chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Arthralgia, Autoimmune disorder, Back pain, Mobility decreased, Rheumatoid factor positive
Clinical narrative: Case number PHHY2013US135790, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 503390) website on 25 Nov 2013 with a follow-up received on 16 Dec 2013. This report refers to a 34-year-old male patient. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported), anthrax vaccine (other manufacturer and batch number: not reported) DTAPHEPBIP (other manufacturer and batch number: not reported) and yellow fever vaccine (other manufacturer and batch number: not reported), all the vaccines in the arm on 15 Jan 2011. On 15 Jun 2011, he experienced pain in back and knees. The events were slight at first and it was hard to him to get up from sitting and substantially they became worse over next two months and gradually worse from then to present. He visited the emergency room. The events were misdiagnosed for about a year. It was later diagnosed as autoimmune disorder by rheumatological testing. The outcome of the events reported as not recovered. The seriousness and causality of the events were not reported. Upon receipt of follow-up information from VAERS, the suspect vaccine was confirmed to be BIOTHRAX (other manufacturer, and batch number: FAV265). No Novartis vaccine was administered to the patient. Therefore, this case would be deactivated. Follow-up received from the Vaccine Adverse Event Reporting System (VAERS reference number: 503390) website on 16 Dec 2013: This patient was only vaccinated with BIOTHRAX (other manufacturer) but not other vaccines. Since, the patient did not receive Novartis vaccine, this case will be deactivated.
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Arthralgia, Autoimmune disorder, Back pain, Dysstasia, Rheumatoid factor positive
Clinical narrative: Case number PHHY2013US135790, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 503390) website on 25 Nov 2013 with a follow-up received on 16 Dec 2013. This report refers to a 34-year-old male patient. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported), anthrax vaccine (other manufacturer and batch number: not reported) DTAPHEPBIP (other manufacturer and batch number: not reported) and yellow fever vaccine (other manufacturer and batch number: not reported), all the vaccines in the arm on 15 Jan 2011. On 15 Jun 2011, he experienced pain in back and knees. The events were slight at first and it was hard to him to get up from sitting and substantially they became worse over next two months and gradually worse from then to present. He visited the emergency room. The events were misdiagnosed for about a year. It was later diagnosed as autoimmune disorder by rheumatological testing. The outcome of the events reported as not recovered. The seriousness and causality of the events were not reported. Upon receipt of follow-up information from VAERS, the suspect vaccine was confirmed to be BIOTHRAX (other manufacturer, and batch number: FAV265). No Novartis vaccine was administered to the patient. Therefore, this case would be deactivated. Follow-up received from the Vaccine Adverse Event Reporting System (VAERS reference number: 503390) website on 16 Dec 2013: This patient was only vaccinated with BIOTHRAX (other manufacturer) but not other vaccines. Since, the patient did not receive Novartis vaccine, this case will be deactivated.
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Fall, Gaze palsy, Tremor, Urinary incontinence
Clinical narrative: Case number PHHY2013US140366 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 503615) website on 03 Dec 2013, with a follow up received from the Quality Assurance (QA Ref: 269573) department on 16 Dec 2013. This report refers to an 11-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M12096, Expiry date: Aug 2014) intramuscularly into right arm on 16 Sep 2013. On the same day, she also received GARDASIL (other manufacturer, batch number: H021861) intramuscularly into left arm and BOOSTRIX (other manufacturer, batch number: AC52B090BA) intramuscularly into right arm. On the same day, five minutes after vaccinations, she was noticed by medical assistant falling off the table with eyes rolled, shaking and there was incontinence of urine. She was taken to hospital (emergency visit) by ambulance. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events. Based on the batch review, it was stated that the concerned MENVEO batch number M12096 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department on 16 Dec 2013: Updated batch review report.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Blood test, Computerised tomogram, Demyelinating polyneuropathy, Electromyogram abnormal
