chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional (consumer) Health Authority (VAERS ID: 682469) and concerns a 35 years old female patient. The patient's concomitant medication included methylprednisolone injections, losartan and LOPID. Administration of Company suspect drug: On 10-Nov-2016, the patient received INN Flu Vaccine Seasonal (dose, expiry date, batch number, route of administration: not reported). Adverse reactions/events and outcomes: On 11-Nov-2016 after administration of influenza vaccine, the patient woke up at 3:30 am and was unable to move her neck side to side or up and down. The patient was in extreme pain in her neck and shoulders extending into her arms. The patient had chiropractic adjustments and physical therapy. The action taken with the vaccine was not reported. The outcome of the event was not reported. Reporter's Assessment: Health Authority did not provide the causality assessment of the events in relation to the INN Flu Vaccine Seasonal. This case was non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Bronchitis
Clinical narrative: This spontaneous case, initially received on 05-May-2017 was reported by other non-health professional via health authority (VAERS ID: 682680) and concerns a female patient of an unspecified age. The patient's historical vaccine included influenza vaccine. On an unspecified date, the patient received INN Flu Vaccine Seasonal (dose number: 3, dose, batch number, expiry date: not reported) at an unknown site via injection NOS. On an unspecified date after administration (within 12 hours of vaccination) of influenza vaccine, pneumonia shot and pneumococcal vaccinated with 1st and 2nd dose of flu shot (influenza vaccine) previously and had bronchitis within 12 hours of taking it. On an unspecified date, the patient also received Pneumonia shot and PREVENAR 13 (dose, batch number, expiry date, route of administration: not reported). The outcome of the event was resolved. The reporter assessed the causality of the event considered to be related to the influenza vaccine. This case was non-serious. Significant case correction received on 17-May-2017. The determined causality was changed from related to unassessable.
Age: 76.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Emotional distress, Gastric dilatation, Gastroenteritis viral, Headache, Muscle spasms
Clinical narrative: This spontaneous case, initially received on 05-May-2017 was reported by a physician (through FDA VAERS ID: 682681) and concerns a 76-years old female patient. The patient's medical history included: arthritis, cancer, depression, hypertension, high cholesterol, rotator cuff repair in the right side (2013) and left knee (2016). The patient's family history included headache or migraine and stroke. The patient had a drug history of codeine allergy. The patient's social condition was non-smoker. The patient's current illness include specific allergy (drug). Administration of Company suspect drug(s): On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (unknown dosage, route of administration: injection, batch number: not reported, expiry date: not reported, site of administration: not reported). Adverse reactions/events and outcomes: On an unspecified date, after administration of INN Flu Vaccine Seasonal, the patient had stomach flu in the interim, leading to vomiting, weakness in the intercostal muscle, feeling upset, snapping sensation in the neck, muscle spasm which lead to head twitch, stress and headache. On 08-Dec-2016, the patient consulted the doctor. Laboratory investigations were reported as body mass index: 28.36, blood pressure: 120/89 mmHg and pulse rate 118 beats/minute. Corrective treatment was not reported. Action taken was not reported. On an unspecified date, patient recovered from headache. The outcome of other events was not reported. Reporter's Assessment: The reported considered the case as non-serious. The causality between the events and the vaccine was not reported. Case correction received on 17-May-2017: As determined causality was corrected from unassessable to not related for all the events.
Age: 76.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Muscle twitching, Respiratory muscle weakness, Stress, Vomiting
Clinical narrative: This spontaneous case, initially received on 05-May-2017 was reported by a physician (through FDA VAERS ID: 682681) and concerns a 76-years old female patient. The patient's medical history included: arthritis, cancer, depression, hypertension, high cholesterol, rotator cuff repair in the right side (2013) and left knee (2016). The patient's family history included headache or migraine and stroke. The patient had a drug history of codeine allergy. The patient's social condition was non-smoker. The patient's current illness include specific allergy (drug). Administration of Company suspect drug(s): On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (unknown dosage, route of administration: injection, batch number: not reported, expiry date: not reported, site of administration: not reported). Adverse reactions/events and outcomes: On an unspecified date, after administration of INN Flu Vaccine Seasonal, the patient had stomach flu in the interim, leading to vomiting, weakness in the intercostal muscle, feeling upset, snapping sensation in the neck, muscle spasm which lead to head twitch, stress and headache. On 08-Dec-2016, the patient consulted the doctor. Laboratory investigations were reported as body mass index: 28.36, blood pressure: 120/89 mmHg and pulse rate 118 beats/minute. Corrective treatment was not reported. Action taken was not reported. On an unspecified date, patient recovered from headache. The outcome of other events was not reported. Reporter's Assessment: The reported considered the case as non-serious. The causality between the events and the vaccine was not reported. Case correction received on 17-May-2017: As determined causality was corrected from unassessable to not related for all the events.
