chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Rash maculo-papular, Urticaria
Clinical narrative: Hives in diaper area 24 hours after flu vaccines maculopapular rash 48 hours after flu vaccine treated with BENADRYL.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Patient describes sharp pain; tingling in (L) arm. 5 mins after receiving FLUZONE c/o weakness in left arm as compared to (R) arm. Symptoms are persistent, not worsening. Seen in office- Dx: Myalgia
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Anxiety
Clinical narrative: Anxiety attack.
Age: 15.0
Sex: F
Vaccine: FLUN4, PPV
Symptoms: Chest discomfort, Chest pain, Local reaction, Myalgia
Clinical narrative: Localized rxn initially and progressed to chest tightness and pain, myalgia over 2 days. Treated with prednisone burst and taper and resolved fully by 10/27/15.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Headache, Muscle twitching, Pyrexia
Clinical narrative: Actually began with mild headache on 10/30 a few hours after the shot. The next day headache got worse with fever, dizziness, fatigue, twitching on the side of my face. As of today, 11/04/2015, 3:20 PM, still have symptoms. I have been taking 400 mg of Motrin every 6 hours. Called the doctor today and reported symptoms to receptionist. She said doctor had no availability today. I should report to pharmacy. Pharmacy was very busy and I asked to speak with manager. I told him that I was reporting adverse reaction to flu shot. He said he would have the nurse return my call. Haven't heard back.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Peripheral swelling
Clinical narrative: Patient had swelling in the lower part of his left arm. He was instructed to contact his MD whom ordered an MRI to rule out a blood clot. The MRI was clear and the patient will see the MD again tomorrow.
Age: 17.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Anaemia, Blood test, Fatigue, Influenza like illness, Pain
Clinical narrative: Fluish like symptoms, fatigue, achy which escalated into extreme fatigue and continuous doctor appt starting in May.  Was suffering from VD deficiency and anemia which continued to escalate.  It took a long time and four different doctors to finally get a hematology referral, and she was put on high dosage of iron.  Iron has just stabilized but still suffering from chronic fatigue and now finding another doctor to address this.
Age: 17.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Vitamin D deficiency
Clinical narrative: Fluish like symptoms, fatigue, achy which escalated into extreme fatigue and continuous doctor appt starting in May.  Was suffering from VD deficiency and anemia which continued to escalate.  It took a long time and four different doctors to finally get a hematology referral, and she was put on high dosage of iron.  Iron has just stabilized but still suffering from chronic fatigue and now finding another doctor to address this.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: L arm numbness x2 weeks.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: L arm numbness since vaccination.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Fatigue, Injection site pain, Neck pain
Clinical narrative: Student administered the influenza vaccine to the patient under the supervision of nursing instructor.  The injection was given into the deltoid muscle approximately 2 inches below the acromian process in the left deltoid muscle.  The patient states that she felt pain in her left upper arm and neck as the injection was given.  The patient also complained of an upset stomach, chills and tiredness the day after the injection. The patient states that her pain is improving on 11/4/2015.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Seizure
Clinical narrative: Patients states she had seizure lasting less than 1 minute after she got home from getting Zostavax vaccine.  Pt was able to talk and was clear headed when she called us at 5 pm. Said she would contact Dr suggested. Pt has been diagnosed with seizure disorder from same doctor who prescribed Zostavax and said she had been compliant with primidone and gabapentin.  Had no history of seizures within last 2 years until now.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Swelling face
Clinical narrative: Student administered the influenza vaccine to the patient under the supervision of nursing instructor.  The injection was given into the deltoid muscle approximately 2 inches below the acromian process in the left deltoid muscle.  The patient states that one-half hour after the shot was given, a pain went up her neck and then the left side of her face swelled up. The swelling and pain was gone by the following day.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Sleep disorder
Clinical narrative: Patient developed severe left arm pain at injection site limiting his range of motion, he was unable to sleep well that night due to significant pain.  He noted mild swelling at the site, but denied bruising, erythema, discharge, or pustule.  He denied SOB or fever.  The following afternoon he took OTC Aleve with some relief and improvement in symptoms.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Immediate post-injection reaction, Neck pain, Pain
Clinical narrative: Student administered the influenza vaccine to the patient under the supervision of nursing instructor.  The injection was given into the deltoid muscle approximately 2 inches below the acromian process in the left deltoid muscle.  The patient states that after the injection she had immediate pain to her neck and head.  The next day she had a fever, chills & body aches.  She went to the ER on 11/2/2015 with a terrible headache.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Student administered the influenza vaccine to the patient under the supervision of nursing instructor.  The injection was given into the deltoid muscle approximately 2 inches below the acromian process in the left deltoid muscle.  The patient states that after the injection she had immediate pain to her neck and head.  The next day she had a fever, chills & body aches.  She went to the ER on 11/2/2015 with a terrible headache.
