chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Fall, Feeling abnormal, Muscular weakness, Tremor, Urinary incontinence
Clinical narrative: Case number PHHY2016US105114, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 637511 website on 01 Aug 2016. This report refers to an 83 years old male patient. Past medical history and concomitant medications were not reported). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly on 01-Oct-2015. On the same day after vaccination (reported as 3 to 4 hours after vaccination), the patient felt chilled, noted shaking in bilateral arms, legs were weak, he fell while walking to the restroom, episode of urinary incontinence during the night which was an unusual occurrence. The patient was able to rise and bear weight the next morning though he did not felt like himself for couple of days. The outcome of the events was unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Chills, Fall, Feeling abnormal, Muscular weakness, Tremor
Clinical narrative: Case number PHHY2016US105114, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 637511 website on 01 Aug 2016. This report refers to an 83 years old male patient. Past medical history and concomitant medications were not reported). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly on 01-Oct-2015. On the same day after vaccination (reported as 3 to 4 hours after vaccination), the patient felt chilled, noted shaking in bilateral arms, legs were weak, he fell while walking to the restroom, episode of urinary incontinence during the night which was an unusual occurrence. The patient was able to rise and bear weight the next morning though he did not felt like himself for couple of days. The outcome of the events was unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Urinary incontinence
Clinical narrative: Case number PHHY2016US105114, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 637511 website on 01 Aug 2016. This report refers to an 83 years old male patient. Past medical history and concomitant medications were not reported). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly on 01-Oct-2015. On the same day after vaccination (reported as 3 to 4 hours after vaccination), the patient felt chilled, noted shaking in bilateral arms, legs were weak, he fell while walking to the restroom, episode of urinary incontinence during the night which was an unusual occurrence. The patient was able to rise and bear weight the next morning though he did not felt like himself for couple of days. The outcome of the events was unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Condition aggravated, Guillain-Barre syndrome
Clinical narrative: Case number PHHY2016US105023, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 637658) on 01 Aug 2016. This report refers to a patient of unspecified demographics. Past medical history included Guillain-Barre Syndrome. Concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. Following the vaccine administration, the patient developed Guillain-Barre Syndrome. No further information was provided. The outcome of the event was unknown. Upon follow up with pharmacist on 13 Nov 2015, it was stated that the cause of Guillain-Barre Syndrome was not known. The event was assessed as non serious and causality was not reported. The seriousness assessment of the event Guillain-Barre Syndrome was upgraded based on the Novartis Important Medical Event List.
Age: 5.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Anaphylactic reaction, Dyspnoea, Pruritus, Rash, Urticaria
Clinical narrative: Case number PHHY2016US105641, is an initial spontaneous report received from Nurse via Pfizer sales representative via Vaccine Adverse Event Reporting System (VAERS reference number: 637659). This report refers to a 5 year old male patient. Medical history included asthma, allergic to cashew and pistachio nuts. Concomitant medications were not reported. The patient was vaccinated with influenza virus seasonal vaccine (Manufacturer unknown, batch number: not reported) between 01 Jan 2009 to 31 Dec 2011. It was reported that, 3 hours after vaccination, the patient experienced anaphylaxis. The symptoms included generalized urticarial, pruritus, rash and shortness of breath. He received treatment with oral antihistamines and oral steroids. Outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious. Reporter commented that attributed trigger was vaccine. Seriousness of the event anaphylaxis was upgraded based on Novartis important medical events list (NVS IME).