Clinical narrative: Case number PHHY2013US135700 is an initial spontaneous report received via vaccine adverse event reporting system (VAERS reference number: 505077) on 25 Nov 2013 with a follow-up received on 16 Dec 2013. This report refers to a 61-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1206201) intramuscularly in to the left arm on 27 Nov 2012. On 15 Dec 2012, he started experiencing tiredness, weakness and weight loss. He eventually experienced neuropathy in hands, arms, feet and legs over next weeks. On unknown date in Mar 2013, he experienced nerve and bodily function break down. He went to emergency room and was hospitalized on 23 Mar 2013. He was in the hospital for next four months and underwent electromyogram which led to the eventual diagnosis of chronic demyelinated neuropathy/Guillain-Barre syndrome. He also had magnetic resonance imaging (MRI), computed axial tomography (CAT) scans, multiple blood tests and X-rays. He underwent rehabilitation therapy in the hospital. The outcome of the event was reported as condition unchanged. He was still going through treatment and follow up. The causality was not reported. Follow-up received from the Vaccine Adverse Event Reporting System (VAERS reference number: 505077) website on 16 Dec 2013: Updated information about trade name of suspect influenza vaccine as FLUVIRIN along with site and route of administration.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Fatigue, General physical health deterioration, Guillain-Barre syndrome, Nervous system disorder, Neuropathy peripheral
Clinical narrative: Case number PHHY2013US135700 is an initial spontaneous report received via vaccine adverse event reporting system (VAERS reference number: 505077) on 25 Nov 2013 with a follow-up received on 16 Dec 2013. This report refers to a 61-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1206201) intramuscularly in to the left arm on 27 Nov 2012. On 15 Dec 2012, he started experiencing tiredness, weakness and weight loss. He eventually experienced neuropathy in hands, arms, feet and legs over next weeks. On unknown date in Mar 2013, he experienced nerve and bodily function break down. He went to emergency room and was hospitalized on 23 Mar 2013. He was in the hospital for next four months and underwent electromyogram which led to the eventual diagnosis of chronic demyelinated neuropathy/Guillain-Barre syndrome. He also had magnetic resonance imaging (MRI), computed axial tomography (CAT) scans, multiple blood tests and X-rays. He underwent rehabilitation therapy in the hospital. The outcome of the event was reported as condition unchanged. He was still going through treatment and follow up. The causality was not reported. Follow-up received from the Vaccine Adverse Event Reporting System (VAERS reference number: 505077) website on 16 Dec 2013: Updated information about trade name of suspect influenza vaccine as FLUVIRIN along with site and route of administration.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging, Weight decreased, X-ray
Clinical narrative: Case number PHHY2013US135700 is an initial spontaneous report received via vaccine adverse event reporting system (VAERS reference number: 505077) on 25 Nov 2013 with a follow-up received on 16 Dec 2013. This report refers to a 61-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1206201) intramuscularly in to the left arm on 27 Nov 2012. On 15 Dec 2012, he started experiencing tiredness, weakness and weight loss. He eventually experienced neuropathy in hands, arms, feet and legs over next weeks. On unknown date in Mar 2013, he experienced nerve and bodily function break down. He went to emergency room and was hospitalized on 23 Mar 2013. He was in the hospital for next four months and underwent electromyogram which led to the eventual diagnosis of chronic demyelinated neuropathy/Guillain-Barre syndrome. He also had magnetic resonance imaging (MRI), computed axial tomography (CAT) scans, multiple blood tests and X-rays. He underwent rehabilitation therapy in the hospital. The outcome of the event was reported as condition unchanged. He was still going through treatment and follow up. The causality was not reported. Follow-up received from the Vaccine Adverse Event Reporting System (VAERS reference number: 505077) website on 16 Dec 2013: Updated information about trade name of suspect influenza vaccine as FLUVIRIN along with site and route of administration.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Fatigue, General physical health deterioration, Guillain-Barre syndrome, Nerve degeneration, Neuropathy peripheral
Clinical narrative: Case number PHHY2013US135700 is an initial spontaneous report received via vaccine adverse event reporting system (VAERS reference number: 505077) on 25 Nov 2013 with a follow-up received on 16 Dec 2013. This report refers to a 61-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1206201) intramuscularly in to the left arm on 27 Nov 2012. On 15 Dec 2012, he started experiencing tiredness, weakness and weight loss. He eventually experienced neuropathy in hands, arms, feet and legs over next weeks. On unknown date in Mar 2013, he experienced nerve and bodily function break down. He went to emergency room and was hospitalized on 23 Mar 2013. He was in the hospital for next four months and underwent electromyogram which led to the eventual diagnosis of chronic demyelinated neuropathy/Guillain-Barre syndrome. He also had magnetic resonance imaging (MRI), computed axial tomography (CAT) scans, multiple blood tests and X-rays. He underwent rehabilitation therapy in the hospital. The outcome of the event was reported as condition unchanged. He was still going through treatment and follow up. The causality was not reported. Follow-up received from the Vaccine Adverse Event Reporting System (VAERS reference number: 505077) website on 16 Dec 2013: Updated information about trade name of suspect influenza vaccine as FLUVIRIN along with site and route of administration.
