chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility 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.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Malaise
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reporting systems (VAERS ID: 683547) on May-2017, was reported by other non-healthcare professional and concerns a male patient of an unspecified age. Administration of Company suspect drug: On an unspecified date, the patient was administered with influenza virus  vaccine polyvalent, route of administration: injection, dose, anatomical location, batch number, expiration date: not reported). Indication was not reported. Adverse events/reactions and outcomes: On an unspecified date, after administration of influenza virus vaccine polyvalent, the patient was sick more times in about eight months or so than he normally gets in two years. Action taken with influenza virus vaccine polyvalent was not reported. The outcome of the event was not reported. Reporter's Assessment: The reporter did not provide causality between influenza virus vaccine polyvalent and event. This case report was non serious.
Age: 60.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: This spontaneous case, initially received on 05-May-2017 was reported by a other non-health professional (through FDA VAERS ID: 683573) and concerns 60-years old female patient. The patient's medication history included: CLL (Chronic lymphocytic leukaemia). At the time of the event the patient had pneumonia (hospitalized for pneumonia 22-Oct-2016 to 25-Oct-2016). Administration of Company suspect vaccine: On 25-Oct-2016, INN Flu Vaccine Seasonal was administered (Dosage: 1DF, route of administration: intramuscular, anatomical site: left arm, batch number: not reported). Adverse reactions/events and outcomes: On 25-Oct-2016 after administration of INN Flu Vaccine Seasonal, the patient's upper left arm muscle where the flu shot was administered was aching ever since, with a gnawing pain and have limited movement and use of the left arm because of the pain. If the patient try to use his left arm, the pain increased in its intensity and therefore have to avoid using, moving it, or event laying on it. Reporter's Assessment: The reporter assessed the events as non-serious. The causality between the events and vaccine was not reported. This case was non serious.
Age: 60.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous case, initially received on 05-May-2017 was reported by a other non-health professional (through FDA VAERS ID: 683573) and concerns 60-years old female patient. The patient's medication history included: CLL (Chronic lymphocytic leukaemia). At the time of the event the patient had pneumonia (hospitalized for pneumonia 22-Oct-2016 to 25-Oct-2016). Administration of Company suspect vaccine: On 25-Oct-2016, INN Flu Vaccine Seasonal was administered (Dosage: 1DF, route of administration: intramuscular, anatomical site: left arm, batch number: not reported). Adverse reactions/events and outcomes: On 25-Oct-2016 after administration of INN Flu Vaccine Seasonal, the patient's upper left arm muscle where the flu shot was administered was aching ever since, with a gnawing pain and have limited movement and use of the left arm because of the pain. If the patient try to use his left arm, the pain increased in its intensity and therefore have to avoid using, moving it, or event laying on it. Reporter's Assessment: The reporter assessed the events as non-serious. The causality between the events and vaccine was not reported. This case was non serious.
Age: 35.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Abdominal pain upper, Dyspepsia, Headache, Sinusitis
Clinical narrative: This spontaneous case, initially received on 05-May-2017, was reported by a other non-health professional (through FDA VAERS ID: 683697) and concerns 35-years-old male patient. Administration of Company suspect drug: On 08-Nov-2016, the patient was administered with influenza virus vaccine polyvalent, dosage, route of administration, batch number: not reported, anatomical location: left arm. Adverse reactions/events and outcomes: On 10-Nov-2016, after administration of INN flu vaccine seasonal, the patient had headache for 2 weeks. The patient also experienced heartburn and stomach pain, sinusitis which were still ongoing. Action taken was not reported. Outcome of the events was not recovered. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and events. This report was not serious.
Age: 71.0
Sex: F
Vaccine: FLUA3, PNC13, FLUA3, PNC13
Symptoms: Rash
Clinical narrative: This spontaneous case, initially received on 05-May-2017 was reported by a other non-health professional via health authority (VAERS ID: 683762) and concerns a 71-years-old elderly female patient. Administration of Company suspect drug: On 19-Jan-2017, the patient received FLUAD batch number: 165801, dose, dose number, expiry date: not reported at right arm via intramuscular route. Non-company suspect drug: On 19-Jan-2017, the patient also received PREVNAR 13 batch number: M88543, dose, dose number, expiry date: not reported at right arm via intramuscular route. Adverse reactions/events and outcomes: On 19-Jan-2017 after administration of influenza vaccine and pneumococcal vaccine, the patient experienced rash on neck and chest. Action taken with the suspect vaccine was not reported. The outcome of the event was recovered. Reporter's Assessment: The reporter did not provide the causality of the event in relation to the influenza vaccine. This case was non-serious.
