chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Electroneurography, Fatigue, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 726923), concerns a 55-year-old, adult, female patient. The patient's current condition included diverticulosis (reported as medical history) (since an unspecified date). The patient's allergies were unknown. The concomitant medication included vitamin D for an unknown indication. On 06-Dec-2016, the patient was administered FLUVIRIN (dose: 0.5 ml, route of administration: injection [reported as SYR], batch number; 181527 [as reported], anatomical location unknown and expiry date: not reported). It was confirmed that, the reported batch number (181527), did not match Seqirus batch numbers (not a valid number), however, because the reporter named Seqirus product 'FLUVIRIN' as the suspect vaccine, this report had been conservatively entered as a Seqirus case. On 16-Dec-2016, 10 days after vaccination, the patient developed neurological symptoms which included weakness and tired feeling in arms and legs, tiredness in jaw muscles while chewing, stiffness in facial muscles, nerve pain in hands and legs, numbness in upper lip and nose for a brief period and sluggish tongue which led to biting of tongue. The patient had an office visit. On an unspecified date, nuclear magnetic resonance imaging (MRI), nerve conduction tests, electromyography and various blood tests were performed for which results were not reported. At the time of this report, the patient had not recovered from the events (intranasal hypoaesthesia, hypoaesthesia oral, stiffness muscle, tongue biting, tongue sluggish, muscle fatigue, weakness of limbs, neurological symptom, tiredness and nerve pain). The reporter assessed the case as non-serious. Update 10-Aug-2018: Non-significant case correction was performed with IRD 10-Jul-2018: It was confirmed that, the reported batch number (181527), did not match Seqirus batch numbers (not a valid number), however, because the reporter named Seqirus product 'FLUVIRIN' as the suspect vaccine, this report had been conservatively entered as a Seqirus case. So, the statement 'however, the query regarding batch number had been raised' was deleted from the narrative.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Mastication disorder, Muscle fatigue, Muscular weakness, Musculoskeletal stiffness, Nerve conduction studies
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 726923), concerns a 55-year-old, adult, female patient. The patient's current condition included diverticulosis (reported as medical history) (since an unspecified date). The patient's allergies were unknown. The concomitant medication included vitamin D for an unknown indication. On 06-Dec-2016, the patient was administered FLUVIRIN (dose: 0.5 ml, route of administration: injection [reported as SYR], batch number; 181527 [as reported], anatomical location unknown and expiry date: not reported). It was confirmed that, the reported batch number (181527), did not match Seqirus batch numbers (not a valid number), however, because the reporter named Seqirus product 'FLUVIRIN' as the suspect vaccine, this report had been conservatively entered as a Seqirus case. On 16-Dec-2016, 10 days after vaccination, the patient developed neurological symptoms which included weakness and tired feeling in arms and legs, tiredness in jaw muscles while chewing, stiffness in facial muscles, nerve pain in hands and legs, numbness in upper lip and nose for a brief period and sluggish tongue which led to biting of tongue. The patient had an office visit. On an unspecified date, nuclear magnetic resonance imaging (MRI), nerve conduction tests, electromyography and various blood tests were performed for which results were not reported. At the time of this report, the patient had not recovered from the events (intranasal hypoaesthesia, hypoaesthesia oral, stiffness muscle, tongue biting, tongue sluggish, muscle fatigue, weakness of limbs, neurological symptom, tiredness and nerve pain). The reporter assessed the case as non-serious. Update 10-Aug-2018: Non-significant case correction was performed with IRD 10-Jul-2018: It was confirmed that, the reported batch number (181527), did not match Seqirus batch numbers (not a valid number), however, because the reporter named Seqirus product 'FLUVIRIN' as the suspect vaccine, this report had been conservatively entered as a Seqirus case. So, the statement 'however, the query regarding batch number had been raised' was deleted from the narrative.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia, Neurological symptom, Nuclear magnetic resonance imaging, Tongue biting, Tongue movement disturbance