Age: 53.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Rash generalised
Clinical narrative: RASH ALL OVER CHEST, ARMS AND UP TO HIS NECK.
Age: 58.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Rash generalised, Swollen tongue
Clinical narrative: Rash all over the body, swelling of tongue.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Pt stated had a spreading red area on the arm not at the injection site but at spot where person giving injection held arm.
Age: 23.0
Sex: M
Vaccine: DTP, FLUX
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea and fever of 103.1. Fever broke at ~9:00 PM on 11/02, nausea/vomiting ceased at 10:00 AM on 11/03 but fever of 100.4 remains as of 9:00 PM on 11/04.
Age: 10.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash at site of injection, on arm. Itch. Break out at site. Benadryl cream applied but ineffective at healing reaction.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient states she experienced swelling, redness and pain at site of injection starting that evening.  By the following morning swelling had gone away however redness and pain remained.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Pt reported symptoms on 11/4; had muscle soreness on the day of vaccine administration (10/22) and then weakness in same arm few days later, pt had trouble lifting things, compared it to carpal tunnel, symptoms have improved since then, but not completely gone, she denies any other conditions or medications, has tried salonpas otc for pain relief; pt was referred to pcp for advice.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Feeling hot, Pallor, Tremor
Clinical narrative: Patient's chief complaint was profound dizziness. She also complained of excessive body heat and feeling "shaky". Vitals showed that she had elevated blood pressure of 143/110 and a pulse of 85. He hands so visible signs of shaking and her face was slightly pale in color. We provided the patient with cold water, a cold compress to apply to her neck, and a small candy bar to help raise her blood sugar. We removed part of her long-sleeved shirt and fanned her with a paper to help cool her down. She refused to lay down on the floor so we instructed her to put her head between her legs to help with blood flow. We kept open communication with the patient about her symptoms and within 20 minutes she stated she was feeling better. Her vitals were rechecked at this time-her blood pressure returned to normal 124/80, but her pulse was still slightly elevated at 80. Her coloring in her face returned to normal and she did not appear to be shaking any longer. She felt comfortable leaving the pharmacy with her husband and stated she felt much better. She went to the restaurant in the store and ate a sub because she stated she had not eaten since early this morning and felt her blood sugar may be low. I called to check on the patient about 6 hours later and she said she still felt a little dizzy and had a headache. She was instructed to follow-up with her primary care physician in the morning if her symptoms persisted and if they became more severe in the night she was to go to the emergency room.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Hypopnoea, Nausea, Oropharyngeal pain
Clinical narrative: Rec'd at around noon by 2:30 felt tired, had throat tickle and soreness cough took an oscullococcinum. By 4:30, I felt extreme fatigued had fever (unknown degrees) increased thirst rapid shallow breathing, queasiness, body aches, sore arm, by the next day, symptoms subsided - except for fatigue and soreness, which continued four Mondays.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Pyrexia, Respiratory rate increased, Thirst
Clinical narrative: Rec'd at around noon by 2:30 felt tired, had throat tickle and soreness cough took an oscullococcinum. By 4:30, I felt extreme fatigued had fever (unknown degrees) increased thirst rapid shallow breathing, queasiness, body aches, sore arm, by the next day, symptoms subsided - except for fatigue and soreness, which continued four Mondays.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Rec'd at around noon by 2:30 felt tired, had throat tickle and soreness cough took an oscullococcinum. By 4:30, I felt extreme fatigued had fever (unknown degrees) increased thirst rapid shallow breathing, queasiness, body aches, sore arm, by the next day, symptoms subsided - except for fatigue and soreness, which continued four Mondays.
