chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Seizure, Syncope
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a currently 14 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated intramuscularly with unidentified Merck HPV vaccine (lot number M004116, dose was not reported). It was unspecified whether it was GARDASIL or GARDASIL 9. Lot number M004116 is an invalid lot number for GARDASIL. However, it is valid for GARDASIL 9. Concomitant therapy was not reported. On an unknown date, after being administered with this vaccine, the patient had a "syncope seizure". There were no lab diagnostics studies performed. There was no treatment given to the patient for the events. The patient was observed in doctor's office for about an hour and recovered on an unknown date. It was not known which dose of HPV vaccine it was and whether the course of vaccinations was/would be completed or not. The relatedness between the events and unidentified Merck HPV vaccine was not reported. Upon internal review the event of seizure was considered to be medically significant. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Decreased appetite, Fatigue, Limb discomfort, Myalgia
Clinical narrative: Pain/tingling in arm, arm felt heavy. Fatigue, fever, muscle aches, chills, loss of appetite. Lasted 3 days (missed 2 days of school).
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Pain/tingling in arm, arm felt heavy. Fatigue, fever, muscle aches, chills, loss of appetite. Lasted 3 days (missed 2 days of school).
Age: 23.0
Sex: F
Vaccine: IPV
Symptoms: Abdominal discomfort, Arthralgia, Hyperaesthesia, Influenza like illness, Nausea
Clinical narrative: Fever, flu-like symptoms (aching joints and hypersensitive skin), nausea and stomach discomfort.
Age: 23.0
Sex: F
Vaccine: IPV
Symptoms: Pyrexia
Clinical narrative: Fever, flu-like symptoms (aching joints and hypersensitive skin), nausea and stomach discomfort.
Age: 34.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via direct contact
Clinical narrative: This spontaneous report was received via a company representative, from a 34 year old female pharmacist, reporting on herself. The patient presented no drug allergies/reactions. She had chickenpox when she was younger and in 2011 (reported as 5 years ago), the patient was tested for immunity titer and the test was positive. On 22-JUN-2016, while reconstituting ZOSTAVAX 19400 PFU, (route reported as subcutaneous) (dose and lot number were not reported) and trying to get bubbles out, somehow a small amount, 1/100th ml, landed in the patient's left eye. Concomitant medications were not reported. The patient did not seek medical attention, no treatment was given and no lab diagnostic studies were performed. Furthermore, it was reported that the patient at the time of reporting, was suffering from cardiac arrhythmia and she was taking metoprolol for it. At the time of reporting, the outcome of arrhythmia and its causal relation with ZOSTAVAX was not reported. No product quality complaint was involved. Upon internal review, cardiac arrhythmia was determined to be medically significant. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016247322) on 18-May-2016. This case involves a male patient (age not reported) who was vaccinated with a dose of Flu Shot (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient had allergy to flu shot ("knows that have flu shot and everything there and he was allergic to that"). Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: M
Vaccine: DTAP
Symptoms: Crying, Injection site erythema, Injection site swelling, Peripheral swelling, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer (patient's father) on 26 May 2016. This case involves a male patient (age not reported) who was vaccinated with a dose of DAPTACEL (batch number, expiry date, site of administration: not provided) by intramuscular route on unspecified date in September 2015 and a dose of DAPTACEL (batch number, expiry date: not provided) by intramuscular route in the arm on an unspecified date. It was reported that the patient either received first and second dose or second and third dose (reporter was not sure about the doses). The patient's illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported. On an unspecified date in September 2015, following the first vaccination, the patient became febrile and his leg became swollen to 2x its size, after the next dose the patient became febrile, his arm became red and swollen at the injection site and the patient cried for four hours. It was reported that the patient required ER/doctor visit. Lab data and corrective treatment were not reported. On an unspecified date, after four hours patient recovered from the event crying, several days later the patient recovered from the event febrile, arm became red and swollen at the injection site. On an unspecified date, patient recovered from the event leg became swollen to 2x its size. List of documents held by sender: none.
Age: 58.0
Sex: U
Vaccine: TDAP
Symptoms: Clostridium test negative, Corynebacterium test negative
Clinical narrative: Initial unsolicited report received from the literature on 01 June 2016. This case is linked to case 2016SA108588, 2016SA108584, 2016SA108575 (same literature). Background. Many adult immunization schedules recommend that tetanus and diphtheria vaccination be performed every 10 years. In light of current epidemiological trends of disease incidence and rates of vaccine-associated adverse events, the 10-year revaccination schedule has come into question. Methods. We performed cross-sectional analysis of serum antibody titers in 546 adult subjects stratified by age or sex. All serological results were converted to international units after calibration with international serum standards. Results. Approximately 97% of the population was seropositive to tetanus and diphtheria as defined by a protective serum antibody titer of greater than or equal to 0.01 IU/mL. Mean antibody titers were 3.6 and 0.35 IU/mL against tetanus and diphtheria, respectively. Antibody responses to tetanus declined with an estimated half-life of 14 years (95% confidence interval, 11-17 years), whereas antibody responses to diphtheria were more long-lived and declined with an estimated half-life of 27 years (18-51 years). Mathematical models combining antibody magnitude and duration predict that 95% of the population will remain protected against tetanus and diphtheria for greater than or equal to 30 years without requiring further booster vaccination. Conclusions. These studies demonstrate that durable levels of protective antitoxin immunity exist in the majority of vaccinated individuals. Together, this suggests that it may no longer be necessary to administer booster vaccinations every 10 years and that the current adult vaccination schedule for tetanus and diphtheria should be revisited. This case involves a 58-year old patient (gender not reported) who was vaccinated with a dose of Tdap (lot number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications was not reported. On an unspecified date, post vaccination the patient lacked immunity to both toxins (diphtheria and Tetanus). A serum antibody titers was performed (results not provided). Other laboratory data and corrective treatment was not reported. The outcome of the event was not reported. Documents held by sender: none.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Contusion
Clinical narrative: Patient bruised for over 1 week, no pain, no fever, no other symptoms.
