chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot#M030380 and expiry date 01-FEB-2019) intramuscularly. No adverse effects were reported. The vaccine was exposed temperature excursion of 32.7 Fahrenheit for 2 hours and 15 minutes and 33.1 Fahrenheit for 4 hours. No previous temperature excursion were reported. Data logger was involved. No product quality complaint (PQC) was filed. This case is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: This spontaneous report received from a pharmacist referred to a 67-year old male patient. The patient's pertinent medical history included arthritis. Concurrent conditions included pain in the right hip. Concomitant medications included Atorvastatin (manufacturer unknown), tamsulosin (manufacturer unknown), omeprazole (manufacturer unknown) and an unspecified multivitamin. Approximately on an unknown date in September 2016 (reported as one month ago), the patient saw a healthcare provider because he had been experiencing pain in right hip. The pain had been occurring for 3 weeks prior to his appointment The healthcare provider recommended steroid therapy but the patient declined receiving it. However during the same appointment, the patient received a dose of ZOSTAVAX (Dose, frequency, lot number and expiry date were not reported). Since then the patient's hip pain got worse. On an unknown date in September 2016, the patient was walking funny (Gait disturbance) because of the pain. The patient had been treating himself with ibuprofen. The patient would probably be starting steroid therapy soon on an unspecified date. The pharmacist stated that the worsening of hip pain has nothing to do with ZOSTAVAX. Outcome of the events was not reported. Causality of worsening of hip pain was reported as not related. Causality of Gait disturbance was not reported. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 26-year-old male patient. No information regarding the patient's pertinent medical history, concurrent conditions or concomitant therapies was provided. On 19-JUL-2016, 19-AUG-2016 and 21-OCT-2016, the patient was vaccinated respectively with the first, second and third dose of GARDASIL 9 intramuscularly, lot # L014198, expiration date 05-SEP-2017 (dose was not reported). There were no adverse effects reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had swelling, redness, pain at injection site. Patient used cold compresses and took BENADRYL, then prednisone.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Rash pruritic, Vaccination site swelling
Clinical narrative: Pt. called into clinic that she had an itchy rash that is not spreading an a bump where the vaccine was given. Phone call made 10/31/2016.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Chills, Erythema, Hyperhidrosis, Pain
Clinical narrative: Cellulitis of left upper limb. Red, swollen, painful, fever 101, chills, sweats.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Swelling
Clinical narrative: Cellulitis of left upper limb. Red, swollen, painful, fever 101, chills, sweats.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Feeling abnormal, Mobility decreased, Peripheral swelling
Clinical narrative: Arm red, swollen and can't move it.   It looks like cellulitis.  Pt. feels like with virus symptoms.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13, RV1
Symptoms: Wrong drug administered
Clinical narrative: PEDIARIX given -combo vaccine w/Hep. B PENTACEL has Hib. Mistaken gave Hep. B also instead of Hib.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Rash.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Infection, Pain, Skin ulcer, Varicella
Clinical narrative: This spontaneous report as received from currently 69 year old male patient, referring to himself. The patient's concurrent conditions included hypertension, cholesterol and thyroid. He experienced drug reactions/allergies to Metoprolol, simvastatin (manufacturer unknown), Lisinopril (manufacturer unknown), codeine, amlodipine, niacin, doxycycline, dicloxacillin, dapsone, penicillin and amoxicillin. On 15-APR-2015, the patient was vaccinated with ZOSTAVAX (dose, site of administration, lot # and expiry date were not reported), intravenously. Concomitant therapies included losartan potassium (manufacturer unknown) 100 mg, "OXYMINE" 100 mg, hydralazine 75 mg, spironolactone 50 mg and meloxicam (manufacturer unknown) 15 mg. Since 19-APR-2015, also reported as for the last year and a half, after having ZOSTAVAX administered, the patient experienced what appears to be chickenpox. He also noted that he was experiencing large, painful open sores and intermittent infections. There was no treatment given for the adverse events. The outcome of the events was unknown. The patient sought unspecified medical attention. The relatedness between the events and ZOSTAVAX was not provided. This is one of several reports regarding the same patient. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from the mother of female patient of unknown age. The patient's medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date the patient was vaccinated with GARDASIL 9, intramuscular (Lot # not provided). On an unknown date the patient experienced an adverse event. The patient's mother refused to answer any questions about this adverse event and request to only submit her feedback. The outcome of adverse event is unknown. No further information was provided. A PQC was not involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Antibody test negative, Full blood count normal, Limb mass, Lipase normal, Metabolic function test normal