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 726923), concerns a 55-year-old, adult, female patient. The patient's current condition included diverticulosis (reported as medical history) (since an unspecified date). The patient's allergies were unknown. The concomitant medication included vitamin D for an unknown indication. On 06-Dec-2016, the patient was administered FLUVIRIN (dose: 0.5 ml, route of administration: injection [reported as SYR], batch number; 181527 [as reported], anatomical location unknown and expiry date: not reported). It was confirmed that, the reported batch number (181527), did not match Seqirus batch numbers (not a valid number), however, because the reporter named Seqirus product 'FLUVIRIN' as the suspect vaccine, this report had been conservatively entered as a Seqirus case. On 16-Dec-2016, 10 days after vaccination, the patient developed neurological symptoms which included weakness and tired feeling in arms and legs, tiredness in jaw muscles while chewing, stiffness in facial muscles, nerve pain in hands and legs, numbness in upper lip and nose for a brief period and sluggish tongue which led to biting of tongue. The patient had an office visit. On an unspecified date, nuclear magnetic resonance imaging (MRI), nerve conduction tests, electromyography and various blood tests were performed for which results were not reported. At the time of this report, the patient had not recovered from the events (intranasal hypoaesthesia, hypoaesthesia oral, stiffness muscle, tongue biting, tongue sluggish, muscle fatigue, weakness of limbs, neurological symptom, tiredness and nerve pain). The reporter assessed the case as non-serious. Update 10-Aug-2018: Non-significant case correction was performed with IRD 10-Jul-2018: It was confirmed that, the reported batch number (181527), did not match Seqirus batch numbers (not a valid number), however, because the reporter named Seqirus product 'FLUVIRIN' as the suspect vaccine, this report had been conservatively entered as a Seqirus case. So, the statement 'however, the query regarding batch number had been raised' was deleted from the narrative.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 726929), concerns a 20-year-old, adult, female patient. On 09-Nov-2017, the patient was administered FLUVIRIN (dose: 0.5 ml [first dose as reported], route of administration: intramuscular, anatomical location: left arm, batch number: 179903P and expiry date: not reported). On the same day (09-Nov-2017), after vaccination, the patient developed the throat tightness. The patient went to hospital and was given prednisone and BENADRYL as treatment for the event. On 15-Nov-2017, the patient returned to store and stated that she took herself an EPIPEN shot for closed throat. At the time of this report, the patient had recovered from the event (throat tightness). The reporter assessed the case as non-serious.
Age: 54.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 726949), concerns a 54-year-old, adult, female patient. On 11-Nov-2017, the patient was administered FLUVIRIN (dose: 0.5 ml [reported as unknown], route of administration: intramuscular, anatomical location: right arm, batch number: 179905P, expiry date: not reported). On the same day, the patient was administered ZOSTAVAX (dose: unknown, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified date in Nov-2017, 5 days after vaccination, the patient developed red, hot, hard lump at the site of injection. At the time of this report, outcome of the events was not reported. The reporter assessed this case as non-serious. Update 14-Aug-2018: Non-significant case correction was performed 10-Jul-2018: The co-suspect vaccine (ZOSTAVAX) was added in case comment.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous case, reported by other health professional to VAERs and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 726986), concerns a 61-year-old, adult, female patient. The patient was allergic to latex. The patient had no concomitant medications or current illness. On 25-Oct-2017, the patient was administered FLUVIRIN Thiomersal (dose: 0.5 ml [reported as first dose], route of administration: intramuscular, anatomical location: left arm, batch number: 1721501 and expiry date: not reported) and ZOSTAVAX (dose: 1 [reported as first dose], route of administration: subcutaneous, anatomical location: right arm, batch number: N020852 and expiry date: not reported). On 30-Oct-2017, 5 days after vaccination, the patient woke up with bright red rash around the injection site. The patient applied hydrocortisone and BENADRYL at the site. As of 03-Nov-2017, the patient was recovering from rash. On the same day, the patient reported all the events to registered pharmacist (Rph). On an unspecified date in 2017, the patient had recovered from the event injection site redness. The reporter assessed the case as non-serious. Update 14-Aug-2018: Significant case correction received with IRD 10-Jul-2018: The determined causality for all the events was changed from 'related' to 'unassessable'. The co-suspect was added in case comment. The narrative was corrected.
Sex: F
Vaccine: FLUC4, FLUX
Symptoms: Back pain, Injection site pain
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 727032), concerns an adult female patient of unspecified age. The patient did not have any medical history and current illnesses. On an unspecified date in 2015, the patient was administered influenza vaccine (dose, frequency, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported). On an unspecified date in 2015 after vaccination, the patient had a reaction to flu vaccine which included an awful pain in her left upper back and shoulder area. The outcome of the event was not reported. This case was linked to case: 201803669 and case: 201803670 owing to the same patient.