Age: 26.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Anaphylactic reaction, Dyspnoea, Heart rate increased, Nasal congestion, Nausea
Clinical narrative: Information has been received from the published literature article referring to a 26 year old female patient (patient# 2) with asthma. On an unknown date, the patient was vaccinated with a dose of PCV (manufacturer unknown) (dose, route and lot# were unknown) and a dose of influenza virus vaccine (unspecified) (dose, route and lot# were unknown). After vaccination, the patient experienced wheeze (bilateral), short of breath, heart rate increased, nasal congestion and nausea. The initial evaluation was performed in an emergency department and the emergency department doctor provided the diagnosis as vaccine-triggered anaphylaxis with Brighton level was 2. The patient was treated with nebulizer. Then on an unknown date, the patient recovered. Upon internal review, the event "vaccine-triggered anaphylaxis" was considered to be medically significant. This is one of several reports from the same source (1211USA007452, 0911USA01970, 1207USA012332, 1606USA012239, 1002USA01291, 1606USA012687, 1606USA012688, 1606USA012689, 1606USA012690, 1606USA012691, 1606USA012692, 1606USA012693). Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Vaccination complication, Wheezing
Clinical narrative: Information has been received from the published literature article referring to a 26 year old female patient (patient# 2) with asthma. On an unknown date, the patient was vaccinated with a dose of PCV (manufacturer unknown) (dose, route and lot# were unknown) and a dose of influenza virus vaccine (unspecified) (dose, route and lot# were unknown). After vaccination, the patient experienced wheeze (bilateral), short of breath, heart rate increased, nasal congestion and nausea. The initial evaluation was performed in an emergency department and the emergency department doctor provided the diagnosis as vaccine-triggered anaphylaxis with Brighton level was 2. The patient was treated with nebulizer. Then on an unknown date, the patient recovered. Upon internal review, the event "vaccine-triggered anaphylaxis" was considered to be medically significant. This is one of several reports from the same source (1211USA007452, 0911USA01970, 1207USA012332, 1606USA012239, 1002USA01291, 1606USA012687, 1606USA012688, 1606USA012689, 1606USA012690, 1606USA012691, 1606USA012692, 1606USA012693). Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Anaphylactic reaction, Cough, Pruritus generalised, Vomiting, Wheezing
Clinical narrative: Information has been received from the published literature article referring to a 5 year old male patient with allergy to fish, peanuts and eggs.  On an unknown date, the patient was vaccinated with a dose of MMR virus vaccine, live (manufacturer unknown) (dose, route and lot# were unknown), varicella virus vaccine live (manufacturer unknown) (dose, route and lot# were unknown) and DTAP-IPV (dose, route and lot# were unknown). Less than 30 minutes later, the patient experienced general pruritus, wheeze, cough and vomiting. The initial evaluation was performed in a clinic and the pediatrician provided the diagnosis as vaccine-triggered anaphylaxis with Brighton level was 2. The patient was treated with epinephrine, oral antihistamine and antiemetic. Then on an unknown date, the patient recovered. Upon internal review, the event "vaccine-triggered anaphylaxis" was considered to be medically significant. This is one of several reports from the same source (1211USA007452, 0911USA01970, 1207USA012332, 1002USA01291, 1606USA012686, 1606USA012687, 1606USA012688, 1606USA012689, 1606USA012690, 1606USA012691, 1606USA012692, 1606USA012693). Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Anti-glomerular basement membrane antibody negative, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Biopsy skin normal, Blood culture negative
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 74-year-old male patient started to receive PREVNAR 13, via an unspecified route of administration at single dose on 18Apr2016. Medical history included diabetes, hypertension, atrial fibrillation, hyperthyroidism (AFib), hypercholesterolaemia, coronary artery bypass graft, anticonvulsant drug level (DPH), heart failure. Concomitant medications were not reported. Around 21Apr2016 or 22Apr2016, the patient experienced cutaneous vasculitis with renal involvement with outcome of unknown. The patient was hospitalized for the events from 31May2016 to 05Jun2016. The patient underwent lab tests and procedures which included Skin biopsy; SPEP; Thyroglobulin; Thyrofibrogen; UPEP; ANCA; ANA; C3 and C4; CH 50; Double stranded DNA; Rheumatoid factor (RF); Blood cultures; CRP; Sjogren antibody; Hepatitis antibody; Anti glomerular basement antibody; Basic Metabolic Panel; P-ANCA. Pharmacist mentioned that the dates of all the tests were within admission dates from 31May2016 to 05Jun2016 and all the results were negative. Reporter confirmed that a patient got hospitalized and discharged with a diagnosis of cutaneous vasculitis with renal involvement. Pharmacist mentioned that the treatment taken was steroid which was Prednisone and this was before going to the hospital. Pharmacist believes that patient experienced cutaneous vasculitis because of PREVNAR 13.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: C-reactive protein normal, Cutaneous vasculitis, Double stranded DNA antibody, Electrophoresis protein normal, Hepatitis viral test negative