Age: 76.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Emotional disorder, Gastroenteritis viral, Headache, Movement disorder, Muscle spasms
Clinical narrative: This spontaneous case, initially received on 05-May-2017 was reported by a physician (through FDA VAERS ID: 682681) and concerns a 76-years old female patient. The patient's medical history included: arthritis, cancer, depression, hypertension, high cholesterol, rotator cuff repair in the right side (2013) and left knee (2016). The patient's family history included headache or migraine and stroke. The patient had a drug history of codeine allergy. The patient's social condition was non-smoker. The patient's current illness include specific allergy (drug). Administration of Company suspect drug(s): On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (unknown dosage, route of administration: injection, batch number: not reported, expiry date: not reported, site of administration: not reported). Adverse reactions/events and outcomes: On an unspecified date, after administration of INN Flu Vaccine Seasonal, the patient had stomach flu in the interim, leading to vomiting, weakness in the intercostal muscle, feeling upset, snapping sensation in the neck, muscle spasm which lead to head twitch, stress and headache. On 08-Dec-2016, the patient consulted the doctor. Laboratory investigations were reported as body mass index: 28.36, blood pressure: 120/89 mmHg and pulse rate 118 beats/minute. Corrective treatment was not reported. Action taken was not reported. On an unspecified date, patient recovered from headache. The outcome of other events was not reported. Reporter's Assessment: The reported considered the case as non-serious. The causality between the events and the vaccine was not reported. Case correction received on 17-May-2017: As determined causality was corrected from unassessable to not related for all the events.
Age: 45.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Injection site nodule, Injection site pain, Injection site ulcer, Pain
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reaction systems (VAERS ID: 682765) on MAY-2017 was reported by a other non health professional concerns a 45 years old female patient. The patient's concomitant medication included PROZAC, ADDERALL. Administration of Company suspect drug (s): On 07-Oct-2016, the patient received influenza virus vaccine polyvalent (route of administration: injection, dose, anatomical site, batch number, expiration date: not reported) on left arm. Adverse reactions/events and outcomes: On 15-Oct-2016, after administration of influenza virus vaccine polyvalent the patient developed deep pain in upper left arm and shoulder affecting movement. The injection site did not heal for about 10 weeks. There was a small knot which did not resolve. The patient had pain in his arm till 15-Feb-2017. The pain forced him to make modifications in the way he did things. The patient received anti-inflammatory drugs for relief from pain and had plan to visit orthopaedic doctor in 2 weeks. Action taken with influenza virus vaccine polyvalent was not reported. The events were not resolved. Reporter's Assessment: The reporter assessed the events as non serious and considered the events as related to the influenza vaccine. This case was non-serious.
Age: 45.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reaction systems (VAERS ID: 682765) on MAY-2017 was reported by a other non health professional concerns a 45 years old female patient. The patient's concomitant medication included PROZAC, ADDERALL. Administration of Company suspect drug (s): On 07-Oct-2016, the patient received influenza virus vaccine polyvalent (route of administration: injection, dose, anatomical site, batch number, expiration date: not reported) on left arm. Adverse reactions/events and outcomes: On 15-Oct-2016, after administration of influenza virus vaccine polyvalent the patient developed deep pain in upper left arm and shoulder affecting movement. The injection site did not heal for about 10 weeks. There was a small knot which did not resolve. The patient had pain in his arm till 15-Feb-2017. The pain forced him to make modifications in the way he did things. The patient received anti-inflammatory drugs for relief from pain and had plan to visit orthopaedic doctor in 2 weeks. Action taken with influenza virus vaccine polyvalent was not reported. The events were not resolved. Reporter's Assessment: The reporter assessed the events as non serious and considered the events as related to the influenza vaccine. This case was non-serious.
Age: 6.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous case, initially received on 05-May-2017 was reported by other non-health professional via regulatory authority (vaccine adverse event reporting system: 682770) and concerns a 6-years-old child male patient. The patient's medication history included: Asthma. Administration of Company suspect drug (s): On 16-Dec-2016, the patient was administered with influenza virus vaccine polyvalent, 0.5 ml, via intramuscular route, batch number not reported, anatomical location: left arm). Adverse reactions/events and outcomes: On 16-Dec-2016 after administration of INN flu vaccine seasonal, the patient experienced entire shoulder where injection was given was red, swollen. The action taken with the INN flu vaccine seasonal 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 seasonal and events. This report was not serious.
Age: 34.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case, initially received on 05-May-2017, which was reported by other Non-health professional via regulatory authority (VAERS ID: 682771) and concerns a 34 years old female patient. Administration of Company suspect drug: On 31-Oct-2016, patient was administered with influenza virus vaccine polyvalent via injection (dose, anatomical location, batch number: not reported). Adverse reactions/events and outcomes: On 31-Oct-2016 after administration of INN Flu Vaccine Seasonal, the patient experienced pain in arm that hurts all the time. Patients doctor advised that it had nothing to do with the flu shot and gave meloxicam for pain. It gave acid reflux to the patient. Patient started to have ADVIL for pain but it did not work out. Action taken with the suspect product was not reported. Outcome of the event was not recovered. Reporter's Assessment: The reporter assessed the events as non-serious and causality was not provided. This report was not serious.
