chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Oedema, Pain, Scab
Clinical narrative: She experienced severe local reaction of erythema, edema, induration and nodule with peripheral vesicles and minor erosion where the band aid made contact. The site was limited to her upper left arm, primarily deltoid. Her arm was painful to move but maintained function. She treated it with ice and NSAIDS, although states she can only tolerate lower doses. She also had severe pain that was improved on NSAIDS. Onset was one day after receipt. Symptoms fully resolved in about a week. She did not take pictures.
Age: 84.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site discomfort, Mobility decreased
Clinical narrative: PATIENT IS HAVING DIFFICULTY MOVING ARM AND STILL EXPERIENCING DISCOMFORT AT INJECTION SITE.
Age: 84.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: PATIENT IS HAVING DIFFICULTY MOVING ARM AND STILL EXPERIENCING DISCOMFORT AT INJECTION SITE.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Erythema, Myalgia, Peripheral swelling
Clinical narrative: Myalgias, chills, redness, swelling to right arm.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Necrosis, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 58 year old male patient. The patient's medical history was unknown. On 01-SEP-2015 the patient was vaccinated with PNEUMOVAX 23 (lot # K010466, exp 23-MAR-2016, dose, route and frequency were not reported). Concomitant therapies included CELEBREX, methotrexate, gabapentin, folic acid, ATIVAN, prednisone, INVOKANA, thyroid medication and nitroglycerin. On approximately 06-SEP-2015 (reported as 5-7 days after vaccination), the patient experienced pain and swelling in the same unspecified arm he received with PNEUMOVAX 23. On an unspecified date the patient was evaluated at an unspecified emergency department. He was not admitted to a hospital. On an unspecified date he was given a diagnosis of "necrosis" and "cellulitis" and was treated with unspecified steroids and unspecified antibiotics for an unspecified length of time. The primary reporter reported the patient's symptoms were life threatening and stated "if the patient did not get treatment, the cellulitis could have gotten worse". The outcome of necrosis and cellulitis was reported as recovered on an unspecified day. The reporter did not provide the causality between the vaccine and the events. Upon internal review, necrosis and cellulitis was considered as medically significant. This is one of several reports received from the same source. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain
Clinical narrative: Pain. Unable to move arm.
Age: 83.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Injection site nodule, Mobility decreased
Clinical narrative: Patient reported loss of mobility and numbness of left arm in the evening of vaccine administration. Patient claims also that a "knot" developed at the injection site.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Feeling cold, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: 10/27/16 1630: Pain at injection site. 1800: Pain spread throughout entire arm. 1900: Chills, subjective fever. 10/28/2016 0130: Fever 102F, took Tylenol. 0200-2300: Fluctuating fever, took Tylenol "around the clock". 10/29/2016 Fever stopped, general fatigue. 10/30/2016 Recovery.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Rash pruritic, Skin warm, Swelling
Clinical narrative: Warm to the touch, Pruritic, swelling.
Age: 56.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Had vaccines on morning of 10/18/2016. According to patient, experienced redness and swelling 4 PM 10/18/2016.  Sought medical treatment of decadron injection, Benadryl and ice on 10/21/2016.
Sex: F
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Musculoskeletal discomfort
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, single dose, subcutaneously; lot # and expiration date were not reported). On an unknown date, the patient experienced an unspecified autoimmune disorder. It was also reported that every month, since an unknown date, the patient got a shingle like sensation in her groin area. The outcome of the adverse events was unknown. The relatedness between the adverse events and ZOSTAVAX was not provided. Upon internal review, the adverse event of an unspecified autoimmune disorder was considered to be medically significant. This is one of two reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Pt. states that her right arm swole up into twice it's size & there were striations. The swelling began the evening the shot was given. She took anti-inflammatories, so the swelling had gone down to moderate swelling on 10/31 when the patient came to the pharmacy. The patient wanted more info on what to do about swelling other than anti-inflammatories, so she was referred to her primary MD.
Age: 15.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Computerised tomogram, Electroencephalogram, Endotracheal intubation, Generalised tonic-clonic seizure, Nuclear magnetic resonance imaging
Clinical narrative: Grand mal seizure. Transported to hospital. Intubated and flown to another facility.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Axillary pain, Musculoskeletal pain
Clinical narrative: Intense shoulder pain for 2 days. No pain at injection site.  I needed to cradle shoulder and protect its movement.  Pain in arm pit and front of shoulder joint. Subsided some for 10 days then returned with a vengeance 10/31/2016.  Doctor prescribed Prednisone 5 day course.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Musculoskeletal pain, Pain, Sleep disorder
Clinical narrative: Intense shoulder pain for 2 days. No pain at injection site.  I needed to cradle shoulder and protect its movement.  Pain in arm pit and front of shoulder joint. Subsided some for 10 days then returned with a vengeance 10/31/2016.  Doctor prescribed Prednisone 5 day course.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives covering back 2 hours after vaccine. Mom gave Benedryl & child saw family physician. Hives gone on Monday, October 24.
