chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Abdominal discomfort, Blindness, Dizziness
Clinical narrative: Dizziness, stomach discomfort, intermittent blindness for 3 days.
Age: 0.67
Sex: F
Vaccine: HEP, IPV
Symptoms: Conjunctivitis viral, Lymphadenopathy, Pyrexia
Clinical narrative: Fever. Lg lymph nodes. Viral conjunctivitis.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Blood creatine phosphokinase, Chills, Full blood count, Hyperhidrosis
Clinical narrative: Sudden onset high fever 102.7 F, chills, sweats, back aches.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Metabolic function test, Pyrexia, Urine analysis
Clinical narrative: Sudden onset high fever 102.7 F, chills, sweats, back aches.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Red, inflammation spot, 3 in. diameter, near injection site. No raised bumps, slowly spreading.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Bumps on neck and around nose. Rash at around nose, itching on nose and neck.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Feeling abnormal, Tremor
Clinical narrative: Approx. 5 min after vaccine, mother was nursing infant. She not his head began shaking back and forth for a few seconds, then he was "out of it" for 1-2 min.
Age: 66.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Constipation, Flatulence, Productive cough
Clinical narrative: This is a spontaneous report from a contactable consumer (the patient) and from a contactable nurse. A 66-year-old male patient received PREVNAR 13, (lot/batch number M20640, expiry date Apr2017) intramuscularly on the right deltoid, on 06Dec2015 at 08:05, at 0.5 ml single for immunization. Relevant medical history included Chronic Sinusitis. Concomitant medications were not reported. The patient experienced arm swelling, constipation, gas and coughing up phlegm and his arm was still sore/sore arm at injection site on 09Dec2015. As the patient had found that diphtheria degraded protein by process of ADP-nitrosylation and that it could be stopped with large doses of niacinamide, he started taking large doses of it and the severe gas and crampings stopped, but when after about 2 months he became worried about the large dosage of niacinamide (1500 to 2000 mg 3 times a day) and he stopped taking it, the gas and crampings returned. He went back on niacinamide that did not work as good as the previous time. The patient did not receive treatment for arm swelling, constipation, coughing up phlegm and his arm was still sore. The patient was not recovered from all these events, apart swelling which outcome was unknown. The patient also experienced redness, tenderness to palpation and warmth on unknown date with unknown outcome. The patient had a laboratory work just as regular. The patient had consulted three doctors and they have told him that his symptoms have not been caused by pneumococcal 13-val conj vac (dipht crm197 protein). They have suggested that it's a bug causing his problems, there was nothing wrong with him. The nurse confirmed that the patient provided information to him/her regarding the reported adverse events with the use of the product. The nurse did not consider that the Pfizer vaccine had a causal effect to the adverse events. Follow-up (28Jun2016): New information reported from a contactable nurse includes: details of vaccination (site of vaccination, date, dose and lot number and expiry date), new events (sore arm at injection site, redness, tenderness to palpation and warmth), outcome, nurse's causality assessment and confirmation that the patient provided information to him/her regarding the reported adverse events with the use of the product. Follow up (02Sep2016): New information reported from the same contactable consumer includes: updated vaccination date, absence of treatment for the events arm swelling, constipation, coughing up phlegm, sore arm at injection site, updated onset date/outcome for the events constipation, gas and coughing up phlegm, and updated outcome for events his arm was still sore/sore arm at injection site. Follow-up attempts completed. No further information expected. Follow-up (07Nov2016): New information reported from a contactable nurse includes medical history. Sender's Comments: Based on the information currently available, the company agrees with the assessment of the reporting nurse and does not attribute the events to PREVNAR 13.
