chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026873 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 53-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 13 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026877, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 21 year old male patient. Past medication history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 24 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not known why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026879, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 37 year old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 07 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026880, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 66 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016 into left deltoid on 08 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026882, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 66-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 07 Oct 2015 which was stored out of recommended temperature range (temperature excursion at 34 degrees). The nurse stated that, the reason was unknown for the refrigerator to be out of temperature range. There was no any further problem since the temperature excursion problem. No further information was provided. No adverse event was reported following this medication errors. Follow up report received from a nurse on 26 Jan 2016: Updated reporters comments.
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site paraesthesia, Paraesthesia, Vaccination site reaction
Clinical narrative: Case number PHHY2015US150234, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 584025) website on 23 Oct 2015. This report refers to a 44 years old female patient. Past medical history was not reported. Concomitant medications included Multi Vitamin, fish oil, calcium and Cinnamon. The patient was vaccinated with FLUVIRIN (batch number: NDC66521-011702) intramuscularly in left arm on 01 Oct 2014. On 02 Oct 2014, patient experienced paresthesia, vaccination site reaction, left arm muscle sore at injection site, continued for several weeks, it had progressively worsened over time, continued to expect it to improve, but it had now worsened and affects range of motion with occasional tingling. Waiting for x-ray results, but had tried ADVIL, hot/cold therapy, and now currently on a prednisone therapy (manufacture unknown). The outcome of the event was reported as condition unchanged. Event was reported as non-serious and causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Case number PHHY2015US150234, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 584025) website on 23 Oct 2015. This report refers to a 44 years old female patient. Past medical history was not reported. Concomitant medications included Multi Vitamin, fish oil, calcium and Cinnamon. The patient was vaccinated with FLUVIRIN (batch number: NDC66521-011702) intramuscularly in left arm on 01 Oct 2014. On 02 Oct 2014, patient experienced paresthesia, vaccination site reaction, left arm muscle sore at injection site, continued for several weeks, it had progressively worsened over time, continued to expect it to improve, but it had now worsened and affects range of motion with occasional tingling. Waiting for x-ray results, but had tried ADVIL, hot/cold therapy, and now currently on a prednisone therapy (manufacture unknown). The outcome of the event was reported as condition unchanged. Event was reported as non-serious and causality was not reported.
Age: 82.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHHY2015US150349, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 585203) website on 23 Oct 2015. This report refers to a 72 year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number, expiry date: not reported) on 14 Oct 2014. It was reported that, FLUVIRIN administered instead of FLUZONE High Dose. Error discovered when reconciling inventory. No adverse event reported after medication error. The outcome of the event was unknown. Event was reported as non-serious and causality was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Wrong drug administered
Clinical narrative: Case number PHHY2015US150774, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 585212) website on 23 Oct 2015. This report refers to a 43 years patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number, expiry date: not reported) intradermal in right arm (forearm) accidentally instead of tuberculin (wrong drug administered) on 21 Apr 2015. On the same day after vaccination, the patient experienced injection site erythema (3 cm area) and mild swelling at the injection site. The patient denied any other problems or history of allergies. The vaccine was then correctly given in the other forearm. The outcome of the events was unknown. Events were reported as non-serious and causality was not reported. Following an internal review done on 20 Nov 2015 for data received on 23 Oct 2015, significant case correction done: Event coding changed injection site swelling to vaccination site swelling.