Age: 73.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Rash
Clinical narrative: This spontaneous case, initially received on 05-May-2017, was reported by other non-health professional via health authority (VAERS ID: 683785) and concerns a 73-years-old elderly male patient. Administration of Company suspect drug: On 12-Jan-2017, the patient received influenza vaccine, dose, dose number, batch number, expiry date and anatomical location: not reported, route of administration: intramuscular route. Adverse reactions/events and outcomes: On 12-Jan-2017, after administration of INN flu vaccine seasonal, the patient developed a rash. Action taken with suspect vaccine was not reported. Outcome of the event was not reported. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and events. This case was not serious.
Age: 47.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injection site erythema, Myalgia, Pyrexia, Vaccination 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: 683875) and concerns a 47-years-old adult female patient. Medical history Included: Diabetes, hypercholesterolemia, depression. Concomitant medications included: Atorvastatin, TANZEUM, hydrochlorothiazide, clonidine, bupropion, trazodone and LANTUS. Administration of Company suspect drug: On 22-Feb-2017, the patient was administered with influenza virus vaccine polyvalent, via intramuscular route, dosage, batch number not reported, anatomical location: gluteus). Non-company suspect drug: On 22-Feb-2017, the patient was administered with PNEUMOVAX (via intramuscular, batch number: M037669, anatomical location: left arm). Adverse reactions/events and outcomes: On 23-Feb-2017, the patient experienced fever of 102.6, redness, swelling of local vaccination area and muscle aches. Action taken with the INN flu vaccine seasonal was not reported. 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: 0.5
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pyrexia
Clinical narrative: This spontaneous case, initially received on 05-May-2017, which was reported by other Non-health professional via regulatory authority (VAERS ID: 683887) and concerns a female patient of age 0.50 (unspecified units). Administration of Company suspect drug: On 24-Feb-2017, patient was administered influenza virus vaccine polyvalent (dosage, route of administration, anatomical location: unknown). Adverse reactions/events and outcomes: On unspecified date after administration of INN Flu Vaccine Seasonal, the patient experienced fever 101.3 for past 2 days since vaccine. Action taken with the suspect product was not reported. Outcome of the event was not reported. Reporter's Assessment: The reporter assessed the events as non-serious and the causality was not provided. This report was not serious. Significant case correction received on 17-May-2017: As determined causality of the event was corrected from unassessable to related and listedness was corrected.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous case, initially received on 05-May-2017, was reported by a physician via regulatory authority (vaccine adverse event reporting system: 683939) and concerns a female patient of unspecified age. Administration of Company suspect drug: On unspecified date, the patient was administered with influenza virus vaccine polyvalent, dosage, batch number, route of administration: not reported. Adverse reactions/events and outcomes: On unspecified date, after administration of influenza vaccine, the patient experienced allergy to vaccine. Action taken with the INN flu vaccine seasonal was not reported. Outcome of the event was not reported. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and event. This report was not serious. Significant case correction received on 17-May-2017: As determined causality of the event allergy to vaccine was corrected from related to unassessable.
Age: 21.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site infection, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other Non-health professional via regulatory authority (VAERS ID: 684062) and concerns a 21-years-old female patient. Patient's medical history Included: Gluten, nuts, pollen, Quinoa, barley allergy and Hashimoto's thyroiditis, Narcolepsy, Cataplexy, GERD, Immunoglobulin M low. Patient's concomitant medication included: ARMOUR THYROID; NUVIGIL, ORTHO-TRICYCLEN, PEPCID, Ferrous sulfate, 5-HTP, Vitamin D, Vitamin B-12 and selenium. On 14-Feb-2017, patient was administered with influenza vaccine, route of administration: injection, dose number: 8, anatomical location: right arm, dose, batch number, expiry date: not reported). On 14-Feb-2017, patient was administered with pneumococcal vaccine (dose: 1 DF, route of administration: left arm, anatomical location, batch number, expiry date: not reported). On 15-Feb-2017, the patient experienced tingling in legs, muscle ache and stiffness, fever, left upper arm around injection site. It was reported that for pneumococcal 23 was swollen, 3-inch red raised rash was developed, skin was warm and infection was developed. Cephalexin 500mg twice a day was prescribed for 7 days. Treatment medications: Cephalexin 500 mg twice a day. Outcome of the events was recovered. The reporter assessed the events as non-serious and the causality was not provided. The report was non-serious. Case correction received on 17-May-2017: Causality and listedness of the events were corrected.