Age: 66.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Constipation, Erythema, Flatulence, Injection site pain, Laboratory test normal
Clinical narrative: This is a spontaneous report from a contactable consumer (the patient) and from a contactable nurse. A 66-year-old male patient received PREVNAR 13, (lot/batch number M20640, expiry date Apr2017) intramuscularly on the right deltoid, on 06Dec2015 at 08:05, at 0.5 ml single for immunization. Relevant medical history included Chronic Sinusitis. Concomitant medications were not reported. The patient experienced arm swelling, constipation, gas and coughing up phlegm and his arm was still sore/sore arm at injection site on 09Dec2015. As the patient had found that diphtheria degraded protein by process of ADP-nitrosylation and that it could be stopped with large doses of niacinamide, he started taking large doses of it and the severe gas and crampings stopped, but when after about 2 months he became worried about the large dosage of niacinamide (1500 to 2000 mg 3 times a day) and he stopped taking it, the gas and crampings returned. He went back on niacinamide that did not work as good as the previous time. The patient did not receive treatment for arm swelling, constipation, coughing up phlegm and his arm was still sore. The patient was not recovered from all these events, apart swelling which outcome was unknown. The patient also experienced redness, tenderness to palpation and warmth on unknown date with unknown outcome. The patient had a laboratory work just as regular. The patient had consulted three doctors and they have told him that his symptoms have not been caused by pneumococcal 13-val conj vac (dipht crm197 protein). They have suggested that it's a bug causing his problems, there was nothing wrong with him. The nurse confirmed that the patient provided information to him/her regarding the reported adverse events with the use of the product. The nurse did not consider that the Pfizer vaccine had a causal effect to the adverse events. Follow-up (28Jun2016): New information reported from a contactable nurse includes: details of vaccination (site of vaccination, date, dose and lot number and expiry date), new events (sore arm at injection site, redness, tenderness to palpation and warmth), outcome, nurse's causality assessment and confirmation that the patient provided information to him/her regarding the reported adverse events with the use of the product. Follow up (02Sep2016): New information reported from the same contactable consumer includes: updated vaccination date, absence of treatment for the events arm swelling, constipation, coughing up phlegm, sore arm at injection site, updated onset date/outcome for the events constipation, gas and coughing up phlegm, and updated outcome for events his arm was still sore/sore arm at injection site. Follow-up attempts completed. No further information expected. Follow-up (07Nov2016): New information reported from a contactable nurse includes medical history. Sender's Comments: Based on the information currently available, the company agrees with the assessment of the reporting nurse and does not attribute the events to PREVNAR 13.
Age: 66.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Muscle spasms, Peripheral swelling, Productive cough, Skin warm, Tenderness
Clinical narrative: This is a spontaneous report from a contactable consumer (the patient) and from a contactable nurse. A 66-year-old male patient received PREVNAR 13, (lot/batch number M20640, expiry date Apr2017) intramuscularly on the right deltoid, on 06Dec2015 at 08:05, at 0.5 ml single for immunization. Relevant medical history included Chronic Sinusitis. Concomitant medications were not reported. The patient experienced arm swelling, constipation, gas and coughing up phlegm and his arm was still sore/sore arm at injection site on 09Dec2015. As the patient had found that diphtheria degraded protein by process of ADP-nitrosylation and that it could be stopped with large doses of niacinamide, he started taking large doses of it and the severe gas and crampings stopped, but when after about 2 months he became worried about the large dosage of niacinamide (1500 to 2000 mg 3 times a day) and he stopped taking it, the gas and crampings returned. He went back on niacinamide that did not work as good as the previous time. The patient did not receive treatment for arm swelling, constipation, coughing up phlegm and his arm was still sore. The patient was not recovered from all these events, apart swelling which outcome was unknown. The patient also experienced redness, tenderness to palpation and warmth on unknown date with unknown outcome. The patient had a laboratory work just as regular. The patient had consulted three doctors and they have told him that his symptoms have not been caused by pneumococcal 13-val conj vac (dipht crm197 protein). They have suggested that it's a bug causing his problems, there was nothing wrong with him. The nurse confirmed that the patient provided information to him/her regarding the reported adverse events with the use of the product. The nurse did not consider that the Pfizer vaccine had a causal effect to the adverse events. Follow-up (28Jun2016): New information reported from a contactable nurse includes: details of vaccination (site of vaccination, date, dose and lot number and expiry date), new events (sore arm at injection site, redness, tenderness to palpation and warmth), outcome, nurse's causality assessment and confirmation that the patient provided information to him/her regarding the reported adverse events with the use of the product. Follow up (02Sep2016): New information reported from the same contactable consumer includes: updated vaccination date, absence of treatment for the events arm swelling, constipation, coughing up phlegm, sore arm at injection site, updated onset date/outcome for the events constipation, gas and coughing up phlegm, and updated outcome for events his arm was still sore/sore arm at injection site. Follow-up attempts completed. No further information expected. Follow-up (07Nov2016): New information reported from a contactable nurse includes medical history. Sender's Comments: Based on the information currently available, the company agrees with the assessment of the reporting nurse and does not attribute the events to PREVNAR 13.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Blood test, Chest pain, Dyskinesia, Dyspnoea, Electroencephalogram