Age: 75.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Fever - 99 t0 101, Still persists on this reporting date, fever decreases temporarily after taking my routine pain medication of Hydrocodone 10-325 up to 6 tabs daily.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Axillary mass, Injection site rash, Tenderness
Clinical narrative: Axillary swelling and tenderness, bumpy rash at injection site.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Chills, Decreased appetite, Erythema, Fatigue
Clinical narrative: Started to get mild headache and then chills.  As night progressed I was very cold with chills, had bad headache, face flushed and red.  By morning, had all the above plus face and lips were swollen, chest was heavy, left arm was almost frozen stiff and had to assist movement with other right hand. Nausea, no appetite, exhaustion.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Feeling cold, Flushing, Headache, Injected limb mobility decreased, Lip swelling
Clinical narrative: Started to get mild headache and then chills.  As night progressed I was very cold with chills, had bad headache, face flushed and red.  By morning, had all the above plus face and lips were swollen, chest was heavy, left arm was almost frozen stiff and had to assist movement with other right hand. Nausea, no appetite, exhaustion.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Nausea, Swelling face
Clinical narrative: Started to get mild headache and then chills.  As night progressed I was very cold with chills, had bad headache, face flushed and red.  By morning, had all the above plus face and lips were swollen, chest was heavy, left arm was almost frozen stiff and had to assist movement with other right hand. Nausea, no appetite, exhaustion.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: Burning & itching sensation on chest. Mom saw 3 red hives running mid-chest down to abdomen. Gave Benedryl.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site movement impairment, Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Pain/stiffness in deltoid, shoulder, neck - right side.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Body temperature increased, Fatigue, Glassy eyes, Injection site induration, Pyrexia
Clinical narrative: 10/26/16, phone call from mother of patient indicating client experienced signs/symptoms of fever, tiredness, pearly eyes, elevated temperature of 102, and hardening at injection site of right deltoid the next day of vaccination. Elevated temperature treated with Motrin alternated with Tylenol. Also, mother expressed concern of mercury in meningitis vaccine according to web site she had visited. Next the mother voiced should she take him to a doctor for follow up. Explained to mother that the patient sign/symptoms are symptoms that can occur up to 3 to 7 days following the meningococcal (meningitis) vaccine however to follow up with the doctor. No answer from mother when asked regarding status of temperature at the time of phone call but she indicated the last dose of Motrin/Tylenol was 10/22/16. Follow phone call 10/31/16, no answer. Message left to call.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Headache, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Redness and soreness around the injection site, redness on the right cheek and right ear with some swelling. Flu like symptoms like aching, dizziness and headache.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Redness and soreness around the injection site, redness on the right cheek and right ear with some swelling. Flu like symptoms like aching, dizziness and headache.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Areflexia, Blood immunoglobulin A increased, Condition aggravated, Dyspnoea, Facial paresis
Clinical narrative: Gradual progressive, respiratory difficulty, tingling in hand and feet and eventually gait imbalance over one week prior to admission. Diagnosis highly consistent with Guillian Barre, patient treated with IV Immune Globulin 0.4gm/kg for 5 days. Imporvement noted after first dose.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness, Nasopharyngitis
Clinical narrative: Gradual progressive, respiratory difficulty, tingling in hand and feet and eventually gait imbalance over one week prior to admission. Diagnosis highly consistent with Guillian Barre, patient treated with IV Immune Globulin 0.4gm/kg for 5 days. Imporvement noted after first dose.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Gradual progressive, respiratory difficulty, tingling in hand and feet and eventually gait imbalance over one week prior to admission. Diagnosis highly consistent with Guillian Barre, patient treated with IV Immune Globulin 0.4gm/kg for 5 days. Imporvement noted after first dose.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pain in right shoulder that radiates across shoulders and into left arm. Was prescribed MEDROL dose pack.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Dyskinesia, Feeling cold, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: Patient reported that she had a high fever with nausea chills muscle pains and sweats, body lurching x 36 hours.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Patient reported that she had a high fever with nausea chills muscle pains and sweats, body lurching x 36 hours.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Insomnia, Pyrexia
Clinical narrative: Patient experienced fever, soreness at injection site, and trouble sleeping at night.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient states that her upper arm began to get sore, red, and hot the evening of 10/30/2016. She stopped in the pharmacy and showed us the area and said that the spot was increasing in size. We recommended that she see a doctor since it was getting worse.  It is located on the upper left arm, starts at middle of upper arm and spreads downwards toward elbow.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Hot, red area with soreness along the whole right upper arm.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Dizziness, Lacrimation increased
Clinical narrative: PATIENT WAS TEARY-EYED, DIZZY, AND HAD A RAPIDLY RISING TEMPERATURE TO TOUCH (NOT EMPIRICALLY MEASURED).
