chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Received INFLUENZA vaccine. Next day had painful, itchy, serious blister at site of injection. Site hot and swollen x 6 days. Serious blister decreased in size and then popped.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Body temperature increased, Fatigue, Headache, Pain
Clinical narrative: Received Influenza Vaccine 10-18-11. On 10-23-11 felt tired & weak. On 10-26-11 had temperature of 102 degrees F & states "everything hurt" - joints, skin, headache. Temperature elevation lasted through 10-27-11. Felt "back to herself" on 11-1-11.
Age: 59.0
Sex: F
Vaccine: FLU3, HEP, JEV1
Symptoms: Dizziness, Feeling abnormal, Feeling of body temperature change, Hallucination, visual, Headache
Clinical narrative: Within 3 hours of receiving 3 vaccines, I began to feel a difference - lightheaded, chilled. After 5 hours I was alternately chilled and too hot, had a headache and became very nauseous. During the night, I awakened and had the sensation of floating ie. leaving my body with other visual hallucinations. Major symptoms were gone in AM but it took 3 days to completely feel better.
Age: 59.0
Sex: F
Vaccine: FLU3, HEP, JEV1
Symptoms: Nausea
Clinical narrative: Within 3 hours of receiving 3 vaccines, I began to feel a difference - lightheaded, chilled. After 5 hours I was alternately chilled and too hot, had a headache and became very nauseous. During the night, I awakened and had the sensation of floating ie. leaving my body with other visual hallucinations. Major symptoms were gone in AM but it took 3 days to completely feel better.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Feeling hot, Flushing
Clinical narrative: Dizziness, warmth, flushing - full body, chest discomfort within 2 min of administration lasting at least 2 hours. No - angioedema, bronchospasm, shock.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Referred pt to urgent care. Swollen, red, hot & very painful arm, from the elbow to shoulder.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Flu like symptoms. Pain scale is 8. Soreness. Tenderness at the site of injection. Swelling. Can't lift his arm due to pain.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Myalgia, Pain
Clinical narrative: Patient complained that she have been experiencing muscle tenderness and painful to touch in her upper left arm where she got the flu shot since the day she received the flu shot. She also complained about pain whenever she lifts her left arm.
Age: 95.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Asthenia, Encephalopathy, Fatigue, Gait disturbance
Clinical narrative: Pt. admitted to hospital 10/27/11. About 4 wks prior had begun feeling weak, stumbling, fatigued. Has lost 15-20 pounds over past mo. Past 3-4 days family reported no verbal responses. Sleeping 16 or more hrs/day. Treated with Acyclovir IV.
Age: 95.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersomnia, Nuclear magnetic resonance imaging brain abnormal, Weight decreased
Clinical narrative: Pt. admitted to hospital 10/27/11. About 4 wks prior had begun feeling weak, stumbling, fatigued. Has lost 15-20 pounds over past mo. Past 3-4 days family reported no verbal responses. Sleeping 16 or more hrs/day. Treated with Acyclovir IV.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pain, Headache, Migraine with aura, Optic neuritis, Photopsia
Clinical narrative: Received vaccine 10/6/11 approx 6 hr late had very bad headache next morning noticed flashing light out of corner of (R) eye. Headache and flashes continued so I called eye dr after 3 eye appt in 3 day determined optic nerve was inflamed and optic migraines prescribed NSAID follow up 6 mth. Headache 15 day still have eye pain.
Age: 0.67
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Injection site induration, Injection site reaction, Rash erythematous
Clinical narrative: Dime-sized, not raised, red spot, distal (L) of injection site. Hard upon palpation.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Pyrexia, Rash, Vaccination site rash
Clinical narrative: Given flu TIV on 10-25-11. On 10-30-11 developed fever, temp. unknown, and increased skin rash. Pt has sickle cell disease and had slight rash at vaccine admin. 10-31-11 went to ER and put on KEFLEX. Seen in our office 11-1-11 and put on steroid and KEFLEX dose increased.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Lip swelling, Rash pruritic, Swelling face
Clinical narrative: Pt received vaccine on 10/25/11 approximately at noon then developed an itchy rash & minor swelling of face & lips on 10/26/11 in the evening. Required a visit to doctor where she received a steroid injection.
