chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Local swelling reaction 3"x5" red and itchy.
Age: 70.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Chronic obstructive pulmonary disease, Pneumonia, Respiratory tract congestion, Total lung capacity decreased
Clinical narrative: Chest congestion.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Pain, Pyrexia
Clinical narrative: First reaction included low grade fever and widespread body aches (muscular). Second reaction caused large round rash on injection site about 10"X5" in area.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood pressure increased, Condition aggravated, Facial pain, Injection site pain, Pain in extremity
Clinical narrative: PATIENT DESCRIBED ISSUES OF PAIN IN HER RIGHT ARM THE DAY/MORNING AFTER RECEIVING THE PNEUMOVAX 23 - SHE SAID THE PAIN BEGAN TO THEN SPREAD THROUGHOUT HER ARM AND SHOULDER INTO THE SIDE OF HER FACE AND THAT HER BLOOD PRESSURE WAS ELEVATED. SHE WENT TO THE EMERGENCY ROOM WHERE SHE WAS GIVEN AN EPI-SHOT, STEROIDS, AND BENADRYL. SHE HAD MINOR PAIN IN HER RIGHT ARM THE NEXT MORNING BUT FELT BETTER/NORMAL.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain
Clinical narrative: Pt had soreness and had trouble moving her arm 2 to 3 hours later.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Altered state of consciousness, Asthenia, Immediate post-injection reaction, Pain, Visual acuity reduced
Clinical narrative: IMMEDIATELY AFTER SHOT-- PAIN ON LEFT SIDE. VISION-- SEEING BLACK. WEAK. ALMOST PASSED OUT.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Aptyalism, Chills, Cough, Dehydration, Diarrhoea
Clinical narrative: In order in which they occurred: coughing 20 mins. sore throat.  could hardly swallow.  saliva dried up. bleary eyes. thick mucous in throat. throat closing up. Above lasted about 2 hours.  Luckily, I could still breathe through my nose. Then, over next 4 hours:  chills  body aches  right arm (site of vaccine & whole upper arm) hurt like hell (8 hours) diarrhea (2 episodes)  nausea At 2:30 am  woke up with fever  dehydrated  splitting headache  arm still hurt a lot By 8:30 am still had splitting headache  other symptoms mostly gone, except arm still pretty sore By 12 noon:  symptoms gone except slight soreness at vaccine site.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysphagia, Headache, Increased upper airway secretion, Injection site pain, Nausea
Clinical narrative: In order in which they occurred: coughing 20 mins. sore throat.  could hardly swallow.  saliva dried up. bleary eyes. thick mucous in throat. throat closing up. Above lasted about 2 hours.  Luckily, I could still breathe through my nose. Then, over next 4 hours:  chills  body aches  right arm (site of vaccine & whole upper arm) hurt like hell (8 hours) diarrhea (2 episodes)  nausea At 2:30 am  woke up with fever  dehydrated  splitting headache  arm still hurt a lot By 8:30 am still had splitting headache  other symptoms mostly gone, except arm still pretty sore By 12 noon:  symptoms gone except slight soreness at vaccine site.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Pyrexia, Throat tightness
Clinical narrative: In order in which they occurred: coughing 20 mins. sore throat.  could hardly swallow.  saliva dried up. bleary eyes. thick mucous in throat. throat closing up. Above lasted about 2 hours.  Luckily, I could still breathe through my nose. Then, over next 4 hours:  chills  body aches  right arm (site of vaccine & whole upper arm) hurt like hell (8 hours) diarrhea (2 episodes)  nausea At 2:30 am  woke up with fever  dehydrated  splitting headache  arm still hurt a lot By 8:30 am still had splitting headache  other symptoms mostly gone, except arm still pretty sore By 12 noon:  symptoms gone except slight soreness at vaccine site.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vaccination site pain, Vision blurred
Clinical narrative: In order in which they occurred: coughing 20 mins. sore throat.  could hardly swallow.  saliva dried up. bleary eyes. thick mucous in throat. throat closing up. Above lasted about 2 hours.  Luckily, I could still breathe through my nose. Then, over next 4 hours:  chills  body aches  right arm (site of vaccine & whole upper arm) hurt like hell (8 hours) diarrhea (2 episodes)  nausea At 2:30 am  woke up with fever  dehydrated  splitting headache  arm still hurt a lot By 8:30 am still had splitting headache  other symptoms mostly gone, except arm still pretty sore By 12 noon:  symptoms gone except slight soreness at vaccine site.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Cough, Dysphagia, Increased viscosity of upper respiratory secretion, Oropharyngeal pain
Clinical narrative: In order in which they occurred: coughing 20 mins. sore throat.  could hardly swallow.  saliva dried up. bleary eyes. thick mucous in throat. throat closing up. Above lasted about 2 hours.  Luckily, I could still breathe through my nose. Then, over next 4 hours:  chills  body aches  right arm (site of vaccine & whole upper arm) hurt like hell (8 hours) diarrhea (2 episodes)  nausea At 2:30 am  woke up with fever  dehydrated  splitting headache  arm still hurt a lot By 8:30 am still had splitting headache  other symptoms mostly gone, except arm still pretty sore By 12 noon:  symptoms gone except slight soreness at vaccine site.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: In order in which they occurred: coughing 20 mins. sore throat.  could hardly swallow.  saliva dried up. bleary eyes. thick mucous in throat. throat closing up. Above lasted about 2 hours.  Luckily, I could still breathe through my nose. Then, over next 4 hours:  chills  body aches  right arm (site of vaccine & whole upper arm) hurt like hell (8 hours) diarrhea (2 episodes)  nausea At 2:30 am  woke up with fever  dehydrated  splitting headache  arm still hurt a lot By 8:30 am still had splitting headache  other symptoms mostly gone, except arm still pretty sore By 12 noon:  symptoms gone except slight soreness at vaccine site.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Pruritus, Skin reaction
