chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Neuropathy peripheral
Clinical narrative: Neuropathy in left thumb between proximal interphalangeal joint and distal interphalangeal joint, no change with chiropractic adjustment to wrist and bones of hand and thumb.
Age: 97.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Eye pruritus, Fatigue, Headache
Clinical narrative: PT COMPLAINED OF ITCHY WATERY EYES, AND COUGH LEADING TO DIFFICULTY BREATHING AND SEVERE HEADACHE - PT TOOK IBUPROFEN, THEN NORCO AND BENEDRYL AND SYMPTOMS RELIEVED - PT SAID SHE WAS STILL FEELING RUN DOWN 24 HOURS AFTER VACCINE.
Age: 97.0
Sex: F
Vaccine: FLU3
Symptoms: Lacrimation increased
Clinical narrative: PT COMPLAINED OF ITCHY WATERY EYES, AND COUGH LEADING TO DIFFICULTY BREATHING AND SEVERE HEADACHE - PT TOOK IBUPROFEN, THEN NORCO AND BENEDRYL AND SYMPTOMS RELIEVED - PT SAID SHE WAS STILL FEELING RUN DOWN 24 HOURS AFTER VACCINE.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Chills, Diarrhoea, Fatigue, Nausea
Clinical narrative: 2017.10.09, 930 PM 100.4 temperature, chills and diarrhea. Took two 500 mg acetaminophen caplets and two 2 mg loperamide HCL tablets. 10:44 PM 100.9 temp, chills and severe diarrhea. 11:47 PM 101.4 temp, chills and diarrhea. 2017.10.10, 2:22 AM 100.4 temp, nausea with vomiting and diarrhea. Would have tried to take more for fever, but couldn't possibly keep anything down. 12:56 PM 100.3 temp and body aches. Mostly diarrhea, chills and nausea had subsided. 1:20 PM took two more 500 mg acetaminophen caplets for remaining temp and body aches. 9:04 PM 98.4 temp with fatigue and body aches. 2017.10.11, spent the majority of the day in bed sleeping and resting. 2017.10.12, back up and about.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Vomiting
Clinical narrative: 2017.10.09, 930 PM 100.4 temperature, chills and diarrhea. Took two 500 mg acetaminophen caplets and two 2 mg loperamide HCL tablets. 10:44 PM 100.9 temp, chills and severe diarrhea. 11:47 PM 101.4 temp, chills and diarrhea. 2017.10.10, 2:22 AM 100.4 temp, nausea with vomiting and diarrhea. Would have tried to take more for fever, but couldn't possibly keep anything down. 12:56 PM 100.3 temp and body aches. Mostly diarrhea, chills and nausea had subsided. 1:20 PM took two more 500 mg acetaminophen caplets for remaining temp and body aches. 9:04 PM 98.4 temp with fatigue and body aches. 2017.10.11, spent the majority of the day in bed sleeping and resting. 2017.10.12, back up and about.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Seizure, Syncope
Clinical narrative: Patient fainted within seconds of influenza vaccination. Patient's entire body seized for about 10 seconds. Patient was unconscious for two to three minutes. Pharmacists kept patient seated on floor once he regained consciousness. Emergency Paramedics were called and patient was taken to a local hospital. Patient was awake and speaking when paramedics arrived to the scene.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Joint stiffness, Malaise, Migraine, Pain, Peripheral swelling
Clinical narrative: Migraine type headache, severe stiffness of joints and body aches, sensitivity to light, sensitivity to noise, frequent urination, swollen arm,  general malaise.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Photophobia, Pollakiuria
Clinical narrative: Migraine type headache, severe stiffness of joints and body aches, sensitivity to light, sensitivity to noise, frequent urination, swollen arm,  general malaise.
