chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHHY2014US048721 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522354) website on 14 Apr 2014. This report refers to a 17 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 010011A) intramuscularly in the left arm on 10 Feb 2014. The seriousness of the case was reported as non-serious. No adverse event was reporting following this administration error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 14 Apr 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Age: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2014US049241 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522446) website on 14 Apr 2014. This report refers to a 16 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX (batch number: 008011A) intramuscularly in the left arm on 08 Jan 2014. The seriousness of the case was reported as non-serious. No adverse event was reporting following this administration error. Following an internal review on 18 Aug 2014 of the data received on 14 Apr 2014, it was identified that the labeling of the event "inappropriate age at vaccine administration" was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Age: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product use issue
Clinical narrative: Case number PHHY2014US055090 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522734) website on 06 May 2014. This report refers to a 13 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUCELVAX (batch number: 010011A) intramuscularly in the left arm on 01 Feb 2014. The seriousness of the case was reported as non-serious. No adverse event was reporting following this administration error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 06 May 2014: The labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Sex: U
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Initial report was received from a consumer on 24 May 2013. This is a cluster of 2 unidentified patients who experienced cellulitis following administration of ADACEL, lot number C4418BA. This case is invalid (no patient identifiers). Two unidentified patients (gender, date of birth and ages not reported) had received an injection of ADACEL, lot number C4418BA (route, site and date of administration not reported) and an unspecified amount of time later developed cellulitis. Treatment included antibiotics. Outcome was unknown. Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: FLUC3, PPV, VARZOS
Symptoms: Chills, Injection site inflammation, Nausea, Pyrexia, Rash
Clinical narrative: Case number PHHY2014US136728 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 537661) web site on 10 Oct 2014. This report refers to a 56 year old female patient. Her medical history and concomitant medication were not reported. On 22 Jul 2014, She was vaccinated with FLUCELVAX (batch number: 011011A) into right arm, PNEUMOVAX (other manufacturer, batch number: J011180) into right arm and ZOSTAVAX (other manufacturer, batch number: K033601) into left arm. On 23 Jul 2014, 24 hours after vaccination, she developed rash, nausea, chills, fever and inflammation around injection site. She was taken to emergency room. Final outcome of the events were unknown. The events were reported as non-serious. Causality was not reported.
Age: 57.0
Sex: F
Vaccine: FLUC3
Symptoms: Arthralgia, Asthenia, Decreased appetite, Headache, Pain
Clinical narrative: Case number PHHY2014US137955 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 537813) website on 10 Oct 2014. This report refers to a 57 year old female patient. She had no medical history, current illness or concomitant medication. On 19 Jul 2014, she was vaccinated with FLUCELVAX (batch number: 011011A) into right arm. On 20 Jul 2014, she experienced headache, joint pain, body aches, loss of energy, heart palpitations and loss of appetite. She was taken to emergency room. Final outcome was unknown (missing). The events were reported as non-serious. Causality was not reported.
Age: 57.0
Sex: F
Vaccine: FLUC3
Symptoms: Palpitations
Clinical narrative: Case number PHHY2014US137955 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 537813) website on 10 Oct 2014. This report refers to a 57 year old female patient. She had no medical history, current illness or concomitant medication. On 19 Jul 2014, she was vaccinated with FLUCELVAX (batch number: 011011A) into right arm. On 20 Jul 2014, she experienced headache, joint pain, body aches, loss of energy, heart palpitations and loss of appetite. She was taken to emergency room. Final outcome was unknown (missing). The events were reported as non-serious. Causality was not reported.
Age: 22.0
Sex: M
Vaccine: FLUC3
Symptoms: Dizziness, Nausea
Clinical narrative: Case number PHHY2014US137840 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 537861) website on 10 Oct 2014. This report refers to a 22 year old male patient. He had no known allergy. He had no current illness. On 27 Jul 2014, he was vaccinated with FLUCELVAX (batch number: 011031A) intramuscularly into left arm. On the same day, approximately 15 minutes after vaccination, patient complained about nausea and lightheadedness. Patient was settled at a safe area on the floor. Final outcome was complete recovery, without further issues, within 10 minutes after onset. The event was reported as non-serious. Causality was not reported. Following an internal review on 26 Oct 2014 for the data received on 10 Oct 2014: A significant correction was performed, the drug code of FLUCELVAX was coded to corrected season.