Clinical narrative: Patient's arm turned red, swollen, itchy. Came back to pharmacy next day, purchased Benadryl topical and systemic to use.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Patient called three days after getting Prevnar 13 vaccination to report skin rash (small bumps) on her arms, chest, and abdomen.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: THERE WAS A SMALL AMOUNT OF BLOOD WITH THE INJECTION AS I WIPED IT AWAY THE INJECTION SITE HAD ALREADY BEGUN TO SWELL. IT SWELLED TO ABOUT THE SIZE OF A PEA. WE APPLIED A COLD PACK TO PREVENT ANY FURTHER SWELLING.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Swelling, redness, tenderness on site of vaccination measuring 1.75 inches in diameter.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Rotator cuff syndrome, X-ray limb abnormal
Clinical narrative: Much pain, inability to lift arm. Applied heat. Took painkillers.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Dyskinesia, Immediate post-injection reaction, Mobility decreased, Pain
Clinical narrative: Immediate pain and reflex arm jerk as the needle was inserted. After the pain remained and was unable to rotate arm fully. The pain decreased over time but arm is still unable to rotate fully even months later. Unsure when/if arm rotation will return to baseline.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Glycosylated haemoglobin increased, Rash, Type 1 diabetes mellitus, Weight decreased
Clinical narrative: Rash followed by severe weight loss, dizziness and after 10 days taken to ER.  Diagnosed with Sudden Onset Type 1 Diabetes.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Syncope
Clinical narrative: Patient fainted after getting up to walk out (possible shock and seizing), patient reported he passed out before due to a vaccination. He woke up after a couple minutes and BP was checked out at 119/80. Paramedics were called and patient refused to be taken to hospital.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Balance disorder, Bone pain, Chills, Fatigue, Feeling of body temperature change
Clinical narrative: On Monday and Tuesday, had fatigue, hot then cold, muscle and bone aches. On Dec 1, 2016 began to notice I was off balance when walking, and several near falls.  Fatigue continues.  Chills and muscle aches stopped after the first 2 days.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia
Clinical narrative: On Monday and Tuesday, had fatigue, hot then cold, muscle and bone aches. On Dec 1, 2016 began to notice I was off balance when walking, and several near falls.  Fatigue continues.  Chills and muscle aches stopped after the first 2 days.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Back pain, Blood culture negative, Blood test, C-reactive protein increased
Clinical narrative: Sever lower back pain, chills, WBC elevated, sedimentation rate elevated, C-reactive protein elevated, generalized weakness, muscle ache all over the body. tachycardia.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Computerised tomogram abdomen normal, Echocardiogram normal, Electrocardiogram normal, Heart rate increased
Clinical narrative: Sever lower back pain, chills, WBC elevated, sedimentation rate elevated, C-reactive protein elevated, generalized weakness, muscle ache all over the body. tachycardia.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Myalgia, Nuclear magnetic resonance imaging normal, Red blood cell sedimentation rate increased, Tachycardia, Urine analysis normal
Clinical narrative: Sever lower back pain, chills, WBC elevated, sedimentation rate elevated, C-reactive protein elevated, generalized weakness, muscle ache all over the body. tachycardia.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: White blood cell count increased
Clinical narrative: Sever lower back pain, chills, WBC elevated, sedimentation rate elevated, C-reactive protein elevated, generalized weakness, muscle ache all over the body. tachycardia.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Case number PHEH2016US031085 is an initial spontaneous report received from consumer on 22 Nov 2016. This case refers to female patient of unknown age. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (lot number: 168904, expiry date: not reported) at a dose of 0.5 ml intramuscular on 20 Oct 2016. On the same day, the patient experienced significant arm pain in the left arm where the injection was given. It was reported that, the patient had still significant arm pain. The outcome of the events was reported as condition unchanged. The seriousness of the event was not reported. Seriousness assessment of event vaccination site pain was upgraded (medically significant) as per information available in source document. The causality of the event was not reported.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash pruritic
Clinical narrative: 3 itchy bumps on face + 3 itchy bumps on back.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Urticaria
Clinical narrative: 2 days after vaccine, patient experienced severe hives (painful) on arms and neck.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Redness on arm, heat on arm. Antibiotic prescribed.