Age: 34.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Gastrooesophageal reflux disease, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 05-May-2017, which was reported by other Non-health professional via regulatory authority (VAERS ID: 682771) and concerns a 34 years old female patient. Administration of Company suspect drug: On 31-Oct-2016, patient was administered with influenza virus vaccine polyvalent via injection (dose, anatomical location, batch number: not reported). Adverse reactions/events and outcomes: On 31-Oct-2016 after administration of INN Flu Vaccine Seasonal, the patient experienced pain in arm that hurts all the time. Patients doctor advised that it had nothing to do with the flu shot and gave meloxicam for pain. It gave acid reflux to the patient. Patient started to have ADVIL for pain but it did not work out. Action taken with the suspect product was not reported. Outcome of the event was not recovered. Reporter's Assessment: The reporter assessed the events as non-serious and causality was not provided. This report was not serious.
Age: 82.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Cough, Nasopharyngitis
Clinical narrative: This spontaneous case, initially received on 05-May-2017 was reported by other non-health professional (consumer) via health authority (VAERS ID: 682867) and concerns a 82-years-old male patient. Administration of Company suspect drug: On an unspecified date, the patient received influenza virus vaccine polyvalent, route of administration: injection, dose, batch number, expiry date and anatomical location: not reported). Non-company suspect drug: On 03-Aug-2016, the patient started XTANDI (dose: 160 mg (also reported as 40 mg), duration: 4 months 12 days, batch number: 1543978PC, expiry date: 15-Dec-2016) daily via oral route for prostate cancer and stopped on 15-Dec-2017. Adverse reactions/events and outcomes: On 26-Oct-2016, after administration of influenza vaccine and enzalutamide (after 84 days), the patient experienced cough and cold. The action taken with the influenza vaccine was not applicable and enzalutamide was drug discontinued. On 22-Dec-2016, the patient was recovering from the events. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the influenza vaccine. The reporter assessed the causality of the events in relation to the enzalutamide because of implied temporal association. This case was not serious.
Age: 82.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Cough, Viral upper respiratory tract infection
Clinical narrative: This spontaneous case, initially received on 05-May-2017 was reported by other non-health professional (consumer) via health authority (VAERS ID: 682867) and concerns a 82-years-old male patient. Administration of Company suspect drug: On an unspecified date, the patient received influenza virus vaccine polyvalent, route of administration: injection, dose, batch number, expiry date and anatomical location: not reported). Non-company suspect drug: On 03-Aug-2016, the patient started XTANDI (dose: 160 mg (also reported as 40 mg), duration: 4 months 12 days, batch number: 1543978PC, expiry date: 15-Dec-2016) daily via oral route for prostate cancer and stopped on 15-Dec-2017. Adverse reactions/events and outcomes: On 26-Oct-2016, after administration of influenza vaccine and enzalutamide (after 84 days), the patient experienced cough and cold. The action taken with the influenza vaccine was not applicable and enzalutamide was drug discontinued. On 22-Dec-2016, the patient was recovering from the events. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the influenza vaccine. The reporter assessed the causality of the events in relation to the enzalutamide because of implied temporal association. This case was not serious.
Age: 69.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site pain, Pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 05-May-2017 was reported by other non-health professional via regulatory authority (vaccine adverse event reporting system: 682892) and concerns a 69-years-old elderly female patient. Medical condition included multiple allergies. Administration of Company suspect drug: On 22-Sep-2016, the patient was administered with influenza virus vaccine polyvalent via intramuscular route, batch number: 5673JA, anatomical location: right deltoid). Adverse reactions/events and outcomes: On 22-Sep-2016, after administration of INN flu vaccine seasonal, the patient experienced arm stung and burning sensation and had pain in that arm and shoulder. The action taken with the INN flu vaccine seasonal 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 seasonal and events. This report was not serious.
Age: 69.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Burning sensation, Injection site pain, Pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 05-May-2017 was reported by other non-health professional via regulatory authority (vaccine adverse event reporting system: 682892) and concerns a 69-years-old elderly female patient. Medical condition included multiple allergies. Administration of Company suspect drug: On 22-Sep-2016, the patient was administered with influenza virus vaccine polyvalent via intramuscular route, batch number: 5673JA, anatomical location: right deltoid). Adverse reactions/events and outcomes: On 22-Sep-2016, after administration of INN flu vaccine seasonal, the patient experienced arm stung and burning sensation and had pain in that arm and shoulder. The action taken with the INN flu vaccine seasonal 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 seasonal and events. This report was not serious.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Influenza
Clinical narrative: This spontaneous case, initially received on 05-May-2017, which was reported by other Non-health professional via regulatory authority (VAERS ID: 682927) and concerns a male patient of unspecified age. Administration of Company suspect drug: On an unknown date in November, patient was administered with INN Flu Vaccine Seasonal via injection NOS route (dosage, anatomical location, batch number: unknown). Indication was not reported. Adverse reactions/events and outcomes: On an unspecified date after administration of INN Flu Vaccine Seasonal, the patient had developed flu. Patient's laboratory data and corrective treatment was not reported. Action taken with the suspect product was not reported. Outcome of the event was not reported. Reporter's Assessment: The reporter did not provide the causality between the event and the INN Flu Vaccine. This report was considered serious (Medically Significant).