Sex: F
Vaccine: FLUX
Symptoms: Headache, Nasopharyngitis, Neck pain, Pain, Poor quality sleep
Clinical narrative: Case number PHHY2015US161402, is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 587556) website on 24 Nov 2015. This report refers to a 61-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date in 2013. On an unknown date after vaccination the patient experienced headaches and felt achy. The patient felt like she had head cold. Further the patient had developed neck ache and the patient was tossing, turning and could not sleep. Final outcome, seriousness and causality were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Cough, Lymphadenopathy, Malaise, Nausea, Pain
Clinical narrative: Case number PHHY2015US161341, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 587613) website on 24 Nov 2015. This report refers to a female patient of an unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date after vaccination the patient became ill. The patient also developed fever (which lasted up to two weeks), enlarged lymph nodes, aching, cough and nausea. The case was assessed as non-serious. Outcome and causality of the events were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2015US161341, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 587613) website on 24 Nov 2015. This report refers to a female patient of an unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date after vaccination the patient became ill. The patient also developed fever (which lasted up to two weeks), enlarged lymph nodes, aching, cough and nausea. The case was assessed as non-serious. Outcome and causality of the events were not reported.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Eye discharge, Eye pain, Eyelid margin crusting, Muscle swelling
Clinical narrative: Case number PHHY2015US151541, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 592232) website on 16 Nov 2015. This report refers to 31 years old female patient. Medical history and concurrent illness were none. Concomitant medications included Valacyclovir, Amphetamine salts, Spironolactone, GILDESS FE and "PRISTIQ". Her vaccination history included administration of FLUVIRIN (batch number: not reported) at the age of one year old and experienced deltoid muscle swelling (see case: PHHY2015US151546). The patient was vaccinated with FLUVIRIN (batch number: UI431AB) intramuscularly into left arm on 26 Aug 2015. Thirty minutes after vaccination she felt eye pain. Further when falling asleep she felt that her right eye was crusty and hurting really bad. When she woke up the following morning, her eyes were crusted over with a white discharge. Also per patient she had a full deltoid muscle swelling. Final outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Age: 31.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscle swelling
Clinical narrative: Case number PHHY2015US151541, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 592232) website on 16 Nov 2015. This report refers to 31 years old female patient. Medical history and concurrent illness were none. Concomitant medications included Valacyclovir, Amphetamine salts, Spironolactone, GILDESS FE and "PRISTIQ". Her vaccination history included administration of FLUVIRIN (batch number: not reported) at the age of one year old and experienced deltoid muscle swelling (see case: PHHY2015US151546). The patient was vaccinated with FLUVIRIN (batch number: UI431AB) intramuscularly into left arm on 26 Aug 2015. Thirty minutes after vaccination she felt eye pain. Further when falling asleep she felt that her right eye was crusty and hurting really bad. When she woke up the following morning, her eyes were crusted over with a white discharge. Also per patient she had a full deltoid muscle swelling. Final outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Age: 1.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Eye discharge, Eye pain, Eyelid margin crusting, Muscle swelling
Clinical narrative: Case number PHHY2015US151546 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 592232) website on 16 Nov 2015. This report refers to one year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. After vaccination the patient developed deltoid muscle swelling. The outcome, seriousness and causality of the event were not reported. Further the patient received FLUVIRIN (batch number: UI431AB) at the age of 31 years old and developed deltoid muscle swelling (see case: PHHY2015US151541).
Age: 1.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscle swelling
Clinical narrative: Case number PHHY2015US151546 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 592232) website on 16 Nov 2015. This report refers to one year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. After vaccination the patient developed deltoid muscle swelling. The outcome, seriousness and causality of the event were not reported. Further the patient received FLUVIRIN (batch number: UI431AB) at the age of 31 years old and developed deltoid muscle swelling (see case: PHHY2015US151541).