Age: 76.0
Sex: U
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Pt developed rash more than 2-3 inches, reported on 12/21/16 2:39 pm. Pt checked with her dr and dr said to contact VAERS.
Age: 37.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sunburn in a 37-year-old male patient who received FLULAVAL QUADRIVALENT. On 26th September 2016, the patient received FLULAVAL QUADRIVALENT .5 ml. On 26th September 26, 2 hrs after receiving FLULAVAL QUADRIVALENT, the patient experienced sunburn, blister, skin peeling, hives, heat rash and erythematous rash. The patient was treated with prednisone and steroids nos (Steroid Injection). On an unknown date, the outcome of the sunburn, blister, skin peeling, hives, heat rash and erythematous rash were not recovered/not resolved. The reporter considered the sunburn, blister, skin peeling, hives, heat rash and erythematous rash to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: At 10:00, the patient received FLULAVAL QUADRIVALENT at his pharmacy. The patient experienced a bad reaction. He broke out in hives and rash with blistering on his back with sunburn and peeling skin on his chest, stomach, back and partial arms. The rash was red and hot and was on his arms and forearms. He was given a steroid injection in the doctor's office and the reaction subsided a little and then came back the next day. The patient was provided a prescription with Prednisone and he completed the Prednisone therapy. The physician said that if he did not improve he might get another steroid injection. The patient asked for legal reimbursement because he had missed work and had expenses with co-pays and medication fees.
Age: 37.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Blister, Miliaria, Rash erythematous, Skin exfoliation, Sunburn
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sunburn in a 37-year-old male patient who received FLULAVAL QUADRIVALENT. On 26th September 2016, the patient received FLULAVAL QUADRIVALENT .5 ml. On 26th September 26, 2 hrs after receiving FLULAVAL QUADRIVALENT, the patient experienced sunburn, blister, skin peeling, hives, heat rash and erythematous rash. The patient was treated with prednisone and steroids nos (Steroid Injection). On an unknown date, the outcome of the sunburn, blister, skin peeling, hives, heat rash and erythematous rash were not recovered/not resolved. The reporter considered the sunburn, blister, skin peeling, hives, heat rash and erythematous rash to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: At 10:00, the patient received FLULAVAL QUADRIVALENT at his pharmacy. The patient experienced a bad reaction. He broke out in hives and rash with blistering on his back with sunburn and peeling skin on his chest, stomach, back and partial arms. The rash was red and hot and was on his arms and forearms. He was given a steroid injection in the doctor's office and the reaction subsided a little and then came back the next day. The patient was provided a prescription with Prednisone and he completed the Prednisone therapy. The physician said that if he did not improve he might get another steroid injection. The patient asked for legal reimbursement because he had missed work and had expenses with co-pays and medication fees.
Age: 37.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sunburn in a 37-year-old male patient who received FLULAVAL QUADRIVALENT. On 26th September 2016, the patient received FLULAVAL QUADRIVALENT .5 ml. On 26th September 26, 2 hrs after receiving FLULAVAL QUADRIVALENT, the patient experienced sunburn, blister, skin peeling, hives, heat rash and erythematous rash. The patient was treated with prednisone and steroids nos (Steroid Injection). On an unknown date, the outcome of the sunburn, blister, skin peeling, hives, heat rash and erythematous rash were not recovered/not resolved. The reporter considered the sunburn, blister, skin peeling, hives, heat rash and erythematous rash to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: At 10:00, the patient received FLULAVAL QUADRIVALENT at his pharmacy. The patient experienced a bad reaction. He broke out in hives and rash with blistering on his back with sunburn and peeling skin on his chest, stomach, back and partial arms. The rash was red and hot and was on his arms and forearms. He was given a steroid injection in the doctor's office and the reaction subsided a little and then came back the next day. The patient was provided a prescription with Prednisone and he completed the Prednisone therapy. The physician said that if he did not improve he might get another steroid injection. The patient asked for legal reimbursement because he had missed work and had expenses with co-pays and medication fees.
Age: 37.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Bursa injury, Pain in extremity
Clinical narrative: Left shoulder starting hurting really bad, and it was difficult to move.  By day 5 I could not move my arm and had surgery on the 6th of October.
Age: 37.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthritis bacterial, Blood test, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Left shoulder starting hurting really bad, and it was difficult to move.  By day 5 I could not move my arm and had surgery on the 6th of October.