Age: 89.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Musculoskeletal stiffness, Rash erythematous
Clinical narrative: PATIENT HAD WHAT APPEARED TO BE AN INJECTION SITE REACTION. PATIENT DESCRIBED RED RASH, SORENESS, STIFFNESS, AND WARMTH LOCALIZED TO AREA AROUND INJECTION IN LEFT ARM.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Somnolence, Syncope
Clinical narrative: Immunization screening/counseling. No contraindications noted and NKA Client fainted while on table, assisted to lying position with assistance of mother. LOC approximately 5 seconds, verbal, but groggy x 10 seconds. Applied cold pack to base of neck. B/P 104/60 which is around "my usual" states client. Increase HOB to Semi reclined position x10 minutes w/o any dizziness. Mom expressed concern with fainting on previous occasions, usually assoc. with a medical procedure. Recommended asking her Dr as a precaution.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Injection site erythema, Injection site mass, Malaise, Pain
Clinical narrative: Fever (100 F) lasting 3 days - low dose NSAI - resolved. Headache lasting 6 days - low dose NSAI - resolved. Body aches (manly torso) lasting 3 days - low dose NSAI - resolved. Malaise lasting 7 days - no treatment / bed rest - resolved. Lump, golf ball sized at injection site lasting 6 days - no treatment- resolved. Erythema at injection site, 7" by 4" sized lasting 7 days - no treatment - resolved.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Fever (100 F) lasting 3 days - low dose NSAI - resolved. Headache lasting 6 days - low dose NSAI - resolved. Body aches (manly torso) lasting 3 days - low dose NSAI - resolved. Malaise lasting 7 days - no treatment / bed rest - resolved. Lump, golf ball sized at injection site lasting 6 days - no treatment- resolved. Erythema at injection site, 7" by 4" sized lasting 7 days - no treatment - resolved.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Fatigue, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Immense swelling in the injection site and surrounding areas such as shoulder, arm and chest. High fever of 104 degrees for seven consecutive days. Fatigue and lethargic movements during the days of fever accompanied with slow speech. Flesh at the injection site is very hot to the touch, and intense pain where swelling has occurred. Called the Advice nurse and was connected to an on site doctor who listened to symptoms and determined patient did not need to be seen. Photos of patient were taken to document image of swelling and redness.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Lethargy, Pyrexia, Slow speech, Swelling
Clinical narrative: Immense swelling in the injection site and surrounding areas such as shoulder, arm and chest. High fever of 104 degrees for seven consecutive days. Fatigue and lethargic movements during the days of fever accompanied with slow speech. Flesh at the injection site is very hot to the touch, and intense pain where swelling has occurred. Called the Advice nurse and was connected to an on site doctor who listened to symptoms and determined patient did not need to be seen. Photos of patient were taken to document image of swelling and redness.
Age: 6.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swollen, red, hot to touch.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test normal, Dizziness, Electrocardiogram normal, Headache
Clinical narrative: Extreme flu-like symptoms, especially dizziness, weakness, blacking out, headache, body aches, nausea began approximately 12 hours after receiving vaccine and lasted 1 1/2 days, tapering off by day 3. Went to GP (CNP), who did a battery of tests: EKG, urinalysis, blood work, neuro exam, all negative.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Loss of consciousness, Nausea, Neurological examination normal, Pain
Clinical narrative: Extreme flu-like symptoms, especially dizziness, weakness, blacking out, headache, body aches, nausea began approximately 12 hours after receiving vaccine and lasted 1 1/2 days, tapering off by day 3. Went to GP (CNP), who did a battery of tests: EKG, urinalysis, blood work, neuro exam, all negative.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Urine analysis normal
Clinical narrative: Extreme flu-like symptoms, especially dizziness, weakness, blacking out, headache, body aches, nausea began approximately 12 hours after receiving vaccine and lasted 1 1/2 days, tapering off by day 3. Went to GP (CNP), who did a battery of tests: EKG, urinalysis, blood work, neuro exam, all negative.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9, MNQ
Symptoms: Cyanosis, Injection site pain, Memory impairment, Seizure, Syncope
Clinical narrative: 2 minutes after HPV was administered the patient complained of pain in the area seconds later turn blue to color and fainted falling to the left side. Patient did three slight convulsions. Within 10 seconds patient came to and did not remember the event that happened. We kept the patient in the office till mom was comfortable with taking him home
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9, MNQ
Symptoms: Fall, Memory impairment, Pain in extremity, Pallor, Seizure
Clinical narrative: 2 minutes after HPV was administered the patient complained of pain in the area seconds later turn blue to color and fainted falling to the left side. Patient did three slight convulsions. Within 10 seconds patient came to and did not remember the event that happened. We kept the patient in the office till mom was comfortable with taking him home
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Developed full body hives.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Arthropod bite, Erythema
Clinical narrative: 2 x 1.5 inch area of erythema.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: 12 hour after flu vaccine patient reports that she developed hives, urticaria, and "silver dollar sized welts" on her buttocks, groin, and backs of arms and legs that felt like being bitten by "fire ants." She reports that all areas that were affected were "covered by clothing." She denies any exposure to new plants, animals, foods, drugs etc. She states she was not gardening prior to her symptoms. She has an allergy to Benadryl, but per her local pharmacisit's  guidance, took one dose of Zyrtec and reports her symptoms resolved 30 minutes later and have not recurred to-date. She did not go to urgent care for her symptoms. She denies rash, swelling, itching to face/throat/neck, difficulty breathing, wheezing. She denies prior history of reaction to flu-shots or any other immunizations.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Injected limb mobility decreased, Injection site warmth, Nausea, Pain in extremity
Clinical narrative: Pain in arm, not able to lift arm where injection administered, headache, site hot to touch, fever and nausea.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Pain in arm, not able to lift arm where injection administered, headache, site hot to touch, fever and nausea.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Localized injection reaction to left upper arm.
Age: 76.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Headache, Peripheral swelling, Skin warm
Clinical narrative: Patients arm started swelling around 9pm after receiving the vaccine at 4:40pm. Also reported fever in her arm and headache and went to the doctor the next night for treatment at the time of reporting the patient has only taken advil for treatment and reported improvement in symptoms
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Pyrexia
Clinical narrative: Patient reported symptoms of chills and fever on the evening after receiving her Tdap vaccine.