Sex: F
Vaccine: FLU3
Symptoms: Ear swelling, Rash
Clinical narrative: Case number PHHY2015US151686, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 594504) website on 16 Nov 2015. This report refers to a 44-year-old female patient. Current conditions included chronic pain and migraine. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 15733P) intramuscularly into the left arm on 26 Aug 2015. On the same day after vaccination the patient experienced ears swelling at night and rash on chest and arms. Final outcome of the events was not recovered. Events were reported as non-serious and causality of the events was not reported.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dizziness, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHHY2015US151593 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 594555) on 16 Nov 2015. This report refers to a 73 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 157601) and PREVENAR 13 (other manufacturer, batch number: J20348); both vaccines administered intramuscularly in the left arm deltoid on 23 Aug 2015. On 24 Aug 2015, the patient returned with feelings of dizziness and swelling in the upper left arm with itching. Her blood pressure was measured as 148/96 (units and normal values were not reported) on an unknown date. She was given diphenhydramine 25 mg. The events outcome was unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Joint range of motion decreased, Muscle spasms, Pain, Pain in extremity
Clinical narrative: Case number PHHY2015US151696, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 595251) website on 16 Nov 2015. This report refers to a 34 year old female patient. Medical history was not reported. Concomitant medication included CELEXA were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) in arm on 14 Aug 2015. On 15 Aug 2015, the patient experienced stabbing pain in arm after flu shot. The patient was also vaccinated with pneumococcal vaccine (other manufacturer, batch number: not reported) 8 days after FLUVIRIN administration in same arm. On an unknown date after vaccination, the patient experienced muscle spasms and limited range of motion of arm. The patient also experienced weakness and pain. The patient experienced pain during sleeping or when attempted to use arm. Events became worse with time. The patient was treated with ALEVE, TYLENOL and ADVIL with no help for pain. Outcome of the events was unknown. Events were reported as non-serious. Causality was not reported.
Age: 81.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Case number PHHY2015US166115, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 596147) website on 14 Dec 2015. This report refers to an 81-year-old female patient. Past medical history was not reported. Concomitant medication included omeprazole, amlodipine, hydrochlorothiazide and Ursodiol. The patient was vaccinated with FLUVIRIN (batch number: 1514701) and PREVNAR 13, batch number: L43700) both intramuscularly into left arm on 12 Sep 2015. On 13 Sep 2015 after vaccination, the patient experienced red, swollen, warm to touch at vaccination site. The patient visited to emergency room. The outcome of the events was reported as condition unchanged. Seriousness of the events was reported as non serious and causality not reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site nodule
Clinical narrative: Case number PHHY2015US165499 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 596222) website on 14 Dec 2015. This report refers to a 62 years old female patient. Concurrent condition included mushroom allergy. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514701) intramuscularly into right arm on 18 Sep 2015. On the same day after vaccination the patient experienced bleeding and nodule formation under injection site. The case was assessed as non-serious. Outcome and causality of the events was not reported.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Case number PHHY2015US153671, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 596227) website on 24 Nov 2015. This report refers to a 38 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 17 Sep 2015. On 18 Sep 2015 after vaccination, the patient experienced hives and itching throughout body, mainly back, head, palms of hands. Patient was treated with BENADRYL. The outcome, seriousness and causality of the events were not reported.
Age: 58.0
Sex: F
Vaccine: FLUX, HEPA
Symptoms: Blood pressure decreased, Diarrhoea, Dizziness, Dyspepsia, Headache
Clinical narrative: Case number PHHY2015US156621, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 597185 on 24 Nov 2015. This report refers to a 58 years old female patient. Historical condition was not reported. Current conditions included allergy to penicillin and had severe case of H1N1 from an unknown date in 2010. Concomitant medications included PROAIR HFA, VALTREX and levothyroxine sodium (manufacture unknown). The patient vaccinated with seasonal influenza vaccine (manufacture unknown, batch number, expiry date: not reported) in right arm along with Hepatitis A (other manufacture, batch number, expiry date: not reported) in right arm both on 18 Sep 2015. On 20 Sep 2015, the patient developed sneezing, mild headache, stiffness. On 21 Sep 2015, the patient experienced muscle ache, vomiting, diarrhoea, fever, fainting and loss of blood pressure. On 22 Sep 2015, patient experienced dizziness, indigestion. The outcome of the events were reported as complete recovery on an unknown date. The seriousness and causality of events were reported as non-serious and causality not reported. Following an internal review for the data received on 24 Nov 2015, significant case correction was performed: Labeling changed.
