chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Productive cough, Secretion discharge
Clinical narrative: Initial report received from a consumer who is also the patient on 18 December 2012. A 78-year-old male patient, had received an intramuscular dose of FLUZONE (Lot number, dose in series, side and site of administration were not reported) on 10 October 2012. Patient had environmental allergies and no illness at time of vaccination. Concomitant medications and medical history were not reported. About 2.5 weeks after vaccination, the patient had come down to flu, coughing up mucus and his body produced a tremendous amount of mucus. Patient could not sleep well, the muscle in his shoulder tightened and he could not lift the arm up. It was reported that, the patient was running a temperature and had not measured it. It was reported that patient was improving. Corrective treatment were not reported. No laboratory investigations were done. On an unspecified date, the patient outcome was recovered. Documents held by sender: None. Follow up information received from a healthcare professional on 09 May 2013. This case is linked to case number 2013-06242 for same patient. The FLUZONE lot number was UH719AB and site of administration was deltoid right. The patient had not return to office with complaint of reaction until all problems were resolved. The patient had flu vaccine previously with no report of reaction in 2009, 2010 and "documented in 2006, patient reported that the flu vaccine always made him sick and had not taken one for 10 years".
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Central nervous system lesion, Clinically isolated syndrome, Lumbar puncture normal, Muscular weakness
Clinical narrative: Pt developed sudden onset RLE weakness and tingling after sudden onset of back pain two days after receiving GARDASIL vaccine. W/U included LP with no evidence of infection or oligoclonal bands. Neuro exam showed dec strength and endurance in RLE. Sensory disturbances as well. MRI later revealed nonenhancing lesions near corpus callosum, dx'd by neuro immunologist with clinically isolated syndrome.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Neurological examination abnormal, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Sensory disturbance
Clinical narrative: Pt developed sudden onset RLE weakness and tingling after sudden onset of back pain two days after receiving GARDASIL vaccine. W/U included LP with no evidence of infection or oligoclonal bands. Neuro exam showed dec strength and endurance in RLE. Sensory disturbances as well. MRI later revealed nonenhancing lesions near corpus callosum, dx'd by neuro immunologist with clinically isolated syndrome.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Adrenergic syndrome, Antiacetylcholine receptor antibody, Antibody test negative, Cardiac electrophysiologic study normal, Cardiovascular autonomic function test abnormal
Clinical narrative: Received GARDASIL 6/26/07 and 8/21/07. Symptoms of dizziness, SOB, near syncope, exercise intolerance began July 2007. ER visit 11/2007 officially dx with POTS. Went on to be tested by cardiologists. EP study, echoes, EKG, Holter, Lab work. Treatment beta blockers, midodrine, FLORINEF, many things were tried. Disabled by 2010. Haven't been able to return to work. GARDASIL given 6/26/07 and 8/21/07. I never received 3rd vaccine as I was sick, under the care of many physicians/tests so I never made it back in to GYN for final one. Symptoms started July 2007. Made a phone call to GYN with complaints of dizziness, feeling shaky, off. Thought it was a side effect to Birth control. They said No however I stopped it on my own. Symptoms never went away. Experienced exercise intolerance and could no longer do elliptical. Dizziness while on feet - needing to drop down to avoid passing out. Work - having trouble with SOB, dizziness, double vision while on feet. ER visit Nov. 2007 showed tachycardia upon standing dx. POTS (Postural orthostatic tachycardia syndrome). - I saw numerous cardiologist. Many ER visits. Holter monitor - tachycardia. Lab work - hormones WNL, 24 hr urine - normal; EP study - No pathways to ablate. Autoimmune panels - Negative. EKG - showed tachycardia. AAG antibody - Neg. Finally after years of searching found a local facility to do formal autonomic test. Showed: Baroreflex failure on Valsalva Maneuver with near syncope. Tilt - tachycardia to 138 beats per minute w/o orthostatic hypotension. Heart rate variability to deep breathing is less than 5th percentile. QSweat shows patent sensory loss. This study is indicative of adrenergic failure. Disabled since 2010.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Diplopia, Dizziness, Dizziness postural, Dyspnoea, Echocardiogram
Clinical narrative: Received GARDASIL 6/26/07 and 8/21/07. Symptoms of dizziness, SOB, near syncope, exercise intolerance began July 2007. ER visit 11/2007 officially dx with POTS. Went on to be tested by cardiologists. EP study, echoes, EKG, Holter, Lab work. Treatment beta blockers, midodrine, FLORINEF, many things were tried. Disabled by 2010. Haven't been able to return to work. GARDASIL given 6/26/07 and 8/21/07. I never received 3rd vaccine as I was sick, under the care of many physicians/tests so I never made it back in to GYN for final one. Symptoms started July 2007. Made a phone call to GYN with complaints of dizziness, feeling shaky, off. Thought it was a side effect to Birth control. They said No however I stopped it on my own. Symptoms never went away. Experienced exercise intolerance and could no longer do elliptical. Dizziness while on feet - needing to drop down to avoid passing out. Work - having trouble with SOB, dizziness, double vision while on feet. ER visit Nov. 2007 showed tachycardia upon standing dx. POTS (Postural orthostatic tachycardia syndrome). - I saw numerous cardiologist. Many ER visits. Holter monitor - tachycardia. Lab work - hormones WNL, 24 hr urine - normal; EP study - No pathways to ablate. Autoimmune panels - Negative. EKG - showed tachycardia. AAG antibody - Neg. Finally after years of searching found a local facility to do formal autonomic test. Showed: Baroreflex failure on Valsalva Maneuver with near syncope. Tilt - tachycardia to 138 beats per minute w/o orthostatic hypotension. Heart rate variability to deep breathing is less than 5th percentile. QSweat shows patent sensory loss. This study is indicative of adrenergic failure. Disabled since 2010.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal, Exercise tolerance decreased, Feeling abnormal, Immunology test normal