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 74-year-old male patient started to receive PREVNAR 13, via an unspecified route of administration at single dose on 18Apr2016. Medical history included diabetes, hypertension, atrial fibrillation, hyperthyroidism (AFib), hypercholesterolaemia, coronary artery bypass graft, anticonvulsant drug level (DPH), heart failure. Concomitant medications were not reported. Around 21Apr2016 or 22Apr2016, the patient experienced cutaneous vasculitis with renal involvement with outcome of unknown. The patient was hospitalized for the events from 31May2016 to 05Jun2016. The patient underwent lab tests and procedures which included Skin biopsy; SPEP; Thyroglobulin; Thyrofibrogen; UPEP; ANCA; ANA; C3 and C4; CH 50; Double stranded DNA; Rheumatoid factor (RF); Blood cultures; CRP; Sjogren antibody; Hepatitis antibody; Anti glomerular basement antibody; Basic Metabolic Panel; P-ANCA. Pharmacist mentioned that the dates of all the tests were within admission dates from 31May2016 to 05Jun2016 and all the results were negative. Reporter confirmed that a patient got hospitalized and discharged with a diagnosis of cutaneous vasculitis with renal involvement. Pharmacist mentioned that the treatment taken was steroid which was Prednisone and this was before going to the hospital. Pharmacist believes that patient experienced cutaneous vasculitis because of PREVNAR 13.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Laboratory test normal, Metabolic function test normal, Protein urine absent, Renal disorder, Rheumatoid factor negative
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 74-year-old male patient started to receive PREVNAR 13, via an unspecified route of administration at single dose on 18Apr2016. Medical history included diabetes, hypertension, atrial fibrillation, hyperthyroidism (AFib), hypercholesterolaemia, coronary artery bypass graft, anticonvulsant drug level (DPH), heart failure. Concomitant medications were not reported. Around 21Apr2016 or 22Apr2016, the patient experienced cutaneous vasculitis with renal involvement with outcome of unknown. The patient was hospitalized for the events from 31May2016 to 05Jun2016. The patient underwent lab tests and procedures which included Skin biopsy; SPEP; Thyroglobulin; Thyrofibrogen; UPEP; ANCA; ANA; C3 and C4; CH 50; Double stranded DNA; Rheumatoid factor (RF); Blood cultures; CRP; Sjogren antibody; Hepatitis antibody; Anti glomerular basement antibody; Basic Metabolic Panel; P-ANCA. Pharmacist mentioned that the dates of all the tests were within admission dates from 31May2016 to 05Jun2016 and all the results were negative. Reporter confirmed that a patient got hospitalized and discharged with a diagnosis of cutaneous vasculitis with renal involvement. Pharmacist mentioned that the treatment taken was steroid which was Prednisone and this was before going to the hospital. Pharmacist believes that patient experienced cutaneous vasculitis because of PREVNAR 13.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Thyroglobulin absent, Total complement activity test
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 74-year-old male patient started to receive PREVNAR 13, via an unspecified route of administration at single dose on 18Apr2016. Medical history included diabetes, hypertension, atrial fibrillation, hyperthyroidism (AFib), hypercholesterolaemia, coronary artery bypass graft, anticonvulsant drug level (DPH), heart failure. Concomitant medications were not reported. Around 21Apr2016 or 22Apr2016, the patient experienced cutaneous vasculitis with renal involvement with outcome of unknown. The patient was hospitalized for the events from 31May2016 to 05Jun2016. The patient underwent lab tests and procedures which included Skin biopsy; SPEP; Thyroglobulin; Thyrofibrogen; UPEP; ANCA; ANA; C3 and C4; CH 50; Double stranded DNA; Rheumatoid factor (RF); Blood cultures; CRP; Sjogren antibody; Hepatitis antibody; Anti glomerular basement antibody; Basic Metabolic Panel; P-ANCA. Pharmacist mentioned that the dates of all the tests were within admission dates from 31May2016 to 05Jun2016 and all the results were negative. Reporter confirmed that a patient got hospitalized and discharged with a diagnosis of cutaneous vasculitis with renal involvement. Pharmacist mentioned that the treatment taken was steroid which was Prednisone and this was before going to the hospital. Pharmacist believes that patient experienced cutaneous vasculitis because of PREVNAR 13.
