.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pruritus
Clinical narrative: Arm swelling, pain, sensation of hardness, blisters, itch. Body aches and chills.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Oropharyngeal pain, Rhinorrhoea, Swollen tongue
Clinical narrative: Rhinorrhea, sore throat, swelling lips/tongue.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Extreme pain and moderate swelling of injection site. The following morning 10/6/15 I woke up with a quarter sized red and hot welp over injection site, pain and soreness continued that day. This morning 10/7/15 I woke up with a half dollar sized welp over injection site with minor pain upon palpation and continued moderate swelling and hot to the touch over injection site.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Extreme pain and moderate swelling of injection site. The following morning 10/6/15 I woke up with a quarter sized red and hot welp over injection site, pain and soreness continued that day. This morning 10/7/15 I woke up with a half dollar sized welp over injection site with minor pain upon palpation and continued moderate swelling and hot to the touch over injection site.
Age: 68.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Chills, Dyspnoea, Eye swelling, Headache, Ocular hyperaemia
Clinical narrative: Pt experienced Fever, headache, red swollen eyes, Shortness of Breath, chills = 3-4 hours after Prevnar administration.
Age: 68.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Pyrexia
Clinical narrative: Pt experienced Fever, headache, red swollen eyes, Shortness of Breath, chills = 3-4 hours after Prevnar administration.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: Approximately 1 hour after vaccination, patient felt nauseous, had some vomiting, body aches in upper body (arms and neck, etc). No reaction at site of injection noted. Symptoms resolved within 48 hours.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Local swelling, Pain, Pyrexia, Skin irritation
Clinical narrative: Local swelling, pain and irretation. Fever.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever (101.6), Nausea onset 10/5/2015.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Flushing, Nasal congestion, Palpitations, Paraesthesia
Clinical narrative: FLUSH FACE, TROUBLE BREATHING, NASAL CONGESTION, PALPITATION, PRICKLY SENSATION.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Hyperhidrosis, Nausea, Pain
Clinical narrative: Nausea, body and joint aches (all over), chills, sweating, felt feverish, most symptoms subsided within 48 hours. Does continue to have slight body aches.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Nausea, body and joint aches (all over), chills, sweating, felt feverish, most symptoms subsided within 48 hours. Does continue to have slight body aches.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching, pain from left shoulder to left elbow. Instructed to take diphenhydramine and call physician.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Pyrexia
Clinical narrative: Redness and itching started 10/6/15. Now, c/o redness, pain, warmth itching. Reaction two fingers below (L) shoulder to about 2 fingers above elbow. Low grade fever at visit (99.2) cetirizine, clobetasol propionate, and prednisone prescribed.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Dysphonia
Clinical narrative: Shivering, hoarseness, chest tightness for about 12 hours. Took some BENADRYL and she thinks that might have helped.
Age: 1.38
Sex: F
Vaccine: FLU3, MMRV
Symptoms: Urticaria
Clinical narrative: Patient developed a few hives on face and torso. These probable hives resolved with BENADRYL being given.
Sex: M
Vaccine: TYP
Symptoms: Urinary tract infection
Clinical narrative: This spontaneous report was received from a consumer and concerns a male subject of unspecified age; local case Identification number: Med-PVX-201509-065. The subject's weight, height and medical history were not reported. The subject received the first dose of typhoid vaccine oral ty21a (capsule, hard, oral) on 22-SEP-2015 and received the second and third dose on alternative days for prophylactic vaccination. Concomitant medications were not reported. It was reported that the subject would be travelling November. On 25-SEP-2015, the subject experienced urinary tract infection. On the same day, the subject started a seven day treatment with levofloxacin. Action taken with typhoid vaccine oral ty21a was unspecified. At the time of this report, the subject had not recovered from urinary tract infection. The reporter provided no causality assessment. Company causality was assessed as doubtful. This report was serious (medically significant). Sender's Comments: Urinary tract infection: Inconsistent causal association to vaccination, likely coincidental event.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Cellulitis at site of injection. Redness, swelling, pain, itching. Right deltoid.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Electroencephalogram, Emotional distress, Fatigue, Feeling abnormal
Clinical narrative: Patient was noted by parents to have extreme fussiness, inconsolable at times, low grade fever, fatigue and diarrhea 2 days after vaccines. Parents continue to note patient having intermittent periods of fussiness, short naps, and then sleeping more than normal when fussiness resolved. Patient was evaluated in office on 9/21/15 by PCP, started medication for reflux and discharged home. By end of week parents report continued intermittent fussiness, fatigue, difficult to wake, and when awake was dazed and lethargic. Patient was re-evaluated on 9/25/15, admitted to hospital for care. Patient developed staring episodes in hospital on 9/26/15, transferred to another hospital for further wup. Patient underwent several tests and procedures, diagnosed with seizures. Seizures have resolved with medication he is now taking.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Full blood count, Gastrooesophageal reflux disease, Hypersomnia, Irritability, Lethargy