Clinical narrative: This spontaneous report as received from a certified medical assistant via Pfizer refers to a 16 year old female patient. The patient's medical history included mood disorder on 31-MAR-2010, anxiety on 20-OCT-2009 and chest pain on 28-MAR-2011. The patient's concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 lot # M005714, expiration date: 03-OCT-2017, via intramuscular route (dose was not reported) in the left upper deltoid, the first dose of TRUMENBA lot# M74089, expiration date: 30-JUN-2017, intramuscularly in the lower left deltoid (dose was not reported) and second dose of MENACTRA lot # 45259AA, expiration date: 13-MAY-2017, intramuscularly in the right deltoid (dose was not reported). The patient was vaccinated at private physician's office, with public funds. On an unknown date, the patient developed anxiety, followed by family stress. On 18-AUG-2016, the patient experienced tremors and on 25-AUG-2016, abnormal involuntary movements were reported. The patient visited an emergency room and her physician. On an unknown date, electroencephalogram (EEG) was performed and the result showed generalized polyspike activity. On 25-AUG-2016, the patient started taking KEPPRA XR 500 mg, one tablet, daily, for 5 days and then the dose would be increased to 2 tablets daily. The outcome of the events was not reported. The causality assessment was not provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Seizure
Clinical narrative: This spontaneous report as received from a certified medical assistant via Pfizer refers to a 16 year old female patient. The patient's medical history included mood disorder on 31-MAR-2010, anxiety on 20-OCT-2009 and chest pain on 28-MAR-2011. The patient's concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 lot # M005714, expiration date: 03-OCT-2017, via intramuscular route (dose was not reported) in the left upper deltoid, the first dose of TRUMENBA lot# M74089, expiration date: 30-JUN-2017, intramuscularly in the lower left deltoid (dose was not reported) and second dose of MENACTRA lot # 45259AA, expiration date: 13-MAY-2017, intramuscularly in the right deltoid (dose was not reported). The patient was vaccinated at private physician's office, with public funds. On an unknown date, the patient developed anxiety, followed by family stress. On 18-AUG-2016, the patient experienced tremors and on 25-AUG-2016, abnormal involuntary movements were reported. The patient visited an emergency room and her physician. On an unknown date, electroencephalogram (EEG) was performed and the result showed generalized polyspike activity. On 25-AUG-2016, the patient started taking KEPPRA XR 500 mg, one tablet, daily, for 5 days and then the dose would be increased to 2 tablets daily. The outcome of the events was not reported. The causality assessment was not provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Anxiety, Dyskinesia, Electroencephalogram abnormal, Tremor
Clinical narrative: This spontaneous report as received from a certified medical assistant via Pfizer refers to a 16 year old female patient. The patient's medical history included mood disorder on 31-MAR-2010, anxiety on 20-OCT-2009 and chest pain on 28-MAR-2011. The patient's concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 lot # M005714, expiration date: 03-OCT-2017, via intramuscular route (dose was not reported) in the left upper deltoid, the first dose of TRUMENBA lot# M74089, expiration date: 30-JUN-2017, intramuscularly in the lower left deltoid (dose was not reported) and second dose of MENACTRA lot # 45259AA, expiration date: 13-MAY-2017, intramuscularly in the right deltoid (dose was not reported). The patient was vaccinated at private physician's office, with public funds. On an unknown date, the patient developed anxiety, followed by family stress. On 18-AUG-2016, the patient experienced tremors and on 25-AUG-2016, abnormal involuntary movements were reported. The patient visited an emergency room and her physician. On an unknown date, electroencephalogram (EEG) was performed and the result showed generalized polyspike activity. On 25-AUG-2016, the patient started taking KEPPRA XR 500 mg, one tablet, daily, for 5 days and then the dose would be increased to 2 tablets daily. The outcome of the events was not reported. The causality assessment was not provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a certified medical assistant via Pfizer refers to a 16 year old female patient. The patient's medical history included mood disorder on 31-MAR-2010, anxiety on 20-OCT-2009 and chest pain on 28-MAR-2011. The patient's concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 lot # M005714, expiration date: 03-OCT-2017, via intramuscular route (dose was not reported) in the left upper deltoid, the first dose of TRUMENBA lot# M74089, expiration date: 30-JUN-2017, intramuscularly in the lower left deltoid (dose was not reported) and second dose of MENACTRA lot # 45259AA, expiration date: 13-MAY-2017, intramuscularly in the right deltoid (dose was not reported). The patient was vaccinated at private physician's office, with public funds. On an unknown date, the patient developed anxiety, followed by family stress. On 18-AUG-2016, the patient experienced tremors and on 25-AUG-2016, abnormal involuntary movements were reported. The patient visited an emergency room and her physician. On an unknown date, electroencephalogram (EEG) was performed and the result showed generalized polyspike activity. On 25-AUG-2016, the patient started taking KEPPRA XR 500 mg, one tablet, daily, for 5 days and then the dose would be increased to 2 tablets daily. The outcome of the events was not reported. The causality assessment was not provided. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9, FLU4, HPV9, FLU4, HPV9
