chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Case number PHHY2014US046143 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 519163) web site on 14 Apr 2014. This report refers to a 58 year old female patient. Her current condition included allergy to cats and perfume. She had no current illness. She was vaccinated with a dose of FLUVIRIN (batch number: 13424P) via intramuscular route into left arm on 09 Jan 2014. On the same day after vaccination, she experienced numbness of face and mouth, difficulty breathing and bad headache. She was taken to emergency room. The treatment was rendered with hydroxyzine pamoate at a dose of 25 mg along with ibuprofen at a dose of 800 mg. The outcome of the events was reported as complete recovery. The event was reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality was not reported.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Case number PHHY2014US046005 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 519204) website on 14 Apr 2014: This report refers to a 65-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: unknown) in to the left arm on 23 Oct 2013. On the same day after vaccination, he presented with complaint of pain in left arm, shoulder to elbow (ache), which caused a sharp pain when attempting to raise his arm above his head. The reaction was ongoing from 23 Oct 2013 to 14 Jan 2014. Patient had not sought any treatment. The events were assessed as serious leading to disability by the reporter. No further information about causality was reported.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Case number PHHY2014US046481 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 520008) on 14 Apr 2014: This report refers to a 51-year-old female patient. Her medical history included sulfa allergy and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1309401) subcutaneously in to the left arm on 09 Oct 2013. On the same day after vaccination, she experienced hives that covered entire body. She took a BENADRYL which did not aleve symptoms. She sought medical attention and was prescribed oral and topical steroids by the physician. Next day, she saw an allergist who prescribed SINGULAIR and ZYRTEC. Symptoms lasted for five to seven days. She visited the emergency room (ER) following these events. Outcome of the events was reported as complete recovery. Events were assessed as non-serious by the reporter; however the case was internally upgraded to serious by agency. No further information about causality was reported.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope, Tachycardia, Urticaria
Clinical narrative: Case number PHHY2014US046541, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520735) website on 14 Apr 2014. This report refers to a 48-year-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1309701) intramuscularly into left arm on 16 Jan 2014. On the same day she experienced syncope, tachycardia and hives. She visited to the emergency room. The outcome of the events was recovered. The causality of the events was not reported. The events were reported as non-serious; however the event syncope was assessed as medically significant and other events as non-serious by the agency.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Blood test, Computerised tomogram, Condition aggravated, Electromyogram abnormal
Clinical narrative: Case number PHHY2014US046580, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520738) website on 14 Apr 2014. This report refers to 22-year-old female patient. Her medical history included numbness in hands, feet, mouth and weakness to extremities after prior vaccination with FLUVIRIN (batch number: unknown) on an unspecified date (See case: PHHY2014US046559). She was allergic to sulfa and antibiotics (unspecified). Concomitant medications included EFFEXOR, PROTONIX, atenolol, topiramate and ranitidine. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into right arm on 03 Sep 2013. On 26 Oct 2013, she experienced numbness in hands, feet, mouth, and weakness in legs, elevated blood pressure and trouble walking. Electromyography (EMG) test was done to confirm Guillain-Barre syndrome (GBS). Laboratory tests included blood work to rule out many things, EMG test and computed tomography (CT) scan. The results of the tests were not reported. Plasmapheresis treatment was done with PCAD in place. The outcome of the events and causality assessment was not reported. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia oral, Muscular weakness
Clinical narrative: Case number PHHY2014US046580, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520738) website on 14 Apr 2014. This report refers to 22-year-old female patient. Her medical history included numbness in hands, feet, mouth and weakness to extremities after prior vaccination with FLUVIRIN (batch number: unknown) on an unspecified date (See case: PHHY2014US046559). She was allergic to sulfa and antibiotics (unspecified). Concomitant medications included EFFEXOR, PROTONIX, atenolol, topiramate and ranitidine. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into right arm on 03 Sep 2013. On 26 Oct 2013, she experienced numbness in hands, feet, mouth, and weakness in legs, elevated blood pressure and trouble walking. Electromyography (EMG) test was done to confirm Guillain-Barre syndrome (GBS). Laboratory tests included blood work to rule out many things, EMG test and computed tomography (CT) scan. The results of the tests were not reported. Plasmapheresis treatment was done with PCAD in place. The outcome of the events and causality assessment was not reported. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Plasmapheresis