Age: 36.0
Sex: F
Vaccine: FLUX, TDAP, FLUX, TDAP
Symptoms: Anaphylactic reaction, Angioedema, Choking, Cough, Heart rate increased
Clinical narrative: Case number PHHY2016US106425, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 637660). This report refers to a 36 year old female patient. Medical history included contact dermatitis and Allergic rhinitis. Concomitant medications were not reported. The patient was vaccinated with Influenza Virus seasonal vaccine (Manufacturer unknown, batch number: not reported) and Diphtheria, Pertussis and Tetanus vaccine (Manufacturer unknown, batch number: not reported) on an unknown date between 01 Jan 2009 through 31 Dec 2011. It was reported that 3 hours after vaccination, the patient experienced anaphylaxis. The symptoms included angioedema, choking, cough, increased heart rate and nausea. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. She received treatment with oral antihistamine, oral steroid and cool compress. Outcome of the event was reported as complete recovery. Seriousness of the events was reported as non serious. Reporter commented that, attributed trigger was vaccine. Seriousness of the event anaphylaxis was upgraded as per the NVS IME list.
Age: 36.0
Sex: F
Vaccine: FLUX, TDAP, FLUX, TDAP
Symptoms: Nausea
Clinical narrative: Case number PHHY2016US106425, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 637660). This report refers to a 36 year old female patient. Medical history included contact dermatitis and Allergic rhinitis. Concomitant medications were not reported. The patient was vaccinated with Influenza Virus seasonal vaccine (Manufacturer unknown, batch number: not reported) and Diphtheria, Pertussis and Tetanus vaccine (Manufacturer unknown, batch number: not reported) on an unknown date between 01 Jan 2009 through 31 Dec 2011. It was reported that 3 hours after vaccination, the patient experienced anaphylaxis. The symptoms included angioedema, choking, cough, increased heart rate and nausea. The case met Brighton Collaboration case definition of anaphylaxis criteria level 2. She received treatment with oral antihistamine, oral steroid and cool compress. Outcome of the event was reported as complete recovery. Seriousness of the events was reported as non serious. Reporter commented that, attributed trigger was vaccine. Seriousness of the event anaphylaxis was upgraded as per the NVS IME list.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Case number PHHY2016US105310, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 637730) website on 01 Aug 2016. This report refers to a female patient of unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: manufacturer unknown) on an unknown date in 2014. On an unknown date, the patient experienced arm swollen and low grade fever. The outcome of the events was unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain
Clinical narrative: Case number PHHY2016US107252, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 637731) website on 01 Aug 2016. This report refers to an unknown age of female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unspecified date, the patient experienced soreness. The outcome of event was reported as unknown. The seriousness of the event was reported as non serious. The causality of the event was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza
Clinical narrative: Case number PHHY2016US105640, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 637738) on 01 Aug 2016. This report refers to a female patient of an unknown age. Past medical history and concomitant medication were not reported. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) on 01 Nov 2014. After vaccination, on an unspecified date in summer of 2015, she experienced influenza. No further information provided. the outcome of the event was unknown. the event was assessed as non serious by the consumer and causality was not reported. the seriousness of the events vaccination failure and influenza were upgraded (medically significant) based on the information available in the source document.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Case number PHHY2016US105640, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 637738) on 01 Aug 2016. This report refers to a female patient of an unknown age. Past medical history and concomitant medication were not reported. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) on 01 Nov 2014. After vaccination, on an unspecified date in summer of 2015, she experienced influenza. No further information provided. the outcome of the event was unknown. the event was assessed as non serious by the consumer and causality was not reported. the seriousness of the events vaccination failure and influenza were upgraded (medically significant) based on the information available in the source document.
Age: 44.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Facial paralysis
Clinical narrative: Case number PHHY2016US105727, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 637765) website on 01 Aug 2016. This report refers to a 44 years old male patient. Past medical history was not reported. Current condition included as sulfa allergy. Concomitant medications was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unspecified date, three months after vaccination, the patient experienced Bell's palsy. The outcome of event was reported as unknown. The seriousness of event was reported as non serious. The causality of event was not reported. Seriousness assessment of facial paralysis was upgraded to serious (medically significant) based on the Novartis Important Medical Event list.