Symptoms: Fatigue, Headache, Immediate post-injection reaction, Nausea, Oropharyngeal pain
Clinical narrative: Headache and sore throat developed minutes after HPV9 and quadrivalent flu shot. The HA has persisted 6 weeks on a daily basis, with exercise and noise exacerbating it. She has also had paresthesia of leg, tics, and muscle aches since the vaccine. She has not been able to participate in her usual activities due to pain. She has seen neurology and rheumatology but is without a firm diagnosis. She has ID and immunology appointments scheduled within the next few weeks.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9, FLU4, HPV9, FLU4, HPV9
Symptoms: Visual impairment
Clinical narrative: Headache and sore throat developed minutes after HPV9 and quadrivalent flu shot. The HA has persisted 6 weeks on a daily basis, with exercise and noise exacerbating it. She has also had paresthesia of leg, tics, and muscle aches since the vaccine. She has not been able to participate in her usual activities due to pain. She has seen neurology and rheumatology but is without a firm diagnosis. She has ID and immunology appointments scheduled within the next few weeks.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9, FLU4, HPV9, FLU4, HPV9
Symptoms: Dizziness, Headache, Nausea, Oropharyngeal pain, Streptococcus test positive
Clinical narrative: Headache and sore throat developed minutes after HPV9 and quadrivalent flu shot. The HA has persisted 6 weeks on a daily basis, with exercise and noise exacerbating it. She has also had paresthesia of leg, tics, and muscle aches since the vaccine. She has not been able to participate in her usual activities due to pain. She has seen neurology and rheumatology but is without a firm diagnosis. She has ID and immunology appointments scheduled within the next few weeks.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9, FLU4, HPV9, FLU4, HPV9
Symptoms: Activities of daily living impaired, Antinuclear antibody negative, C-reactive protein normal, Complement factor C3, Complement factor C4
Clinical narrative: Headache and sore throat developed minutes after HPV9 and quadrivalent flu shot. The HA has persisted 6 weeks on a daily basis, with exercise and noise exacerbating it. She has also had paresthesia of leg, tics, and muscle aches since the vaccine. She has not been able to participate in her usual activities due to pain. She has seen neurology and rheumatology but is without a firm diagnosis. She has ID and immunology appointments scheduled within the next few weeks.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9, FLU4, HPV9, FLU4, HPV9
Symptoms: Complement factor normal, Full blood count normal, Headache, Liver function test normal, Metabolic function test normal
Clinical narrative: Headache and sore throat developed minutes after HPV9 and quadrivalent flu shot. The HA has persisted 6 weeks on a daily basis, with exercise and noise exacerbating it. She has also had paresthesia of leg, tics, and muscle aches since the vaccine. She has not been able to participate in her usual activities due to pain. She has seen neurology and rheumatology but is without a firm diagnosis. She has ID and immunology appointments scheduled within the next few weeks.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9, FLU4, HPV9, FLU4, HPV9
Symptoms: Myalgia, Oropharyngeal pain, Pain, Paraesthesia, Red blood cell sedimentation rate normal
Clinical narrative: Headache and sore throat developed minutes after HPV9 and quadrivalent flu shot. The HA has persisted 6 weeks on a daily basis, with exercise and noise exacerbating it. She has also had paresthesia of leg, tics, and muscle aches since the vaccine. She has not been able to participate in her usual activities due to pain. She has seen neurology and rheumatology but is without a firm diagnosis. She has ID and immunology appointments scheduled within the next few weeks.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9, FLU4, HPV9, FLU4, HPV9
Symptoms: Thyroid function test normal, Tic
Clinical narrative: Headache and sore throat developed minutes after HPV9 and quadrivalent flu shot. The HA has persisted 6 weeks on a daily basis, with exercise and noise exacerbating it. She has also had paresthesia of leg, tics, and muscle aches since the vaccine. She has not been able to participate in her usual activities due to pain. She has seen neurology and rheumatology but is without a firm diagnosis. She has ID and immunology appointments scheduled within the next few weeks.
Age: 51.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Migraine
Clinical narrative: Pt contracted viral meningitis three days following administration of influenza vaccination. Pt was hospitalized x1 week. Pt. experienced same outcome after flu shot approximately 15 years ago.
Age: 51.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Meningitis viral
Clinical narrative: Pt contracted viral meningitis three days following administration of influenza vaccination. Pt was hospitalized x1 week. Pt. experienced same outcome after flu shot approximately 15 years ago.