Age: 32.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Pain in extremity, Synovitis
Clinical narrative: This spontaneous report was received from a pharmacist concerning about a 32 year old female patient. On 09-NOV-2013 the patient was vaccinated with PNEUMOVAX23 lot # J007060 expiration date 28-AUG-2014, dose 1, 0.5 ml, intramuscular in the arm. There were no concomitant medications. On 09-NOV-2013 patient received her first dose of PNEUMOVAX23 and "later that evening" she reported having numbness and pain in her arm. The pharmacist stated that the patient lost her range of motion and was unable to move her arm. The pharmacist reported that "two days after injection" the patient was seen in the emergency department of an unspecified hospital but was not admitted. The patient was given unspecified oral steroids and referred to an unspecified orthopedist. The patient was diagnosed with transient synovitis by the orthopedist. The pharmacist stated that the patient said that she was improving with her oral "steroid therapy" but did not yet have full range of motion in her arm. At the time of the report outcome of the events was reported as recovering/resolving. Numbness in arm and transient synovitis were considered to be disabling by the registered pharmacist. Labs diagnostics studies performed were unspecified by the reporter. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypoaesthesia, Joint range of motion decreased, Mobility decreased, Pain in extremity, Synovitis
Clinical narrative: This spontaneous report was received from a pharmacist concerning about a 32 year old female patient. On 09-NOV-2013 the patient was vaccinated with PNEUMOVAX23 lot # J007060 expiration date 28-AUG-2014, dose 1, 0.5 ml, intramuscular in the arm. There were no concomitant medications. On 09-NOV-2013 patient received her first dose of PNEUMOVAX23 and "later that evening" she reported having numbness and pain in her arm. The pharmacist stated that the patient lost her range of motion and was unable to move her arm. The pharmacist reported that "two days after injection" the patient was seen in the emergency department of an unspecified hospital but was not admitted. The patient was given unspecified oral steroids and referred to an unspecified orthopedist. The patient was diagnosed with transient synovitis by the orthopedist. The pharmacist stated that the patient said that she was improving with her oral "steroid therapy" but did not yet have full range of motion in her arm. At the time of the report outcome of the events was reported as recovering/resolving. Numbness in arm and transient synovitis were considered to be disabling by the registered pharmacist. Labs diagnostics studies performed were unspecified by the reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Thyroid function test normal
Clinical narrative: My daughter starting losing large amounts of hair a couple weeks after her second Gardasil shot. It is still falling out in large amounts. The doctor checked her thyroid which tested normal. A perfectly healthy girl that does not take any medication. Never sick. Hasn't changed her lifestyle.  Hair loss began shortly after second shot.
Age: 46.0
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Pain
Clinical narrative: Big area above injection site was red and painful after injection. Redness resolved in 2 days. Pain still persists. Any movement that involves left arm is painful.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood test, Muscular weakness, Pain in extremity
Clinical narrative: This spontaneous report as received from a 74 year old male consumer refers to himself with bronchiolitis obliterans with organizing pneumonia (BOOP) (a chronic lung disease), penicillin allergy and CIPRO allergy. On 30-SEP-2013 the patient was vaccinated with PNEUMOVAX23 (lot # J004747, expiration date 20-JUL-2014, dose and route unknown) because he had BOOP and FLUVIRIN (manufactured by Novartis) (dose and route unknown) at the same time. Concomitant therapies included prednisone (manufacturer unknown) and fosinopril sodium. On 01-OCT-2013, the patient experienced pain and muscle weakness in both arms and both hands since receiving the vaccinations. The patient took TYLENOL and ALEVE for treatment. On an unknown date blood test was done (result unspecified). The patient called his physician and made an appointment for next month. The patient was not recovered from the events at the time of reporting. No product quality complaint (PQC) was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: This spontaneous report as received from a pharmacist via employee refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX vial 19400 PFU. On an unknown date the patient experienced burning sensation during the administration of ZOSTAVAX. Th pharmacist mentioned the sensation lasted a little bit after vaccination. The patient sought medical attention she was in pharmacy. The outcome of burning sensation was reported as recovered/resolved. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine in AM - states with pain and swelling in (R) upper arm, got very hot - went to Urgent Care Friday AM. Started on PCN and Minocycline by Dr.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Pruritus, Rash
Clinical narrative: This spontaneous report as received from a 72 year old male consumer with no drug reactions/allergies refers to himself. The patient's pertinent medical history included 14 stents. The patient reported that he had accidentally received two unspecified doses of ZOSTAVAX on different dates. The patient was given the first dose of ZOSTAVAX on 09-DEC-2010 and he had no adverse experiences from it. On 11-SEP-2013 the patient was vaccinated with a second dose of ZOSTAVAX (dose, route and lot # unknown) because he and his physician had forgotten that he had the ZOSTAVAX injection. Three days later on 14-SEP-2013, the patient started to develop a rash on his arms and chest. The patient became very itchy. The patient then called his physician between the dates 15-SEP-2013 - 20-SEP-2013 and told him of the adverse experience. The physician gave him a prednisone shot. Then after 5 days, the itching came back. The physician gave him a higher dose of prednisone, but after 8 days or so the itching came back again. The patient was going to go see a 'skin/rash' doctor tomorrow. He could not remember the name of the physician he was going to go see tomorrow. There were no lab diagnostics performed. The outcome of very itchy and rash on his arm and chest was reported as not recovered. The relatedness between ZOSTAVAX and adverse events was not reported. Upon internal review rash on arms and chest and pruritus were considered to be medically significant events. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Swelling, Urticaria
