chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX, PPV, FLUX
Symptoms: Erythema, Pruritus
Clinical narrative: Case PHHY2016US116681 is an initial spontaneous case received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 640156) website on 23 Aug 2016. This report refers to 72 year old female patient. The patient medical history included she received Influenza virus vaccine at the age of 13, 17 year old. The patient current condition included diabetes, she has no any current illness at the time of vaccination. Concomitant medication included SYNTHROID, JANUMET; Baby Aspirin; Vitamin C; Simvastatin. The patient was vaccinated with Influenza virus vaccine seasonal influenza vaccine (manufacturer: unknown, batch number: not reported) on 19 Jun 2016. On the same day, after the injection the patient experienced itching and then as time progressed she had a lot of pain and swelling. She had experienced much more swelling and pain down to her elbow. On an unknown date the patient had visited emergency rom. The outcome of event was reported as completely recovery. The seriousness of the event was reported as non serious. The causality of the event was not reported.
Sex: F
Vaccine: FLUX, PPV, FLUX
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Case PHHY2016US116681 is an initial spontaneous case received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 640156) website on 23 Aug 2016. This report refers to 72 year old female patient. The patient medical history included she received Influenza virus vaccine at the age of 13, 17 year old. The patient current condition included diabetes, she has no any current illness at the time of vaccination. Concomitant medication included SYNTHROID, JANUMET; Baby Aspirin; Vitamin C; Simvastatin. The patient was vaccinated with Influenza virus vaccine seasonal influenza vaccine (manufacturer: unknown, batch number: not reported) on 19 Jun 2016. On the same day, after the injection the patient experienced itching and then as time progressed she had a lot of pain and swelling. She had experienced much more swelling and pain down to her elbow. On an unknown date the patient had visited emergency rom. The outcome of event was reported as completely recovery. The seriousness of the event was reported as non serious. The causality of the event was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Immediate post-injection reaction, Musculoskeletal pain, Pain
Clinical narrative: Case number PHHY2016US115937 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 640765) on 23 Aug 2016. This report refers to a 33 year old female patient. She had no medical history or current conditions. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 20 Nov 2015. On the same day after vaccination, she experienced immediate pain and sore shoulder. The pain increased over next few days. She sought physician care approximately 1 week after vaccination. She was administered 2 cortisone injections and underwent physical therapy. The outcome of the events was unknown. The events were reported as non-serious. The causality of the events was not reported.
Sex: M
Vaccine: DTAP, FLUX, DTAP, FLUX
Symptoms: Alopecia
Clinical narrative: Case number PHHY2016US116281, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 641216) website on 23 Aug 2016. This report refers to a 1 years old male patient (reported as 1.5 years). Past medical history was not reported. Concomitant medications included TYLENOL CHILDRENS (reported as child TYLENOL). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) and DTAP vaccine (manufacturer unknown and batch number: not reported) on 17 May 2015. On 21 May 2015, the patient reported lost patches of hair on his head, it took months to grow and 6 months later he lost more patches of hair. The patient visited the emergency room. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Hypersensitivity
Clinical narrative: Case number PHHY2016US116624 is an initial incomplete report received from Vaccine Adverse Event Reporting System (VAERS reference number: 641482) website on 23 Aug 2016. This report refers to a patient of unknown age and gender. Medical history and concomitant medication was not reported. The patient was vaccinated with Seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unknown date. After vaccination, the patient experienced allergy. Lab data and corrective treatments were not reported. Outcome, seriousness and causality of the event was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Blood test, Computerised tomogram, Menstrual disorder, Ovarian cyst, Ultrasound scan
Clinical narrative: Case number PHHY2016US115991 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 641904) on 23 AUG 2016. This report refers to a 12 year old female patient. Her current conditions included sports induced asthma. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 04 Dec 2010. On 30 Jan 2015, she experienced extreme menstrual cycles and had ovarian cysts. She went to emergency room and computed tomography (CT) scan, ultrasound, blood and urine tests were performed, but results were not reported. The outcome of the events was reported as conditions unchanged. The events were reported as non-serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Urine analysis