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza
Clinical narrative: This spontaneous case, initially received on 05-May-2017 was reported by other non-health professional via health authority (VAERS ID: 682949) and concerns a female patient of an unspecified age. Administration of Company suspect drug: On 01-Nov-2016, the patient received INN Flu Vaccine Seasonal (dose, batch number, expiry date: not reported) at unknown site via route of injection NOS. Adverse reactions/events and outcomes: On unspecified date, it was reported that just last week, following the vaccination the patient was ended up getting the flu. The patient's laboratory investigations and corrective treatment were not reported. The action taken with the vaccine was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter considered the event as related to the suspect vaccine. This case was serious (medically significant).
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Bronchitis, Chills, Cough, Feeling of body temperature change, Headache
Clinical narrative: This spontaneous case, initially received on 05-May-2017 by other non-health professional via (VAERS ID 682950). Patient's age and gender were not reported. Administration of Company suspect drug(s): On 10-Nov-2016 approximately at 11:00 am, INN Flu Vaccine Seasonal was administered (dosage, batch number, expiration date: not reported, route of administration: injection NOS, anatomical location: unknown). Adverse reactions/events and outcomes: On 13-Nov-2016, three days following the vaccination, the patient experienced typical flu symptoms included bad head cold, runny nose, sneezing, coughing, hot and cold spells, chills, headache. On an unspecified date, the patient had developed sinus infection and suspected bronchial infection. Laboratory investigations were not reported. On 21-Nov-2016, the patient was treated with amoxicillin/clavulanic acid at a dose of 875 mg/125 mg. Action taken was not reported. Outcome of the events typical flu symptoms included bad head cold, runny nose, sneezing, coughing, hot and cold spells, chills, headache, sinus infection and suspected bronchial infection were not recovered. Reporter's Assessment: The causality between the suspect and the events were not reported. This case was serious (Medically significant).
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Influenza, Nasopharyngitis, Rhinorrhoea, Sinusitis, Sneezing
Clinical narrative: This spontaneous case, initially received on 05-May-2017 by other non-health professional via (VAERS ID 682950). Patient's age and gender were not reported. Administration of Company suspect drug(s): On 10-Nov-2016 approximately at 11:00 am, INN Flu Vaccine Seasonal was administered (dosage, batch number, expiration date: not reported, route of administration: injection NOS, anatomical location: unknown). Adverse reactions/events and outcomes: On 13-Nov-2016, three days following the vaccination, the patient experienced typical flu symptoms included bad head cold, runny nose, sneezing, coughing, hot and cold spells, chills, headache. On an unspecified date, the patient had developed sinus infection and suspected bronchial infection. Laboratory investigations were not reported. On 21-Nov-2016, the patient was treated with amoxicillin/clavulanic acid at a dose of 875 mg/125 mg. Action taken was not reported. Outcome of the events typical flu symptoms included bad head cold, runny nose, sneezing, coughing, hot and cold spells, chills, headache, sinus infection and suspected bronchial infection were not recovered. Reporter's Assessment: The causality between the suspect and the events were not reported. This case was serious (Medically significant).
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Influenza, Rhinorrhoea, Sinusitis, Sneezing, Viral upper respiratory tract infection
Clinical narrative: This spontaneous case, initially received on 05-May-2017 by other non-health professional via (VAERS ID 682950). Patient's age and gender were not reported. Administration of Company suspect drug(s): On 10-Nov-2016 approximately at 11:00 am, INN Flu Vaccine Seasonal was administered (dosage, batch number, expiration date: not reported, route of administration: injection NOS, anatomical location: unknown). Adverse reactions/events and outcomes: On 13-Nov-2016, three days following the vaccination, the patient experienced typical flu symptoms included bad head cold, runny nose, sneezing, coughing, hot and cold spells, chills, headache. On an unspecified date, the patient had developed sinus infection and suspected bronchial infection. Laboratory investigations were not reported. On 21-Nov-2016, the patient was treated with amoxicillin/clavulanic acid at a dose of 875 mg/125 mg. Action taken was not reported. Outcome of the events typical flu symptoms included bad head cold, runny nose, sneezing, coughing, hot and cold spells, chills, headache, sinus infection and suspected bronchial infection were not recovered. Reporter's Assessment: The causality between the suspect and the events were not reported. This case was serious (Medically significant).