Age: 66.0
Sex: M
Vaccine: FLUC3
Symptoms: Blood test, Computerised tomogram, Dizziness, Electrocardiogram, Nausea
Clinical narrative: Case number PHHY2014US136559, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 538035) website on 10 Oct 2014. This report refers to a 66-year old male patient. Historical conditions and current illness were none. Concomitant medications included allopurinol, lisinopril, TOPROL and temazepam. He was vaccinated with FLUCELVAX (batch number: 011011A) intramuscularly on 22 Jul 2014. On the same day after vaccination, when he woke up from nap, he was very dizzy and feeling nauseated. He was sent to emergency room. He underwent EKG, CAT scan and blood work (no results reported). The final outcome of the events was complete recovery. The events were reported as non-serious. Causality was not reported.
Age: 56.0
Sex: M
Vaccine: FLUC3
Symptoms: Abasia, Muscle spasms
Clinical narrative: Case number PHHY2014US136557, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 538538) website on 10 Oct 2014. This report refers to a 56-year-old male patient. Past medical history included increase cholesterol, high blood pressure and GERD. Current illness was none. No concomitant medication was reported. He was vaccinated with FLUCELVAX (batch number: 011011A) intramuscularly on 01 Aug 2014. On the same day after vaccination, he waited in the store for approximately 20 minutes and walked around the store. He felt muscles in the leg cramped and could not walk for a few seconds. The final outcome of the events was complete recovery. The events were reported as non-serious; however the case was internally upgraded as medically significant by the MAH. Causality was not reported.
Age: 47.0
Sex: F
Vaccine: FLUC3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHHY2014US137095, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 539563) website on 10 Oct 2014. This report refers to a 47 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUCELVAX (batch number: 011011A) intramuscular into left arm on 23 Jul 2014. On the same day her arm was sore and continued to get worse and go down arm and up over shoulder. For a few days where could not move arm, recovering and doing physical therapy. He visited the emergency room. Final outcome of the events was unknown and causality assessment was not reported. The events were reported as non-serious.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Dyspnoea, Injection site swelling, Local reaction, Peripheral swelling
Clinical narrative: Initial report was received on 09 September 2014 from a health care professional. An eight year-old male patient had received a left arm injection of FLUZONE QUADRIVALENT (lot number UI188AA) and later on the ride home, experienced a tickly throat. The patient returned to physician's office and was treated for a anaphylactic reaction with EPI. The patient's left arm also started to show a local reaction. The patient went to the ER and about one hour after the injection arm began to be heavily swollen. The patient had received a nasal flu vaccine for the past four years and had flu immunizations every year with no prior episodes. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none. Follow-up information received from a healthcare professional on 06-Oct-2014: The patient was actually 10 years old at the time of the events. He had received his dose of "FLUZONE", batch number LUI188AA, in the left arm, on 08-Sep-2014 at 4 pm. The same day, at 4:15 pm, he developed hives, throat swelling and trouble breathing. The site of administration was also reported as very swollen. The patient had previously received 6 doses of FLUZONE. He had had no illness at the time of the vaccination and no pre-existing physician-diagnosed allergies or medical conditions. He recovered on an unspecified date.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Pharyngeal oedema, Throat irritation, Urticaria
Clinical narrative: Initial report was received on 09 September 2014 from a health care professional. An eight year-old male patient had received a left arm injection of FLUZONE QUADRIVALENT (lot number UI188AA) and later on the ride home, experienced a tickly throat. The patient returned to physician's office and was treated for a anaphylactic reaction with EPI. The patient's left arm also started to show a local reaction. The patient went to the ER and about one hour after the injection arm began to be heavily swollen. The patient had received a nasal flu vaccine for the past four years and had flu immunizations every year with no prior episodes. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none. Follow-up information received from a healthcare professional on 06-Oct-2014: The patient was actually 10 years old at the time of the events. He had received his dose of "FLUZONE", batch number LUI188AA, in the left arm, on 08-Sep-2014 at 4 pm. The same day, at 4:15 pm, he developed hives, throat swelling and trouble breathing. The site of administration was also reported as very swollen. The patient had previously received 6 doses of FLUZONE. He had had no illness at the time of the vaccination and no pre-existing physician-diagnosed allergies or medical conditions. He recovered on an unspecified date.