Clinical narrative: Case number PHHY2014US046580, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520738) website on 14 Apr 2014. This report refers to 22-year-old female patient. Her medical history included numbness in hands, feet, mouth and weakness to extremities after prior vaccination with FLUVIRIN (batch number: unknown) on an unspecified date (See case: PHHY2014US046559). She was allergic to sulfa and antibiotics (unspecified). Concomitant medications included EFFEXOR, PROTONIX, atenolol, topiramate and ranitidine. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into right arm on 03 Sep 2013. On 26 Oct 2013, she experienced numbness in hands, feet, mouth, and weakness in legs, elevated blood pressure and trouble walking. Electromyography (EMG) test was done to confirm Guillain-Barre syndrome (GBS). Laboratory tests included blood work to rule out many things, EMG test and computed tomography (CT) scan. The results of the tests were not reported. Plasmapheresis treatment was done with PCAD in place. The outcome of the events and causality assessment was not reported. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Case number PHHY2014US047051 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520895) 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 FLUVIRIN (batch number: 13415P) in the left arm on 11 Jan 2014. After administration of the vaccine (about 5 minutes), she experienced an episode of syncope. She regained consciousness after a few seconds without further complaints. She visited to the emergency room. The event was reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality of the event was not reported. No additional information was available.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Induration, Pyrexia, Skin warm
Clinical narrative: Case number PHHY2014US047065, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520899) website on 14 Apr 2014. This report refers to 50-year-old female patient. Her medical history included asthma. Concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1309701) into right arm on 31 Oct 2013. On the same day she was vaccinated with PNEUMOVAX (other manufacturer, batch number: J004080) into left arm. On 01 Nov 2013, she developed cellulitis in left arm which was warm and hard. She also had fever. She visited the emergency room the following day or two. Treatment medications included CEFTIN 500mg and CIPRO 500mg. The outcome of the events was recovered and causality assessment was not reported. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Headache, Injection site pain, Injection site reaction, Muscular weakness
Clinical narrative: Case number PHHY2014US048930 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 521206) web site on 14 Apr 2014. This report refers to a 60 year old male patient. He had no medical history or current illness. His concomitant medication included omeprazole at a dose of 20 mg per day. He was vaccinated with FLUVIRIN (batch number: 1310301) via intramuscular route into left arm on 18 Jan 2014. On 19 Jan 2014, he experienced nerve pain at injection site arm which was moving through neck and back area, severe headaches, pain upon touch and weakness in extremities upper body. He was taken to emergency room where physician could not help him with the events. He would visit his regular physician soon. The outcome was not reported. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Neck pain, Neuralgia
Clinical narrative: Case number PHHY2014US048930 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 521206) web site on 14 Apr 2014. This report refers to a 60 year old male patient. He had no medical history or current illness. His concomitant medication included omeprazole at a dose of 20 mg per day. He was vaccinated with FLUVIRIN (batch number: 1310301) via intramuscular route into left arm on 18 Jan 2014. On 19 Jan 2014, he experienced nerve pain at injection site arm which was moving through neck and back area, severe headaches, pain upon touch and weakness in extremities upper body. He was taken to emergency room where physician could not help him with the events. He would visit his regular physician soon. The outcome was not reported. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency.
Age: 50.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Cardiac stress test, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: Case number PHHY2014US046454 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 521356) web site on 14 Apr 2014. This report refers to a 50 year old female patient. Her medical history included prediabetes, vitamin D deficiency, subclinical hypothyroid with thyroid cyst, allergic rhinitis, idiopathic urticaria, gastrooesophageal reflux disease (GERD), colon polyps and obesity. Her concomitant medications were metformin, Vitamin D (ergocalciferol), Vitamin C (ascorbic acid), fexofenadine, MVI (vitamins), PEPCID and MAALOX. She was vaccinated with FLUVIRIN (batch number: not reported) and ADACEL (batch number: 7GH61) intramuscularly in the right arm on 14 Oct 2013. On 26 Oct 2013, she developed numbness and tingling. She went to emergency room and was admitted to hospital with Guillain Barre syndrome. It was reported that she was in hospital for 13 days and was treated with steroids and intravenous globulins. She underwent lumbar puncture and nuclear stress test and the results were not reported. The events were reported as condition unchanged. The events were reported as life threatening with hospitalization. The causality was not reported.
