chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Hypoaesthesia, Injection site pain, Joint range of motion decreased, Mobility decreased
Clinical narrative: This Spontaneous case, initially received via VAERS on 12-Apr-2017, was reported by an other non-health professional and concerns a adult female patient. The patient's medication history included: anxiety, depression, migraine and acid reflux (oesophageal). The patient's concomitant medication included: BUSPAR, SINGULAIR, ZYRTEC, Probiotics, NEXIUM, PROZAC, ZANTAC and XANAX. Administration of Company suspect drug: On 22-Nov-2016, the patient administered with INN flu vaccine, (Dose, batch number, Route of administration: intramuscular). Adverse reactions/events and outcomes: The reporter reported that, on 22-Nov-2016 after administration of INN Flu Vaccine, the patient experienced limited range of motion, cannot raise her arm. She also experienced severe pain, tingling, numbness, pain to touch at the injection site and burning sensation. Action taken with INN flu vaccine seasonal was not reported. The outcome of the event was not reported. Reporter's Assessment: The reporter implied that the causality between INN flu vaccine seasonal and events as related. Company assessed the causality between INN flu vaccine seasonal and events as related. This report was not serious.
Sex: F
Vaccine: FLUX
Symptoms: Pain, Paraesthesia, X-ray normal
Clinical narrative: This Spontaneous case, initially received via VAERS on 12-Apr-2017, was reported by an other non-health professional and concerns a adult female patient. The patient's medication history included: anxiety, depression, migraine and acid reflux (oesophageal). The patient's concomitant medication included: BUSPAR, SINGULAIR, ZYRTEC, Probiotics, NEXIUM, PROZAC, ZANTAC and XANAX. Administration of Company suspect drug: On 22-Nov-2016, the patient administered with INN flu vaccine, (Dose, batch number, Route of administration: intramuscular). Adverse reactions/events and outcomes: The reporter reported that, on 22-Nov-2016 after administration of INN Flu Vaccine, the patient experienced limited range of motion, cannot raise her arm. She also experienced severe pain, tingling, numbness, pain to touch at the injection site and burning sensation. Action taken with INN flu vaccine seasonal was not reported. The outcome of the event was not reported. Reporter's Assessment: The reporter implied that the causality between INN flu vaccine seasonal and events as related. Company assessed the causality between INN flu vaccine seasonal and events as related. This report was not serious.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 was reported by other non-health professional (consumer) via health authority (reference no: 673027) and concerns a 62-years-old female patient. Administration of Company suspect drug: On 10-Sep-2016, the patient received INN Flu Vaccine (dose, expiry date, batch number and route of administration: not reported). Adverse reactions/events and outcomes: On 10-Sep-2016 after administration of influenza vaccine, the patient experienced pain in the muscle of her arm. The action taken with 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.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Headache, Wheezing
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by other non-health professional via health authority (VAERS ID: 673037) and concerns 43 years old male adult patient. There was no any medical history of the patient. Administration of Company suspect drug: On 18-Dec-2016, the patient received INN Flu Vaccine (dose, expiry date, batch number, route of administration: not reported) at an unknown site. Indication not reported. Adverse reactions/events and outcomes: On 18-Dec-2016, after administration of influenza vaccine, the patient experienced intense coughing and wheezing followed by headache. Action taken with the suspect vaccine was not reported. The patient had not any treatment for the events because medical facility was closed. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the INN Flu Vaccine. This case was non-serious.