Age: 58.0
Sex: F
Vaccine: FLUX, HEPA
Symptoms: Musculoskeletal stiffness, Myalgia, Pyrexia, Sneezing, Syncope
Clinical narrative: Case number PHHY2015US156621, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 597185 on 24 Nov 2015. This report refers to a 58 years old female patient. Historical condition was not reported. Current conditions included allergy to penicillin and had severe case of H1N1 from an unknown date in 2010. Concomitant medications included PROAIR HFA, VALTREX and levothyroxine sodium (manufacture unknown). The patient vaccinated with seasonal influenza vaccine (manufacture unknown, batch number, expiry date: not reported) in right arm along with Hepatitis A (other manufacture, batch number, expiry date: not reported) in right arm both on 18 Sep 2015. On 20 Sep 2015, the patient developed sneezing, mild headache, stiffness. On 21 Sep 2015, the patient experienced muscle ache, vomiting, diarrhoea, fever, fainting and loss of blood pressure. On 22 Sep 2015, patient experienced dizziness, indigestion. The outcome of the events were reported as complete recovery on an unknown date. The seriousness and causality of events were reported as non-serious and causality not reported. Following an internal review for the data received on 24 Nov 2015, significant case correction was performed: Labeling changed.
Age: 58.0
Sex: F
Vaccine: FLUX, HEPA
Symptoms: Vomiting
Clinical narrative: Case number PHHY2015US156621, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 597185 on 24 Nov 2015. This report refers to a 58 years old female patient. Historical condition was not reported. Current conditions included allergy to penicillin and had severe case of H1N1 from an unknown date in 2010. Concomitant medications included PROAIR HFA, VALTREX and levothyroxine sodium (manufacture unknown). The patient vaccinated with seasonal influenza vaccine (manufacture unknown, batch number, expiry date: not reported) in right arm along with Hepatitis A (other manufacture, batch number, expiry date: not reported) in right arm both on 18 Sep 2015. On 20 Sep 2015, the patient developed sneezing, mild headache, stiffness. On 21 Sep 2015, the patient experienced muscle ache, vomiting, diarrhoea, fever, fainting and loss of blood pressure. On 22 Sep 2015, patient experienced dizziness, indigestion. The outcome of the events were reported as complete recovery on an unknown date. The seriousness and causality of events were reported as non-serious and causality not reported. Following an internal review for the data received on 24 Nov 2015, significant case correction was performed: Labeling changed.
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Skin warm
Clinical narrative: Case number PHHY2015US166208 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 597450) on 14 Dec 2015. This report refers to a 29 year old female patient. She has no medical history, current conditions or concomitant medications. The patient was vaccinated with FLUVIRIN (batch number: 157604 intramuscularly in the left arm on 25 Sep 2015. On the same day after vaccination, the patient felt warm all. She felt that her body was heavy. Her blood pressure and pulse were monitored. She was given diphenhydramine 25 mg liquid. She was continuously monitored and her blood pressure and pulse were monitored for the next 50 to 60 minutes. No other 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: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: Case number PHHY2015US161962, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 597523) website on 24 Nov 2015. This report refers to a 48-years-old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 24 Sep 2015. On 24 Sep 2015, the patient experienced itching, burning hives in both legs at around 7:30 PM and applied BENADRYL and at 7:00 AM in the morning itching and burning hives started again in left arm and applied some more cream. On 27 Sep 2015 at 8:00 PM itching and burning hives started in left knees. The patient was treated with BENADRYL capsules () and anti itching cream (manufacturer unknown). The pharmacist also instructed the patient to take BENADRYL every 6 hours and if gets worse visit an emergency room. The outcome of the events was not reported. The seriousness of the events was reported as non serious by the health authority. The causality of the events was not reported.