Age: 33.0
Sex: M
Vaccine: FLU4, HEPAB
Symptoms: Dizziness, Loss of consciousness, Posture abnormal, Unresponsive to stimuli
Clinical narrative: Pharmacist asked patient about his past history of vaccinations. Patient reported no past history of dizziness, fainting, or adverse reaction to any vaccine. After administering both vaccines, pharmacist informed patient he needed to stay around for a minimum of 20 min. to ensure that he had no severe reaction that required medical attention. He was told to let the pharmacist know if he started feeling funny. He immediately told the pharmacist that he felt as if he were going to faint. At that time the patient closed his eyes. The pharmacist called out to patient and asked if he was ok. The pharmacists patted the patient to see if he was still conscious. The patient did not respond. The pharmacist then proceeded to stand up beside patient in case he were to go limp and/or fall out of chair. Pharmacist informed the other pharmacist on duty of the patients condition and requested a cool compress from the emergency supply kit. The cool compress was applied and the pharmacist continued to call out to patient. The pharmacist checked the patient for a pulse. A strong pulse was present. The other pharmacist present retrieved an epipen from the emergency supply kit in case it was needed. The The pharmacist had someone bring some orange juice to the patient to drink. The pharmacists observed the patient for approx 30 minutes after the incident. Upon leaving the patient reported having no more symptoms and told his coworks he was fine to drive. The pharmacist called the patient that evening at 7:45pm. The patient said he felt fine and had no more complications. The patient's primary doctor was notified the next day of the incident.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: DTaP lot expired on 5/17/17 and was administered after the expiration date on 5/23/2017. No signs, symptoms, or issues resulted in vaccine being administered after the expiration date. Patient tolerated the vaccines.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Immediate post-injection reaction, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Employee health flu shot clinic. No privacy area set up. Asked to pull shirt down over my shoulder. Concerned that I could not pull it far enough down. RN administering vaccine stated "it should be good enough" and injected me quickly, at the top of my shoulder. Did not use landmarks. Felt buzz/shock feeling with administration of medication. Arm ached immediately and continued to hurt. Progressed over the next couple of days to where I could not lift arm more than 45 degrees or cross it over my chest without pain. Diagnosed with bursitis at the ER (09/22/2017) and impingement syndrome at the Orthopedic office(09/29/2017).  Currently taking Naproxen, applying heat and doing two arm stretch exercises daily.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Rotator cuff syndrome, X-ray limb abnormal
Clinical narrative: Employee health flu shot clinic. No privacy area set up. Asked to pull shirt down over my shoulder. Concerned that I could not pull it far enough down. RN administering vaccine stated "it should be good enough" and injected me quickly, at the top of my shoulder. Did not use landmarks. Felt buzz/shock feeling with administration of medication. Arm ached immediately and continued to hurt. Progressed over the next couple of days to where I could not lift arm more than 45 degrees or cross it over my chest without pain. Diagnosed with bursitis at the ER (09/22/2017) and impingement syndrome at the Orthopedic office(09/29/2017).  Currently taking Naproxen, applying heat and doing two arm stretch exercises daily.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase increased, Biopsy bone marrow, Blood alkaline phosphatase normal
Clinical narrative: Patient is a 14 year old male who received an Influenza Vaccine IM 3 yrs + 4 Valent IIV4 manufactured by Sanofi Pasteur (Lot#: UT5937KA) on 10/6/2017. He was admitted to Hospital on 10/8 for generalized rash, SIRS criteria, and hemodynamic instability, and mild joint pain. He has a past medical history significant for Juvenile idiopathic arthritis (JIA) diagnosed 8/2017 and well controlled on 100 mg Anakinra SubQ QD for previous 5 weeks. He had cellulitis S/P BACTRIM treatment 1 week (D/C Friday 10/6), healing well. He met SIRS criteria in ED, and was hypotensive with wide pulse pressure. He was given 3x boluses IVF and started on ceftriaxone 10/8 which was discontinued on 10/9 with symptomatic improvement and no source of infection. ID consulted, suspected ehrlichiosis, started on empiric doxycycline. Patient was symptomatically unchanged on 10/10; however, ferritin and CRP rose strikingly, Rheum concerned for worsening JIA complicated by Macrophage activation syndrome (MAS). Possibly JIA secondary to URI. Anakinra doubled. On 10/11 patient developed moderate transaminitis, with LDH elevated 1270; minor concern for leukemia. Symptomatically unchanged. Bone marrow biopsy was successfully performed on 10/12; pathology and cytogenetics pending, AM labs showed significant decrease in inflammatory markers, WBC and platelet levels, patient symptomatically better. Anticipate discharge on 10/13 if AM inflammatory markers are improving.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Blood bilirubin decreased, Blood creatine phosphokinase normal, Blood lactate dehydrogenase increased, Blood uric acid increased, C-reactive protein increased