Age: 37.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Surgery, X-ray
Clinical narrative: Left shoulder starting hurting really bad, and it was difficult to move.  By day 5 I could not move my arm and had surgery on the 6th of October.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Information was received from a medical assistant concerning a 11 year old female patient, who on 15-NOV-2016 was vaccinated with her first dose of GARDASIL 9 (lot # L036301, expiration date 20-DEC-2017), 0.5 ml intramuscularly once. There was no pertinent medical history or history of drug allergies, and no concomitant medications. It was reported that the patient felt dizzy on 15-NOV-2016, approximately 5 minutes after receiving the GARDASIL 9. The medical assistant reported that the patient was lowered to the floor and the patient's feet were elevated. The patient's initial vital signs were blood pressure 135/80, pulse 70, respirations 22, and temperature 98.2 F. The patient had ice packs applied to forehead and chest, given water to drink, and was examined by the physician. The medical assistant reported that the patient had recovered in 5 to 6 minutes. After 15 minutes, the patient's blood pressure was 114/72, pulse 76, respirations 18, and temperature 98.2 F. The patient was reported to have fully recovered and was sent home after a total of 20 minutes. No further information was provided. The causality of the dizziness to the GARDASIL 9 was not provided by the reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Bradycardia, Brain death, Brain oedema, Cerebral haemorrhage, Cerebrovascular accident
Clinical narrative: Headaches, seizures, strokes, swelling of the brain, blood pooling in the brain, brain dead, repetitive speech, fainting, tachycardia, fever, lethargic, emotional, bradycardia, incontinent.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Cerebrovascular disorder, Emotional disorder, Headache, Incontinence, Lethargy
Clinical narrative: Headaches, seizures, strokes, swelling of the brain, blood pooling in the brain, brain dead, repetitive speech, fainting, tachycardia, fever, lethargic, emotional, bradycardia, incontinent.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia, Repetitive speech, Seizure, Syncope, Tachycardia
Clinical narrative: Headaches, seizures, strokes, swelling of the brain, blood pooling in the brain, brain dead, repetitive speech, fainting, tachycardia, fever, lethargic, emotional, bradycardia, incontinent.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Axillary pain, Burning sensation, Lymphadenopathy, Tonsillar inflammation
Clinical narrative: I awoke the day after with swollen tonsils and upper body lymph-nodes. The lymph-nodes under the arms (armpit area) were particularly sore three days after the vaccination and persisted for 6 days. My tonsils reduced in swelling after 4 days. However, my left (side of the vaccination) fingertips experienced a persistent burning sensation for 10 days. This is the fist non-single dose flu vaccination after being diagnosed with Lyme-disease.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Mobility decreased, Pain, Paraesthesia
Clinical narrative: Numbness. Tingling sensation. Pain. Restricted arm movement (Can't move arm as much).
Age: 22.0
Sex: F
Vaccine: FLUX, SMALL
Symptoms: Erythema, Injection site erythema, Rash pustular, Secretion discharge, Skin warm
Clinical narrative: Initial unsolicited report received from a Consumer on 21 November 2016. This case involves a 22-year-old female patient who was vaccinated percutaneously with a first dose of ACAM2000 (Lot number-VV04003A, expiry date, dose, dose in series were unknown) in left deltoid and a dose of INFLUENZA VACCINE (Lot number, expiry date, dose, dose in series were unknown) in right deltoid on 24 October 2016. The patient's Illness at time of vaccination was reported as Stuffy nose and Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as none. The patient's Concomitant medications were reported as none. On 17 November 2016, 24 days following the vaccination, the patient developed raised areas around he vaccination site, also experienced a red hot area with a pus like drainage and it was below the vaccination area and there was a second site on her elbow. The patient's laboratory investigation and Corrective treatment was reported as none. The patient required emergency visit after events on an unspecified date. The patient was not recovered from the event. List of documents held by sender: none.
Age: 22.0
Sex: F
Vaccine: FLUX, SMALL
Symptoms: Vaccination site discharge, Vaccination site pustule, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Initial unsolicited report received from a Consumer on 21 November 2016. This case involves a 22-year-old female patient who was vaccinated percutaneously with a first dose of ACAM2000 (Lot number-VV04003A, expiry date, dose, dose in series were unknown) in left deltoid and a dose of INFLUENZA VACCINE (Lot number, expiry date, dose, dose in series were unknown) in right deltoid on 24 October 2016. The patient's Illness at time of vaccination was reported as Stuffy nose and Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as none. The patient's Concomitant medications were reported as none. On 17 November 2016, 24 days following the vaccination, the patient developed raised areas around he vaccination site, also experienced a red hot area with a pus like drainage and it was below the vaccination area and there was a second site on her elbow. The patient's laboratory investigation and Corrective treatment was reported as none. The patient required emergency visit after events on an unspecified date. The patient was not recovered from the event. List of documents held by sender: none.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Dysphagia, Swollen tongue
Clinical narrative: Initial unsolicited report received from a consumer on 22 November 2016. This case involves a 66-year-old male patient, who was vaccinated with a dose of FLUZONE Quadrivalent batch number: UI444AB, expiry date: 30 June 2016, dose, dose in series and route of administration were not reported) in right deltoid on 07 October 2015. Patient's illness at time of vaccination was reported as none and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as Allergies: none. Concomitant medication was not reported. On 07 October 2015, same day following the vaccination, the patient developed bottom side tongue swelling and had some difficulty swallowing. Lab data was reported as none. Corrective treatment was not reported. On an unspecified date, the patient difficulty of swallowing was recovered on its own and tongue swelling was not recovered. List of documents held by sender: none.