Clinical narrative: Received GARDASIL 6/26/07 and 8/21/07. Symptoms of dizziness, SOB, near syncope, exercise intolerance began July 2007. ER visit 11/2007 officially dx with POTS. Went on to be tested by cardiologists. EP study, echoes, EKG, Holter, Lab work. Treatment beta blockers, midodrine, FLORINEF, many things were tried. Disabled by 2010. Haven't been able to return to work. GARDASIL given 6/26/07 and 8/21/07. I never received 3rd vaccine as I was sick, under the care of many physicians/tests so I never made it back in to GYN for final one. Symptoms started July 2007. Made a phone call to GYN with complaints of dizziness, feeling shaky, off. Thought it was a side effect to Birth control. They said No however I stopped it on my own. Symptoms never went away. Experienced exercise intolerance and could no longer do elliptical. Dizziness while on feet - needing to drop down to avoid passing out. Work - having trouble with SOB, dizziness, double vision while on feet. ER visit Nov. 2007 showed tachycardia upon standing dx. POTS (Postural orthostatic tachycardia syndrome). - I saw numerous cardiologist. Many ER visits. Holter monitor - tachycardia. Lab work - hormones WNL, 24 hr urine - normal; EP study - No pathways to ablate. Autoimmune panels - Negative. EKG - showed tachycardia. AAG antibody - Neg. Finally after years of searching found a local facility to do formal autonomic test. Showed: Baroreflex failure on Valsalva Maneuver with near syncope. Tilt - tachycardia to 138 beats per minute w/o orthostatic hypotension. Heart rate variability to deep breathing is less than 5th percentile. QSweat shows patent sensory loss. This study is indicative of adrenergic failure. Disabled since 2010.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Impaired work ability, Laboratory test normal, Nervousness, Postural orthostatic tachycardia syndrome, Presyncope
Clinical narrative: Received GARDASIL 6/26/07 and 8/21/07. Symptoms of dizziness, SOB, near syncope, exercise intolerance began July 2007. ER visit 11/2007 officially dx with POTS. Went on to be tested by cardiologists. EP study, echoes, EKG, Holter, Lab work. Treatment beta blockers, midodrine, FLORINEF, many things were tried. Disabled by 2010. Haven't been able to return to work. GARDASIL given 6/26/07 and 8/21/07. I never received 3rd vaccine as I was sick, under the care of many physicians/tests so I never made it back in to GYN for final one. Symptoms started July 2007. Made a phone call to GYN with complaints of dizziness, feeling shaky, off. Thought it was a side effect to Birth control. They said No however I stopped it on my own. Symptoms never went away. Experienced exercise intolerance and could no longer do elliptical. Dizziness while on feet - needing to drop down to avoid passing out. Work - having trouble with SOB, dizziness, double vision while on feet. ER visit Nov. 2007 showed tachycardia upon standing dx. POTS (Postural orthostatic tachycardia syndrome). - I saw numerous cardiologist. Many ER visits. Holter monitor - tachycardia. Lab work - hormones WNL, 24 hr urine - normal; EP study - No pathways to ablate. Autoimmune panels - Negative. EKG - showed tachycardia. AAG antibody - Neg. Finally after years of searching found a local facility to do formal autonomic test. Showed: Baroreflex failure on Valsalva Maneuver with near syncope. Tilt - tachycardia to 138 beats per minute w/o orthostatic hypotension. Heart rate variability to deep breathing is less than 5th percentile. QSweat shows patent sensory loss. This study is indicative of adrenergic failure. Disabled since 2010.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Sensory disturbance, Tachycardia, Tilt table test positive, Urine analysis normal, Valsalva maneuver
Clinical narrative: Received GARDASIL 6/26/07 and 8/21/07. Symptoms of dizziness, SOB, near syncope, exercise intolerance began July 2007. ER visit 11/2007 officially dx with POTS. Went on to be tested by cardiologists. EP study, echoes, EKG, Holter, Lab work. Treatment beta blockers, midodrine, FLORINEF, many things were tried. Disabled by 2010. Haven't been able to return to work. GARDASIL given 6/26/07 and 8/21/07. I never received 3rd vaccine as I was sick, under the care of many physicians/tests so I never made it back in to GYN for final one. Symptoms started July 2007. Made a phone call to GYN with complaints of dizziness, feeling shaky, off. Thought it was a side effect to Birth control. They said No however I stopped it on my own. Symptoms never went away. Experienced exercise intolerance and could no longer do elliptical. Dizziness while on feet - needing to drop down to avoid passing out. Work - having trouble with SOB, dizziness, double vision while on feet. ER visit Nov. 2007 showed tachycardia upon standing dx. POTS (Postural orthostatic tachycardia syndrome). - I saw numerous cardiologist. Many ER visits. Holter monitor - tachycardia. Lab work - hormones WNL, 24 hr urine - normal; EP study - No pathways to ablate. Autoimmune panels - Negative. EKG - showed tachycardia. AAG antibody - Neg. Finally after years of searching found a local facility to do formal autonomic test. Showed: Baroreflex failure on Valsalva Maneuver with near syncope. Tilt - tachycardia to 138 beats per minute w/o orthostatic hypotension. Heart rate variability to deep breathing is less than 5th percentile. QSweat shows patent sensory loss. This study is indicative of adrenergic failure. Disabled since 2010.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Dizziness, Dyspnoea, Electrocardiogram, Heart rate abnormal