Age: 62.0
Sex: F
Vaccine: FLUC3
Symptoms: Rash morbilliform
Clinical narrative: Case number PHHY2014US150884, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543616) website on 13 Nov 2014. This report refers to a 62-year-old female patient. Medical history included German measles. Concurrent conditions included diabetes, autonomic dysfunction and heart condition (unspecified). She was vaccinated with FLUCELVAX (batch number: 011031A) intramuscularly into left arm on 09 Sep 2014. On 12 Sep 2014, she developed a rash that looks like measles. Outcome of the event was reported as fading at the time of this report. The event was reported as non-serious. Causality of the event was not reported.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Case number PHHY2014US170081, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546845) website on 29 Dec 2014 and with follow up information received from the quality assurance department (QA reference number: 345053) on 06 Jan 2015, with the follow-up information received from Quality Assurance Department (reference number: 345053) on 19 Jan 2015. This report refers to an 11 year old male patient. Current condition included allergic rhinitis and asthma. Historical drug included pseudoephedrine hydrochloride. On 30 Sep 2014, he was vaccinated with MENVEO (batch number: M14023 and expiry date: Jul 2015) into right arm. On the same day he also received GARDASIL (batch number: J015378, other manufacturer) into left arm; BOOSTRIX (batch number: N3BE2, other manufacturer) into right arm and FLUARIX (batch number: LZ4S2, other manufacturer) into left arm. On the same day post vaccination he developed cellulitis right deltoid at the site. He went to the emergency room. Outcome of the event was unknown. Causality assessment was not reported. Seriousness assessment of vaccination site cellulitis was upgraded based on information available in the source documents. Based on the investigation performed, the QA department stated that, MENVEO vaccine (batch number: M14023) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 345053) on 06 Jan 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 345053) on 19 Jan 2015: Updated MENVEO batch review report.
Age: 47.0
Sex: F
Vaccine: FLUC3
Symptoms: Hypoaesthesia
Clinical narrative: Case number PHEH2014US021323 is an initial spontaneous report from the nurse received on 20 Oct 2014. This report refers to a 47-year-old female patient. She was vaccinated with FLUCELVAX (batch number: 017011A) intramuscularly on an unknown date. On 13 Oct 2014, 9 hours after vaccination she experienced numbness of the face. The outcome of the event was unknown. The seriousness and causality of the event were not reported.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: This spontaneous report was received form a 52 year old diabetic female consumer, reporting on herself, with no drug reaction/allergies. On 27-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose number, lot number and expiration date were not reported), 1 DF (reported as 1 single shot), subcutaneous. Concomitant therapies included insulin, atorvastatin and atenolol. Patient reported having swelling, tenderness, and a bright red rash at the injection site after receiving ZOSTAVAX on 27-DEC-2014. The patient reported this adverse experience has lasted for four days. At the time of the report the outcome was unknown. No lab diagnostics test were performed. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Cough, Tic
Clinical narrative: Patient had facial twitching/blinking prior to flu shot. Mother has given anti-vaccine interviews in press.
Age: 11.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Blood selenium increased, Unevaluable event, Vitamin B12 increased
Clinical narrative: Patient had facial twitching/blinking prior to flu shot. Mother has given anti-vaccine interviews in press.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Blood test, Injection site vesicles, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report was received from a consumer refers to herself as a 63 year old female patient. No medical history and drug reaction or allergies were reported. On 29-JUL-2014, the patient was vaccinated with ZOSTAVAX (strength, dose, route were not reported) lot # J014566. Concomitant therapies included oxybutynin (dose, frequency and manufacturer unknown), pravastatin (dose, frequency unspecified), and pantoprazole (dose, frequency unspecified). On 15-AUG-2014, 18 days after onset of therapy, the patient was diagnosed with permanent retina damage in her right eye after receiving ZOSTAVAX. The patient sought medical attention through office visit on an unknown date. The consumer stated that she was hospitalized on 26-OCT-2014 until 30-OCT-2014. Lab diagnostics studies performed were eye scans and tests, brain MRI (magnetic resonance imaging) and scan, orbits MRI (magnetic resonance imaging), lumbar puncture, multi-focal electroretinogram and blood tests and the results were unknown. On an unknown date, the patient was treated with steroid infusions (dose, frequency and manufacturer unknown). No product quality complaint was involved. The outcome of event was reported as not recovered/not resolved. The reporter causality was not provided. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging brain, Retinal injury, Retinogram, Scan brain, Visual field tests