Age: 44.0
Sex: M
Vaccine: IPV
Symptoms: Disturbance in attention, Dizziness, Headache, Visual impairment
Clinical narrative: Headache, dizzy, vision, inability to concentrate.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Coagulopathy, Ecchymosis, Product used for unknown indication
Clinical narrative: Pt has ecchymosis that lasted 7 days. Pt also on blood thinner and aspirin.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Abasia, Cyanosis, Full blood count normal, Metabolic function test normal, Purpura
Clinical narrative: H/o bluish purpura on both sites 1-2 hr after the immz. H/o transient inability to walk next AM lasting 1 hr or so.
Age: 0.69
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site induration
Clinical narrative: Two weeks after receiving a Hib vaccine, parent brought child back to our clinic, concerned about a marble-sized induration at the injection site - (L) thigh that had not yet resolved. Child was not experiencing pain. Induration appeared 1 day after injection.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient given PNEUMOVAX 23 0.5ml in (L) deltoid on 10/31/11. Lot 0614AA Exp 9/27/12. Came to pharmacy on 11/2/11 with (L) biceps had normal sequelae (red, swollen & hot to touch).
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Agitation, Decreased appetite, Headache, Restlessness
Clinical narrative: Within 6 hours of flu vaccine he became agitated, restless, anorexic, had headache. H/A resolved, still restless, anorexic.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Patient husband said had shoulder pain & needed to see MD for pain meds after shot given on 10/17/11.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. received flu injection to (R) arm on 10/10/11. Pt. called next day post inj. with c/o swelling, redness & fever to inj. site. Pt. told to come in to facility. Pt. was assessed by nurse mngr. Pt. also with c/o chest pain post injection. Denied resp. distress.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Immunizations given too close together.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Injection site erythema, Injection site warmth, Malaise, Skin warm
Clinical narrative: Received shot 10/18/11. 10/19/11 noticed hot red area (R) upper arm at site. 10/20/11 20x14cm hot inflamed area. Afebrile. Malaise. Not signs of systemic involvement. Tx with antihistamine/ice unless systemic s/s then antibiotics.
Age: 14.0
Sex: F
Vaccine: TYP
Symptoms: Convulsion, Muscle twitching, Syncope
Clinical narrative: Mother states patient went to school after receiving vaccine and displayed seizure behavior 2 hours after vaccination, i.e., "stood up, fainted to the floor and twitched".
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Immunizations given too close together.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture, Full blood count normal, Pyrexia, Urine analysis normal
Clinical narrative: Fever 104-102.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Muscular weakness, Musculoskeletal stiffness, Nerve conduction studies, Nerve injury
Clinical narrative: Pt reports stiff neck after flu shot 9/18. Went to PCP 9/20 and given Ibuprofen. 9/21 experienced (R) arm weakness above elbow. Went to ED 9/22 and diagnosed w/ inflamed nerve from flu shot. F/U'd w/ PCP and given referral to neurologist. Also started physical therapy on 10/21. No previous rxn to flu shot.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Pt reports stiff neck after flu shot 9/18. Went to PCP 9/20 and given Ibuprofen. 9/21 experienced (R) arm weakness above elbow. Went to ED 9/22 and diagnosed w/ inflamed nerve from flu shot. F/U'd w/ PCP and given referral to neurologist. Also started physical therapy on 10/21. No previous rxn to flu shot.
