chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTAP, FLUX, HEP, IPV, PPV, DTAP, FLUX, HEP, PPV
Symptoms: Faeces discoloured, Middle insomnia, Mucous stools, Urticaria
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 was reported by a other non-health professional via health authority (VAERS ID: 677536) concerns a 05 months old female patient. There were no any medical history and current condition of the patient. There were no any medical history and current condition of the patient. Administration of Company suspect drug: On 19-Oct-2016, the patient received INN Flu Vaccine Seasonal (dose, expiry date, batch number: not reported) at left gluteus via injection NOS route. Non-company suspect drugs: On 19-Oct-2016, the patient also received Diphtheria tetanus acellular pertussis, Hepatitis B, Poliovirus vaccine and Pneumococcal vaccine polyvalent (dose number: 2, dose, batch number, expiry date: not reported) at left gluteus via injection NOS. Adverse reactions/events and outcomes: On 19-Oct-2016 after the administration of the vaccine suspect es, the patient experienced hives, redness under eyes, abdominal pain, constipation for 5 days, followed by BMs with large globs of mucus, green BMs. The reporter stated that the abdominal distress was continued for a week. The patient got up hourly at night with discomfort. Action taken with the suspect vaccines was not reported. The patient was recovered from the events. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the influenza vaccine.
Age: 52.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, was reported by a physician via regulatory authority (Vaccine Adverse Event Reporting System: 677569) and concerns a 52-years-old adult female patient. Administration of Company suspect drug(s): On 03-Oct-2016 the patient was administered with INN Flu Vaccine (dosage, batch number, route of administration: not reported). Adverse reactions/events and outcomes: On 04-Oct-2016 the patient experienced pain in left arm continued to get worse. She went back to MD then ortho. Then chirop. The patient is now on physiotherapy. The action taken with the INN flu vaccine was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine and events. This report was not serious.
Sex: M
Vaccine: FLUA3, PNC13, FLUA3
Symptoms: Cellulitis, Injection site pruritus
Clinical narrative: Patient developed cellulitis. Itching at site of injection.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Blood test normal, Gastrointestinal disorder, Pain, Respiratory disorder
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional (consumer) via health authority (VAERS ID: 677699) and concerns a 53 years old male patient. The patient's concomitant medications included fish oil, vitamin and aspirin. There were no any current and historical condition. Administration of Company suspect drug: On 27-Oct-2016, the patient received INN Flu Vaccine (dose, expiry date, batch number, route of administration: not reported) at right arm via intramuscular route. Adverse reactions/events and outcomes: On 31-Dec-2016 after administration of influenza vaccine, the patient experienced excruciating pain on the sides of his bodies where flu shots were administered (the specific area of the upper arm where he received the shot). The patient stated that he had the symptoms for 12 days, commenced 2 to 3 days after the recovery of intestinal illness. On an unspecified date, blood test was performed and noted normal. The action taken with the vaccine was not reported. The outcome of the event gastrointestinal disorder was recovered and injection site pain was not recovered. Reporter's Assessment: The reporter assessed the causality of the events considered to be related to the INN Flu Vaccine. This case was non-serious.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Blood test normal, Gastrointestinal disorder, Injection site pain
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional (consumer) via health authority (VAERS ID: 677699) and concerns a 53 years old male patient. The patient's concomitant medications included fish oil, vitamin and aspirin. There were no any current and historical condition. Administration of Company suspect drug: On 27-Oct-2016, the patient received INN Flu Vaccine (dose, expiry date, batch number, route of administration: not reported) at right arm via intramuscular route. Adverse reactions/events and outcomes: On 31-Dec-2016 after administration of influenza vaccine, the patient experienced excruciating pain on the sides of his bodies where flu shots were administered (the specific area of the upper arm where he received the shot). The patient stated that he had the symptoms for 12 days, commenced 2 to 3 days after the recovery of intestinal illness. On an unspecified date, blood test was performed and noted normal. The action taken with the vaccine was not reported. The outcome of the event gastrointestinal disorder was recovered and injection site pain was not recovered. Reporter's Assessment: The reporter assessed the causality of the events considered to be related to the INN Flu Vaccine. This case was non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Abdominal pain, Allergy to vaccine, Asthma, Drug hypersensitivity, Ear pain