Age: 33.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Inflammation, Joint stiffness, Musculoskeletal pain, Rotator cuff syndrome
Clinical narrative: This spontaneous case, initially received on 05-May-2017, which was reported by an other-non health professional via regulatory authority (VAERS ID: 683021) and concerns a 33 years old adult female patient. Patient had a history of seasonal allergies, shellfish allergy and allergy induced asthma since an unspecified date. Concomitant medication includes ZYRTEC and BCP (birth control pills). Administration of company suspect drug: On 21-Oct-2016, the patient was administered with influenza virus vaccine polyvalent (dose, route of administration, anatomical location, batch no. and expiry date: not reported). Adverse reactions/events and outcomes: On 21-Oct-2016, the patient experienced extreme inflammation, pain and tightness in left shoulder following flu vaccine. Patient was in physical therapy since Dec-2016 which was ongoing treatment to stretch and strengthen shoulder muscles. On an unspecified date the patient also experienced left shoulder impingement syndrome. Action taken with the influenza vaccine was not reported. Outcome of the event were not recovered/not resolved. Lab data includes: left shoulder impingement syndrome with marked internal rotation contractive. Reporter's Assessment: The other non-health professional did not provide any causality assessment. This case was non-serious.
Age: 26.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Neck pain, Pain
Clinical narrative: This spontaneous case, initially received on 05-May-2017 was reported by a other non-health professional and concerns 26-years old female patient. The drug history included ciprofloxacin, latex. Administration of Company suspect drug (s): On from 03-Feb-2017, INN Flu Vaccine Seasonal was administered (unknown dosage, route of administration, intramuscular, anatomical location: right arm, batch number: not reported). On from 03-Feb-2017, Pneumococcal vaccine was administered (unknown dosage, route of administration: intramuscular, anatomical location: Left arm, batch number: not reported). Adverse reactions/events and outcomes: On 03-Feb-2017 after administration of INN Flu Vaccine Seasonal and pneumococcal vaccine, the patient got pneumonia-adult shot in the left arm. The patient felt that his shoulder and arm was breaking in pieces. The pain travelled to the left side of neck and down to the left leg/hip that it was very painful to even walk. The patient couldn't move the arm at all and was extremely painful. Action taken was not reported. Outcome of the events were recovered. Reporter's Assessment: The Health Authority considered the events as non-serious. The causality between the events and vaccine were not reported.
Age: 26.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case, initially received on 05-May-2017 was reported by a other non-health professional and concerns 26-years old female patient. The drug history included ciprofloxacin, latex. Administration of Company suspect drug (s): On from 03-Feb-2017, INN Flu Vaccine Seasonal was administered (unknown dosage, route of administration, intramuscular, anatomical location: right arm, batch number: not reported). On from 03-Feb-2017, Pneumococcal vaccine was administered (unknown dosage, route of administration: intramuscular, anatomical location: Left arm, batch number: not reported). Adverse reactions/events and outcomes: On 03-Feb-2017 after administration of INN Flu Vaccine Seasonal and pneumococcal vaccine, the patient got pneumonia-adult shot in the left arm. The patient felt that his shoulder and arm was breaking in pieces. The pain travelled to the left side of neck and down to the left leg/hip that it was very painful to even walk. The patient couldn't move the arm at all and was extremely painful. Action taken was not reported. Outcome of the events were recovered. Reporter's Assessment: The Health Authority considered the events as non-serious. The causality between the events and vaccine were not reported.
Age: 26.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Arthralgia, Mobility decreased, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: This spontaneous case, initially received on 05-May-2017 was reported by a other non-health professional and concerns 26-years old female patient. The drug history included ciprofloxacin, latex. Administration of Company suspect drug (s): On from 03-Feb-2017, INN Flu Vaccine Seasonal was administered (unknown dosage, route of administration, intramuscular, anatomical location: right arm, batch number: not reported). On from 03-Feb-2017, Pneumococcal vaccine was administered (unknown dosage, route of administration: intramuscular, anatomical location: Left arm, batch number: not reported). Adverse reactions/events and outcomes: On 03-Feb-2017 after administration of INN Flu Vaccine Seasonal and pneumococcal vaccine, the patient got pneumonia-adult shot in the left arm. The patient felt that his shoulder and arm was breaking in pieces. The pain travelled to the left side of neck and down to the left leg/hip that it was very painful to even walk. The patient couldn't move the arm at all and was extremely painful. Action taken was not reported. Outcome of the events were recovered. Reporter's Assessment: The Health Authority considered the events as non-serious. The causality between the events and vaccine were not reported.