Age: 51.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLUX
Symptoms: Anaemia, Back pain, Guillain-Barre syndrome, Headache, Hypertension
Clinical narrative: Case number PHHY2011US95036 is an initial spontaneous report derived from Vaccine Adverse Event Reporting System website on 27 Oct 2011. This case refers to a 51-year-old female patient. Her preexisting condition included thyroid cyst. She was vaccinated with S-OIV FLUVIRIN (batch number: UP012AA) and influenza vaccine (other manufacturer, batch number: 4018042) intramuscularly into her left arm on 21 Jan 2010. On 15 Feb 2010, she developed Guillain Barre syndrome, muscle weakness, anemia, low back pain, hypertension, psychosis NOS, Bell's Palsy and mastoiditis. She was receiving outpatient therapy and was hospitalized subsequently. Her hospitalization extended for about 43 days. Her symptoms also included numbness, headache, fever, loss of limbs control and weakness. These events were considered life-threatening. It was reported that she will recover in about two to three years.
Age: 51.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLUX
Symptoms: Hypoaesthesia, Loss of control of legs, Mastoiditis, Muscular weakness, Psychotic disorder
Clinical narrative: Case number PHHY2011US95036 is an initial spontaneous report derived from Vaccine Adverse Event Reporting System website on 27 Oct 2011. This case refers to a 51-year-old female patient. Her preexisting condition included thyroid cyst. She was vaccinated with S-OIV FLUVIRIN (batch number: UP012AA) and influenza vaccine (other manufacturer, batch number: 4018042) intramuscularly into her left arm on 21 Jan 2010. On 15 Feb 2010, she developed Guillain Barre syndrome, muscle weakness, anemia, low back pain, hypertension, psychosis NOS, Bell's Palsy and mastoiditis. She was receiving outpatient therapy and was hospitalized subsequently. Her hospitalization extended for about 43 days. Her symptoms also included numbness, headache, fever, loss of limbs control and weakness. These events were considered life-threatening. It was reported that she will recover in about two to three years.
Age: 51.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLUX
Symptoms: Pyrexia, Quadriparesis, VIIth nerve paralysis
Clinical narrative: Case number PHHY2011US95036 is an initial spontaneous report derived from Vaccine Adverse Event Reporting System website on 27 Oct 2011. This case refers to a 51-year-old female patient. Her preexisting condition included thyroid cyst. She was vaccinated with S-OIV FLUVIRIN (batch number: UP012AA) and influenza vaccine (other manufacturer, batch number: 4018042) intramuscularly into her left arm on 21 Jan 2010. On 15 Feb 2010, she developed Guillain Barre syndrome, muscle weakness, anemia, low back pain, hypertension, psychosis NOS, Bell's Palsy and mastoiditis. She was receiving outpatient therapy and was hospitalized subsequently. Her hospitalization extended for about 43 days. Her symptoms also included numbness, headache, fever, loss of limbs control and weakness. These events were considered life-threatening. It was reported that she will recover in about two to three years.
Age: 51.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLUX
Symptoms: Anaemia, Asthenia, Back pain, Guillain-Barre syndrome, Headache
Clinical narrative: Case number PHHY2011US95036 is an initial spontaneous report derived from Vaccine Adverse Event Reporting System website on 27 Oct 2011. This case refers to a 51-year-old female patient. Her preexisting condition included thyroid cyst. She was vaccinated with S-OIV FLUVIRIN (batch number: UP012AA) and influenza vaccine (other manufacturer, batch number: 4018042) intramuscularly into her left arm on 21 Jan 2010. On 15 Feb 2010, she developed Guillain Barre syndrome, muscle weakness, anemia, low back pain, hypertension, psychosis NOS, Bell's Palsy and mastoiditis. She was receiving outpatient therapy and was hospitalized subsequently. Her hospitalization extended for about 43 days. Her symptoms also included numbness, headache, fever, loss of limbs control and weakness. These events were considered life-threatening. It was reported that she will recover in about two to three years.