Sex: M
Vaccine: MENB
Symptoms: Laboratory test, Lumbar puncture, Neck pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. An adolescent male patient of unspecified ethnicity received the first dose of TRUMENBA via an unspecified route of administration, on unknown date, at single dose. Relevant medical history and concomitant medications were not reported. The patient experienced high fever and neck pain on unknown date, the day after the vaccination. The patient was hospitalized due to the events. He had a spinal tap and other tests to make sure he did not have meningitis. The outcome of the events was unknown.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood test normal, Dizziness, Loss of consciousness
Clinical narrative: This is a spontaneous report from a contactable nurse received via a sales representative. A female patient of an unspecified age and ethnicity received the first dose of TRUMENBA, intramuscular at 0.5 ml single and the first dose of MENVEO, intramuscular at 1 DF single, both on the same unspecified date. The patient medical history and concomitant medications were not reported. A few hours after vaccines were given, the patient experienced dizziness/ lightheadedness and passed out. Patient went to the Emergency Department. Date of visit to Emergency Department unknown, duration of visit unknown. Treatment unknown by caller. He stated she had blood work done and the blood work was fine. Patient's outcome reported as recovered completely.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (the patient). A patient of unspecified age, ethnicity and gender received a single dose of pneumococcal 13-val conj vac (dipht crm 197 protein) (unknown manufacturer), via an unspecified route of administration on an unspecified date. Relevant medical history and concomitant medications were not reported. The patient experienced cellulitis on an unspecified date. The outcome of the event was unknown. Pfizer is a Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm 197 protein) in the reporter's country. This may be a duplicate report if another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm 197 protein) has submitted the same report to the regulatory authorities. No follow up attempts possible. No further information received.
Age: 12.0
Sex: M
Vaccine: MEN, MMRV, TDAP
Symptoms: Anaphylactic reaction, Cough, Pruritus, Rash, Urticaria
Clinical narrative: Information has been received from the published literature article referring to a 12 year old male patient with asthma and allergy to eggs. His medical history included atopic dermatitis and allergic rhinitis. On an unknown date, the patient was vaccinated with a dose of MMRV (manufacturer unknown), a dose of meningococcal conj vaccine (unspecified) and a dose of Tdap (dose, route and lot# were unknown). Less than 3 hours after vaccination, the patient experienced generalized urticaria, pruritus, rash and cough. The initial evaluation was performed in a clinic and the pediatrician provided the diagnosis as vaccine-triggered anaphylaxis with Brighton level was 2. The patient was treated with oral antihistamine and cool compress. Then on an unknown date, the patient recovered. Upon internal review, the event "vaccine-triggered anaphylaxis" was considered to be medically significant. This is one of several reports from the same source (1211USA007452, 0911USA01970, 1207USA012332, 1606USA012239, 1002USA01291, 1606USA012686, 1606USA012687, 1606USA012689, 1606USA012690, 1606USA012691, 1606USA012692, 1606USA012693). Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HEPA, MEN, TDAP, VARCEL
Symptoms: Anaphylactic reaction, Blood pressure decreased, Injection site erythema, Injection site urticaria, Vaccination complication
Clinical narrative: Information has been received from the published literature article referring to a 11 year old male patient with no history of atopy. On an unknown date, the patient was vaccinated with a dose of hepatitis A vaccine, inactivated (manufacturer unknown), varicella virus vaccine live (manufacturer unknown), Tdap and meningococcal conj vaccine (unspecified) (dose, route and lot# were unknown). After vaccination (onset not documented), the patient experienced injection site urticaria and erythema and measured blood pressure decreased. The initial evaluation was performed in a clinic and the pediatrician provided the diagnosis as vaccine-triggered anaphylaxis with Brighton level was 2. The patient was treated with oral antihistamine. Then on an unknown date, the patient recovered. Upon internal review, the event "vaccine-triggered anaphylaxis" was considered to be medically significant. This is one of several reports from the same source (1211USA007452, 0911USA01970, 1207USA012332, 1606USA012239, 1002USA01291, 1606USA012686, 1606USA012687, 1606USA012688, 1606USA012689, 1606USA012691, 1606USA012692, 1606USA012693). Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, PPV, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Day 1-3 fever, treated with Tylenol & Motrin; day 4-full body rash appears.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Swelling, erythema, pruritis.
Age: 45.0
Sex: F
Vaccine: HEPAB
Symptoms: Dyskinesia, Erythema, Hyperhidrosis, Limb discomfort, Loss of consciousness
Clinical narrative: Syncopal episode. Patient started feeling nauseous a minute or two after vaccination. She turned red and then passed out while sitting.  She was unconscious for maybe 10 seconds then started coming around. While unconscious her arms went very stiff and jerked twice. When she was awake she was very pale and sweaty.  She complained of blurry vision, nausea, and tingling heavy arms. We gave her some cold water and a cold compress for her head an had her lie down for a few minutes until she felt better. The whole episode lasted about 20 minutes.  She was instructed to follow-up with her PCP.
