chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Blood pressure increased, Chest discomfort, Dizziness, Feeling jittery
Clinical narrative: Case number PHHY2015US173384, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 603058) website on 29 Dec 2015. This report refers to a 33 years old female patient. Past medical history and current illness was reported was not reported. Concomitant medication included WELLBUTRIN XL. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported) on 15 Oct 2015. About 30 minutes after vaccination, she started feeling like her heart was racing, lightheaded, like there was a brick on chest, really weak. She reached home around 3 and immediately laid down. When she woke up, her throat felt like it was swelling, her heart was still racing and she was uncomfortably jittery, her blood pressure and pulse were elevated. She received treatment with BENADRYL and NASACORT. As BENADRYL started to work, her blood pressure and pulse went down. Her throat still felt constricted but it was not getting worse. When she woke up the next morning her throat did not feel as constricted but was real sore. She felt jittery till about 13:00 hours that afternoon. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality was not reported. The seriousness assessment of the events palpitations, chest discomfort, pharyngeal oedema, throat tightness was upgraded (medically significant) based on the information available in the source document.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased, Oropharyngeal pain, Palpitations, Pharyngeal oedema
Clinical narrative: Case number PHHY2015US173384, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 603058) website on 29 Dec 2015. This report refers to a 33 years old female patient. Past medical history and current illness was reported was not reported. Concomitant medication included WELLBUTRIN XL. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number and expiry: not reported) on 15 Oct 2015. About 30 minutes after vaccination, she started feeling like her heart was racing, lightheaded, like there was a brick on chest, really weak. She reached home around 3 and immediately laid down. When she woke up, her throat felt like it was swelling, her heart was still racing and she was uncomfortably jittery, her blood pressure and pulse were elevated. She received treatment with BENADRYL and NASACORT. As BENADRYL started to work, her blood pressure and pulse went down. Her throat still felt constricted but it was not getting worse. When she woke up the next morning her throat did not feel as constricted but was real sore. She felt jittery till about 13:00 hours that afternoon. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality was not reported. The seriousness assessment of the events palpitations, chest discomfort, pharyngeal oedema, throat tightness was upgraded (medically significant) based on the information available in the source document.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Fatigue, Feeling abnormal, Feeling of body temperature change, Nausea
Clinical narrative: Case number PHHY2016US011347 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 603072) on 18 Jan 2016. This report refers to a 36 year old female patient. She had no medical history, current condition or concomitant medications. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in the left arm on 12 Oct 2015. On 14 Oct 2015, the patient experienced nausea, stomach cramps, fatigue, hot/cold sensation and she was feeling floaty. She was a little better on 17 Oct 2015, but still she was not 100% fine. No laboratory tests were done. The outcome of the events was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Feeling abnormal, Headache, Influenza virus test negative, Limb discomfort
Clinical narrative: Case number PHHY2015US171420, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 603111) website on 29 Dec 2015. This report refers to a 52 years old female patient. Medical history was not reported. Past medication included novacaine (manufacture unknown). Concomitant medication included SYNTHROID, lisinopril/hydrochlorothiazide (manufacture unknown), atenolol (manufacture unknown) and PREMPRO. The patient was vaccinated with seasonal influenza vaccine (manufacture unknown, batch number and expiry date: not reported) intramuscularly in arm on 13 Oct 2015. On the same after vaccination, she felt her legs as could not pick them up (weighed 500 pounds each), experienced headache which was severe and progressed to worse, tightness in chest, fever (ranging from 100.5 to 104.7) (unit not reported) and all over aches and pain. The patient felt like she wanted to die. The patient was taken to an emergency room and the physician swabbed nose to rule out flu and the test result was negative for flu. Outcome of events was reported as unknown. Seriousness of the events was reported as non serious and causality not reported. Seriousness assessment of chest discomfort and pyrexia was upgraded based on information available in source document.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia
Clinical narrative: Case number PHHY2015US171420, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 603111) website on 29 Dec 2015. This report refers to a 52 years old female patient. Medical history was not reported. Past medication included novacaine (manufacture unknown). Concomitant medication included SYNTHROID, lisinopril/hydrochlorothiazide (manufacture unknown), atenolol (manufacture unknown) and PREMPRO. The patient was vaccinated with seasonal influenza vaccine (manufacture unknown, batch number and expiry date: not reported) intramuscularly in arm on 13 Oct 2015. On the same after vaccination, she felt her legs as could not pick them up (weighed 500 pounds each), experienced headache which was severe and progressed to worse, tightness in chest, fever (ranging from 100.5 to 104.7) (unit not reported) and all over aches and pain. The patient felt like she wanted to die. The patient was taken to an emergency room and the physician swabbed nose to rule out flu and the test result was negative for flu. Outcome of events was reported as unknown. Seriousness of the events was reported as non serious and causality not reported. Seriousness assessment of chest discomfort and pyrexia was upgraded based on information available in source document.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Joint range of motion decreased, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Case number PHHY2016US010822, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 603145) website on 18 Jan 2016. This report refers to a 26-years-old female patient. Past medical history was not reported. Concomitant medications included dexamethasone (manufacturer unknown) and ORTHO TRI CYCLEN LO. She was vaccinated with FLUVIRIN (batch number: 1515101) intramuscularly in left arm on 19 Sep 2015. On the same day, she experienced intense pain radiating down to wrist, shoulder pain and immobility, limited range motion that was ongoing. She was visited the emergency room. 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: FLU3
Symptoms: Dehydration, Dizziness, Headache, Muscle spasms, Nasal congestion
Clinical narrative: Case number PHHY2016US009889, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 603194) on 18 Jan 2016. This report refers to a 50 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 15722P) intramuscularly into the left leg on 14 Oct 2015. After vaccination, on the same day, she had onset of dizziness, mild nausea and headache. By second day, on 15 Oct 2015, she experienced severe nasal congestion and sore throat. She went to urgent care at work and physician said the symptoms could last 2 days. She was advised to take rest and fluids. She came home the next day with escalating symptoms. On 16 Oct 2015, third day after vaccination, she experienced 103 degree Celsius fever by 02:00 am. After 8 hours, fever broke. It was reported that after two days, it was still recovering. On an unknown date, she experienced dehydration and a severe muscle spasm in low back. The outcome of the events was reported as complete recovery on an unknown date. The events were assessed as non serious and causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Case number PHHY2016US009889, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 603194) on 18 Jan 2016. This report refers to a 50 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 15722P) intramuscularly into the left leg on 14 Oct 2015. After vaccination, on the same day, she had onset of dizziness, mild nausea and headache. By second day, on 15 Oct 2015, she experienced severe nasal congestion and sore throat. She went to urgent care at work and physician said the symptoms could last 2 days. She was advised to take rest and fluids. She came home the next day with escalating symptoms. On 16 Oct 2015, third day after vaccination, she experienced 103 degree Celsius fever by 02:00 am. After 8 hours, fever broke. It was reported that after two days, it was still recovering. On an unknown date, she experienced dehydration and a severe muscle spasm in low back. The outcome of the events was reported as complete recovery on an unknown date. The events were assessed as non serious and causality was not reported.
Age: 61.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Erythema, Pain, Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2016US010036, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 603219) on 18 Jan 2016. This report refers to a 61 years old male patient. Past medical history was not reported. Concomitant medications included TRADJENTA, losartan (manufacturer unknown), glipizide (manufacturer unknown) and metformin (manufacturer unknown). He was vaccinated with FLUVIRIN (batch number: 1514701) and PREVNAR (other manufacturer) batch number: L43700); both into the left arm intramuscularly on 30 Sep 2015. After vaccination, on 01 Oct 2015, he felt drowsy, was weak, had a fever, aches, his arm became very red, very sore and painful. It was reported that he was weak two weeks later. Final outcome of the events was reported as complete recovery on an unknown date. The events were assessed as non serious and causality was not reported.