Clinical narrative: Case number PHHY2016US115991 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 641904) on 23 AUG 2016. This report refers to a 12 year old female patient. Her current conditions included sports induced asthma. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 04 Dec 2010. On 30 Jan 2015, she experienced extreme menstrual cycles and had ovarian cysts. She went to emergency room and computed tomography (CT) scan, ultrasound, blood and urine tests were performed, but results were not reported. The outcome of the events was reported as conditions unchanged. The events were reported as non-serious. The causality of the events was not reported.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Body temperature increased, Influenza like illness, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Case number PHHY2016US116805, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 642413) on 23 Aug 2016. This report refers to a 76 years old male patient. Past medical history was not reported. Current conditions included diabetes, high blood pressure, arthritis, allergies to bug spray, bug parts, airborne toxins and pollen. Concomitant medication was not reported. He was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) on 06 Jul 2016. After vaccination, on 07 Jul 2016, he experienced stiffness and pain in his shoulder, slight temperature increase and he felt like he was coming down with the flu. The outcome of the events was reported as complete recovery on an unknown date. The events seriousness and causality were not reported.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Influenza like illness, Musculoskeletal pain, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Case number PHHY2016US116805, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 642413) on 23 Aug 2016. This report refers to a 76 years old male patient. Past medical history was not reported. Current conditions included diabetes, high blood pressure, arthritis, allergies to bug spray, bug parts, airborne toxins and pollen. Concomitant medication was not reported. He was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) on 06 Jul 2016. After vaccination, on 07 Jul 2016, he experienced stiffness and pain in his shoulder, slight temperature increase and he felt like he was coming down with the flu. The outcome of the events was reported as complete recovery on an unknown date. The events seriousness and causality were not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Drug hypersensitivity, Influenza
Clinical narrative: Case number PHHY2016US159223, is an initial spontaneous report received from consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 645098) website on 21 Nov 2016. This report refers to a female patient of unknown age. Past medical history and concomitant medications were not reported. The patient was not allergic to eggs, latex. The patient was vaccinated with seasonal influenza vaccine inn (manufacturer unknown and batch number: not reported) on an unknown date. On an unknown date following vaccination, the patient experienced sensitivity to the ingredients and got the flu each time she took a shot. Laboratory data and corrective treatment were not reported. The outcome of the events was not reported. The seriousness and causality of the events was not reported. The causality of the events was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza, Reaction to preservatives
Clinical narrative: Case number PHHY2016US159223, is an initial spontaneous report received from consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 645098) website on 21 Nov 2016. This report refers to a female patient of unknown age. Past medical history and concomitant medications were not reported. The patient was not allergic to eggs, latex. The patient was vaccinated with seasonal influenza vaccine inn (manufacturer unknown and batch number: not reported) on an unknown date. On an unknown date following vaccination, the patient experienced sensitivity to the ingredients and got the flu each time she took a shot. Laboratory data and corrective treatment were not reported. The outcome of the events was not reported. The seriousness and causality of the events was not reported. The causality of the events was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Electromyogram, Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia
Clinical narrative: Case number PHHY2016US159920 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 646189) on 21 Nov 2016. This report refers to a 37 year old female patient. The past medical history included seasonal allergies. Concomitant medication was not reported. The patient was vaccinated with seasonal Influenza vaccine (manufacturer unknown) into left arm on 28 Oct 2015. On the same day, the patient experienced numbness, pain, tingling and loss of feeling at injection site plus entire arm, right hand and shoulder. It was reported that, as of today, the patient had still no relief. The patient visited emergency room on an unspecified date. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site reaction, Pain in extremity, Paraesthesia, Sensory loss
Clinical narrative: Case number PHHY2016US159920 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 646189) on 21 Nov 2016. This report refers to a 37 year old female patient. The past medical history included seasonal allergies. Concomitant medication was not reported. The patient was vaccinated with seasonal Influenza vaccine (manufacturer unknown) into left arm on 28 Oct 2015. On the same day, the patient experienced numbness, pain, tingling and loss of feeling at injection site plus entire arm, right hand and shoulder. It was reported that, as of today, the patient had still no relief. The patient visited emergency room on an unspecified date. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Injection site reaction