Age: 27.0
Sex: F
Vaccine: FLUX, FLUX(H1N1), FLUX, FLUX(H1N1)
Symptoms: Anaphylactic reaction, Chest discomfort, Eye pruritus, Generalised erythema, Heart rate increased
Clinical narrative: Case number PHHY2016US107772, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 637773) on 01 Aug 2016. This report refers to a 27 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with Seasonal Influenza Virus vaccine (manufacturer and batch number: not reported) and H1N1 (manufacturer and batch number: not reported) between 01 Jan 2009 to 31 Dec 2011. It was reported that, 2 hours after vaccination, the patient experienced anaphylaxis. The symptoms included generalized erythema and rash, red itchy eyes, increased heart rate, palpitations, swelling (throat) and chest heaviness. She received treatment with oral antihistamines and acetaminophen. The patient was referred to primary care physician. Outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious. Reporter commented that (causality of the events), the trigger was vaccine. The case met Brighton Collaboration case definition of anaphylaxis criteria level 1. Seriousness of the event anaphylactic reaction was upgraded based on Novartis important medical event list (NVS IME) list.
Age: 27.0
Sex: F
Vaccine: FLUX, FLUX(H1N1), FLUX, FLUX(H1N1)
Symptoms: Ocular hyperaemia, Palpitations, Pharyngeal oedema, Rash
Clinical narrative: Case number PHHY2016US107772, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 637773) on 01 Aug 2016. This report refers to a 27 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with Seasonal Influenza Virus vaccine (manufacturer and batch number: not reported) and H1N1 (manufacturer and batch number: not reported) between 01 Jan 2009 to 31 Dec 2011. It was reported that, 2 hours after vaccination, the patient experienced anaphylaxis. The symptoms included generalized erythema and rash, red itchy eyes, increased heart rate, palpitations, swelling (throat) and chest heaviness. She received treatment with oral antihistamines and acetaminophen. The patient was referred to primary care physician. Outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious. Reporter commented that (causality of the events), the trigger was vaccine. The case met Brighton Collaboration case definition of anaphylaxis criteria level 1. Seriousness of the event anaphylactic reaction was upgraded based on Novartis important medical event list (NVS IME) list.
Age: 27.0
Sex: F
Vaccine: FLUX, FLUX(H1N1), FLUX, FLUX(H1N1)
Symptoms: Ocular hyperaemia, Palpitations, Pharyngeal oedema, Rash generalised
Clinical narrative: Case number PHHY2016US107772, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 637773) on 01 Aug 2016. This report refers to a 27 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with Seasonal Influenza Virus vaccine (manufacturer and batch number: not reported) and H1N1 (manufacturer and batch number: not reported) between 01 Jan 2009 to 31 Dec 2011. It was reported that, 2 hours after vaccination, the patient experienced anaphylaxis. The symptoms included generalized erythema and rash, red itchy eyes, increased heart rate, palpitations, swelling (throat) and chest heaviness. She received treatment with oral antihistamines and acetaminophen. The patient was referred to primary care physician. Outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious. Reporter commented that (causality of the events), the trigger was vaccine. The case met Brighton Collaboration case definition of anaphylaxis criteria level 1. Seriousness of the event anaphylactic reaction was upgraded based on Novartis important medical event list (NVS IME) list.
Age: 63.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Decreased appetite, Dizziness, Malaise, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Case number PHHY2016US105878, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 637831) website on 01 Aug 2016. This report refers to a 63 years old female patient. Past medical history included as atherosclerosis of arteries of the extremities. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date and Praluent prefilled pen (alirocumab, injection) at a dose of 75 mg every other week subcutaneously for mixed hyperlipidemia on 27 Apr 2016. It was stated that, the patient received last injection of alirocumab on 11 May 2016. On 16 May 2016 (Monday) (after 19 days vaccination), the patient experienced cold. The patient was sick and her whole body was hurting. She had no appetite and throat started hurting. On Tuesday, the patient felt lightheaded and stopped up. The outcome of events was reported as unknown. The seriousness of events was reported as non serious. The causality of events was not reported.