Age: 61.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Somnolence
Clinical narrative: Case number PHHY2016US010036, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 603219) on 18 Jan 2016. This report refers to a 61 years old male patient. Past medical history was not reported. Concomitant medications included TRADJENTA, losartan (manufacturer unknown), glipizide (manufacturer unknown) and metformin (manufacturer unknown). He was vaccinated with FLUVIRIN (batch number: 1514701) and PREVNAR (other manufacturer) batch number: L43700); both into the left arm intramuscularly on 30 Sep 2015. After vaccination, on 01 Oct 2015, he felt drowsy, was weak, had a fever, aches, his arm became very red, very sore and painful. It was reported that he was weak two weeks later. Final outcome of the events was reported as complete recovery on an unknown date. The events were assessed as non serious and causality was not reported.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2016US010086, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 603267) on 18 Jan 2016. This report refers to a 44 years old female patient. Past medical history was not reported. Concomitant medications included PRILOSEC, SYNTHROID and PRESTIQ. She was vaccinated with FLUVIRIN (batch number: 173537) into the left arm on 30 Sep 2015. On 01 Oct 2015, she had inability to abduct left arm with secondary pain, moderate swelling and passive range of motion was painful. Her hand was put in sling. She received treatment with non steroidal anti inflammatory agents, physical therapy and LIDODERM patch to increase motion in left arm. The outcome of the events was reported as condition unchanged. The events were  assessed as non serious and causality was not reported. Following an internal review done on 27 Jan 2016 for the data received on MRD 18 Jan 2016: A significant case correction was done. Changed coding of verbatim passive range of motion painful to pain upon movement and moderate swelling to arm swelling.
Age: 29.0
Sex: F
Vaccine: FLUC3
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Case number PHHY2016US007187, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 603293) website on 18 Jan 2016. This report refers to a 29 years old female patient. Past medical history was not reported. Concomitant medications included birth control pill (reported as BCP) (unspecified). She was vaccinated with FLUCELVAX (batch number: 174274) intramuscularly on 11 Oct 2015. On the same day 4 hours later, she experienced itching and rash from head to toe. She was treated with BENADRYL at home. It was reported that, when she woke rash and itching was gone. 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. The seriousness assessment of the events rash generalised and pruritus generalised was upgraded to be medically significant based on the information provided in the source document.
Age: 57.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: Case number PHHY2016US011240, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 603367) on 18 Jan 2016. This report refers to a 57 years old male patient. Past medical history was not reported. Concomitant medications included clonazepam (manufacturer unknown) 1 mg, doxepin (manufacturer unknown) 25 mg, escitalopram (manufacturer unknown) 20 mg, omeprazole (manufacturer unknown) 40 mg, furosemide (manufacturer unknown) 20 mg, oxycodone (manufacturer unknown) 15 mg, levetiracetam (manufacturer unknown) 500 mg and lisinopril (manufacturer unknown) 20 mg. He was vaccinated with FLUVIRIN (batch number: 157604) and PREVNAR 13 (other manufacturer) batch number: M13067); both into the left arm intramuscularly on 15 Oct 2015. After vaccination, on 16 Oct 2015, he experienced swelling, redness, hardness of upper arm. The outcome of the events was reported as complete recovery on an unknown day. The events were assessed as non serious and causality was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Case number PHHY2016US010437 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 603383) website on 18 Jan 2016. This report refers to a 62 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157805) intramuscularly in the right arm and PREVENAR (batch number: M06900) intramuscularly in the right arm both received on 14 Oct 2015. After vaccination, the patient's whole upper arm was red and swollen. Patient applied ice packs and used ALEVE. It was reported that 5 days later the patient still experienced redness and swollen. Outcome of the events was reported as unknown. Seriousness of the events was reported as non serious and causality of the events was not reported.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHHY2016US010463 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 603384) website on 18 Jan 2016. This report refers to a 6 months old male patient. Medical history and concomitant medications were not reported. This 6 months old male patient was inadvertently vaccinated with FLUVIRIN (batch number: 1515201) intramuscularly in the right leg instead of FLUZONE (batch number: not reported) on 19 Oct 2015. No adverse event was reported following this administration error.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Rash, Rash erythematous
Clinical narrative: Case number PHHY2015US173657, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 603427) on 29 Dec 2015. This report refers to a 54 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 07 Oct 2015. On the same day after vaccination, the patient developed a bumpy rash on face, down on the neck and onto torso. Later the patient developed tiny red spots appeared over her chest. Outcome of the event was reported as complete recovery about 2 days after onset. Event was reported as non-serious. Seriousness assessment of the event rash erythematous was upgraded (medically significant) based on the information available in the source document. Causality was not reported.