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site paraesthesia
Clinical narrative: Pain shot down arm at time of injection and still "tingles" 2 weeks later.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Activities of daily living impaired, Burning sensation, Hypoaesthesia, Injection site rash, Injection site swelling
Clinical narrative: 10/23/16 - pt. woke up to her right arm being numb. This subsided through out the morning. Swelling with rash near the injection site extending down close to the elbow. Painful to close fingers - had little strength in hand. She couldn't make a fist with right hand, difficulty removing a ring that was worn. 10/25/16 - pain and difficulty brushing teeth, chopping vegetables, lifting tea pot. Burning sensation in upper arm where rash is. 10/24/16 - pt. was seen for OV. Ibuprofen 400 mg - 600 mg every 6 hrs recommended. 10/31/16 - still mild hand/finger swelling.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: 10/23/16 - pt. woke up to her right arm being numb. This subsided through out the morning. Swelling with rash near the injection site extending down close to the elbow. Painful to close fingers - had little strength in hand. She couldn't make a fist with right hand, difficulty removing a ring that was worn. 10/25/16 - pain and difficulty brushing teeth, chopping vegetables, lifting tea pot. Burning sensation in upper arm where rash is. 10/24/16 - pt. was seen for OV. Ibuprofen 400 mg - 600 mg every 6 hrs recommended. 10/31/16 - still mild hand/finger swelling.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, pain and warmth at injection site. Express care diagnosed cellulitis. Given oral prednisone and cephalexin.
Age: 1.25
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Blister, Pallor, Rash papular
Clinical narrative: VARIVAX given 10/14, on 10/28/16 rash appeared 2-4 mm papules, few with small vesicles, appeared on arms and legs. Confluent, pink, blanching rash on abdomen, lower back and axilla.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: Dad noted area 1/2" above injection site down to 4"-5" below (elbow area) a pink blushing/fading bruise like area on 10/28/16 9 AM. On 10/29/16 patient seen at ED for increased redness/warmth. BENADRYL given with good effect. Script for azithromycin given if no improvement from BENADRYL - not needed due to improvement after BENADRYL.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Exposure to contaminated device, Infection, Injection site erythema, Injection site swelling
Clinical narrative: 10-28-16 phone call from pt's husband stating pt's arm is red and swollen where she received the pneumonia yesterday. Encouraged to contact MD for evaluation. Phone call received from pt's husband stating pt is being admitted to hospital for IV antibiotics. 10-31-16 phone call to pt husband states was in the hospital for 3 day and was sent home with oral antibiotics. States MD told them she had an infection from a contaminated needle.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dysphonia, Eye discharge, Lacrimation increased, Lip swelling
Clinical narrative: Fever, eyes watered, bloodshot and yellow custard stuff ran out of them. One eye turned in and my eyes did not look the same direction with severe photophobia. Nose plugged, sneezing, hoarse. Nose and bottom lip swelled. Joints and muscles ached. Ran fever Thursday, Friday and Saturday.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nasal congestion, Ocular hyperaemia, Photophobia, Pyrexia
Clinical narrative: Fever, eyes watered, bloodshot and yellow custard stuff ran out of them. One eye turned in and my eyes did not look the same direction with severe photophobia. Nose plugged, sneezing, hoarse. Nose and bottom lip swelled. Joints and muscles ached. Ran fever Thursday, Friday and Saturday.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Sneezing, Strabismus, Swelling
Clinical narrative: Fever, eyes watered, bloodshot and yellow custard stuff ran out of them. One eye turned in and my eyes did not look the same direction with severe photophobia. Nose plugged, sneezing, hoarse. Nose and bottom lip swelled. Joints and muscles ached. Ran fever Thursday, Friday and Saturday.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Hyperhidrosis
Clinical narrative: Fatigue, Chills, Hot sweats, loss of appetite.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Pruritus, Rash
Clinical narrative: Started to develop rash and itching on face.  Then at 1:30 pm noticed shortness of breath, took two Benadryl but at 2 pm still shortness of breath.  Had Epipen and felt better within 10 minutes.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Dyskinesia, Pain in jaw
Clinical narrative: Patient jerked away during IM administration of FLUZONE HIGH DOSE vaccine.  Stated it felt like I "hit a nerve" and felt immediate jaw pain that quickly subsided.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site swelling, Pruritus
Clinical narrative: Swelling of R arm where the immunization was given, itching and redness.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Erythema, Gait disturbance, Lethargy, Mobility decreased
Clinical narrative: High temp not measured, inability to move, extreme lethargy, unable to ambulate alone, nausea, diarrhea, vomiting, extremely swollen & red arm where vax given. Lasting 3 days. No specific treatment other than ibuprophen.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: High temp not measured, inability to move, extreme lethargy, unable to ambulate alone, nausea, diarrhea, vomiting, extremely swollen & red arm where vax given. Lasting 3 days. No specific treatment other than ibuprophen.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, stomach cramps.