Age: 13.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: This spontaneous case, initially received via Vaccine Adverse Event Reaction System (VAERS ID: 673039) on Apr-2017 was reported by other non-health professional and concerns a 13-years-old child male patient. The patient's current condition included sinus infection. The patient's concomitant included AUGMENTIN 875. Administration of Company suspect drug: On 13-Dec-16, the patient was administered with INN Flu Vaccine (route of administration: intramuscular, anatomical location: right arm, dose, batch number, expiration date: not reported). Indication not reported. Adverse events/reactions and outcomes: On 16-Dec-16, after administration with INN Flu Vaccine, the patient experienced itching and hives all over the body and within 24 hours covered half of his body in patches of hives. The action taken with INN Flu Vaccine was not reported. The outcome of the events was not reported. Report's Assessment: The reporter did not provide the causality between INN Flu Vaccine and events. This case report was non-serious.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injection site erythema, Injection site rash, Pain in extremity
Clinical narrative: This Spontaneous case Vaccine Adverse Event Reaction Systems (VAERS ID: 673055), initially received on Apr-2017 was reported by other non-healthcare professional and concerns a 61 years old male patient. Administration of Company suspect drug(s): On 09-Dec-2016 the patient was administered by INN Flu Vaccine (route of administration: intramuscular, dose, expiration date, batch number: not reported). Adverse events/reactions and outcomes: On 10-Dec-2016 after administration INN Flu Vaccine, the patient experienced bright red raised rash around injection site only on the arm, on left arm and pain and numbness in left arm. The outcome of the events were unknown. The patient was treated with MEDROL (route of administration, dose, expiration date, batch number: not reported) and ZOVIRAX (route of administration, dose, expiration date, batch number: not reported). The action taken with INN Flu Vaccine was not reported. Reporter's Assessment: The other non-healthcare professional assessed the events experienced bright red raised rash around injection site only on the arm, on left arm and pain and numbness in left arm as non-serious, and the causality of the events was not reported. This case report was non-serious.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other non health professional regulatory authority (VAERS ID: 673266) and concerns a 65 years old male patient. Administration of Company suspect drug: On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dosage, route of administration: unknown) at arm. Non-company suspect drug: On an unspecified date the patient was administered PNEUMOVAX 23 (lot number 2568254242, dose, route and expiry date: not reported) at arm. Adverse reactions/events and outcomes: On unspecified date INN Flu vaccine (seasonal) and PNEUMOVAX, the patient was vaccinated in the same arm on the same day. On an unknown date the patient's arm swelled up and he experienced fever. The patient did not seek medical attention and had no treatment. Action taken with INN Flu Vaccine Seasonal was not reported. The patient was recovered from fever and swelling arm and not reported for vaccine administered at inappropriate site. Reporter's Assessment: The reporter did not provide the causality between INN Flu Vaccine Seasonal and events. This report was not serious.
Sex: F
Vaccine: FLUX
Symptoms: Incorrect product storage, Wrong drug administered
Clinical narrative: This Spontaneous case initially received via Vaccine adverse event reaction system (VAERS ID: 673458) on Apr-2017 was reported by other healthcare professional and concern a 47-year-old adult female patient. Administration of Co-suspect drug: On an unspecified date in 2015, the patient was administered by insulin (route of administration, dose, batch number, expiration date: not reported), indication was not reported instead of INN Flu vaccine seasonal (route of administration, dose, batch number, expiration date: not reported). Adverse events/reactions and outcomes: On an unspecified date in 2015, the patient had administration of insulin instead of influenza vaccine (wrong drug administration) and improper storage (drug stored in wrong location). As instead of INN Flu vaccine seasonal, insulin was administered as wrong drug administration dud to improper storage. The outcome of the events were  unknown. The action taken after INN Flu vaccine seasonal was not reported. Reporter's Assessment: The reporter did not provided the causality of the events. This case report was non-serious.
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Condition aggravated, Guttate psoriasis
Clinical narrative: This Spontaneous case, initially received on 12-APR-2017 was reported by an other health professional via Health Authority (FDA VAERS number: 673540) and concerns a 40 years old female patient. The patient's medication history included: Chickenpox, Psoriasis, Herpes simplex. The patient's concomitant medication included: Lisinopril, Acyclovir. Administration of Company suspect drug (s) On 23-Oct-2016, the patient received intramuscular INN Flu Vaccine Seasonal (unknown dosage, frequency, duration, batch number: not reported) at left arm. Non-company suspect drug (s): On 23-Oct-2016, the patient received intramuscular VARIVAX at left arm. (Unknown dose, frequency, duration, batch number). Adverse reactions/events and outcomes: On 24-oct-2016, the patient received varicella immunization and influenza vaccine at the same time on same arm characterised as drug administration error (Seriousness criteria: Non-serious event), (Outcome - Not recovered). On 24-Oct-2016, after administration of INN Flu Vaccine Seasonal, VARIVAX, the patient experienced massive Guttate psoriasis outbreaks (Seriousness criteria: Non-serious event), (Outcome - Not recovered) which had previously been dormant for at least 10 years. The patient had emergency room visit. Action taken was not reported. Reporter's Assessment: The Health Authority assessed the events as non-serious and the causality was not reported.