Age: 84.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial unsolicited report received from a consumer on 22 November 2016. This case involves an 84-year-old male patient who was vaccinated with Fluzone HD intramuscularly (lot number, expiration date and dose were not reported) in right deltoid on 03 November 2016. The patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown and illness at time of vaccination was also reported as unknown. Concomitant medications were not reported. On 04 November 2016, one day following vaccination, patient experienced soreness on injection site and had difficulty to bend the right arm. Laboratory investigations and corrective treatment were not reported. The outcome of events was reported as not recovered. List of documents held by sender: none.
Age: 84.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Initial unsolicited report received from a consumer on 22 November 2016. This case involves an 84-year-old male patient who was vaccinated with Fluzone HD intramuscularly (lot number, expiration date and dose were not reported) in right deltoid on 03 November 2016. The patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown and illness at time of vaccination was also reported as unknown. Concomitant medications were not reported. On 04 November 2016, one day following vaccination, patient experienced soreness on injection site and had difficulty to bend the right arm. Laboratory investigations and corrective treatment were not reported. The outcome of events was reported as not recovered. List of documents held by sender: none.
Sex: F
Vaccine: FLU3, UNK
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial unsolicited report received from a consumer on 22-Nov-2016. This case involves a male patient (age not reported) who was vaccinated with Fluzone HD via intramuscular route (batch number, dose, expiration date was not reported) at right deltoid on 03-Nov-2016. Illness at time of vaccination was reported as unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions were also reported as unknown. Concomitant medications were not reported. On 04-Nov-2016, one day following vaccination, patient experienced soreness on injection site and had difficulty to bend the right arm. Lab data and corrective treatment were not reported. Outcome of the events were reported as not recovered. List of documents held by sender: none.
Sex: F
Vaccine: FLU3, UNK
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer on 22-Nov-2016. This case involves a male patient (age not reported) who was vaccinated with Fluzone HD via intramuscular route (batch number, dose, expiration date was not reported) at right deltoid on 03-Nov-2016. Illness at time of vaccination was reported as unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions were also reported as unknown. Concomitant medications were not reported. On 04-Nov-2016, one day following vaccination, patient experienced soreness on injection site and had difficulty to bend the right arm. Lab data and corrective treatment were not reported. Outcome of the events were reported as not recovered. List of documents held by sender: none.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain, Arthralgia, Headache, Heart rate increased, Myalgia
Clinical narrative: Fever, headache, rapid heartbeat, abdominal pain, joint pain, muscle pain.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fever, headache, rapid heartbeat, abdominal pain, joint pain, muscle pain.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Atrial fibrillation, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Information has been received from a medical assistant referring to a 69 year old male patient. The patient's concurrent condition included cardiac failure congestive (CHF). Concomitant therapys included atorvastatin, amlodipine, losartan potassium (manufacturer unknown) and acetaminophen, chlorpheniramine maleate, aspirin (manufacturer unknown). Medical history was not reported. The patient had no drug reactions/allergies. On 29-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M032635, expiration date: 20-MAY-2018, dose and route were unknown). On 30-NOV-2016 the patient came to office and had redness and swelling at injection site. The patient "wasn't feeling well", and was admitted to a hospital and diagnosed with new onset atrial fibrillation. Unspecified treatments were given for the events. The outcome of the events were unknown. Causality was not provided. The reporter was requesting lot check. Upon internal review, atrial fibrillation was determined to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: Initial unsolicited report received from consumer on 18 November 2016. This case involves a 62-year-old female patient who was vaccinated with a dose of FLU VACCINE (dose, batch number, expiration date and route of administration was not reported) in dorso gluteal area, on an unspecified date (Reported as last year). The patient's Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions include not provided has autoimmune disorder no other info. Concomitant medication was reported unknown. On an unspecified date, few days following vaccination patient had flu like symptoms. Lab data was reported as none. Corrective treatment was not reported. On an unspecified date patient was recovered from events. List of documents held by sender: none.