Clinical narrative: This spontaneous report was received from a consumer refers to herself as a 63 year old female patient. No medical history and drug reaction or allergies were reported. On 29-JUL-2014, the patient was vaccinated with ZOSTAVAX (strength, dose, route were not reported) lot # J014566. Concomitant therapies included oxybutynin (dose, frequency and manufacturer unknown), pravastatin (dose, frequency unspecified), and pantoprazole (dose, frequency unspecified). On 15-AUG-2014, 18 days after onset of therapy, the patient was diagnosed with permanent retina damage in her right eye after receiving ZOSTAVAX. The patient sought medical attention through office visit on an unknown date. The consumer stated that she was hospitalized on 26-OCT-2014 until 30-OCT-2014. Lab diagnostics studies performed were eye scans and tests, brain MRI (magnetic resonance imaging) and scan, orbits MRI (magnetic resonance imaging), lumbar puncture, multi-focal electroretinogram and blood tests and the results were unknown. On an unknown date, the patient was treated with steroid infusions (dose, frequency and manufacturer unknown). No product quality complaint was involved. The outcome of event was reported as not recovered/not resolved. The reporter causality was not provided. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Visual impairment
Clinical narrative: This spontaneous report was received from a consumer refers to herself as a 63 year old female patient. No medical history and drug reaction or allergies were reported. On 29-JUL-2014, the patient was vaccinated with ZOSTAVAX (strength, dose, route were not reported) lot # J014566. Concomitant therapies included oxybutynin (dose, frequency and manufacturer unknown), pravastatin (dose, frequency unspecified), and pantoprazole (dose, frequency unspecified). On 15-AUG-2014, 18 days after onset of therapy, the patient was diagnosed with permanent retina damage in her right eye after receiving ZOSTAVAX. The patient sought medical attention through office visit on an unknown date. The consumer stated that she was hospitalized on 26-OCT-2014 until 30-OCT-2014. Lab diagnostics studies performed were eye scans and tests, brain MRI (magnetic resonance imaging) and scan, orbits MRI (magnetic resonance imaging), lumbar puncture, multi-focal electroretinogram and blood tests and the results were unknown. On an unknown date, the patient was treated with steroid infusions (dose, frequency and manufacturer unknown). No product quality complaint was involved. The outcome of event was reported as not recovered/not resolved. The reporter causality was not provided. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Lumbar puncture, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Ophthalmological examination
Clinical narrative: This spontaneous report was received from a consumer refers to herself as a 63 year old female patient. No medical history and drug reaction or allergies were reported. On 29-JUL-2014, the patient was vaccinated with ZOSTAVAX (strength, dose, route were not reported) lot # J014566. Concomitant therapies included oxybutynin (dose, frequency and manufacturer unknown), pravastatin (dose, frequency unspecified), and pantoprazole (dose, frequency unspecified). On 15-AUG-2014, 18 days after onset of therapy, the patient was diagnosed with permanent retina damage in her right eye after receiving ZOSTAVAX. The patient sought medical attention through office visit on an unknown date. The consumer stated that she was hospitalized on 26-OCT-2014 until 30-OCT-2014. Lab diagnostics studies performed were eye scans and tests, brain MRI (magnetic resonance imaging) and scan, orbits MRI (magnetic resonance imaging), lumbar puncture, multi-focal electroretinogram and blood tests and the results were unknown. On an unknown date, the patient was treated with steroid infusions (dose, frequency and manufacturer unknown). No product quality complaint was involved. The outcome of event was reported as not recovered/not resolved. The reporter causality was not provided. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Retinal injury, Retinogram
Clinical narrative: This spontaneous report was received from a consumer refers to herself as a 63 year old female patient. No medical history and drug reaction or allergies were reported. On 29-JUL-2014, the patient was vaccinated with ZOSTAVAX (strength, dose, route were not reported) lot # J014566. Concomitant therapies included oxybutynin (dose, frequency and manufacturer unknown), pravastatin (dose, frequency unspecified), and pantoprazole (dose, frequency unspecified). On 15-AUG-2014, 18 days after onset of therapy, the patient was diagnosed with permanent retina damage in her right eye after receiving ZOSTAVAX. The patient sought medical attention through office visit on an unknown date. The consumer stated that she was hospitalized on 26-OCT-2014 until 30-OCT-2014. Lab diagnostics studies performed were eye scans and tests, brain MRI (magnetic resonance imaging) and scan, orbits MRI (magnetic resonance imaging), lumbar puncture, multi-focal electroretinogram and blood tests and the results were unknown. On an unknown date, the patient was treated with steroid infusions (dose, frequency and manufacturer unknown). No product quality complaint was involved. The outcome of event was reported as not recovered/not resolved. The reporter causality was not provided. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Paraesthesia, Sensory loss