Sex: F
Vaccine: FLUC4, FLUX
Symptoms: Back pain, Musculoskeletal pain
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 727032), concerns an adult female patient of unspecified age. The patient did not have any medical history and current illnesses. On an unspecified date in 2015, the patient was administered influenza vaccine (dose, frequency, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported). On an unspecified date in 2015 after vaccination, the patient had a reaction to flu vaccine which included an awful pain in her left upper back and shoulder area. The outcome of the event was not reported. This case was linked to case: 201803669 and case: 201803670 owing to the same patient.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pallor, Posture abnormal, Syncope
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 727190), concerns a 08-year-old, female child. The patient received yearly vaccine in the left deltoid while sitting on the exam table. On an unspecified date in 2016 (reported as last year), during blood withdrawal, the patient fainted. On 16-Nov-2017, the patient was administered FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 179902P, expiry date: not reported). A few minutes later after vaccination, the patient walked over to sit on a chair. While sitting on the chair, the patient stated that she was not feeling good (stated to her mom). The registered nurse (RN) noticed that, the patient turned pale and head was dropped to chest. The patient's mother and the registered pharmacist scooped up the child and carried her over to the exam table. It was reported that, the patient opened her eyes, was alert while lying on the table. The physician was called, and vital signs were checked which was found to be stable [VSS]. The patient was alert and oriented x 3 (person, time, place). The patient's extremities were warm to touch, and bilateral radial pulses were good. The child rested for 15 minutes. After 5 minutes, the patient stood up, walked normally around the room and was escorted out to the car with nurse, MOC (as reported) and sister. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious. Update 14-Aug-2018: Non-significant case correction received with IRD 10-Jul-2018: The sentences in narrative were changed from 'carried over the exam table' to 'carried her over to the exam table' and 'vital signs were taken' to 'vital signs were checked'. The case comment was modified from 'female child patient was not feeling good, turned pale and had posture was abnormal' to 'female patient experienced feeling abnormal, pallor and posture abnormal'.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure normal, Dizziness, Gait disturbance, Heart rate normal
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 727198), concerns a 65-year-old, elderly, female patient. The patient's current condition included depression (since unspecified date) and the concomitant medications included risperidone (since and unspecified date) for an unknown indication. On 14-Nov-2017, the patient was administered FLUVIRIN (dose: 0.5 ml [first dose as reported], route of administration: intramuscular, anatomical location: left arm, batch number: 170102P and expiry date: not reported). On the same day (14-Nov-2017), 20 minutes after vaccination, while walking from pharmacy, the patient started stumbling and felt really dizzy. The pharmacist called emergency medical services. The patient had an emergency room (dates and reason unspecified) visit. The patient's heart rate (pulse), and blood pressure were checked which found to be normal. The patient left the ER without going to hospital. At the time of this report, the patient had recovered from the events (dizziness and stumbling). The reporter assessed the case as non-serious.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Musculoskeletal disorder
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 727275), concerns a 58-year-old, adult, female patient. The patient's historical conditions and concomitant medications were unknown. On 26-Oct-2017, the patient was administered FLUVIRIN (dose: 0.5 ml, batch number: 179903P, anatomical location: left arm, route of administration: unknown and expiry date: not reported). On 27-Oct-2017, one day after vaccination, the patient experienced injection site hardness and redness. Furthermore, the patient was unable to use her arm and went to the emergency room. Lab investigations (unspecified) performed for which results were not reported. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious. Update 31-Jul-2018: Case correction was performed 10-Jul-2018: The sentence in the case comment was corrected from 'the company assessed the causality of the events as related to the suspect vaccine due to anatomical site-specific reaction and plausible temporal relationship to 'the company assessed the causality of the events as related to the suspect vaccine due to injection site reaction and plausible temporal relationship'.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia, Sensory disturbance
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 727318), concerns a 47-year-old, adult female patient. The patient had no relevant medical history. Concomitant medications included MICROGESTIN, acyclovir and Vitamin D all for unknown indications. On 13-Oct-2017, the patient was administered FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 179723P, expiry date: not reported). On 27-Oct-2017, 14 days after vaccination, the patient experienced symmetric bilateral tingling in feet and low legs. It was reported that, the patient also experienced a sensation which was more of a "pinging" sensation over rest of her body at random places and at random times. In addition, the patient experienced bilateral thigh soreness. It was reported that, the patient's bilateral thigh soreness had not resolved with rest and her symptoms worsened with time. At the time of this report, the patient had not recovered from all the events. The reporter assessed the case as non-serious. Update 14-Aug-2018: Non-significant case correction was performed with IRD 10-Jul-2018: The sentence 'later, the patient had some rest' was removed from the narrative.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Feeling cold, Headache, Pain, Tremor