Age: 21.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Musculoskeletal stiffness, Myalgia, Paraesthesia, Pyrexia
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other Non-health professional via regulatory authority (VAERS ID: 684062) and concerns a 21-years-old female patient. Patient's medical history Included: Gluten, nuts, pollen, Quinoa, barley allergy and Hashimoto's thyroiditis, Narcolepsy, Cataplexy, GERD, Immunoglobulin M low. Patient's concomitant medication included: ARMOUR THYROID; NUVIGIL, ORTHO-TRICYCLEN, PEPCID, Ferrous sulfate, 5-HTP, Vitamin D, Vitamin B-12 and selenium. On 14-Feb-2017, patient was administered with influenza vaccine, route of administration: injection, dose number: 8, anatomical location: right arm, dose, batch number, expiry date: not reported). On 14-Feb-2017, patient was administered with pneumococcal vaccine (dose: 1 DF, route of administration: left arm, anatomical location, batch number, expiry date: not reported). On 15-Feb-2017, the patient experienced tingling in legs, muscle ache and stiffness, fever, left upper arm around injection site. It was reported that for pneumococcal 23 was swollen, 3-inch red raised rash was developed, skin was warm and infection was developed. Cephalexin 500mg twice a day was prescribed for 7 days. Treatment medications: Cephalexin 500 mg twice a day. Outcome of the events was recovered. The reporter assessed the events as non-serious and the causality was not provided. The report was non-serious. Case correction received on 17-May-2017: Causality and listedness of the events were corrected.
Age: 21.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injection site infection, Injection site reaction, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other Non-health professional via regulatory authority (VAERS ID: 684062) and concerns a 21-years-old female patient. Patient's medical history Included: Gluten, nuts, pollen, Quinoa, barley allergy and Hashimoto's thyroiditis, Narcolepsy, Cataplexy, GERD, Immunoglobulin M low. Patient's concomitant medication included: ARMOUR THYROID; NUVIGIL, ORTHO-TRICYCLEN, PEPCID, Ferrous sulfate, 5-HTP, Vitamin D, Vitamin B-12 and selenium. On 14-Feb-2017, patient was administered with influenza vaccine, route of administration: injection, dose number: 8, anatomical location: right arm, dose, batch number, expiry date: not reported). On 14-Feb-2017, patient was administered with pneumococcal vaccine (dose: 1 DF, route of administration: left arm, anatomical location, batch number, expiry date: not reported). On 15-Feb-2017, the patient experienced tingling in legs, muscle ache and stiffness, fever, left upper arm around injection site. It was reported that for pneumococcal 23 was swollen, 3-inch red raised rash was developed, skin was warm and infection was developed. Cephalexin 500mg twice a day was prescribed for 7 days. Treatment medications: Cephalexin 500 mg twice a day. Outcome of the events was recovered. The reporter assessed the events as non-serious and the causality was not provided. The report was non-serious. Case correction received on 17-May-2017: Causality and listedness of the events were corrected.
Age: 21.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Myalgia, Paraesthesia, Pyrexia, Rash erythematous
Clinical narrative: This spontaneous case, initially received on 12-Apr-2017, which was reported by other Non-health professional via regulatory authority (VAERS ID: 684062) and concerns a 21-years-old female patient. Patient's medical history Included: Gluten, nuts, pollen, Quinoa, barley allergy and Hashimoto's thyroiditis, Narcolepsy, Cataplexy, GERD, Immunoglobulin M low. Patient's concomitant medication included: ARMOUR THYROID; NUVIGIL, ORTHO-TRICYCLEN, PEPCID, Ferrous sulfate, 5-HTP, Vitamin D, Vitamin B-12 and selenium. On 14-Feb-2017, patient was administered with influenza vaccine, route of administration: injection, dose number: 8, anatomical location: right arm, dose, batch number, expiry date: not reported). On 14-Feb-2017, patient was administered with pneumococcal vaccine (dose: 1 DF, route of administration: left arm, anatomical location, batch number, expiry date: not reported). On 15-Feb-2017, the patient experienced tingling in legs, muscle ache and stiffness, fever, left upper arm around injection site. It was reported that for pneumococcal 23 was swollen, 3-inch red raised rash was developed, skin was warm and infection was developed. Cephalexin 500mg twice a day was prescribed for 7 days. Treatment medications: Cephalexin 500 mg twice a day. Outcome of the events was recovered. The reporter assessed the events as non-serious and the causality was not provided. The report was non-serious. Case correction received on 17-May-2017: Causality and listedness of the events were corrected.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pruritus, Urticaria
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: 684092) and concerns a 63 years old female patient. Patient had no known drug allergies. Administration of company suspect drug: On 25-Jan-2017, 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 27-Jan-2017, patient experienced urticaria and pruritus. Patient was treated with diphenhydramine, sulfamethizole and trimethoprim for adverse events. Action taken with the influenza vaccine was not reported. Outcome of the events were recovered/resolved on an unspecified date. Reporter's Assessment: The other-non health professional did not provide any causality assessment. The case was non-serious.