Sex: U
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information was received from a consumer on 30-OCT-2015 via Sanofi Pasteur (MSD) and refers to an unspecified number of children patients of unknown ages and genders. This report was found in the comments part of a petition about HPV vaccine. On an unspecified date, the patients were vaccinated with a dose of GARDASIL (lot number, expiration date, dose and route of administration were not reported). There was no concomitant medication reported. The reporter stated that "it's hard to imagine that GARDASIL and other vaccines for the HPV virus were still on the market knowing the hundreds of our children that had died (dates were not specified) and those that had harmful adverse reactions and were living with new medical conditions after receiving the vaccine". The cause of death was not reported and it was unknown if autopsy was performed. This is one of several reports from the same reporter. Additional information is not expected as no reporter details were provided.
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Activities of daily living impaired, Fall, Fatigue, Immune system disorder
Clinical narrative: This spontaneous report as received from a consumer's mother via Sanofi Pasteur MSD refers to her daughter of unknown age. The reporter stated that her daughter was once a young healthy cheerleader. Beauty pageant queen, and a personal trainer. She loved life and was very active with a promising career ahead of her. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route, lot number and expiration date were not reported). There was no concomitant medication provided. On an unknown date, her health rapidly declined. She ended up in a wheelchair not able to walk for two years and her immune system was shot, so she got sick all of the time. She could not work, drive, or live a normal life. She fall all of the time and it was all that she could do to get a shower and eat without being exhausted. The primary reporter also stated that GARDASIL had ruined her daughter's life. The outcome of abasia, malaise, fall, immune system disorder was unknown, and the outcome of impaired work ability and daily living impaired was not recovered as she still cannot live a normal life. The reporter considered abasia, activities of daily living impaired, impaired work ability, malaise, fall, fatigue and immune system disorder to be related to GARDASIL. Upon internal review, she was not able to walk for two years, impaired work ability and daily living impaired were determined to be serious due to disability. Additional information is not expected because the reporter details were not provided.
Sex: F
Vaccine: HPV4
Symptoms: Impaired driving ability, Impaired work ability, Malaise, Quality of life decreased, Wheelchair user
Clinical narrative: This spontaneous report as received from a consumer's mother via Sanofi Pasteur MSD refers to her daughter of unknown age. The reporter stated that her daughter was once a young healthy cheerleader. Beauty pageant queen, and a personal trainer. She loved life and was very active with a promising career ahead of her. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route, lot number and expiration date were not reported). There was no concomitant medication provided. On an unknown date, her health rapidly declined. She ended up in a wheelchair not able to walk for two years and her immune system was shot, so she got sick all of the time. She could not work, drive, or live a normal life. She fall all of the time and it was all that she could do to get a shower and eat without being exhausted. The primary reporter also stated that GARDASIL had ruined her daughter's life. The outcome of abasia, malaise, fall, immune system disorder was unknown, and the outcome of impaired work ability and daily living impaired was not recovered as she still cannot live a normal life. The reporter considered abasia, activities of daily living impaired, impaired work ability, malaise, fall, fatigue and immune system disorder to be related to GARDASIL. Upon internal review, she was not able to walk for two years, impaired work ability and daily living impaired were determined to be serious due to disability. Additional information is not expected because the reporter details were not provided.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 3.5 x 2.5 redness and swelling at injection sight (L) thigh.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Fungal test negative, Pruritus
Clinical narrative: Patient received GARDASIL (4) for the first time. On March 27 2015. In July of 2015 she noticed a bald spot and itching on the left side of her head. She came into the office for those sx on 9-2-15. Fungal cx. negative , referral to dermatologist. Mom feels vaccine is to blame for hair loss.
Age: 1.56
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEPA, PNC13
Symptoms: Wrong drug administered
Clinical narrative: Gave PREVNAR instead of PENTACEL. Provider notified. Gave PENTACEL as ordered.