Clinical narrative: Patient is a 14 year old male who received an Influenza Vaccine IM 3 yrs + 4 Valent IIV4 manufactured by Sanofi Pasteur (Lot#: UT5937KA) on 10/6/2017. He was admitted to Hospital on 10/8 for generalized rash, SIRS criteria, and hemodynamic instability, and mild joint pain. He has a past medical history significant for Juvenile idiopathic arthritis (JIA) diagnosed 8/2017 and well controlled on 100 mg Anakinra SubQ QD for previous 5 weeks. He had cellulitis S/P BACTRIM treatment 1 week (D/C Friday 10/6), healing well. He met SIRS criteria in ED, and was hypotensive with wide pulse pressure. He was given 3x boluses IVF and started on ceftriaxone 10/8 which was discontinued on 10/9 with symptomatic improvement and no source of infection. ID consulted, suspected ehrlichiosis, started on empiric doxycycline. Patient was symptomatically unchanged on 10/10; however, ferritin and CRP rose strikingly, Rheum concerned for worsening JIA complicated by Macrophage activation syndrome (MAS). Possibly JIA secondary to URI. Anakinra doubled. On 10/11 patient developed moderate transaminitis, with LDH elevated 1270; minor concern for leukemia. Symptomatically unchanged. Bone marrow biopsy was successfully performed on 10/12; pathology and cytogenetics pending, AM labs showed significant decrease in inflammatory markers, WBC and platelet levels, patient symptomatically better. Anticipate discharge on 10/13 if AM inflammatory markers are improving.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Haemodynamic instability, Haemoglobin normal, Human ehrlichiosis, Hypotension, Pathology test
Clinical narrative: Patient is a 14 year old male who received an Influenza Vaccine IM 3 yrs + 4 Valent IIV4 manufactured by Sanofi Pasteur (Lot#: UT5937KA) on 10/6/2017. He was admitted to Hospital on 10/8 for generalized rash, SIRS criteria, and hemodynamic instability, and mild joint pain. He has a past medical history significant for Juvenile idiopathic arthritis (JIA) diagnosed 8/2017 and well controlled on 100 mg Anakinra SubQ QD for previous 5 weeks. He had cellulitis S/P BACTRIM treatment 1 week (D/C Friday 10/6), healing well. He met SIRS criteria in ED, and was hypotensive with wide pulse pressure. He was given 3x boluses IVF and started on ceftriaxone 10/8 which was discontinued on 10/9 with symptomatic improvement and no source of infection. ID consulted, suspected ehrlichiosis, started on empiric doxycycline. Patient was symptomatically unchanged on 10/10; however, ferritin and CRP rose strikingly, Rheum concerned for worsening JIA complicated by Macrophage activation syndrome (MAS). Possibly JIA secondary to URI. Anakinra doubled. On 10/11 patient developed moderate transaminitis, with LDH elevated 1270; minor concern for leukemia. Symptomatically unchanged. Bone marrow biopsy was successfully performed on 10/12; pathology and cytogenetics pending, AM labs showed significant decrease in inflammatory markers, WBC and platelet levels, patient symptomatically better. Anticipate discharge on 10/13 if AM inflammatory markers are improving.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Platelet count decreased, Pulse pressure increased, Rash generalised, Red blood cell sedimentation rate increased, Reticulocyte count decreased
Clinical narrative: Patient is a 14 year old male who received an Influenza Vaccine IM 3 yrs + 4 Valent IIV4 manufactured by Sanofi Pasteur (Lot#: UT5937KA) on 10/6/2017. He was admitted to Hospital on 10/8 for generalized rash, SIRS criteria, and hemodynamic instability, and mild joint pain. He has a past medical history significant for Juvenile idiopathic arthritis (JIA) diagnosed 8/2017 and well controlled on 100 mg Anakinra SubQ QD for previous 5 weeks. He had cellulitis S/P BACTRIM treatment 1 week (D/C Friday 10/6), healing well. He met SIRS criteria in ED, and was hypotensive with wide pulse pressure. He was given 3x boluses IVF and started on ceftriaxone 10/8 which was discontinued on 10/9 with symptomatic improvement and no source of infection. ID consulted, suspected ehrlichiosis, started on empiric doxycycline. Patient was symptomatically unchanged on 10/10; however, ferritin and CRP rose strikingly, Rheum concerned for worsening JIA complicated by Macrophage activation syndrome (MAS). Possibly JIA secondary to URI. Anakinra doubled. On 10/11 patient developed moderate transaminitis, with LDH elevated 1270; minor concern for leukemia. Symptomatically unchanged. Bone marrow biopsy was successfully performed on 10/12; pathology and cytogenetics pending, AM labs showed significant decrease in inflammatory markers, WBC and platelet levels, patient symptomatically better. Anticipate discharge on 10/13 if AM inflammatory markers are improving.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Serum ferritin increased, Systemic inflammatory response syndrome, Transaminases increased, White blood cell count decreased