Clinical narrative: Received GARDASIL 6/26/07 and 8/21/07. Symptoms of dizziness, SOB, near syncope, exercise intolerance began July 2007. ER visit 11/2007 officially dx with POTS. Went on to be tested by cardiologists. EP study, echoes, EKG, Holter, Lab work. Treatment beta blockers, midodrine, FLORINEF, many things were tried. Disabled by 2010. Haven't been able to return to work. GARDASIL given 6/26/07 and 8/21/07. I never received 3rd vaccine as I was sick, under the care of many physicians/tests so I never made it back in to GYN for final one. Symptoms started July 2007. Made a phone call to GYN with complaints of dizziness, feeling shaky, off. Thought it was a side effect to Birth control. They said No however I stopped it on my own. Symptoms never went away. Experienced exercise intolerance and could no longer do elliptical. Dizziness while on feet - needing to drop down to avoid passing out. Work - having trouble with SOB, dizziness, double vision while on feet. ER visit Nov. 2007 showed tachycardia upon standing dx. POTS (Postural orthostatic tachycardia syndrome). - I saw numerous cardiologist. Many ER visits. Holter monitor - tachycardia. Lab work - hormones WNL, 24 hr urine - normal; EP study - No pathways to ablate. Autoimmune panels - Negative. EKG - showed tachycardia. AAG antibody - Neg. Finally after years of searching found a local facility to do formal autonomic test. Showed: Baroreflex failure on Valsalva Maneuver with near syncope. Tilt - tachycardia to 138 beats per minute w/o orthostatic hypotension. Heart rate variability to deep breathing is less than 5th percentile. QSweat shows patent sensory loss. This study is indicative of adrenergic failure. Disabled since 2010.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Postural orthostatic tachycardia syndrome, Urine analysis
Clinical narrative: Received GARDASIL 6/26/07 and 8/21/07. Symptoms of dizziness, SOB, near syncope, exercise intolerance began July 2007. ER visit 11/2007 officially dx with POTS. Went on to be tested by cardiologists. EP study, echoes, EKG, Holter, Lab work. Treatment beta blockers, midodrine, FLORINEF, many things were tried. Disabled by 2010. Haven't been able to return to work. GARDASIL given 6/26/07 and 8/21/07. I never received 3rd vaccine as I was sick, under the care of many physicians/tests so I never made it back in to GYN for final one. Symptoms started July 2007. Made a phone call to GYN with complaints of dizziness, feeling shaky, off. Thought it was a side effect to Birth control. They said No however I stopped it on my own. Symptoms never went away. Experienced exercise intolerance and could no longer do elliptical. Dizziness while on feet - needing to drop down to avoid passing out. Work - having trouble with SOB, dizziness, double vision while on feet. ER visit Nov. 2007 showed tachycardia upon standing dx. POTS (Postural orthostatic tachycardia syndrome). - I saw numerous cardiologist. Many ER visits. Holter monitor - tachycardia. Lab work - hormones WNL, 24 hr urine - normal; EP study - No pathways to ablate. Autoimmune panels - Negative. EKG - showed tachycardia. AAG antibody - Neg. Finally after years of searching found a local facility to do formal autonomic test. Showed: Baroreflex failure on Valsalva Maneuver with near syncope. Tilt - tachycardia to 138 beats per minute w/o orthostatic hypotension. Heart rate variability to deep breathing is less than 5th percentile. QSweat shows patent sensory loss. This study is indicative of adrenergic failure. Disabled since 2010.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Dyspnoea, Electromyogram normal, Endotracheal intubation, Guillain-Barre syndrome
Clinical narrative: Pt. three days ago was camping, where he noted the beginning of numbness of all his fingers. This then progressed to a weakness. Pt. states he had no vision change/motor or sensation or swallowing change. Per pt. the pt wife noted three days ago he couldn't talk right for about five minutes. The sx did not change except he noted this morning at 0430 he became progressively weaker. It started in the legs and was accompanied by SOB (worse SOB than usual). On 6/5/15 neurology believed symptoms to be due to GBS versus CDIP, myasthenia gravis, or critical illness neuropathy. Patient also started receiving an 8-day course of IVIG at 0.4g/kg/day (normally a 5-day course, but patient didn't initially respond and therefore treatment was extended). Patient was on acute care medicine from 5/23/15 to 6/6/15 when he was transferred to the ICU. He required intubation and ventilation on 6/7/15, which progressed to a tracheostomy on 6/22/15. Patient slowly began to recover from weakness but now requires extensive rehabilitation. Globulin, immune 44.8 gm every day.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Intensive care, Mechanical ventilation, Muscular weakness
Clinical narrative: Pt. three days ago was camping, where he noted the beginning of numbness of all his fingers. This then progressed to a weakness. Pt. states he had no vision change/motor or sensation or swallowing change. Per pt. the pt wife noted three days ago he couldn't talk right for about five minutes. The sx did not change except he noted this morning at 0430 he became progressively weaker. It started in the legs and was accompanied by SOB (worse SOB than usual). On 6/5/15 neurology believed symptoms to be due to GBS versus CDIP, myasthenia gravis, or critical illness neuropathy. Patient also started receiving an 8-day course of IVIG at 0.4g/kg/day (normally a 5-day course, but patient didn't initially respond and therefore treatment was extended). Patient was on acute care medicine from 5/23/15 to 6/6/15 when he was transferred to the ICU. He required intubation and ventilation on 6/7/15, which progressed to a tracheostomy on 6/22/15. Patient slowly began to recover from weakness but now requires extensive rehabilitation. Globulin, immune 44.8 gm every day.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Nerve conduction studies abnormal, Speech disorder, Tracheostomy