Age: 18.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Hyperhidrosis, Nausea, Skin warm
Clinical narrative: Information has been received from a medical assistant referring to a 18 years old male patient. There was no pertinent medical history, concomitant therapy and drug reactions or allergies. On 25-AUG-2016, the patient received dose 1 of GARDASIL 9 (route, dose, lot number and expiration date unknown). The patient had no adverse symptoms with dose 1. On 26-OCT-2016, the patient was vaccinated with dose 2 GARDASIL 9 (lot # M028323 with expiration date 26-SEP-2018) 0.5 ml, intramuscularly. On the same day, within one minute after administration, the patient asked for a glass of water and said he felt "weird and lightheaded". He started to feel warm and started sweating. He became nauseous. The medical assistant had him sit on the floor and he drank some water. The medical assistant also turned on a fan in the room. She then had the patient lay down and she elevated the patient's feet. The patient started to feel better "pretty quickly" and approximately 15 minutes after the onset  of the symptoms the patient had recovered while still in the office. The causal relationship between GARDASIL 9 and the events was reported as unknown. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Feeling abnormal, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: Information has been received from a medical assistant referring to a 18 years old male patient. There was no pertinent medical history, concomitant therapy and drug reactions or allergies. On 25-AUG-2016, the patient received dose 1 of GARDASIL 9 (route, dose, lot number and expiration date unknown). The patient had no adverse symptoms with dose 1. On 26-OCT-2016, the patient was vaccinated with dose 2 GARDASIL 9 (lot # M028323 with expiration date 26-SEP-2018) 0.5 ml, intramuscularly. On the same day, within one minute after administration, the patient asked for a glass of water and said he felt "weird and lightheaded". He started to feel warm and started sweating. He became nauseous. The medical assistant had him sit on the floor and he drank some water. The medical assistant also turned on a fan in the room. She then had the patient lay down and she elevated the patient's feet. The patient started to feel better "pretty quickly" and approximately 15 minutes after the onset  of the symptoms the patient had recovered while still in the office. The causal relationship between GARDASIL 9 and the events was reported as unknown. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 02 November 2016. This case involves a 28-year-old female patient, who was vaccinated with a dose of FLUZONE QIV batch number: UI690AB, (expiry date, dose, dose in series were not reported) in left deltoid via intramuscularly on 30 September 2016. Patient's illness at time of vaccination was reported as none and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as Allergies: none known as per reporter. Concomitant medication was not reported. On 30 September 2016, same day following the vaccination, the patient experienced soreness at injection site. On an unspecified date, about one month following the vaccination patient experienced arm pain with decreased mobility of arm due to the pain. It was reported that patient had pain to lift arm and continues to have pain to this day 02 November 2016. Lab data and Corrective treatment were not reported. On an unspecified date, few days following the vaccination patient's outcome for the event soreness at injection site was recovered and outcome of other events was not recovered. List of documents held by sender: none.
Age: 28.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a pharmacist on 02 November 2016. This case involves a 28-year-old female patient, who was vaccinated with a dose of FLUZONE QIV batch number: UI690AB, (expiry date, dose, dose in series were not reported) in left deltoid via intramuscularly on 30 September 2016. Patient's illness at time of vaccination was reported as none and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as Allergies: none known as per reporter. Concomitant medication was not reported. On 30 September 2016, same day following the vaccination, the patient experienced soreness at injection site. On an unspecified date, about one month following the vaccination patient experienced arm pain with decreased mobility of arm due to the pain. It was reported that patient had pain to lift arm and continues to have pain to this day 02 November 2016. Lab data and Corrective treatment were not reported. On an unspecified date, few days following the vaccination patient's outcome for the event soreness at injection site was recovered and outcome of other events was not recovered. List of documents held by sender: none.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Erythema, Skin warm, Tenderness, Testicular pain, Testicular swelling