Clinical narrative: This spontaneous case, initially on 12-Apr-2017, which was reported by a physician via regulatory authority (VAERS ID: 677729) and concerns a 69 years old elderly female patient. The patient's medication history included: Dizziness, Head spinning, Headache, Hives, Light headedness, Malaise, Migraine, Nausea Neuropathy, Sleepy, Stomach cramps, Water retention, Congestive heart failure, Guillain Barre syndrome and Abdominal pain. The drug history included Doxycylinehyclate, Nitrofurantoin monohydrate, Doxycylinehyclate, PHENERGAN, ADVAIR, Gabapentin, PROZAC, SALAGEN, Antibiotics, LOTENSIN, ALEVE and FLOVENT. At the time of the event the patient had Depression, Insomnia, Muscular weakness, Hypersensitivity, Hypertension, Chronic obstructive pulmonary disease, Intervertebral disc degeneration, Disability, Drug hypersensitivity, Fibromyalgia, Gastroesophageal reflux disease, Blood cholesterol increased, Pruritus, Lactose intolerance, Migraine, Osteoporosis, Polyneuropathy, Rash, Sjogren's syndrome, Abasia, walking aid walker, Wheelchair user. The patient's concomitant medication included: Acyclovir, Albuterol, Allopurinol, Amantadine HCL, Benzocaine, Artificial tears, BENADRYL allergy, Calcium +D, Captopril, Cinnamon, Fluticasone propionate, Glipizide xl, Furosemide, Hydrocodone, Acetaminophen, A/b otic , Magnesium oxide, Diphenhydramine, Phenylalanine, Metolazone, Paracetamol, Ipratropium bromide, Lidocaine hydrochloride, Pregabalin, Potassium chloride, Ascorbic acid, Vitamin b NOS, Nystatin, Fish oil, pantoprazole sodium, Prednisone, Tramadol, Trimethobenzamide, Salbutamol sulphate, Tocopherol, SYMBICORT for asthma, PRILOSEC, PULMICORT and Phenazone. Administration of Company suspect drug: On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, anatomical location, batch no., expiry date: not reported, route of administration: intranasal). Adverse reactions/events and outcomes: On unspecified date patient was administered influenza vaccine, influenza virus vaccine polyvalent through intranasal route of administration which was considered as medication error. Action taken with the suspect product was not reported. Outcome of the event was not reported. Relevant Test Results: Blood pressure measurement (130/70), Body mass index (45.05 kg/m2), Body surface area (2.04 m2), Body temperature (99.2 degree Fahrenheit), Heart rate (118 BPM), Oxygen saturation (96 percent) and Respiratory rate (16). Reporter's Assessment: The physician did not provide any causality assessment. This case was not serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Gait disturbance, Hypersensitivity, Malaise, Migraine, Muscle spasms
Clinical narrative: This spontaneous case, initially on 12-Apr-2017, which was reported by a physician via regulatory authority (VAERS ID: 677729) and concerns a 69 years old elderly female patient. The patient's medication history included: Dizziness, Head spinning, Headache, Hives, Light headedness, Malaise, Migraine, Nausea Neuropathy, Sleepy, Stomach cramps, Water retention, Congestive heart failure, Guillain Barre syndrome and Abdominal pain. The drug history included Doxycylinehyclate, Nitrofurantoin monohydrate, Doxycylinehyclate, PHENERGAN, ADVAIR, Gabapentin, PROZAC, SALAGEN, Antibiotics, LOTENSIN, ALEVE and FLOVENT. At the time of the event the patient had Depression, Insomnia, Muscular weakness, Hypersensitivity, Hypertension, Chronic obstructive pulmonary disease, Intervertebral disc degeneration, Disability, Drug hypersensitivity, Fibromyalgia, Gastroesophageal reflux disease, Blood cholesterol increased, Pruritus, Lactose intolerance, Migraine, Osteoporosis, Polyneuropathy, Rash, Sjogren's syndrome, Abasia, walking aid walker, Wheelchair user. The patient's concomitant medication included: Acyclovir, Albuterol, Allopurinol, Amantadine HCL, Benzocaine, Artificial tears, BENADRYL allergy, Calcium +D, Captopril, Cinnamon, Fluticasone propionate, Glipizide xl, Furosemide, Hydrocodone, Acetaminophen, A/b otic , Magnesium oxide, Diphenhydramine, Phenylalanine, Metolazone, Paracetamol, Ipratropium bromide, Lidocaine hydrochloride, Pregabalin, Potassium chloride, Ascorbic acid, Vitamin b NOS, Nystatin, Fish oil, pantoprazole sodium, Prednisone, Tramadol, Trimethobenzamide, Salbutamol sulphate, Tocopherol, SYMBICORT for asthma, PRILOSEC, PULMICORT and Phenazone. Administration of Company suspect drug: On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, anatomical location, batch no., expiry date: not reported, route of administration: intranasal). Adverse reactions/events and outcomes: On unspecified date patient was administered influenza vaccine, influenza virus vaccine polyvalent through intranasal route of administration which was considered as medication error. Action taken with the suspect product was not reported. Outcome of the event was not reported. Relevant Test Results: Blood pressure measurement (130/70), Body mass index (45.05 kg/m2), Body surface area (2.04 m2), Body temperature (99.2 degree Fahrenheit), Heart rate (118 BPM), Oxygen saturation (96 percent) and Respiratory rate (16). Reporter's Assessment: The physician did not provide any causality assessment. This case was not serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Neuropathy peripheral
Clinical narrative: This spontaneous case, initially on 12-Apr-2017, which was reported by a physician via regulatory authority (VAERS ID: 677729) and concerns a 69 years old elderly female patient. The patient's medication history included: Dizziness, Head spinning, Headache, Hives, Light headedness, Malaise, Migraine, Nausea Neuropathy, Sleepy, Stomach cramps, Water retention, Congestive heart failure, Guillain Barre syndrome and Abdominal pain. The drug history included Doxycylinehyclate, Nitrofurantoin monohydrate, Doxycylinehyclate, PHENERGAN, ADVAIR, Gabapentin, PROZAC, SALAGEN, Antibiotics, LOTENSIN, ALEVE and FLOVENT. At the time of the event the patient had Depression, Insomnia, Muscular weakness, Hypersensitivity, Hypertension, Chronic obstructive pulmonary disease, Intervertebral disc degeneration, Disability, Drug hypersensitivity, Fibromyalgia, Gastroesophageal reflux disease, Blood cholesterol increased, Pruritus, Lactose intolerance, Migraine, Osteoporosis, Polyneuropathy, Rash, Sjogren's syndrome, Abasia, walking aid walker, Wheelchair user. The patient's concomitant medication included: Acyclovir, Albuterol, Allopurinol, Amantadine