Age: 12.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: Case number PHHY2016US006880, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 603463) website on 18 Jan 2016. This report refers to a 12 years old male patient. Past historical condition and concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unknown date. The patient experienced dizziness on an unknown date. The outcome of the event was unknown. The seriousness was reported as non serious and causality was not reported. The seriousness assessment of the event dizziness was upgraded based on the information available in source document.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Rash
Clinical narrative: Case number PHHY2015US171979, is an initial spontaneous report received from a consumer (also patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 603503) website on 29 Dec 2015. This report refers to a 48-year-old female patient. The patient had no medical history and current illness. Vaccination history included administration of flu shots (manufacturer and batch number: not reported) with no side effects. Concomitant medications included Vitamin B, Vitamin D and Box 13 (manufacturer: not reported). The patient was vaccinated seasonal influenza vaccine (manufacturer and batch number: not reported) into the left arm on 10 Oct 2015. On 12 Oct 2015 roughly two days after vaccination, the patient experienced lots of itching and bumps initially around neck and then on head, upper legs and torso. It was close to 10 days now and the events occur off and on. The events were not life threatening but felt it was important to report the events. Final outcome of the events was recovered. Events were reported as non-serious. Causality was not reported. Seriousness of the events was upgraded based on information available in the source document.
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Rash pruritic, Rhinorrhoea
Clinical narrative: Case number PHHY2016US010489, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 603705) on 18 Jan 2016. This report refers to a 64 years old female patient. Past medical history was not reported. Current condition included allergy to penicillin. Concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1514601) into the left arm on 07 Oct 2015. After vaccination, on 08 Oct 2015, she experienced itching rash on back of knees, spread to left of trunk, feeling worn out and nasal drainage. She was feeling better as of 20 Nov 2015. Final outcome of the events was reported as complete recovery on an unknown date. The events were assessed as non serious and causality was not reported.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Chest X-ray normal, Chills, Cough, Dyspnoea, Ear pain
Clinical narrative: Case number PHHY2015US171992, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 603754) website on 29 Dec 2015. This report refers to a 46 years old female patient. Concurrent conditions included diabetes and COPD. Concomitant medications included HUMALOG, LANTUS, sertraline and gabapentin. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 16 Oct 2015. On the same day after vaccination the patient presented with cough, body aches, shortness of breath, ear pain, fever, chills, nausea and vomiting. The patient went to emergency room and had chest x-ray which was normal. Outcome of the events was reported as not recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "shortness of breath" and "vomiting" was upgraded based on information in the source document.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2015US171992, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 603754) website on 29 Dec 2015. This report refers to a 46 years old female patient. Concurrent conditions included diabetes and COPD. Concomitant medications included HUMALOG, LANTUS, sertraline and gabapentin. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 16 Oct 2015. On the same day after vaccination the patient presented with cough, body aches, shortness of breath, ear pain, fever, chills, nausea and vomiting. The patient went to emergency room and had chest x-ray which was normal. Outcome of the events was reported as not recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "shortness of breath" and "vomiting" was upgraded based on information in the source document.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Eye pruritus, Wheezing