Clinical narrative: Pt. received Meningococcal 12/17 and w/i one hour dev. hive/swelling. Has periodically been taking BENADRYL. F/U 12/19 hive continues - tx. BENADRYL and Loratadine. F/U 12/23 and PRN.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Mass
Clinical narrative: Burning and swelling at site of injection. Noticed 2 days after. Pt described 2" lump.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: Pt. passed out after flu shot.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Tenderness
Clinical narrative: Large (approx. 2" x 3"), red, swollen, tender area of left upper arm. This occurred approx 36 hrs. after receiving "shingles" vaccine.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Body temperature increased
Clinical narrative: Then 101.7 approximately 4-6 hrs after DTaP, Hib, PCV.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Feeling cold, Malaise, Nausea
Clinical narrative: Approximately 6 hrs after injection felt weak, pain in arm which quickly lead to severe shaking chill, nausea and extreme weakness and need to lie down. Could not get warm or stop shaking. Took BENADRYL 50 mgm which helped in about 30 min. Was in bed for 24 hours. Malaise lasted sev. more days. Have had flu shot x 40 yrs - no previous reaction.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Tremor
Clinical narrative: Approximately 6 hrs after injection felt weak, pain in arm which quickly lead to severe shaking chill, nausea and extreme weakness and need to lie down. Could not get warm or stop shaking. Took BENADRYL 50 mgm which helped in about 30 min. Was in bed for 24 hours. Malaise lasted sev. more days. Have had flu shot x 40 yrs - no previous reaction.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Dizziness, Vertigo
Clinical narrative: Initial onset was mild vertigo starting at approximately 0030 hours prior to sleep.  After sleeping and getting up at approximately 0530 hours, extreme vertigo and dizziness to the point of not being able to walk.  Vertigo subsided to moderate level and still remains.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Headache, Malaise
Clinical narrative: Headache, dizziness, malaise, nausea.  12/19/13 fever, anorexia, nausea, headache, loose stool.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pyrexia
Clinical narrative: Headache, dizziness, malaise, nausea.  12/19/13 fever, anorexia, nausea, headache, loose stool.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Pt states started to have a high fever in middle of night last night. No respiratory symptoms. Pt took Tylenol and reduced fever. Pt states had fever or possibly flu the last time had Td vaccine 20 yrs ago.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal discomfort, Musculoskeletal stiffness, Night sweats, Pain
Clinical narrative: Started with neck stiffness, that was very uncomfortable to start off with, then the stiffness worked its way thru my entire body. With the left side ( the side I got the shot on) becoming extremely stiff and to the point painful.  Night sweats.  It took two days to feel better sort of.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Swelling face
Clinical narrative: Employee felt pressure on the right side of her head and noticed swelling on the right side of her face.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site urticaria, Pruritus, Urticaria
Clinical narrative: 10 minutes after administration employee developed red hives on neck, chest, injection site and down left arm, back, abdomen, thighs and buttocks - completely generalized. Itching profusely. Benadryl given by mouth for treatment.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Itching and rash at injection site.
Age: 65.0
Sex: F
Vaccine: FLU3, MMR
Symptoms: Antinuclear antibody, Arthralgia, Gait disturbance, HLA marker study, Lymphadenopathy
Clinical narrative: Approx, 4-5 days later experience neck pain & swollen lymph glds in neck & around ears. Symptoms progressed to severe arthralgia in joints, knees, ankles, wrists & fingers. Became difficult to walk, up down stairs & to hold onto objects. Broke out in rash red dots over legs, chest, and stomach.
Age: 65.0
Sex: F
Vaccine: FLU3, MMR
Symptoms: Neck pain, Rash, Rash erythematous, Red blood cell sedimentation rate increased, Rheumatoid factor increased
Clinical narrative: Approx, 4-5 days later experience neck pain & swollen lymph glds in neck & around ears. Symptoms progressed to severe arthralgia in joints, knees, ankles, wrists & fingers. Became difficult to walk, up down stairs & to hold onto objects. Broke out in rash red dots over legs, chest, and stomach.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Patient had rash on face, neck, forearms, and back 10/12/13. Referred to private MD if rash continues.
Age: 44.0
Sex: F
Vaccine: FLUC3
Symptoms: Injected limb mobility decreased, Injection site haematoma, Injection site pain, Nuclear magnetic resonance imaging abnormal, Paraesthesia
Clinical narrative: "Developed left shoulder pain at the flu shot site few days after the flu vaccination. Then 2 days later, developed limitation in the range of motion of the left arm and left shoulder, then noticed the large hematoma at the site where the flu shot was given. Also noticed tingling in my small and ring fingers."
Age: 44.0
Sex: F
Vaccine: FLUC3
Symptoms: Tendonitis
Clinical narrative: "Developed left shoulder pain at the flu shot site few days after the flu vaccination. Then 2 days later, developed limitation in the range of motion of the left arm and left shoulder, then noticed the large hematoma at the site where the flu shot was given. Also noticed tingling in my small and ring fingers."
Age: 46.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Blood creatine phosphokinase, Full blood count, Hyperhidrosis, Metabolic function test
Clinical narrative: Patient received pneumo PRSV 12-10-13. Patient called complaining of pain "head to toe". States body hurts, joint pain and fever - non confirmed 12-11-13. Appt made 12-12-13. Patient canceled. Patient called 12-16-13, c/o sweating, achy, ribs hurt. Patient schedule appt 12-17-13 for 12-18-13. Arrived.