Age: 56.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Insomnia, Limb discomfort, Mobility decreased, Pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received via vaccine adverse event reporting systems (VAERS ID: 683078) on May-2017, was reported by other-non-health professional and concerns a 56-years-old female patient. The patient's concomitant medication included triamterene, simvastatin. On 11-Jan-2017, the patient received, influenza virus vaccine polyvalent (dose, route of administration, anatomical location, batch number, expiration date: not reported). On 12-Jan-2017, the patient had soreness and severe limited mobility of arm for approximately a week. Over a month, the patient had pain/discomfort in the arm. Also, the patient had difficulty to sleep at night and had pain while moving arm. The patient was given meloxicam 7.5 (units not given) for pain. The patient had to follow up with MRI within a week if no improvement. The outcome of the events was not reported. The reporter did not provide the causality between INN flu vaccine seasonal and events. This case was not serious. Case correction received on 17-May-2017: Causality of all the events were corrected.
Age: 27.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reporting systems (VAERS ID: 683086) on May-2017 was reported by other non-healthcare professional and concerns a 27-year-old female patient. Administration of Company suspect drug: On 13-Oct-2016, the patient was administered with influenza virus vaccine polyvalent, route of administration: intramuscular, anatomical location: left arm, batch number, dose, expiration date: not reported. Adverse events/reactions and outcomes: On 13-Oct-2016, after administration of influenza virus vaccine polyvalent, the patient experienced soreness at injection site. Action taken with influenza virus vaccine polyvalent was not reported. Outcome of the event was recovered/resolved. Reporter's assessment: The reporter assessed the causality between influenza virus vaccine polyvalent and event was not reported. This report was not serious.
Age: 18.0
Sex: F
Vaccine: FLUX, HPV9, FLUX, HPV9
Symptoms: Injection site nodule, Rash
Clinical narrative: This spontaneous case, initially received on 05-May-2017, which was reported by other Non-health professional via regulatory authority (VAERS ID: 683101) and concerns an 18-years-old female patient. Patient's current condition included Prophylaxis. On 15-Sep-2016, patient was administered with influenza virus vaccine polyvalent in unspecified arm (dose, route of administration, batch number, expiration date: not reported). On 01-Jul-2016, patient was administered 1st dose of GARDASIL (dose: 1 DF, route of administration, anatomical location, lot number and expiration date: not reported). On an unknown date in Sep-2016, patient was administered 2nd dose of GARDASIL 9 in opposite arm of unspecified arm (dose, route of administration, lot number and expiration date: not reported. On unspecified date, after administration of INN flu vaccine seasonal and GARDASIL 9, the patient experienced huge knot on the arm where the GARDASIL 9 was administered and a bad rash on her upper body. On an unknown date, after 2 weeks, the patient was recovered from both the events. The reporter assessed the events as non-serious and the causality was not reported. This report was not serious. Significant case correction received on 17-May-2017: The determined causality was changed from unassessable to not related.
Age: 18.0
Sex: F
Vaccine: FLUX, HPV9, FLUX, HPV9
Symptoms: Nodule, Rash
Clinical narrative: This spontaneous case, initially received on 05-May-2017, which was reported by other Non-health professional via regulatory authority (VAERS ID: 683101) and concerns an 18-years-old female patient. Patient's current condition included Prophylaxis. On 15-Sep-2016, patient was administered with influenza virus vaccine polyvalent in unspecified arm (dose, route of administration, batch number, expiration date: not reported). On 01-Jul-2016, patient was administered 1st dose of GARDASIL (dose: 1 DF, route of administration, anatomical location, lot number and expiration date: not reported). On an unknown date in Sep-2016, patient was administered 2nd dose of GARDASIL 9 in opposite arm of unspecified arm (dose, route of administration, lot number and expiration date: not reported. On unspecified date, after administration of INN flu vaccine seasonal and GARDASIL 9, the patient experienced huge knot on the arm where the GARDASIL 9 was administered and a bad rash on her upper body. On an unknown date, after 2 weeks, the patient was recovered from both the events. The reporter assessed the events as non-serious and the causality was not reported. This report was not serious. Significant case correction received on 17-May-2017: The determined causality was changed from unassessable to not related.
Age: 60.0
Sex: F
Vaccine: FLUX, PPV, TDAP, VARZOS, FLUX, PPV, TDAP, VARZOS
Symptoms: Erythema, Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reporting systems (VAERS ID: 683161) on May-2017 was reported by an other non health professional and concerns a 60 years old female patient. The patient's medication history included fibromyalgia, osteoporosis, osteoarthritis generalised, diabetes, carpal tunnel syndrome, high blood pressure, fatty liver, shingles, sleep apnea. The drug history included DEMEROL rash, penicillin rash, erythromycin: nausea, vomiting, metformin: nausea; SAVELLA: nausea; nickel: very bad rash. The patient's concomitant medication included magnesium w/zing, stress B complex, FOSAMAX, trazodone, carvedilol, enalapril, CYMBALTA, PREVACID, diazepam, ZANAFLEX, fluticasone propionate, LYRICA, oxycodone, LIDODERM, CENTRUM SILVER, vitamin D3, fish oil w/omega-3 fatty acids. Administration of Company suspect drug: On 18-Sep-2014, the patient received influenza virus vaccine polyvalent, anatomical site: arm, route of administration, dose, batch number, expiration date: not reported. Non-company suspect drug (s): PNEUMOVAX, TDAP IPV, ZOSTAVAX was administered on 18-Sep-2014. (anatomical site: arm, route of administration, dose, batch number, expiration date: not reported). Adverse reactions/events and outcomes: On 18-Feb-2015 the patient developed itching and pain. On left hip had painful outbreak which moved to bottom spine and appeared as red stripe and had to visit emergency room. She went to walk in clinic and consulted doctor who suggested as shingles. She also stated that no such reaction occurred before when she took zoster shot. The patient was given BACTROBAN 2% cream, antibiotic and antiviral. She also had new worse lip for the first time on 25-01-2017. Still she had outbreaks. Action taken with influenza vaccine was not reported. The events were not recovered. Reporter's Assessment: The reporter assessed the events as non serious and causality was not reported. This case was non serious.