Age: 91.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Peripheral swelling, Rash, Skin warm
Clinical narrative: Case number PHHY2015US166252 is an initial spontaneous report received via Vaccine Adverse Events Reporting (VAERS reference number: 597575) on 14 Dec 2015. This report refers to a 91 year old female patient. Her historical drug in included Aspirin. She had no current conditions. Her concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514701) and PREVNAR 13 (batch number: L79530); both vaccines given intramuscularly on 20 Sep 2015. On 27 Sep 2015 morning, her right upper hand was red, hot and swollen. She complained of rash in the area. She went to emergency room. No laboratory tests were done. 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: FLUX
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Case number# PHHY2015US160211, is an initial spontaneous report received from a health care professional via regulatory authority from a health authority on 24 Nov 2015. This report refers to a 3-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient received Influenza Virus Vacc Seasonal INN from 01 Oct 2015 at a dose of (intramuscular). On 03 Oct 2015, the patient developed "itching, swelling, redness and hives at injection site" (vaccination site swelling), "itching, swelling, redness and hives at injection site" (vaccination site pruritus), "itching, swelling, redness and hives at injection site" (vaccination site urticaria) and "itching, swelling, redness and hives at injection site" (vaccination site erythema). The outcome of the events vaccination site swelling, vaccination sited erythema, vaccination site urticaria and vaccination site pruritus was not reported. These events vaccination site swelling, vaccination site pruritus, vaccination site urticaria, vaccination site erythema were considered non-serious by the health care professional. The causality of the events vaccination site swelling, vaccination site pruritus, vaccination site urticaria and vaccination site erythema was not assessable/not reported. The Regulatory Ref. number was reported as 598468.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Pain in extremity, Weight bearing difficulty
Clinical narrative: Case number PHHY2015US166126 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting (VAERS reference number: 600952) on 14 Dec 2015. This report refers to a 56 year old female patient. Her medical history was not reported. Her current condition included allergy to ciprofloxacin, standard grass and mold allergies, thyroid disease and gastrooesophargeal reflux disease (GERD). Her concomitant medications were SYNTHROID, FLONASE, CENTRUM Silver, Vitamin, Flaxseed oil and PRILOSEC. The patient was vaccinated with FLUVIRIN (batch number: Q2037) intramuscularly in the left arm on 06 Oct 2015. On the same day after vaccination, the patient had sudden severe pain in her left foot. The pain was so severe that she could barely walk on it and it hurt when putting pressure on foot. She took ADVIL immediately and took more during the evening. She stated that neither she stepped on anything nor did anything that would make her foot so sore. Approximately 20 hours later the pain was going away. The outcome of the event pain in left foot was reported as condition improving and that of could barely walk was not reported. The events were reported as non-serious. The causality of the events was not reported.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle spasms, Myalgia, Paraesthesia
Clinical narrative: Case number PHHY2015US165572 is an initial spontaneous report received via Vaccine Adverse Events Reporting (VAERS reference number: 601701) on 14 Dec 2015. This report refers to a 58 year old male patient. His medical history, current conditions and concomitant medications were unknown. The patient was vaccinated with FLUVIRIN (batch number: 174084) intramuscularly in the left arm on 29 Sep 2015. On 05 Oct 2015, he had intense tingling on the left leg. Tingling later occurred in right leg, right arm and upper back. On 07 Oct 2015, he had muscle cramping and burning. It was reported that he still had intense tingling on forehead and arm. Laboratory tests done were unknown. He was advised to see doctor. The outcome of the event was unknown. The event was reported as non-serious. The causality of the event was not reported.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Hallucination, Incoherent, Injection site pain, Injection site rash