Clinical narrative: Lump (L) arm, noted day after GARDASIL immunization. Resolved after 10 days and then recurred 4 weeks after initial immunization. Pt. also noticed increased nausea x 1 month starting the day after the immunization.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Urine analysis normal
Clinical narrative: Lump (L) arm, noted day after GARDASIL immunization. Resolved after 10 days and then recurred 4 weeks after initial immunization. Pt. also noticed increased nausea x 1 month starting the day after the immunization.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 26-OCT-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB injection, lot # M007762, expiration date 07-DEC-2018 (dose, route and site of administration were not reported). There was no adverse effect reported. Product quality complaint was not involved. The administered dose of vaccine was stored in the temperature of 33 degrees Fahrenheit for 4 days and 19 hours. There were no previous temperature excursions reported. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 26-OCT-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, lot # M007764, expiration date 30-JAN-2018 (dose, route and site of administration were not reported). There was no adverse effect reported. Product quality complaint was not involved. The administered dose of vaccine was stored in the temperature of 33 degrees Fahrenheit for 4 days and 19 hours. There were no previous temperature excursions reported. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 26-OCT-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, lot # M007764, expiration date 30-JAN-2018 (dose, route and site of administration were not reported). There was no adverse effect reported. Product quality complaint was not involved. The administered dose of vaccine was stored in the temperature of 33 degrees Fahrenheit for 4 days and 19 hours. Data logger was not involved. There were no previous temperature excursions reported. 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 was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-OCT-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB injection, lot # M007762, expiration date 07-DEC-2018 (dose, route and site of administration were not reported). There was no adverse effect reported. Product quality complaint was not involved. The administered dose of vaccine was stored in the temperature of 33 degrees Fahrenheit for 4 days and 19 hours. There were no previous temperature excursions reported. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medial history, drug reactions or allergies and concomitant therapies were reported. On 10-OCT-2016, the patient was vaccinated was an expired dose of ZOSTAVAX one vial, once, subcutaneously (lot # L017139, expiration date 13-AUG-2016). 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 nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction/allergies and concomitant medications were not reported. On an unknown date the patient was vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # M024683 and expiry date 18-MAY-2018), subcutaneously. No adverse effects were reported. The vaccine was exposed to temperature excursion of 30.4 Fahrenheit for 6 hours. Digital data logger was involved. No previous temperature excursion was reported. No product quality complaint was filed. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Medical Assistant referring to unspecified amount of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On 26-OCT-2016, the patients  were vaccinated with improperly stored doses of GARDASIL 9 (lot # reported as M026306 with expiration date 30-APR-2018, lot # M007728 with expiration date 21-MAR-2018, lot # reported as M021407 with expiration date 30-APR-2018, lot # M023169 with expiration date 13-JUN-2018; dose and route were not provided), which were exposed to 49.1 Fahrenheit (F) for 55 minutes. No adverse effects were reported. The data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified amount of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On 26-OCT-2016, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L040053 with expiration date 10-MAY-2017, lot # M024673 with expiration date 17-NOV-2017; dose and route were not provided), which was exposed to 49.1 Fahrenheit (F) for 55 minutes. No adverse effects were reported. The data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified amount of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On 26-OCT-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M033096 with expiration date 31-MAY-2018, lot # M001579 with expiration date 05-OCT-2018, lot # M000442 with expiration date 31-MAR-2018, lot # M023718 with expiration