Age: 7.0
Sex: F
Vaccine: TYP
Symptoms: Rash generalised
Clinical narrative: Developed rash on face, trunk and extremities.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: SORE ARM, RED SPOTS, FEELS LIKE HEAT RADIATING OFF THE ARM.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Angioedema
Clinical narrative: Angioedema.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Hives on his wrist, feet, torso, and arms.  Everywhere but his face.  Complained of severe leg pains.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Pruritus, Urticaria
Clinical narrative: From the itchy ankles it progressed to first mild itch and then hives on upper torso and arms by day four and has  continued to less and less until today. Accompanied by headache and mildly upset stomach. it's now 10/31/2016 and I have yet to recover fully.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: 10x11 cm area of erythema, raised swelling and tenderness.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: Patient experienced pain and aches all over body, especially on her left shoulder.  She couldn't move her arms or lift things up.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Tremor, Urticaria
Clinical narrative: Hives, shakes, labored breathing.
Age: 45.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Asthenia, Chills, Decreased appetite, Depressed mood, Diarrhoea
Clinical narrative: This spontaneous report as received from a physician refers to a 45 year old male patient. The patient's concurrent conditions included migraines. The patient had none drug reactions/allergies or concomitant medications. On an unspecified date in July 2016, the patient was vaccinated with the first dose of RECOMBIVAX HB (Lot #, expiration date, Strength and dose were not reported), route of administration was unknown by the reporter. On an unspecified date in 2016 (reported as an unspecified amount of time after the dose was administered), the patient experienced fever, chills, diarrhea, body aches, itchy palms and itchy feet for a "few days", then the events resolved on an unspecified date in 2016. On an unspecified date in August 2016, the patient was vaccinated with the second dose of RECOMBIVAX HB Lot # reported as M033096, expiration date: 31-MAY-2018, (Strength and dose were not reported), route of administration was unknown by the reporter. On an unspecified date in 2016 (reported as an unspecified amount of time after the dose was administered), the patient experienced "diarrhea for two weeks causing a 12 pound weight loss", fever, chills, body aches, itchy palms and itchy feet, weakness, diminished appetite and depressed mood that had not resolved. The patient did not receive any treatment for the events. In addition, the following lab diagnostics tests were performed to the patient on unspecified dates in 2016 complete blood count (CBC) (results not provided), comprehensive metabolic panel (CMP) (results not provided). The physician considered the events to be disabling and he stated that because of the systemic reactions the patient was unable to work. The reporter did not provide the causality between RECOMBIVAX HB and the events. A product quality complaint was not involved. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Full blood count, Impaired work ability, Metabolic function test, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a physician refers to a 45 year old male patient. The patient's concurrent conditions included migraines. The patient had none drug reactions/allergies or concomitant medications. On an unspecified date in July 2016, the patient was vaccinated with the first dose of RECOMBIVAX HB (Lot #, expiration date, Strength and dose were not reported), route of administration was unknown by the reporter. On an unspecified date in 2016 (reported as an unspecified amount of time after the dose was administered), the patient experienced fever, chills, diarrhea, body aches, itchy palms and itchy feet for a "few days", then the events resolved on an unspecified date in 2016. On an unspecified date in August 2016, the patient was vaccinated with the second dose of RECOMBIVAX HB Lot # reported as M033096, expiration date: 31-MAY-2018, (Strength and dose were not reported), route of administration was unknown by the reporter. On an unspecified date in 2016 (reported as an unspecified amount of time after the dose was administered), the patient experienced "diarrhea for two weeks causing a 12 pound weight loss", fever, chills, body aches, itchy palms and itchy feet, weakness, diminished appetite and depressed mood that had not resolved. The patient did not receive any treatment for the events. In addition, the following lab diagnostics tests were performed to the patient on unspecified dates in 2016 complete blood count (CBC) (results not provided), comprehensive metabolic panel (CMP) (results not provided). The physician considered the events to be disabling and he stated that because of the systemic reactions the patient was unable to work. The reporter did not provide the causality between RECOMBIVAX HB and the events. A product quality complaint was not involved. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Pyrexia, Weight decreased