Age: 66.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm lasting several months.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, swollen, warm, itchy; resolved in 2 days.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Rash
Clinical narrative: Patient stated she had redness on entire upper (L) arm where shot was administered. Then developed rashes on forehead. Symptoms only subsided 10 days later. Patient has received vaccine before with no reactions.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Sore after shot then itching, redness, and feels hot started 11/3/15 just on (R) deltoid I.M.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Pain in extremity
Clinical narrative: N.P. called 11/4/15 6:30pm and stated pt was being treated for pain and loss of mobility in left arm that occurred after receiving flu shot. Patient was receiving PT. Tried following up with patient - no answer. N.P believes pain is due to location of where the shot was given. N.P stated she believed shot was given too high on arm and may have entered bursa. Staff will be reeducated on proper injection technique.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Vaccine administered 11/02/15, redness at injection site same day, hives began 11/03/15.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning to a 14 year old patient of unknown gender. No medical history, concurrent conditions or concomitant therapies were reported. On an unknown dates, the patient was vaccinated with the first and second dose of GARDASIL (dose, strength, route of administration and lot number were not provided). On 03-NOV-2015, the patient was in the reporter's office to receive the third dose of the vaccines series with GARDAIL 9, lot number L000610 with expiration date 31-JAN-2017 (dose, strength, route of administration were not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On unspecified dates, the unknown number of patients were vaccinated improperly stored doses of (Oka/Merck) VARIVAX lot # L001325, expiration date 13-JAN-2017, lot # L001335, expiration date 13-JAN-2017 and lot # reported as L024255, expiration date 01-JUL-2015 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports receive from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On unspecified dates, the unknown number of patients were vaccinated with improperly stored doses of PROQUAD lot # L02311, expiration date 24-DEC-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested .
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On unspecified dates, the unknown number of patients were vaccinated improperly stored doses of ZOSTAVAX lot # L015416, expiration date 01-AUG-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist referring to a 49 year old male patient with high blood pressure. The patient's medical history included unspecified nasal problem. On 07-OCT-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L017265 with expired date 10-FEB-2017; 0.5 ml, intramuscular) (inappropriate schedule of drug administration). Concomitant therapies included FLONASE, lisinopril (manufacturer unknown) and clopidogrel. The reporter also stated that the patient received an unspecified flu vaccine (unspecified manufacturer) every year (unspecified dates). A week after receiving PNEUMOVAX 23, on approximately 14-OCT-2015, the patient developed an unspecified fever, "achiness all over his body" and unspecified swollen glands. On 18-OCT-2015, the patient went into the pharmacy for medical attention and was informed to take TYLENOL 500mg every six hours for the fever. No lab test was performed. At the time of reporting, the patient did not recover from the events. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a medical assistant referring to a 26 year old female patient. No relevant medical history or concurrent conditions were reported. On 07-AUG-2015 the patient was vaccinated with VARIVAX (Merck) (lot # L001330, expiration date 13-JAN-2017; dose and route not reported) which had been exposed to temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On unspecified dates, the unspecified patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L012835, expiration date 11-MAR-2018 and lot # K008879, expiration date 30-MAR-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions and allergies were reported. On 02-NOV-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (strength, dose, frequency and route were not reported) lot # L014418 with an expiry date of 13-APR-2017. No concomitant medications were reported. No symptoms were reported. There was no product quality complaint. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored PROQUAD (strength, dose, frequency and route were not reported) lot # K022446 and lot # K020751 expiry dates not reported. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On unspecified dates, the unspecified patients were vaccinated with improperly stored doses of GARDASIL lot # K007264, expiration date 02-MAR-2017, lot # K011325, expiration date 08-APR-2017 and lot # J009788, expiration date 17-MAR-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: FLU3, HPV4, HPV4, FLUX, HPV4
Symptoms: Blood culture, Culture urine, Dyskinesia, Echocardiogram normal, Electroencephalogram normal
Clinical narrative: Shortness of breath, tonic clonic seizure like activity and now 8 weeks later still having autonomic dysfunction low blood pressure and inappropriate tachycardia.
Age: 18.0
Sex: M
Vaccine: FLU3, HPV4, HPV4, FLUX, HPV4
Symptoms: Full blood count, Hyperventilation, Induration, Malaria antibody test, Metabolic function test
Clinical narrative: Shortness of breath, tonic clonic seizure like activity and now 8 weeks later still having autonomic dysfunction low blood pressure and inappropriate tachycardia.
Age: 18.0
Sex: M
Vaccine: FLU3, HPV4, HPV4, FLUX, HPV4
Symptoms: Muscle twitching, Nuclear magnetic resonance imaging normal, Polymerase chain reaction, Urine analysis
Clinical narrative: Shortness of breath, tonic clonic seizure like activity and now 8 weeks later still having autonomic dysfunction low blood pressure and inappropriate tachycardia.