Clinical narrative: Case number PHHY2015US173563, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 603763) website on 29 Dec 2015. This report refers to a 7-year-old male patient. Current condition included runny nose for two days and the patient was on ALLEGRA. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 19 Oct 2015. On the same day after vaccination, the patient experienced itchy eyes, cough and wheezing. The patient did not develop hives. The patient went to emergency room (ER). Final outcome of the events was recovered. Events were reported as non-serious. Causality was not reported. Seriousness of the events was upgraded based on information available in the source document.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Case number PHHY2016US009237, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 603839) on 18 Jan 2016. This report refers to a 45 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157405) into right arm on 07 Oct 2015. On 08 Oct 2015 the patient experienced pain in arm and stiffness. Her arm hurts while doing normal day to day activity for example putting seat belt on. It was reported that the patient still had pain after two weeks and stiffness progressively worsening as day goes on. The patient was going to physician on 21 Oct 2015. Final outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site scab, Injection site swelling
Clinical narrative: Case number PHHY2016US011232, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 604124) on 18 Jan 2016. This report refers to a 56 years old female patient. Medical history included cleft lip/palate repair during childhood. Concurrent conditions included hypothyroidism and allergy to sulfa drugs. Concomitant medication included levothyroxine. The patient was vaccinated with FLUVIRIN (batch number: 157401) intramuscularly into right arm on 30 Sep 2015. On 01 Oct 2015 the patient's injection site was tender to touch, red, raised and scabbed over. On 22 Oct 2015 the patient was sent to doctor for evaluation. The case was assessed as non-serious. Outcome and causality of the events was not reported.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Case number PHHY2016US010384, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 604149) on 18 Jan 2016. This report refers to a 38 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 15753P) intramuscularly into right arm on 28 Sep 2015. On the same day after vaccination the patient presented soreness, aching and decreased range of motion. Outcome of the events was unknown The case was assessed as non-serious. Causality of the events was not reported.
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal stiffness, Nausea
Clinical narrative: Case number PHHY2016US010385, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 604162) on 18 Jan 2016. This report refers to a 72 years old female patient. The patient's concurrent condition included diabetes. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515801) into right arm along with PREVNAR 13 (batch number: L77780, other manufacturer) into left arm on 15 Oct 2015. On the same day after vaccination the patient experienced pain, redness and swelling at the injection site. Further the patient experienced stiffness and abdominal nausea. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Crying, Injection site pain, Middle insomnia, Sleep disorder
Clinical narrative: Case number PHHY2016US010664, is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 604278) on 18 Jan 2016. This report refers to a 60-year-old female patient. The patient was allergic to penicillin and PERCOCET. The patient was vaccinated with FLUVIRIN (batch number: 1515101) intramuscularly into the left deltoid on 01 Oct 2015. On the same day instantly after vaccination approximately at 16:00, the patient experienced pain in left deltoid. It was reported that at that time and on through the pain was so bad that the patient cried. The patient continued to have pain when the patient reaches behind her, raises arm, picks up anything heavy and cannot carry her purse on the left arm. Further with movements pain will shoot down to her elbow. The pain continued to awake the patient from sleep and the patient can no longer lie in bed and had to sleep in recliner. Final outcome of events was not recovered. Events were reported as non-serious. Causality was not reported.
Age: 14.0
Sex: F
Vaccine: FLUX
Symptoms: Ear swelling, Eye swelling, Lethargy, Lip swelling, Pain
Clinical narrative: Case number PHHY2015US173572, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 604317) on 29 Dec 2015. This report refers to a 14 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in left arm on 13 Oct 2015. On 14 Oct 2015, after 24 hours of vaccination, the patient developed swelling of eyes, cheeks, lips and left ear. Within 48 hours of vaccination, the patient experienced body aches and pain with severe lethargy. Outcome of the events was complete recovery. Events were reported as non-serious. Seriousness assessment of the event "swelling face" was upgraded (medically significant) based on the information available in the source document. Causality was not reported.