Age: 66.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Rash
Clinical narrative: This spontaneous case, initially received on 05-May-2017 was reported by other non-health Professional (through FDA VAERS ID: 684093) and concerns 66-Years old male patient. Administration of Company suspect drug (s): On 29-Sep-2016, INN Flu Vaccine Seasonal was administered (unknown dosage, route of administration: unknown, anatomical site: unknown, batch number: not reported). Non-company suspect drug (s): On 29-Sep-2016, Pneumococcal vaccine polyvalent was administered (unknown dosage, route of administration: unknown, anatomical site: unknown, batch number: not reported). Adverse reactions/events and outcomes: On 29-Sep-2016, after administration of INN Flu Vaccine Seasonal, Pneumococcal vaccine polyvalent, the patient experienced rash. Action taken was not reported. Outcome of the event rash is recovered. Reporter's Assessment: The reporter assessed the event rash as non-serious. The causality between the event and the vaccine is not reported.
Age: 65.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Allergy to vaccine, Drug hypersensitivity
Clinical narrative: This spontaneous case, initially received on 05-May-2017, which was reported by a Physician, healthcare professional via regulatory authority (VAERS ID: 684169) and concerns a 65-years-old female patient. The patient's medical history Included: drug allergy to cephalosporins. Patient's concomitant drugs included bacitracin, NEOSPORIN, ibuprofen, aspirin, BENADRYL, SUDAFED NON-DRYING SINUS, VERSED, SENOKOT all via unknown routes of administration and unknown dose. Indication was not reported. On an unspecified date, patient was administered with influenza virus vaccine polyvalent, dose: 1DF, route of administration, anatomical location, batch number: not reported. On an unspecified date, patient was administered with PREVNAR 13 (dose: 1 DF, route of administration, anatomical location, batch number: not reported). On unspecified date after administration of INN flu vaccine seasonal and PREVNAR 13, the patient experienced allergies to pneumococcal, ibuprofen, aspirin, bacitracin, influenza virus vaccine, SUDAFED NON-DRYING SINUS, NEOSPORIN, SENOKOT, VERSED and BENADRYL. Outcome of the events were not reported. The reporter did not provide the causality between influenza vaccine and events. This report was not serious. Case correction received on 17-May-2017: Causality for the event drug hypersensitivity was corrected from unassessable to not related.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Pyrexia
Clinical narrative: This spontaneous case, initially received on 05-MAY-2017 00:00:00 was reported by a other health professional via (FDA VAERS ID: 684173) and concerns a patient of unknown age and gender. Administration of Company suspect drug(s): On an unspecified date (reported as 2005-2006), INN Flu Vaccine Seasonal was administered (dosage, route of administration, anatomical site, batch number, expiration date: not reported). Adverse reactions/events and outcomes: On unspecified date, after administration of INN Flu Vaccine Seasonal, the patient had experienced high fever (type of reaction: allergic) and was hospitalised. Lab data and corrective treatment was not reported. Action taken was not reported. The event outcome was not reported. Reporter's Assessment: The causality between the event and the vaccine was not reported. This case was serious (hospitalisation).
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Hypersensitivity, Pyrexia
Clinical narrative: This spontaneous case, initially received on 05-MAY-2017 00:00:00 was reported by a other health professional via (FDA VAERS ID: 684173) and concerns a patient of unknown age and gender. Administration of Company suspect drug(s): On an unspecified date (reported as 2005-2006), INN Flu Vaccine Seasonal was administered (dosage, route of administration, anatomical site, batch number, expiration date: not reported). Adverse reactions/events and outcomes: On unspecified date, after administration of INN Flu Vaccine Seasonal, the patient had experienced high fever (type of reaction: allergic) and was hospitalised. Lab data and corrective treatment was not reported. Action taken was not reported. The event outcome was not reported. Reporter's Assessment: The causality between the event and the vaccine was not reported. This case was serious (hospitalisation).