Age: 50.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Paraesthesia
Clinical narrative: Case number PHHY2014US046454 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 521356) web site on 14 Apr 2014. This report refers to a 50 year old female patient. Her medical history included prediabetes, vitamin D deficiency, subclinical hypothyroid with thyroid cyst, allergic rhinitis, idiopathic urticaria, gastrooesophageal reflux disease (GERD), colon polyps and obesity. Her concomitant medications were metformin, Vitamin D (ergocalciferol), Vitamin C (ascorbic acid), fexofenadine, MVI (vitamins), PEPCID and MAALOX. She was vaccinated with FLUVIRIN (batch number: not reported) and ADACEL (batch number: 7GH61) intramuscularly in the right arm on 14 Oct 2013. On 26 Oct 2013, she developed numbness and tingling. She went to emergency room and was admitted to hospital with Guillain Barre syndrome. It was reported that she was in hospital for 13 days and was treated with steroids and intravenous globulins. She underwent lumbar puncture and nuclear stress test and the results were not reported. The events were reported as condition unchanged. The events were reported as life threatening with hospitalization. The causality was not reported.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Pharyngeal oedema
Clinical narrative: Case number PHHY2014US047028 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522045) on 14 Apr 2014. This report refers to a 54 years old female patient. Her medical history included allergy to sulfa drugs and penicillin (rash). Her concomitant medication was not reported. Her vaccination history included administration of flu shot (no more details available) on unspecified date (reported around 2 years ago) which was well tolerated and temperature with in normal limits. She was vaccinated with FLUVIRIN (batch number: 13465P) intramuscularly in left arm on 06 Feb 2014. It was reported that 5 minutes after vaccination her throat was swelled and feeling flushed. She was treated with KENALOG at a dose of 40 mg intramuscularly at 7:52 pm and with BENADRYL at a dose of 25mg orally at 19:58. Patient was monitored for about 28 minutes. After which she felt better, her vital signs stable (VSS) and examination results were within normal limits (WNL). The outcome of the event was reported as complete recovery on the same day of vaccination. The seriousness and the causality of the events were not reported. However, the event pharyngeal edema was assessed as medically significant, and feeling flushed as non-serious by agency.
Age: 21.0
Sex: M
Vaccine: ADEN_4_7, FLU3, HEPA, MNQ, TDAP, VARCEL
Symptoms: Lip swelling, Nausea
Clinical narrative: Case number PHHY2014US047167 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 522172) on 14 Apr 2014. This report refers to a 21 years old male patient. His medical history was not reported. His concomitant medications included BICILLIN intramuscularly at LT gluteus. He was vaccinated with FLUVIRIN (batch number: 13141P) intramuscularly in right arm on 28 Jan 2014. He was also vaccinated with Adenovirus types 4 and 7, live vaccine (other manufacturer, batch  number: 34600149) orally, HAVRIX (other manufacturer, batch number: K94NR) intramuscularly in left arm, MENACTRA (other manufacturer, batch number: U4686AA) intramuscularly in left arm, BOOSTRIX (other manufacturer, batch number: N4L77) intramuscularly in right arm and VARIVAX (other manufacturer, batch number: H020256) subcutaneously in left arm on 28 Jan 2014. On 28 Jan 2014 he presented with lip swelling and experienced nausea. The outcome of the events was reported as complete recovery by 27 Feb 2014. The seriousness and causality of the events were not reported.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Guillain-Barre syndrome, Pain
Clinical narrative: Case number PHHY2014US054809 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 523487) website on 06 May 2014. This report refers to a 49-year-old male patient. He had a medical history of diabetes. His concomitant medications were not reported. On 11 Jan 2014, he was vaccinated with FLUVIRIN (batch number: 13471P) intramuscularly in the left arm. Following the vaccination, on 14 Jan 2014 he developed Guillain-Barre syndrome. He also reported that he woke up with aches and could not get out of bed. Due to the events, he was taken to the emergency room. No treatment was rendered and he was advised to take rest. The final outcome was reported as complete recovery. The causality of the events was not reported. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency.
Age: 28.0
Sex: M
Vaccine: ADEN_4_7, FLU3, MNQ, TDAP
Symptoms: Blood creatine phosphokinase, Computerised tomogram abnormal, Guillain-Barre syndrome, Lumbar puncture abnormal, Muscular weakness
Clinical narrative: Case number PHHY2014US055173 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 524617) website on 06 May 2014. This report refers to a 28-year-old male patient. He did not have any pre-existing diagnoses and there were no known medical conditions at the time of vaccination. His concomitant medications included BICILLIN. He was vaccinated with FLUVIRIN (batch number: 13141P) and BOOSTRIX (batch number: N4L77); both vaccines administered intramuscularly in the right arm on 28 Jan 2014. On the same day he also received MENACTRA (batch number: U4686AA) intramuscularly in the left arm and Adenovirus type 4 and 7 live vaccine (other manufacturer, batch number: 34600135) via oral route. It was reported that after receiving "INH" on 13 Feb 2014, he complained of rash, stiffness. He also had leg weakness on unknown date. He had a neurology follow up and underwent lumbar puncture, computerised tomogram (CT) scan, blood creatine phosphokinase (CPK) and thyroid function test (TFT) and the results were not reported. It was reported that he was diagnosed with Guillain-Barre syndrome. The final outcome of the event was reported as complete recovery. The event was reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality of the event was not reported.