Clinical narrative: Case number PHHY2016US159920 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 646189) on 21 Nov 2016. This report refers to a 37 year old female patient. The past medical history included seasonal allergies. Concomitant medication was not reported. The patient was vaccinated with seasonal Influenza vaccine (manufacturer unknown) into left arm on 28 Oct 2015. On the same day, the patient experienced numbness, pain, tingling and loss of feeling at injection site plus entire arm, right hand and shoulder. It was reported that, as of today, the patient had still no relief. The patient visited emergency room on an unspecified date. The outcome of the events was reported as condition unchanged. 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 in extremity, Paraesthesia, Sensory loss
Clinical narrative: Case number PHHY2016US159920 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 646189) on 21 Nov 2016. This report refers to a 37 year old female patient. The past medical history included seasonal allergies. Concomitant medication was not reported. The patient was vaccinated with seasonal Influenza vaccine (manufacturer unknown) into left arm on 28 Oct 2015. On the same day, the patient experienced numbness, pain, tingling and loss of feeling at injection site plus entire arm, right hand and shoulder. It was reported that, as of today, the patient had still no relief. The patient visited emergency room on an unspecified date. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: U
Vaccine: FLUX, PNC13, FLUX, PNC13
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2016US160901, is an initial spontaneous report received from a pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 646255) website on 21 Nov 2016. This report refers to a patient of an unknown age and gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on an unspecified date. The patient also vaccinated with PREVNAR 13 vaccine (other  manufacturer, batch number: not reported) on an unknown date. On an unspecified date, following the vaccination, the patient had experienced Guillain-Barre syndrome (GBS). The outcome of event was reported as condition unchanged. The seriousness of the event was reported as non serious. The causality of the event was not reported. Seriousness assessment of Guillain-Barre syndrome was upgraded to serious (medically significant) based on the Novartis important medical event list.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Muscle contractions involuntary, Paraesthesia
Clinical narrative: Case number PHHY2016US160763, is an initial spontaneous report received from consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 646474) website on 21 Nov 2016. This report refers to a patient of an unknown age and gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with first dose of seasonal influenza vaccine INN (manufacturer and batch number not reported) intramuscularly on an unspecified date. On an unspecified date, few years following the vaccination, the patient developed six months of fasciculation and tingling. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Case number PHHY2016US160861, is an initial spontaneous report received from a health care professional via Pfizer (reference number: 2016005924) and via the Vaccine Adverse Event Reporting System (VAERS, reference number: 647102) on 21 Nov 2016. This report refers to a female patient of an unknown age. Medical history and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unspecified date (route and site of vaccination were not reported). On an unknown date, following the vaccination the patient experienced allergy to vaccine. Laboratory data and corrective treatment were not reported. The outcome, seriousness and causality of the event was not reported.
Age: 0.3
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2016US160946, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 647683) website on 21 Nov 2016. This report refers to a 04 months old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) into arm (unspecified) on 20 Jun 2015 when he was 04 months old. On the same day after vaccination, the patient had got high fever and patient was hospitalized for one day. The patient visited the emergency room. The patient was given TYLENOL and cool bath every hour. The outcome of the event was reported as complete recovery on an unknown date. The seriousness of the event was reported as serious (life threatening). The causality of the event was not reported.
Age: 0.3
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Drug administered to patient of inappropriate age, Pyrexia
Clinical narrative: Case number PHHY2016US160946, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 647683) website on 21 Nov 2016. This report refers to a 04 months old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) into arm (unspecified) on 20 Jun 2015 when he was 04 months old. On the same day after vaccination, the patient had got high fever and patient was hospitalized for one day. The patient visited the emergency room. The patient was given TYLENOL and cool bath every hour. The outcome of the event was reported as complete recovery on an unknown date. The seriousness of the event was reported as serious (life threatening). The causality of the event was not reported.