Clinical narrative: Tingling and loss of feelings overnight in both legs. Treated with corticosterioids.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Head injury, Syncope
Clinical narrative: This spontaneous report has been received from a registered nurse refers to an 11 year old female patient. The patient had no pertinent medical history or drug allergies. On 01-OCT-2007, the patient was vaccinated with the first dose of GARDASIL injection (strength and dose not reported, lot # reported as 10614, expiration date: 14-APR-2010), intramuscularly. The patient had no concomitant therapies. On the same date, after receiving that vaccination, the patient fainted in the office and hit her head on a door jam which resulting in a contact seizure. No treatment was given. No labs were performed. The patient was taken back to a room, observed, recovered quickly and sent back home within 15 minutes. On 13-JAN-2015 the patient was vaccinated with the second dose of GARDASIL (strength, dose, route and lot # not reported), with no reported concerns. Lot number 10614 is an invalid lot number for GARDASIL. Upon internal review, contact seizure was considered to be medically significant. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Mumps, Polymerase chain reaction
Clinical narrative: This spontaneous report was received from a physician via a company representative, concerning a 2 year old female patient. Patient concurrent conditions and relevant medical history was not reported. On an unknown date, the patient was vaccinated with the first dose of M-M-R II (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. The reporter stated that the patient was diagnosed with mumps (hospitalization) on an unspecified date, sometime after receiving M-M-R II. The patient was admitted to the hospital but the reporter was not sure for how long the patient was in hospital. Polymerase chain reaction (PCR) test was conducted on an unknown date and results were not reported. The reporter was also unsure if the mumps was life threatening, since the patient was currently under observation and was unsure how she was doing. The patient was being comforted in the hospital. The outcome of mumps was reported as not recovered/not resolved. The causality of the event with M-M-R II was not reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Administration site pain, Administration site reaction, Lip swelling, Local swelling, Musculoskeletal stiffness
Clinical narrative: Patient reported localized pain and stiffness at administration site as well as swelling in the axillary region starting the evening following administration. The Morning of 1/19/15 the patient reported swelling of the left side of face and upper lip. She did not report any difficulty breathing. The patient went to her primary care physician and received a steroid shot as well as a prescription for a steroid dose pack. She was also instructed to take diphenhydramine.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling face
Clinical narrative: Patient reported localized pain and stiffness at administration site as well as swelling in the axillary region starting the evening following administration. The Morning of 1/19/15 the patient reported swelling of the left side of face and upper lip. She did not report any difficulty breathing. The patient went to her primary care physician and received a steroid shot as well as a prescription for a steroid dose pack. She was also instructed to take diphenhydramine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Pruritus, Swelling, Tenderness, Tremor
Clinical narrative: At first, I experienced severe swelling, itching, tenderness and warmth. This subsided over a course of 10 days.  My major concern is that now I have a hand tremor in my left hand which I did not experience before the vaccination.  My reason for submitting it is twofold, to inform you and to learn if this has been reported by anyone else.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Flushing, Hypersensitivity, Urticaria
Clinical narrative: Initial unsolicited case received from a non healthcare professional on 13 January 2015. A 54-year-old male patient with a reported medical history of hypertension and elevated cholesterol, had received his "first ever" dose of FLUZONE (lot number UI198AA, route of administration not reported) in the left deltoid on 12 January 2015. After the patient received his flu shot, he was fine in the office, but, in the evening, the patient developed flushing, hives and shortness of breath (reported as SOB). He was treated at the emergency room for an allergic reaction and recovered from the event. No admission to the hospital was necessary. Illness at time of vaccination and pre-existing allergies were reported as none. Relevant diagnostic tests/laboratory data were reported as unknown. The event was considered serious per the reporter as it was considered as a life-threatening illness. The outcome was reported as recovered. Documents held by sender: none.