Clinical narrative: Case number PHHY2015US165475 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602252) website on 14 Dec 2015. This report refers to a 48 years old polymedicated female patient. Medical history included  back pain. The patient was vaccinated with FLUVIRIN (batch number: 157925) intramuscularly into left arm on 13 Oct 2015. On the same day after vaccination she complained of hallucinating, pain and rash around the injection site. Further stated that she didn't know where she was or who she was with, she felt tired and was talking out of head. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 23.0
Sex: M
Vaccine: DTP, FLUX
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2015US173935, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 607433) website on 29 Dec 2015. This report refers to a 23 years old male patient. Historical conditions included polyarthralgia, GERD (gastrooesophageal reflux disease) and plantar's fasciitis. Concomitant medication included omeprazole (manufacture unknown). The patient was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) along with diphtheria and tetanus toxoids and pertussis vaccine (other manufacturer, batch number: not reported) on 02 Nov 2015. Same day after vaccination, the patients fever broke at 9:00 PM. The patient experienced nausea, vomiting and fever of 103.1 (unit unspecified) on 03 Nov 2015. The event nausea and vomiting ceased at 10:00 AM on 03 Nov 2015. Fever of 100.4 (unit unspecified) remains as of 9:00 PM on 04 Nov 2015. The seriousness was reported as non serious and causality not reported.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2015US173892, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 607999) website on 29 Dec 2015. This report refers to a 61 years old female patient. Historical condition included ulcerative colitis. The concomitant medication was reported as ASACOL, REMICADE infusion, PROVERA, CELEXA. The patient was vaccinated with seasonal influenza vaccine (manufacture unknown, batch number: not reported) on 15 Oct 2015. On the same day after vaccination, patient developed site of injection, it swelled up a lot became very itchy and warm to the touch. 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 not reported.
Age: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2016US008607 is an initial spontaneous report received from a nurse on 05 Apr 2016. This report refers to a 13 year old male patient. Medical history and concomitant medications were not reported. This patient under the age of 18 was vaccinated with FLUCELVAX (batch number: 174087A) intramuscularly on 01 Dec 2015 instead of FLUARIX (manufacture unknown, batch number: 9JX2N, expiry date: 16 Jun 2016) on an unknown date. No adverse event was reported following maladministration. Follow up information received from nurse on 22 Jun 2016: Added new suspect drug FLUARIX and its details (lot number and expiry date), added new event, deleted the event appropriate age at vaccine administration and updated narrative accordingly.
Age: 17.0
Sex: M
Vaccine: FLUC3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2016US008620, is a spontaneous report initially from a nurse on 05 Apr 2016. This report refers to a 17 year old male patient. Medical history and concomitant medication were not reported. This patient (under the age of 18 years) was vaccinated with FLUCELVAX (batch number: 174087A) on 15 Oct 2015, intramuscularly instead of FLUARIX (batch number: 9JX2N, expiration date: 16 Jun 2016) as the patient was supposed to receive/ was prescribed FLUARIX. No adverse event was reported following this maladministration (the patient was under the age of 18 received FLUCELVAX). Follow up report received from a nurse via fax on 22 Jun 2016: Reporter details (title, fax number, report media and alternate phone number), co suspect (FLUARIX) and event (the patient was prescribed/ supposed to receive FLUARIX instead of FLUCELVAX) were updated.
Age: 12.0
Sex: M
Vaccine: FLUC3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2016US008621, is an initial spontaneous report received from a nurse on 05 Apr 2016. This report refers to a 12 year old male patient. Medical history was not reported. Concomitant medication was not reported. This patient under the age of 18 years was vaccinated with FLUCELVAX (batch number: 174087A) intramuscularly on 01 Dec 2015 instead of FLUARIX (manufacturer: unknown, batch number: 9JX2N, expiry date: 16 Jun 2016) on an unknown date. No adverse event was reported following this maladministration. Follow up information received from nurse on 22 Jun 2016: Added new suspect drug FLUARIX and its details (lot number and expiry date), added new event, deleted the event inappropriate age at vaccine administration and updated narrative accordingly.