Age: 51.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLUX
Symptoms: Hypertension, Hypoaesthesia, Mastoiditis, Movement disorder, Muscular weakness
Clinical narrative: Case number PHHY2011US95036 is an initial spontaneous report derived from Vaccine Adverse Event Reporting System website on 27 Oct 2011. This case refers to a 51-year-old female patient. Her preexisting condition included thyroid cyst. She was vaccinated with S-OIV FLUVIRIN (batch number: UP012AA) and influenza vaccine (other manufacturer, batch number: 4018042) intramuscularly into her left arm on 21 Jan 2010. On 15 Feb 2010, she developed Guillain Barre syndrome, muscle weakness, anemia, low back pain, hypertension, psychosis NOS, Bell's Palsy and mastoiditis. She was receiving outpatient therapy and was hospitalized subsequently. Her hospitalization extended for about 43 days. Her symptoms also included numbness, headache, fever, loss of limbs control and weakness. These events were considered life-threatening. It was reported that she will recover in about two to three years.
Age: 51.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLUX
Symptoms: Psychotic disorder, Pyrexia, VIIth nerve paralysis
Clinical narrative: Case number PHHY2011US95036 is an initial spontaneous report derived from Vaccine Adverse Event Reporting System website on 27 Oct 2011. This case refers to a 51-year-old female patient. Her preexisting condition included thyroid cyst. She was vaccinated with S-OIV FLUVIRIN (batch number: UP012AA) and influenza vaccine (other manufacturer, batch number: 4018042) intramuscularly into her left arm on 21 Jan 2010. On 15 Feb 2010, she developed Guillain Barre syndrome, muscle weakness, anemia, low back pain, hypertension, psychosis NOS, Bell's Palsy and mastoiditis. She was receiving outpatient therapy and was hospitalized subsequently. Her hospitalization extended for about 43 days. Her symptoms also included numbness, headache, fever, loss of limbs control and weakness. These events were considered life-threatening. It was reported that she will recover in about two to three years.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Malaise, Type 1 diabetes mellitus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 year old male patient with heart murmur, no previous illness and no known drug allergies and a history of tympanostomy who on 18-JUL-2011 was vaccinated IM with the first dose of GARDASIL into the right arm (lot number: 669308/0636AA). Concomitant therapy included the first dose IM of MENACTRA into the left arm (lot number: U4000AA) and the sixth dose IM of ADACEL (lot number: U3979DA). On 20-JUL-2011, child became ill 2 days after vaccinations. He was diagnosed 12 days later with new onset Type 1 Diabetes Mellitus. The patient was diagnosed with Diabetic ketoacidosis (DKA). Concurrent condition included nausea, vomiting, decreased appetite, fatigue, lethargic, excessive sleepiness, sunken eyes, headache, increased thirst, dehydration, increased urination, abdominal pain, excessive weight loss. Physical examination to abdomen and tenderness to palpation (TTP). Hospital course characterized by intravenous fluids repletion (IVF); insulin titration; diabetic education. Discharge in stable condition to follow up Primary Care Physician (PCP) at endocrinologist. On 10-AUG-2011. Hospital records: Blood glucose 456 mg/dL (High), blood ketones: positive. Urine ketones: positive. U/A: urine glucose 301-1000 mg/dL (High). Urine ketones >/= 80 mg/dL (High). Urine blood: small (High). Urine protein: small (High). Labs/diagnostics. : Islet cell antigen-2: 9.6 u/mL (High). Glutamic acid decarboxylase Ab >250 IU/mL (High). Potassium (K) 3.1 mmol/L (Low), chloride (CI) 114 mmol/L (High), Phosphorus test (PO4) 2.6 mg/dL (Low). The patient required an emergency room visit. This report was considered serious by the agency. The events were considered lift threatening. The original reporting source was not provided. The VAERS ID # is 428606. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Abdominal tenderness, Abnormal loss of weight, Anti-GAD antibody positive, Anti-islet cell antibody positive