Clinical narrative: This spontaneous report was received from a medical assistant via a field representative referring to a 12 year old male patient. Information about concurrent condition and medical history was not provided. Concomitant medication included vitamins (unspecified). On 04-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot # M020103, expiration date 15-FEB-2018) (strength, dose, frequency and route were not reported). On the same day, the patient developed "swelling to the testicles that was tender and warm to the touch". The patient's mother called the office and reported the events. The reporter did not specify the duration of the reaction. The patient did not seek medical attention. No treatment was given for the event. At the time of reporting, the outcome of the events was unknown. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Skin warm, Tenderness, Testicular swelling
Clinical narrative: This spontaneous report was received from a medical assistant via a field representative referring to a 12 year old male patient. Information about concurrent condition and medical history was not provided. Concomitant medication included vitamins (unspecified). On 04-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot # M020103, expiration date 15-FEB-2018) (strength, dose, frequency and route were not reported). On the same day, the patient developed "swelling to the testicles that was tender and warm to the touch". The patient's mother called the office and reported the events. The reporter did not specify the duration of the reaction. The patient did not seek medical attention. No treatment was given for the event. At the time of reporting, the outcome of the events was unknown. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash macular
Clinical narrative: Initial unsolicited report received from a pharmacist on 03 Nov 2016. This case involves a 70-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number: UI728AB, expiry date: 03 June 2017, dose, dose in series, were not reported) intramuscularly in left deltoid on 01 Nov 2016. Illness at the time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergies. Concomitant medications were not reported. On 01 Nov 2016, same day following the vaccination, the patient had developed had blotchy areas-"purplish"- all over arm (injected arm) and Swelling at injection site. On an unknown date, the patient was seen by physician. The patient previously vaccinated with FLUZONE HD in last year (in 2015). The patient's laboratory data was not reported. The patient was treated with prednisone and Bactrim DS. The outcome of the event was reported as unknown. List of documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site swelling, Rash macular, Skin discolouration
Clinical narrative: Initial unsolicited report received from a pharmacist on 03 Nov 2016. This case involves a 70-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number: UI728AB, expiry date: 03 June 2017, dose, dose in series, were not reported) intramuscularly in left deltoid on 01 Nov 2016. Illness at the time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergies. Concomitant medications were not reported. On 01 Nov 2016, same day following the vaccination, the patient had developed had blotchy areas-"purplish"- all over arm (injected arm) and Swelling at injection site. On an unknown date, the patient was seen by physician. The patient previously vaccinated with FLUZONE HD in last year (in 2015). The patient's laboratory data was not reported. The patient was treated with prednisone and Bactrim DS. The outcome of the event was reported as unknown. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 66-year-old female patient received PREVNAR 13 (Lot # N16515, Expiry Date Oct2017, NDC number 00005197101), intramuscular at 0.5 ml single in the left arm on 27Oct2016 17:20 for immunisation. Medical history included ongoing hypothyroidism taking levothyroxine, ongoing bone density taking Fosamax. Concomitant medication included Levothyroxine, FOSAMAX. The patient previously took Fluzone (Lot: UI659AA), intramuscular in the left arm for immunisation, oral ciprofloxacin and experienced red rash. In Oct2016, the patient developed a red rash a half inch below injection site; red rash was 3 to 4 inches in diameter with outcome of recovered.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Rash erythematous
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 66-year-old female patient received PREVNAR 13 (Lot # N16515, Expiry Date Oct2017, NDC number 00005197101), intramuscular at 0.5 ml single in the left arm on 27Oct2016 17:20 for immunisation. Medical history included ongoing hypothyroidism taking levothyroxine, ongoing bone density taking Fosamax. Concomitant medication included Levothyroxine, FOSAMAX. The patient previously took Fluzone (Lot: UI659AA), intramuscular in the left arm for immunisation, oral ciprofloxacin and experienced red rash. In Oct2016, the patient developed a red rash a half inch below injection site; red rash was 3 to 4 inches in diameter with outcome of recovered.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose normal, Dizziness
Clinical narrative: Lightheaded/dizziness.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Gait disturbance, Myalgia
Clinical narrative: SEVERE MUSCLE ACHE ON LEFT SIDE UPPER TORSO ALONG RIB CAGE, SEVERE WEAKNESS OF ENTIRE BODY AND FEELING FAINT WHEN WALKING.
Age: 42.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Mobility decreased
Clinical narrative: Lower back started hurting extremely bad. Could not get out of bed the next day, back still hurting throughout weekend, really bad. Going on Tuesday and my back still hurts pretty bad, but getting slowly better.