Clinical narrative: Patient is a 14 year old male who received an Influenza Vaccine IM 3 yrs + 4 Valent IIV4 manufactured by Sanofi Pasteur (Lot#: UT5937KA) on 10/6/2017. He was admitted to Hospital on 10/8 for generalized rash, SIRS criteria, and hemodynamic instability, and mild joint pain. He has a past medical history significant for Juvenile idiopathic arthritis (JIA) diagnosed 8/2017 and well controlled on 100 mg Anakinra SubQ QD for previous 5 weeks. He had cellulitis S/P BACTRIM treatment 1 week (D/C Friday 10/6), healing well. He met SIRS criteria in ED, and was hypotensive with wide pulse pressure. He was given 3x boluses IVF and started on ceftriaxone 10/8 which was discontinued on 10/9 with symptomatic improvement and no source of infection. ID consulted, suspected ehrlichiosis, started on empiric doxycycline. Patient was symptomatically unchanged on 10/10; however, ferritin and CRP rose strikingly, Rheum concerned for worsening JIA complicated by Macrophage activation syndrome (MAS). Possibly JIA secondary to URI. Anakinra doubled. On 10/11 patient developed moderate transaminitis, with LDH elevated 1270; minor concern for leukemia. Symptomatically unchanged. Bone marrow biopsy was successfully performed on 10/12; pathology and cytogenetics pending, AM labs showed significant decrease in inflammatory markers, WBC and platelet levels, patient symptomatically better. Anticipate discharge on 10/13 if AM inflammatory markers are improving.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: Pt states her arm was swollen, pink, sore and hard. Says these symptoms are dissipating as the days progress. Pt was given diphenhydramine and asked to put cold compress on the area. Patient came to pharmacy two days after receiving her PPSV23 and High-dose FLUZONE in one arm. Certain spots on the arm were red and swollen. Pt. was instructed by the pharmacy to put cold compress on the arm and given diphenhydramine.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Influenza like illness, Injection site pain, Swelling
Clinical narrative: Patient received vaccination at a vaccine event. The following day she experienced soreness at the injection site. Over the next couple of days she experienced flu like symptoms. One week later, today, patient complains of a large area of redness and swelling.
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Blister, Pyrexia, Rash
Clinical narrative: Patient describes fever, rash and blisters on the day following vaccination.
Age: 47.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt developed erythema, swelling, and tenderness to injection site. Treated with Ibuprofen and/or TYLENOL, and cold compress.
Age: 3.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mild erythema and swelling at the site of injection. No fever/chills. No other adverse effects.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Mass, Skin warm
Clinical narrative: Lump under skin. Skin was red circle and warm to touch.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Nausea, Pyrexia
Clinical narrative: Received call today 10/12/2017 at approx. 1:00 pm. As per patient's spouse, patient experienced injection site pain, up and down arm. Pain started approximately 3 hours after injection. Patient reported no adverse  effect at time of injection. Patient left and began to experience pain approximately 3 hours after injection. Slight fever and some nausea. Received call from patient's spouse asking for guidance as to what to do concerning reaction, I asked if patient was still experiencing pain, he stated yes. Then, I asked if patient had taken tylenol or ibuprofen. Patient's spouse stated she took tylenol # 3. No relief in pain symptoms experienced.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Immobile, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling around injection site. Pain in lower back to the point of immobilization.
Age: 81.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema
Clinical narrative: Patient said he started having redness that night and getting chills. He went to the Doctor two days later and was given a ROCEPHIN shot and BACTRIM DS.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Pain, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Labored breathing, body aches and pain, congestion in chest, runny nose, coughing.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Cheilitis
Clinical narrative: C/O "sore on lip" 2 hours after flu shot.
Age: 81.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Erythema, Heart rate increased, Muscle spasms, Peripheral swelling, Pyrexia
Clinical narrative: Fever, fast pulse, cramps in arm and legs, swollen arm with redness.
Age: 81.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Cellulitis, Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Fever, fast pulse, cramps in arm and legs, swollen arm with redness.
Age: 81.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Pyrexia
Clinical narrative: Fever, fast pulse, cramps in arm and legs, swollen arm with redness.
Age: 81.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Erythema, Heart rate increased, Muscle spasms, Peripheral swelling, Pyrexia
Clinical narrative: Pt C/O fever, body/leg aches, swollen/red (L) arm starting 4pm day after vaccine given. Pt Dx w/cellulitis at urgent care and prescribed LEVAQUIN 250mg QD x 7 days. Will follow up in 1-2 days.
Age: 81.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Cellulitis, Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Pt C/O fever, body/leg aches, swollen/red (L) arm starting 4pm day after vaccine given. Pt Dx w/cellulitis at urgent care and prescribed LEVAQUIN 250mg QD x 7 days. Will follow up in 1-2 days.