Age: 45.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injury associated with device, Laceration
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (Practice Manager) on 18 November 2016. This case involves a 45-year-old female patient who was inflicted with injury (from a shattered ACTHIB vial) of PENTACEL (batch number: C5223AA, expiry date: 16 July 2017, route, dose and dose in series were not reported) via right index finger in the on 18 November 2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not provided and Illness at the time of vaccination was reported as none. Concomitant medications were not reported and any other vaccinations within four weeks of vaccinations were also not reported. On 18 November 2016, the patient had a cut in her index finger on broken glass from a shattered ACTHIB vial. It was also reported that the patient had first aid to her finger and applied a bandage and no stitches required. The patient required emergency room (ER) visit. Laboratory investigations were reported as none. Corrective treatment was not reported. The outcome of event was reported as not recovered. List of documents held by sender: none.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Asthenia, Bacterial test positive, Blood sodium decreased, Gait disturbance
Clinical narrative: Admitted to Medical Center on 11/18/16 with hyponatremia, epigastric pain, UTI, bilateral lower extremity numbness and gait disturbance and generalized weakness. Clt had lumbar puncture and was diagnosed with Guillain Barre Syndrome. Remained in hospital x 10 days and was then transferred to Inpatient rehab at Med Center.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Hyponatraemia, Lumbar puncture, Protein urine present
Clinical narrative: Admitted to Medical Center on 11/18/16 with hyponatremia, epigastric pain, UTI, bilateral lower extremity numbness and gait disturbance and generalized weakness. Clt had lumbar puncture and was diagnosed with Guillain Barre Syndrome. Remained in hospital x 10 days and was then transferred to Inpatient rehab at Med Center.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Urinary tract infection
Clinical narrative: Admitted to Medical Center on 11/18/16 with hyponatremia, epigastric pain, UTI, bilateral lower extremity numbness and gait disturbance and generalized weakness. Clt had lumbar puncture and was diagnosed with Guillain Barre Syndrome. Remained in hospital x 10 days and was then transferred to Inpatient rehab at Med Center.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse reaction, wrong vaccine was given. Two hep b's were given at the time of the visit instead of a hep b and a hib.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site infection, Staphylococcal infection, Swelling
Clinical narrative: After her flu shot patient reports she noticed a bump forming.  She reports she went to urgent care on 12/4 and is being treated for a staph infection at the injection site.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Malaise, Muscular weakness
Clinical narrative: Mother states pt felt fatigued and lower leg weakness. MOC states pt felt unwell and stayed in bed 11/3/16-11/4/16 due to weakness. There was no medication given and no other visit.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Muscular weakness, Pain in extremity
Clinical narrative: I'm having weakness in my arm and I can only have a little range of motion in it and it is very sore all the time and I can't lay on it in bed.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Musculoskeletal pain, Pain in extremity
Clinical narrative: I saw patient for eval of severe (R) shoulder/arm pain immediately following admin of her influenza vacc at your pharmacy 11/25/16. I'm about possibility of post injection chemical neuritis and have prescribed steroids, Gabapentin, opioid and will possibly refer to neuropathy if sxs present.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling and warmth at injection site. Treatment was to watch and wait.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: Symptoms of CIPD.
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Adverse drug reaction, Blood test, Bronchitis, Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for a male patient (husband). An 89-year-old male patient received PREVNAR 13 at single dose in right arm for preventive for pneumonia, INFLUENZA VACCINE, both via an unspecified route of administration in Oct2016 at 12 O'clock for immunization, administered by a nurse at the responsible Physician. The patient medical history was not reported. Concomitant medication included levothyroxine (LEVOTHYROXINE) tablet 75 mcg, once a day approximately from 15 years and ongoing for thyroid. No other vaccines were given 4 weeks prior to the day of suspected vaccine. On an unspecified date, bronchitis about 2 weeks later weeks after getting his PCV13 shot. He started experiencing congestion in lungs probably about 2 to 3 weeks before this report and it was going on for 4 weeks. He thought it was bronchitis so he went to the doctor who gave him Prednisone and prescription for antibiotics: he was started on doxycycline (unknown manuf.) for treatment, but was allergic and broke out in big red splotches. His physician then switched him to a Z-PAK, albuterol and prednisolone. He still had the bad congestion in his lungs. Consumer asked that if there was something good that he could take for infection in his lungs that came from that pneumonia shot. On an unspecified date the patient also experienced infection in his lungs with outcome of not recovered, bad congestion in his lungs on an unspecified date with outcome of not recovered, bronchitis on an unspecified date with outcome of unknown, sick with outcome of not recovered, COPD (chronic obstructive pulmonary disease) with outcome of not recovered, patient received PREVNAR 13 and flu shot together with outcome of unknown. In response to other medication conditions, reporter stated that the patient had COPD and when the patient went to the doctor this Sunday (20Nov2016?) after the Lung infections, doctor told him that he had COPD. Reporter added that Sunday (20Nov2016?) was the first day when they knew about that the patient had COPD. The patient had blood work this past Sunday (20Nov2016?) but the reporter did not have the result of the blood work. The current status of infection in lungs and bad congestion in lungs was still in existence. Patient had bronchitis before, but the reporter had never known that if he would have bronchitis that long. It was four weeks now that the patient became sick. A product complaint was filed.