Clinical narrative: This spontaneous report as received from a physician refers to a 45 year old male patient. The patient's concurrent conditions included migraines. The patient had none drug reactions/allergies or concomitant medications. On an unspecified date in July 2016, the patient was vaccinated with the first dose of RECOMBIVAX HB (Lot #, expiration date, Strength and dose were not reported), route of administration was unknown by the reporter. On an unspecified date in 2016 (reported as an unspecified amount of time after the dose was administered), the patient experienced fever, chills, diarrhea, body aches, itchy palms and itchy feet for a "few days", then the events resolved on an unspecified date in 2016. On an unspecified date in August 2016, the patient was vaccinated with the second dose of RECOMBIVAX HB Lot # reported as M033096, expiration date: 31-MAY-2018, (Strength and dose were not reported), route of administration was unknown by the reporter. On an unspecified date in 2016 (reported as an unspecified amount of time after the dose was administered), the patient experienced "diarrhea for two weeks causing a 12 pound weight loss", fever, chills, body aches, itchy palms and itchy feet, weakness, diminished appetite and depressed mood that had not resolved. The patient did not receive any treatment for the events. In addition, the following lab diagnostics tests were performed to the patient on unspecified dates in 2016 complete blood count (CBC) (results not provided), comprehensive metabolic panel (CMP) (results not provided). The physician considered the events to be disabling and he stated that because of the systemic reactions the patient was unable to work. The reporter did not provide the causality between RECOMBIVAX HB and the events. A product quality complaint was not involved. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Arthralgia, Chills, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: This spontaneous report as received from a physician refers to a 45 year old male patient. The patient's concurrent conditions included migraines. The patient had none drug reactions/allergies or concomitant medications. On an unspecified date in July 2016, the patient was vaccinated with the first dose of RECOMBIVAX HB (Lot #, expiration date, Strength and dose were not reported), route of administration was unknown by the reporter. On an unspecified date in 2016 (reported as an unspecified amount of time after the dose was administered), the patient experienced fever, chills, diarrhea, body aches, itchy palms and itchy feet for a "few days", then the events resolved on an unspecified date in 2016. On an unspecified date in August 2016, the patient was vaccinated with the second dose of RECOMBIVAX HB Lot # reported as M033096, expiration date: 31-MAY-2018, (Strength and dose were not reported), route of administration was unknown by the reporter. On an unspecified date in 2016 (reported as an unspecified amount of time after the dose was administered), the patient experienced "diarrhea for two weeks causing a 12 pound weight loss", fever, chills, body aches, itchy palms and itchy feet, weakness, diminished appetite and depressed mood that had not resolved. The patient did not receive any treatment for the events. In addition, the following lab diagnostics tests were performed to the patient on unspecified dates in 2016 complete blood count (CBC) (results not provided), comprehensive metabolic panel (CMP) (results not provided). The physician considered the events to be disabling and he stated that because of the systemic reactions the patient was unable to work. The reporter did not provide the causality between RECOMBIVAX HB and the events. A product quality complaint was not involved. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Headache, Influenza like illness, Pruritus, Pyrexia, Vision blurred
Clinical narrative: This spontaneous report as received from a physician refers to a 45 year old male patient. The patient's concurrent conditions included migraines. The patient had none drug reactions/allergies or concomitant medications. On an unspecified date in July 2016, the patient was vaccinated with the first dose of RECOMBIVAX HB (Lot #, expiration date, Strength and dose were not reported), route of administration was unknown by the reporter. On an unspecified date in 2016 (reported as an unspecified amount of time after the dose was administered), the patient experienced fever, chills, diarrhea, body aches, itchy palms and itchy feet for a "few days", then the events resolved on an unspecified date in 2016. On an unspecified date in August 2016, the patient was vaccinated with the second dose of RECOMBIVAX HB Lot # reported as M033096, expiration date: 31-MAY-2018, (Strength and dose were not reported), route of administration was unknown by the reporter. On an unspecified date in 2016 (reported as an unspecified amount of time after the dose was administered), the patient experienced "diarrhea for two weeks causing a 12 pound weight loss", fever, chills, body aches, itchy palms and itchy feet, weakness, diminished appetite and depressed mood that had not resolved. The patient did not receive any treatment for the events. In addition, the following lab diagnostics tests were performed to the patient on unspecified dates in 2016 complete blood count (CBC) (results not provided), comprehensive metabolic panel (CMP) (results not provided). The physician considered the events to be disabling and he stated that because of the systemic reactions the patient was unable to work. The reporter did not provide the causality between RECOMBIVAX HB and the events. A product quality complaint was not involved. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a 45 year old male patient. The patient's concurrent conditions included migraines. The patient had none drug reactions/allergies or concomitant medications. On an unspecified date in July 2016, the patient was vaccinated with the first dose of RECOMBIVAX HB (Lot #, expiration date, Strength and dose were not reported), route of administration was unknown by the reporter. On an unspecified date in 2016 (reported as an unspecified amount of time after the dose was administered), the patient experienced fever, chills, diarrhea, body aches, itchy palms and itchy feet for a "few days", then the events resolved on an unspecified date in 2016. On an unspecified date in August 2016, the patient was vaccinated with the second dose of RECOMBIVAX HB Lot # reported as M033096, expiration date: 31-MAY-2018, (Strength and dose were not reported), route of administration was unknown by the reporter. On an unspecified date in 2016 (reported as an unspecified amount of time after the dose was administered), the patient experienced "diarrhea for two weeks causing a 12 pound weight loss", fever, chills, body aches, itchy palms and itchy feet, weakness, diminished appetite and depressed mood that had not resolved. The patient did not receive any treatment for the events. In addition, the following lab diagnostics tests were performed to the patient on unspecified dates in 2016 complete blood count (CBC) (results not provided), comprehensive metabolic panel (CMP) (results not provided). The physician considered the events to be disabling and he stated that because of the systemic reactions the patient was unable to work. The reporter did not provide the causality between RECOMBIVAX HB and the events. A product quality complaint was not involved. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report as received from a physician refers to a 45 year old male patient. The patient's concurrent conditions included migraines. The patient had none drug reactions/allergies or concomitant medications. On an unspecified date in July 2016, the patient was vaccinated with the first dose of RECOMBIVAX HB (Lot #, expiration date, Strength and dose were not reported), route of administration was unknown by the reporter. On an unspecified date in 2016 (reported as an unspecified amount of time after the dose was administered), the patient experienced fever, chills, diarrhea, body aches, itchy palms and itchy feet for a "few days", then the events resolved on an unspecified date in 2016. On an unspecified date in August 2016, the patient was vaccinated with the second dose of RECOMBIVAX HB Lot # reported as M033096, expiration date: 31-MAY-2018, (Strength and dose were not reported), route of administration was unknown by the reporter. On an unspecified date in 2016 (reported as an unspecified amount of time after the dose was administered), the patient experienced "diarrhea for two weeks causing a 12 pound weight loss", fever, chills, body aches, itchy palms and itchy feet, weakness, diminished appetite and depressed mood that had not resolved. The patient did not receive any treatment for the events. In addition, the following lab diagnostics tests were performed to the patient on unspecified dates in 2016 complete blood count (CBC) (results not provided), comprehensive metabolic panel (CMP) (results not provided). The physician considered the events to be disabling and he stated that because of the systemic reactions the patient was unable to work. The reporter did not provide the causality between RECOMBIVAX HB and the events. A product quality complaint was not involved. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Basal cell carcinoma, Biopsy skin abnormal, Injection site reaction, Rash erythematous, Skin neoplasm excision
Clinical narrative: A year later I had a red circle Skin rash that is at the site where I had the injection for shingles. Now that same spot has been removed and was basil cell carcinoma.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, heat, swelling - of left arm, day after given FLUZONE HIGH-DOSE 2016-17 SYR - applied ice, took antihistamine - 25 mg - Redness (heat) lasting 5 days - below injection site - in muscle area.
Age: 83.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema
Clinical narrative: Erythematous local reaction at injection site within 48 hrs of administration.
Age: 50.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Headache, Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site vesicles
Clinical narrative: Patient had red, inflamed, and blistered skin at injection site. Stated it was extremely itchy and she has been scratching a lot. Reported headache, low grade fever, and stinging for approximately 3 hours. Per MD, the site appeared to be contact dermatitis from the band-aid. MD also told the patient she could be contagious and advised not to go to work. Vaccine given 10/22/16, visited MD on 10/25/16.