Clinical narrative: Patient was noted by parents to have extreme fussiness, inconsolable at times, low grade fever, fatigue and diarrhea 2 days after vaccines. Parents continue to note patient having intermittent periods of fussiness, short naps, and then sleeping more than normal when fussiness resolved. Patient was evaluated in office on 9/21/15 by PCP, started medication for reflux and discharged home. By end of week parents report continued intermittent fussiness, fatigue, difficult to wake, and when awake was dazed and lethargic. Patient was re-evaluated on 9/25/15, admitted to hospital for care. Patient developed staring episodes in hospital on 9/26/15, transferred to another hospital for further wup. Patient underwent several tests and procedures, diagnosed with seizures. Seizures have resolved with medication he is now taking.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Nuclear magnetic resonance imaging, Pyrexia, Seizure, Somnolence, Staring
Clinical narrative: Patient was noted by parents to have extreme fussiness, inconsolable at times, low grade fever, fatigue and diarrhea 2 days after vaccines. Parents continue to note patient having intermittent periods of fussiness, short naps, and then sleeping more than normal when fussiness resolved. Patient was evaluated in office on 9/21/15 by PCP, started medication for reflux and discharged home. By end of week parents report continued intermittent fussiness, fatigue, difficult to wake, and when awake was dazed and lethargic. Patient was re-evaluated on 9/25/15, admitted to hospital for care. Patient developed staring episodes in hospital on 9/26/15, transferred to another hospital for further wup. Patient underwent several tests and procedures, diagnosed with seizures. Seizures have resolved with medication he is now taking.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Ultrasound scan, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Patient was noted by parents to have extreme fussiness, inconsolable at times, low grade fever, fatigue and diarrhea 2 days after vaccines. Parents continue to note patient having intermittent periods of fussiness, short naps, and then sleeping more than normal when fussiness resolved. Patient was evaluated in office on 9/21/15 by PCP, started medication for reflux and discharged home. By end of week parents report continued intermittent fussiness, fatigue, difficult to wake, and when awake was dazed and lethargic. Patient was re-evaluated on 9/25/15, admitted to hospital for care. Patient developed staring episodes in hospital on 9/26/15, transferred to another hospital for further wup. Patient underwent several tests and procedures, diagnosed with seizures. Seizures have resolved with medication he is now taking.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Rec'd flu shot. 9/22/15 in (L) arm-developed shooting pain later that day-feels like its getting worse-some restriction of motion.
Age: 63.0
Sex: M
Vaccine: FLUC3
Symptoms: Bronchitis
Clinical narrative: Case number PHEH2015US019165, is an initial spontaneous report received from a consumer on 24 Sep 2015. This case report refers to 63 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 174268), intramuscularly on 16 Sep 2015. On 23 Sep 2015, he experienced bronchitis. The seriousness, outcome and causality of the event were not reported. The seriousness of the event was upgraded to serious (medically significant) based on the NVS IME list.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Low grade fever (100) and severe leg pain (leg the shots were given). By 1 AM the fever was 103.5. The high fever lasted about 24 hours.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Electrocardiogram, Fibrin D dimer, Tachycardia, Troponin, Ventricular extrasystoles
Clinical narrative: Tachycardia and PVC.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Sensory disturbance
Clinical narrative: Decreased sensation to right side of face and upper back/chest, left lower leg within 30 minutes of vaccine. Next day sensation mostly decreased in face, some neck and leg.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Nausea, Pain, Pruritus, Tenderness
Clinical narrative: Nausea, soreness, itching, tenderness to the affected area, weakness.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: High fever (102.5); aches, pains; ibruprofen.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, warmth to the area and tenderness, fatigue.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Swelling, redness, warmth to the area and tenderness, fatigue.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Seizure
Clinical narrative: Approximately 15 mins after receiving the second dose of HPV the child began to have a seizure.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pyrexia, Swelling, Throat tightness
Clinical narrative: SWOLLEN, ERYTHEMA, LOW GRADE TEMPERATURE, FELT THROAT THICKENING BUT AIRWAY NOT OBSTRUCTED.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Seizure
Clinical narrative: After a few minutes of receiving her third dose of HPV the patient fell onto the floor and had a brief seizure.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Patient devolped severe bruising and sore arm around flu vaccine.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dermatitis contact, Eczema, Injection site rash
Clinical narrative: Patient got vaccines on 09/30/2015. Started Amoxil on 10/01/2015 for OM. Band Aids at injection site were not taken off until the morning of 10/01/2015 by patients grandmother. On 10/02/2015 patients mother noticed a rash from knee to hip on front of left and right thighs. Patient had no SOB, difficulty breathing, or fever. No change in appetite, sleep, or activity. Per mom the rash did not spread or worsen. Per PCPs notes patient did not take antibiotic on 10/04/2015 or 10/05/2015.