Age: 28.0
Sex: M
Vaccine: ADEN_4_7, FLU3, MNQ, TDAP
Symptoms: Musculoskeletal stiffness, Rash, Thyroid function test abnormal
Clinical narrative: Case number PHHY2014US055173 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 524617) website on 06 May 2014. This report refers to a 28-year-old male patient. He did not have any pre-existing diagnoses and there were no known medical conditions at the time of vaccination. His concomitant medications included BICILLIN. He was vaccinated with FLUVIRIN (batch number: 13141P) and BOOSTRIX (batch number: N4L77); both vaccines administered intramuscularly in the right arm on 28 Jan 2014. On the same day he also received MENACTRA (batch number: U4686AA) intramuscularly in the left arm and Adenovirus type 4 and 7 live vaccine (other manufacturer, batch number: 34600135) via oral route. It was reported that after receiving "INH" on 13 Feb 2014, he complained of rash, stiffness. He also had leg weakness on unknown date. He had a neurology follow up and underwent lumbar puncture, computerised tomogram (CT) scan, blood creatine phosphokinase (CPK) and thyroid function test (TFT) and the results were not reported. It was reported that he was diagnosed with Guillain-Barre syndrome. The final outcome of the event was reported as complete recovery. The event was reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality of the event was not reported.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Fall, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Case number PHHY2014US070861, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 526903) website on 09 Jun 2014. This report refers to an 87-year-old male patient. Past medical history included high cholesterol and mild dementia. Concomitant medications included pravastatin and alprazolam. He was vaccinated with FLUVIRIN (batch number: 1307601) intramuscularly on 11 Sep 2013. Three to four weeks post-vaccination, he began to experience balance difficulty. Also he complained of loss of feeling in feet about six weeks post vaccination and difficulty walking followed by falls eight to ten weeks post-vaccination. A presumptive diagnosis of Guillain Barre Syndrome was made. He was treated for Guillain Barre Syndrome with five days of IV gamma globulin. He did not regain loss of feeling/nerve damage in feet and was bed/wheelchair bound. Rehabilitation and physical therapy for eight plus weeks had little/no improvement. He was transferred to long-term care nursing home after no improvement in physical therapy. In addition to loss of feeling waist down, he was now incontinent. On an unknown date he underwent spinal tap; however the result was not provided. He was hospitalized for nine days. The outcome of the events was condition unchanged. The seriousness of the events was reported as hospitalization and permanent disability. Causality was not reported.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Incontinence, Lumbar puncture, Nerve injury, Sensory loss
Clinical narrative: Case number PHHY2014US070861, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 526903) website on 09 Jun 2014. This report refers to an 87-year-old male patient. Past medical history included high cholesterol and mild dementia. Concomitant medications included pravastatin and alprazolam. He was vaccinated with FLUVIRIN (batch number: 1307601) intramuscularly on 11 Sep 2013. Three to four weeks post-vaccination, he began to experience balance difficulty. Also he complained of loss of feeling in feet about six weeks post vaccination and difficulty walking followed by falls eight to ten weeks post-vaccination. A presumptive diagnosis of Guillain Barre Syndrome was made. He was treated for Guillain Barre Syndrome with five days of IV gamma globulin. He did not regain loss of feeling/nerve damage in feet and was bed/wheelchair bound. Rehabilitation and physical therapy for eight plus weeks had little/no improvement. He was transferred to long-term care nursing home after no improvement in physical therapy. In addition to loss of feeling waist down, he was now incontinent. On an unknown date he underwent spinal tap; however the result was not provided. He was hospitalized for nine days. The outcome of the events was condition unchanged. The seriousness of the events was reported as hospitalization and permanent disability. Causality was not reported.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Hypertension, Renal impairment, Renal injury
Clinical narrative: This medically confirmed health authority report (initial receipt 19-May-2014) concerns a 71 year old female patient. On the 29-Jan-2014, the patient received AFLURIA (batch number R56608) in the left arm via the intramuscular route. On the 29-Jan-2014, the patient went to the ER (Emergency Room) because her eyes swelled shut several hours after the shot. The patient was given diphenhydramine. Her blood pressure was taken and was very high. The patient reported kidney damage and now had 50% function. Outcome was reported as recovered. Reporter comments: The regulator reported the case as serious. The regulator reported the term 'eyelid oedema'.