Age: 46.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Musculoskeletal chest pain, Pain, Pyrexia, Red blood cell sedimentation rate decreased, Urine analysis
Clinical narrative: Patient received pneumo PRSV 12-10-13. Patient called complaining of pain "head to toe". States body hurts, joint pain and fever - non confirmed 12-11-13. Appt made 12-12-13. Patient canceled. Patient called 12-16-13, c/o sweating, achy, ribs hurt. Patient schedule appt 12-17-13 for 12-18-13. Arrived.
Age: 46.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Patient received pneumo PRSV 12-10-13. Patient called complaining of pain "head to toe". States body hurts, joint pain and fever - non confirmed 12-11-13. Appt made 12-12-13. Patient canceled. Patient called 12-16-13, c/o sweating, achy, ribs hurt. Patient schedule appt 12-17-13 for 12-18-13. Arrived.
Age: 14.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Discomfort, Disorientation, Dizziness, Electrocardiogram, Emotional distress
Clinical narrative: 12 minutes after immunizations while she was with her mother in the front waiting room she became dizzy and lost consciousness bumping her right cheek on the rounded edge of a wooden coffee table. She remained semi-responsive for 30 seconds or so. Ultimately became conversant and relatively oriented though she had difficulty remembering what day it was and initially what month it was. Ice pack was applied to her right cheek. There was a tiny point of bleeding and swelling. Malar bones appeared normal. She was observed in the office for almost 2 hours but became somewhat dizzy and nauseous when she sat up. The patient admitted part of her discomfort was emotional. We did ultimately take her to the emergency room in a wheelchair. She seemed to be improving actually at that point.
Age: 14.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Face injury, Haemorrhage, Hyporesponsive to stimuli, Loss of consciousness, Nausea
Clinical narrative: 12 minutes after immunizations while she was with her mother in the front waiting room she became dizzy and lost consciousness bumping her right cheek on the rounded edge of a wooden coffee table. She remained semi-responsive for 30 seconds or so. Ultimately became conversant and relatively oriented though she had difficulty remembering what day it was and initially what month it was. Ice pack was applied to her right cheek. There was a tiny point of bleeding and swelling. Malar bones appeared normal. She was observed in the office for almost 2 hours but became somewhat dizzy and nauseous when she sat up. The patient admitted part of her discomfort was emotional. We did ultimately take her to the emergency room in a wheelchair. She seemed to be improving actually at that point.
Age: 14.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Swelling
Clinical narrative: 12 minutes after immunizations while she was with her mother in the front waiting room she became dizzy and lost consciousness bumping her right cheek on the rounded edge of a wooden coffee table. She remained semi-responsive for 30 seconds or so. Ultimately became conversant and relatively oriented though she had difficulty remembering what day it was and initially what month it was. Ice pack was applied to her right cheek. There was a tiny point of bleeding and swelling. Malar bones appeared normal. She was observed in the office for almost 2 hours but became somewhat dizzy and nauseous when she sat up. The patient admitted part of her discomfort was emotional. We did ultimately take her to the emergency room in a wheelchair. She seemed to be improving actually at that point.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Myalgia, Sensation of heaviness, Tenderness
Clinical narrative: Patient says that muscle soreness started (as expected) after the injection.  At the time the soreness was not at a level to be concerned.  The soreness has continued beyond the expected three days and has somewhat increased.  Patient has not yet been seen by a physician; she noted the continued soreness to another pharmacist and was told to contact the pharmacy where she had received the vaccination.  She reports that the muscle soreness is "sore" and feels "heavy" like she has worked out strenously.  She claims that it is at a level of impairing her day to day functions.   She says that the soreness occurs when she lifts objects, bumps her arm, or lays on the arm.   She reports no recent illnesses, no fever, no discoloration, and no swelling of the arm or at the injection site.  She says that the soreness has been persistent since receiving the injection on 11/24/13.  She has not yet treated the soreness but was advised to be seen by a physician.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: Patient developed an allergic reaction several hours after recieving the flu immunization. Patient reported to the ER and was treated and released.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling around injection site and spreading to underarm. Started on cephalexin 500 mg PO TID for 10 days on 12/19/13.