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Insomnia, Local swelling, Loss of personal independence in daily activities, Manipulation, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, was reported by other non-health professional (consumer) via health authority (reference no: 673541) and concerns a 27-years-old female patient. Administration of Company suspect drug: On 30-Nov-2016, the patient received INN Flu Vaccine Seasonal (dose, expiry date, route of administration: not reported and anatomical location: left arm). Adverse reactions/events and outcomes: On 11-Dec-2016, after two weeks of administration of INN Flu Vaccine Seasonal, the patient woke up on with severe pain in upper arm near inoculation site. The patient could not take on or off shirts without yelling. After concluding, the patient did not sleep one night and arm pain progressed throughout his arm through the week and dressing was still a one arm operation. On 19-Dec-2016 (Monday) after one week of initial pain, the patient went to a doctor and received osteopathic manipulation to relieve the tension. A large bump had formed in upper his arm. and needed to be broken down to allow his arm to function again. The patient was admitted to emergency room. It was also reported that the patient received shot at flu shot clinic day. 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: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, was reported by other non-health professional (consumer) via health authority (reference no: 673541) and concerns a 27-years-old female patient. Administration of Company suspect drug: On 30-Nov-2016, the patient received INN Flu Vaccine Seasonal (dose, expiry date, route of administration: not reported and anatomical location: left arm). Adverse reactions/events and outcomes: On 11-Dec-2016, after two weeks of administration of INN Flu Vaccine Seasonal, the patient woke up on with severe pain in upper arm near inoculation site. The patient could not take on or off shirts without yelling. After concluding, the patient did not sleep one night and arm pain progressed throughout his arm through the week and dressing was still a one arm operation. On 19-Dec-2016 (Monday) after one week of initial pain, the patient went to a doctor and received osteopathic manipulation to relieve the tension. A large bump had formed in upper his arm. and needed to be broken down to allow his arm to function again. The patient was admitted to emergency room. It was also reported that the patient received shot at flu shot clinic day. 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
Symptoms: Bed rest, Nausea, Pyrexia, Vomiting
Clinical narrative: This spontaneous case initially received on 12-Apr-2017, which reported by other non-health professional via regulatory authority (VAERS ID: 673542) and concerns a 17-years-old male patient. The patient's medication history included: ADHD and Asperger's syndrome since an unknown date. Concomitant medication included: Metadate CD, escitalopram, flaxseed oil and WELLBUTRIN for an unknown indication. Patient was also treated with ibuprofen for fever. Administration of Company suspect drug: On 18-Dec-2016, patient was administered with INN Flu vaccine seasonal (dosage: unknown, route of administration: intramuscular, anatomical location: left arm). Adverse reactions/events and outcomes: On 19-Dec-2016, patient experienced fever over 101 degrees/several breaking resurgences of fever, nausea and vomiting which were treated with bed rest, fluids and ibuprofen. Symptoms dissipated over the course of the next 24 hrs. The action taken with the suspect product was not reported. The outcome was recovered. Reporter's Assessment: The reporter did not provide causality between INN Flu vaccine seasonal and events. This report was not serious.
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Limb discomfort, Mobility decreased, Pain in extremity
Clinical narrative: This Spontaneous case initially received via VAERS on 12-Apr-2017, was reported by a other non-health professional and concerns a 59 years old adult female patient. Administration of Company suspect drug: On 10-Nov-2016, the patient administered with INN flu vaccine seasonal (Dose, batch number, Route of administration: intramuscular). Adverse reactions/events and outcomes: The reporter reported that, on 11-Nov-2016 after administration of INN Flu vaccine seasonal, the patient experienced soreness, extreme pain (pain in arm), limited mobility (injected limb mobility decreased), burning sensation and discomfort down entire arm. Action taken with INN flu vaccine seasonal was not reported. The outcome of the event was unknown. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and events. This report was not serious.
Sex: F
Vaccine: FLUA3, IPV, PPV, TDAP
Symptoms: Chest discomfort, Dyspnoea, Immediate post-injection reaction
Clinical narrative: This Spontaneous case initially received on 12-APR-2017 was reported by an other non health professional via Health Authority (FDA VAERS number: 673713) concerns a 73 years old female patient. The patient's medical history included asthma. Administration of Company suspect drug(s): On 12 Dec-2016, the patient received 1 dose of intramuscular FLUAD (TIV) (unknown dosage, frequency, batch number: 166101) on right arm. Non-company suspect drug (S): On 12-Dec-2016 itself upon patient request, she was given intramuscular PNEUMOVAX 1 dose on right arm of batch number M037669 and intramuscular TDAP 1 dose on left arm of batch number 4SN42. Adverse reaction/events and outcomes: On 12-Dec-2016 after administration of FLUAD (TIV), PNEUMOVAX, TDaP IPV, the patient immediately experienced post-injection reaction, shortness of breath (dyspnoea) and chest tightness. It was stated that patient felt better after providing breathing treatment by EMS. The outcome of the events were reported as recovered. The action taken with FLUAD (TIV) was not reported. Reporter's Assessment: The reporter causality for the events post-injection reaction, shortness of breath and chest tightness was not provided. The report was non-serious.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017 was reported by a other non-health professional via Health Authority (reference no: 673714) and concerns 78 years old female patient. Weight: 129 lbs. Administration of Company suspect drug: On an unspecified date, the patient received INN Flu Vaccine (dose, expiry date, batch no: not reported) at an unknown site via intramuscular route. Adverse reactions/events and outcomes: On 15-Oct-2011, the patient experienced some swelling after a flu shot. Action taken with the vaccine was not reported. Treatment medication include BENADRYL. The outcome of the event was unknown. Reporter's Assessment: The reporter considered the causality between the event in relation to the INN Flu Vaccine was related. This case was non-serious.