Age: 1.0
Sex: F
Vaccine: FLUX, HBHEPB, MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Chicken pox rash - 20+ pocks all over body.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Trigeminal neuralgia
Clinical narrative: Initial unsolicited report received from other non-healthcare professional on 03 November 2016. This case involves a 72-year-old female patient who was vaccinated with a dose of Fluzone HD (batch number: UI704AA, expiry date: 17 May 2017, dose not reported) intramuscularly in the left deltoid on 11 Oct 2016. Illness at time of vaccination reported as: unknown and pre-existing physician diagnosed allergies, birth defects and medical conditions include no known allergy. Concomitant medication was not reported. On 18 October 2016, seven days following the vaccination, the patient was complaining of earache and diagnosed as trigeminal neuralgia by a neurologist. On an unspecified date patient required emergency room or doctor visit. Lab data and corrective treatment was not reported. The patient was not recovered from events. List of documents held by sender: none.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Initial unsolicited report received from a nurse on 03 November 2016. This case involves a 21-years-old female patient who was vaccinated with a first dose of FLUZONE ID (batch number- UT5572BA, expiratory date-30 June 2017) (dose in series and dose was not reported) via intradermal route in right forearm on 01 November 2016. The patient had allergy to sulfa and illness at time of vaccination was reported as none. Concomitant medications were not reported. On 02 November 2016, (It was reported as within 24 hours) following the vaccination, the patient had developed an irregular reddened area at site of vaccination, measuring 7cm x 7cm and was warm to touch and after 24-48 hours increased in size to 8cm x 13 cm and it's warm to touch and tender. Patient was required doctor visit. Relevant laboratory data was reported as none. The patient received Zyrtec, ibuprofen (using cool and warm compresses to area) as corrective treatment. The outcome of the event was reported as unknown. List of documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Seizure, Tremor
Clinical narrative: Initial unsolicited report received from a consumer on 03-Nov-2016. This case involves a patient (age and gender unknown) who was vaccinated with FLUZONE HD (lot number, expiration date, dose, route, site of administration not reported) on an unknown date. The patient's medical history and the concomitant medications were not reported. On an unknown date, after the vaccination, patient experienced chills and shakes for two hours that felt like convulsions. The patient's laboratory details and corrective treatment were not reported. The patient recovered from all events on an unknown date. Upon internal review the case was considered as serious because of important medical event: convulsions. List of the documents held by sender: none. Sender's Comments: Patient received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and reported For two hours patient had chills and shakes that felt like convulsions. Convulsions and chills is listed with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, However Time to onset was not specified. Details regarding as latency from last INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE administered, relevant medical history, patients age and gender, and diagnostic work-up- are lacking to allow adequate medical assessment.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Herpes zoster
Clinical narrative: Initial unsolicited report received from a nurse on 03-Nov-2016. This case involves a 55-year-old female patient, who was vaccinated FLUZONE via intramuscular route (batch number: UI657AB, expiry date: 30-Jun-2017) (dose and dose in series not reported) in left deltoid on 04-Oct-2016. Patient's illness at time of vaccination and pre-existing physician diagnosed allergies were reported as unknown. Concomitant medications were not reported. On 22-Oct-2016, 17-day following the vaccination, the patient had shingles symptoms. On 28-Oct-2016, 23-day after vaccination patient had visible outbreak. It was also reported that a physician diagnosed the event as shingles. Patient required ER/doctor visit. Lab test and concomitant medication was not reported. Outcome of the events were reported as not recovered. Upon internal review the case was considered as serious because of important medical event: shingles. Documents held by sender: none. Sender's Comments: This case concerns 55 years old female who received INFLUENZA QUADRIVAL A-B VACCINE and experienced Shingles. Time to onset 18 days is compatible with the role of vaccine. Shingles is due to a reactivation of varicella zoster virus (VZV) within a patient's body. Details regarding relevant medical history, any previous history of Chickenpox and information on infections occurring prior to vaccination are needed for complete assessment of the case. Based on the available information role of the vaccine can be excluded.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Initial unsolicited report received from a non-health care professional on 03 Nov 2016. This case involve three patients (gender and age not reported) who were vaccinated with a dose of Fluzone ID QIV (Batch number: UT5572BA, expiration date: 30 Jun 2017, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was not reported. Illness at the time of vaccination was also not reported. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unknown date, unspecified timeframe following the vaccination, the patients had developed red, inflammed, itchy, painful, area at injection site with lump noted at injection site. Laboratory investigations and corrective treatment were not reported. The outcome of events was recovering (reported as after 4 days symptoms began to resolve). List of documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Middle insomnia, Pain
Clinical narrative: Initial unsolicited report received from consumer (Patient) on 03-Nov-2016. This case involves 71 year old female patient who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration were not reported) on Oct-2016 on an unspecified date (it was reported that patient had a flu shot last week and purposefully waited for a week to take Praluent). The patient had also taken 75mg of first dose of PRALUENT (batch number: 6F040A, expiry date: 31-Mar-2017, route and site of administration were not reported) at 17:00 pm on 02-NOV-2016. Medical history and concomitant medications were not reported. On 02-Nov-2016, 1 week after vaccination, the patient had experienced diarrhea, racquetball sized, round, red, raised swelling area at the injection site on her right upper leg and had little sore, on same day few hours after the patient had taken the Praluent. On 02-Nov-2016, 1 week after vaccination, the patient woke up during the night with diarrhea, on same day few hours after the patient had taken the Praluent. Laboratory investigations and corrective treatments were not reported. On an unspecified date, patient recovered from event diarrhea and woke up during the night. On 02-NOV-2016, patient recovered from event racquetball sized, round, red, raised swelling area at the injection site which lasted for approximately half an hour and went away and sore. Documents held by sender: none.