Sex: M
Vaccine: RAB, TTOX
Symptoms: Dyspnoea, Immediate post-injection reaction, Immune system disorder, Pain in extremity, Pallor
Clinical narrative: Case number PHEH2013US025792 is an initial spontaneous report received from a consumer (patient) on 12 Dec 2013. This report refers to a male patient of an unknown age. His medical history and concomitant medications were not reported. He was vaccinated with RABAVERT (batch number: unknown), with first dose on 03 Nov 2013 (day 0) and second dose on 06 Nov 2013 (day 3). He was vaccinated with IMOVAX (other manufacturer, batch number: unknown) intramuscularly as third dose on 11 Nov 2013 (day 7). On the same day, immediately after IMOVAX administration, he felt pale, could not breathe, had arm pain and went to cardiologist who gave him a tetanus shot that helped him to breathe. He was 99.99% sure that it was acute blood poisoning. He insisted that he overheard that the nurse saying it was the first time administering IMOVAX to a patient and therefore he believed that the nurse had caused acute blood poisoning. He received treatment with IV fluids, an HIV cocktail (started the day after IMOVAX), and antibiotics that were taken for the arm pain (starting with CIPRO followed by LEVAQUIN). His WBC level was increased, after IMOVAX administration, compared to the values seen one week prior. He also reported that "his immune system crashed three weeks ago after an exchange of body fluids that occurred" which was treated with TRUVADA, which allowed him to breathe 90% better. He received remaining two post exposure injections with RABAVERT (batch number unknown) on unspecified dates. He stated that he was 99 to 100% sure that he had reported all the events. Outcome of the events was unknown. No seriousness and causality was reported for the events.
Sex: M
Vaccine: RAB, TTOX
Symptoms: Poisoning, White blood cell count increased
Clinical narrative: Case number PHEH2013US025792 is an initial spontaneous report received from a consumer (patient) on 12 Dec 2013. This report refers to a male patient of an unknown age. His medical history and concomitant medications were not reported. He was vaccinated with RABAVERT (batch number: unknown), with first dose on 03 Nov 2013 (day 0) and second dose on 06 Nov 2013 (day 3). He was vaccinated with IMOVAX (other manufacturer, batch number: unknown) intramuscularly as third dose on 11 Nov 2013 (day 7). On the same day, immediately after IMOVAX administration, he felt pale, could not breathe, had arm pain and went to cardiologist who gave him a tetanus shot that helped him to breathe. He was 99.99% sure that it was acute blood poisoning. He insisted that he overheard that the nurse saying it was the first time administering IMOVAX to a patient and therefore he believed that the nurse had caused acute blood poisoning. He received treatment with IV fluids, an HIV cocktail (started the day after IMOVAX), and antibiotics that were taken for the arm pain (starting with CIPRO followed by LEVAQUIN). His WBC level was increased, after IMOVAX administration, compared to the values seen one week prior. He also reported that "his immune system crashed three weeks ago after an exchange of body fluids that occurred" which was treated with TRUVADA, which allowed him to breathe 90% better. He received remaining two post exposure injections with RABAVERT (batch number unknown) on unspecified dates. He stated that he was 99 to 100% sure that he had reported all the events. Outcome of the events was unknown. No seriousness and causality was reported for the events.
Age: 0.97
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray normal, Cough, Dyspnoea, Nasal congestion, Respiratory distress
Clinical narrative: Shortness of breath onset Monday night and continued for following 2 nights and went to ER on the third night. In ER T 98.3, HR 120bpm, RR 32, O2 sat 100% on admission, nasal congestion, coughing, worsens when supine. Discharged same day with Dx of resp. distress. Followed up by PCP on 12/19/13. Lungs clear, afebrile, Dx URI.
Age: 0.97
Sex: M
Vaccine: FLU3
Symptoms: Spinal X-ray normal, Upper respiratory tract infection
Clinical narrative: Shortness of breath onset Monday night and continued for following 2 nights and went to ER on the third night. In ER T 98.3, HR 120bpm, RR 32, O2 sat 100% on admission, nasal congestion, coughing, worsens when supine. Discharged same day with Dx of resp. distress. Followed up by PCP on 12/19/13. Lungs clear, afebrile, Dx URI.
Age: 41.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pain, Soft tissue mass, Swelling, Tenderness
Clinical narrative: Redness, pain and swelling - soft tissue mass mildly tender well circumscribe.
Age: 41.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Varicella virus test
Clinical narrative: Redness, pain and swelling - soft tissue mass mildly tender well circumscribe.
Age: 1.86
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Decreased appetite, Pyrexia
Clinical narrative: High fever, with acetaminophen of 103 sustained for 2 days. Loss of appetite.
Age: 17.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site pruritus, Injection site urticaria, Injection site warmth, Malaise
Clinical narrative: Hives, itching, warmth around injection site.  General ill feeling.  Given Motrin 600 mg at onset.  Applied OTC Cortisone 10 cream in late PM and in AM of 12/19/13.  Gave Benadryl 25 mg at bedtime on 12/18/13.
Age: 21.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered
Clinical narrative: Client was given a pediatric dose of Hepatitis A instead of adult dose and was given a Tdap that was not yet due.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Local swelling
Clinical narrative: Pt contacted the pharmacy on 12/18/13 and stated that she had redness at the site of injection and that her arm has a raised swollen area of 1&1/2 inches. Spoke to the pt on 12/19/13 and she says the arm is about the same. She thinks taking Benadryl and using aloe on the site has helped some. At this time she did not think she needed to contact the doctor but if it started to get worse she would call the doctor.