Age: 17.0
Sex: F
Vaccine: FLUX, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by an other-non health professional via regulatory authority (VAERS ID: 673813) and concerns a 17 years old female patient. Concomitant medication includes trazodone for headache and estrogen. Patient was also treated with BENADRYL for itching and TYLENOL for arm ache. Administration of Company suspect drug: On 19-Dec-2016, patient was administered with INN Flu Vaccine Seasonal (dosage: unknown, route of administration: unknown, anatomical location: right arm). Administration of Non-company suspect drug: MENVEO (dosage: unknown, route of administration: unknown, anatomical location: left arm). VARIVAX (dosage: 1 DF, route of administration: unknown, anatomical location: left arm). Adverse reactions/events and outcomes: On 19-Dec-2016, the patient experienced site was red, hot, swollen. On 20-Dec-2016 morning, rash was larger and arm arched very bad. Cold compression and TYLENOL was given as treatment. By 10 PM, the top site was one and half inch in diameter, bottom side was four inches (breadth) and seven inches (length), red, hot, hard and it was itching her. BENADRYL cream was given as treatment. Action taken with the suspect product was not reported. Outcome of the events were not recovered/not resolved. Reporter's Assessment: The reporter did not provided any causality assessment. This report is not serious.
Age: 17.0
Sex: F
Vaccine: FLUX, MNQ, VARCEL
Symptoms: Rash, Rash pruritic
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by an other-non health professional via regulatory authority (VAERS ID: 673813) and concerns a 17 years old female patient. Concomitant medication includes trazodone for headache and estrogen. Patient was also treated with BENADRYL for itching and TYLENOL for arm ache. Administration of Company suspect drug: On 19-Dec-2016, patient was administered with INN Flu Vaccine Seasonal (dosage: unknown, route of administration: unknown, anatomical location: right arm). Administration of Non-company suspect drug: MENVEO (dosage: unknown, route of administration: unknown, anatomical location: left arm). VARIVAX (dosage: 1 DF, route of administration: unknown, anatomical location: left arm). Adverse reactions/events and outcomes: On 19-Dec-2016, the patient experienced site was red, hot, swollen. On 20-Dec-2016 morning, rash was larger and arm arched very bad. Cold compression and TYLENOL was given as treatment. By 10 PM, the top site was one and half inch in diameter, bottom side was four inches (breadth) and seven inches (length), red, hot, hard and it was itching her. BENADRYL cream was given as treatment. Action taken with the suspect product was not reported. Outcome of the events were not recovered/not resolved. Reporter's Assessment: The reporter did not provided any causality assessment. This report is not serious.
Sex: F
Vaccine: FLUX
Symptoms: Lymphadenopathy
Clinical narrative: This Spontaneous case, initially received via VAERS (VAERS ID-673879) on 12-Apr-2017, was reported by other non-health professional and concerns a female patient of unspecified age. At the time of the event the patient had blood glucose abnormal. The patient's concomitant medication included: Metformin, JANUVIA and Glimepiride. Administration of Company suspect drug: On an unspecified date, the patient administered with INN flu vaccine (Dose, batch number, Route of administration: injection NOS). Adverse reactions/events and outcomes: The reporter reported that, on an unspecified date and duration following the vaccination she had enlarged lymph nodes. The Action taken with INN flu vaccine was not reported. The outcome of the event was not recovered. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine and event. This report was not serious.
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Back pain, Cough, Decreased appetite, Disorientation
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: 673990) and concerns a 44-years-old adult male patient. The patient's medication history included: depression, anxiety, upper respiratory infection, kidney infection. At the time of the event the patient had HIV antibody positive. The patient's concomitant medication included: STRIBILD, Atorvastatin. Administration of Company suspect drug: On 14-Dec-2016, the patient was administered with INN Flu Vaccine Seasonal (dosage, batch number and route of administration: not reported). Adverse reactions/events and outcomes: On 14-Dec-2016, the patient arms were sore, appetite absent and things tasty funny to him. On 15-dec-2016 the patient's legs were numb, he couldn't catch his breath without coughing, arms and feet tingled, lower back pain, couldn't get his bearings for 5 min and had migraine like headaches. On 16-dec-2016 the patient felt drained of energy. On unspecified date went from 5 hours of sleep to 2.5 may be 3. Action taken with the INN Flu Vaccine Seasonal was not reported and outcome of the events was not reported. Reporter's Assessment: The reporter did not provide any causality between INN Flu Vaccine Seasonal and events. This report was not serious.