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site infection, Injection site scab, Injection site swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 12-May-2014) concerns a 67 year old male patient. On the 10-Oct-2013, the patient received AFLURIA (batch number R54808) dose 1 in the right arm. On an unspecified date, at the time of the administration of the vaccine, the site of the injection became red and swollen with some urticaria. It eventually scabbed over and resolved on its own without incident. The patient stated that the scab and redness returned approximately two weeks prior to being seen in the ED (Emergency Department). He decided to get it checked out and therefore reported to the ED on the 06-Jan-2014. There was a quarter sized scabbed area in the right deltoid with slight redness but no drainage. The patient was diagnosed with cellulitis and was given a ten day supply of sulfamethoxazole/trimethoprim. The infection resolved. Outcome was reported as recovered. Reporter comments: the regulator reported the case as non-serious. The regulator reported the Preferred Term of 'injection site infection' and 'injection site cellulitis'.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site urticaria
Clinical narrative: This medically confirmed health authority report (initial receipt 12-May-2014) concerns a 67 year old male patient. On the 10-Oct-2013, the patient received AFLURIA (batch number R54808) dose 1 in the right arm. On an unspecified date, at the time of the administration of the vaccine, the site of the injection became red and swollen with some urticaria. It eventually scabbed over and resolved on its own without incident. The patient stated that the scab and redness returned approximately two weeks prior to being seen in the ED (Emergency Department). He decided to get it checked out and therefore reported to the ED on the 06-Jan-2014. There was a quarter sized scabbed area in the right deltoid with slight redness but no drainage. The patient was diagnosed with cellulitis and was given a ten day supply of sulfamethoxazole/trimethoprim. The infection resolved. Outcome was reported as recovered. Reporter comments: the regulator reported the case as non-serious. The regulator reported the Preferred Term of 'injection site infection' and 'injection site cellulitis'.
Age: 44.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Erythema multiforme, Pain, Rash, Swelling
Clinical narrative: This spontaneous health authority report (initial receipt 16-Jun-2014) concerns a 44-year old male patient. The patient had a medical history of human immunodeficiency virus (HIV), chronic hepatitis C and back pain. His concomitant medication included mirtazapine, abacavir w/lamivudine, atazanavir, ibuprofen, entecavir, loratadine, multi-vitamin infusion and guaifenesin syrup. On 25-Sep-2013, the patient received AFLURIA (batch number: R52907) in the left arm and the same day, he also received PREVNAR 13 (batch number H00672) in the right arm. On 25-Sep-2013, the patient experienced rash and swelling for approximately 1 week post injection. The rash spread from shoulder to elbow. The pain lasted for about 1 and half month after injection. Outcome was reported as recovered. Reporter's comments: The health authority assessed the case as non-serious. The health authority reported term was 'erythema multiforme'.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Computerised tomogram head, Electrocardiogram
Clinical narrative: This medically confirmed health authority report (initial receipt 25-Aug-2014) concerns a 61 year old male patient who had a medical history of stage 1 lung cancer in 2013 (survivor) after an upper right lobectomy and COPD (Chronic Obstructive Pulmonary Disease). Concomitant medication included TUDORZA. On the 03-Apr-2014, the patient received AFLURIA (batch number 08949211A). On the 12-Apr-2014, the patient developed pain across the shoulders and numbness and tingling in the feet, hands and throat. The patient was presented in the emergency room and was hospitalised for 32 days. Laboratory tests included a blood test, a head scan, chest x-rays, EKG (Electrocardiogram), MRI (Magnetic Resonance Imaging), CT scan (Computerised Tomography), a spinal tap, EMG (Electromyogram) and a barium swallow test. Outcome was unknown. Reporter comments: the regulator reported the case as serious (hospitalisation) and reported the Preferred Term of 'throat irritation'.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram, Hypoaesthesia, Lumbar puncture, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: This medically confirmed health authority report (initial receipt 25-Aug-2014) concerns a 61 year old male patient who had a medical history of stage 1 lung cancer in 2013 (survivor) after an upper right lobectomy and COPD (Chronic Obstructive Pulmonary Disease). Concomitant medication included TUDORZA. On the 03-Apr-2014, the patient received AFLURIA (batch number 08949211A). On the 12-Apr-2014, the patient developed pain across the shoulders and numbness and tingling in the feet, hands and throat. The patient was presented in the emergency room and was hospitalised for 32 days. Laboratory tests included a blood test, a head scan, chest x-rays, EKG (Electrocardiogram), MRI (Magnetic Resonance Imaging), CT scan (Computerised Tomography), a spinal tap, EMG (Electromyogram) and a barium swallow test. Outcome was unknown. Reporter comments: the regulator reported the case as serious (hospitalisation) and reported the Preferred Term of 'throat irritation'.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Pharyngeal hypoaesthesia