HCL, Benzocaine, Artificial tears, BENADRYL allergy, Calcium +D, Captopril, Cinnamon, Fluticasone propionate, Glipizide xl, Furosemide, Hydrocodone, Acetaminophen, A/b otic , Magnesium oxide, Diphenhydramine, Phenylalanine, Metolazone, Paracetamol, Ipratropium bromide, Lidocaine hydrochloride, Pregabalin, Potassium chloride, Ascorbic acid, Vitamin b NOS, Nystatin, Fish oil, pantoprazole sodium, Prednisone, Tramadol, Trimethobenzamide, Salbutamol sulphate, Tocopherol, SYMBICORT for asthma, PRILOSEC, PULMICORT and Phenazone. Administration of Company suspect drug: On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, anatomical location, batch no., expiry date: not reported, route of administration: intranasal). Adverse reactions/events and outcomes: On unspecified date patient was administered influenza vaccine, influenza virus vaccine polyvalent through intranasal route of administration which was considered as medication error. Action taken with the suspect product was not reported. Outcome of the event was not reported. Relevant Test Results: Blood pressure measurement (130/70), Body mass index (45.05 kg/m2), Body surface area (2.04 m2), Body temperature (99.2 degree Fahrenheit), Heart rate (118 BPM), Oxygen saturation (96 percent) and Respiratory rate (16). Reporter's Assessment: The physician did not provide any causality assessment. This case was not serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Incorrect route of drug administration
Clinical narrative: This spontaneous case, initially on 12-Apr-2017, which was reported by a physician via regulatory authority (VAERS ID: 677729) and concerns a 69 years old elderly female patient. The patient's medication history included: Dizziness, Head spinning, Headache, Hives, Light headedness, Malaise, Migraine, Nausea Neuropathy, Sleepy, Stomach cramps, Water retention, Congestive heart failure, Guillain Barre syndrome and Abdominal pain. The drug history included Doxycylinehyclate, Nitrofurantoin monohydrate, Doxycylinehyclate, PHENERGAN, ADVAIR, Gabapentin, PROZAC, SALAGEN, Antibiotics, LOTENSIN, ALEVE and FLOVENT. At the time of the event the patient had Depression, Insomnia, Muscular weakness, Hypersensitivity, Hypertension, Chronic obstructive pulmonary disease, Intervertebral disc degeneration, Disability, Drug hypersensitivity, Fibromyalgia, Gastroesophageal reflux disease, Blood cholesterol increased, Pruritus, Lactose intolerance, Migraine, Osteoporosis, Polyneuropathy, Rash, Sjogren's syndrome, Abasia, walking aid walker, Wheelchair user. The patient's concomitant medication included: Acyclovir, Albuterol, Allopurinol, Amantadine HCL, Benzocaine, Artificial tears, BENADRYL allergy, Calcium +D, Captopril, Cinnamon, Fluticasone propionate, Glipizide xl, Furosemide, Hydrocodone, Acetaminophen, A/b otic , Magnesium oxide, Diphenhydramine, Phenylalanine, Metolazone, Paracetamol, Ipratropium bromide, Lidocaine hydrochloride, Pregabalin, Potassium chloride, Ascorbic acid, Vitamin b NOS, Nystatin, Fish oil, pantoprazole sodium, Prednisone, Tramadol, Trimethobenzamide, Salbutamol sulphate, Tocopherol, SYMBICORT for asthma, PRILOSEC, PULMICORT and Phenazone. Administration of Company suspect drug: On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, anatomical location, batch no., expiry date: not reported, route of administration: intranasal). Adverse reactions/events and outcomes: On unspecified date patient was administered influenza vaccine, influenza virus vaccine polyvalent through intranasal route of administration which was considered as medication error. Action taken with the suspect product was not reported. Outcome of the event was not reported. Relevant Test Results: Blood pressure measurement (130/70), Body mass index (45.05 kg/m2), Body surface area (2.04 m2), Body temperature (99.2 degree Fahrenheit), Heart rate (118 BPM), Oxygen saturation (96 percent) and Respiratory rate (16). Reporter's Assessment: The physician did not provide any causality assessment. This case was not serious.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Abasia, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 00:00:00 was reported by a other non-health professional through FDA VAERS ID: 677744 and concerns a 43 years old female patient. The patient's concomitant medication included: PROZAC. Administration of Company suspect drug(s): On 06-Jan-2017, INN flu vaccine was administered (unknown dosage, unknown duration, batch number: None, route of administration: unknown). Non-company suspect drug(s): On 06-Jan-2017, pneumococcal vaccine polyvalent was administered (Dosage Regimen: unspecified dose, unknown duration). Adverse reactions/events and outcomes: On 06-Jan-2017, the patient was feeling very lightheaded and floaty in the early evening while she was watching TV. The patient got up to get to the kitchen and remembered that she had vaccinations-influenza and pneumonia (in Left Thigh)-thigh was sore. About 8:30, the patient realized that, she was having a slight reaction to the vaccine, typical, so took a shower and readied for bed. While in shower, the patient had back muscles spasming and cramping. Almost immediately, got chills and realized that she actually had fever and went to sleep. The patient experienced pain in leg (immense), moving or covers touching it woke her up. Fever, cramping, and chills continued through the night and continued the next day, and got worsened as Saturday progressed. Saturday afternoon, the patient got off work and got home, overwhelmed by exhaustion. The patient took 800 mg ibuprofen and went to sleep. After 2 hours of sleep, she woke up, had to crawl down stairs. Pain in leg was incapacitating. The patient was not able to walk without hanging on to walls. Fever, chills, body aches continued to the next day. On Sunday, the fever was mostly