Age: 34.0
Sex: F
Vaccine: YF
Symptoms: Activities of daily living impaired, Dizziness, Headache, Lumbar puncture abnormal, Malaise
Clinical narrative: Initial report received from a healthcare professional on 10 December 2013: A 34 year-old female patient who had no illness at the time of vaccination, had iodine allergy and concomitant medication were not reported, had received a subcutaneous dose of YF-VAX (lot number, dose number, and anatomical site of administration were not reported) on 03 December 2013. On 03 December 2013 at evening, the patient had a severe headache and malaise. Next day, the physician saw the patient and still the patient had severe frontal headache, dizziness, and not able to function normally. The patient went to Emergency Room. Lumbar puncture performed and results showed Aseptic Meningitis. The patient was admitted and discharged after 3 days. The patient had received TYLENOL, IMITREX, REGLAN, TORADOL, Magnesium and DECADRON as corrective treatments. At the time of this report, the patient had not recovered from events.
Age: 34.0
Sex: F
Vaccine: YF
Symptoms: Meningitis aseptic
Clinical narrative: Initial report received from a healthcare professional on 10 December 2013: A 34 year-old female patient who had no illness at the time of vaccination, had iodine allergy and concomitant medication were not reported, had received a subcutaneous dose of YF-VAX (lot number, dose number, and anatomical site of administration were not reported) on 03 December 2013. On 03 December 2013 at evening, the patient had a severe headache and malaise. Next day, the physician saw the patient and still the patient had severe frontal headache, dizziness, and not able to function normally. The patient went to Emergency Room. Lumbar puncture performed and results showed Aseptic Meningitis. The patient was admitted and discharged after 3 days. The patient had received TYLENOL, IMITREX, REGLAN, TORADOL, Magnesium and DECADRON as corrective treatments. At the time of this report, the patient had not recovered from events.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. On 23-SEP-2013, the patient was vaccinated with GARDASIL (lot # J003727 and expiration date 07-NOV-2015 (also reported as 08-NOV-2015). It was reported that the vaccine was improperly stored and was exposed to below 31.6 Fahrenheit from 09-SEP-2013 to 23-SEP-2013. No further information was available at the time of the report. The case is linked to 1312USA001445, 1312USA008847, 1312USA008940, 1312USA008941, 1312USA008942, 1312USA008944, 1312USA008945 (same reporter link). Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site nodule, Local reaction, Local swelling, Pruritus
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 67 year old female patient who on 02-DEC-2013 at 10:24 am, was vaccinated with the 1st dose of ZOSTAVAX (lot # J006827, expiration date 14-SEP-2014 in the left arm. Concomitant therapies included fluconazole, VAGIFEM, vitamin D, NEXIUM, azelastine hydrochloride, BENICAR and SPIRIVA. On 28-OCT-2013, the patient received a dose of FLUZONE HIGH DOSE in the left arm too. On 06-DEC-2013, the patient experienced localized reaction of a large knot developing at injection site, redness and swelling of arm that spread to elbow from middle of upper arm. The patient required emergency room/doctor visit. She was treated with BENADRYL for itching and clindamycin. The outcome of swelling of arm that spread to elbow from middle of upper arm, redness and localized reaction of a large knot developing at injection site was reported as recovered/resolved on an unknown date. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Fall, Guillain-Barre syndrome
Clinical narrative: Admitted to acute hospital after a fall at home 9/24/13. Pt fell out of her wheelchair. She had recently seen a neurologist for increased weakness. Pt has received inpatient skilled care for this weakness and is still all inpatient. Neurologist saw pt 11/4/13. Diagnosed Guillain Barre.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site induration, Pruritus, Rash, Skin warm
Clinical narrative: Rash on entire tricep and radiating around toward bicep on right arm. Itchy, warm to touch, red circular spots around tricep, injection site hard/firm to touch.
Age: 1.65
Sex: F
Vaccine: DTAP, FLU3, HEPA
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site swelling
Clinical narrative: Right thigh injection site started swelling and reddened approximately 24 hours after. Approximately 36 hours after had bleeding from site. Redness and swelling cont to increase. Red area 14 cm x 7 cm.
Age: 18.0
Sex: M
Vaccine: FLUC3
Symptoms: Fall
Clinical narrative: Pt breathing hard before immunization leaning forward. Administered vaccine, asked pt if they wanted a Band-Aid. Turned to grab a Band-Aid and pt fell to the ground face first. Pt MD told him to come in.
Age: 39.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Activated partial thromboplastin time, Contusion, Ecchymosis, Full blood count, Injection site swelling
Clinical narrative: Urticaria, bruising/ecchymosis, malaise, localized swelling at injection site.