Age: 14.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling face
Clinical narrative: Case number PHHY2015US173572, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 604317) on 29 Dec 2015. This report refers to a 14 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in left arm on 13 Oct 2015. On 14 Oct 2015, after 24 hours of vaccination, the patient developed swelling of eyes, cheeks, lips and left ear. Within 48 hours of vaccination, the patient experienced body aches and pain with severe lethargy. Outcome of the events was complete recovery. Events were reported as non-serious. Seriousness assessment of the event "swelling face" was upgraded (medically significant) based on the information available in the source document. Causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Limb mass
Clinical narrative: Case number PHHY2016US011455 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 604342) on 18 Jan 2016. This report refers to a 69 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1516601) intramuscularly in the right arm on 12- Oct 2015. On 20 Oct 2015, the patient experienced hard lump by lower biceps. The patient went to emergency room. She was obtaining magnetic resonance imaging (MRI) on 22 Oct 2015. The outcome of the events was reported as unknown. The events were reported as non-serious. Causality of the event was not reported.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Case number PHHY2015US171218, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 604515) website on 29 Dec 2015. This report refers to a 42-year-old female patient. Medical history and current illness was none. Concomitant medication was none. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into the right arm on 08 Oct 2015. On 09 Oct 2015, the patient experienced itchy skin all over and broke out in hives. The patient had taken hydrocortisone and BENADRYL but they are not helping much. Final outcome of the events was unknown. Events were reported as non-serious. Causality was not reported. Seriousness of the events was upgraded based on information available in the source document.
Age: 8.0
Sex: M
Vaccine: FLUX
Symptoms: Hypersensitivity, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Case number PHHY2015US170800, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 604586) website on 29 Dec 2015. This report refers to a 08 years old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine (unknown manufacture, batch number and expiry date: not reported) intramuscularly in the left deltoid on 23 Oct 2015. Approximately 24 hours after vaccine administration, on 24 Dec 2015, patient's mom noticed that the vaccine site (left deltoid) was swollen. The patient was afebrile and did not appear to be in any distress. On examination, the patient's left arm (from Left pectoris to Left elbow joint) was diffusely swollen, tense, erythematous, warm, and mildly tender. There was slight limitation of range of motion due to pain. This appeared to be an impressive hypersensitivity reaction rather than an infectious etiology such as cellulitis. The seriousness of the events was reported as non serious. Outcome of the events was reported as unknown. Causality of the events was not reported. Seriousness of the events was upgraded based on the available information in the source document.
Age: 8.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site warmth, Pain, Tension, Vaccination site swelling
Clinical narrative: Case number PHHY2015US170800, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 604586) website on 29 Dec 2015. This report refers to a 08 years old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine (unknown manufacture, batch number and expiry date: not reported) intramuscularly in the left deltoid on 23 Oct 2015. Approximately 24 hours after vaccine administration, on 24 Dec 2015, patient's mom noticed that the vaccine site (left deltoid) was swollen. The patient was afebrile and did not appear to be in any distress. On examination, the patient's left arm (from Left pectoris to Left elbow joint) was diffusely swollen, tense, erythematous, warm, and mildly tender. There was slight limitation of range of motion due to pain. This appeared to be an impressive hypersensitivity reaction rather than an infectious etiology such as cellulitis. The seriousness of the events was reported as non serious. Outcome of the events was reported as unknown. Causality of the events was not reported. Seriousness of the events was upgraded based on the available information in the source document.