Age: 0.63
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: This is one case out of a cumulative total of 246 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 13 January 2015. These 246 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 13 January 2015 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 16-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 1 dose of PENTACEL on 08 October 2013, batch number C4232AA, a second dose of PENTACEL on 07 February 2014, batch C4638AA and a third dose of PENTACEL on 07 March 2014, batch number C4638AA (routes and sites not reported). On 15 December 2014, the subject developed a cough and a paroxysmal cough with a whoop on 19 December 2014 approximately 9 months after the last dose. The subject experienced posttussive vomiting on an unreported date. The subject experienced cold symptoms starting on 15 December 2014. The subject experienced sleep disturbance and did not experience apnea. Laboratory testing included a positive PCR on 20 December 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 22 December 2014 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 09 January 2015, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.63
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 246 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 13 January 2015. These 246 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 13 January 2015 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 16-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 1 dose of PENTACEL on 08 October 2013, batch number C4232AA, a second dose of PENTACEL on 07 February 2014, batch C4638AA and a third dose of PENTACEL on 07 March 2014, batch number C4638AA (routes and sites not reported). On 15 December 2014, the subject developed a cough and a paroxysmal cough with a whoop on 19 December 2014 approximately 9 months after the last dose. The subject experienced posttussive vomiting on an unreported date. The subject experienced cold symptoms starting on 15 December 2014. The subject experienced sleep disturbance and did not experience apnea. Laboratory testing included a positive PCR on 20 December 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 22 December 2014 for an unknown number of days. The subject was not hospitalized. At the time of final contact on 09 January 2015, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB, FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 1.5 inch area of erythema. Raised and warm to touch. Tender. Located on left upper thigh.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Cough, Pyrexia
Clinical narrative: Report of fever 102.4 and cough after FLUMIST.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bowel movement irregularity, Dysgeusia, Glossodynia, Musculoskeletal stiffness, Rhinorrhoea
Clinical narrative: Burning and swelling of tongue with metallic taste, hives body wide, chest congestion, runny nose, stiff neck, no normal bowel movement for 11 days.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Burning and swelling of tongue with metallic taste, hives body wide, chest congestion, runny nose, stiff neck, no normal bowel movement for 11 days.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysgeusia, Pruritus, Swollen tongue, Tongue disorder
Clinical narrative: Burning and swelling of tongue with metallic taste, hives body wide, chest congestion, runny nose, stiff neck, no normal bowel movement for 11 days.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Hep A vaccine was given instead of HIB. No adverse reactions.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased, Irritability
Clinical narrative: Temp to 100.4. Fussiness.
Sex: U
Vaccine: RV5
Symptoms: Malaise, Vomiting projectile
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with first dose of ROTATEQ route of administration reported as oral, dosage schedule was not reported). The physician stated that the patient received three other concomitant unspecified vaccines (unspecified names, doses/frequencies and manufacturers) on the same unspecified date. The physician also stated that she was unsure if the patient will receive any subsequent doses of oral, ROTATEQ. On an unknown date the patient experienced projectile vomiting and was extremely ill. Patient sought medical attention (office visit on an unspecified date). The outcome of projectile vomiting and was extremely ill was reported as recovered/resolved on unknown date. Relatedness between events and vaccination with oral, ROTATEQ was not reported. Additional information has been requested.
Age: 0.65
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Diagnostic procedure, Diarrhoea, Ear infection, Irritability, Poor quality sleep
Clinical narrative: Fever 103. Hives. Adverse event started: fever-after injections, hives-2 days after immunization. This 7 month old male presents to Clinic today for an ER follow-up. He is brought today by the patient's mother. Current medication allergies include No Known Drug Allergies. The historian denies travel outside of the country during the past four weeks. Aside from the patient's current illness, since his last visit, has had an emergency room/Urgent Care visit. He was seen in the emergency room 2 days ago for an ear infection. Records of the visit will be reviewed. He was seen in the ER and diagnosed with fever. ER notes are available for review. The patient had a maximum temperature of 103-104 F, several days ago and lasted until now. Other than the temperature as noted, the patient's symptoms include the following: fussiness, diarrhea, a rash, and restless at night. He has had several episodes of diarrhea in the past 1 day. The rash involves the generalized and developed 3 days ago. Symptoms denied: pulling at the ears, nasal congestion, nasal discharge, coughing, hair changes, enlarged lymph nodes, and new medication allergies.