Clinical narrative: This medically confirmed health authority report (initial receipt 25-Aug-2014) concerns a 61 year old male patient who had a medical history of stage 1 lung cancer in 2013 (survivor) after an upper right lobectomy and COPD (Chronic Obstructive Pulmonary Disease). Concomitant medication included TUDORZA. On the 03-Apr-2014, the patient received AFLURIA (batch number 08949211A). On the 12-Apr-2014, the patient developed pain across the shoulders and numbness and tingling in the feet, hands and throat. The patient was presented in the emergency room and was hospitalised for 32 days. Laboratory tests included a blood test, a head scan, chest x-rays, EKG (Electrocardiogram), MRI (Magnetic Resonance Imaging), CT scan (Computerised Tomography), a spinal tap, EMG (Electromyogram) and a barium swallow test. Outcome was unknown. Reporter comments: the regulator reported the case as serious (hospitalisation) and reported the Preferred Term of 'throat irritation'.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema multiforme, Pruritus, Rash, Urticaria
Clinical narrative: This medically confirmed health authority report (initial receipt 14-JUL-2014) concerns a 32-year-old female patient. On 27-Sep-2013, the patient received AFLURIA (batch number-R54207) in the left arm. On 28-Sep-2014, the patient experienced skin rash, erythema multiforme, urticarial and pruritus. The patient was treated with loratadine at 10 mg in the morning. The outcome was reported as recovered. Reporter's comments: The authority assessed the events as non-serious.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Angioedema, Lip swelling, Swelling face
Clinical narrative: This medically confirmed health authority report (initial receipt 14-Jul-2014) concerns a 63-year-old male patient. The patient had a medical history of hypertension (HTN), hyperlipidemia (HLD) and prostate cancer (Gleason 7). Concomitant medication included lisinopril. On 19-Sep-2013 at 11.00 am, the patient received AFLURIA (batch number R53607) 1 dose in the left arm. On 19-Sep-2014 at 14:30pm, the patient noted a sudden onset of left sided facial swelling that continued to worsen. The patient presented to the emergency department (ED) with acute onset of left sided facial swelling. He denied any difficulty breathing or difficulty swallowing. He denied any pain, numbness or tingling. He had no mouth ulcers or sores. There were no recent illnesses, fevers or chills. On physical exam, the patient was in no acute distress. The left sided facial swelling involved the left lip and cheek. There were no ulcers or lesions, no oropharyngeal oedema, the oropharynx was clear and open. There was no erythema or exudates, no stridor. There was no tenderness to palpitation, normal sensation. The outcome was reported as recovered. Reporter's comments: It was reported that facial swelling was attributed to angioedema from lisinopril versus a reaction to the influenza vaccine. The reporter assessed the events as non-serious. Case correction (07-Aug-2014) - AE 2 and AE 3 recoded.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Guillain-Barre syndrome, Hyperaesthesia, Influenza like illness
Clinical narrative: Case number PHHY2014US100399, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 533469) website on 08 Aug 2014. This report refers to a 71 year old female patient. She was vaccinated with FLUVIRIN (batch number: 130960) intramuscularly in the arm on 15 Oct 2013. On 29 Oct 2013, she experienced flu like symptoms (extreme), extreme weakness, lack of energy, tingling in extremities and sensitivity to touch. She visited the emergency room and the nerve tests conducted showed positive for Guillain Barre and the results of blood work were not provided. The outcome of the events reported as recovered on an unknown date. The events reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality of the events was not reported.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Neurological examination abnormal, Paraesthesia
Clinical narrative: Case number PHHY2014US100399, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 533469) website on 08 Aug 2014. This report refers to a 71 year old female patient. She was vaccinated with FLUVIRIN (batch number: 130960) intramuscularly in the arm on 15 Oct 2013. On 29 Oct 2013, she experienced flu like symptoms (extreme), extreme weakness, lack of energy, tingling in extremities and sensitivity to touch. She visited the emergency room and the nerve tests conducted showed positive for Guillain Barre and the results of blood work were not provided. The outcome of the events reported as recovered on an unknown date. The events reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality of the events was not reported.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: Case number PHHY2014US111988, is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 533894) website on 03 Sep 2014. This report refers to a 54-year-old female patient. Historical conditions and concomitant medication were none. She was vaccinated with FLUVIRIN (batch number: 1309101) into the arm on 24 Oct 2013. On 10 Nov 2013, she experienced Guillain Barre Syndrome and had numbness in hands, arms, legs and feet. She was hospitalized for nine days. In Jan 2014, she underwent spinal tap at hospital (result not reported). Treatment was rendered with three doses of immunoglobulin therapy in Jan 2014. The outcome of the events was condition unchanged. The seriousness of the events was reported as hospitalization and permanent disability. Causality of the events was not reported.