Clinical narrative: Pt. three days ago was camping, where he noted the beginning of numbness of all his fingers. This then progressed to a weakness. Pt. states he had no vision change/motor or sensation or swallowing change. Per pt. the pt wife noted three days ago he couldn't talk right for about five minutes. The sx did not change except he noted this morning at 0430 he became progressively weaker. It started in the legs and was accompanied by SOB (worse SOB than usual). On 6/5/15 neurology believed symptoms to be due to GBS versus CDIP, myasthenia gravis, or critical illness neuropathy. Patient also started receiving an 8-day course of IVIG at 0.4g/kg/day (normally a 5-day course, but patient didn't initially respond and therefore treatment was extended). Patient was on acute care medicine from 5/23/15 to 6/6/15 when he was transferred to the ICU. He required intubation and ventilation on 6/7/15, which progressed to a tracheostomy on 6/22/15. Patient slowly began to recover from weakness but now requires extensive rehabilitation. Globulin, immune 44.8 gm every day.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Injection site pain, Respiratory tract congestion, Skin warm
Clinical narrative: Initial report received from a consumer who is also the patient on 09 September 2013. A 55-year-old male patient, had received a dose of FLUZONE (lot number: UH896AA, expiry date: 30 June 2014) intramuscular in right deltoid on 06 September 2013. The patient had no illness at time of vaccination. The patient had COPD (Chronic obstructive pulmonary disease), allergic to FENTANYL and seasonal allergies. Concomitant medications were not reported. On 07 September 2013, 1 day after vaccination, in morning the patient woke up with chest congestion, feeling tired, feels light headed at times, temperature of 98.8 F (oral) and had been as low as 97F, injection site (right deltoid) was sore with no redness or swelling. The patient's wife touched his forehead and felt he was burning up however the temperature was not high when checked and no other symptoms were reported. No laboratory investigations were done and corrective treatments were not reported. The patient outcome was not recovered. Documents held by sender: none.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Initial report received from a health care professional on 09 October 2012. A 48-year-old female patient, whose medical history was not reported, received a intramuscular dose of FLUZONE vaccine (dose number not reported, Lot number UH713AB) in left deltoid on 05 October 2012. The patient took yearly flu shots and reporter unsure however patient does take inhalers. It was reported that on 06 October 2012 i.e. 01 days after vaccination the patient experienced redness and swelling that extended 20cm from injection site down the left arm with hardness and pain at the injection site. She also reported chills and sweats. Also reported that patient felt as if the muscle was dissected as the shot was administered. At the time of vaccination patient was not acutely ill. The patient self-treated with MOTRIN, and symptoms had resolved and site was prepped with alcohol. Laboratory investigations and relevant diagnostic test were reported as none. On an unspecified date the outcome of the events was recovered. Documents held by sender: none.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site swelling, Myalgia
Clinical narrative: Initial report received from a health care professional on 09 October 2012. A 48-year-old female patient, whose medical history was not reported, received a intramuscular dose of FLUZONE vaccine (dose number not reported, Lot number UH713AB) in left deltoid on 05 October 2012. The patient took yearly flu shots and reporter unsure however patient does take inhalers. It was reported that on 06 October 2012 i.e. 01 days after vaccination the patient experienced redness and swelling that extended 20cm from injection site down the left arm with hardness and pain at the injection site. She also reported chills and sweats. Also reported that patient felt as if the muscle was dissected as the shot was administered. At the time of vaccination patient was not acutely ill. The patient self-treated with MOTRIN, and symptoms had resolved and site was prepped with alcohol. Laboratory investigations and relevant diagnostic test were reported as none. On an unspecified date the outcome of the events was recovered. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Laceration, Syringe issue
Clinical narrative: Initial information received from a health care professional on 22 October 2012. A female patient whose age, medical history and concomitant medications were not reported was MA at facility and upon administration of FLUZONE (Lot no: U4544EA) did not see barrel flange was broken with rough edge exposed. She administered vaccine to patient however when pushing on plunger rod cut her finger on broken barrel flange and there was "small cut" which did not need stitches. Laboratory details and corrective treatment were not reported. On an unspecified date, the patient had recovered. Documents held by sender: none.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, FLU3
Symptoms: Coxsackie viral infection, Ear infection, Head titubation, Rash