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 727417), concerns a 65-year-old, elderly, female patient. The patient's current condition included asthma (reported as medical history). Concomitant medications included ADVIL, Vitamin C, Vitamin E, Calcium and probiotic. The patient took green tea. On 14-Nov-2017, the patient was administered FLUVIRIN (dose: 0.5 ml, route of administration, anatomical location, batch number, expiry date: not reported). On 15-Nov-2017, 12:30 am, 1 day after vaccination, the patient woke up due to stomach upset, body aches with freezing and shaking, severe headache and vomiting (for 6 times) which lasted until 05:30 am. The headache lasted throughout the day with weakness and body aches. The patient was unable to leave the bed. On 16-Nov-2017 (Thursday), the patient was able to move on the couch and all around. On 17-Nov-2017 (Friday), the patient was almost herself. On an unspecified date, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 727417), concerns a 65-year-old, elderly, female patient. The patient's current condition included asthma (reported as medical history). Concomitant medications included ADVIL, Vitamin C, Vitamin E, Calcium and probiotic. The patient took green tea. On 14-Nov-2017, the patient was administered FLUVIRIN (dose: 0.5 ml, route of administration, anatomical location, batch number, expiry date: not reported). On 15-Nov-2017, 12:30 am, 1 day after vaccination, the patient woke up due to stomach upset, body aches with freezing and shaking, severe headache and vomiting (for 6 times) which lasted until 05:30 am. The headache lasted throughout the day with weakness and body aches. The patient was unable to leave the bed. On 16-Nov-2017 (Thursday), the patient was able to move on the couch and all around. On 17-Nov-2017 (Friday), the patient was almost herself. On an unspecified date, the patient had recovered from the events. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLU3
Symptoms: C-reactive protein normal, Dizziness, Electromyogram, Hypoaesthesia, Muscle spasms
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 727575), concerns a 39-year-old, adult, female patient. The patient had no historical condition and current illness. The patient was allergic to minocycline and erythromycin. The patient had not received any concomitant medication. On 19-Oct-2017, the patient was FLUVIRIN (dose: 0.5 ml [frequency reported as 1], route of administration: intramuscular, anatomical location: right arm, batch number: 179902P and expiry date: not reported). On 20-Oct-2017, one day after vaccination, the patient had fever, tremors, muscle twitching and muscle spasms. The patient also experienced numbness and tingling sensation in her legs, dizziness and reported to have electrical like feeling throughout her body. The patient continued to have muscle twitching, spasms, dizziness at the time of reporting. On an unspecified date, the patient made an office visit. On an unspecified date in Nov-2017, nuclear magnetic resonance imaging (MRI) of brain, cervical spine (C-spine) and thoracic spine (T-spine) were found to be clear, C-reactive protein, red blood cell sedimentation rate and thyroid function test were found to be normal. Results of electromyogram and nerve conduction studies were unknown and further lab works were pending. The events-muscle twitching, muscle spasm and dizziness were not resoled and outcome of the events-fever, tremors, numbness and tingling in legs were not reported. The repeater assessed this case as non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Muscle twitching, Nerve conduction studies, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Paraesthesia
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 727575), concerns a 39-year-old, adult, female patient. The patient had no historical condition and current illness. The patient was allergic to minocycline and erythromycin. The patient had not received any concomitant medication. On 19-Oct-2017, the patient was FLUVIRIN (dose: 0.5 ml [frequency reported as 1], route of administration: intramuscular, anatomical location: right arm, batch number: 179902P and expiry date: not reported). On 20-Oct-2017, one day after vaccination, the patient had fever, tremors, muscle twitching and muscle spasms. The patient also experienced numbness and tingling sensation in her legs, dizziness and reported to have electrical like feeling throughout her body. The patient continued to have muscle twitching, spasms, dizziness at the time of reporting. On an unspecified date, the patient made an office visit. On an unspecified date in Nov-2017, nuclear magnetic resonance imaging (MRI) of brain, cervical spine (C-spine) and thoracic spine (T-spine) were found to be clear, C-reactive protein, red blood cell sedimentation rate and thyroid function test were found to be normal. Results of electromyogram and nerve conduction studies were unknown and further lab works were pending. The events-muscle twitching, muscle spasm and dizziness were not resoled and outcome of the events-fever, tremors, numbness and tingling in legs were not reported. The repeater assessed this case as non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Red blood cell sedimentation rate normal, Thyroid function test normal, Tremor