Age: 60.0
Sex: F
Vaccine: FLUX, PPV, TDAP, VARZOS, FLUX, PPV, TDAP, VARZOS
Symptoms: Erythema, Herpes zoster, Lip disorder, Pain, Pruritus
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reporting systems (VAERS ID: 683161) on May-2017 was reported by an other non health professional and concerns a 60 years old female patient. The patient's medication history included fibromyalgia, osteoporosis, osteoarthritis generalised, diabetes, carpal tunnel syndrome, high blood pressure, fatty liver, shingles, sleep apnea. The drug history included DEMEROL rash, penicillin rash, erythromycin: nausea, vomiting, metformin: nausea; SAVELLA: nausea; nickel: very bad rash. The patient's concomitant medication included magnesium w/zing, stress B complex, FOSAMAX, trazodone, carvedilol, enalapril, CYMBALTA, PREVACID, diazepam, ZANAFLEX, fluticasone propionate, LYRICA, oxycodone, LIDODERM, CENTRUM SILVER, vitamin D3, fish oil w/omega-3 fatty acids. Administration of Company suspect drug: On 18-Sep-2014, the patient received influenza virus vaccine polyvalent, anatomical site: arm, route of administration, dose, batch number, expiration date: not reported. Non-company suspect drug (s): PNEUMOVAX, TDAP IPV, ZOSTAVAX was administered on 18-Sep-2014. (anatomical site: arm, route of administration, dose, batch number, expiration date: not reported). Adverse reactions/events and outcomes: On 18-Feb-2015 the patient developed itching and pain. On left hip had painful outbreak which moved to bottom spine and appeared as red stripe and had to visit emergency room. She went to walk in clinic and consulted doctor who suggested as shingles. She also stated that no such reaction occurred before when she took zoster shot. The patient was given BACTROBAN 2% cream, antibiotic and antiviral. She also had new worse lip for the first time on 25-01-2017. Still she had outbreaks. Action taken with influenza vaccine was not reported. The events were not recovered. Reporter's Assessment: The reporter assessed the events as non serious and causality was not reported. This case was non serious.
Age: 60.0
Sex: F
Vaccine: FLUX, PPV, TDAP, VARZOS, FLUX, PPV, TDAP, VARZOS
Symptoms: Spinal pain
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reporting systems (VAERS ID: 683161) on May-2017 was reported by an other non health professional and concerns a 60 years old female patient. The patient's medication history included fibromyalgia, osteoporosis, osteoarthritis generalised, diabetes, carpal tunnel syndrome, high blood pressure, fatty liver, shingles, sleep apnea. The drug history included DEMEROL rash, penicillin rash, erythromycin: nausea, vomiting, metformin: nausea; SAVELLA: nausea; nickel: very bad rash. The patient's concomitant medication included magnesium w/zing, stress B complex, FOSAMAX, trazodone, carvedilol, enalapril, CYMBALTA, PREVACID, diazepam, ZANAFLEX, fluticasone propionate, LYRICA, oxycodone, LIDODERM, CENTRUM SILVER, vitamin D3, fish oil w/omega-3 fatty acids. Administration of Company suspect drug: On 18-Sep-2014, the patient received influenza virus vaccine polyvalent, anatomical site: arm, route of administration, dose, batch number, expiration date: not reported. Non-company suspect drug (s): PNEUMOVAX, TDAP IPV, ZOSTAVAX was administered on 18-Sep-2014. (anatomical site: arm, route of administration, dose, batch number, expiration date: not reported). Adverse reactions/events and outcomes: On 18-Feb-2015 the patient developed itching and pain. On left hip had painful outbreak which moved to bottom spine and appeared as red stripe and had to visit emergency room. She went to walk in clinic and consulted doctor who suggested as shingles. She also stated that no such reaction occurred before when she took zoster shot. The patient was given BACTROBAN 2% cream, antibiotic and antiviral. She also had new worse lip for the first time on 25-01-2017. Still she had outbreaks. Action taken with influenza vaccine was not reported. The events were not recovered. Reporter's Assessment: The reporter assessed the events as non serious and causality was not reported. This case was non serious.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, FLUX, MMRV, DTAPHEPBIP, FLUX, MMRV
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: This spontaneous case, initially received on 05-May-2017, which was reported by other-non health professional via regulatory authority (VAERS ID: 683184) and concerns a 4-years-old male patient. Administration of company suspect drug: On 13-Feb-2017, the patient was administered with influenza virus vaccine polyvalent (route of administration: intramuscular, dose, anatomical location, batch number, and expiry date: not reported. Administration of non-company suspect drug: On 13-Feb-2017, the patient was administered with PEDIARIX (route of administration: intramuscular, dose, anatomical location, batch no. and expiry date: not reported). Administration of non-company suspect drug: On 13-Feb-2017, the patient was administered with PROQUAD (route of administration: subcutaneous, dose, anatomical location, batch no. and expiry date: not reported). Adverse reactions/events and outcomes: On 13-Feb-2017, after receiving measles vaccines, mumps vaccine, rubella vaccine, varicella zoster vaccine at health department, patient experienced rash to face on 16-Feb-2017. It was reported that, on 17-Feb-2017 at office, increasing erythematous, papulovesicular lesions to face, neck, legs and abdomen were also seen. Action taken with the influenza vaccine was not reported. Outcome of the event were not recovered/not resolved. Reporter's Assessment: The reporter did not provide causality between INN flu vaccine seasonal and the events. This case was not serious.