Clinical narrative: Initial report received from a healthcare professional on 23 October 2012. A 6-month-old male patient, who had no medical history and whose concomitant medications were not reported, received a dose of FLUZONE (lot number: U4488EA) intramuscularly in the right deltoid and PENTACEL (Lot number: C4299AA) intramuscularly in the left deltoid on 16 October 2012. On 19 October 2012, 3 days after vaccination, the patient began shaking his head. The patient was taken to ER and was diagnosed to have ear infection. There were no laboratory investigations done. The patient received Amoxicillin as the corrective medication. The patient is also referred to neurologist, however the appointment is pending. On 22 October 2012, the patient was seen by MD and the ear infection had resolved, however the patient is still shaking the head. As of 23 October 2012, the patient had not recovered. List of documents held by sender: none. Follow up information received on 25 January 2013. On 27 October 2012 patient had developed coxsackie vesicles in oropharynx, rash on B/L legs and feet. Next visit after that 14 January 2013 no report of any issue or neurological deficit. Initial visit on 23 October 2012 no record of that specialty visit ever done.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: Initial report received from a health care professional on 23 October 2012. A 53-year-old female patient with no relevant medical history and no illness at the time of vaccination, had received an intramuscular dose of FLUZONE in left deltoid on 03 October 2012 (Lot number UH732AA). On 03 October 2012 i.e. 03 hours after receiving vaccine the patient had developed "body wide pruritus" which was without rash. At the time of report laboratory investigations were unknown. As corrective medication the patient received BENADRYL orally on unspecified date. The patient was recovered on the same day i.e. on 03 October 2012. Documents held by sender: None.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Laryngitis
Clinical narrative: Initial report received from a consumer who is also the patient on 25 October 2012 and follow up information received on 26 October 2012. A female patient, whose age, medical history and concomitant medications were not reported, received a dose of flu vaccine manufacturer unknown (lot number, route and site of vaccination not reported) on 18 October 2012. On an unspecified date, after vaccination the patient developed laryngitis and flu symptoms. Corrective medications and laboratory investigations were not reported. The patient's outcome was not recovered. List of documents held by sender: None. Follow-up information received from a healthcare professional on 21 February 2013. A 68-year-old patient received 11th dose of FLUZONE with lot number: UH729AB in right deltoid. At the time of this report, the outcome of the patient was not reported.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site joint movement impairment, Injection site pain
Clinical narrative: Initial report received from a healthcare professional on 30 October 2012. A 68-year-old male patient, whose medical history included lupus and concomitant medications were not reported, had received an intramuscular dose of FLUZONE (lot number: UH713AB) in left shoulder on 13 September 2012. On 15 September 2012, 2 days after the vaccination, the patient had developed the events of left shoulder soreness, limited mobility and ROM. Complementary investigations were reported as none, and patient did not seek medical evaluation and did not self-treat. As of 30 October 2012, the symptoms still persist. The patient's outcome was reported as "unknown". Documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Skin disorder
Clinical narrative: Initial report received from a healthcare professional on 05 June 2013. A 58-year-old female patient had received second dose of FLUZONE (lot number-UH716AA, route of administration was not reported) in left deltoid on 23 October 2012. The patient's pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. The patient had no illness at time of vaccination and had not received any concomitant medications. On 17 May 2013, the patient developed dimple, not scar, no pain and no tenderness. It was reported that the patient would go to her own physician. Laboratory investigations/details and corrective treatments were not reported. At the time of this report, the patient had not recovered from the event. List of documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Muscle spasms, Muscle tightness
Clinical narrative: This case was linked with case 2012-10261 (reported by same reporter for FLUZONE). Initial report received from a healthcare professional on 29 October 2012. A female patient with no reported medical history or concomitant medications received a dose of FLUZONE (0.5 ml pre filled syringe) intramuscularly (batch number: UH791AC) in the right deltoid on an unspecified date. 1 day post vaccination, the patient had tense shoulder and neck. There was no redness or swelling at injection site. The patient also complained of muscle spasms. The lab investigations and the patient requested muscle relaxer for spasms. The patient's outcome was not reported. Document held by sender: None. Follow up information received from healthcare professional on 11 February 2013. The patient was vaccinated on 17 October 2012. It was reported that event was not related to influenza vaccine and clinical finding from neurologist related symptoms were related to C6 C7 weakness.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Arthritis, Hypoaesthesia, Injection site pain, Laboratory test, Musculoskeletal stiffness