date 09-AUG-2018, lot # M029233 with expiration date 09-AUG-2018; dose and route were not provided), which were exposed to 49.1 Fahrenheit (F) for 55 minutes. No adverse effects were reported. The data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 9-year-old non-pregnant female patient. The patient did not have any pertinent medical history, drug reactions or allergies. She was not taking any concomitant medications. On 18-OCT-2016, the patient was vaccinated with a dose of VAQTA lot # M015290, expiration date 20-SEP-2017 (dose, route of administration and anatomical location were not reported) to prevent HepA. On 18-OCT-2016, five minutes after receiving VAQTA, the patient experienced fainting. On the same day (reported as one minute later), the patient recovered from fainting. The patient sought medical attention by contacting physician but there was no treatment given for the adverse event. No lab diagnostics studies were performed. The relatedness between fainting and VAQTA was not reported. This was one of two reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 12-year-old non-pregnant female patient. The patient did not have any pertinent medical history, drug reactions or allergies. She was not taking any concomitant medications. On 18-OCT-2016, the patient was vaccinated with a dose of VAQTA (lot # M015290, expiration date 20-SEP-2017 (dose, route of administration and anatomical location were not reported)). On 18-OCT-2016, five minutes after receiving the VAQTA, the patient experienced fainting. On the same day (reported as one minute later), the patient recovered from fainting. The patient sought medical attention by contacting physician but there was no treatment given for the adverse event. No lab diagnostics studies were performed. The relatedness between fainting and VAQTA was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with a dose of improperly stored ROTATEQ (dose was unknown, lot # M031802, expiration date: 09-NOV-2017) orally. The vaccines were exposed to high temperature excursion of 47 degrees Fahrenheit for 30 minutes and low temperature excursion of 35 degrees Fahrenheit for 8 hours, cycles: 7 times. No adverse effects were reported. 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: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with a dose of improperly stored PEDVAXHIB (dose and route unknown, lot # M025193, expiration date: 21-MAR-2019; lot # L009649 expiration date: 29-NOV-2017). The vaccines were exposed to high temperature excursion of 47 degrees Fahrenheit for 30 minutes and low temperature excursion of 35 degrees Fahrenheit for 8 hours (7 cycles). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 22-OCT-2016, the patient was inadvertently vaccinated with a dose of improperly stored ZOSTAVAX (lot # reported as M033335, expiration date 11-OCT-2017, dose not reported) subcutaneously. No adverse effects were reported. Additional information is not expected as there was no consent to contact the reporter.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from an unspecified reporter via a field employee referring to a 18 year old patient of unknown gender. On an unknown date the patient was vaccinated with (Oka-Merck) PROQUAD (lot#, expire date, strength, dosage, frequency and route unspecified) (drug administered to patient of inappropriate age). No adverse effects were reported. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin irritation, Skin warm
Clinical narrative: Patient's arm is red and irritated. Warm to the touch. Saw doctor on 11-7-16 and is being treated with BENADRYL.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on day 13 after receiving vaccine.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness, Pain
Clinical narrative: On 10/7/16, left deltoid pain and had a hard time raising anteriorly until a couple days ago. Arm is weak and sore with anterior abduction. Seen by Dr. 10/31/16, no redness or swelling with anterior abduction he can get to 45 to 50 degrees with discomfort. Dr. feels this will all clear up. No treatment at this time.
Sex: U
Vaccine: UNK
Symptoms: Chest pain, Pain in extremity
Clinical narrative: Pain in upper arm and goes to chest pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash
Clinical narrative: Rash 9"x11".
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Large, reddened, irritated area on back of arm at injection site.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Right arm patient received TDaP and MENACTRA. Developed swelling pain and redness after shot 20 x 10 inches. Seen 2 days later with problems. No chest pain.
Age: 28.0
Sex: M
Vaccine: HEPAB
Symptoms: Cold sweat, Hyperhidrosis, Mydriasis, Unresponsive to stimuli
Clinical narrative: 10:50 received vaccine, 11:04 am became diaphoretic, clammy, pupils dilated, unresponsive 1-2 sec., 11:05A BP 100/50, P-45, R-16, 11:06 am EMS called, pt. responsive after 1-2 seconds, 11:20A EMS arrived monitored pt. 11:30 am EMS left. Pt monitored 30 min. Give 4-5 6 oz. glasses H2O, 8 oz. OJ. 12:00 BP 118/88, P88, Pulse OX 100%. Released to home.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Hyperhidrosis, Injected limb mobility decreased, Injection site pain