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Inflammation, Injected limb mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: This medically confirmed health authority report (initial receipt 25-Aug-2014) concerns a 50 year old female patient who had a medical history of adhesive capsulitis in the left shoulder after receiving the influenza vaccination in 2012 (see case 2014044810). On the 27-Nov-2013, the patient received AFLURIA (batch number R55108) dose 1, via the intramuscular route in the RA deltoid (right arm). On the 27-Nov-2013, the patient developed worsening stiffness. About two weeks after administration of AFLURIA, the patient developed pain which progressed into adhesive capsulitis/chronic inflammation of the entire shoulder girdle causing severe pain lasting many months post injection. Treatment included orthopedic medicine, pain management, rheumatology, internal medicine and physical therapy. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious and reported the Preferred Terms of 'injected limb mobility decreased, injection site inflammation, injection site pain'.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Periarthritis
Clinical narrative: This medically confirmed health authority report (initial receipt 25-Aug-2014) concerns a 50 year old female patient who had a medical history of adhesive capsulitis in the left shoulder after receiving the influenza vaccination in 2012 (see case 2014044810). On the 27-Nov-2013, the patient received AFLURIA (batch number R55108) dose 1, via the intramuscular route in the RA deltoid (right arm). On the 27-Nov-2013, the patient developed worsening stiffness. About two weeks after administration of AFLURIA, the patient developed pain which progressed into adhesive capsulitis/chronic inflammation of the entire shoulder girdle causing severe pain lasting many months post injection. Treatment included orthopedic medicine, pain management, rheumatology, internal medicine and physical therapy. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious and reported the Preferred Terms of 'injected limb mobility decreased, injection site inflammation, injection site pain'.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Myalgia, Pyrexia, Rash
Clinical narrative: This medically confirmed health authority report (initial receipt-14-Jul-2014) concerns a 46-year-old male patient. On 14-Dec-2013, the patient received dose one of AFLURIA (batch number-R55908A) in the right arm and dose one of PNEUMOVAX (batch number-J010332) in the left arm. On 14-Dec-2013, the patient experienced chills, headache, sedation, myalgia, fever and skin rash. The outcome was reported as recovered. Reporter's comments: The authority assessed the events as serious as it led to hospitalisation of the patient.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Sedation
Clinical narrative: This medically confirmed health authority report (initial receipt-14-Jul-2014) concerns a 46-year-old male patient. On 14-Dec-2013, the patient received dose one of AFLURIA (batch number-R55908A) in the right arm and dose one of PNEUMOVAX (batch number-J010332) in the left arm. On 14-Dec-2013, the patient experienced chills, headache, sedation, myalgia, fever and skin rash. The outcome was reported as recovered. Reporter's comments: The authority assessed the events as serious as it led to hospitalisation of the patient.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Disturbance in attention, Hypoaesthesia oral, Hypogeusia, Paraesthesia oral
Clinical narrative: This medically confirmed health authority report (initial receipt 25-Aug-2014) concerns a 27 year old male patient who had a medical history of PCN (penicillin) allergy and sinus problems. On the 21-Mar-2014, the patient had a TB (Tuberculosis) skin test. On the 24-Mar-2014, the patient received AFLURIA (batch number R52406) in the RA (right arm) via the intramuscular route. On the 24-Mar-2014, the patient's speech was impaired, had trouble focusing and developed a swollen tongue and a tingle and numbness in the tongue. The patient also developed a yellow film on the tongue in the morning, blurred eyes, had trouble tasting food and intermittent unsteadiness. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious, and coded the Preferred Term of 'Hypogeusia'. Case correction (12-Sep-2014): AE # 4 LLT re-coded.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Speech disorder, Swollen tongue, Tongue coated, Vision blurred
Clinical narrative: This medically confirmed health authority report (initial receipt 25-Aug-2014) concerns a 27 year old male patient who had a medical history of PCN (penicillin) allergy and sinus problems. On the 21-Mar-2014, the patient had a TB (Tuberculosis) skin test. On the 24-Mar-2014, the patient received AFLURIA (batch number R52406) in the RA (right arm) via the intramuscular route. On the 24-Mar-2014, the patient's speech was impaired, had trouble focusing and developed a swollen tongue and a tingle and numbness in the tongue. The patient also developed a yellow film on the tongue in the morning, blurred eyes, had trouble tasting food and intermittent unsteadiness. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious, and coded the Preferred Term of 'Hypogeusia'. Case correction (12-Sep-2014): AE # 4 LLT re-coded.