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 727575), concerns a 39-year-old, adult, female patient. The patient had no historical condition and current illness. The patient was allergic to minocycline and erythromycin. The patient had not received any concomitant medication. On 19-Oct-2017, the patient was FLUVIRIN (dose: 0.5 ml [frequency reported as 1], route of administration: intramuscular, anatomical location: right arm, batch number: 179902P and expiry date: not reported). On 20-Oct-2017, one day after vaccination, the patient had fever, tremors, muscle twitching and muscle spasms. The patient also experienced numbness and tingling sensation in her legs, dizziness and reported to have electrical like feeling throughout her body. The patient continued to have muscle twitching, spasms, dizziness at the time of reporting. On an unspecified date, the patient made an office visit. On an unspecified date in Nov-2017, nuclear magnetic resonance imaging (MRI) of brain, cervical spine (C-spine) and thoracic spine (T-spine) were found to be clear, C-reactive protein, red blood cell sedimentation rate and thyroid function test were found to be normal. Results of electromyogram and nerve conduction studies were unknown and further lab works were pending. The events-muscle twitching, muscle spasm and dizziness were not resoled and outcome of the events-fever, tremors, numbness and tingling in legs were not reported. The repeater assessed this case as non-serious.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Dermatitis contact, Injection site pruritus, Injection site vesicles
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 728275), concerns a 16-year-old, female adolescent patient. On 05-Nov-2017, the patient was administered FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, batch number: 179804P, anatomical location: unknown and expiry date: not reported). On 06-Nov-2017, 1 day after vaccination, the patient developed blister with water beneath surface and itching, where band aid adhesive touched skin near immunization site. The patient was taken to physician (MD) by her mother today (as reported). The patient had an emergency room visit. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Limb discomfort
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 728361), concerns a 23-year-old, adult, female patient. On 25-Oct-2017, the patient was administered FLUVIRIN (dose: 0.5 ml, [reported as unknown], route of administration: intramuscular, anatomical location: left arm, batch number: 179805P and expiry date: not reported). On the same day after vaccination, the patient experienced soreness in the arm. The patient had limited mobility with difficulty in raising arm. The patient reported that, even 3 weeks after vaccination the events persisted. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Erythema, Pruritus, Skin warm, Urticaria
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 728641), concerns a 11-year-old, female child patient. The patient had no relevant medical history, current illness and allergies. The patient did not receive any concomitant medications. On 25-Nov-2017, the patient was administered FLUVIRIN (dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location: left arm, batch number, expiry date: not reported). On the same day, the patient was administered non-company suspect drugs MENACTRA (route of administration: injection (reported as SYR), anatomical location: left arm, dose, batch number, expiry date: not reported) and Tdap (dose, route of administration, anatomical location, batch number, expiry date: not reported). On the same day (25-Nov-2017) after vaccination, the patient experienced redness, itching, area was warm, and the skin was lifted as in a hive. Two days later, the patient made a visit to the physician and was advised to apply ice to the area. However, the patient did not know the exact type of vaccine shots she received. At the time of report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 728721), concerns a 69-year-old, elderly, female patient. On 15-Nov-2017, the patient was administered FLUVIRIN Thiomersal (dose: 0.5 ml [reported as UNK], batch number: 1721501, route of administration and anatomical location: not reported). On the same day, the patient also received non-company suspect Pneumo (dose: reported as UNK, batch number: M040804, route of administration; unknown, anatomical location: left arm). On the same day, after vaccination, the patient experienced raised, redness on upper side (reported as inside) of the left arm about 4-5 inches in diameter. The outcome of the events (raised, redness on upper inside of the left arm about 4-5 inches in diameter) was unknown. The reporter assessed this case as non-serious. Update 31-Jul-2018: Non-significant case correction was performed with IRD 10-Jul-2018: Added the reason 'causal role of suspect vaccine cannot be ruled out completely' for the causality assessment in the case comment. Case comment was amended. No changes were made in the narrative.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This non-serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 10-Jul-2018 by Seqirus from VAERS (VAERS ID: 728902), concerns an adult female patient of an unspecified age. On an unspecified date (reported as 10 years ago), the patient was administered influenza vaccine, (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, after vaccination, the patient got sick. At the time of this report, the outcome of the event was not reported. This case was cross linked to case 201802829 (same patient).