Clinical narrative: Within 5 hours extreme soreness at injection site progressing to limited range of motion of right arm. Pt. went to bed woke up about midnight with severe body aches, primarily on right side of neck and right side rib cage. Pt. had severe sweats and body chills for most of night. Experienced generalized fatigue for next 3 days.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal chest pain, Neck pain, Pain
Clinical narrative: Within 5 hours extreme soreness at injection site progressing to limited range of motion of right arm. Pt. went to bed woke up about midnight with severe body aches, primarily on right side of neck and right side rib cage. Pt. had severe sweats and body chills for most of night. Experienced generalized fatigue for next 3 days.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling
Clinical narrative: (R) arm with redness, swelling circumference of (R) arm 2 cm greater than (L) arm.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Chest pain, Electrocardiogram normal, Full blood count normal, Headache
Clinical narrative: Received FLUVIRIN 10/25/16 stated felt weakness, clear rhinitis, N and V XI symptoms lasted through 10/26/16. 10/27/16 symptoms resolved reported to Employee Health for scheduled 2nd dose Hep B vaccine IM (R) arm. 10/28/16 upon awakening 0700 c/o pain (R) arm and (R) chest pain. C/O nausea denies vomiting, SOB, diaphoresis. Admitted to ER for evaluation. C/O HA, very tender (R) arm and (R) chest wall with light palpitation. DC ER follow up with PCP.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Metabolic function test normal, Myocardial necrosis marker normal, Nausea, Pain in extremity, Rhinitis
Clinical narrative: Received FLUVIRIN 10/25/16 stated felt weakness, clear rhinitis, N and V XI symptoms lasted through 10/26/16. 10/27/16 symptoms resolved reported to Employee Health for scheduled 2nd dose Hep B vaccine IM (R) arm. 10/28/16 upon awakening 0700 c/o pain (R) arm and (R) chest pain. C/O nausea denies vomiting, SOB, diaphoresis. Admitted to ER for evaluation. C/O HA, very tender (R) arm and (R) chest wall with light palpitation. DC ER follow up with PCP.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Tenderness, Urine analysis normal, Vomiting
Clinical narrative: Received FLUVIRIN 10/25/16 stated felt weakness, clear rhinitis, N and V XI symptoms lasted through 10/26/16. 10/27/16 symptoms resolved reported to Employee Health for scheduled 2nd dose Hep B vaccine IM (R) arm. 10/28/16 upon awakening 0700 c/o pain (R) arm and (R) chest pain. C/O nausea denies vomiting, SOB, diaphoresis. Admitted to ER for evaluation. C/O HA, very tender (R) arm and (R) chest wall with light palpitation. DC ER follow up with PCP.
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Posture abnormal, Syncope, Visual impairment
Clinical narrative: Syncopal event approx 3-5 min after Hep B vaccine. Pt had left the office and was waiting for the elevator and felt weak with vision changes. Slumped on mom's shoulder. Returned to baseline after juice. Vital signs stable.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Back pain, Erythema, Headache, Injection site pain
Clinical narrative: Given PNEUMOVAX 7/8/16. Called on 7/11/16 reported severe arm soreness, redness, joint pain, headache and backache. Unable to get out of bed due to joint pain. Continued pain left shoulder x 4 mo.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Given PNEUMOVAX 7/8/16. Called on 7/11/16 reported severe arm soreness, redness, joint pain, headache and backache. Unable to get out of bed due to joint pain. Continued pain left shoulder x 4 mo.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Malaise, Rash generalised
Clinical narrative: Rash spread over body. Malaise - tired for 2-3 days. Felt malaise starting 10/29 vaccinated 10/28. Rash started on arm spread to body.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site infection
Clinical narrative: As per patients doctor she developed infection at the injection site.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Irritability, Seizure, Tremor
Clinical narrative: 3 hrs after injection/immunization became fussy. Temp 98.9. Began having "seizure". Shaking of arms and legs rhythmically for 5-10 min. Seemed alert and responsive. After laid quietly in mom's arms but did not sleep. TYLENOL given just prior.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest X-ray normal, Chest discomfort, Cough, Fatigue, Injection site pain
Clinical narrative: 9/22 - began feeling tightness in chest, cough, and soreness around injection site. 9/23 - increased congestion, fever, fatigue, noticed several pox around inj. site. 9/24 - 9/27 - increased congestion in chest, wheezing, fever (intermittently 100 degrees F - 101 degrees F). 9/29 - visit to provider.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pustule, Pyrexia, Respiratory tract congestion, Varicella virus test negative, Wheezing