Age: 0.65
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Pyrexia, Rash generalised, Urticaria
Clinical narrative: Fever 103. Hives. Adverse event started: fever-after injections, hives-2 days after immunization. This 7 month old male presents to Clinic today for an ER follow-up. He is brought today by the patient's mother. Current medication allergies include No Known Drug Allergies. The historian denies travel outside of the country during the past four weeks. Aside from the patient's current illness, since his last visit, has had an emergency room/Urgent Care visit. He was seen in the emergency room 2 days ago for an ear infection. Records of the visit will be reviewed. He was seen in the ER and diagnosed with fever. ER notes are available for review. The patient had a maximum temperature of 103-104 F, several days ago and lasted until now. Other than the temperature as noted, the patient's symptoms include the following: fussiness, diarrhea, a rash, and restless at night. He has had several episodes of diarrhea in the past 1 day. The rash involves the generalized and developed 3 days ago. Symptoms denied: pulling at the ears, nasal congestion, nasal discharge, coughing, hair changes, enlarged lymph nodes, and new medication allergies.
Age: 92.0
Sex: M
Vaccine: PPV
Symptoms: Aphasia, Pyrexia, Tremor, Urinary incontinence
Clinical narrative: 102 degree fever. Shaking uncontrollable. Loss of bladder. Unable to talk or comprehend.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy bone marrow abnormal, Blood test abnormal, Computerised tomogram head normal, Electrolyte imbalance, Guillain-Barre syndrome
Clinical narrative: Ascending paralysis. Major electrolyte imbalance. Morbid hypokalemia. Acute renal failure. Still under treatment. (Diag: GBS Guillain Barre Syndrome).
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: HIV test negative, Hypokalaemia, Lumbar puncture normal, Nuclear magnetic resonance imaging spinal normal, Renal failure acute
Clinical narrative: Ascending paralysis. Major electrolyte imbalance. Morbid hypokalemia. Acute renal failure. Still under treatment. (Diag: GBS Guillain Barre Syndrome).
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Atrial fibrillation, Blood test, Chest X-ray, Computerised tomogram, Computerised tomogram head
Clinical narrative: No allergies. Syncope, HBP, broken nose, black eyes, split lip, Rx lisinopril. Four days acute care in hospital's cardiology department. Following discharge TeleSentry recorder revealed atrial fibrillation. Rx to follow. For 86 years, no Rx required.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Echocardiogram, Electrocardiogram, Facial bones fracture, Haematocrit, Hypertension
Clinical narrative: No allergies. Syncope, HBP, broken nose, black eyes, split lip, Rx lisinopril. Four days acute care in hospital's cardiology department. Following discharge TeleSentry recorder revealed atrial fibrillation. Rx to follow. For 86 years, no Rx required.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Lip injury, Periorbital contusion, Syncope
Clinical narrative: No allergies. Syncope, HBP, broken nose, black eyes, split lip, Rx lisinopril. Four days acute care in hospital's cardiology department. Following discharge TeleSentry recorder revealed atrial fibrillation. Rx to follow. For 86 years, no Rx required.
Age: 1.03
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Papule, Pyrexia, Rash, Rash pustular, Varicella post vaccine
Clinical narrative: Vaccine reaction (varicella). Symptoms include fever and rash - scattered papules and pustules on trunk, face and back.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, VIIth nerve paralysis
Clinical narrative: Pt hx 4 prev. episodes since age 3rd grade -> pt reports "immune disorder" and consults for rh. arthritis. AFLURIA given 12/16/14 - 12/18. 12/18 ER visit, dx Bell's Palsy - steroidal course - No improvement 1/7/15.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Aphasia, Arrhythmia, Asthenia, Depression
Clinical narrative: Fainting, Dizzy, Nauseous, Migraine with Aura, heaviness in legs, hands and feet numbness and tingling, TIA - ischemic attacks, Guillain Barre Syndrome, Optic Neuritis, Bell's Palsy, Loss of speech, Weakness in facial muscles, loss of symmetry in eyes, tremors, involuntary muscles spasms, tics, anxiety, panic attacks, arrhythmia, palpitations, nervousness, depression, overall weakness.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Eye movement disorder, Facial paresis, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Fainting, Dizzy, Nauseous, Migraine with Aura, heaviness in legs, hands and feet numbness and tingling, TIA - ischemic attacks, Guillain Barre Syndrome, Optic Neuritis, Bell's Palsy, Loss of speech, Weakness in facial muscles, loss of symmetry in eyes, tremors, involuntary muscles spasms, tics, anxiety, panic attacks, arrhythmia, palpitations, nervousness, depression, overall weakness.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Limb discomfort, Migraine with aura, Muscle spasms, Nausea, Nervousness