Age: 63.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain, Type V hyperlipidaemia
Clinical narrative: Case number PHHY2016US105878, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 637831) website on 01 Aug 2016. This report refers to a 63 years old female patient. Past medical history included as atherosclerosis of arteries of the extremities. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date and Praluent prefilled pen (alirocumab, injection) at a dose of 75 mg every other week subcutaneously for mixed hyperlipidemia on 27 Apr 2016. It was stated that, the patient received last injection of alirocumab on 11 May 2016. On 16 May 2016 (Monday) (after 19 days vaccination), the patient experienced cold. The patient was sick and her whole body was hurting. She had no appetite and throat started hurting. On Tuesday, the patient felt lightheaded and stopped up. The outcome of events was reported as unknown. The seriousness of events was reported as non serious. The causality of events was not reported.
Age: 63.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Dizziness, Malaise, Nasal congestion, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Case number PHHY2016US105878, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 637831) website on 01 Aug 2016. This report refers to a 63 years old female patient. Past medical history included as atherosclerosis of arteries of the extremities. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date and Praluent prefilled pen (alirocumab, injection) at a dose of 75 mg every other week subcutaneously for mixed hyperlipidemia on 27 Apr 2016. It was stated that, the patient received last injection of alirocumab on 11 May 2016. On 16 May 2016 (Monday) (after 19 days vaccination), the patient experienced cold. The patient was sick and her whole body was hurting. She had no appetite and throat started hurting. On Tuesday, the patient felt lightheaded and stopped up. The outcome of events was reported as unknown. The seriousness of events was reported as non serious. The causality of events was not reported.
Age: 63.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Respiratory tract congestion
Clinical narrative: Case number PHHY2016US105878, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 637831) website on 01 Aug 2016. This report refers to a 63 years old female patient. Past medical history included as atherosclerosis of arteries of the extremities. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date and Praluent prefilled pen (alirocumab, injection) at a dose of 75 mg every other week subcutaneously for mixed hyperlipidemia on 27 Apr 2016. It was stated that, the patient received last injection of alirocumab on 11 May 2016. On 16 May 2016 (Monday) (after 19 days vaccination), the patient experienced cold. The patient was sick and her whole body was hurting. She had no appetite and throat started hurting. On Tuesday, the patient felt lightheaded and stopped up. The outcome of events was reported as unknown. The seriousness of events was reported as non serious. The causality of events was not reported.
Age: 46.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2016US107157, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 638070) website on 01 Aug 2016. This report refers to a 46 years old female patient. Past medical history included migraine without aura, obstructive sleep apnea (OSA) on continuous positive airway pressure (CPAP) and tethered spinal cord. Current conditions included Ehlers Danlos syndrome type III and chiari malformation type I. Concomitant medications included Acetaminophen (paracetamol), diazepam, Bi est cream (estradiol, estriol), progesterone, oxycodone, spironolactone and Venlafaxine XR (venlafaxine hydrochloride). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) intramuscularly on 31 Jan 2016. On 09 Feb 2016, the patient experienced intermittent low grade fevers to about 100.4 (units and normal range unspecified). The outcome of the events was reported unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Anaphylactic reaction, Vaccination complication
Clinical narrative: Case number PHHY2016US106707, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 639050) on 01 Aug 2016. This report refers to a female patient of unknown age. Medical history was not reported. Current condition included allergies. Concomitant medication was not reported. The patient was vaccinated with influenza virus seasonal vaccine (manufacturer unknown, batch number: not reported) on unknown date. After the vaccination, the patient experienced anaphylactic reaction. Outcome of the event was reported as unknown. Seriousness of the event was reported as non serious. Causality of the event was not reported. Seriousness of the event anaphylactic reaction was upgraded based on the Novartis Important Medical event (NVS-IME) list.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Case number PHHY2016US106707, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 639050) on 01 Aug 2016. This report refers to a female patient of unknown age. Medical history was not reported. Current condition included allergies. Concomitant medication was not reported. The patient was vaccinated with influenza virus seasonal vaccine (manufacturer unknown, batch number: not reported) on unknown date. After the vaccination, the patient experienced anaphylactic reaction. Outcome of the event was reported as unknown. Seriousness of the event was reported as non serious. Causality of the event was not reported. Seriousness of the event anaphylactic reaction was upgraded based on the Novartis Important Medical event (NVS-IME) list.