Clinical narrative: 9/22 - began feeling tightness in chest, cough, and soreness around injection site. 9/23 - increased congestion, fever, fatigue, noticed several pox around inj. site. 9/24 - 9/27 - increased congestion in chest, wheezing, fever (intermittently 100 degrees F - 101 degrees F). 9/29 - visit to provider.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Activities of daily living impaired, Arthralgia, Back pain, C-reactive protein increased, Fatigue
Clinical narrative: Employee has history of receiving three documented doses of hepatitis B vaccine on 9/23/06, 5/6/08 and 1/3/09. A borderline HBsAB was drawn on 7/26/16. Booster dose of Hepatitis B vaccine was administered of 8/19/16. Medical history reported by employee includes HTN and pre-diabetes. His daily medications include ASA 81 mg, MV, Vitamin B, WELLBUTRIN and Lisinopril. Employee came in today for follow up HBsAB which was drawn; results are pending. Employee reports the following symptoms and events following the hepatitis B vaccine administered on 8/19/16. One week after receiving the hepatitis B vaccine employee reported pain and stiffness in lower extremity joints. Four weeks later after playing golf, he felt pain and stiffness in back and shoulders that was acute and nearly incapacitating. Bilateral pain and stiffness in shoulders, back and hips continued with increased immobility, pain, stiffness, and fatigue. During the week of October 17 symptoms worsen along with severe muscle spasms throughout pelvic area. Trouble with ADLs included: getting in and out of bed, getting in and out of the shower, independently dressing and toileting, getting in and out chairs and climbing up and down stairs. Employee went to urgent care on October 20 after being incapacitated. Hips x-rays were taken with negative results. Labs were all normal except for a high C reactive protein and elevated sedimentation (ESR). NSAIDs and skeletal muscle relaxants were prescribed. Employee was unable to work October 24-26 and 28 with fever on October 26-28. PCP appointment on October 26; prednisone was prescribed and referral made to rheumatologist. Since starting the prednisone pain and stiffness in joints has lessened with onset of numbness and tingling present in both legs and feet. Continued pain bilaterally in both shoulders, hands, low back and knees. Employee is currently waiting to see a rheumatologist.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Impaired work ability, Joint stiffness, Mobility decreased, Muscle spasms
Clinical narrative: Employee has history of receiving three documented doses of hepatitis B vaccine on 9/23/06, 5/6/08 and 1/3/09. A borderline HBsAB was drawn on 7/26/16. Booster dose of Hepatitis B vaccine was administered of 8/19/16. Medical history reported by employee includes HTN and pre-diabetes. His daily medications include ASA 81 mg, MV, Vitamin B, WELLBUTRIN and Lisinopril. Employee came in today for follow up HBsAB which was drawn; results are pending. Employee reports the following symptoms and events following the hepatitis B vaccine administered on 8/19/16. One week after receiving the hepatitis B vaccine employee reported pain and stiffness in lower extremity joints. Four weeks later after playing golf, he felt pain and stiffness in back and shoulders that was acute and nearly incapacitating. Bilateral pain and stiffness in shoulders, back and hips continued with increased immobility, pain, stiffness, and fatigue. During the week of October 17 symptoms worsen along with severe muscle spasms throughout pelvic area. Trouble with ADLs included: getting in and out of bed, getting in and out of the shower, independently dressing and toileting, getting in and out chairs and climbing up and down stairs. Employee went to urgent care on October 20 after being incapacitated. Hips x-rays were taken with negative results. Labs were all normal except for a high C reactive protein and elevated sedimentation (ESR). NSAIDs and skeletal muscle relaxants were prescribed. Employee was unable to work October 24-26 and 28 with fever on October 26-28. PCP appointment on October 26; prednisone was prescribed and referral made to rheumatologist. Since starting the prednisone pain and stiffness in joints has lessened with onset of numbness and tingling present in both legs and feet. Continued pain bilaterally in both shoulders, hands, low back and knees. Employee is currently waiting to see a rheumatologist.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Employee has history of receiving three documented doses of hepatitis B vaccine on 9/23/06, 5/6/08 and 1/3/09. A borderline HBsAB was drawn on 7/26/16. Booster dose of Hepatitis B vaccine was administered of 8/19/16. Medical history reported by employee includes HTN and pre-diabetes. His daily medications include ASA 81 mg, MV, Vitamin B, WELLBUTRIN and Lisinopril. Employee came in today for follow up HBsAB which was drawn; results are pending. Employee reports the following symptoms and events following the hepatitis B vaccine administered on 8/19/16. One week after receiving the hepatitis B vaccine employee reported pain and stiffness in lower extremity joints. Four weeks later after playing golf, he felt pain and stiffness in back and shoulders that was acute and nearly incapacitating. Bilateral