Age: 85.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Dizziness, Myalgia
Clinical narrative: Chills, muscle aches, a little dizzy.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: Patient stated that he has a pink area about 2 inches by 3 inches at the site of the injection. I advised him to seek medical attention if it worsens or does not improve in a day or two. At the time of the vaccination he stated he had not received Pneumovax before, but then yesterday or today realized that in fact he had received the vaccine in 2012 (and not Prevnar as he had indicated). Counseled patient to get Prevnar in 12 months.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Asthma, Condition aggravated
Clinical narrative: Patient called and stated she was having an asthma attack. She was advised to go to the emergency room. She went to a walk in clinic 7 days later.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Hot flush, Pain
Clinical narrative: Hot flashes, temperature of 100.1F, body aches, symptoms resolved after approximately 24 hours.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Rash, Vomiting
Clinical narrative: Started with rash, then vomited, very tired.
Age: 1.0
Sex: M
Vaccine: FLUX, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever of 103F, mild rash on legs, back and little in front and neck. Give Tylenol and motrin for fever.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Itch and rash to upper torso and bilateral upper extremities.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Arrhythmia, Chest pain, Headache, Oropharyngeal pain, Pneumonia
Clinical narrative: Sore throat, head ache, fever, pneumonia, chest pain, cardiac arrhythmia.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Sore throat, head ache, fever, pneumonia, chest pain, cardiac arrhythmia.
Age: 50.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea
Clinical narrative: Frequent, loose bowel movements onset 12 days after completing course of Vivotif Berna (oral typhoid vaccine).  Continued symptoms without fever or rash 19 days after onset.  Taking intermittent diphenoxylate with temporary benefit.  Probiotic supplement has not helped. Patient treated with 3 day course of ciprofloxacin; stool analysis to be performed if symptoms fail to improve.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Immediate post-injection reaction, Tinnitus, Urticaria
Clinical narrative: Hives right after the shot, dizziness and ringing in the ears started about 4 hours later.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Urticaria chronic
Clinical narrative: Chronic urticarial started 1 month following first anthrax vaccination.
Age: 77.0
Sex: M
Vaccine: FLU3, PNC13, TDAP
Symptoms: Injection site reaction
Clinical narrative: Patient was administered Prevnar in left arm where adverse event occurred. Patient also got Fluzone HD and Boostrix in his right arm, one inch apart.
Age: 57.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Chills, fatigue, headache, feeling feveris, ill,and weak; injection site swelling, stiffness and pain.
Age: 57.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Injection site reaction, Injection site swelling, Malaise, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Chills, fatigue, headache, feeling feveris, ill,and weak; injection site swelling, stiffness and pain.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site rash, Injection site warmth
Clinical narrative: She looked to have a rash in the area, she mentioned heat at the rash site and a headache, referred her to her MD right away.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site rash
Clinical narrative: Quarter sized bumpy red rash over injection site and 2 inch wide red streak going down arm toward elbow. Urgent care physician put her on Keflex in case it was cellulitis but thought it was just an injection site rxn.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Quarter sized bumpy red rash over injection site and 2 inch wide red streak going down arm toward elbow. Urgent care physician put her on Keflex in case it was cellulitis but thought it was just an injection site rxn.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain, itchiness, and swelling at injection site. Antihistamines and hydrocortisone recommended.