Age: 68.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Blood test, Chest pain, Electrocardiogram, Headache
Clinical narrative: Case number PHHY2016US160972, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 653911) website on 21 Nov 2016. This report refers to a 68 years old female patient. Past medical history was not reported. Concomitant medications included as Diltiazem CD and lisinopril. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) into left arm on 03 Sep 2016. On 04 Sep 2016, the patient suffered with headache that would not go away. On 03 day ended up in emergency room via ambulance with severe headache and chest pains on 04 Sep 2016. The patient performed electrocardiogram (EKG) and blood tests with no results. The patient visited the emergency room. The outcome of events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness assessment of chest pain was upgraded to serious (medically significant) based on the information available in the source document.
Age: 43.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Fatigue, Headache, Hepatic enzyme, Hypersensitivity, Lacrimation increased
Clinical narrative: Case number PHHY2016US160879, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 653953) on 21 Nov 2016. This report refers to a 43-year-old female patient. Medical history was not reported. Current condition included Hashimoto's disease. Concomitant medication included NATURES WAY Immune gummies multivitamin. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into left arm on 12 Sep 2016. On 13 Sep 2016, the patient experienced extreme fatigue, sore throat and felt heavy limbed. The next morning (on 14 Sep 2016) the patient experienced allergic reaction, head congestion, violent headache and eyes streaming. On the same day in am, she had stiff and painful neck, migraine and photosensitivity that lasted for 3 days. The patient took ZYRTEC that helped to stave off her allergic reaction for 24 hours. On the same day, before going to bed she had XYZAL as her throat felt like closing off. Following the events the patient visited emergency room. She underwent pancreatic and liver enzyme test (results not reported). She was tested negative for streptococcus. She did not test for Epstein Barr reactivation. The outcome of the events was reported as complete recovery. The seriousness of the events was not reported, but the event allergic reaction was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 43.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Limb discomfort, Migraine, Musculoskeletal stiffness, Neck pain, Oropharyngeal pain
Clinical narrative: Case number PHHY2016US160879, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 653953) on 21 Nov 2016. This report refers to a 43-year-old female patient. Medical history was not reported. Current condition included Hashimoto's disease. Concomitant medication included NATURES WAY Immune gummies multivitamin. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into left arm on 12 Sep 2016. On 13 Sep 2016, the patient experienced extreme fatigue, sore throat and felt heavy limbed. The next morning (on 14 Sep 2016) the patient experienced allergic reaction, head congestion, violent headache and eyes streaming. On the same day in am, she had stiff and painful neck, migraine and photosensitivity that lasted for 3 days. The patient took ZYRTEC that helped to stave off her allergic reaction for 24 hours. On the same day, before going to bed she had XYZAL as her throat felt like closing off. Following the events the patient visited emergency room. She underwent pancreatic and liver enzyme test (results not reported). She was tested negative for streptococcus. She did not test for Epstein Barr reactivation. The outcome of the events was reported as complete recovery. The seriousness of the events was not reported, but the event allergic reaction was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 43.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pancreatic enzymes, Photosensitivity reaction, Streptococcus test negative, Upper respiratory tract congestion