Age: 65.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Fatigue, Headache, Initial insomnia, Nuclear magnetic resonance imaging, Pain
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reporting systems (VAERS ID: 683296) on May-2017 was reported by other non-healthcare professional and concerns a 65-year-old female patient. The patient's historical vaccine included PREVNAR 13 (route of administration: intramuscular, anatomical location: left arm, dose, batch number, expiration date: not reported). Administration of Company suspect drug: On 21-OCT-2016, the patient was administered with influenza virus vaccine polyvalent (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: U162622, expiration date: not reported). Adverse events/reactions and outcomes: On an unspecified date, after administration of influenza virus vaccine polyvalent, the patient had developed fatigue, mild headache, pain and sometimes trouble in falling asleep (awaken every day between 3 - 5 am). Lab test: The lab test of the patient included X-ray and Magnetic resonance imaging (MRIS) was performed on an unknown date. Treatment medications: The treatment medication of the patient was included ibuprofen and physical therapy. Action taken with influenza virus vaccine polyvalent was not reported. The outcome of the event mild headache was recovered/resolved, the outcome of the events the patient had developed fatigue, pain and sometimes trouble in falling asleep (awaken every day between 3- 5 am) was not reported. Reporter's Assessment: The reporter assessed the causality between influenza virus vaccine polyvalent and event was not reported. This case report was non serious.
Age: 65.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: X-ray
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reporting systems (VAERS ID: 683296) on May-2017 was reported by other non-healthcare professional and concerns a 65-year-old female patient. The patient's historical vaccine included PREVNAR 13 (route of administration: intramuscular, anatomical location: left arm, dose, batch number, expiration date: not reported). Administration of Company suspect drug: On 21-OCT-2016, the patient was administered with influenza virus vaccine polyvalent (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: U162622, expiration date: not reported). Adverse events/reactions and outcomes: On an unspecified date, after administration of influenza virus vaccine polyvalent, the patient had developed fatigue, mild headache, pain and sometimes trouble in falling asleep (awaken every day between 3 - 5 am). Lab test: The lab test of the patient included X-ray and Magnetic resonance imaging (MRIS) was performed on an unknown date. Treatment medications: The treatment medication of the patient was included ibuprofen and physical therapy. Action taken with influenza virus vaccine polyvalent was not reported. The outcome of the event mild headache was recovered/resolved, the outcome of the events the patient had developed fatigue, pain and sometimes trouble in falling asleep (awaken every day between 3- 5 am) was not reported. Reporter's Assessment: The reporter assessed the causality between influenza virus vaccine polyvalent and event was not reported. This case report was non serious.
Age: 52.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reporting systems (VAERS ID: 683377) on May-2017, was reported by other non-health professional and concerns a 52-years-old female patient. Administration of Company suspect drug: On 06-Jan-2017, the patient administered with influenza virus vaccine polyvalent, route of administration: injection, anatomical location: left arm, dose, batch number, expiration date: not reported. Adverse reactions/events and outcomes: On 09-Jan-2017, after administration of INN flu vaccine seasonal on left arm, the patient experienced soreness and limited range of motion in the left arm. This continued even after six and half weeks. The patient had to visit emergency room for the relief. Action taken with INN flu vaccine seasonal was not reported. Outcome of the events was not recovered. Reporter's Assessment: The reporter considered the causality between INN flu vaccine seasonal and events as related. This case was not serious.