Age: 45.0
Sex: F
Vaccine: HEPAB
Symptoms: Musculoskeletal stiffness, Nausea, Pallor, Paraesthesia, Syncope
Clinical narrative: Syncopal episode. Patient started feeling nauseous a minute or two after vaccination. She turned red and then passed out while sitting.  She was unconscious for maybe 10 seconds then started coming around. While unconscious her arms went very stiff and jerked twice. When she was awake she was very pale and sweaty.  She complained of blurry vision, nausea, and tingling heavy arms. We gave her some cold water and a cold compress for her head an had her lie down for a few minutes until she felt better. The whole episode lasted about 20 minutes.  She was instructed to follow-up with her PCP.
Age: 45.0
Sex: F
Vaccine: HEPAB
Symptoms: Vision blurred
Clinical narrative: Syncopal episode. Patient started feeling nauseous a minute or two after vaccination. She turned red and then passed out while sitting.  She was unconscious for maybe 10 seconds then started coming around. While unconscious her arms went very stiff and jerked twice. When she was awake she was very pale and sweaty.  She complained of blurry vision, nausea, and tingling heavy arms. We gave her some cold water and a cold compress for her head an had her lie down for a few minutes until she felt better. The whole episode lasted about 20 minutes.  She was instructed to follow-up with her PCP.
Age: 25.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Patient states he had localized swelling and rash at injection site.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chest pain, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Fatigue, rapid heartbeat, dizzy. Progressed into Saturday and symptoms continued to worsen. Difficult to breath, Rapid heart rate 96bpm while resting up into the 100's just walking, light headed, dizzy, extreme fatigue, large hives on right arm. By saturday evening symptoms continued to worsen legs became weak and dizziness worsened, and pain in my chest started, couldn't catch my breath.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Heart rate increased, Urticaria
Clinical narrative: Fatigue, rapid heartbeat, dizzy. Progressed into Saturday and symptoms continued to worsen. Difficult to breath, Rapid heart rate 96bpm while resting up into the 100's just walking, light headed, dizzy, extreme fatigue, large hives on right arm. By saturday evening symptoms continued to worsen legs became weak and dizziness worsened, and pain in my chest started, couldn't catch my breath.
Age: 13.0
Sex: F
Vaccine: FLU3, FLUN4, HPV9, FLU4, FLUN4, HPV4
Symptoms: Dizziness, Epistaxis, Haematemesis, Vaccination error
Clinical narrative: Received 1/2 dose of FLUMIST spray in error (perhaps expired med), following immediately by dose of FLUZONE injection. Also received GARDASIL-9 vaccine same day. Day later, pt experienced nosebleed and hematemesis. Dizziness continued 2 wks later perhaps due to anemia (undiagnosed) or poor sleeping habits.
Age: 13.0
Sex: F
Vaccine: FLU3, FLUN4, HPV9, FLU4, FLUN4, HPV4
Symptoms: Anaemia, Dizziness, Epistaxis, Haematemesis, Haemoptysis
Clinical narrative: Received 1/2 dose of FLUMIST spray in error (perhaps expired med), following immediately by dose of FLUZONE injection. Also received GARDASIL-9 vaccine same day. Day later, pt experienced nosebleed and hematemesis. Dizziness continued 2 wks later perhaps due to anemia (undiagnosed) or poor sleeping habits.
Age: 13.0
Sex: F
Vaccine: FLU3, FLUN4, HPV9, FLU4, FLUN4, HPV4
Symptoms: Incorrect dose administered, Poor quality sleep
Clinical narrative: Received 1/2 dose of FLUMIST spray in error (perhaps expired med), following immediately by dose of FLUZONE injection. Also received GARDASIL-9 vaccine same day. Day later, pt experienced nosebleed and hematemesis. Dizziness continued 2 wks later perhaps due to anemia (undiagnosed) or poor sleeping habits.