Age: 15.0
Sex: M
Vaccine: FLUC3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2016US008626, is an initial spontaneous report received from a nurse on 05 April 2016. This report refers to a 15 year old male patient. Medical history was not reported. Concomitant medication was not reported. This patient under the age of 18 years was vaccinated with FLUCELVAX (batch number: 174087A) intramuscularly on 17 Oct 2015 instead of FLUARIX (manufacturer: unknown, batch number: 9JX2N, expiry date: 16 Jun 2016) on an unknown date. No adverse event was reported following this maladministration (wrong drug administered). Follow up information received from nurse on 22 Jun 2016: Added new suspect drug FLUARIX and its details (lot number and expiry date), added new event (wrong drug administered), deleted the event inappropriate age at vaccine administration.
Age: 36.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Cough, Erythema, Full blood count normal, Metabolic function test normal
Clinical narrative: Case number PHHY2016US161971 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 646931) on 21 Nov 2016. This report refers to a 36 year old male patient. Medical history was not reported. Concomitant medication included as CENTRUM. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number not reported) on 25 Sep 2015. On 26 Sep 2015, one day following the vaccination the patient had experienced cold for two days and it got worsened. The symptoms include coughing, weakness and throwing up. The patient required an emergency room/doctor visit on an unspecified date. The laboratory data included blood count as complete blood count (CBC) normal and metabolic panel test normal other laboratory data was not reported. On an unknown date patient received CENTRUM specialist energy (batch, route, dose were not reported). On 02 Nov 2015, the patient's nail gradually started to turn red. It had started with the moon shaped white spot on his nails turning red and then the redness seemed to spread out. On 05 Nov 2015, the patient stopped taking CENTRUM. The patient had received amoxicillin as corrective treatment. The patient was recovered from the event on an unspecified date. The outcome of the event was reported as complete recovery. The seriousness and causality of the event was not reported.
Age: 36.0
Sex: M
Vaccine: FLUX
Symptoms: Nasopharyngitis, Vomiting
Clinical narrative: Case number PHHY2016US161971 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 646931) on 21 Nov 2016. This report refers to a 36 year old male patient. Medical history was not reported. Concomitant medication included as CENTRUM. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number not reported) on 25 Sep 2015. On 26 Sep 2015, one day following the vaccination the patient had experienced cold for two days and it got worsened. The symptoms include coughing, weakness and throwing up. The patient required an emergency room/doctor visit on an unspecified date. The laboratory data included blood count as complete blood count (CBC) normal and metabolic panel test normal other laboratory data was not reported. On an unknown date patient received CENTRUM specialist energy (batch, route, dose were not reported). On 02 Nov 2015, the patient's nail gradually started to turn red. It had started with the moon shaped white spot on his nails turning red and then the redness seemed to spread out. On 05 Nov 2015, the patient stopped taking CENTRUM. The patient had received amoxicillin as corrective treatment. The patient was recovered from the event on an unspecified date. The outcome of the event was reported as complete recovery. The seriousness and causality of the event was not reported.
Age: 50.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Induration, Nodule, Swelling
Clinical narrative: Case number PHHY2016US161868 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 651065) on 21 Nov 2016. This report refers to 50 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, lot number: 168704) into let arm intramuscular and ZOSTAVAX (other manufacturer, lot number: L037790) subcutaneously into right arm on 01 Sep 2016. On 02 Sep 2016, the patient developed redness, hard nodule and severe swelling. The patient was at urgent care (on an unspecified date) for another issue and had the physician look at her injection site. The physician told that it could be from a skin infection and dispensed antibiotics (unspecified) to her. 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.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain, Computerised tomogram abdomen abnormal, Constipation, Pyrexia
Clinical narrative: Case PHEH2016US023308 is a combined initial spontaneous report received from pharmacist on 10 Sep 2016 and 12 Sep 2016. This report refers to female patient of unknown age. Past medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUCELVAX Quadrivalent (batch number: 185886, expiry date: Apr 2017) at a dose of 0.5 ml intramuscular on 31 Aug 2016. It was reported that, symptoms occurred 2 days after vaccination, the patient experienced fever and sharp abdominal pain. The patient sought medical attention and went to emergency room but not hospitalized after these adverse event. The abdominal pain was resolved however the fever continued. A CT scan (computerized tomography) was performed in the emergency room which showed the patient was constipated. The patient was prescribed with prednisone and MOTRIN as treatment for the events. The outcome of abdominal pain was completely recovered, fever was condition unchanged and constipation was unknown. The seriousness of the events was non serious. The causality of the events was not reported.