Clinical narrative: This case was linked with case 2012-10260 (reported by same reporter for FLUZONE). Initial report received from a healthcare professional on 29 October 2012. A 48-year-old male patient, whose medical history and concomitant medications were not reported, had received a dose of intramsucular FLUZONE vaccine, 0.5 ml pre-filled syringe (Lot number UH753AB, dose number not reported) in left deltoid on an unspecified date. After 7-10 days post vaccination, the patient presented pain radiating from injection site, stiff neck, numbness in fingers and face on the same side of the body as the injection was given. No visible redness or swelling at injection site was observed. Laboratory work was done to rule out underlying inflammatory disease. Corrective treatment was not reported. The patient's outcome was not reported. List of documents held by the sender: None. Follow-up information recevied from healthcare professional on 11 February 2013. Patient's demographics updated. The patient received FLUZONE vaccine on 08 October 2012. It was reported that, the patient saw by Primary Medical Doctor (PMD) and neurologist, had Magnetic resonance imaging (MRI) (results were not reported) completed. It was reported that, symptoms were deemed none influenza related and diagnosed as arthritis and "nerve issue". On an unspecified date, the outcome was recovered.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Neurological symptom, Nuclear magnetic resonance imaging
Clinical narrative: This case was linked with case 2012-10260 (reported by same reporter for FLUZONE). Initial report received from a healthcare professional on 29 October 2012. A 48-year-old male patient, whose medical history and concomitant medications were not reported, had received a dose of intramsucular FLUZONE vaccine, 0.5 ml pre-filled syringe (Lot number UH753AB, dose number not reported) in left deltoid on an unspecified date. After 7-10 days post vaccination, the patient presented pain radiating from injection site, stiff neck, numbness in fingers and face on the same side of the body as the injection was given. No visible redness or swelling at injection site was observed. Laboratory work was done to rule out underlying inflammatory disease. Corrective treatment was not reported. The patient's outcome was not reported. List of documents held by the sender: None. Follow-up information recevied from healthcare professional on 11 February 2013. Patient's demographics updated. The patient received FLUZONE vaccine on 08 October 2012. It was reported that, the patient saw by Primary Medical Doctor (PMD) and neurologist, had Magnetic resonance imaging (MRI) (results were not reported) completed. It was reported that, symptoms were deemed none influenza related and diagnosed as arthritis and "nerve issue". On an unspecified date, the outcome was recovered.
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: A female patient, whose age, date of birth, medical history and concomitant medications were not reported, received a dose of FLUZONE vaccine (Lot number: unknown) intramuscularly in the left arm on 23 August 2012. On 24 Sep 2012, 1 day after the vaccination, the patient felt  his arm was stiff and experienced pain with limb movement. Concomitant medications and laboratory investigations were not reported. The patient's outcome was not recovered. Documents held by sender: None.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Antibody test positive, Conjunctivitis, Hepatitis B surface antibody positive, Measles antibody positive, Mumps antibody test positive
Clinical narrative: Initial report received from a non healthcare professional who is also the patient on 03 December 2012. A 41-year-old female patient, who has history of seasonal allergies and exercise induced asthma, had no illness at the time of vaccination and no concomitant medications, had received a dose of FLUZONE vaccine (batch number-UH759AB, dose number not reported) intramuscularly in left deltoid on 27 November 2012. On 28 November 2012, the patient had Pink eye in the morning. On an unspecified date, patient was treated with "Cipro" eye drops. The laboratory investigations were none. The symptoms had resolved pretty much but the final outcome was unknown. As per the physician of the patient, the event was not related to vaccine. Follow-up information received from healthcare professional on 12 April 2013: The patient was visited physician on 02 December 2012. On unspecified date, after 3 days of antibiotic "Cipro" eye drops, the patient's eyes were improved. No signs of infection. The patient had occupational health initial injury evaluation done on 30 November 2012 which showed possible bilateral conjunctivitis provisional work related. Documents held by sender: Employee health sheet and occupational health initial injury evaluation report.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Rubella antibody positive, Tuberculin test negative
Clinical narrative: Initial report received from a non healthcare professional who is also the patient on 03 December 2012. A 41-year-old female patient, who has history of seasonal allergies and exercise induced asthma, had no illness at the time of vaccination and no concomitant medications, had received a dose of FLUZONE vaccine (batch number-UH759AB, dose number not reported) intramuscularly in left deltoid on 27 November 2012. On 28 November 2012, the patient had Pink eye in the morning. On an unspecified date, patient was treated with "Cipro" eye drops. The laboratory investigations were none. The symptoms had resolved pretty much but the final outcome was unknown. As per the physician of the patient, the event was not related to vaccine. Follow-up information received from healthcare professional on 12 April 2013: The patient was visited physician on 02 December 2012. On unspecified date, after 3 days of antibiotic "Cipro" eye drops, the patient's eyes were improved. No signs of infection. The patient had occupational health initial injury evaluation done on 30 November 2012 which showed possible bilateral conjunctivitis provisional work related. Documents held by sender: Employee health sheet and occupational health initial injury evaluation report.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: C-reactive protein increased, Differential white blood cell count abnormal, Erythema, Full blood count abnormal, Joint warmth