Age: 14.0
Sex: F
Vaccine: FLUX, HPV9, FLUX, HPV9
Symptoms: Dehydration, Dizziness, Headache, Lethargy, Lymphadenopathy
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: 684181) and concerns a 14-years-old adolescent female patient. On 04-Jan-2017, the patient was administered with influenza virus vaccine polyvalent, dosage, batch number, route of administration: not reported). On 04-Jan-2017, the patient was administered with GARDASIL 9 (dosage, batch number, route of administration: not reported). On the same day after administration the patient experienced lethargy, nausea, muscle spasm, continual headache, dehydration, felt faint at time of injection, fever, swollen glands, leg pain, aching muscles, dizziness. The outcome of the events was recovering. The reporter did not provide the causality between INN flu vaccine seasonal and events. This report was not serious. Significant case correction was received on 17-May-2017: Event swelling face was removed and the company causality was changed to related for the events headache, myalgia, pyrexia, nausea, lethargy and muscle spasm.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV9, FLUX, HPV9
Symptoms: Muscle spasms, Myalgia, Nausea, Pain in extremity, Pyrexia
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: 684181) and concerns a 14-years-old adolescent female patient. On 04-Jan-2017, the patient was administered with influenza virus vaccine polyvalent, dosage, batch number, route of administration: not reported). On 04-Jan-2017, the patient was administered with GARDASIL 9 (dosage, batch number, route of administration: not reported). On the same day after administration the patient experienced lethargy, nausea, muscle spasm, continual headache, dehydration, felt faint at time of injection, fever, swollen glands, leg pain, aching muscles, dizziness. The outcome of the events was recovering. The reporter did not provide the causality between INN flu vaccine seasonal and events. This report was not serious. Significant case correction was received on 17-May-2017: Event swelling face was removed and the company causality was changed to related for the events headache, myalgia, pyrexia, nausea, lethargy and muscle spasm.
Age: 65.0
Sex: F
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Chills, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reporting systems (VAERS ID: 684209) on MAY-2017 was reported by a other non health professional concerns a 65 years old female patient. At the time of the event the patient had hypertension. Administration of Company suspect drug: On 27-Jan-2017, the patient received influenza virus vaccine polyvalent (dose-1DF, route of administration, anatomical site, batch number, expiration date: not reported) on right arm. Non-company suspect drug: On 27-Jan-2017, the patient received PREVNAR 13 (dose- 0.5 ml, anatomical site-left deltoid, batch number-S15227, expiration date-01-Feb-2018). Adverse reactions/events and outcomes: On an unspecified date after immunisation the patient experienced fever, chills and swelling at the injection site. Action taken with influenza vaccine was not reported. The outcome of the event was unknown. Reporter's Assessment: The reporter assessed the events as non serious and the causality for the events was related. The case was non serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received via vaccine adverse event reporting systems (VAERS ID: 684216) on May-2017, was reported by other non-health professional and concerns a 64-years-old female patient. Administration of Company suspect drug: On 20-Oct-2016, the patient received influenza virus vaccine polyvalent, dose, route of administration, batch number, expiration date: not reported and anatomical location: left arm). Adverse reactions/events and outcomes: On 22-Oct-2016, after administration of INN flu vaccine seasonal, the patient experienced moderate pain from elbow to shoulder and slight pain from elbow to wrist. No treatment was taken. Action taken with INN flu vaccine seasonal was not reported. Outcome of the event was not recovered. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and events. This case was not serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case, initially received via vaccine adverse event reporting systems (VAERS ID: 684216) on May-2017, was reported by other non-health professional and concerns a 64-years-old female patient. Administration of Company suspect drug: On 20-Oct-2016, the patient received influenza virus vaccine polyvalent, dose, route of administration, batch number, expiration date: not reported and anatomical location: left arm). Adverse reactions/events and outcomes: On 22-Oct-2016, after administration of INN flu vaccine seasonal, the patient experienced moderate pain from elbow to shoulder and slight pain from elbow to wrist. No treatment was taken. Action taken with INN flu vaccine seasonal was not reported. Outcome of the event was not recovered. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and events. This case was not serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Asthma, Chest discomfort, Chest pain, Condition aggravated, Fatigue
Clinical narrative: This Spontaneous case, initially received via Health Authority (VAERS ID: 684252) on 05-May-2017 was reported by other non-healthcare professional and concerns a 66-years-old elderly female patient. The patient's medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions included numerous allergies with antibiotics, birth defects, seasonal allergies, cats, dogs, shellfish, pollen, trees allergies and bronchial asthma. Administration of Company suspect drug: On an unspecified date in 2009, the patient was administered with INN Flu Vaccine Seasonal, (dose, route of administration, batch number, expiration date: not reported). Illness at the time of vaccination were none. Adverse events/reactions and outcomes: On an unspecified date in 2009, after administered with INN Flu Vaccine Seasonal, the patient experienced symptoms flu, worsening of bronchial asthma, chest pressure and pain. Patient felt tired for 2 years following vaccination. The action taken with INN Flu Vaccine Seasonal was not reported. The outcome of the events was reported as recovered/resolved. It was reported that after two years symptoms gradually improved and for last couple years patient had no symptoms. Reporter's Assessment: The report did not provide the causality between INN Flu Vaccine Seasonal and events. The seriousness of the event influenza was upgraded to serious (medically significant) as per IME list. This case report was serious (medically significant).