Sex: M
Vaccine: FLUX
Symptoms: Dysgeusia, Dyspnoea, Hypoaesthesia, Insomnia, Migraine
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: 673990) and concerns a 44-years-old adult male patient. The patient's medication history included: depression, anxiety, upper respiratory infection, kidney infection. At the time of the event the patient had HIV antibody positive. The patient's concomitant medication included: STRIBILD, Atorvastatin. Administration of Company suspect drug: On 14-Dec-2016, the patient was administered with INN Flu Vaccine Seasonal (dosage, batch number and route of administration: not reported). Adverse reactions/events and outcomes: On 14-Dec-2016, the patient arms were sore, appetite absent and things tasty funny to him. On 15-dec-2016 the patient's legs were numb, he couldn't catch his breath without coughing, arms and feet tingled, lower back pain, couldn't get his bearings for 5 min and had migraine like headaches. On 16-dec-2016 the patient felt drained of energy. On unspecified date went from 5 hours of sleep to 2.5 may be 3. Action taken with the INN Flu Vaccine Seasonal was not reported and outcome of the events was not reported. Reporter's Assessment: The reporter did not provide any causality between INN Flu Vaccine Seasonal and events. This report was not serious.
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity, Paraesthesia
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: 673990) and concerns a 44-years-old adult male patient. The patient's medication history included: depression, anxiety, upper respiratory infection, kidney infection. At the time of the event the patient had HIV antibody positive. The patient's concomitant medication included: STRIBILD, Atorvastatin. Administration of Company suspect drug: On 14-Dec-2016, the patient was administered with INN Flu Vaccine Seasonal (dosage, batch number and route of administration: not reported). Adverse reactions/events and outcomes: On 14-Dec-2016, the patient arms were sore, appetite absent and things tasty funny to him. On 15-dec-2016 the patient's legs were numb, he couldn't catch his breath without coughing, arms and feet tingled, lower back pain, couldn't get his bearings for 5 min and had migraine like headaches. On 16-dec-2016 the patient felt drained of energy. On unspecified date went from 5 hours of sleep to 2.5 may be 3. Action taken with the INN Flu Vaccine Seasonal was not reported and outcome of the events was not reported. Reporter's Assessment: The reporter did not provide any causality between INN Flu Vaccine Seasonal and events. This report was not serious.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal discomfort, Abdominal pain upper, Dizziness, Emotional distress, Influenza like illness
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other Non-health professional via regulatory authority (VAERS ID: 674057) and concerns a 66 years old male patient. Administration of Company suspect drug: On 27-Oct-2016, patient was administered with INN Flu Vaccine (dosage, route of administration, anatomical location: unknown). Adverse reactions/events and outcomes: On 28-Oct-2016 after administration of INN Flu Vaccine, the patient experienced flu like symptoms, dizziness, nausea, losing control, Intestinal distress, Congestion, Stomach pain that has lasted for 2 months. Outcome of the events were not recovered/not resolved. Reporter's Assessment: The reporter assessed the events as non-serious and the causality was not provided. This report was not serious.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea, Respiratory tract congestion
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other Non-health professional via regulatory authority (VAERS ID: 674057) and concerns a 66 years old male patient. Administration of Company suspect drug: On 27-Oct-2016, patient was administered with INN Flu Vaccine (dosage, route of administration, anatomical location: unknown). Adverse reactions/events and outcomes: On 28-Oct-2016 after administration of INN Flu Vaccine, the patient experienced flu like symptoms, dizziness, nausea, losing control, Intestinal distress, Congestion, Stomach pain that has lasted for 2 months. Outcome of the events were not recovered/not resolved. Reporter's Assessment: The reporter assessed the events as non-serious and the causality was not provided. This report was not serious.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Asthenia, Cold sweat, Dizziness, Influenza like illness
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, was reported by a physician via regulatory authority (vaccine adverse event reporting system: 674058) and concerns a 65-years-old female patient. Administration of Company suspect drug: On 27-Oct-2016, the patient was administered with influenza virus vaccine polyvalent, dosage, batch number, route of administration: not reported). Adverse reactions/events and outcomes: On 28-Oct-2016, the patient experienced Flu like symptoms, Intestinal distress, weakness, feeling of light headed dizziness, cold sweat. 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: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by an other-non health professional via regulatory authority (VAERS ID: 674260) and concerns a 50 years old female patient. At the time of vaccination the patient had rheumatoid arthritis since an unspecified date. Concomitant medication included MTX (Methotrexate) for rheumatoid arthritis. Administration of Company suspect drug: On 16-Dec-2016, patient was administered with INN Flu Vaccine Seasonal (dosage, route of administration, anatomical location: Unknown). Administration of non-company suspect drug: On 16-Dec-2016, patient was administered with PNEUMOVAX (dosage, route of administration, anatomical location: Unknown). Adverse reactions/events and outcomes: On 17-Dec-2016, the patient experienced erythema, induration and tenderness right deltoid. Action taken with the suspect product was not reported. Outcome of the events were not recovered/ not resolved. Reporter's Assessment: The other-non health professional did not provided the causality. This report is not serious.