Age: 44.0
Sex: M
Vaccine: HEPA
Symptoms: Anaphylactic reaction, Chest pain, Disorientation, Pharyngeal oedema, Pruritus generalised
Clinical narrative: Information has been received from the published literature article referring to a 44 year old male with allergy to penicillin class medications. His medical history included allergic rhinitis. On an unknown date, the patient was vaccinated with a dose of hepatitis A vaccine, inactivated (manufacturer unknown) (dose, route and lot# were unknown). Two hours after vaccination, the patient experienced generalized pruritus and rash, swelling (throat), chest pain, vomiting and disorientation. The initial evaluation was performed in the emergency department and the doctor in emergency department provided the diagnosis as vaccine-triggered anaphylaxis with Brighton level was 1. The patient was treated with oral and parenteral antihistamine, parenteral steroid, intravenous therapy, ketorolac and ibuprofen. Then on an unknown date, the patient recovered. Upon internal review, the event "vaccine-triggered anaphylaxis" was considered to be medically significant. This is one of several reports from the same source (1211USA007452, 0911USA01970, 1207USA012332, 1606USA012239, 1002USA01291, 1606USA012686, 1606USA012687, 1606USA012688, 1606USA012689, 1606USA012690, 1606USA012692, 1606USA012693). Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: HEPA
Symptoms: Rash generalised, Vomiting
Clinical narrative: Information has been received from the published literature article referring to a 44 year old male with allergy to penicillin class medications. His medical history included allergic rhinitis. On an unknown date, the patient was vaccinated with a dose of hepatitis A vaccine, inactivated (manufacturer unknown) (dose, route and lot# were unknown). Two hours after vaccination, the patient experienced generalized pruritus and rash, swelling (throat), chest pain, vomiting and disorientation. The initial evaluation was performed in the emergency department and the doctor in emergency department provided the diagnosis as vaccine-triggered anaphylaxis with Brighton level was 1. The patient was treated with oral and parenteral antihistamine, parenteral steroid, intravenous therapy, ketorolac and ibuprofen. Then on an unknown date, the patient recovered. Upon internal review, the event "vaccine-triggered anaphylaxis" was considered to be medically significant. This is one of several reports from the same source (1211USA007452, 0911USA01970, 1207USA012332, 1606USA012239, 1002USA01291, 1606USA012686, 1606USA012687, 1606USA012688, 1606USA012689, 1606USA012690, 1606USA012692, 1606USA012693). Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP, VARCEL
Symptoms: Anaphylactic reaction, Angioedema, Immediate post-injection reaction, Pruritus generalised, Rash generalised
Clinical narrative: Information has been received from the published literature article referring to an 11 year old male patient with asthma and allergy to fluconazole and penicillins. On an unknown date, the patient was vaccinated with a dose of varicella virus vaccine live (manufacturer unknown), a dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and a dose of meningococcal conj vaccine (unspecified) (dose, route and lot# were unknown).  Immediately after vaccination, the patient experienced generalized urticaria, pruritus and rash, angioedema and swelling (tonsils). The initial evaluation was performed in a clinic and a family practice provider provided the diagnosis as vaccine-triggered anaphylaxis with Brighton level was 1. The patient was treated with epinephrine and parenteral steroid. Then on an unknown date, the patient recovered. Upon internal review, the event "vaccine-triggered anaphylaxis" was considered to be medically significant. This is one of several reports from the same source (1211USA007452, 0911USA01970, 1207USA012332, 1606USA012239, 1002USA01291, 1606USA012686, 1606USA012687, 1606USA012688, 1606USA012689, 1606USA012690, 1606USA012691, 1606USA012693). Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP, VARCEL
Symptoms: Swelling, Tonsillitis, Urticaria, Vaccination complication
Clinical narrative: Information has been received from the published literature article referring to an 11 year old male patient with asthma and allergy to fluconazole and penicillins. On an unknown date, the patient was vaccinated with a dose of varicella virus vaccine live (manufacturer unknown), a dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and a dose of meningococcal conj vaccine (unspecified) (dose, route and lot# were unknown).  Immediately after vaccination, the patient experienced generalized urticaria, pruritus and rash, angioedema and swelling (tonsils). The initial evaluation was performed in a clinic and a family practice provider provided the diagnosis as vaccine-triggered anaphylaxis with Brighton level was 1. The patient was treated with epinephrine and parenteral steroid. Then on an unknown date, the patient recovered. Upon internal review, the event "vaccine-triggered anaphylaxis" was considered to be medically significant. This is one of several reports from the same source (1211USA007452, 0911USA01970, 1207USA012332, 1606USA012239, 1002USA01291, 1606USA012686, 1606USA012687, 1606USA012688, 1606USA012689, 1606USA012690, 1606USA012691, 1606USA012693). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Anaphylactic reaction, Angioedema, Swollen tongue
Clinical narrative: Information has been received from the published literature article referring to a 15 year old female patient with allergy to shellfish and methylprednisolone. Medical history included allergic rhinitis. On an unknown date, the patient was vaccinated with a dose of varicella virus vaccine live (manufacturer unknown) and a dose of Tdap (dose, route and lot# were unknown). 30 to 60 minutes after vaccination, the patient experienced angioedema (lips) and swelling (tongue). The initial evaluation was performed in a clinic and the family practice provider provided the diagnosis as vaccine-triggered anaphylaxis with Brighton level 2. The patient was treated with epinephrine, oral antihistamine and oral steroid. Then on an unknown date, the patient recovered. Upon internal review, the event "vaccine-triggered anaphylaxis" was considered to be medically significant. This is one of several reports from the same source (1211USA007452, 0911USA01970, 1207USA012332, 1606USA012239, 1002USA01291, 1606USA012686, 1606USA012687, 1606USA012688, 1606USA012689, 1606USA012690, 1606USA012691, 1606USA012692). Additional information has been requested.