Age: 50.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pain, Pyrexia, Scratch
Clinical narrative: Patient had red, inflamed, and blistered skin at injection site. Stated it was extremely itchy and she has been scratching a lot. Reported headache, low grade fever, and stinging for approximately 3 hours. Per MD, the site appeared to be contact dermatitis from the band-aid. MD also told the patient she could be contagious and advised not to go to work. Vaccine given 10/22/16, visited MD on 10/25/16.
Age: 68.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Blister, Erythema, Peripheral swelling
Clinical narrative: Developed red swollen upper arm and blisters/blood blisters on right hand.
Age: 0.92
Sex: M
Vaccine: FLU4
Symptoms: Blood electrolytes, Blood glucose, Full blood count, Muscle rigidity, Muscle spasms
Clinical narrative: On 10-10-16 parent noted episodes of Lt. foot spasms. Foot would turn up and outward, very resistant to movement rigid to touch for periods of 5-15 mins. Referred to neurologist.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Urticaria
Clinical narrative: Patient received vaccine Friday am- That evening had 101.9 temp- Lasted through Saturday afternoon. Sunday started with hives.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Rash
Clinical narrative: Red and rash 2 hrs w/in receiving inj. No treatment given.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Patient presented to MD w/rash all over body. MD has attributed rash to vaccine upon examination and prescribed steroid TX 10/31/16 for 12 days.
Age: 13.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Client given Hep B (Pediatric/Adolescent) vaccine too early; Vaccination was not due until 12/20/2016.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13, FLU4, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient received PREVNAR on 9/20/16 on left arm. She claims that it was painful during the injection. She noticed a rectangular red patch on left deltoid 1-2 days later and was still sore. There was swelling around injection site and she noticed an indentation about 1 week later but less sore. Indentation continued to worsen 1 week later and the soreness returned. Patient went to see her doctor 1 week later when her put her on 1 week of prednisone.  There was no improvement and she will be going back to the doctor today 10/31/16.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13, FLU4, PNC13
Symptoms: Skin disorder
Clinical narrative: Patient received PREVNAR on 9/20/16 on left arm. She claims that it was painful during the injection. She noticed a rectangular red patch on left deltoid 1-2 days later and was still sore. There was swelling around injection site and she noticed an indentation about 1 week later but less sore. Indentation continued to worsen 1 week later and the soreness returned. Patient went to see her doctor 1 week later when her put her on 1 week of prednisone.  There was no improvement and she will be going back to the doctor today 10/31/16.
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Mobility decreased, Pain
Clinical narrative: Patient experienced pain and aches all over body, especially on her left shoulder.  She couldn't move her arms or lift things up.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Eating disorder, Electrocardiogram, Facial paralysis, Hypoaesthesia, Neurological symptom
Clinical narrative: The patient was brought to the ED by his wife shortly after 10am for his stroke-like symptoms; approximately 10 hours after his influenza vaccination. Left-sided facial droop, numbness, and tingling. He was discharged with a diagnosis of Bell's palsy, and was prescribed Valtrex, prednisone, and eye ointments. After 3 weeks, he fully recovered, though he had difficulty eating and drinking during that time and could not eat.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: The patient was brought to the ED by his wife shortly after 10am for his stroke-like symptoms; approximately 10 hours after his influenza vaccination. Left-sided facial droop, numbness, and tingling. He was discharged with a diagnosis of Bell's palsy, and was prescribed Valtrex, prednisone, and eye ointments. After 3 weeks, he fully recovered, though he had difficulty eating and drinking during that time and could not eat.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling
Clinical narrative: Patient reports lower lip started swelling. She went to PCP @ O:oo AM and received a steroid shot.  Reports lower lip swelling resolved.
Age: 19.0
Sex: F
Vaccine: FLU4, HEPA, HPV9
Symptoms: Incorrect dose administered
Clinical narrative: Administered pediatric Hepatitis A vaccine instead of adult Hepatitis A vaccine which was indicated.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: CO SORENESS AT SITE ,REDENESS,STATES UNABLE TO LIFT LEFT ARM TO ABOVE HEAD.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Per patient, shoulder was sore from time of vaccination. Progressed to pain and now (about 1 month later) not able to lift arm above shoulder due to pain. Has been taking NSAIDs per doctor's instructions.
Age: 42.0
Sex: M
Vaccine: FLUC4
Symptoms: Bowel movement irregularity, Chest discomfort, Dizziness, Headache, Pain
Clinical narrative: Severe body aches, lightheaded, pressure on chest, dizziness, headache, sluggishness, odd bowel movements starting within 8 hours.