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Balance disorder, C-reactive protein increased, Hypoaesthesia oral, Inflammatory marker increased, Malaise
Clinical narrative: Case number PHHY2016US115292, is an initial spontaneous case received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 641439) website on 23 Aug 2016. This report refers to a female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine (Manufacturer unknown, batch number: not reported) on an unspecified date. Post vaccination on the same evening, the patient suffered from extreme flu like symptoms. The Outcome, seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Pain, Polymyalgia rheumatica, Pruritus, Red blood cell sedimentation rate increased, Tremor
Clinical narrative: Case number PHHY2016US115292, is an initial spontaneous case received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 641439) website on 23 Aug 2016. This report refers to a female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine (Manufacturer unknown, batch number: not reported) on an unspecified date. Post vaccination on the same evening, the patient suffered from extreme flu like symptoms. The Outcome, seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Vision blurred
Clinical narrative: Case number PHHY2016US115292, is an initial spontaneous case received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 641439) website on 23 Aug 2016. This report refers to a female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine (Manufacturer unknown, batch number: not reported) on an unspecified date. Post vaccination on the same evening, the patient suffered from extreme flu like symptoms. The Outcome, seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Influenza like illness
Clinical narrative: Case number PHHY2016US115292, is an initial spontaneous case received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 641439) website on 23 Aug 2016. This report refers to a female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine (Manufacturer unknown, batch number: not reported) on an unspecified date. Post vaccination on the same evening, the patient suffered from extreme flu like symptoms. The Outcome, seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Joint range of motion decreased, Musculoskeletal discomfort, Musculoskeletal pain, Pain, Sleep disorder
Clinical narrative: Case number PHHY2016US115304 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 643262) on 23 Aug 2016. This report refers to a 41 year old female patient. She had no medical history and current conditions. Her concomitant medication were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 27 Oct 2013. On 17 Nov 2013, the patient had increasing shoulder pain with movement and limited range of motion. It was progressed to where she could not raise her arm above shoulder level. She went to the emergency room. On an unknown date, the events improved with medication to the point of chronic discomfort; however, she was unable to sleep on that side and still did not have full range of motion. The outcome of shoulder pain and limited range of motion was reported as condition improving and that of chronic discomfort and unable to sleep on that side was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Discomfort, Joint range of motion decreased, Musculoskeletal pain, Pain, Sleep disorder
Clinical narrative: Case number PHHY2016US115304 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 643262) on 23 Aug 2016. This report refers to a 41 year old female patient. She had no medical history and current conditions. Her concomitant medication were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 27 Oct 2013. On 17 Nov 2013, the patient had increasing shoulder pain with movement and limited range of motion. It was progressed to where she could not raise her arm above shoulder level. She went to the emergency room. On an unknown date, the events improved with medication to the point of chronic discomfort; however, she was unable to sleep on that side and still did not have full range of motion. The outcome of shoulder pain and limited range of motion was reported as condition improving and that of chronic discomfort and unable to sleep on that side was reported as condition unchanged. The events were reported as non-serious. The causality of the events was not reported.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Blood test, Chest pain, Dyskinesia, Dyspnoea, Electroencephalogram
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received TRUMENBA on an unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced a reaction to vaccine on an unspecified date with unknown outcome.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Seizure
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received TRUMENBA on an unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced a reaction to vaccine on an unspecified date with unknown outcome.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Anxiety, Dyskinesia, Electroencephalogram abnormal, Tremor
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received TRUMENBA on an unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced a reaction to vaccine on an unspecified date with unknown outcome.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV4, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Vaccination complication
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received TRUMENBA on an unspecified date at single dose for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced a reaction to vaccine on an unspecified date with unknown outcome.