gone and she felt much more herself, but could not move leg normally. She could not stand even brushing anywhere on her entire thigh muscle, and a rash appeared right about her inner knee. The treatment drug ibuprofen was useless. The pain scale 10:9 for migraine, 8 for pain in leg, childbirth. As of today, Wednesday, the 11th, leg is still very tender, but the patient is not able to both gently touch it and move the foot normally while walking. She still walked with a limp, and her thigh feels extremely stiff and tight. After the tenderness dissipates a little, she started doing some light stretches as she honestly worried that, she may lose some range of motion if she doesn't do the light stretches. The patient felt that it was very unpleasant. Action taken was not reported. Outcome of the events were not reported. Reporter's Assessment: The Health Authority considered the events as non-serious and the causality was not reported.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Gait disturbance, Injection site pain, Migraine, Mobility decreased, Muscle spasms
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 00:00:00 was reported by a other non-health professional through FDA VAERS ID: 677744 and concerns a 43 years old female patient. The patient's concomitant medication included: PROZAC. Administration of Company suspect drug(s): On 06-Jan-2017, INN flu vaccine was administered (unknown dosage, unknown duration, batch number: None, route of administration: unknown). Non-company suspect drug(s): On 06-Jan-2017, pneumococcal vaccine polyvalent was administered (Dosage Regimen: unspecified dose, unknown duration). Adverse reactions/events and outcomes: On 06-Jan-2017, the patient was feeling very lightheaded and floaty in the early evening while she was watching TV. The patient got up to get to the kitchen and remembered that she had vaccinations-influenza and pneumonia (in Left Thigh)-thigh was sore. About 8:30, the patient realized that, she was having a slight reaction to the vaccine, typical, so took a shower and readied for bed. While in shower, the patient had back muscles spasming and cramping. Almost immediately, got chills and realized that she actually had fever and went to sleep. The patient experienced pain in leg (immense), moving or covers touching it woke her up. Fever, cramping, and chills continued through the night and continued the next day, and got worsened as Saturday progressed. Saturday afternoon, the patient got off work and got home, overwhelmed by exhaustion. The patient took 800 mg ibuprofen and went to sleep. After 2 hours of sleep, she woke up, had to crawl down stairs. Pain in leg was incapacitating. The patient was not able to walk without hanging on to walls. Fever, chills, body aches continued to the next day. On Sunday, the fever was mostly gone and she felt much more herself, but could not move leg normally. She could not stand even brushing anywhere on her entire thigh muscle, and a rash appeared right about her inner knee. The treatment drug ibuprofen was useless. The pain scale 10:9 for migraine, 8 for pain in leg, childbirth. As of today, Wednesday, the 11th, leg is still very tender, but the patient is not able to both gently touch it and move the foot normally while walking. She still walked with a limp, and her thigh feels extremely stiff and tight. After the tenderness dissipates a little, she started doing some light stretches as she honestly worried that, she may lose some range of motion if she doesn't do the light stretches. The patient felt that it was very unpleasant. Action taken was not reported. Outcome of the events were not reported. Reporter's Assessment: The Health Authority considered the events as non-serious and the causality was not reported.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 00:00:00 was reported by a other non-health professional through FDA VAERS ID: 677744 and concerns a 43 years old female patient. The patient's concomitant medication included: PROZAC. Administration of Company suspect drug(s): On 06-Jan-2017, INN flu vaccine was administered (unknown dosage, unknown duration, batch number: None, route of administration: unknown). Non-company suspect drug(s): On 06-Jan-2017, pneumococcal vaccine polyvalent was administered (Dosage Regimen: unspecified dose, unknown duration). Adverse reactions/events and outcomes: On 06-Jan-2017, the patient was feeling very lightheaded and floaty in the early evening while she was watching TV. The patient got up to get to the kitchen and remembered that she had vaccinations-influenza and pneumonia (in Left Thigh)-thigh was sore. About 8:30, the patient realized that, she was having a slight reaction to the vaccine, typical, so took a shower and readied for bed. While in shower, the patient had back muscles spasming and cramping. Almost immediately, got chills and realized that she actually had fever and went to sleep. The patient experienced pain in leg (immense), moving or covers touching it woke her up. Fever, cramping, and chills continued through the night and continued the next day, and got worsened as Saturday progressed. Saturday afternoon, the patient got off work and got home, overwhelmed by exhaustion. The patient took 800 mg ibuprofen and went to sleep. After 2 hours of sleep, she woke up, had to crawl down stairs. Pain in leg was incapacitating. The patient was not able to walk without hanging on to walls. Fever, chills, body aches continued to the next day. On Sunday, the fever was mostly gone and she felt much more herself, but could not move leg normally. She could not stand even brushing anywhere on her entire thigh muscle, and a rash appeared right about her inner knee. The treatment drug ibuprofen was useless. The pain scale 10:9 for migraine, 8 for pain in leg, childbirth. As of today, Wednesday, the 11th, leg is still very tender, but the patient is not able to both gently touch it and move the foot normally while walking. She still walked with a limp, and her thigh feels extremely stiff and tight. After the tenderness dissipates a little, she started doing some light stretches as she honestly worried that, she may lose some range of motion if she doesn't do the light stretches. The patient felt that it was very unpleasant. Action taken was not reported. Outcome of the events were not reported. Reporter's Assessment: The Health Authority considered the events as non-serious and the causality was not reported.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Sleep disorder, Tenderness