Age: 42.0
Sex: M
Vaccine: FLUC4
Symptoms: Sluggishness
Clinical narrative: Severe body aches, lightheaded, pressure on chest, dizziness, headache, sluggishness, odd bowel movements starting within 8 hours.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site papule, Injection site pruritus, Injection site urticaria
Clinical narrative: Parents describe "hives" locally on the left thigh where administered. Itching reported. After 5 days, red papules only left.
Age: 7.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site pain, Lethargy, Mobility decreased, Pyrexia
Clinical narrative: Fever (102.5) + severe pain at injection site.  Not able to move arm.  Very lethargic and tired.  Needed to rest after standing for a few minutes.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Facial paralysis, Hypoaesthesia
Clinical narrative: "Reports since receiving his flu vaccination, he has experienced progressively worsening right sided facial numbness. Within the last three hours, he has begun to experience mild right sided facial droop."
Age: 91.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient had swelling, redness, and itching from the injection site all the way down to her elbow that had persisted for 4 days.  Patient visited medical doctor who did not prescribe medication but recommended she return to the pharmacy to show reaction.  At that time, she was told by RPh to take Benadryl as directed on package and watch site.  If no better within a couple of days or if worse or red streaks were noticed from site, then patient was told to seek medical treatment immediately. Pharmacy manager will contact patient within 2 days to check on progress. Patient did not report anaphylaxis at any time.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Fatigue, Hypovolaemia, Pallor
Clinical narrative: Pale, tired, hypovolemic reaction.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chills, Diarrhoea, Fatigue, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (Pfizer employee and patient mother).  A 17-year-old male patient received TRUMENBA at 0.5 ml single and MENACTRA at 1 DF single, both on 19Aug2016 at 15:30, in arm, for immunisation. No other vaccine was given on the same day or within 4 weeks. Medical history none. There were no concomitant medications. The patient experienced high fever on 20Aug2016 with outcome of recovered in Aug2016, fatigue in Aug2016 with outcome of recovered in Aug2016, diarrhea in 21Aug2016 with outcome of recovered on 25Aug2016, chills on 20Aug2016 with outcome of recovered in Aug2016. Therapeutic measures were taken as a result of high fever and chills and included TYLENOL and ADVIL. The patient was treated at home. The patient visited the doctor who said that fever, chills and fatigue were probably associated with the vaccine (unspecified), the diarrhoea several days after may not be go away and it was related to Trumenba, not the Menactra vaccine. Follow-up (27Oct2016): New information received from the same contactable consumer includes: reaction data.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Nodule, Skin warm
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A 68-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on 02Sep2016 at 0.5 ml single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient was vaccinated on 02Sep2016. The patient returned to the pharmacy a week later on an unknown date in Sep2016, and reported lot of redness, warmth and a hard knot. The outcome was unknown. The reporter considered the Pfizer product had a causal effect to the adverse event. Follow-up (25Oct2016): New information from a contactable Pharmacist  included: causality assessment. Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's wife). A 79-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at 0.5 ml single dose for immunization. The patient's medical history and concomitant medications were not reported. On the same date, the patient experienced arm hurt/ soreness, and was hospitalzed.  He went swimming and his arm hurt, so he stopped swimming. The outcome was recovered on an unknown date.
Age: 80.0
Sex: F
Vaccine: DTOX, PNC13
Symptoms: Chest discomfort, Choking sensation, Eye swelling, Eyelid oedema, Generalised erythema
Clinical narrative: This is a spontaneous report from a contactable consumer. An 80-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on 26Jul2016 at single dose in right shoulder, for immunisation.  On the same date the patient received diphtheria vaccine in left shoulder. Medical history included two previous pneumonia vaccinations on an unknown date. The patient's concomitant medications were not reported.  A couple days after vaccination, the patient started to experience the following symptoms: raised at the injection site, itching all over, scratched until bleed, red patches all over my body (on ankles, the bottom of foot, toes, close to groin). The area around injection site became brown. Also had throat swollen up, felt like had a lump in throat and in between the chest, like if she was choking, but it went away after a while.  Lips and tongue were swollen, eyes were so swollen in the urgent care, they were almost closed shut, can't sleep because the itching. The patient went to see a specialist and her doctor, also showed the arm to the pharmacist. The patient was hospitalized twice since got the injection. The nurse in the urgent care documented that the patient had hives all over the body. They gave topical cortisone cream, anti- itch cream. Patient's doctor prescribed ZYRTEC but it didn t do anything. The outcome of 'felt like had a lump in throat and in between the chest, like if she was choking' was recovered, all other events outcome were unknown.