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Computerised tomogram, Dyspnoea, Injection site rash, Rash generalised
Clinical narrative: This is spontaneous case, reported by other health professional to VAERS and initially retrieved on 17-Jul-2018 by Seqirus from VAERS (VAERS ID: 728957), concerns a 34-year-old, adult female patient. The patient had no relevant medical history, allergies or current illness. The patient's concomitant medication included Acyclovir and PNV for unknown indications. On 14-Jun-2015, the patient was administered FLUVIRIN (dose: 0.5 ml [unknown], route of administration: injection [reported as SYR], anatomical location: not reported, batch number: not reported). On the same day, after vaccination, the patient developed injection site rash which covered the body and shortness of breath. On an unspecified date, the patient visited the emergency room. The patient was treated with BENADRYL (oral and IV [intravenous]) and unspecified nebulizer. On an unspecified date, chest X-ray and computed tomography [CT] scan was performed, the results were not reported. The patient had recovered from the events (rash from injection site covering body and shortness of breath). The reporter assessed this case as non-serious.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 17-Jul-2018 by Seqirus from VAERS (VAERS ID: 729348), concerns a 57-year-old, adult, female patient. On 13-Nov-2017, the patient was administered FLUVIRIN [dose: 0.5 ml, route of administration: unknown, anatomical location: right arm, batch number: 179807P [as reported], expiry date: not reported]. On the same day, the patient was administered PNEUMOVAX [dose: unknown, route of administration: unknown, anatomical location: left arm, batch number: N019837, expiry date: not reported]. On the same day (13-Nov-2017) after vaccination, the patient experienced fever and swelling. The patient was advised to take TYLENOL. The patient also used ice packs on the affected area. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious. Update 24-Aug-2018: Non-significant case correction performed 17-Jul-2018: The sentence in the product section of the narrative was modified to align it with the reported information and the co-suspect 'PNEUMOVAX' was added in the case comment.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Loss of personal independence in daily activities, Pain in extremity, Sleep disorder
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 17-Jul-2018 by Seqirus from VAERS (VAERS ID: 729360), concerns a 57-year-old, adult, female patient. The patient had no relevant medical history or concurrent conditions and no known allergies. It was unknown whether patient received any concomitant medication at the time of vaccination. On 01-Nov-2017, the patient was administered FLUVIRIN (dose: 0.5 ml [frequency reported as 1], route of administration: intramuscular, anatomical location: left arm, batch number: 1721501). On the same day, upon vaccine administration, the patient's arm hurt more than normal and the pain (rated as 9) went down to the bones. Later, the pain was reported as 7-8. That the patient stated that, the pain was continuous, but it hurt when lifting, taking off shirt and when she put her arm over her head. Also, if the arm was put in a certain position during sleep, the patient woke up. The patient took ALEVE on the same day of shot but did not take it since that day. At the time of the report, the patient had not recovered from all the events. The reporter assessed this case as non-serious. Update 14-Aug-2018: Significant case correction was performed with IRD 17-Jul-2018: The causality of the event 'sleep disorder' was corrected from related to not related. The case comment was corrected accordingly.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Tenderness
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 17-Jul-2018 by Seqirus from VAERS (VAERS ID: 729423), concerns a 37-year-old, adult female patient. The patient's medical history, allergies, current illness and concomitant medications were unknown. On 02-Nov-2017, the patient was administered FLUVIRIN (dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 179803P, expiry date: not reported). On 09-Nov-2017, 7 days after vaccination, the patient's arm started to hurt (considered as pain in arm) and was tender to touch. The patient denied fever, swelling, redness or any nodules. The patient stated that, the pain persisted one month later. The pharmacist referred the patient to physician for evaluation. At the time of this report, the patient has not recovered from the events. The reporter assessed the case as non-serious.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Cough, Eye infection, Nausea, Sensation of foreign body