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 00:00:00 was reported by a other non-health professional through FDA VAERS ID: 677744 and concerns a 43 years old female patient. The patient's concomitant medication included: PROZAC. Administration of Company suspect drug(s): On 06-Jan-2017, INN flu vaccine was administered (unknown dosage, unknown duration, batch number: None, route of administration: unknown). Non-company suspect drug(s): On 06-Jan-2017, pneumococcal vaccine polyvalent was administered (Dosage Regimen: unspecified dose, unknown duration). Adverse reactions/events and outcomes: On 06-Jan-2017, the patient was feeling very lightheaded and floaty in the early evening while she was watching TV. The patient got up to get to the kitchen and remembered that she had vaccinations-influenza and pneumonia (in Left Thigh)-thigh was sore. About 8:30, the patient realized that, she was having a slight reaction to the vaccine, typical, so took a shower and readied for bed. While in shower, the patient had back muscles spasming and cramping. Almost immediately, got chills and realized that she actually had fever and went to sleep. The patient experienced pain in leg (immense), moving or covers touching it woke her up. Fever, cramping, and chills continued through the night and continued the next day, and got worsened as Saturday progressed. Saturday afternoon, the patient got off work and got home, overwhelmed by exhaustion. The patient took 800 mg ibuprofen and went to sleep. After 2 hours of sleep, she woke up, had to crawl down stairs. Pain in leg was incapacitating. The patient was not able to walk without hanging on to walls. Fever, chills, body aches continued to the next day. On Sunday, the fever was mostly gone and she felt much more herself, but could not move leg normally. She could not stand even brushing anywhere on her entire thigh muscle, and a rash appeared right about her inner knee. The treatment drug ibuprofen was useless. The pain scale 10:9 for migraine, 8 for pain in leg, childbirth. As of today, Wednesday, the 11th, leg is still very tender, but the patient is not able to both gently touch it and move the foot normally while walking. She still walked with a limp, and her thigh feels extremely stiff and tight. After the tenderness dissipates a little, she started doing some light stretches as she honestly worried that, she may lose some range of motion if she doesn't do the light stretches. The patient felt that it was very unpleasant. Action taken was not reported. Outcome of the events were not reported. Reporter's Assessment: The Health Authority considered the events as non-serious and the causality was not reported.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Abasia, Chills, Dizziness, Dysstasia, Fatigue
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 00:00:00 was reported by a other non-health professional through FDA VAERS ID: 677744 and concerns a 43 years old female patient. The patient's concomitant medication included: PROZAC. Administration of Company suspect drug(s): On 06-Jan-2017, INN flu vaccine was administered (unknown dosage, unknown duration, batch number: None, route of administration: unknown). Non-company suspect drug(s): On 06-Jan-2017, pneumococcal vaccine polyvalent was administered (Dosage Regimen: unspecified dose, unknown duration). Adverse reactions/events and outcomes: On 06-Jan-2017, the patient was feeling very lightheaded and floaty in the early evening while she was watching TV. The patient got up to get to the kitchen and remembered that she had vaccinations-influenza and pneumonia (in Left Thigh)-thigh was sore. About 8:30, the patient realized that, she was having a slight reaction to the vaccine, typical, so took a shower and readied for bed. While in shower, the patient had back muscles spasming and cramping. Almost immediately, got chills and realized that she actually had fever and went to sleep. The patient experienced pain in leg (immense), moving or covers touching it woke her up. Fever, cramping, and chills continued through the night and continued the next day, and got worsened as Saturday progressed. Saturday afternoon, the patient got off work and got home, overwhelmed by exhaustion. The patient took 800 mg ibuprofen and went to sleep. After 2 hours of sleep, she woke up, had to crawl down stairs. Pain in leg was incapacitating. The patient was not able to walk without hanging on to walls. Fever, chills, body aches continued to the next day. On Sunday, the fever was mostly gone and she felt much more herself, but could not move leg normally. She could not stand even brushing anywhere on her entire thigh muscle, and a rash appeared right about her inner knee. The treatment drug ibuprofen was useless. The pain scale 10:9 for migraine, 8 for pain in leg, childbirth. As of today, Wednesday, the 11th, leg is still very tender, but the patient is not able to both gently touch it and move the foot normally while walking. She still walked with a limp, and her thigh feels extremely stiff and tight. After the tenderness dissipates a little, she started doing some light stretches as she honestly worried that, she may lose some range of motion if she doesn't do the light stretches. The patient felt that it was very unpleasant. Action taken was not reported. Outcome of the events were not reported. Reporter's Assessment: The Health Authority considered the events as non-serious and the causality was not reported.