Clinical narrative: Case number PHHY2016US160879, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 653953) on 21 Nov 2016. This report refers to a 43-year-old female patient. Medical history was not reported. Current condition included Hashimoto's disease. Concomitant medication included NATURES WAY Immune gummies multivitamin. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into left arm on 12 Sep 2016. On 13 Sep 2016, the patient experienced extreme fatigue, sore throat and felt heavy limbed. The next morning (on 14 Sep 2016) the patient experienced allergic reaction, head congestion, violent headache and eyes streaming. On the same day in am, she had stiff and painful neck, migraine and photosensitivity that lasted for 3 days. The patient took ZYRTEC that helped to stave off her allergic reaction for 24 hours. On the same day, before going to bed she had XYZAL as her throat felt like closing off. Following the events the patient visited emergency room. She underwent pancreatic and liver enzyme test (results not reported). She was tested negative for streptococcus. She did not test for Epstein Barr reactivation. The outcome of the events was reported as complete recovery. The seriousness of the events was not reported, but the event allergic reaction was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 43.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pancreatic enzymes, Photosensitivity reaction, Respiratory tract congestion, Streptococcus test negative, Throat tightness
Clinical narrative: Case number PHHY2016US160879, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 653953) on 21 Nov 2016. This report refers to a 43-year-old female patient. Medical history was not reported. Current condition included Hashimoto's disease. Concomitant medication included NATURES WAY Immune gummies multivitamin. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into left arm on 12 Sep 2016. On 13 Sep 2016, the patient experienced extreme fatigue, sore throat and felt heavy limbed. The next morning (on 14 Sep 2016) the patient experienced allergic reaction, head congestion, violent headache and eyes streaming. On the same day in am, she had stiff and painful neck, migraine and photosensitivity that lasted for 3 days. The patient took ZYRTEC that helped to stave off her allergic reaction for 24 hours. On the same day, before going to bed she had XYZAL as her throat felt like closing off. Following the events the patient visited emergency room. She underwent pancreatic and liver enzyme test (results not reported). She was tested negative for streptococcus. She did not test for Epstein Barr reactivation. The outcome of the events was reported as complete recovery. The seriousness of the events was not reported, but the event allergic reaction was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Dysphemia
Clinical narrative: Case number PHHY2016US160821, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 653972) website on 21 Nov 2016. This report refers to a 03 years old male patient. Past medical history was not reported. Current conditions included sensory processing disorder, cold, seasonal allergies, asthma and allergies. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) in left arm on 02 Sep 2016. On 03 Sep 2016, the patient experienced stuttering. It was reported that he never stuttered at all. He loved to talk and talked clearly. However he stuttered over every word he said and he did not wanted to talk anymore. The outcome of the event stuttering was reported as condition unchanged. The seriousness and causality of the event were not reported.
Age: 58.0
Sex: F
Vaccine: FLU4, TDAP, FLUX, TDAP
Symptoms: Dyspnoea
Clinical narrative: I was fine just after the vaccinations, talking to the nurse, then I am blank.  I remember nothing, not leaving the facility, not even the drive home.
Age: 58.0
Sex: F
Vaccine: FLU4, TDAP, FLUX, TDAP
Symptoms: Amnesia, Computerised tomogram, Oral mucosal eruption, Rash
Clinical narrative: I was fine just after the vaccinations, talking to the nurse, then I am blank.  I remember nothing, not leaving the facility, not even the drive home.
Age: 27.0
Sex: F
Vaccine: FLUX, VARCEL, FLUX, VARCEL
Symptoms: Hypersomnia, Incorrect route of drug administration, Myalgia, Neck pain
Clinical narrative: Case number PHEH2016US028867, is an initial spontaneous report from a consumer (also a nurse) via pharmaceutical company (Merck Research Laboratories) received on 12 Oct 2016. This report refers to a 27 years old female patient. Prior vaccination history included vaccination with VARIVAX vaccine (Other manufacturer, batch number; not reported) on an unspecified date in 2001, 2009 and 2011. Past medical history was not reported. Current condition included as penicillin allergy. Concomitant medications was not reported. On an unspecified date in 2015, she had blood work drawn to check varicella titers and stated, she was protected but was told that her titers were right on the border of not being protected. That was the reason, patient vaccinated with fourth dose of VARIVAX vaccine (other manufacturer, batch number: L021211 and expiry date: 10 Jun 2017) intramuscularly on 10 Oct 2016. The patient was also vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 10 Oct 2016. It was reported that, the next morning, the patient experienced muscle aches, sore neck and sleeping a lot more than normal. The outcome, seriousness and causality of the events were not reported.