Age: 39.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Fatigue, Hypoaesthesia, Limb discomfort
Clinical narrative: Case number PHEH2016US023833, is an initial spontaneous report received from a pharmacist on 14 Sep 2016. This report refers to a 39 years old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with one single dose of FLUCELVAX Quadrivalent (batch number: 185284) at a dose of 0.5 ml, intramuscularly on 14 Sep 2016. On the same day after vaccination 03 hours later, he experienced legs feel numb from his hips down, feels super numb and heavy, feeling very tired and was dizzy. The outcome of events was reported as unknown on 14 Sep 2016. The seriousness of the events was reported as non-serious. The causality of the events was not reported.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Dyspnoea, Muscular weakness, Nausea, Paraesthesia
Clinical narrative: Case number PHHY2016US161951 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 654671) on 21 Nov 2016. This report refers to 40 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown) intramuscular into right arm on 22 Sep 2016. On the same day, 2 minute after shot the patient developed extreme dizziness, nausea, difficulty breathing, tingly arms and weakness in legs. The outcome of the events was completely recovered on an unknown date. The seriousness of the events was reported as non serious. Seriousness of event dyspnea and dizziness was upgraded based on information available in source document. The causality of the events was not reported.
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Monoplegia
Clinical narrative: Case PHHY2016US162722 is an initial spontaneous report received from other health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 655101) on 21 Nov 2016. Patient preexisting condition included high cholesterol. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (unknown manufacturer) 0.5 ml intramuscular on 14 Aug 2015. On 09 Feb 2016, the patient had developed Guillain Barre Syndrome, right leg paralysis and patient had received 4 doses IVIG (Intravenous immunoglobulin) on an unspecified date. Subsequently patient was hospitalized for 45 day, hospital stay (extended). The outcome of the events was reported as condition unchanged. The seriousness of the events was also reported as permanent disability. The causality of events was not reported.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness
Clinical narrative: Case number PHEH2016US025360, is an initial spontaneous report received from nurse on 29 Sep 2016. This report refers to 45 years old female patient. Past medical history was not reported. Concomitant medications included as steroid injection for bronchitis and ELAVIL for pain and sleep. The patient was vaccinated with single dose of FLUCELVAX Quadrivalent (batch number: 185888) into left deltoid, at a dose of 0.5 ml, intramuscularly on 27 Sep 2016 at 4:10 PM. On the same day, patient felt dizzy all evening and next day it was improving on 28 Sep 2016 afternoon, it was unknown if completely resolved. On an unspecified date, the patient felt dizzy and lightheadedness the morning after injection which worsened for a few hours then began to lessen in intensity symptom gradually reverse since 28 Sep 2016 to 30 Sep 2016 and sign and symptoms subsided after approximately 01 Oct 2016. The outcome of event was reported as complete recovery on an unknown date. The seriousness of event was reported as non-serious. The causality of event was not reported. Following an internal review done on 10 Oct 2016, for the data received on 07 Oct 2016: Significant case correction was performed, listedness was changed from listed to unlisted. Follow up report from a nurse received on 02 Nov 2016: Added patient demographics (patient height and weight), concomitant medications (steroid injection and ELAVIL) and suspect drug information (vaccination site and vaccination time), event (lightheadedness) and outcome of event.