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Feeling abnormal, Gait disturbance, Migraine, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 00:00:00 was reported by a other non-health professional through FDA VAERS ID: 677744 and concerns a 43 years old female patient. The patient's concomitant medication included: PROZAC. Administration of Company suspect drug(s): On 06-Jan-2017, INN flu vaccine was administered (unknown dosage, unknown duration, batch number: None, route of administration: unknown). Non-company suspect drug(s): On 06-Jan-2017, pneumococcal vaccine polyvalent was administered (Dosage Regimen: unspecified dose, unknown duration). Adverse reactions/events and outcomes: On 06-Jan-2017, the patient was feeling very lightheaded and floaty in the early evening while she was watching TV. The patient got up to get to the kitchen and remembered that she had vaccinations-influenza and pneumonia (in Left Thigh)-thigh was sore. About 8:30, the patient realized that, she was having a slight reaction to the vaccine, typical, so took a shower and readied for bed. While in shower, the patient had back muscles spasming and cramping. Almost immediately, got chills and realized that she actually had fever and went to sleep. The patient experienced pain in leg (immense), moving or covers touching it woke her up. Fever, cramping, and chills continued through the night and continued the next day, and got worsened as Saturday progressed. Saturday afternoon, the patient got off work and got home, overwhelmed by exhaustion. The patient took 800 mg ibuprofen and went to sleep. After 2 hours of sleep, she woke up, had to crawl down stairs. Pain in leg was incapacitating. The patient was not able to walk without hanging on to walls. Fever, chills, body aches continued to the next day. On Sunday, the fever was mostly gone and she felt much more herself, but could not move leg normally. She could not stand even brushing anywhere on her entire thigh muscle, and a rash appeared right about her inner knee. The treatment drug ibuprofen was useless. The pain scale 10:9 for migraine, 8 for pain in leg, childbirth. As of today, Wednesday, the 11th, leg is still very tender, but the patient is not able to both gently touch it and move the foot normally while walking. She still walked with a limp, and her thigh feels extremely stiff and tight. After the tenderness dissipates a little, she started doing some light stretches as she honestly worried that, she may lose some range of motion if she doesn't do the light stretches. The patient felt that it was very unpleasant. Action taken was not reported. Outcome of the events were not reported. Reporter's Assessment: The Health Authority considered the events as non-serious and the causality was not reported.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Pain, Pain in extremity, Pyrexia, Rash, Tenderness
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 00:00:00 was reported by a other non-health professional through FDA VAERS ID: 677744 and concerns a 43 years old female patient. The patient's concomitant medication included: PROZAC. Administration of Company suspect drug(s): On 06-Jan-2017, INN flu vaccine was administered (unknown dosage, unknown duration, batch number: None, route of administration: unknown). Non-company suspect drug(s): On 06-Jan-2017, pneumococcal vaccine polyvalent was administered (Dosage Regimen: unspecified dose, unknown duration). Adverse reactions/events and outcomes: On 06-Jan-2017, the patient was feeling very lightheaded and floaty in the early evening while she was watching TV. The patient got up to get to the kitchen and remembered that she had vaccinations-influenza and pneumonia (in Left Thigh)-thigh was sore. About 8:30, the patient realized that, she was having a slight reaction to the vaccine, typical, so took a shower and readied for bed. While in shower, the patient had back muscles spasming and cramping. Almost immediately, got chills and realized that she actually had fever and went to sleep. The patient experienced pain in leg (immense), moving or covers touching it woke her up. Fever, cramping, and chills continued through the night and continued the next day, and got worsened as Saturday progressed. Saturday afternoon, the patient got off work and got home, overwhelmed by exhaustion. The patient took 800 mg ibuprofen and went to sleep. After 2 hours of sleep, she woke up, had to crawl down stairs. Pain in leg was incapacitating. The patient was not able to walk without hanging on to walls. Fever, chills, body aches continued to the next day. On Sunday, the fever was mostly gone and she felt much more herself, but could not move leg normally. She could not stand even brushing anywhere on her entire thigh muscle, and a rash appeared right about her inner knee. The treatment drug ibuprofen was useless. The pain scale 10:9 for migraine, 8 for pain in leg, childbirth. As of today, Wednesday, the 11th, leg is still very tender, but the patient is not able to both gently touch it and move the foot normally while walking. She still walked with a limp, and her thigh feels extremely stiff and tight. After the tenderness dissipates a little, she started doing some light stretches as she honestly worried that, she may lose some range of motion if she doesn't do the light stretches. The patient felt that it was very unpleasant. Action taken was not reported. Outcome of the events were not reported. Reporter's Assessment: The Health Authority considered the events as non-serious and the causality was not reported.