Age: 27.0
Sex: F
Vaccine: FLUX, VARCEL, FLUX, VARCEL
Symptoms: Hypersomnia, Inappropriate schedule of drug administration, Myalgia, Nasal discomfort
Clinical narrative: Case number PHEH2016US028867, is an initial spontaneous report from a consumer (also a nurse) via pharmaceutical company (Merck Research Laboratories) received on 12 Oct 2016. This report refers to a 27 years old female patient. Prior vaccination history included vaccination with VARIVAX vaccine (Other manufacturer, batch number; not reported) on an unspecified date in 2001, 2009 and 2011. Past medical history was not reported. Current condition included as penicillin allergy. Concomitant medications was not reported. On an unspecified date in 2015, she had blood work drawn to check varicella titers and stated, she was protected but was told that her titers were right on the border of not being protected. That was the reason, patient vaccinated with fourth dose of VARIVAX vaccine (other manufacturer, batch number: L021211 and expiry date: 10 Jun 2017) intramuscularly on 10 Oct 2016. The patient was also vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 10 Oct 2016. It was reported that, the next morning, the patient experienced muscle aches, sore neck and sleeping a lot more than normal. The outcome, seriousness and causality of the events were not reported.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Aptyalism, Chills, Cough, Dehydration, Diarrhoea
Clinical narrative: Initial unsolicited report received from a consumer on 05 Dec 2016. This case involves a 66 years old female patient who was vaccinated with first dose of FLUZONE HD (batch number, expiry date, dose and route of injection unknown) in right deltoid on 10 Nov 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Any other vaccinations within 4 weeks of vaccination was reported as none. The patient concomitant medications were not reported. On 10 Nov 2016, within four hours following the vaccination, the patient experienced coughing, had a sore throat and began to have difficulty swallowing. In a short time she began to have very thick mucus which made swallowing more difficult. Later that night she developed low grade fever, chills, body aches and soreness down her right arm. Laboratory investigations were reported as none. The patient corrective treatment were reported as none. The patient recovered from all the events within 12 hours. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysphagia, Headache, Increased upper airway secretion, Injection site pain, Nausea
Clinical narrative: Initial unsolicited report received from a consumer on 05 Dec 2016. This case involves a 66 years old female patient who was vaccinated with first dose of FLUZONE HD (batch number, expiry date, dose and route of injection unknown) in right deltoid on 10 Nov 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Any other vaccinations within 4 weeks of vaccination was reported as none. The patient concomitant medications were not reported. On 10 Nov 2016, within four hours following the vaccination, the patient experienced coughing, had a sore throat and began to have difficulty swallowing. In a short time she began to have very thick mucus which made swallowing more difficult. Later that night she developed low grade fever, chills, body aches and soreness down her right arm. Laboratory investigations were reported as none. The patient corrective treatment were reported as none. The patient recovered from all the events within 12 hours. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Pyrexia, Throat tightness
Clinical narrative: Initial unsolicited report received from a consumer on 05 Dec 2016. This case involves a 66 years old female patient who was vaccinated with first dose of FLUZONE HD (batch number, expiry date, dose and route of injection unknown) in right deltoid on 10 Nov 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Any other vaccinations within 4 weeks of vaccination was reported as none. The patient concomitant medications were not reported. On 10 Nov 2016, within four hours following the vaccination, the patient experienced coughing, had a sore throat and began to have difficulty swallowing. In a short time she began to have very thick mucus which made swallowing more difficult. Later that night she developed low grade fever, chills, body aches and soreness down her right arm. Laboratory investigations were reported as none. The patient corrective treatment were reported as none. The patient recovered from all the events within 12 hours. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vaccination site pain, Vision blurred
Clinical narrative: Initial unsolicited report received from a consumer on 05 Dec 2016. This case involves a 66 years old female patient who was vaccinated with first dose of FLUZONE HD (batch number, expiry date, dose and route of injection unknown) in right deltoid on 10 Nov 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Any other vaccinations within 4 weeks of vaccination was reported as none. The patient concomitant medications were not reported. On 10 Nov 2016, within four hours following the vaccination, the patient experienced coughing, had a sore throat and began to have difficulty swallowing. In a short time she began to have very thick mucus which made swallowing more difficult. Later that night she developed low grade fever, chills, body aches and soreness down her right arm. Laboratory investigations were reported as none. The patient corrective treatment were reported as none. The patient recovered from all the events within 12 hours. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Cough, Dysphagia, Increased viscosity of upper respiratory secretion, Oropharyngeal pain
Clinical narrative: Initial unsolicited report received from a consumer on 05 Dec 2016. This case involves a 66 years old female patient who was vaccinated with first dose of FLUZONE HD (batch number, expiry date, dose and route of injection unknown) in right deltoid on 10 Nov 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Any other vaccinations within 4 weeks of vaccination was reported as none. The patient concomitant medications were not reported. On 10 Nov 2016, within four hours following the vaccination, the patient experienced coughing, had a sore throat and began to have difficulty swallowing. In a short time she began to have very thick mucus which made swallowing more difficult. Later that night she developed low grade fever, chills, body aches and soreness down her right arm. Laboratory investigations were reported as none. The patient corrective treatment were reported as none. The patient recovered from all the events within 12 hours. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer on 05 Dec 2016. This case involves a 66 years old female patient who was vaccinated with first dose of FLUZONE HD (batch number, expiry date, dose and route of injection unknown) in right deltoid on 10 Nov 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Any other vaccinations within 4 weeks of vaccination was reported as none. The patient concomitant medications were not reported. On 10 Nov 2016, within four hours following the vaccination, the patient experienced coughing, had a sore throat and began to have difficulty swallowing. In a short time she began to have very thick mucus which made swallowing more difficult. Later that night she developed low grade fever, chills, body aches and soreness down her right arm. Laboratory investigations were reported as none. The patient corrective treatment were reported as none. The patient recovered from all the events within 12 hours. List of documents held by sender: none.