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: Case number PHHY2016US011422 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 604657) on 18 Jan 2016. This report refers to a 41 year old female patient. She had no allergies. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 15722P) intramuscularly in the right arm on 22 Oct 2015. On the same day, around 5 pm and later that night, her hand was swelling and there was no redness. It was reported that she could not tell how far up her arm it went. The swelling eventually went down on its own. The outcome of the events was reported as complete recovery. The events were reported as non-serious. The patient was not sure if the event was related to the flu shot.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Arthralgia, Body temperature increased, Decreased appetite, Erythema, Mobility decreased
Clinical narrative: Case number PHHY2016US011174, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 604853) on 18 Jan 2016. This report refers to a 65 years old female patient. The patient's concurrent condition included shellfish allergy. Concomitant medications were not reported. The patient was vaccinated with PREVNAR 13 (batch number: L99271) into left arm on 01 Oct 2015. On the same day, about 5 hours after vaccinations, the patient experienced aches and pain. Further the patient experienced body temperature of 103 degrees, loss of appetite, pain in joints, swelling and redness in left arm of about 5 inches x 3 inches in size. The patient could not lift herself out of chair. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain, Peripheral swelling
Clinical narrative: Case number PHHY2016US011174, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 604853) on 18 Jan 2016. This report refers to a 65 years old female patient. The patient's concurrent condition included shellfish allergy. Concomitant medications were not reported. The patient was vaccinated with PREVNAR 13 (batch number: L99271) into left arm on 01 Oct 2015. On the same day, about 5 hours after vaccinations, the patient experienced aches and pain. Further the patient experienced body temperature of 103 degrees, loss of appetite, pain in joints, swelling and redness in left arm of about 5 inches x 3 inches in size. The patient could not lift herself out of chair. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Limb mass, Pain
Clinical narrative: Case number PHHY2016US011406, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS, reference number: 604855) on 18 Jan 2016. This report refers to a 62 years old female patient. Medical history and current illness were none. Concomitant medication included Lisinopril. The patient was vaccinated with FLUVIRIN (batch number: not reported) on 11 Sep 2015. It was reported that the injection was placed too high and too far to the front of arm, into a tendon. On 17 Sep 2015 the patient complained that certain arm movements were terribly painful. Further the patient complained of lump in her arm. The patient had consulted two doctors, one recommended ice and other recommended heat which did not work. The patient still had a lump in her arm, after one month. Final outcome of the events was condition unchanged. The case was assessed as non-serious. Causality of the events was not reported.
Age: 48.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site infection
Clinical narrative: Case number PHHY2016US008266 is a spontaneous report initially received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 604868) on 18 Jan 2016. This report refers to a 48 years old female patient. The patient's current condition included egg allergy. Concomitant medication included sertraline. The patient was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly into left arm on 15 Oct 2015. On 22 Oct 2015 the patient's arm infected at the site of injection. Outcome of the event was recovered. The case was assessed as non-serious. Causality of the event was not reported. Seriousness assessment of "vaccination site infection" was upgraded based on the NVS-IMS list. Since the batch number was not reported, a batch specific review could not be performed. Based on the Annual Product Review (APR) of FLUCELVAX vaccine, it was concluded that FLUCELVAX manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the compliant production, testing and supply processes for FLUCELVAX vaccine. From this conclusion there was no reason or explanation to account for the reported adverse event. Non-significant follow-up information from quality assurance department (QA reference nr. 1013463) received on 17 Mar 2016: Updated QA reference number only. Follow up information from quality assurance department (QA) on 04 Apr 2016; Added Annual Product Review.