Age: 81.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Pyrexia
Clinical narrative: Pt C/O fever, body/leg aches, swollen/red (L) arm starting 4pm day after vaccine given. Pt Dx w/cellulitis at urgent care and prescribed LEVAQUIN 250mg QD x 7 days. Will follow up in 1-2 days.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Neck pain
Clinical narrative: Patient came back to the pharmacy on 10/10/17 complaining of severe shoulder pain on both sides, and neck pain. Advised patient to use ice/heat and take acetaminophen for pain, and see MD if symptoms did not improve. Patient saw his MD on 10/11/17, and was prescribed cyclobenzaprine 10mg, amoxicillin 500mg, and prednisone 10mg. MD told patient it may have been caused by getting 2 injections at one time.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Eye discharge, Eyelid oedema, Injection site erythema, Injection site swelling
Clinical narrative: The patient received her vaccine on 10/11/17 and returned to the clinic on 10/12/17. She reported waking up on the morning of 10/12/17 with swollen eye lids, drainage from the left eye and swelling/redness at the site of the injection. Her eyes were not red, itchy or painful. The swelling resolved throughout the day and was almost completely gone at the time of her appointment (4:45 PM) on 10/12.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: THE NEXT DAY OF VACCINATION. VERY SORE ARM AND WHAT THE PATIENT DESCRIBED AS FLUISH LIKE SYMPTOMS THAT KEPT HER IN BED FOR A WHOLE DAY.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: THE NEXT DAY OF VACCINATION. VERY SORE ARM AND FLUISH LIKE SYMPTOMS THAT KEPT THE PATIENT IN BED FOR A WHOLE DAY.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Patient described having a rash and some swelling at the injection site in her right arm. She said she always experienced a mild fever and chills. She stated that she self-treated with TYLENOL and BENADRYL and her symptoms subsided.
Age: 89.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site pain, Pain in extremity, Swelling
Clinical narrative: Patient received both the flu shot and PNEUMOVAX vaccine in the same arm. He reported redness and swelling of the arm that seemed to worsen. The pain started in the area of vaccine and radiated down the arm to under the elbow. He was seen at MD and prescribed cephalexin. No other symptoms.
Age: 48.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Malaise
Clinical narrative: PATIENT CLAIMS OF GETTING FLU AND GETTING SICK FROM FLU VACCINE.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Diarrhoea, Pyrexia, Rash, Urticaria
Clinical narrative: Raised hives/whelps within the first 2 hours, low grade fever, severe diarrhea causing sever rash. Given 2.5ml of benadryl morning and night but the symptoms continued for at over 72 hours.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Diarrhoea, Dizziness, Haemorrhage, Hyperhidrosis
Clinical narrative: Patient bleed a lot immediately after the vaccination. Pressure was applied to stop the bleeding and patient was bandaged. Patient was instructed to stay at the pharmacy for 15 minutes for observance. Within 10 minutes, patient start to experience diarrhea sensation, sweating, low blood pressure, dizziness, nausea and vomiting, and almost fainting sensation. Vitamin water was given to patient, and blood pressure was checked which was low according to the patient. This sensation lasted about 5 minutes, and patient recovered, but still felt weak.  She was comfortable to leave after 30 minutes of rest at the pharmacy.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Hypotension, Immediate post-injection reaction, Nausea, Vomiting
Clinical narrative: Patient bleed a lot immediately after the vaccination. Pressure was applied to stop the bleeding and patient was bandaged. Patient was instructed to stay at the pharmacy for 15 minutes for observance. Within 10 minutes, patient start to experience diarrhea sensation, sweating, low blood pressure, dizziness, nausea and vomiting, and almost fainting sensation. Vitamin water was given to patient, and blood pressure was checked which was low according to the patient. This sensation lasted about 5 minutes, and patient recovered, but still felt weak.  She was comfortable to leave after 30 minutes of rest at the pharmacy.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Needle issue
Clinical narrative: Rubber core from vial may have been present on syringe at time of administration. The needle was difficult to penetrate the skin and caused pain upon entry. Pain ensued upon depressing the plunger to administer contents of syringe. Upon needle exiting, a small blackish gray spot was present at injection site. Upon inspection after about 5 minutes, spot was absent, but raised redness was present at injection site. Patient did not continue to experience pain.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Rash pruritic
Clinical narrative: INJECTION SITE BECAME SWOLLEN HOT RED AND ITCHY. PT HAS BEEN EXPERIENCING ITCHY RASH EVER SINCE. SHE TOOK ONE DOSE FROM A MEDROL DOSPAK WHICH DID NOT HELP, I ADVISED HER TO GET AND TAKE SOME DIPHENHYDRAMINE AND TO SEE HER MD OR OTHER DOCTOR CARE AS SOON AS POSSIBLE.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The day after the vaccination, patient reported pain at injection site with no other symptoms. We asked if there was any redness or fever. No fever but she couldn't see if it was red. She came in and showed us. It did not appear red. She was advised to monitor for any signs of worsening or new symptoms that may arise. Recommended no action if condition begins to improve, go to ER if any signs of generalized reaction or if worsens considerably, see doctor if doesn't improve as expected or if slightly worse. The next morning it was more swollen, warm, and red. She saw the doctor and they called to check lot and exp and which arm. They later prescribed steroid and antibiotic. Patient reports that Dr believes it to be an infection. I called the doctor's office near end of day for diagnosis and they said the doctor hadn't written the notes yet and they would call me back. I did not get a call back and do not have final diagnosis information. The administering pharmacist reports using gloves and alcohol swab as per protocol.