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Lung infection, Malaise, Product quality issue, Pulmonary congestion, Rash macular
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for a male patient (husband). An 89-year-old male patient received PREVNAR 13 at single dose in right arm for preventive for pneumonia, INFLUENZA VACCINE, both via an unspecified route of administration in Oct2016 at 12 O'clock for immunization, administered by a nurse at the responsible Physician. The patient medical history was not reported. Concomitant medication included levothyroxine (LEVOTHYROXINE) tablet 75 mcg, once a day approximately from 15 years and ongoing for thyroid. No other vaccines were given 4 weeks prior to the day of suspected vaccine. On an unspecified date, bronchitis about 2 weeks later weeks after getting his PCV13 shot. He started experiencing congestion in lungs probably about 2 to 3 weeks before this report and it was going on for 4 weeks. He thought it was bronchitis so he went to the doctor who gave him Prednisone and prescription for antibiotics: he was started on doxycycline (unknown manuf.) for treatment, but was allergic and broke out in big red splotches. His physician then switched him to a Z-PAK, albuterol and prednisolone. He still had the bad congestion in his lungs. Consumer asked that if there was something good that he could take for infection in his lungs that came from that pneumonia shot. On an unspecified date the patient also experienced infection in his lungs with outcome of not recovered, bad congestion in his lungs on an unspecified date with outcome of not recovered, bronchitis on an unspecified date with outcome of unknown, sick with outcome of not recovered, COPD (chronic obstructive pulmonary disease) with outcome of not recovered, patient received PREVNAR 13 and flu shot together with outcome of unknown. In response to other medication conditions, reporter stated that the patient had COPD and when the patient went to the doctor this Sunday (20Nov2016?) after the Lung infections, doctor told him that he had COPD. Reporter added that Sunday (20Nov2016?) was the first day when they knew about that the patient had COPD. The patient had blood work this past Sunday (20Nov2016?) but the reporter did not have the result of the blood work. The current status of infection in lungs and bad congestion in lungs was still in existence. Patient had bronchitis before, but the reporter had never known that if he would have bronchitis that long. It was four weeks now that the patient became sick. A product complaint was filed.
Age: 65.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Novartis Pharmaceuticals Corporation (Novartis Reference #: PHEH2016US029422_NS). A contactable consumer reported for himself. A 65-Year-old male patient of an unspecified route received PREVNAR 13 at single dose on the right arm and influenza vaccine on the left arm both via an unspecified route on 18Oct2016 for immunization. The right arm where he received pneumococcal 13-val conj vac (dipht crm197 protein) appeared swollen. The outcome of the event was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc. (manufacturer control number: 00271495). A contactable pharmacist reported for a patient of an unspecified age, race, ethnicity and gender who received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date for immunization.  The patient medical history and concomitant medications were not reported.  After the vaccination the patient experienced hives. Outcome was unknown. No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Insomnia, Malaise, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's parent). A 18-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date at 05:00 PM the patient experienced nausea, dizziness, feeling unwell and did not sleep well. Outcome of the events was unknown.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient, reported to physician on 12/5/2016 that since her vaccination she has had decreased motion of her right arm and pain.  This started the next day after her vaccination and she continued to have difficulty at the time of report.
Age: 52.0
Sex: F
Vaccine: FLUX, PPV, TTOX, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Red, raised, hard, bumpy rash at injection site, hot to touch. Redness spreading hourly.
Age: 1.5
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Acute myeloid leukaemia, Blood immunoglobulin G normal, Blood immunoglobulin M, Cellulitis, Laboratory test
Clinical narrative: On 9/17/2016 child with fever and cellulitis of hand. Started on cephalexin 9/20 seen again for otitis media and sinusitis 9/24 seen for rash, sent to ER and diagnosed with leukemia and vaccination induced varicella.
Age: 1.5
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Otitis media, Pyrexia, Rash, Sinusitis, Varicella post vaccine
Clinical narrative: On 9/17/2016 child with fever and cellulitis of hand. Started on cephalexin 9/20 seen again for otitis media and sinusitis 9/24 seen for rash, sent to ER and diagnosed with leukemia and vaccination induced varicella.
Age: 1.5
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Varicella virus test
Clinical narrative: On 9/17/2016 child with fever and cellulitis of hand. Started on cephalexin 9/20 seen again for otitis media and sinusitis 9/24 seen for rash, sent to ER and diagnosed with leukemia and vaccination induced varicella.