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 17-Jul-2018 by Seqirus from VAERS (VAERS ID: 729462), concerns a 58-year-old, adult female patient. The patient's current illness included flu like symptoms (since an unspecified date). On 08-Nov-2017, the patient was administered FLUVIRIN (dose: 0.5 ml, route of administration and anatomical location: unknown, batch number and expiry date: not reported). On 09-Nov-2017, one day after vaccination, the patient experienced severe cough which led to nausea and vomiting. The patient also experienced loss of her voice, eye infection and felt a lump in her throat. At the time of this report, the patient had not recovered from the events (cough, vomiting, nausea, lost voice, eye infection and felt a lump in her throat). The reporter assessed the case as non-serious. Update received on 05-Sep-2018: Non-significant case correction (IRD: 17-Jul-2018): The age at vaccination was added in the patient tab and the event verbatim of the event (Aphonia) was changed from 'lost voice' to 'lost her voice' in event tab.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 17-Jul-2018 by Seqirus from VAERS (VAERS ID: 729462), concerns a 58-year-old, adult female patient. The patient's current illness included flu like symptoms (since an unspecified date). On 08-Nov-2017, the patient was administered FLUVIRIN (dose: 0.5 ml, route of administration and anatomical location: unknown, batch number and expiry date: not reported). On 09-Nov-2017, one day after vaccination, the patient experienced severe cough which led to nausea and vomiting. The patient also experienced loss of her voice, eye infection and felt a lump in her throat. At the time of this report, the patient had not recovered from the events (cough, vomiting, nausea, lost voice, eye infection and felt a lump in her throat). The reporter assessed the case as non-serious. Update received on 05-Sep-2018: Non-significant case correction (IRD: 17-Jul-2018): The age at vaccination was added in the patient tab and the event verbatim of the event (Aphonia) was changed from 'lost voice' to 'lost her voice' in event tab.
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site streaking, Injection site warmth
Clinical narrative: This spontaneous case, reported by a physician to VAERS and initially retrieved on 06-Jun-2018 by Seqirus from VAERS (VAERS ID: 729477), concerns a female patient of unspecified age. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were unknown. Concomitant therapy included sterile diluent (Merck). On an unspecified date, the patient was administered influenza vaccine, (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, the patient was administered with PNEUMOVAX (dose, route of administration, anatomical location, batch number, expiry date: not reported) and ZOSTAVAX (dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified date, after vaccination, the patient experienced localized site reaction which included, warmth to the touch, pain, and red streaks from the injection site to the inside of the patient's arm (as reported). The patient visited the physician's office and was treated with unspecified medications. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 64.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 17-Jul-2018 by Seqirus from VAERS (VAERS ID: 729935), concerns a 64-year-old, adult female patient. The patient had no relevant medical history and no current illness. Concomitant medications included: HCTZ, hydrocodone and potassium. On 30-Nov-2017, the patient was administered FLUVIRIN (dose: 0.5 ml [reported as 1st dose], route of administration: intramuscular, anatomical location: left arm, batch number: 179903P, expiry date: not reported). On the same day, the patient also received non-company suspect drug PREVNAR 13, dose: single dose, route of administration: intramuscular, anatomical location: right arm, batch number: S58704, expiry date: not reported). On 03-Dec-2017, 3 days after vaccination, while sitting in church, the patient realized that the skin was itchy and raised at the injection site. No lab test was done. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious. Update 14-Aug-2018: Significant case correction was performed 17-Jul-2018: The causality of the events (injection site swelling and injection site itching) was corrected from related to unassessable. The case comment was corrected accordingly.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 17-Jul-2018 by Seqirus from VAERS (VAERS ID: 729952), concerns a 11-year-old, child, female patient. It was reported that the patient might have an injection site reaction (injection site erythema, injection site pruritus and injection site warmth) with vaccine (unspecified) but was unsure. On 07-Dec-2017, the patient was administered FLUVIRIN (dose: 0.5 ml [N/A as reported], route of administration: intramuscular, anatomical location: left arm, batch number: 179702P and expiry date: not reported). On the same day, after administration of the vaccine, (at night) the patient had a 2-inch by 2-inch red circle around the injection site which felt warm to touch and said that it itched. Patient was given BENADRYL and ibuprofen, but the site was warm, and itching returned. Patient's mother stated that she would take the patient to urgent