pain and stiffness in shoulders, back and hips continued with increased immobility, pain, stiffness, and fatigue. During the week of October 17 symptoms worsen along with severe muscle spasms throughout pelvic area. Trouble with ADLs included: getting in and out of bed, getting in and out of the shower, independently dressing and toileting, getting in and out chairs and climbing up and down stairs. Employee went to urgent care on October 20 after being incapacitated. Hips x-rays were taken with negative results. Labs were all normal except for a high C reactive protein and elevated sedimentation (ESR). NSAIDs and skeletal muscle relaxants were prescribed. Employee was unable to work October 24-26 and 28 with fever on October 26-28. PCP appointment on October 26; prednisone was prescribed and referral made to rheumatologist. Since starting the prednisone pain and stiffness in joints has lessened with onset of numbness and tingling present in both legs and feet. Continued pain bilaterally in both shoulders, hands, low back and knees. Employee is currently waiting to see a rheumatologist.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Red blood cell sedimentation rate increased, X-ray of pelvis and hip normal
Clinical narrative: Employee has history of receiving three documented doses of hepatitis B vaccine on 9/23/06, 5/6/08 and 1/3/09. A borderline HBsAB was drawn on 7/26/16. Booster dose of Hepatitis B vaccine was administered of 8/19/16. Medical history reported by employee includes HTN and pre-diabetes. His daily medications include ASA 81 mg, MV, Vitamin B, WELLBUTRIN and Lisinopril. Employee came in today for follow up HBsAB which was drawn; results are pending. Employee reports the following symptoms and events following the hepatitis B vaccine administered on 8/19/16. One week after receiving the hepatitis B vaccine employee reported pain and stiffness in lower extremity joints. Four weeks later after playing golf, he felt pain and stiffness in back and shoulders that was acute and nearly incapacitating. Bilateral pain and stiffness in shoulders, back and hips continued with increased immobility, pain, stiffness, and fatigue. During the week of October 17 symptoms worsen along with severe muscle spasms throughout pelvic area. Trouble with ADLs included: getting in and out of bed, getting in and out of the shower, independently dressing and toileting, getting in and out chairs and climbing up and down stairs. Employee went to urgent care on October 20 after being incapacitated. Hips x-rays were taken with negative results. Labs were all normal except for a high C reactive protein and elevated sedimentation (ESR). NSAIDs and skeletal muscle relaxants were prescribed. Employee was unable to work October 24-26 and 28 with fever on October 26-28. PCP appointment on October 26; prednisone was prescribed and referral made to rheumatologist. Since starting the prednisone pain and stiffness in joints has lessened with onset of numbness and tingling present in both legs and feet. Continued pain bilaterally in both shoulders, hands, low back and knees. Employee is currently waiting to see a rheumatologist.
Age: 81.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Saliva discolouration, Vertigo, Vomiting
Clinical narrative: 10/20 dizzy, vomiting 4 times till stomach empty. Then yellow, saliva. 10/22 ER, IV, motion sickness pill. Diagnosis: Vertigo.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Chest pain, Erythema, Peripheral swelling
Clinical narrative: Redness and swelling on underarm down pass the elbow. Soreness in axilla and chest - painful. Used aloe to decrease redness and swelling.
Age: 76.0
Sex: M
Vaccine: FLUX
Symptoms: Decreased appetite, Hyperhidrosis, Nausea, Pain, Weight decreased
Clinical narrative: Initial unsolicited report received from a consumer on 28 October 2016. This case involves a 76-year-old male patient who was vaccinated with a dose INFLUENZA VACCINE (batch number: unknown, expiration date, dose and route of administration were not reported) in the left deltoid on 25 September 2015. Previous doses were reported as multiple in previous years. Patient's Illness at time of vaccination was reported as none and Pre-existing physician diagnosed allergies, birth defects, medical conditions included Diabetes, "S/P kidney transplant" and Sulfa Allergy. Any other vaccinations within 4 weeks of vaccinations were reported as none. On 26 September 2015, one (next) day following the vaccination, the patient had no appetite and "his appetite was gone for many months", began sweating during the night, was achy, nauseous, and had generalized body pain. It was reported that patient had in total lost 35 pounds, had put some weight back on, but his weight had gone from 145 pounds to 122 pounds. On an unspecified date following the vaccination patient appetite had returned (since) but he was unable to gain any more weight. Patient had visited his physician or emergency room. Patient's Lab data were ordered but was unknown. Patient's corrective treatment was not reported. Outcome of the event was reported as not recovered. List of documents held by sender: none.