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Crepitations, Joint instability, Joint range of motion decreased
Clinical narrative: Case number PHHY2016US011175, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 604870) on 18 Jan 2016. This report refers to a 23 years old female patient. Medical history was noncontributory. Current illnesses were none. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157105) intramuscularly into left arm on 21 Oct 2015. On the same day after vaccination the patient reports shoulder joint pain, crepitus, shoulder instability and limited range of motion of shoulder due to pain. The patient underwent physical examination due to these events. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Age: 39.0
Sex: F
Vaccine: FLU3, HEP, TDAP
Symptoms: Abdominal pain upper, Chills, Headache, Injection site induration, Injection site nodule
Clinical narrative: Case number PHHY2016US011305 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 604877) on 18 Jan 2016. This report refers to a 39 years old female patient. Her current condition included Crohn's. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1515301) in the left arm, RECOMBIVAX HB (batch number: J009374) in the right arm and BOOSTRIX (batch number: 9245B) in the left leg; all vaccines administered intramuscularly on 17 Oct 2015. On 18 Oct 2015, the patient experienced nausea, vomiting, stomach ache, chills, body aches, headache, fever, injection site swelling in the left leg, left leg pain and a hard knot at the injection site. She went to the emergency room, but no laboratory tests were done. She was treated with alternate ibuprofen and TYLENOL. She also used alternate hot and cold packs. The outcome of the events was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 39.0
Sex: F
Vaccine: FLU3, HEP, TDAP
Symptoms: Injection site swelling, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2016US011305 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 604877) on 18 Jan 2016. This report refers to a 39 years old female patient. Her current condition included Crohn's. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1515301) in the left arm, RECOMBIVAX HB (batch number: J009374) in the right arm and BOOSTRIX (batch number: 9245B) in the left leg; all vaccines administered intramuscularly on 17 Oct 2015. On 18 Oct 2015, the patient experienced nausea, vomiting, stomach ache, chills, body aches, headache, fever, injection site swelling in the left leg, left leg pain and a hard knot at the injection site. She went to the emergency room, but no laboratory tests were done. She was treated with alternate ibuprofen and TYLENOL. She also used alternate hot and cold packs. The outcome of the events was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 39.0
Sex: F
Vaccine: FLU3, HEP, TDAP
Symptoms: Vomiting
Clinical narrative: Case number PHHY2016US011305 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 604877) on 18 Jan 2016. This report refers to a 39 years old female patient. Her current condition included Crohn's. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1515301) in the left arm, RECOMBIVAX HB (batch number: J009374) in the right arm and BOOSTRIX (batch number: 9245B) in the left leg; all vaccines administered intramuscularly on 17 Oct 2015. On 18 Oct 2015, the patient experienced nausea, vomiting, stomach ache, chills, body aches, headache, fever, injection site swelling in the left leg, left leg pain and a hard knot at the injection site. She went to the emergency room, but no laboratory tests were done. She was treated with alternate ibuprofen and TYLENOL. She also used alternate hot and cold packs. The outcome of the events was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 31.0
Sex: F
Vaccine: FLUX, FLUX, FLUX(H1N1)
Symptoms: Exposure during pregnancy
Clinical narrative: Case number PHHY2015US173585, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 604878) website on 29 Dec 2015. This report refers to a 31 years old female patient. Past medical history included asthma and food allergies and sensitivities. Concomitant medications included TYLENOL. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 27 Oct 2010. The patient felt for the first time in 9 months that, her baby was regressed, stopped talking, autism spectrum diagnosis, and compromised immune system and finally harmed him to the point to be treated for sensory processing disorder (which includes eating disorder). She also felt that, all of the subsequent vaccines she received did more and more harm with each one (for baby case see cases: PHHY2015US173413 and PHHY2015US173584). The final outcome, seriousness and causality of the event was not reported. The seriousness assessment of the event vaccine exposure during pregnancy was upgraded to be medically significant based on the information available in the source document.
Age: 31.0
Sex: F
Vaccine: FLUX, FLUX, FLUX(H1N1)
Symptoms: Foetal exposure during pregnancy, Gastrooesophageal reflux disease
Clinical narrative: Case number PHHY2015US173585, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 604878) website on 29 Dec 2015. This report refers to a 31 years old female patient. Past medical history included asthma and food allergies and sensitivities. Concomitant medications included TYLENOL. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 27 Oct 2010. The patient felt for the first time in 9 months that, her baby was regressed, stopped talking, autism spectrum diagnosis, and compromised immune system and finally harmed him to the point to be treated for sensory processing disorder (which includes eating disorder). She also felt that, all of the subsequent vaccines she received did more and more harm with each one (for baby case see cases: PHHY2015US173413 and PHHY2015US173584). The final outcome, seriousness and causality of the event was not reported. The seriousness assessment of the event vaccine exposure during pregnancy was upgraded to be medically significant based on the information available in the source document.