Age: 77.0
Sex: M
Vaccine: FLUA3
Symptoms: Myalgia, Vomiting
Clinical narrative: Severe muscle ache, vomiting.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Diarrhoea, Oesophageal candidiasis, Vulvovaginal mycotic infection
Clinical narrative: Vaginal yeast infection, thrush of the esophagus - day 8, severe diarrhea, stomach cramps - day 3.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: On 10/12/17 patient was shopping in the store and mentioned that she still had a bruise at the injection site. Upon clarification patient had bruising and soreness at the injection site starting the day after the injection and bruise still visible on 10/12/17.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Mild tingling sensation on tip of fingers and toes, and mild itching on ankles area, no rashes, no local reaction, no fever, no wheezing or respiratory symptom.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Hypersensitivity
Clinical narrative: Pt with anaphylactic reaction following administration of vaccine (FLULAVAL). Pt presented and was discharged home after fluids, BENADRYL, epinephrine, steroids, albuterol, and famotidine. Pt. was sent home on albuterol, BENADRYL, prednisone and was compliant with meds at home; however re-presented with systemic allergic reaction the following evening (10/11/17) and again required epinephrine, steroids, and famotidine and fluids. (BENADRYL and albuterol were given prior to arrival). Pt. improved but was however admitted for observation.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal disorder, Pain
Clinical narrative: Was given a Tdap and every since I have not been able to use my arm properly and have been in pain (paper included).
Age: 91.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Onset of redness, swelling, warmth and itching approx. 48 hours after injection.
Age: 70.0
Sex: U
Vaccine: PPV
Symptoms: Neck pain
Clinical narrative: Daughter stated pain radiating to neck after shot.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Vision blurred, Visual impairment
Clinical narrative: Headache - blurred vision - visual changes.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy, Blood test, Dehydration, Erythema, Fatigue
Clinical narrative: 8/25 high fever 102.6, exhausted, slept for 24 hrs. Dehydrated. 9/1 red areas on back and chest.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 8/25 high fever 102.6, exhausted, slept for 24 hrs. Dehydrated. 9/1 red areas on back and chest.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Pt retuned to office after 15 min. of vaccines given. Pt's hands and feet were swollen. Pt has hives from head to toe. Pt was given CLARITIN 10mg and Prednisolone 10ml. Pt was asked to wait 30 min and was rechecked before leaving. Pt was prescribed Prednisolone 15mg/5.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site vesicles
Clinical narrative: Had blister formation at site of vaccination 24hr after flu vaccine.
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Rash generalised, Skin exfoliation
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of fever in a female patient who received Influenza vaccine Quadrivalent unspecified season. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced fever, generalized rash and scales. The patient was treated with Steroids. On an unknown date, the outcome of the fever, generalized rash and scales were recovered/resolved. It was unknown if the reporter considered the fever, generalized rash and scales to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. On an unknown date, the patient had flu shot of Influenza vaccine Quadrivalent unspecified season. The patient developed a fever and proceeded then to rash and scale from the top of her head to toes and she was in that condition for a week and had to receive steroids, high dose steroids to get through it.