Age: 15.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Fatigue, Headache, Pyrexia, Vomiting
Clinical narrative: This spontaneous report was received from a consumer, mother of 15 year old male patient. Pertinent medical history, drug reactions and allergies were not reported. On 14-SEP-2016, the patient was vaccinated with his first dose of VARIVAX, (dosage not reported) lot # MO216789, subcutaneous. On the same date, the patient developed restlessness, headache and fever within twenty four hours. The patient's mother stated that her son developed nausea and vomiting two days later with minor traces of blood. The fever continued and patient woke up at 2 am with a fever of 101 degrees. The patient's mother stated that her family moved two months ago. Her son was required to receive the VARIVAX vaccine. Reporter consulted his physician by phone and was advised to give patient Ibuprofen. The nausea and vomiting have subsided, however, the fever has not. Reporter was scheduling a doctor's appointment for her son on 19-SEP-2016 (reported as today). The outcome of haematemesis, nausea, headache and restlessness was reported as recovering/resolving. The outcome for pyrexia was not recovered/not resolved. The causality assessment was not provided. Upon internal review, the event haematemesis was determined to be medically significant. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Haematemesis, Headache, Nausea, Pyrexia, Restlessness
Clinical narrative: This spontaneous report was received from a consumer, mother of 15 year old male patient. Pertinent medical history, drug reactions and allergies were not reported. On 14-SEP-2016, the patient was vaccinated with his first dose of VARIVAX, (dosage not reported) lot # MO216789, subcutaneous. On the same date, the patient developed restlessness, headache and fever within twenty four hours. The patient's mother stated that her son developed nausea and vomiting two days later with minor traces of blood. The fever continued and patient woke up at 2 am with a fever of 101 degrees. The patient's mother stated that her family moved two months ago. Her son was required to receive the VARIVAX vaccine. Reporter consulted his physician by phone and was advised to give patient Ibuprofen. The nausea and vomiting have subsided, however, the fever has not. Reporter was scheduling a doctor's appointment for her son on 19-SEP-2016 (reported as today). The outcome of haematemesis, nausea, headache and restlessness was reported as recovering/resolving. The outcome for pyrexia was not recovered/not resolved. The causality assessment was not provided. Upon internal review, the event haematemesis was determined to be medically significant. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Seen 9/21/16 by Primary Care, has cellulitis on (L) upper arm. Received influenza and Pneumo on 9/18/16 at local pharmacy. (No previous hx of adverse reaction). Given rx of amoxicillin 500 mg x 10 days.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: Seen 9/21/16 by Primary Care, has cellulitis on (L) upper arm. Received influenza and Pneumo on 9/18/16 at local pharmacy. (No previous hx of adverse reaction). Given rx of amoxicillin 500 mg x 10 days.
Sex: M
Vaccine: UNK
Symptoms: Mobility decreased, Nausea
Clinical narrative: Initial unsolicited report received from a non-health care professional on 12 September 2016. This case involves an 86-year-old male patient who was vaccinated with a dose of FLUZONE HD (batch number, expiration date, route, dose not reported) on an unspecified date. Patient's medical history includes diabetes. Illness at time of vaccination was not reported. Any other vaccinations within 4 weeks of vaccinations were not reported. Concomitant medications were not provided. On an unspecified date, following the vaccination, the patient cannot move arm or hand (in frozen state) and experienced nausea. Lab data and corrective treatment was not reported. It was unknown that patient was recovered or not. List of documents held by sender: none.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haemorrhage
Clinical narrative: Initial unsolicited report received from a pharmacist on 15 September 2016. This case involves a 77-year-old male patient who was vaccinated with a dose of FLUZONE HD (batch number: UI634AA, expiration date: 22 March 2017, dose not reported) intramuscularly in the left deltoid on 08 Sep 2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and illness at time of vaccination were reported as none. Concomitant medications were not provided. It was reported that, the patient was not on blood thinners or blood pressure medicines. On 08 Sep 2016, same day following the vaccination, the patient experienced bleeding at the injection site (from the time of the vaccine administration until the next morning). Also reported that, next day in the morning patient had a blood stain on his shirt at the injection site. Lab data was reported as none. Corrective treatment was not reported. On an unspecified date, the patient was recovered from the event. List of documents held by sender: none.