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 year old male patient with heart murmur, no previous illness and no known drug allergies and a history of tympanostomy who on 18-JUL-2011 was vaccinated IM with the first dose of GARDASIL into the right arm (lot number: 669308/0636AA). Concomitant therapy included the first dose IM of MENACTRA into the left arm (lot number: U4000AA) and the sixth dose IM of ADACEL (lot number: U3979DA). On 20-JUL-2011, child became ill 2 days after vaccinations. He was diagnosed 12 days later with new onset Type 1 Diabetes Mellitus. The patient was diagnosed with Diabetic ketoacidosis (DKA). Concurrent condition included nausea, vomiting, decreased appetite, fatigue, lethargic, excessive sleepiness, sunken eyes, headache, increased thirst, dehydration, increased urination, abdominal pain, excessive weight loss. Physical examination to abdomen and tenderness to palpation (TTP). Hospital course characterized by intravenous fluids repletion (IVF); insulin titration; diabetic education. Discharge in stable condition to follow up Primary Care Physician (PCP) at endocrinologist. On 10-AUG-2011. Hospital records: Blood glucose 456 mg/dL (High), blood ketones: positive. Urine ketones: positive. U/A: urine glucose 301-1000 mg/dL (High). Urine ketones >/= 80 mg/dL (High). Urine blood: small (High). Urine protein: small (High). Labs/diagnostics. : Islet cell antigen-2: 9.6 u/mL (High). Glutamic acid decarboxylase Ab >250 IU/mL (High). Potassium (K) 3.1 mmol/L (Low), chloride (CI) 114 mmol/L (High), Phosphorus test (PO4) 2.6 mg/dL (Low). The patient required an emergency room visit. This report was considered serious by the agency. The events were considered lift threatening. The original reporting source was not provided. The VAERS ID # is 428606. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Blood chloride increased, Blood glucose increased, Blood ketone body increased, Blood phosphorus decreased, Blood potassium decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 year old male patient with heart murmur, no previous illness and no known drug allergies and a history of tympanostomy who on 18-JUL-2011 was vaccinated IM with the first dose of GARDASIL into the right arm (lot number: 669308/0636AA). Concomitant therapy included the first dose IM of MENACTRA into the left arm (lot number: U4000AA) and the sixth dose IM of ADACEL (lot number: U3979DA). On 20-JUL-2011, child became ill 2 days after vaccinations. He was diagnosed 12 days later with new onset Type 1 Diabetes Mellitus. The patient was diagnosed with Diabetic ketoacidosis (DKA). Concurrent condition included nausea, vomiting, decreased appetite, fatigue, lethargic, excessive sleepiness, sunken eyes, headache, increased thirst, dehydration, increased urination, abdominal pain, excessive weight loss. Physical examination to abdomen and tenderness to palpation (TTP). Hospital course characterized by intravenous fluids repletion (IVF); insulin titration; diabetic education. Discharge in stable condition to follow up Primary Care Physician (PCP) at endocrinologist. On 10-AUG-2011. Hospital records: Blood glucose 456 mg/dL (High), blood ketones: positive. Urine ketones: positive. U/A: urine glucose 301-1000 mg/dL (High). Urine ketones >/= 80 mg/dL (High). Urine blood: small (High). Urine protein: small (High). Labs/diagnostics. : Islet cell antigen-2: 9.6 u/mL (High). Glutamic acid decarboxylase Ab >250 IU/mL (High). Potassium (K) 3.1 mmol/L (Low), chloride (CI) 114 mmol/L (High), Phosphorus test (PO4) 2.6 mg/dL (Low). The patient required an emergency room visit. This report was considered serious by the agency. The events were considered lift threatening. The original reporting source was not provided. The VAERS ID # is 428606. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Blood urine present, Decreased appetite, Dehydration, Diabetic ketoacidosis, Eyes sunken