Age: 33.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2016US024428, is an initial spontaneous report received from a pharmacist on 20 Sep 2016. This report refers to a 33 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUAD (batch number: 165803) at a dose of 0.5 ml intramuscularly on 19 Sep 2016, when he was at the age of 33 years old. The pharmacist did not realized until after administration that the labeling was for persons 65 years and older. No adverse event was reported following this administration error. Follow up received on 12-Apr-2017: updated event no adverse event. VAERS ID.
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Case PHEH2016US025479, is an initial spontaneous report received from a pharmacist on 30 Sep 2016. This is also a quality complaint report (QA reference number: 1017148). This report refers to a patient of an unknown age and gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUAD (batch number: 165902, expiry date: 30 Apr 2017) on 27 Sep 2016. The pharmacist stated that, she administered FLUAD to a patient and during the administration of the product, she noticed that part of the vaccine leaked out from between the needle and syringe. Patient did not receive a full dose. Also the patient (reported as customer) did not think the needle was tight. No adverse event was reported following this maladministration (underdose and syringe issue). Batch review report reference number [1017148] received from quality assurance department on 22 Nov 2016. Based on the document review, it was stated that the concerned FLUAD batch number [165902] was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from Quality assurance department (QA reference number: 1017148) on 22 Nov 2016: Added QA investigation summary. Follow up received from VAERS on 12-Apr-2017: Updated VAERS (Vaccine Adverse Event Reporting System) ID.
Age: 62.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2016US025981 is a spontaneous report initially received from a healthcare professional on 05 Oct 2016. This report refers to a 62 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with single dose of FLUAD (batch number: 165803) at the age of 60 years (patient under age 65) at a dose of 0.5 ml intramuscularly on 28 Sep 2016. On 28-Sep-2016, the patient was administered with seasonal influenza vaccine (Inappropriate age at vaccine administration) considered as medication error. Action taken with the influenza vaccine was not reported. Outcome of the events was unknown. Reporters assessment: The pharmacist did not provide any causality assessment. This report is not serious. Non significant information received from a healthcare professional on 05 Oct 2016: Updated reporter information. Follow up report received on 12-Apr-2017: Report sent to regulatory authority and intermediary updated for primary and secondary reporter, VAERS ID: 674292 was added, administered by and purchased by were updated. No adverse event was added as an event. Outcome updated as not reported. Listedness assessment updated as per relevant data sheets for no adverse event.
Age: 65.0
Sex: M
Vaccine: FLUA3
Symptoms: Chills, Pyrexia
Clinical narrative: Case PHEH2016US025988 is an initial spontaneous report received from nurse on 05 Oct 2016. This report refers to a 65 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with single dose of FLUAD (batch number: 166002) at a dose of 0.5 ml into deltoid on 29 Sep 2016. On the same day, the patient experienced fever and hard chills after vaccination at evening (night). On 30 Sep 2016, the patients were completely recovered on next morning. The outcome of events was completely recovered on 30 Sep 2016. The seriousness of the events was reported as non serious. The causality of events were not reported. Follow up report received from nurse on 03 Nov 2016: Patient detail updated (age), event details (onset and recovery date, seriousness) updated and updated narrative accordingly. Follow up received on 12-Apr-2017: updated VAERS ID.
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain
Clinical narrative: Case number PHEH2016US026564, is an initial spontaneous report received from a consumer on 11 Oct 2016. This report refers to a 75 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUAD (batch number: 166001) at a dose of 0.5 ml intramuscularly in left arm on 06 Sep 2016. On the same of day vaccination, patient experienced sore in upper left arm. It was reported that, patient received FLUAD about 3 weeks ago her arm still bothered her where the injection was given. Symptoms began since day of administration and continued till the day of report. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event was not reported. Follow up received from VAERS on 12-Apr-2017: Updated vaccine adverse event reporting system (VAERS) ID.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Case number PHEH2016US026693, is an initial spontaneous report received from a consumer on 12 Oct 2016. This report refers to an unknown age of female patient. Past medical history was not reported. Current condition included as immune issues. Concomitant medications was not reported. She was vaccinated with influenza vaccine (unknown whether seasonal or pandemic, manufacturer and batch number: not reported) on an unknown date. On an unspecified date, the patient experienced sick every year. The outcome of the event was reported as unknown. Seriousness and causality of the event were not reported. Follow up received on 12-Apr-2017: VAERS ID was updated.