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 00:00:00 was reported by a other non-health professional through FDA VAERS ID: 677744 and concerns a 43 years old female patient. The patient's concomitant medication included: PROZAC. Administration of Company suspect drug(s): On 06-Jan-2017, INN flu vaccine was administered (unknown dosage, unknown duration, batch number: None, route of administration: unknown). Non-company suspect drug(s): On 06-Jan-2017, pneumococcal vaccine polyvalent was administered (Dosage Regimen: unspecified dose, unknown duration). Adverse reactions/events and outcomes: On 06-Jan-2017, the patient was feeling very lightheaded and floaty in the early evening while she was watching TV. The patient got up to get to the kitchen and remembered that she had vaccinations-influenza and pneumonia (in Left Thigh)-thigh was sore. About 8:30, the patient realized that, she was having a slight reaction to the vaccine, typical, so took a shower and readied for bed. While in shower, the patient had back muscles spasming and cramping. Almost immediately, got chills and realized that she actually had fever and went to sleep. The patient experienced pain in leg (immense), moving or covers touching it woke her up. Fever, cramping, and chills continued through the night and continued the next day, and got worsened as Saturday progressed. Saturday afternoon, the patient got off work and got home, overwhelmed by exhaustion. The patient took 800 mg ibuprofen and went to sleep. After 2 hours of sleep, she woke up, had to crawl down stairs. Pain in leg was incapacitating. The patient was not able to walk without hanging on to walls. Fever, chills, body aches continued to the next day. On Sunday, the fever was mostly gone and she felt much more herself, but could not move leg normally. She could not stand even brushing anywhere on her entire thigh muscle, and a rash appeared right about her inner knee. The treatment drug ibuprofen was useless. The pain scale 10:9 for migraine, 8 for pain in leg, childbirth. As of today, Wednesday, the 11th, leg is still very tender, but the patient is not able to both gently touch it and move the foot normally while walking. She still walked with a limp, and her thigh feels extremely stiff and tight. After the tenderness dissipates a little, she started doing some light stretches as she honestly worried that, she may lose some range of motion if she doesn't do the light stretches. The patient felt that it was very unpleasant. Action taken was not reported. Outcome of the events were not reported. Reporter's Assessment: The Health Authority considered the events as non-serious and the causality was not reported.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other Non-health professional Health Authority (VAERS ID: 677864) and concerns a 50 years old male patient. Administration of Company suspect drug: On 02-Nov-2015, the patient was administered with INN Flu Vaccine Seasonal (dosage, route of administration, anatomical location: unknown). Adverse reactions/events and outcomes: On an unspecified date, the patient experienced that her arm hurt at the injection site for longer than normal. A couple months later it began to feel like patient was carrying a newspaper under armpit all the time. The patient also experienced limited movement like wearing a shirt that is too small. The pain came back and went away several times over the next year. And it was never debilitating but was noticeable. In the last couple months, the pain was more persistent and grown in intensity and the swelling under arm was increased. Outcome of the events was not reported. Reporter's Assessment: The reporter assessed the event as non-serious and causality assessment for the events was not provided. Health Authority considered the case as non serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Mobility decreased, Swelling
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other Non-health professional Health Authority (VAERS ID: 677864) and concerns a 50 years old male patient. Administration of Company suspect drug: On 02-Nov-2015, the patient was administered with INN Flu Vaccine Seasonal (dosage, route of administration, anatomical location: unknown). Adverse reactions/events and outcomes: On an unspecified date, the patient experienced that her arm hurt at the injection site for longer than normal. A couple months later it began to feel like patient was carrying a newspaper under armpit all the time. The patient also experienced limited movement like wearing a shirt that is too small. The pain came back and went away several times over the next year. And it was never debilitating but was noticeable. In the last couple months, the pain was more persistent and grown in intensity and the swelling under arm was increased. Outcome of the events was not reported. Reporter's Assessment: The reporter assessed the event as non-serious and causality assessment for the events was not provided. Health Authority considered the case as non serious.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Influenza
Clinical narrative: Case number PHEH2015US025690, is an initial spontaneous report received from a consumer via pharmaceutical company on 02 Dec 2015. This report refers to a patient of an unknown age and gender. Medical history was not reported. Concomitant medication was not reported. The patient received influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, the patient experienced flu. Final outcome, seriousness and causality were not reported. Follow up received from VAERS on 12-Apr-2017: This case was upgraded to serious considering influenza as a serious event. Updated vaccine adverse event reporting system (VAERS) ID. This case was serious (medically significant).