Clinical narrative: Fainting, Dizzy, Nauseous, Migraine with Aura, heaviness in legs, hands and feet numbness and tingling, TIA - ischemic attacks, Guillain Barre Syndrome, Optic Neuritis, Bell's Palsy, Loss of speech, Weakness in facial muscles, loss of symmetry in eyes, tremors, involuntary muscles spasms, tics, anxiety, panic attacks, arrhythmia, palpitations, nervousness, depression, overall weakness.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Optic neuritis, Palpitations, Panic attack, Paraesthesia, Syncope
Clinical narrative: Fainting, Dizzy, Nauseous, Migraine with Aura, heaviness in legs, hands and feet numbness and tingling, TIA - ischemic attacks, Guillain Barre Syndrome, Optic Neuritis, Bell's Palsy, Loss of speech, Weakness in facial muscles, loss of symmetry in eyes, tremors, involuntary muscles spasms, tics, anxiety, panic attacks, arrhythmia, palpitations, nervousness, depression, overall weakness.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Tic, Transient ischaemic attack, Tremor, VIIth nerve paralysis
Clinical narrative: Fainting, Dizzy, Nauseous, Migraine with Aura, heaviness in legs, hands and feet numbness and tingling, TIA - ischemic attacks, Guillain Barre Syndrome, Optic Neuritis, Bell's Palsy, Loss of speech, Weakness in facial muscles, loss of symmetry in eyes, tremors, involuntary muscles spasms, tics, anxiety, panic attacks, arrhythmia, palpitations, nervousness, depression, overall weakness.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain
Clinical narrative: Couldn't raise arm, EXTREME pain.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Constipation, Injection site nodule, Injection site pain
Clinical narrative: Soreness/pain at injection site, 2 months duration at least. Sore nodule at inj site. Severe constipation 1 month duration.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient received FLUZONE HD on 12/1/14 and is still complaining of a sore arm to this date where vaccine administered.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Development of hives on upper arms, lower back and waist. For approx 3 wks. Treatment: Methylprednisolone 4 mg., SARNA 1% lotion.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Red patchy area that is growing larger and warm to the touch.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large area of erythema around three injection sites on right anterior thigh, approx. 25 cm x 20 cm. Warm to touch. One small area on right thigh around on of the two injection sites approx 2 cm x 3 cm. BENADRYL given in office and parent told to repeat every 6 hours as needed. ZYRTEC or CLARITIN 10 mg daily.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Injected limb mobility decreased
Clinical narrative: Pt. called health director and reported limited range of motion to (R) arm after receiving flu vaccine.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt. called health director and reported limited range of motion to (R) arm after receiving flu vaccine.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal disorder, Vaccination site pain
Clinical narrative: Severe and debilitating pain at site of vaccination which is still present. Have limited use of arm.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever of 103
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site became swollen and red.
Age: 9.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: Fever, chills, rigors, "shocking" sensation in elbow, muscle aches, nausea/vomiting, headache, dizziness.  I've called doctors office but have not heard back yet.
Age: 9.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia, Pyrexia, Vomiting
Clinical narrative: Fever, chills, rigors, "shocking" sensation in elbow, muscle aches, nausea/vomiting, headache, dizziness.  I've called doctors office but have not heard back yet.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Injection site joint pain, Insomnia, Swelling
Clinical narrative: Patient describes as arthritis pain at elbow in arm where vaccine was given. "Very painful", not a light ache. Usually doesn't complain about mild pain, but this was very painful. Upon follow-up on 1/20/15, pain was still present but has improved. Slight swelling. Experienced sleep loss due to pain while he was sleeping. Patient took acetaminophen upon recommendation from pharmacist.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient states her left arm (in which the vaccine was given) began to feel sore and painful "a couple days after" getting the flu shot. She states the pain grew worse over the next couple of months. She says she has limited range of motion and trouble completing daily tasks like getting dressed. She denies inflammation or redness in her arm. Pain radiates down her left arm from her shoulder.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pain
Clinical narrative: Erythema, induration, pain.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Nerve pain below ear.