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza
Clinical narrative: This Spontaneous case, initially received via Health Authority (VAERS ID: 684252) on 05-May-2017 was reported by other non-healthcare professional and concerns a 66-years-old elderly female patient. The patient's medical history was reported that pre-existing physician diagnosed allergies, birth defects, medical conditions included numerous allergies with antibiotics, birth defects, seasonal allergies, cats, dogs, shellfish, pollen, trees allergies and bronchial asthma. Administration of Company suspect drug: On an unspecified date in 2009, the patient was administered with INN Flu Vaccine Seasonal, (dose, route of administration, batch number, expiration date: not reported). Illness at the time of vaccination were none. Adverse events/reactions and outcomes: On an unspecified date in 2009, after administered with INN Flu Vaccine Seasonal, the patient experienced symptoms flu, worsening of bronchial asthma, chest pressure and pain. Patient felt tired for 2 years following vaccination. The action taken with INN Flu Vaccine Seasonal was not reported. The outcome of the events was reported as recovered/resolved. It was reported that after two years symptoms gradually improved and for last couple years patient had no symptoms. Reporter's Assessment: The report did not provide the causality between INN Flu Vaccine Seasonal and events. The seriousness of the event influenza was upgraded to serious (medically significant) as per IME list. This case report was serious (medically significant).
Age: 30.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Pain
Clinical narrative: This Spontaneous case, initially received via Vaccine adverse event reporting systems (VAERS ID: 684690) on May-2017 was reported by other non-healthcare professional and concerns a 30-year-old female patient. Administration of Company suspect drug: On 15-Dec-2016, the patient was administered with influenza virus vaccine polyvalent), (route of administration: injection, anatomical location: arm, dose, batch number, expiration date: not reported). Indication was not reported. Adverse events/reactions and outcomes: On 18-Jan-2017, after administration of influenza virus vaccine polyvalent, the patient arm was still throbbing with pain in the same spot from where patient received the shot and every time patient moved my arm it hurt really bad, the pain is event in my shoulder now. It has been months and patient sill have pain. Treatment drugs: The patient's treatment included TB skin test on the same exact day. Action taken with influenza virus vaccine polyvalent was not reported. The outcome of the events was not recovered/not resolved. Reporter's Assessment: The reporter did not provide causality between influenza virus vaccine polyvalent and event. This case report was non serious.
Age: 30.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: This Spontaneous case, initially received via Vaccine adverse event reporting systems (VAERS ID: 684690) on May-2017 was reported by other non-healthcare professional and concerns a 30-year-old female patient. Administration of Company suspect drug: On 15-Dec-2016, the patient was administered with influenza virus vaccine polyvalent), (route of administration: injection, anatomical location: arm, dose, batch number, expiration date: not reported). Indication was not reported. Adverse events/reactions and outcomes: On 18-Jan-2017, after administration of influenza virus vaccine polyvalent, the patient arm was still throbbing with pain in the same spot from where patient received the shot and every time patient moved my arm it hurt really bad, the pain is event in my shoulder now. It has been months and patient sill have pain. Treatment drugs: The patient's treatment included TB skin test on the same exact day. Action taken with influenza virus vaccine polyvalent was not reported. The outcome of the events was not recovered/not resolved. Reporter's Assessment: The reporter did not provide causality between influenza virus vaccine polyvalent and event. This case report was non serious.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, FLUX, HEPA, HIBV, MMR, PPV, VARCEL, DTAPHEPBIP, FLUX, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Drug administered to patient of inappropriate age
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: 684828) and concerns a 3-years-old male patient. Administration of Company suspect drug: On 10-Oct-2016, the patient was administered with influenza virus vaccine polyvalent, dosage, batch number, route of administration, anatomical location: not reported). Non-company suspect drug: On 10-Oct-2016, the patient was administered with PEDIARIX, dosage, batch number, route of administration, anatomical location: not reported). On 10-Oct-2016, the patient was administered with ACTHIB (batch number: UI553AAA, route of administration, anatomical location: not reported). On 10-Oct-2016 the patient was administered with Hepatitis A, batch number, route of administration, anatomical location: not reported. On 10-Oct-2016 the patient was administered with Measles vaccine, Mumps vaccine, Rubella vaccine, batch number, route of administration, anatomical location: not reported). On 10-Oct-2016 the patient was administered with Pneumococcal vaccine, batch number, route of administration, anatomical location: not reported). On 10-Oct-2016 the patient was administered with Varicella vaccine, live, batch number, route of administration, anatomical location: not reported. Adverse reactions/events and outcomes: On 10-Oct-2016, the 3 years old patient was administered with vaccines. Action taken with INN flu vaccine seasonal was not reported. Outcome of the event was not reported. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and events. This case was not serious.