Clinical narrative: Initial report received from healthcare professional on 14 December 2012. A 02-year-old male patient, who had no known allergies, no illness at time of vaccination with no medical conditions, had received a intramuscular dose of FLUZONE dose last year. On 14 December 2012, the patient had red and hot area on bilateral joints (ankle, knee, elbow, toe joints), quarter sized area on the back of right leg was red and had red area on the left arm. Corrective treatment and relevant laboratory tests were not reported. At the time of this report, the patient had not recovered from the events. Documents held by sender: None. Follow-up information received from a healthcare professional on 03 May 2013. It was reported that the patient had received first dose of FLUZONE vaccine on an unspecified date in 2011. The patient had no illness at the time of vaccination and the patient had not received any vaccine within 4 weeks of FLUZONE vaccine. The patients birth weight reported as 5lb and 7oz. The patient has 1 twin brother. On 14 December 2012 the CBC was done with manual differential was ordered results were consistent with viral illness, however still undetermined if the viral illness caused the red and hot joints (ankles, knees, elbows and toe joints) additional labs were ordered C-reactive protein, SED rate were mildly elevated ASO titer was negative. The patient was instructed to take ZYRTEC 5 mg daily. On 29 April 2013 symptoms were fully resolved without any complications.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate increased, Streptococcus test negative, Viral infection
Clinical narrative: Initial report received from healthcare professional on 14 December 2012. A 02-year-old male patient, who had no known allergies, no illness at time of vaccination with no medical conditions, had received a intramuscular dose of FLUZONE dose last year. On 14 December 2012, the patient had red and hot area on bilateral joints (ankle, knee, elbow, toe joints), quarter sized area on the back of right leg was red and had red area on the left arm. Corrective treatment and relevant laboratory tests were not reported. At the time of this report, the patient had not recovered from the events. Documents held by sender: None. Follow-up information received from a healthcare professional on 03 May 2013. It was reported that the patient had received first dose of FLUZONE vaccine on an unspecified date in 2011. The patient had no illness at the time of vaccination and the patient had not received any vaccine within 4 weeks of FLUZONE vaccine. The patients birth weight reported as 5lb and 7oz. The patient has 1 twin brother. On 14 December 2012 the CBC was done with manual differential was ordered results were consistent with viral illness, however still undetermined if the viral illness caused the red and hot joints (ankles, knees, elbows and toe joints) additional labs were ordered C-reactive protein, SED rate were mildly elevated ASO titer was negative. The patient was instructed to take ZYRTEC 5 mg daily. On 29 April 2013 symptoms were fully resolved without any complications.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional (patient's mother) on 12 December 2012. An 11-year-old male patient, had received an intramuscular dose of ADACEL vaccine (lot number: unknown) on the left deltoid, an intramuscular dose of Flu vaccine (Mfr Unk) (lot number: unknown) on the left deltoid and an intramuscular dose of Meningococcal vaccine (Mfr Unk) (lot number: unknown) on the right deltoid, all of 10 December 2012.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This is cluster case of four patients (same reporter, same product and same batch number) and is linked to case numbers 2012-11083, 2012-11080, 2012-11094. Initial report received from a healthcare professional on 19 November 2012. A 65-year-old male patient, whose medical history, concomitant medications and illness at the time of vaccination were not reported, bad received a dose of FLUZONE vaccine (batch number: UH728AA, dose number and site of administration were not reported) intramuscular on 12 October 2012. It was reported that, the patient was unable to raise his arm for several days after the injection. On 19 November 2012, the patient was unable to raise his arm for several days after the injection. On 19 November 2012, the patient was unable to life his arm over his head because of site soreness, but otherwise he was able to use the arm without incident. As per the reporter, the patient would be seeing the physician on 19 November 2012. Corrective medications were not reported and lab investigations were unknown. At the time of this report, the outcome of the event was unknown. At the time of this report, the outcome of the event was unknown. Follow up information received from a healthcare professional on 09 April 2013: The patient's medical history included clinical depression, MI (Myocardial Infarction), TURP (Transurethral resection of the prostate), CABG (Coronary artery bypass graft) and femoral hernia. The patient's concomitant medications (experimental medications) included Fluoxetine Hydrochloride, Aspirin, Omeprazole and Clonazepam. The patient had received FLUZONE vaccine on the right deltoid on 12 October 2012 at 07:15 hours. The patient had not mentioned about Influenza injection to the physician. The patient had recovered from the events on an unspecified date. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Swollen tongue
Clinical narrative: Initial report received from other company (Merck) on 04 December 2012. This case was initially reported by a healthcare professional. Other company reference number: 1-5748203747. A patient, whose age, gender, medical history and concomitant medications were not reported, had received a dose of FLUZONE vaccine (lot number, dose number, route and site of vaccination were not reported) on an unspecified date. It was reported that on an unspecified date, after vaccination, the patient developed a swollen tongue and throat. Laboratory data was not reported. The patient did not receive any corrective treatment. On an unspecified date, the events resolved without treatment. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Pain in extremity, Swelling, Tenderness