Age: 18.0
Sex: M
Vaccine: FLU3, HPV4, HPV4, FLUX, HPV4
Symptoms: Blood culture negative, Borrelia test negative, Culture urine negative, Echocardiogram normal, Electroencephalogram normal
Clinical narrative: Shortness of breath, tonic clonic seizure like activity and now 8 weeks later still having autonomic dysfunction low blood pressure and inappropriate tachycardia.
Age: 18.0
Sex: M
Vaccine: FLU3, HPV4, HPV4, FLUX, HPV4
Symptoms: Full blood count normal, Generalised tonic-clonic seizure, Laboratory test normal, Metabolic function test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Shortness of breath, tonic clonic seizure like activity and now 8 weeks later still having autonomic dysfunction low blood pressure and inappropriate tachycardia.
Age: 18.0
Sex: M
Vaccine: FLU3, HPV4, HPV4, FLUX, HPV4
Symptoms: Polymerase chain reaction, Smear site unspecified normal, Urine analysis normal
Clinical narrative: Shortness of breath, tonic clonic seizure like activity and now 8 weeks later still having autonomic dysfunction low blood pressure and inappropriate tachycardia.
Age: 18.0
Sex: M
Vaccine: FLU3, HPV4, HPV4, FLUX, HPV4
Symptoms: Autonomic nervous system imbalance, Blood test, Dyspnoea, Electrocardiogram ambulatory abnormal, Hypotension
Clinical narrative: Shortness of breath, tonic clonic seizure like activity and now 8 weeks later still having autonomic dysfunction low blood pressure and inappropriate tachycardia.
Age: 18.0
Sex: M
Vaccine: FLU3, HPV4, HPV4, FLUX, HPV4
Symptoms: Psychogenic seizure, Tachycardia, Tilt table test, Tonic clonic movements
Clinical narrative: Shortness of breath, tonic clonic seizure like activity and now 8 weeks later still having autonomic dysfunction low blood pressure and inappropriate tachycardia.
Age: 64.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Arthralgia, Fatigue, Joint stiffness, Pain, Paraesthesia
Clinical narrative: Pt had possible rabies exposure, was given rabies immune globulin and the rabies vaccine series. Pt c/o increased stiffness, increased arthritis symptoms, tiredness, joint pain. Pt. continues to c/o discomfort, is not seeing improvement in symptoms. I suggested that patient call the manufacturer to report the problem. Lot number 559011A, Exp 4/30/18 used as well as one noted on other part of form. Rabies immune globulin also administered 1160 units. 150 IU/ml GRIFOLS lot number exp unknown. NDC13533-0618-10.
Age: 64.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Arthralgia, Fatigue, Hypersensitivity, Inflammatory marker increased, Insomnia
Clinical narrative: Pt had possible rabies exposure, was given rabies immune globulin and the rabies vaccine series. Pt c/o increased stiffness, increased arthritis symptoms, tiredness, joint pain. Pt. continues to c/o discomfort, is not seeing improvement in symptoms. I suggested that patient call the manufacturer to report the problem. Lot number 559011A, Exp 4/30/18 used as well as one noted on other part of form. Rabies immune globulin also administered 1160 units. 150 IU/ml GRIFOLS lot number exp unknown. NDC13533-0618-10.
Age: 64.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Joint swelling, Laboratory test abnormal, Mobility decreased, Muscle spasms, Muscle tightness
Clinical narrative: Pt had possible rabies exposure, was given rabies immune globulin and the rabies vaccine series. Pt c/o increased stiffness, increased arthritis symptoms, tiredness, joint pain. Pt. continues to c/o discomfort, is not seeing improvement in symptoms. I suggested that patient call the manufacturer to report the problem. Lot number 559011A, Exp 4/30/18 used as well as one noted on other part of form. Rabies immune globulin also administered 1160 units. 150 IU/ml GRIFOLS lot number exp unknown. NDC13533-0618-10.
Age: 64.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Pt had possible rabies exposure, was given rabies immune globulin and the rabies vaccine series. Pt c/o increased stiffness, increased arthritis symptoms, tiredness, joint pain. Pt. continues to c/o discomfort, is not seeing improvement in symptoms. I suggested that patient call the manufacturer to report the problem. Lot number 559011A, Exp 4/30/18 used as well as one noted on other part of form. Rabies immune globulin also administered 1160 units. 150 IU/ml GRIFOLS lot number exp unknown. NDC13533-0618-10.