Age: 29.0
Sex: F
Vaccine: FLU4, PPV, TDAP, FLUX, PPV, TDAP
Symptoms: Adverse reaction
Clinical narrative: Case number PHEH2016US030568, is an initial spontaneous report received from a pharmacist on 17 Nov 2016. This report refer to a 29-years-old-female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of seasonal virus vaccine INN (unknown manufacturer, batch number: not reported) at a dose of 0.5 ml intramuscularly on 03 Oct 2016. The patient was also vaccinated with TDAP (manufacturer unknown, batch number: not reported) and PNEUMOVAX (batch number: not reported) on 03 Oct 2016. On 05 Oct 2016, 48 hours after vaccination, the patient experienced soreness in the arm at the injection site. The outcome of the event soreness in the arm at the injection site was reported as complete recovery on an unspecified date. The seriousness of the event soreness in the arm at the injection site was reported as non-serious. The causality of event soreness in the arm at the injection site was not reported.
Age: 29.0
Sex: F
Vaccine: FLU4, PPV, TDAP, FLUX, PPV, TDAP
Symptoms: Injection site pain
Clinical narrative: Case number PHEH2016US030568, is an initial spontaneous report received from a pharmacist on 17 Nov 2016. This report refer to a 29-years-old-female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of seasonal virus vaccine INN (unknown manufacturer, batch number: not reported) at a dose of 0.5 ml intramuscularly on 03 Oct 2016. The patient was also vaccinated with TDAP (manufacturer unknown, batch number: not reported) and PNEUMOVAX (batch number: not reported) on 03 Oct 2016. On 05 Oct 2016, 48 hours after vaccination, the patient experienced soreness in the arm at the injection site. The outcome of the event soreness in the arm at the injection site was reported as complete recovery on an unspecified date. The seriousness of the event soreness in the arm at the injection site was reported as non-serious. The causality of event soreness in the arm at the injection site was not reported.