Age: 39.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Malaise, Metabolic function test, Prothrombin time, Urine analysis, Urticaria
Clinical narrative: Urticaria, bruising/ecchymosis, malaise, localized swelling at injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash itching.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local reaction to vaccine site on upper left arm - redness and wamrth present with mild swelling. No induration. Orapred 15mg/5ml 1 tsp PO given at visit and prescription for same dose x 3 more days given.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Limb discomfort, Pyrexia
Clinical narrative: BOTH VACCINES GIVEN IN LEFT ARM 11/26/13.  11/27/13 MORNING THE L ARM BECAME VERY UNCOMFORTABLE; SYSTEMIC PAIN IN JOINTS; 11/27 PM BECAME FEVERISH TEMP 101.6. 11/28/13 P.M. TEMP 103.3 X 24 HOURS; SAW PRIVATE MD 11/29/13. Rx KEFLEX 500 MGM QID; SAW MD AGAIN 11/30/13 AND STARTED ON PREDNISONE.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Conjunctivitis
Clinical narrative: Development of bilateral conjunctivitis within 3 hours of nasal flu vaccine.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Emotional distress, Injection site erythema, Injection site swelling, Screaming
Clinical narrative: Patient screamed and cried uncontrollably for hours. Patient was unable to be consoled and felt very warm to the touch. Pt's thigh was also very swollen and red.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Skin warm
Clinical narrative: Patient screamed and cried uncontrollably for hours. Patient was unable to be consoled and felt very warm to the touch. Pt's thigh was also very swollen and red.
Age: 12.0
Sex: M
Vaccine: FLUN4
Symptoms: Pyrexia
Clinical narrative: Fever for < 24 hours: 100.5.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Large red swollen area around vaccine admin site, spreading length of arm from elbow to shoulder. Red, warm.
Age: 4.0
Sex: F
Vaccine: MMRV, PPV
Symptoms: Abasia, Lethargy, Pyrexia, Vomiting
Clinical narrative: Inability to walk. Severe vomiting episode. Low grade fever, lethargy.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Immediate post-injection reaction, Injection site nerve damage, Injection site pain, Middle insomnia
Clinical narrative: Immediately had a soreness from shot (which is normal).  Then that evening it was worse and the next day it was worse and the next day as well.  I took ibuprofen but it really didn't help.  My arm was so painful that it woke me up at nights.  I had sharp shooting pains when lifted a certain way.  I lost strength in the arm.  I have had the flu shot about 6 times now but it was the first time in my left arm.  Normally I get it in the right arm.  After about 3 weeks of it not getting better, I went to the doctor who said that the nurse probably hit a nerve.  I am petite and have very lean arms.  He prescribed vicodin, Gabapentin, and Nabumetone.  I am now on my 2nd prescription of Nabumetone.  I still have pain and it is almost 2 months after the flu shot.  I am very healthy and exercise on a regular basis and have no physical problems.  I know this reaction is from the flu shot because it immediately started bothering me and hasn't stopped yet.  I have lost strength in my arm and it continues to hurt.  I hope it isn't permanent but I am not sure.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity
Clinical narrative: Immediately had a soreness from shot (which is normal).  Then that evening it was worse and the next day it was worse and the next day as well.  I took ibuprofen but it really didn't help.  My arm was so painful that it woke me up at nights.  I had sharp shooting pains when lifted a certain way.  I lost strength in the arm.  I have had the flu shot about 6 times now but it was the first time in my left arm.  Normally I get it in the right arm.  After about 3 weeks of it not getting better, I went to the doctor who said that the nurse probably hit a nerve.  I am petite and have very lean arms.  He prescribed vicodin, Gabapentin, and Nabumetone.  I am now on my 2nd prescription of Nabumetone.  I still have pain and it is almost 2 months after the flu shot.  I am very healthy and exercise on a regular basis and have no physical problems.  I know this reaction is from the flu shot because it immediately started bothering me and hasn't stopped yet.  I have lost strength in my arm and it continues to hurt.  I hope it isn't permanent but I am not sure.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Arm swelled up and become hot and itchy and sore.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Tenderness
Clinical narrative: Patient says that he developed the expected muscle soreness from the injection but that it did not go away after 3 days.  He claims that his arm is still sore (he likens it to a rotator cuff injury).  The pain has not increased from the original soreness.  He claims that the soreness goes away but comes back when he touches his arm or he sleeps on his arm.  He reports no swelling, no fever, and no discoloration of the arm or around the injection site.  He has not had any recent illnesses (nor before the vaccine) and did not have any recent vaccines prior to the flu shot.  He reports that he has not yet seen a physician regarding the soreness.  His reaction was brought to our attention by his friend who was vaccinated at the same time and reports a similar reaction (VAERS E-report number E-76990).  He says his only treatment thus far has been to ice his arm.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia, Flushing, Headache, Swelling face
Clinical narrative: Pt became flush and had a headache.  One side of his jaw became swollen.  Had difficulty swallowing. Went to ER. Was given 2 Benadryl tablets and observed for 1 hour.  Then pt was released.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient states that she has gotten injected to her tendon and she experiences pain and unable to lift her arm.
Age: 0.6
Sex: F
Vaccine: 6VAX-F, PPV, RVX
Symptoms: Urticaria
Clinical narrative: Urticaria.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event. Error in vaccine administration.