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via vaccine adverse reaction reporting system (VAERS: 677966) and concerns a 40 years old female patient. The patient's concomitant medication included: EFFEXOR, vit B12, ATIVAN, NEUROTIN and Thiamine. Administration of Company suspect drug: 01-Oct-2016, the patient received INN Flu Vaccine Seasonal (dose, expiry date, batch no, site and route of administration: not reported). Adverse reactions/events and outcomes: On 01-Oct-2016 after administration of influenza vaccine, the patient stated that her right (R) deltoid is painful with range of motion. Action taken with the vaccine was not reported. The outcome of the event was unknown. Reporter's Assessment: The reporter did not provide the causality assessment of the event in relation to the INN Flu Vaccine Seasonal. This case was non-serious.
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Erythema, Joint range of motion decreased, Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous case initially received on 12-Apr-2017 via Health Authority (VAERS-677973) was reported by an other non-health professional and concerns an 73 years old female elderly patient. The patient's medication history included COPD (chronic obstructive pulmonary disease). Administration of Company suspect drug: On 29-Dec-2016 the patient was administered with FLUAD (TIV) (batch number:166001), dosage: 0.5ml, unknown duration, route of administration: intramuscular in right arm). Non-company suspect drug: On 29-Dec-2016 the patient was administered with PNEUMOCAX via intramuscular route in left arm. (batch number: M043987, dose and duration: not reported). Adverse reactions/events and outcomes: On 30-Dec-2016 the patient arm became red (Erythema), swollen (peripheral swelling) with a loss in range of motion and patient had Pyrexia. Action taken with FLUAD (TIV) and PNEUMOVAX was not reported and outcome of the events was reported as not recovered. Reporter's Assessment: Health Authority did not provided any causality assessment between the events and suspect vaccine FLUAD (TIV). This report was non-serious.
Age: 71.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Dizziness, Fatigue, Headache, Musculoskeletal stiffness, Pain
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (vaccine adverse event reporting system: 677974) and concerns a 71-years-old elderly female patient. The patient's concomitant medication included: Valsartan and Aspirin. Administration of Company suspect drug: On 11-Jan-2017, the patient was administered with influenza virus vaccine polyvalent, Batch number: GY807) (dose, route of administration and indication: not reported). Other company suspect drug: On 11-Jan-2017, the patient was administered PNEUMOVAX (Batch number BL118) (dose, route of administration and indication: not reported). Adverse reactions/events and outcomes: On 11-Jan-2016 the patient had swelling, stiff neck, head ache, fever, aching all over the body, dizziness and tired. Action taken with the INN Flu Vaccine Seasonal and pneumococcal vaccine was not reported and outcome of the events swelling, stiff neck, head ache, fever, aching all over the body, dizziness and tired was unknown. Reporter's Assessment: The reporter did not provide the causality between the all events and INN Flu Vaccine Seasonal. This report was not serious.
Age: 71.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (vaccine adverse event reporting system: 677974) and concerns a 71-years-old elderly female patient. The patient's concomitant medication included: Valsartan and Aspirin. Administration of Company suspect drug: On 11-Jan-2017, the patient was administered with influenza virus vaccine polyvalent, Batch number: GY807) (dose, route of administration and indication: not reported). Other company suspect drug: On 11-Jan-2017, the patient was administered PNEUMOVAX (Batch number BL118) (dose, route of administration and indication: not reported). Adverse reactions/events and outcomes: On 11-Jan-2016 the patient had swelling, stiff neck, head ache, fever, aching all over the body, dizziness and tired. Action taken with the INN Flu Vaccine Seasonal and pneumococcal vaccine was not reported and outcome of the events swelling, stiff neck, head ache, fever, aching all over the body, dizziness and tired was unknown. Reporter's Assessment: The reporter did not provide the causality between the all events and INN Flu Vaccine Seasonal. This report was not serious.
Age: 14.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Dyskinesia, Fall, Nausea, Seizure, Unresponsive to stimuli
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via regulatory authority (Vaccine Adverse Event Reporting System: 677975) and concerns a 14-years-old female patient. Administration of Company suspect drug: On 30-Dec-2016, the patient was administered with INN Flu Vaccine (dosage, batch number: not reported). Adverse reactions/events and outcomes: On 30-Dec-2016 after the flu shot was administered the patient stand up to leave and fell on the floor, she was unresponsive to stimuli and her body was jerking. She had a seizure which lasted to 30 seconds and felt nauseous afterward. It was reported that the pharmacist who administered the shot monitored her for 10 minutes and released her back to her mother's care. Action taken with the INN Flu Vaccine was not reported. The outcome of the events fall, dyskinesia, nausea, seizure and unresponsive to stimuli was reported as recovered. Reporter's Assessment: The reporter did not provide the causality between the events and INN Flu Vaccine. This report was not serious.