Sex: F
Vaccine: PPV, PPV
Symptoms: Local reaction, Peripheral swelling, Skin reaction
Clinical narrative: Information has been received from a pharmacist concerning a 72 year old female patient. In 2015 (also reported as "last year"), the patient was received pneumococcal conjugate vaccine. The patient developed rash due to using amoxicillin. On 07-DEC-2016 the patient was vaccinated with PNEUMOVAX23 (strength, dose, frequency, lot# and expiration date were unknown) intramuscularly for prevention of pneumococcal disease. On 08-DEC-2016, the patient experienced local swelling of the right deltoid and the patient sought medical attention at the hospital on 09-DEC-2016. The comprehensive metabolic panel and complete blood count was performed on that day. The outcome of local swelling was reported as not recovered. The causality between PNEUMOVAX23 and the event was unknown.  Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Full blood count, Local swelling, Metabolic function test
Clinical narrative: Information has been received from a pharmacist concerning a 72 year old female patient. In 2015 (also reported as "last year"), the patient was received pneumococcal conjugate vaccine. The patient developed rash due to using amoxicillin. On 07-DEC-2016 the patient was vaccinated with PNEUMOVAX23 (strength, dose, frequency, lot# and expiration date were unknown) intramuscularly for prevention of pneumococcal disease. On 08-DEC-2016, the patient experienced local swelling of the right deltoid and the patient sought medical attention at the hospital on 09-DEC-2016. The comprehensive metabolic panel and complete blood count was performed on that day. The outcome of local swelling was reported as not recovered. The causality between PNEUMOVAX23 and the event was unknown.  Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 15.0
Sex: M
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a physician referring to a 14 years old male patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient inadvertently received a dose of PROQUAD injection (lot #, expiration date, dose and route were unknown) for prophylaxis, which was outside the recommendations per the prescribing information (drug administered to patient of inappropriate age). No adverse effects were reported. Follow up information has been received from the physician on 02-DEC-2016 referring to the 15 year old patient. On 26-AUG-2016 at 09:13, the patient received the first dose of PROQUAD (lot# M014302, subcutaneous in right arm) in private doctor's office/hospital with private funds. Additional information is not expected as all correspondence has been received. Reporter information, patient information, product, event and narrative had been updated. Sender's Comments: MERCK 1610USA002049:Mfr number.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to 4 patients of unknown age and gender. The patients' pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of ROTATEQ lot # M006112 for prophylaxis. The vaccine was exposed to temperature of 49 Fahrenheit for 30 minutes. No previous temperature excursion was reported. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. Follow up information has been received on 22-NOV-2016, than all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from the nurse on 06-DEC-2016, who stated that the 6 months old patient of unknown gender was vaccinated on 20-OCT-2016 with a dose of ROTATEQ orally (volume/dose reported as 2). This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA004378: US-009507513-1610USA004376: US-009507513-1610USA004377: US-009507513-1612USA006676: US-009507513-1612USA006673: US-009507513-1612USA006675: US-009507513-1612USA006674: US-009507513-1612USA006672:, MERCK 1610USA003097:Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager refers to an unknown number of patients of unknown age and gender. No pertinent medical history and drug reactions/Allergies were reported. On an unknown dates, the unknown number of patients were vaccinated with improperly stored (incorrect product storage) doses of GARDASIL 9 (lot # M021407 and expiry date 30-APR-2018) (dosing regimen was unknown by the reporter) for prophylaxis. No concomitant medications were reported. The vaccine was exposed to temperature excursion of 31.3 Fahrenheit for 15 minutes. No adverse effects were reported. No product quality complaint (PQC) was reported. Follow-up information was received on 20-DEC-2016 from the office manager. The reporter stated that she had faxed the information in the past, but would refax it. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA012917: US-009507513-1610USA012405: MERCK 1610USA012922:Mfr number.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age and gender. No pertinent medical history, drug reactions/allergies and concomitant medications were reported. On an unspecified dates between September 2016 to October 2016, the unspecified patients were vaccinated with improperly stored doses of  PROQUAD (lot # M021731 and expiry date 29-OCT-2017) (lot # M031941 and expiry date 27-DEC-2017) (dosing regimen unknown) for prophylaxis. On an unspecified dates between September 2016 to October 2016, PROQUAD with lot number M021731 was exposed to temperature excursion of 6.7 Fahrenheit for 2 hours and 3 minutes, 18.7F for 3 hours and 39 minutes, 11.9 F for 2 hours and 37 minutes, 10.3F for 1 hour and 22 minutes, 9.5F for 3 hours and 32 minutes, 9.4F for 2 hours and 53 minutes, 8.8F for 56 minutes, 9.7F for 4 hours and 42 minutes and with lot number M031941 was exposed to 10.3 F for 1 hour and 22 minutes, 9.5F for 3 hours and 32 minutes , 9.4F for 2 hours and 53 minutes, 8.8 F for 56 minutes and 9.7 F for 4 hours and 42 minutes. No Previous temperature excursion were reported. The call was due to digital data logger. No symptoms were reported. No product quality complaint was filed. Information was received on 03-NOV-2016, lot number M031941(rHA) with expiry date 27-DEC-2017 was verified to be a valid lot number for PROQUAD. Information was received on 20-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA010372: MERCK 1610USA015091:Mfr number.