Age: 56.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Injection site pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome, X-ray
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reporting systems (VAERS ID: 684913) on May-2017 was reported by an other-non-health profession and concerns a 56-years-old female patient. The patient's medical history included Sjogren's syndrome, Hashimoto's disease, orthostatic tachycardia, peripheral neuropathy. The patient's concomitant medications included: SYNTHROID, NORTHERA, atenolol, NEURONTIN, MESTINON, PLAQUENIL, ZYRTEC. Administration of Company suspect drug: On 20-Dec-2016, the patient received influenza virus vaccine polyvalent (route of administration: injection, anatomical site: left arm, dose, batch number, expiration date: not reported). Indication not reported. Adverse reactions/events and outcomes: On 24-Dec-2016, the patient experienced developed severe pain at the injection site (left shoulder). On 31-Dec-2016 he consulted at urgent care and X-ray was taken. On 13-Jan-2017 he visited primary doctor and an orthopaedic doctor. He was prescribed with pain killers, anti-inflammatories and physical therapy (5 weeks). The patient stated that pain is still severe and limiting and had to visit emergency room. Later on 25-Feb-2017 nuclear magnetic resonance imaging was done and revealed that the patient had torn rotator cuff for which surgery was planned for 09-Mar-2017. Action taken with influenza vaccine was not reported. Outcome of the events were not recovered. Reporter's Assessment: The reporter considered the causality between influenza vaccine and events as related. This report was not serious.
Sex: M
Vaccine: FLU4, HPV9, FLUX, HPV9
Symptoms: Erythema, Skin warm
Clinical narrative: This spontaneous case initially received on 05-May-2017 was reported by other non-health professional via health authority (VAERS ID: 685055) and concerns a 12-years-old male adolescent patient. Administration of Company suspect drug: On 28-Feb-2017, the patient received INN Flu vaccine seasonal (dose number: 3, batch number: B00092, expiry date: not reported) at left arm via intramuscular route. Indication not reported. Non-company suspect drug: On 28-Feb-2017, the patient also received GARDASIL 9 (dose number: 2, batch number: N036059, expiry date: not reported) at left arm via intramuscular route. Indication not reported. Adverse reactions/events and outcomes: On 02-Mar-2017 after administration of INN Flu vaccine seasonal and human papilloma vaccine, the patient had 19 cm by 19 cm area of erythema on arm. On an unspecified date, the patient experienced warmth of area. The patient had not any trouble in breathing, swelling and redness. Relevant Test Results: On an unspecified date, the patient's body temperature was 36.5 degree celsius and blood pressure was 123/74. Treatment medications: The patient was prescribed with cetirizine 10 mg in (am) morning and BENADRYL 25 mg in night for 4 days for the events. Action taken with the suspect vaccine was not reported. The patient was recovered from the events. Reporter's Assessment: The reporter did not provide the causality of the events in relation to the INN Flu vaccine seasonal. This report was not serious.
Age: 28.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Chills, Confusional state, Headache, Joint range of motion decreased, Mobility decreased
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reporting systems (VAERS ID: 685145) on 05-May-2017 was reported by other non-healthcare professional and concerns a 28-year-old female patient. The patient's concomitant medication included Omeprazole. On 21-Feb-2016, the patient was administered with influenza virus vaccine polyvalent, (dose: 1 DF, route of administration: intramuscular, anatomical location: left arm, batch number, expiration date: not reported). Indication was not reported. On 21-Feb-2017, the patient was administered with Pneumococcal vaccine, (dose: 1 DF, route of administration: intramuscular, anatomical location: left arm, batch number, expiration date: not reported). Indication was not reported. On 21-Feb-2017, after administration of influenza virus vaccine polyvalent, the patient experienced body aches, chills, fever, headache at base of neck, confusion lasting for 4 days, unable to move arm for 5 days, extreme pain and lost full ROM (Range of Motion). INN flu vaccine seasonal and pneumococcal vaccine were administered to same arm. The outcome of the events was recovered/resolved. The outcome of the event drug administration error was not reported. The reporter assessed the causality between influenza virus vaccine polyvalent and event was not reported. This case report was non serious. Case corrections received on 17-May-2017: The listedness of the event chills was amended to listed. As determined causality of the events pain, chills, fever and headache was amended from unassessable to not related. The event INN flu vaccine seasonal and pneumococcal vaccine were administered to same arm was coded to drug administration error.