Sex: U
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Syringe issue, Underdose
Clinical narrative: Case number PHEH2016US028241, is a spontaneous report initially received from a pharmacist on 24 Oct 2016 (combined report). This is also a quality complaint report (QA reference number: 1017508). This report refers to a patient of an unknown age and gender. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUAD (batch number: 166002, expiry date: Apr 2017) on an unknown date. The pharmacist stated that, while administering the FLUAD vaccine to the patient, she noticed that the vaccine squirted out on the pants of the patient and did not know from where exactly the product leaked. The needle was placed in the sharp containers. It was also reported that, the patient received partial dose. No adverse event was reported following this maladministration. Upon follow up, the pharmacist reported that, the patient was hesitant to receive a high dose flu shot and was not interested in revaccination as she got a partial dose. There were no adverse effects. They had inquired to determine if they could continue to use the batch as this was the first dose out of it. Batch review report reference number [1017508] received from quality assurance department on 13 Dec 2016. Based on the document review, it was stated that the concerned FLUAD batch number [166002] was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information was received from a pharmacist on 06 Dec 2016 and on 06 Dec 2016 (combined report): Reporter comments were updated. Follow up information received from Quality assurance department (QA reference number: 1017508) on 13 Dec 2016: Added QA investigation summary. Follow up received on 12-Apr-2017: VAERS ID and event No adverse event were updated.
Age: 71.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: This Spontaneous case, initially received on 12-APR-2017 was reported by an other non health professional via Health Authority (VAERS number: 674399) and concerns a 71 years old female patient. Administration of Company suspect drug(s): On 08-Dec-2016, the patient received intramuscular FLUAD (TIV) of batch number: 166002 was for unknown indication at left arm. Non-company suspect drug(s): On 08-Dec-2016, the patient also received intramuscular PREVNAR 13 (Pfizer/Wyeth) batch number: N97936 at left arm. Adverse reactions/events and outcomes: On 08-Dec-2016 after the administration of FLUAD (TIV), the patient experienced, injection site reaction, redness, swelling, soreness in (L) arm (characterised as injection site erythema, injection site pain injection site swelling and injection site pain) (Seriousness criteria: Non-Serious event), (Outcome - Recovered/Resolved). The events, injection site reaction, redness, swelling, soreness in left arm were resolved on an unspecified date. The other non health care professional reported the events injection site reaction, redness, swelling and soreness in L arm. Reporter's Assessment: The Health Authority assessed the events as non-serious and the causality was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Influenza like illness, Influenza virus test negative, Nasal congestion
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 was reported by other non-health professional via Vaccine Adverse Event Reporting System (VAERS ID: 674532) and concerns a 62 years old female patient. The patient's current condition included high cholesterol. The concomitant medication was not reported. Administration of Company suspect drug: On an unspecified date, the patient received INN Flu Vaccine Seasonal (dose, batch no, expiry date and route of administration: not reported). Non-company suspect drug: On an unspecified date, the patient received study medication (Alirocumab, dose, batch no, expiry date, route of administration: not reported) injects q2weeks for over a year ago. Adverse reactions/events and outcomes: On 07-Dec-2016, the patient started experienced mild flu or flu-like symptoms which became full blown on Friday 09-Dec-2016 and it was reported as the patient said she had to go to the hospital for a morphine shot on Friday 09-Dec-2016 and 11-Dec-2016 and the patient told that the physician in the hospital said that the tests for the flu were negative, and the patient got her flus shot 6 weeks ago and it was reported as the patient had nasal congestion since she started the study medication but she could tolerate it and she was advised to contact her healthcare provider about her symptoms. The patient's any other lab tests and corrective treatment was not reported. Action taken with the vaccine was not reported. The outcome of the event was unknown. Reporter's Assessment: The reporter did not provide causality assessment of the events in relation to the INN Flu Vaccine Seasonal. This case was non-serious.
Age: 40.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Blood test, Exostosis
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 00:00:00 was reported by other non-health professional through FDA VAERS ID: 674691 and concerns a 40 years old male patient. The patient's concomitant medication included Ibuprofen. Administration of company suspect drug(s): On 12-Dec-2016, INN Flu Vaccine Seasonal was administered for indication not reported (intramuscular, unknown dosage, unknown duration, batch number: Not reported). Adverse reactions/events and outcomes: On 12-Dec-2016, the patient was administered with INN Flu Vaccine Seasonal. On 13-Dec-2016, the patient felt new symptoms. The patient was having random soreness and severe pain in other parts of my feet, legs, hips, lower torso (stomach muscles), back and arms. Pain is worse at night. The patient was also experiencing night sweats. The patient has undergone blood test and X-ray was done. It was determined that the patient was having small bone spurs in the heels. Action taken was not reported. Outcome for the events back pain, arthralgia, abdominal pain upper, pain in extremity, night sweats, exostosis was not recovered. The Health Authority considered the case as non-serious and the causality was not reported.