Age: 64.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Peripheral swelling, Rheumatoid arthritis, Swelling, Vaccination complication
Clinical narrative: Pt had possible rabies exposure, was given rabies immune globulin and the rabies vaccine series. Pt c/o increased stiffness, increased arthritis symptoms, tiredness, joint pain. Pt. continues to c/o discomfort, is not seeing improvement in symptoms. I suggested that patient call the manufacturer to report the problem. Lot number 559011A, Exp 4/30/18 used as well as one noted on other part of form. Rabies immune globulin also administered 1160 units. 150 IU/ml GRIFOLS lot number exp unknown. NDC13533-0618-10.
Age: 64.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Arthralgia, Arthritis, Condition aggravated, Discomfort, Fatigue
Clinical narrative: Pt had possible rabies exposure, was given rabies immune globulin and the rabies vaccine series. Pt c/o increased stiffness, increased arthritis symptoms, tiredness, joint pain. Pt. continues to c/o discomfort, is not seeing improvement in symptoms. I suggested that patient call the manufacturer to report the problem. Lot number 559011A, Exp 4/30/18 used as well as one noted on other part of form. Rabies immune globulin also administered 1160 units. 150 IU/ml GRIFOLS lot number exp unknown. NDC13533-0618-10.
Age: 64.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Musculoskeletal stiffness
Clinical narrative: Pt had possible rabies exposure, was given rabies immune globulin and the rabies vaccine series. Pt c/o increased stiffness, increased arthritis symptoms, tiredness, joint pain. Pt. continues to c/o discomfort, is not seeing improvement in symptoms. I suggested that patient call the manufacturer to report the problem. Lot number 559011A, Exp 4/30/18 used as well as one noted on other part of form. Rabies immune globulin also administered 1160 units. 150 IU/ml GRIFOLS lot number exp unknown. NDC13533-0618-10.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Cough, Influenza like illness, Myalgia, Pain
Clinical narrative: 73yr old female. First over-65-dose of flu virus vaccine received Oct 2. Had severe pain in area where shot received, left arm, and included the elbow. Fever just under 101 degrees. Coughing. Muscle and whole body joint pain. Fever broke about 24 hours later but remained in bed for 36 hours. No diarrhea and no upset stomach. The pain in my left upper arm is still so bad that it limits range of motion in all daily activities. I cannot sleep on my left side because it causes more pain. I have attempted to resume exercises but it's too painful. It's been 26 days and no sign of relief. My doctor is on vacation. Doctor appointment is on Nov 13. Initial report of side effects to pharmacy was on Mon Oct 5 but did not include length of time of continued pain in the left arm.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pyrexia
Clinical narrative: 73yr old female. First over-65-dose of flu virus vaccine received Oct 2. Had severe pain in area where shot received, left arm, and included the elbow. Fever just under 101 degrees. Coughing. Muscle and whole body joint pain. Fever broke about 24 hours later but remained in bed for 36 hours. No diarrhea and no upset stomach. The pain in my left upper arm is still so bad that it limits range of motion in all daily activities. I cannot sleep on my left side because it causes more pain. I have attempted to resume exercises but it's too painful. It's been 26 days and no sign of relief. My doctor is on vacation. Doctor appointment is on Nov 13. Initial report of side effects to pharmacy was on Mon Oct 5 but did not include length of time of continued pain in the left arm.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Cough, Exercise tolerance decreased, Injection site pain
Clinical narrative: 73yr old female. First over-65-dose of flu virus vaccine received Oct 2. Had severe pain in area where shot received, left arm, and included the elbow. Fever just under 101 degrees. Coughing. Muscle and whole body joint pain. Fever broke about 24 hours later but remained in bed for 36 hours. No diarrhea and no upset stomach. The pain in my left upper arm is still so bad that it limits range of motion in all daily activities. I cannot sleep on my left side because it causes more pain. I have attempted to resume exercises but it's too painful. It's been 26 days and no sign of relief. My doctor is on vacation. Doctor appointment is on Nov 13. Initial report of side effects to pharmacy was on Mon Oct 5 but did not include length of time of continued pain in the left arm.