Age: 44.0
Sex: F
Vaccine: FLUC3
Symptoms: Chest discomfort, Dizziness, Dysphonia, Erythema, Urticaria
Clinical narrative: Case number PHHY2014US135391, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 537362) website on 10 Oct 2014. This report refers to a 44-year-old female patient. Her medical history included migraines. She was vaccinated with FLUCELVAX (batch number: 011011A) intramuscularly in the left arm on 22 Jul 2014. On the same date, one hour after vaccination she developed hoarseness in voice. On the same date, she also got hives from head to toe. The patient received two 25 mg tablets of diphenhydramine for the events. The event redness subsided but she also developed dizziness and chest tightness. The patient was taken to the emergency room. The outcome of the events reported as recovered. The events reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality of the events was not reported.
Age: 62.0
Sex: F
Vaccine: FLUC3
Symptoms: Peripheral swelling, Throat tightness
Clinical narrative: Case number PHHY2014US142500, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 541269) website on 28 Oct 2014. This report refers to a 62-year-old female patient. Concurrent conditions included dust allergy. No concomitant medication was reported. She was vaccinated with FLUCELVAX (batch number: 011021A) into the left arm on 23 Aug 2014. On the same day, an hour after vaccination, she experienced swelling in the left calf and her throat was closing up. Treatment was rendered with BENADRYL and that helped. She did not receive emergency treatment. She completely recovered from the events. The events were reported as non-serious. Causality was not reported. Seriousness assessment of the event throat was closing up was based on agency list.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: CSF glucose normal, CSF lymphocyte count increased, CSF protein increased, CSF white blood cell count increased, Cough
Clinical narrative: Case number PHHY2014US170740, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546261) website on 29 Dec 2014. This report refers to a 13-year-old male patient. His medical history included acne. On 20 Aug 2014, he was vaccinated with MENVEO (batch number: A14052) intramuscularly in the right arm along with VAQTA (other manufacturer, batch number: K0077921) intramuscularly in the left arm and BOOSTRIX (other manufacturer, batch number: 7KM4D) intramuscularly in the left leg. On an unknown date, he experienced cough and congestion. On 24 Sep 2014, he experienced acute onset of bilateral upper extremity weakness which progressed and involved lower extremities and weak cough. On 25 Sep 2014, he was admitted to the hospital and her cerebrospinal fluid showed 129 white blood cells (82% lymphocytes) with normal glucose and protein of 123 mg/dL. Nuclear magnetic resonance showed abnormal T2 hyperintensity along the spinal cord. He was treated with intravenous steroids and plasmapheresis with some improvement. At the time of the report, the patient was still hospitalized. The outcome of the events was not reported. The causality of the events was not reported.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging spinal abnormal, Plasmapheresis, Respiratory tract congestion
Clinical narrative: Case number PHHY2014US170740, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546261) website on 29 Dec 2014. This report refers to a 13-year-old male patient. His medical history included acne. On 20 Aug 2014, he was vaccinated with MENVEO (batch number: A14052) intramuscularly in the right arm along with VAQTA (other manufacturer, batch number: K0077921) intramuscularly in the left arm and BOOSTRIX (other manufacturer, batch number: 7KM4D) intramuscularly in the left leg. On an unknown date, he experienced cough and congestion. On 24 Sep 2014, he experienced acute onset of bilateral upper extremity weakness which progressed and involved lower extremities and weak cough. On 25 Sep 2014, he was admitted to the hospital and her cerebrospinal fluid showed 129 white blood cells (82% lymphocytes) with normal glucose and protein of 123 mg/dL. Nuclear magnetic resonance showed abnormal T2 hyperintensity along the spinal cord. He was treated with intravenous steroids and plasmapheresis with some improvement. At the time of the report, the patient was still hospitalized. The outcome of the events was not reported. The causality of the events was not reported.
Age: 43.0
Sex: F
Vaccine: FLUC3
Symptoms: Anaphylactic reaction
Clinical narrative: Case number PHEH2014US020815 is an initial spontaneous report received from a pharmacist on 16 Oct 2014. This report refers to a 43 year old female patient. The patient was very allergic to dogs and her concomitant medications were not reported. On 16 Oct 2014, she was vaccinated with FLUCELVAX (batch number: 161207) intramuscularly. On the same day, after the vaccination, she developed an anaphylactic reaction. The patient completely recovered from the event on the same day. The seriousness and causality of the event were not reported.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Rash.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report as received from a patient's mother via social media, refers to a female patient of unknown age. Medical history was not reported. On an unknown date the patient was vaccinated with GARDASIL (lot#, expiration date, strength, dosage, and route were not provided). Concomitant therapy was not reported. The consumer informed that the patient died from getting GARDASIL. The cause of death was unknown. It was unknown if autopsy was performed. Additional information is not expected because no reporter details were provided.