Age: 1.25
Sex: F
Vaccine: DTAP, DTAPHEPBIP
Symptoms: Accidental overdose, Irritability
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 15-month-old female patient who received PEDIARIX. Co-suspect products included INFANRIX. On an unknown date, the patient received PEDIARIX at an unknown dose and INFANRIX at an unknown dose. On an unknown date, unknown after receiving PEDIARIX and INFANRIX, the patient experienced accidental overdose and irritability. On an unknown date, the outcome of the accidental overdose and irritability were unknown. It was unknown if the reporter considered the irritability to be related to PEDIARIX and INFANRIX. Additional details were reported as follows: The patient was given PEDIARIX and INFANRIX on the same day by mistake, which led to accidental overdose for DTP component. The patient was more cranky than usual. No further information was provided.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Joint range of motion decreased, Pain, Skin warm, Swelling
Clinical narrative: Received vaccination on 10/6/17 at 1400. Mild pain noticed at 2330 that night. Next morning, she had erythema, swelling from deltoid to distal left elbow, pain, increased warmth, and descreased ROM. Applied ice. Symptoms mostly subsided after 3 days.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Bordetella test positive, Pertussis, Polymerase chain reaction positive
Clinical narrative: Diagnosed with pertussis 9/26/17 was fully vaccinated-see attached record.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 52-year-old female patient who received FLUARIX QUADRIVALENT (batch number K4GP4, expiry date 24th June 2018). On 3rd October 2017, the patient received FLUARIX QUADRIVALENT .5 ml. In October 2017, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced injection site erythema, injection site induration, injection site tenderness and injection site swelling. In October 2017, the outcome of the injection site erythema, injection site induration, injection site tenderness and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site tenderness and injection site swelling to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient was a GlaxoSmithKline employee.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Prolonged soreness in left shoulder since time of injection. Three weeks to date. Have reached out to doctor - waiting to hear back.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site pain
Clinical narrative: Patient reported painful injection site Mon. and Tuesday. Went to emergency room. Treated with IV antibiotics and 2-3 oral antibiotics. Pt. was told by ER doctor this is from injection received on Monday for ZOSTAVAX. Diagnosis - cellulitis. Currently monitored by MD.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Arm pain when moved, trouble with movement.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Daughter stated Mothers arm hurt right away > 1 week later still hurting.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 26-year-old female patient who received ENGERIX B adult (batch number 53P39, expiry date 12th February 2020). On 4th October 2017, the patient received ENGERIX B adult 1 ml. On 4th October 2017, less than a day after receiving ENGERIX B adult, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was not recovered/not resolved. The reporter considered the dizziness to be unlikely related to ENGERIX B adult. Additional details were reported as follows: The patient received ENGERIX B adult in left arm.
Sex: F
Vaccine: HEP
Symptoms: Therapy non-responder
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in a female patient who received ENGERIX B. Co-suspect products included ENGERIX B, ENGERIX B and ENGERIX B. On an unknown date, the patient received the 1st dose of ENGERIX B, the 2nd dose of ENGERIX B, the 3rd dose of ENGERIX B and the 4th dose of ENGERIX B. On an unknown date, unknown after receiving ENGERIX B, ENGERIX B and ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B, ENGERIX B, ENGERIX B and ENGERIX B. Additional details were reported as follows: The age at vaccination was not reported. The patient had received 4 doses of ENGERIX-B, and still did not have an adequate response. The healthcare professional (HCP) had limited data about the patient. The HCP had no data on lot number or expiry date of the vaccine.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swelling and pain in left arm. Patient sent to emergency room.
Age: 62.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: At ZOSTAVAX injection site guest experience redness and swelling at injection site (right arm). Given subq. She has been icing the injection site and taking oral BENADRYL since. Signs/symptoms started and has improved tremendously.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash, Vomiting
Clinical narrative: Fever approximately 102 on 10/5/17, seen in office 10/6 with fever, fussy, vomited x1. 10/9/17 - Rash started on abdomen, trunk, back, buttocks, face.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Red and very itchy at the site.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Arm was numb and tingly. Injections given in AM 10-11. Called pt. at approximately 5pm said it was better but was achy at inj site (shoulder) tried to call on 10-12 no answer.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Pyrexia, Tremor
Clinical narrative: 10/10/17 7pm started shaking w/fevers, trouble breathing (felt like I couldn't catch breath). 10/11/17 another fever at night and difficulty breathing has continued since 10/10/17 evening.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLU4, PPV
Symptoms: Asthenia, Chills, Muscular weakness
Clinical narrative: This spontaneous report as received from a patient's husband, referring to his 70 year old wife. The patient's medical history included surgical removal of meningioma in 1997. As a current condition, it was reported that a calcified partial meningioma remains. The patient's drug allergies included penicillin and sulfa drugs. Concomitant therapies included unspecified vitamins. On 26-SEP-2017, the patient was vaccinated with PNEUMOVAX 23, intramuscular, for prevention of pneumococcal disease (strength, dose, frequency, lot # and expiration date were not reported) and FLUZONE (strength, dose, frequency, route, lot # and expiration date were not reported). Later on the same date in the evening, the patient experienced severe chills and became unresponsive, so the reporter had to call to the emergency number and when the emergency medical technicians arrived "diagnosed her with a stroke as she had no motor reponses". On an unspecified date in September 2017, she was transported to a hospital, where she was seen by multiple unspecified physicians and teams of neurologists. After some tests including magnetic resonance imaging (MRI), computed tomography (CT-scan) and lumbar puncture (reported as hundred of tests), it was found that the patient did not have a stroke but had an infection, however, no cause could be determined regarding the infection. It was reported that the patient was hospitalized for 4 days and then released on therapy with unspecified antibiotics. Additionally, the reporter stated she still felt weak and lethargic. At the time of reporting, the outcome of lethargic, felt weak and infection were not recovered. The outcome of unresponsive to stimuli was unknown (also reported as not recovered; conflicting information). Additionally, the assessment causality between chills, unresponsive to stimuli, infection, felt weak, and lethargic with PNEUMOVAX 23 was not provided. Upon internal review, unresponsive to stimuli was determined to be medically significant. Sender's Comments: US-009507513-1710USA001228.