Age: 73.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Myalgia, Pyrexia, Sleep disorder
Clinical narrative: 73yr old female. First over-65-dose of flu virus vaccine received Oct 2. Had severe pain in area where shot received, left arm, and included the elbow. Fever just under 101 degrees. Coughing. Muscle and whole body joint pain. Fever broke about 24 hours later but remained in bed for 36 hours. No diarrhea and no upset stomach. The pain in my left upper arm is still so bad that it limits range of motion in all daily activities. I cannot sleep on my left side because it causes more pain. I have attempted to resume exercises but it's too painful. It's been 26 days and no sign of relief. My doctor is on vacation. Doctor appointment is on Nov 13. Initial report of side effects to pharmacy was on Mon Oct 5 but did not include length of time of continued pain in the left arm.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: Injection was given very high up on left shoulder (too high).  Severe pain the left shoulder/arm constantly since injection.  I have visited my orthopedic doctor two times.  He has x-rayed my shoulder and he administered a cortisone injection and prescribed physical therapy.  I have gone to three physical therapy sessions and continued the exercises at home.   There has been little relief in the pain.  There is now a MRI scheduled for 11/10/15.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Injection site pain, Pain in extremity, X-ray limb
Clinical narrative: Injection was given very high up on left shoulder (too high).  Severe pain the left shoulder/arm constantly since injection.  I have visited my orthopedic doctor two times.  He has x-rayed my shoulder and he administered a cortisone injection and prescribed physical therapy.  I have gone to three physical therapy sessions and continued the exercises at home.   There has been little relief in the pain.  There is now a MRI scheduled for 11/10/15.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Pain
Clinical narrative: This spontaneous report was received from a 66 year old female patient reporting on herself. The patient has no pertinent medical history and no known drug reactions/allergies. It was reported that on 20-OCT-2015 the patient was vaccinated with a "blooster" of PNEUMOVAX 23 (dose and route were not provided), Lot # reported as K010464, exp date on 23-MAR-2016, left arm. Concomitantly, the patient received on the same date a flu shot in her right arm (therapy unspecific). Other concomitant therapy includes omeprazole (manufacturer unknown). On the same day, the patient reported that her left arm began to hurt. On the next date, the patient reported she could not lift her arm above her waistline. On 22-OCT-2015 patient stated that she was now able to lift her arm, but there was redness at the injection site that traveled throughout the same day to her left elbow, and then to her left forearm. On 23-OCT-2015, she went to an unspecified physician who informed her she had an infection. The same unspecified physician prescribed cefadroxil 500 mg to be taken 2 times a day for 10 days. The patient reported that the redness was getting worse, and she was not feeling well, so she went to an unspecified hospital on 25-OCT-2015. At the unspecified hospital (at which she was not admitted), she was instructed to stop taking the prescribed cefadroxil. The hospital took unspecified blood tests and she was told that her body "was not fighting the infection". An unspecified healthcare provider at the hospital prescribed amoxicillin and clavulanate, 875mg, twice a day for a week and SULFATRIM DS, 100mg, 2 times a day for a week and administered an unspecified dose of IV ZOSYN. The patient also reported that she started taking acidophilus for her stomach, on 25-OCT-2015. At the time of the report, the patient had not recovered from injection site infection, infection not responding, and feeling unwell. The relatedness between the events and suspect therapy was not provided. Lot # K010464 was not valid for PNEUMOVAX 23. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a 66 year old female patient reporting on herself. The patient has no pertinent medical history and no known drug reactions/allergies. It was reported that on 20-OCT-2015 the patient was vaccinated with a "blooster" of PNEUMOVAX 23 (dose and route were not provided), Lot # reported as K010464, exp date on 23-MAR-2016, left arm. Concomitantly, the patient received on the same date a flu shot in her right arm (therapy unspecific). Other concomitant therapy includes omeprazole (manufacturer unknown). On the same day, the patient reported that her left arm began to hurt. On the next date, the patient reported she could not lift her arm above her waistline. On 22-OCT-2015 patient stated that she was now able to lift her arm, but there was redness at the injection site that traveled throughout the same day to her left elbow, and then to her left forearm. On 23-OCT-2015, she went to an unspecified physician who informed her she had an infection. The same unspecified physician prescribed cefadroxil 500 mg to be taken 2 times a day for 10 days. The patient reported