Age: 0.75
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Crying, Pyrexia, Screaming, Vomiting
Clinical narrative: After falling asleep 2 hours earlier than usual, she woke up after 2 hours crying with a fever.  Her cries soon became high pitched screams like I've never heard before.  It went in for a good half hour or longer with some vomitting.  We gave her Tylenol and it eventually stopped and she was then able to nurse.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Hypersensitivity, Incomplete course of vaccination, Muscular weakness, Urticaria
Clinical narrative: He developed hives on his entire body and was given Benydryl. Hives subsided with Benadryl but reoccurred again the next morning. Unsure of whether this is temporary or chronic at this point. We will not proceed with other shots in the series, as this is definitely an allergic reaction. My son also says he is experiencing weakness in his legs.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Typical arm soreness and limited range of movement. However, it has not gone away and has gotten worse over the past two weeks to now include some numbness and tingling in fingers of left hand.
Age: 66.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness
Clinical narrative: Dizziness.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Cardiac monitoring, Computerised tomogram head, Electroencephalogram, Headache
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 year old female patient who was not pregnant. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On an unknown date in 2015 (reported as "about a year ago"), the patient was vaccinated with the first dose of GARDASIL 9 (lot #, expiration date, dose and route were unknown). On an unknown date in 2015, about a month following the administration, the patient passed out while she was running. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 (lot #, expiration date, dose and route were unknown) and was well tolerated. On an unknown date in July 2016, the patient was vaccinated with the third dose of GARDASIL 9 (lot #, expiration date, dose and route were unknown). On an unknown date in September 2016, the patient passed out while she was running cross country. So she was rushed to an unspecified emergency room at an unknown hospital where was performed a computerised tomogram (CAT scan) and an electroencephalogram (EEG) to rule out seizures. Unspecified blood tests were also performed (results were pending) and a cardiac monitoring was placed on an unknown date. At reporting time in September 2016, the patient experienced headaches and tingling feeling in her left arm. The patient was not admitted to the unknown hospital, and was discharged from the emergency department on an unknown date in September 2016. At the time of the reporting, the outcome of the events was not reported. The causal relationship between the events and GARDASIL 9 was not provided. Upon internal review, pass out was considered to be medically significant. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Paraesthesia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 year old female patient who was not pregnant. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On an unknown date in 2015 (reported as "about a year ago"), the patient was vaccinated with the first dose of GARDASIL 9 (lot #, expiration date, dose and route were unknown). On an unknown date in 2015, about a month following the administration, the patient passed out while she was running. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 (lot #, expiration date, dose and route were unknown) and was well tolerated. On an unknown date in July 2016, the patient was vaccinated with the third dose of GARDASIL 9 (lot #, expiration date, dose and route were unknown). On an unknown date in September 2016, the patient passed out while she was running cross country. So she was rushed to an unspecified emergency room at an unknown hospital where was performed a computerised tomogram (CAT scan) and an electroencephalogram (EEG) to rule out seizures. Unspecified blood tests were also performed (results were pending) and a cardiac monitoring was placed on an unknown date. At reporting time in September 2016, the patient experienced headaches and tingling feeling in her left arm. The patient was not admitted to the unknown hospital, and was discharged from the emergency department on an unknown date in September 2016. At the time of the reporting, the outcome of the events was not reported. The causal relationship between the events and GARDASIL 9 was not provided. Upon internal review, pass out was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to the patients of unknown age and gender. The patient's medical histories, concurrent conditions and concomitant therapies were not reported. The doses of M-M-R II were improperly stored at 1.5 Celsius degree for 29 minutes on 15-AUG-2016. Prior excursions included 10.2 Celsius degree for 6 hours 35 minutes on 21-JUN-2016 and 1.4 Celsius degree for 53 minutes on 09-AUG-2016. On unknown dates in 2016 (reported as "after 15-AUG-2016"), the patients were vaccinated with improperly stored M-M-R II( dose, lot #, expiration date and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Back pain, Chest discomfort, Dyspnoea, Immediate post-injection reaction, Musculoskeletal stiffness