Sex: U
Vaccine: DTAP, HIBV
Symptoms: Extra dose administered, Hypotonia, Muscular weakness
Clinical narrative: Initial unsolicited misuse report received from a non-healthcare professional on 8 June 2016. This case involves an infant patient (age and gender not reported) who was vaccinated with an extra dose of DTaP and possibly Acthib (batch number, expiry date, dose, route and site of administration was not reported) on an unspecified date in October 2011. The patient's medical history included infant had been born prematurely and concomitant medications were not reported. On an unspecified date, few months (reported as couple of months later) following the vaccination, the patient had experienced muscle weakness and poor muscle tone. It was a case of extra dose administered. Laboratory data and corrective treatment was not reported. The outcome of the event was reported unknown. List of documents held by sender: none.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Seroma
Clinical narrative: 8cm seroma.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Hyperhidrosis, Pyrexia, Vomiting projectile
Clinical narrative: Pt has projectile vomited 4 x yesterday and 3 x today and pt is sweaty Pt had shots on Tuesday and had a fever of 101.5 rectally on that day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Started at twice the size of a quarter red spot. Then next day spot elongated to twice that size. Next day 06/27 now 5" long going down my arm and raised.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Musculoskeletal pain, Nuclear magnetic resonance imaging, Periarthritis, Surgery
Clinical narrative: Experienced immediate shoulder pain. Had PT for frozen shoulder, MRI and surgery.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Adverse event
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a patient who received FLUARIX TETRA. On an unknown date, the patient received FLUARIX TETRA at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX TETRA, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to FLUARIX TETRA. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported an adverse event from a patient who had received FLUARIX QIV. The pharmacist did not specify the adverse event. The pharmacist was called twice and left voice mails. She did not return to the calls.
Age: 1.24
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Adverse Event. Patient was given Proquad MMR/VAR vaccine and Varicella inadvertently. Which gave her two doses of varicella at same time.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient stated arm was red swollen heat to touch circular around injection site-went to her primary care and described as cellulitis-like reaction; patient given Keflex 500mg bid x 10 days as prophylaxis; on Tuesday 6/20/16 patient came to pharmacy-reaction already dissipating; came to pharmacy to inform administrator.
Age: 29.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling, Pyrexia, Varicella post vaccine
Clinical narrative: Started with fever after the Varivax vaccination and on June 15, 2016 chickenpox appeared. My left arm was swollen and burned at the injection site.
Age: 0.21
Sex: M
Vaccine: 6VAX-F, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: None, Reporting administration of 2 HBV immunizations on the same date.
Age: 0.17
Sex: F
Vaccine: DTPIHI, IPV
Symptoms: Bradycardia, Eating disorder, Oxygen saturation decreased
Clinical narrative: My daughter was very premature but she had overcome all obstacles. She was breathing on her own with no issues & eating by bottle; since she had the vaccinations, she's been struggling bad with eating & she's been having desats as well as bradys. She had to go back on oxygen today after 3 weeks of breathing on her own!!!
Age: 33.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Immediate post-injection reaction, Musculoskeletal pain, Pain
Clinical narrative: Immediate pain and sore shoulder. Pain increased over next few days. Sought physician care approximately 1 week after vaccination. Has resulted in 2 cortisone injections and physical therapy.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain to (L) deltoid.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Urinary tract infection, Urine analysis
Clinical narrative: Child went to hospital; febrile seizure; dx with UTI.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Haemoglobin normal, Injection site erythema, Injection site reaction, Injection site swelling, Irritability
Clinical narrative: (History obtained from EMR and patient's parents. VAERS report filed by the local Health Dept.) The patient received their 12 month MMR (right thigh), Hep. A (right thigh), Varicella (left thigh), and PCV-13 (left thigh) on 6/1/2016. The patient experienced low grade fever and was irritable for the next five days. On 6/6/2016 a raised, erythematous lesion began around the injection site on the left thigh. On 6/7/2017 the rash was also note on the back of the patient's neck and where the patient's diaper contacted the skin. The patient's mother describes the rash as, "red, pimply, like chicken pox, like roseola rash." By 6/8/2016 the rash had spread to the trunk, legs and arms. By 6/9/2016 the rash had spread to the face. The patient's mother states that she believes the rash was itchy or irritating the patient because that patient responded to topical creams. The patient's rash had cleared by 6/25/2016 with the exception of some continued, mild erythema at the injection site. The patient is also now afebrile and has normal behavior. The patient was not treated with anything but diaper rash creams and topical antibiotic and moisturizing creams.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Measles antibody positive, Pyrexia, Rash, Rash erythematous, Rash vesicular