Clinical narrative: Initial report received from a health care professional on 27 September 2012. A female patient (age not reported) received FLUZONE vaccine intramuscularly in her left deltoid (batch number: UH716AB) on 20 September 2012. The patient's illness at the time of vaccination was none. The patients preexisting illness included HTN and allergic to PCN. The patient also had a scar at the site of previous vaccination (unknown vaccine). Concomitant medications were not reported. On 20 September 2012, the patient developed redness, swelling, induration at an area of her arm 3 inches from the injection site. This was the same location where she had an old scar from a previous vaccine. The area was tender and painful to touch, and the whole arm hurt when she tried to move. The lab investigations were none and treatment medications were not reported. At the time of this report, the outcome was reported as not recovered. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Initial misuse information received from another manufacturer (service request number 1-5565106668) on 02 October 2012. The information was originally provided to the other manufacturer from a health care professional. A patient, whose age, gender, medical history and concomitant medications were not reported, had received a dose of FLUZONE (lot number and route of vaccination not reported) behind the arm on an unspecified date. It was reported that, the patient received vaccine behind the arm instead of deltoid muscle leading to vaccination at wrong site. As per reporter the patient did not experienced any adverse event. List of documents held by sender: None.
Age: 54.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Headache, Neck pain, Poor quality sleep
Clinical narrative: Initial report received from a healthcare professional on 05 October 2012. A 54-year-old male patient, whose medical history was unknown and concomitant medications was not reported, had received intramuscular ADACEL vaccine (lot number U4384AA) in right deltoid and FLUZONE vaccine intramuscular in arm (batch number: UH7454AC) on 12 September 2012. 2-3 days after vaccination, the patient had headaches, neck pain and was not resting well. The symptoms were getting worse. Laboratory details and corrective treatment were not reported. The patient's outcome was not recovered. Document Held by Sender: None. Follow-up information received from a healthcare professional on 17 December 2012. The patient had not received any other vaccinations within 4 weeks of 12 September 2012. No laboratory investigations were done. The patient felt well around 30 days afterwards and had recovered from the events on an unspecified date.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin tightness, Swelling, Urticaria
Clinical narrative: Initial report was received from a health care professional on 09 October 2012. A 35-year-old female patient, whose medical history and concomitant medications were not reported, had received FLUZONE (batch number: UH713AB) intramuscularly in left deltoid on 08 October 2012. On 08 October 2012, the patient received FLUZONE at 11:45AM and by 3:30PM broke out in hives on left wrist, right wrist and on feet. Skin was reddened, hives present that was itchy, and skin in these areas feels tight, also there was slight swelling. The patient received BENADRYL and symptoms were begun to clear. The laboratory investigations were not done. The events resolved on an unspecified date. Follow-up information received on 02 January 2013: Patient's concomitant medications, risk factors and medical history and illness at the time of vaccination were none. Patient had not received any other vaccine. Patient had no other medical condition. It was reported that the swelling was not at vaccination site. Event cessation date was 11 October 2012.
Sex: U
Vaccine: FLU3
Symptoms: Cough, Exposure during breast feeding, Hypersomnia, Insomnia
Clinical narrative: This case is linked with case number 2012-09363 a Mother Case over dose of FLUZONE (lot number UH717AC) without any adverse events. This case was also linked with 2012-11230. Initial report received from a healthcare professional on 04 October 2012. A patient, whose age, gender, date of birth, medical history and concomitant medication not reported, exposure of FLUZONE via breast milk (dose number not reported, Lot number: UH717AC) on 28 September 2012. It was reported that after vaccination to mother her baby who was breasted, tend to more sleeping. Baby also developed cough on unspecified date. Corrective medications and laboratory investigations were not reported. The patient's outcome was unknown. Follow-up information received on 04 October 2012 in the medication error report from a nurse: It was reported that the baby now had cough and was not sleeping; however previously reported as tend to "more sleeping". List of documents held by sender: none. This case was also linked with 2012-11230.
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Overdose
Clinical narrative: A female patient, whose concomitant medication and illness at the time of vaccination was not reported and allergies was reported as "none known", received a dose of FLUZONE vaccine (Lot number: Uh756AB, dose number, route and site of vaccination were not reported) on an unspecified date. It was reported that the patient received 0.5 ml dose of FLUZONE vaccine instead of age appropriate dose of 0.25 ml dose. The patient also experienced rash at injection site which resolved a "couple days" later on an unspecified date. Laboratory details and corrective treatment were not reported. On an unspecified date, patient outcome of the event was reported as recovered. Documents held by sender: none. Follow-up information received from a Healthcare professional on 31 Jan 2013. The patient had no illness at the time of vaccination. The case was medically confirmed.