Clinical narrative: This spontaneous report was received from a nurse and refers to a 39 year old male patient. The patient's pertinent medical history included Crohn's disease, diverticulitis and history of elevated liver function tests. He did not have any drug reactions or allergies. Concomitant therapies included HUMIRA, albuterol, amlodipine, aspirin (manufacturer unknown), atenolol, IMURAN, SYMBICORT, CELEXA, clonidine, FLEXERIL, VALIUM, LASIX, LOPID, GLUCOPHAGE, PERCOCET, potassium (unspecified), simvastatin (manufacturer unknown) and DIOVAN HCT. On 15-SEP-2016 at 15:00, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M020521, expiration date 17-NOV-2017, intramuscularly; site and dose were not reported, indication provided as "based upon patient's condition"). On the same day, immediately after vaccination, the patient experienced shortness of breath, chest tightness, severe back pain and stiffness in all extremities. He received epinephrine and the symptoms quickly subsided. The outcome of the events was recovered in approximately September 2016. The relatedness between the events and PNEUMOVAX 23 was not reported. The reporter determined shortness of breath, chest tightness, severe back pain and stiffness in all extremities to be medically significant as they required an intervention to prevent a serious outcome (it was reported that without epinephrine, the adverse events could have been life threatening). Additional information has been requested.
Sex: U
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Case number PHEH2016US018062, is an initial spontaneous report received from a pharmacist on 13 Jul 2016. This report refers to a patient of an unknown age and gender. Past medical history and concomitant medication were not reported. The patient was vaccinated with influenza vaccine (unknown whether seasonal or pandemic, manufacturer and batch number: not reported) on an unknown date. On an unspecified date, the patient had anaphylactic reaction. The outcome of the event was not reported. The seriousness of the event was reported as serious. The causality of the event was not reported. Case lost to follow up until further follow up.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Altered state of consciousness, Asthenia, Burning sensation, Dizziness, Dyspepsia
Clinical narrative: 2 hours after injection, pt felt weakness, dizziness and heart palpitations. Pt also felt like he had heart burn in his chest and abdomen. Pt laid down and felt like he was going to pass out. Symptoms lasted 45 min. Burning sensation lasted a full day and night.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Palpitations
Clinical narrative: 2 hours after injection, pt felt weakness, dizziness and heart palpitations. Pt also felt like he had heart burn in his chest and abdomen. Pt laid down and felt like he was going to pass out. Symptoms lasted 45 min. Burning sensation lasted a full day and night.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash on face and neck which continued to cover my trunk both front and back.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Skin warm, Swelling, Urticaria
Clinical narrative: Swelling welt that is very hot.  The welt continued to swell overnight - the next morning it was approx 6" in diameter and still spreading and extremely hot.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a 73 years old female patient via field representative concerning herself, and the patient is a retired physician. The patient's concurrent conditions, medical history and concomitant medication were not reported. In August 2016 (reported as two Friday's ago), the patient was vaccinated with ZOSTAVAX (strength, dose, route, lot number and expiration date were unknown). In August 2016, after vaccinated the ZOSTAVAX, the patient experienced injection site red, hot and painful. The patient received treatment with hydrocortisone. The outcome of the events was unknown. The causal relationship between the events and ZOSTAVAX was unknown. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness/warmth at injection site 24 hours following injection TYLENOL 325 mg x 2 po for comfort.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Patient seen in office 3 days after vaccination for redness and swelling of extremity where vaccine was given. Arm circumference on non-affected arm = 18.5 cm. On affected arm circumference was 21.5 cm. Recommended antihistamine once per day until resolved, and to follow-up with the allergist to evaluate for possible allergy to flu vaccine.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient seen 2 days post vaccination for redness and swelling one extremity where vaccine was administered. Patient was referred to the local ED. Discharged same day. By day 8 post vaccination symptoms had resolved per Mom.