care to make sure if the site was not infected. At the time of this report, it was unknown if the patient had recovered from the events. The reporter assessed the case as non-serious. Update 14-Aug-2018: Non-significant case correction was performed with IRD 17-Jul-2018: The case comment was corrected from 'on the same day after vaccination with FLUVIRIN, at night, an 11-year-old female patient had a 2-inch by 2-inch red circle around the injection site which felt warm to touch and said that it itched. The company assessed the causality of the events as related to the suspect vaccine due to anatomical site-specific reaction and plausible temporal relationship' to 'a 11-year-old female patient experienced injection site warm, pruritus, erythema on the same day after vaccination with the suspect vaccine (FLUVIRIN). The company assessed the causality of the anatomical site-specific events as related to the suspect vaccine due to plausible temporal relationship'.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 17-Jul-2018 by Seqirus from VAERS (VAERS ID: 729980), concerning a 63-year-old, adult, male patient. The patient's current condition included tooth infection (since an unspecified date) and concomitant medication included NEXIUM for an unknown indication. On 06-Dec-2017, the patient was administered FLUVIRIN (dose: 0.5 ml [reported as first dose], route of administration: intramuscular, anatomical location: left arm, batch number: 179701P and expiry date: not reported) and non-company suspect products PNEUMOVAX (dose: 1st dose [as reported], route of administration: intramuscular, anatomical location: left arm, batch number: N019983 and expiry date: not reported) and BOOSTRIX (dose: 1st dose [as reported], route of administration: intramuscular, anatomical location: right arm, batch number: 7Y29Z and expiry date: not reported). On the same day, after vaccination, the patient developed redness, pain and swelling in left arm. The patient had an office visit and no lab investigations were performed. At the time of this report, the patient had not recovered from the events (redness, pain and swelling in left arm). The reporter assessed the case as non-serious.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Altered state of consciousness, Dizziness, Immediate post-injection reaction, Inflammation, Nodule
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 17-Jul-2018 by Seqirus from VAERS (VAERS ID: 730028), concerning a 51-year-old adult, female patient. The patient's historical condition included neck and back pain, thyroid and cholesterol (since any unspecified date) and the allergies were not reported. The patient had no concomitant medications. On 03-Dec-2017, the patient was administered FLUVIRIN (dose: 0.5 ml, frequency: 1, route of administration: subcutaneous, anatomical location: left arm, batch number: 179905P and expiry date: not reported). On the same day, immediately after vaccination, the patient developed knot and the arm became inflamed and swollen. The patient experienced dizziness, thirst and almost passed out. On the same day, the patient was taken to medical center and had an emergency room visit. The patient's lab data was unknown. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious. Update 14-Aug-2018: Significant case correction was performed 17-Jul-2018: The medical conditions thyroid and cholesterol were re-coded as historical conditions. The events inflammation, peripheral swelling and nodule was changed to symptoms of immediate post injection reaction and dizziness was mapped as symptom of the event depressed level of consciousness. Narrative was amended accordingly.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Thirst
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 17-Jul-2018 by Seqirus from VAERS (VAERS ID: 730028), concerning a 51-year-old adult, female patient. The patient's historical condition included neck and back pain, thyroid and cholesterol (since any unspecified date) and the allergies were not reported. The patient had no concomitant medications. On 03-Dec-2017, the patient was administered FLUVIRIN (dose: 0.5 ml, frequency: 1, route of administration: subcutaneous, anatomical location: left arm, batch number: 179905P and expiry date: not reported). On the same day, immediately after vaccination, the patient developed knot and the arm became inflamed and swollen. The patient experienced dizziness, thirst and almost passed out. On the same day, the patient was taken to medical center and had an emergency room visit. The patient's lab data was unknown. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious. Update 14-Aug-2018: Significant case correction was performed 17-Jul-2018: The medical conditions thyroid and cholesterol were re-coded as historical conditions. The events inflammation, peripheral swelling and nodule was changed to symptoms of immediate post injection reaction and dizziness was mapped as symptom of the event depressed level of consciousness. Narrative was amended accordingly.