Age: 40.0
Sex: M
Vaccine: FLUX
Symptoms: Night sweats, Pain in extremity, X-ray limb abnormal
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 00:00:00 was reported by other non-health professional through FDA VAERS ID: 674691 and concerns a 40 years old male patient. The patient's concomitant medication included Ibuprofen. Administration of company suspect drug(s): On 12-Dec-2016, INN Flu Vaccine Seasonal was administered for indication not reported (intramuscular, unknown dosage, unknown duration, batch number: Not reported). Adverse reactions/events and outcomes: On 12-Dec-2016, the patient was administered with INN Flu Vaccine Seasonal. On 13-Dec-2016, the patient felt new symptoms. The patient was having random soreness and severe pain in other parts of my feet, legs, hips, lower torso (stomach muscles), back and arms. Pain is worse at night. The patient was also experiencing night sweats. The patient has undergone blood test and X-ray was done. It was determined that the patient was having small bone spurs in the heels. Action taken was not reported. Outcome for the events back pain, arthralgia, abdominal pain upper, pain in extremity, night sweats, exostosis was not recovered. The Health Authority considered the case as non-serious and the causality was not reported.
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This spontaneous case, initially received on 12-APR-2017 was reported by an other non health professional via Health Authority (FDA VAERS number: 674714) and concerns a 73 years old male patient. The patient's medical history Included: blood pressure high. Administration of Company suspect drug(s): On 29-Sep-2016, the patient received INN Flu Vaccine (dose, route and batch number: not reported). Indication was not reported. Adverse reactions/events and outcomes: On 30-Sep-2016 after administration of INN Flu Vaccine, the patient experienced numbness and tingling of left arm from shoulder down to wrist on the back. Action taken with INN flu vaccine was not reported. Outcome for events was not recovered. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine and events. Company assessed the causality between INN flu vaccine and event as related. This report was not serious.
Sex: F
Vaccine: FLUX
Symptoms: Administration site pain, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other Non-health professional Health Authority (VAERS ID: 674717) and concerns a 46 years old female patient. Patient's concomitant medication included: ARMOR THYROID. Administration of Company suspect drug: On 26-Oct-2016, patient was administered with INN Flu Vaccine Seasonal (dosage, route of administration, anatomical location: unknown). Adverse reactions/events and outcomes: On 26-dec-2016 after administration of INN Flu Vaccine Seasonal, the patient experienced sharp pain at the administration site that made her fingers pain feel. The pain was ongoing at the site of the needle injections. The patient could not lift her arm as it hurts and could not press on the spot where the needle punctured. Pain persists when the patient moves her arm to lift or lay on that side in the bed. It also hurts while changing shirt. Outcome of the events was not recovered / Not resolved. Reporter's Assessment: The Health Authority assessed the events as Non-serious. The reporter did not provide the causality of the events. This report is not serious.
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Erythema, Hypersensitivity, Influenza, Malaise
Clinical narrative: This Spontaneous case, initially received via vaccine adverse event reaction system (VAERS ID: 674859) on 12-Apr-2017, was reported by other non-health professional and concerns a 76-year-old female patient. Administration of Company suspect drug: On an unspecified date, the patient was administered by influenza virus vaccine polyvalent, (anatomical location, route of administration, dose, batch number, expiration date: not reported) for an unknown indication. Adverse events/reactions and outcomes: On 22-Nov-16, within 4 days of vaccination of INN Flu Vaccine Seasonal, the patient was down and out, sick for two weeks, had flu with fever, vomiting, coughing, cheeks were bright red. On an unspecified date, after vaccination of INN Flu Vaccine Seasonal, the patient had sinus congestion and pain, had allergy, sinuses blew up and received double dose. Treatment medication: The patient's treatment drugs included ADVIL CONGESTION RELIEF from 21-Nov-17 to 22-Nov-17, ibuprofen (200 mg) as corrective medication three shots of Cortisone, pain shot and antibiotic shot. On an unspecified date, the sinuses were so bad and received three shots one day before received two shots of ADVIL. The action taken with INN Flu Vaccine Seasonal was not reported. The outcome of the events was recovering/resolving. Reporter's Assessment: The reporter did not provide the causality between INN Flu Vaccine Seasonal and events. This report was not serious.