Age: 42.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Asthma, C-reactive protein normal, Cough, Diarrhoea, Dyspnoea
Clinical narrative: 42 yo F with moderate persistent asthma, tobacco abuse and other comorbidies was seen in clinic following treatment of URI/asthma exacerbation that included steroid burst x 5 days.  At the time of the 11/28 visit, patient had improved dry cough and continued to have nasal discharge.  During clinic visit patient was vaccinated with PNEUMOVAX 23 IM in left deltoid and Influenza vaccine was given IM in right deltoid at 1601.  Patient developed nausea, emesis, diarrhea, arm became painful overnight. On 11/29 she presented to Clinic with ongoing nausea, sense of "heat" but no fever, right upper arm warm, erthyematous and tender. Also had wheezing and some shortness of breath (Hx asthma) which required an albuterol breathing treatment. It is unreported if the patient started Dulera prior to onset of SOB and wheezing.  Patient to take diphenhydramine q6h over next few days and to purchase a nebulizer.
Age: 42.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Erythema, Feeling hot, Glycosylated haemoglobin increased, Nausea, Neutrophil count increased
Clinical narrative: 42 yo F with moderate persistent asthma, tobacco abuse and other comorbidies was seen in clinic following treatment of URI/asthma exacerbation that included steroid burst x 5 days.  At the time of the 11/28 visit, patient had improved dry cough and continued to have nasal discharge.  During clinic visit patient was vaccinated with PNEUMOVAX 23 IM in left deltoid and Influenza vaccine was given IM in right deltoid at 1601.  Patient developed nausea, emesis, diarrhea, arm became painful overnight. On 11/29 she presented to Clinic with ongoing nausea, sense of "heat" but no fever, right upper arm warm, erthyematous and tender. Also had wheezing and some shortness of breath (Hx asthma) which required an albuterol breathing treatment. It is unreported if the patient started Dulera prior to onset of SOB and wheezing.  Patient to take diphenhydramine q6h over next few days and to purchase a nebulizer.
Age: 42.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Neutrophil count normal, Pain in extremity, Rhinorrhoea, Tenderness, Tobacco abuse
Clinical narrative: 42 yo F with moderate persistent asthma, tobacco abuse and other comorbidies was seen in clinic following treatment of URI/asthma exacerbation that included steroid burst x 5 days.  At the time of the 11/28 visit, patient had improved dry cough and continued to have nasal discharge.  During clinic visit patient was vaccinated with PNEUMOVAX 23 IM in left deltoid and Influenza vaccine was given IM in right deltoid at 1601.  Patient developed nausea, emesis, diarrhea, arm became painful overnight. On 11/29 she presented to Clinic with ongoing nausea, sense of "heat" but no fever, right upper arm warm, erthyematous and tender. Also had wheezing and some shortness of breath (Hx asthma) which required an albuterol breathing treatment. It is unreported if the patient started Dulera prior to onset of SOB and wheezing.  Patient to take diphenhydramine q6h over next few days and to purchase a nebulizer.
Age: 42.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Vomiting, Wheezing, White blood cell count increased, White blood cell count normal
Clinical narrative: 42 yo F with moderate persistent asthma, tobacco abuse and other comorbidies was seen in clinic following treatment of URI/asthma exacerbation that included steroid burst x 5 days.  At the time of the 11/28 visit, patient had improved dry cough and continued to have nasal discharge.  During clinic visit patient was vaccinated with PNEUMOVAX 23 IM in left deltoid and Influenza vaccine was given IM in right deltoid at 1601.  Patient developed nausea, emesis, diarrhea, arm became painful overnight. On 11/29 she presented to Clinic with ongoing nausea, sense of "heat" but no fever, right upper arm warm, erthyematous and tender. Also had wheezing and some shortness of breath (Hx asthma) which required an albuterol breathing treatment. It is unreported if the patient started Dulera prior to onset of SOB and wheezing.  Patient to take diphenhydramine q6h over next few days and to purchase a nebulizer.
Age: 42.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: C-reactive protein, Diarrhoea, Feeling hot, Full blood count, Injection site erythema
Clinical narrative: 42 yo F with moderate persistent asthma, tobacco abuse and other comorbidies was seen in clinic following treatment of URI/asthma exacerbation that included steroid burst x 5 days.  At the time of the 11/28 visit, patient had improved dry cough and continued to have nasal discharge.  During clinic visit patient was vaccinated with PNEUMOVAX 23 IM in left deltoid and Influenza vaccine was given IM in right deltoid at 1601.  Patient developed nausea, emesis, diarrhea, arm became painful overnight. On 11/29 she presented to Clinic with ongoing nausea, sense of "heat" but no fever, right upper arm warm, erthyematous and tender. Also had wheezing and some shortness of breath (Hx asthma) which required an albuterol breathing treatment. It is unreported if the patient started Dulera prior to onset of SOB and wheezing.  Patient to take diphenhydramine q6h over next few days and to purchase a nebulizer.