that the redness was getting worse, and she was not feeling well, so she went to an unspecified hospital on 25-OCT-2015. At the unspecified hospital (at which she was not admitted), she was instructed to stop taking the prescribed cefadroxil. The hospital took unspecified blood tests and she was told that her body "was not fighting the infection". An unspecified healthcare provider at the hospital prescribed amoxicillin and clavulanate, 875mg, twice a day for a week and SULFATRIM DS, 100mg, 2 times a day for a week and administered an unspecified dose of IV ZOSYN. The patient also reported that she started taking acidophilus for her stomach, on 25-OCT-2015. At the time of the report, the patient had not recovered from injection site infection, infection not responding, and feeling unwell. The relatedness between the events and suspect therapy was not provided. Lot # K010464 was not valid for PNEUMOVAX 23. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Blood test, Erythema, Injection site erythema, Injection site infection, Malaise
Clinical narrative: This spontaneous report was received from a 66 year old female patient reporting on herself. The patient has no pertinent medical history and no known drug reactions/allergies. It was reported that on 20-OCT-2015 the patient was vaccinated with a "blooster" of PNEUMOVAX 23 (dose and route were not provided), Lot # reported as K010464, exp date on 23-MAR-2016, left arm. Concomitantly, the patient received on the same date a flu shot in her right arm (therapy unspecific). Other concomitant therapy includes omeprazole (manufacturer unknown). On the same day, the patient reported that her left arm began to hurt. On the next date, the patient reported she could not lift her arm above her waistline. On 22-OCT-2015 patient stated that she was now able to lift her arm, but there was redness at the injection site that traveled throughout the same day to her left elbow, and then to her left forearm. On 23-OCT-2015, she went to an unspecified physician who informed her she had an infection. The same unspecified physician prescribed cefadroxil 500 mg to be taken 2 times a day for 10 days. The patient reported that the redness was getting worse, and she was not feeling well, so she went to an unspecified hospital on 25-OCT-2015. At the unspecified hospital (at which she was not admitted), she was instructed to stop taking the prescribed cefadroxil. The hospital took unspecified blood tests and she was told that her body "was not fighting the infection". An unspecified healthcare provider at the hospital prescribed amoxicillin and clavulanate, 875mg, twice a day for a week and SULFATRIM DS, 100mg, 2 times a day for a week and administered an unspecified dose of IV ZOSYN. The patient also reported that she started taking acidophilus for her stomach, on 25-OCT-2015. At the time of the report, the patient had not recovered from injection site infection, infection not responding, and feeling unwell. The relatedness between the events and suspect therapy was not provided. Lot # K010464 was not valid for PNEUMOVAX 23. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from a 66 year old female patient reporting on herself. The patient has no pertinent medical history and no known drug reactions/allergies. It was reported that on 20-OCT-2015 the patient was vaccinated with a "blooster" of PNEUMOVAX 23 (dose and route were not provided), Lot # reported as K010464, exp date on 23-MAR-2016, left arm. Concomitantly, the patient received on the same date a flu shot in her right arm (therapy unspecific). Other concomitant therapy includes omeprazole (manufacturer unknown). On the same day, the patient reported that her left arm began to hurt. On the next date, the patient reported she could not lift her arm above her waistline. On 22-OCT-2015 patient stated that she was now able to lift her arm, but there was redness at the injection site that traveled throughout the same day to her left elbow, and then to her left forearm. On 23-OCT-2015, she went to an unspecified physician who informed her she had an infection. The same unspecified physician prescribed cefadroxil 500 mg to be taken 2 times a day for 10 days. The patient reported that the redness was getting worse, and she was not feeling well, so she went to an unspecified hospital on 25-OCT-2015. At the unspecified hospital (at which she was not admitted), she was instructed to stop taking the prescribed cefadroxil. The hospital took unspecified blood tests and she was told that her body "was not fighting the infection". An unspecified healthcare provider at the hospital prescribed amoxicillin and clavulanate, 875mg, twice a day for a week and SULFATRIM DS, 100mg, 2 times a day for a week and administered an unspecified dose of IV ZOSYN. The patient also reported that she started taking acidophilus for her stomach, on 25-OCT-2015. At the time of the report, the patient had not recovered from injection site infection, infection not responding, and feeling unwell. The relatedness between the events and suspect therapy was not provided. Lot # K010464 was not valid for PNEUMOVAX 23. Additional information has been requested.