Clinical narrative: (History obtained from EMR and patient's parents. VAERS report filed by the local Health Dept.) The patient received their 12 month MMR (right thigh), Hep. A (right thigh), Varicella (left thigh), and PCV-13 (left thigh) on 6/1/2016. The patient experienced low grade fever and was irritable for the next five days. On 6/6/2016 a raised, erythematous lesion began around the injection site on the left thigh. On 6/7/2017 the rash was also note on the back of the patient's neck and where the patient's diaper contacted the skin. The patient's mother describes the rash as, "red, pimply, like chicken pox, like roseola rash." By 6/8/2016 the rash had spread to the trunk, legs and arms. By 6/9/2016 the rash had spread to the face. The patient's mother states that she believes the rash was itchy or irritating the patient because that patient responded to topical creams. The patient's rash had cleared by 6/25/2016 with the exception of some continued, mild erythema at the injection site. The patient is also now afebrile and has normal behavior. The patient was not treated with anything but diaper rash creams and topical antibiotic and moisturizing creams.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Skin lesion
Clinical narrative: (History obtained from EMR and patient's parents. VAERS report filed by the local Health Dept.) The patient received their 12 month MMR (right thigh), Hep. A (right thigh), Varicella (left thigh), and PCV-13 (left thigh) on 6/1/2016. The patient experienced low grade fever and was irritable for the next five days. On 6/6/2016 a raised, erythematous lesion began around the injection site on the left thigh. On 6/7/2017 the rash was also note on the back of the patient's neck and where the patient's diaper contacted the skin. The patient's mother describes the rash as, "red, pimply, like chicken pox, like roseola rash." By 6/8/2016 the rash had spread to the trunk, legs and arms. By 6/9/2016 the rash had spread to the face. The patient's mother states that she believes the rash was itchy or irritating the patient because that patient responded to topical creams. The patient's rash had cleared by 6/25/2016 with the exception of some continued, mild erythema at the injection site. The patient is also now afebrile and has normal behavior. The patient was not treated with anything but diaper rash creams and topical antibiotic and moisturizing creams.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Headache, Injection site erythema
Clinical narrative: 4/4/16-dad called, states site of injection red with "wart-like" area.  Resolved.  4/11/16-Seen in office for sore throat, stomach ache.  Rapid Strep and culture negative, not treated.  4/14/16-Twin + strep, patient with peristent sore throat/stomach ache, fever.  Not seen, treated with Amoxicillin.  4/20/16-seen due to light headed, dizzy, headache.  Labs ordered.  4/22/16.  Seen due to +ASO, treated with Amoxicillin.  Saw neurologist (around 5/4) started on Tenex for tics.  Continued with no energy, pale, weak.  Encouraged to increase salt/fluids.  On Zofran and Antivert.  Saw Cardiologist 5/11/16, Per mom, cardiologist did not find cause of symtpoms.  5/16/16-seen in office for sore neck, dx'd with wry neck.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site reaction, Neck pain, Oropharyngeal pain, Pallor, Pyrexia
Clinical narrative: 4/4/16-dad called, states site of injection red with "wart-like" area.  Resolved.  4/11/16-Seen in office for sore throat, stomach ache.  Rapid Strep and culture negative, not treated.  4/14/16-Twin + strep, patient with peristent sore throat/stomach ache, fever.  Not seen, treated with Amoxicillin.  4/20/16-seen due to light headed, dizzy, headache.  Labs ordered.  4/22/16.  Seen due to +ASO, treated with Amoxicillin.  Saw neurologist (around 5/4) started on Tenex for tics.  Continued with no energy, pale, weak.  Encouraged to increase salt/fluids.  On Zofran and Antivert.  Saw Cardiologist 5/11/16, Per mom, cardiologist did not find cause of symtpoms.  5/16/16-seen in office for sore neck, dx'd with wry neck.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Streptococcus test positive, Tic, Torticollis
Clinical narrative: 4/4/16-dad called, states site of injection red with "wart-like" area.  Resolved.  4/11/16-Seen in office for sore throat, stomach ache.  Rapid Strep and culture negative, not treated.  4/14/16-Twin + strep, patient with peristent sore throat/stomach ache, fever.  Not seen, treated with Amoxicillin.  4/20/16-seen due to light headed, dizzy, headache.  Labs ordered.  4/22/16.  Seen due to +ASO, treated with Amoxicillin.  Saw neurologist (around 5/4) started on Tenex for tics.  Continued with no energy, pale, weak.  Encouraged to increase salt/fluids.  On Zofran and Antivert.  Saw Cardiologist 5/11/16, Per mom, cardiologist did not find cause of symtpoms.  5/16/16-seen in office for sore neck, dx'd with wry neck.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site oedema, Vaccination site warmth
Clinical narrative: 1/3 of arm red, edema, warm from vaccine site towards elbow.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 1/3 of arm red, swollen, warm  from site of vaccine towards elbow.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Chest pain, Erythema, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Pain rash with erythema down inside of right arm to shoulder and chest area.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Pain rash with erythema down inside of right arm to shoulder and chest area.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 1/2 of arm red, swollen, warm from vaccine site to elbow, with blistered appearing center at injection site.
Age: 72.0
Sex: F
Vaccine: YF
Symptoms: Headache, Malaise, Nausea, Pain, Rash
Clinical narrative: Achy, headache progressed from moderate to severe, nausea, vomiting, rash, general malaise.  Symptoms are now on day 6 and beginning to recede.
Age: 72.0
Sex: F
Vaccine: YF
Symptoms: Vomiting
Clinical narrative: Achy, headache progressed from moderate to severe, nausea, vomiting, rash, general malaise.  Symptoms are now on day 6 and beginning to recede.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Patient reported a low grade fever and marked soreness in and around the injection point on 6/25/16 and a fever of approximately 101 degrees F through 6/26/16 into the morning of 6/27/16.