Age: 76.0
Sex: M
Vaccine: FLUX
Symptoms: Weight gain poor
Clinical narrative: Initial unsolicited report received from a consumer on 28 October 2016. This case involves a 76-year-old male patient who was vaccinated with a dose INFLUENZA VACCINE (batch number: unknown, expiration date, dose and route of administration were not reported) in the left deltoid on 25 September 2015. Previous doses were reported as multiple in previous years. Patient's Illness at time of vaccination was reported as none and Pre-existing physician diagnosed allergies, birth defects, medical conditions included Diabetes, "S/P kidney transplant" and Sulfa Allergy. Any other vaccinations within 4 weeks of vaccinations were reported as none. On 26 September 2015, one (next) day following the vaccination, the patient had no appetite and "his appetite was gone for many months", began sweating during the night, was achy, nauseous, and had generalized body pain. It was reported that patient had in total lost 35 pounds, had put some weight back on, but his weight had gone from 145 pounds to 122 pounds. On an unspecified date following the vaccination patient appetite had returned (since) but he was unable to gain any more weight. Patient had visited his physician or emergency room. Patient's Lab data were ordered but was unknown. Patient's corrective treatment was not reported. Outcome of the event was reported as not recovered. List of documents held by sender: none.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, FLU4, HPV9, MNQ
Symptoms: Dyspnoea, Pharyngeal oedema, Swelling face, Urticaria
Clinical narrative: Pt developed generalized urticarial. He was seen in urgent care at 10:00 PM on 10-11-16. Discharged but returned at 2:00 AM because of lip/face swelling and difficulty breathing.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, FLU4, HPV9, MNQ
Symptoms: Dyspnoea, Lip swelling, Swelling face, Urticaria
Clinical narrative: Pt developed generalized urticarial. He was seen in urgent care at 10:00 PM on 10-11-16. Discharged but returned at 2:00 AM because of lip/face swelling and difficulty breathing.
Age: 21.0
Sex: M
Vaccine: FLU3, JEV1, SMALL
Symptoms: Secretion discharge, Skin lesion
Clinical narrative: Patient received a tattoo or tattoo touchup on 31OCT2016 following administration of vaccinia vaccine on 27OCT2016.  The tattoo work was done over the site of vaccinia vaccine administration.  Pt came to clinic with multiple auto-inoculation sites as a result.  Pt last seen for follow-up on 07NOV2016.  His lesions are worsening, and he was given Bactrim to treat for any possible bacterial cellulitis vs wound infection, as there was a fair amount of yellow-green discharge without odor.  Next follow-up will be on 09Nov2016 to continue monitoring progression of the lesions.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cough, Eye discharge, Eye swelling, Feeling jittery
Clinical narrative: Wheezing even after inhaler, fever of 101.6, chills, extreme body aches, swollen blood shot eyes, goopiness in eyes and throat, jittery like I was jumping out of my skin, like I was on a high dose of steroid. Next morning I woke up to slight cough that was gone within a few hours. I have never experienced this extreme of a reaction.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Increased upper airway secretion, Ocular hyperaemia, Pain, Pyrexia, Wheezing
Clinical narrative: Wheezing even after inhaler, fever of 101.6, chills, extreme body aches, swollen blood shot eyes, goopiness in eyes and throat, jittery like I was jumping out of my skin, like I was on a high dose of steroid. Next morning I woke up to slight cough that was gone within a few hours. I have never experienced this extreme of a reaction.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Insomnia, Joint range of motion decreased, Pain, Tendonitis
Clinical narrative: Limited range of motion. Numbness in the left hand. Sharp pain causing sleeplessness when moving.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Dizziness, Gastrointestinal disorder, Mental impairment
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 20 Oct 2016. This case involves a 76-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose: not reported) by intramuscular route in left deltoid on 17 Oct 2016. Illness at time of vaccination was reported as convalescent stage of GI problems 1 week earlier, pre-existing physician diagnosed allergies, birth defects, medical conditions included recent stomach problems patient was taking CARAFATE 3-4 times daily (concomitant medications). On 17 Oct 2016, same day following the vaccination the patient experienced her whole digestive system was being affected and she felt dizzy and had could not think straight. Patient reported that she was recuperating from having GI problems and claimed that they were reactivated after receiving the flu shot, the patient planned to contact her physician on 20 Oct 2016 regarding her symptoms. The patient's lab tests and corrective treatment was not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: Initial unsolicited report received from a pharmacist on 26 October 2016. This case involves a 68-year-old male who was vaccinated with a dose of Fluzone Hd (batch number: UI712AA, expiry date: 25 May 2017) intramuscularly in left deltoid and dose of Pneumovax (batch number, expiry date and route of administration was not reported) in left deltoid on 11 October 2016. Illness at time of vaccination includes none reported and pre-existing physician diagnosed allergies, birth defects, a medical condition was reported allergies: none known. Concomitant medication was not reported. On 11 October 2016, same day following the vaccination, patient experienced pain in entire left arm that limits movement and was unable to sleep due to the pain. Lab data and corrective treatment were not reported. Patient was not recovered from events. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a Pharmacist on 26 October 2016. This case involves a patient (age and gender was not reported) who was vaccinated with a dose Fluzone Qiv (batch number: UT5673LA, expiration date: 30 June 2017, dose was not reported) intramuscularly in the deltoid on an unspecified date in October 2016. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Any other vaccinations within 4 weeks of vaccinations were not reported. On an unspecified date in October 2016, (reported as two weeks ago) following the vaccination, the patient arm was "severly sore, feels like can't lift over head". It was reported that patient was referred to see Healthcare professional. Patient's Lab data and corrective treatment was not reported. Outcome of the event was reported as not recovered. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Headache, Neck pain, Pain, Pyrexia
Clinical narrative: Initial unsolicited report received from other non-health care professional on 26 October 2016. This case involves 17-year-old female patient who was vaccinated with a 0.5 ml dose of FLUZONE QIV (batch number: UI684AC, expiry date: 30 June 2017, and route of administration was not reported) in left deltoid on 03 October 2016. Illness at time of vaccination reported as unknown and pre-existing physician diagnosed allergies, birth defects, a medical condition was reported carpal tunnel syndrome, left sided neck pain. Concomitant medication reported none. On 21 October 2016, 18 days following the vaccination, patient began to have generalized body aches, headache, increased Left sided neck pain and developed fever of 101.5 (unit not reported). On 23 October 2016, 20 days following vaccination patient was febrile maximum temperature of 101.5 (unit not reported). On 26 October 2016 patient was seen by physician for symptoms. Patient required emergency room or doctor visit. Lab data reported as none. Corrective treatment was not reported. Outcome of events was reported as unknown. List of documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Borrelia test negative, Laboratory test normal, Myalgia
Clinical narrative: Initial unsolicited report received from a consumer on 27 Oct 2016. This case involves a 51-year-old male patient who was vaccinated with a dose of Fluzone (batch number: UH953AB, expiry date: 30 Jun 2014, route, dose not reported) on 20 Jan 2014. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) revealed that patient was allergic to severel food and no known drug allergies was reported. Medical history includes Eczema. Concomitant medications were not provided. On 21 Jan 2014, one day following the vaccination, the patient experienced joint and muscle pain all over body. Also reported that, the patient still had intermittent intervals of joint and muscle pain. Patient required ER and doctor visit. Lab data includes test for Lyme disease, arthritis and tests were negative. Corrective treatment was not reported. It was unknown if patient was recovered from the events. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Injection site reaction, Pruritus, Pyrexia, Rash
Clinical narrative: Initial solicited report received on 26 October 2016 from an investigator participating in the study. This case involves a 66-year-old female subject who had injection site reaction, rash, fever, itchiness and was very uncomfortable. The subject's medical history and concomitant therapies were not reported. The subject stated that, two years ago she had this specific intramuscular dose of FLUZONE HD and had violent reaction within 24 hours; rash, fever, itchiness and was very uncomfortable (date unspecified) and developed injection site reaction in 2014 (latency unknown). The subject further mentioned that now she had just regular shot and was not allergic to anything and before that and since she did not had any reaction of any sort. Lab data and corrective treatment were not reported. The outcome of injection site reaction, rash, fever, itchiness and very uncomfortable was not reported. Relationship to investigational product according to investigator: not reported. Relationship to investigational product according to Company: associated.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Gastric disorder, Nausea, Vertigo
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (patient) on 27 October 2016. This case involves a 70 years old male patient who was vaccinated with a dose of FLUZONE HD (dose, dose in series, batch number, expiry date were not reported) intramuscularly in the left arm on 26 October 2016. The patients' illness at time of vaccination was reported as unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as amoxicillin and ASA allergies. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 28 October 2016, 2 days following the vaccination, the patient got up to go to the bathroom and had gastric disorder, vertigo and felt on the floor. Up the whole night the patient had sick feeling in his stomach. The patient required ER/ doctor visit. Laboratory investigations were not reported. Corrective treatment was not reported. The outcome of the events was reported as not recovered. List of documents held by sender: none.