Sex: M
Vaccine: PPV
Symptoms: Injection site abscess
Clinical narrative: This spontaneous report was received from office manager refers to a male patient of unknown age. The patient's pertinent medical history and concomitant medications were unknown. He had no known drug reactions/allergies. On 03-NOV-2016 the patient was vaccinated with PNEUMOVAX 23 (lot # L035687 and expiry date 16-FEB-2017) intramuscular. On an unknown date in November 2016, he experienced abscess at the injection site and went to unspecified hospital overnight during which he received 2 different antibiotics. The outcome of injection site abscess was unknown. The reporter did not provide relatedness of the event with PNEUMOVAX 23. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Dehydration, Influenza, Malaise
Clinical narrative: Contracted employee vaccinated with influenza vaccine per policy. Patient reported not feeling well and dehydration to employee health on 10/17/16. Stated started developing flu symptoms later in the week of 10/10/16. I instructed to report to her employer. Also, stated she was dehydrated and encouraged to go to ER immediately for evaluation on 10/17/16. Since not our employee we do not have access to medical records because of HIPPA. My understanding is there was discussion on whether this was related to her flu shot. She was admitted to hospital and then I believe transferred to another hospital. Records would need to be obtained through those facilities. We felt we should report it to VAERS to determine or in case there are other similar occurrences so that they can be tracked.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site swelling, Musculoskeletal pain
Clinical narrative: Swelling at site of shot, considerable pain in shoulder, numbness in arm. Treated with Ibuprofen and warm compress. No change in symptoms as of four weeks later.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Dizziness, Laboratory test, Loss of consciousness, Seizure
Clinical narrative: After the flu shot patient stated feeling a little dizzy and wants to stay on the chair. Was talking to her dad for a little and then passed out and started to have a seizure; also lost bladder control. A few minutes later patient was wake, alert and coherent.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Urinary incontinence
Clinical narrative: After the flu shot patient stated feeling a little dizzy and wants to stay on the chair. Was talking to her dad for a little and then passed out and started to have a seizure; also lost bladder control. A few minutes later patient was wake, alert and coherent.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site pain, Nodule
Clinical narrative: Arm sore at injection site. Nurse noted red area approx. 4x4" diameter with knot 1.5" diameter.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site pruritus, Injection site swelling, Rash macular
Clinical narrative: Immediately after vaccination patient had a bruise at injection site and swelling at injection site. She was told to watch the injection site and call the pharmacy that night to let us know of any further reactions. On 11/2/16 she called to describe a bruise at the injection site and red, hot blotches down her arm and elbow that started that morning (morning after the injection). There was no pain. There was itching at the injection site. On Thursday 11/3/16 she was called to check on the reaction and she stated that it was getting better and not getting worse.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Immediately after vaccination patient had a bruise at injection site and swelling at injection site. She was told to watch the injection site and call the pharmacy that night to let us know of any further reactions. On 11/2/16 she called to describe a bruise at the injection site and red, hot blotches down her arm and elbow that started that morning (morning after the injection). There was no pain. There was itching at the injection site. On Thursday 11/3/16 she was called to check on the reaction and she stated that it was getting better and not getting worse.
Age: 49.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Patient received Tdap (Adacel) and arm from shoulder to elbow swelled up and got red.  Patient has no pain, but complains of itchiness.  Recommended cold compress, hydrocortisone 1% cream and Benadryl.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: RASH.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea
Clinical narrative: Shortness of Breath; Benadryl taken.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 31 October 2016. This case involves a 47-year-old female patient who was vaccinated with a dose of Fluzone QIV (Batch number: UI708AB, expiry date: 30 June 2017, dose and dose in series were not reported) intramuscularly in the left deltoid on 24 October 2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as no known drug allergies (NKDA). Illness at the time of vaccination was reported as no. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 25 October 2016, one day following the vaccination, the patient had developed a fever of 101.5 degree Fahrenheit, shaking, chills and teeth chattering. Other Laboratory investigations were reported as none. Corrective treatment was not reported. The patient was recovered from all the events on an unknown date (reported as symptoms lasted for 24 hours). List of documents held by sender: none.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Soreness at injection site (continues as of today), limited range of motion which has gradually improved to almost normal range over the course of 1 week with oral analgesics.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Parent found unresponsive around 4 am, arrived at Hospital at 4:46 am, pronounced dead at 4:48 am.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient complained of redness, itching, swelling and warm to touch at injection site.