Age: 28.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reporting systems (VAERS ID: 685145) on 05-May-2017 was reported by other non-healthcare professional and concerns a 28-year-old female patient. The patient's concomitant medication included Omeprazole. On 21-Feb-2016, the patient was administered with influenza virus vaccine polyvalent, (dose: 1 DF, route of administration: intramuscular, anatomical location: left arm, batch number, expiration date: not reported). Indication was not reported. On 21-Feb-2017, the patient was administered with Pneumococcal vaccine, (dose: 1 DF, route of administration: intramuscular, anatomical location: left arm, batch number, expiration date: not reported). Indication was not reported. On 21-Feb-2017, after administration of influenza virus vaccine polyvalent, the patient experienced body aches, chills, fever, headache at base of neck, confusion lasting for 4 days, unable to move arm for 5 days, extreme pain and lost full ROM (Range of Motion). INN flu vaccine seasonal and pneumococcal vaccine were administered to same arm. The outcome of the events was recovered/resolved. The outcome of the event drug administration error was not reported. The reporter assessed the causality between influenza virus vaccine polyvalent and event was not reported. This case report was non serious. Case corrections received on 17-May-2017: The listedness of the event chills was amended to listed. As determined causality of the events pain, chills, fever and headache was amended from unassessable to not related. The event INN flu vaccine seasonal and pneumococcal vaccine were administered to same arm was coded to drug administration error.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Crying, Gait disturbance, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous case, initially received on 05-May-2017, was reported by other health care professional via regulatory authority (vaccine adverse event reporting system: 685301) and concerns a 5-years-old child male patient. Administration of Company suspect drug: On 11-Dec-2016 the patient was administered with influenza virus vaccine polyvalent, dosage, batch number, route of administration: not reported. Adverse reactions/events and outcomes: On the same day after the administration of the vaccine the patient experienced the entire thigh started to swell and heat up at the injection site, it swells up the point of pain and crying of the patient. Reporter took him to the walk in, where they said it could be an infection or an allergic reaction. They circled the swollen, red area, which was already the size of his entire thigh. The patient was made to rest and iced it. The next day swelling was bigger, he was limping, and pain was still there. The previous year when the patient took flu shot, same reaction occurred at the injection site of his arm which was considered as infection and took antibiotics. It was resolved in 4 days. This year same reaction occurred but at different injection site. It took about 5 days for the swelling, heat, and pain to clear up. They did try antibiotics this time also but, didn't help. The action taken with the INN flu vaccine seasonal was not reported. The outcome of the events was reported as recovered. 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: Injection site warmth
Clinical narrative: This spontaneous case, initially received on 05-May-2017, was reported by other health care professional via regulatory authority (vaccine adverse event reporting system: 685301) and concerns a 5-years-old child male patient. Administration of Company suspect drug: On 11-Dec-2016 the patient was administered with influenza virus vaccine polyvalent, dosage, batch number, route of administration: not reported. Adverse reactions/events and outcomes: On the same day after the administration of the vaccine the patient experienced the entire thigh started to swell and heat up at the injection site, it swells up the point of pain and crying of the patient. Reporter took him to the walk in, where they said it could be an infection or an allergic reaction. They circled the swollen, red area, which was already the size of his entire thigh. The patient was made to rest and iced it. The next day swelling was bigger, he was limping, and pain was still there. The previous year when the patient took flu shot, same reaction occurred at the injection site of his arm which was considered as infection and took antibiotics. It was resolved in 4 days. This year same reaction occurred but at different injection site. It took about 5 days for the swelling, heat, and pain to clear up. They did try antibiotics this time also but, didn't help. The action taken with the INN flu vaccine seasonal was not reported. The outcome of the events was reported as recovered. Reporter's Assessment: The reporter did not provide the causality between INN flu vaccine seasonal and events. This report was not serious.
Age: 60.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: This spontaneous case, initially received via Vaccine adverse event reporting systems (VAERS ID: 685312) on May-2017, was reported by other non-health professional and concerns a 60-years-old male patient. Administration of Company suspect drug: On 26-Sep-2016, the patient received influenza virus vaccine polyvalent, route of administration, anatomical site, dose, batch number, expiration date: not reported). Adverse reactions/events and outcomes: On 26-Sep-2016, after administration of INN flu vaccine seasonal, the patient experienced nausea, diarrhoea and vomiting. Action taken with INN flu vaccine seasonal was not reported. Outcome of the event 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.