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 year old male patient with heart murmur, no previous illness and no known drug allergies and a history of tympanostomy who on 18-JUL-2011 was vaccinated IM with the first dose of GARDASIL into the right arm (lot number: 669308/0636AA). Concomitant therapy included the first dose IM of MENACTRA into the left arm (lot number: U4000AA) and the sixth dose IM of ADACEL (lot number: U3979DA). On 20-JUL-2011, child became ill 2 days after vaccinations. He was diagnosed 12 days later with new onset Type 1 Diabetes Mellitus. The patient was diagnosed with Diabetic ketoacidosis (DKA). Concurrent condition included nausea, vomiting, decreased appetite, fatigue, lethargic, excessive sleepiness, sunken eyes, headache, increased thirst, dehydration, increased urination, abdominal pain, excessive weight loss. Physical examination to abdomen and tenderness to palpation (TTP). Hospital course characterized by intravenous fluids repletion (IVF); insulin titration; diabetic education. Discharge in stable condition to follow up Primary Care Physician (PCP) at endocrinologist. On 10-AUG-2011. Hospital records: Blood glucose 456 mg/dL (High), blood ketones: positive. Urine ketones: positive. U/A: urine glucose 301-1000 mg/dL (High). Urine ketones >/= 80 mg/dL (High). Urine blood: small (High). Urine protein: small (High). Labs/diagnostics. : Islet cell antigen-2: 9.6 u/mL (High). Glutamic acid decarboxylase Ab >250 IU/mL (High). Potassium (K) 3.1 mmol/L (Low), chloride (CI) 114 mmol/L (High), Phosphorus test (PO4) 2.6 mg/dL (Low). The patient required an emergency room visit. This report was considered serious by the agency. The events were considered lift threatening. The original reporting source was not provided. The VAERS ID # is 428606. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Fatigue, Glucose urine present, Headache, Lethargy, Malaise
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 year old male patient with heart murmur, no previous illness and no known drug allergies and a history of tympanostomy who on 18-JUL-2011 was vaccinated IM with the first dose of GARDASIL into the right arm (lot number: 669308/0636AA). Concomitant therapy included the first dose IM of MENACTRA into the left arm (lot number: U4000AA) and the sixth dose IM of ADACEL (lot number: U3979DA). On 20-JUL-2011, child became ill 2 days after vaccinations. He was diagnosed 12 days later with new onset Type 1 Diabetes Mellitus. The patient was diagnosed with Diabetic ketoacidosis (DKA). Concurrent condition included nausea, vomiting, decreased appetite, fatigue, lethargic, excessive sleepiness, sunken eyes, headache, increased thirst, dehydration, increased urination, abdominal pain, excessive weight loss. Physical examination to abdomen and tenderness to palpation (TTP). Hospital course characterized by intravenous fluids repletion (IVF); insulin titration; diabetic education. Discharge in stable condition to follow up Primary Care Physician (PCP) at endocrinologist. On 10-AUG-2011. Hospital records: Blood glucose 456 mg/dL (High), blood ketones: positive. Urine ketones: positive. U/A: urine glucose 301-1000 mg/dL (High). Urine ketones >/= 80 mg/dL (High). Urine blood: small (High). Urine protein: small (High). Labs/diagnostics. : Islet cell antigen-2: 9.6 u/mL (High). Glutamic acid decarboxylase Ab >250 IU/mL (High). Potassium (K) 3.1 mmol/L (Low), chloride (CI) 114 mmol/L (High), Phosphorus test (PO4) 2.6 mg/dL (Low). The patient required an emergency room visit. This report was considered serious by the agency. The events were considered lift threatening. The original reporting source was not provided. The VAERS ID # is 428606. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Nausea, Pollakiuria, Protein urine present, Somnolence, Thirst
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 year old male patient with heart murmur, no previous illness and no known drug allergies and a history of tympanostomy who on 18-JUL-2011 was vaccinated IM with the first dose of GARDASIL into the right arm (lot number: 669308/0636AA). Concomitant therapy included the first dose IM of MENACTRA into the left arm (lot number: U4000AA) and the sixth dose IM of ADACEL (lot number: U3979DA). On 20-JUL-2011, child became ill 2 days after vaccinations. He was diagnosed 12 days later with new onset Type 1 Diabetes Mellitus. The patient was diagnosed with Diabetic ketoacidosis (DKA). Concurrent condition included nausea, vomiting, decreased appetite, fatigue, lethargic, excessive sleepiness, sunken eyes, headache, increased thirst, dehydration, increased urination, abdominal pain, excessive weight loss. Physical examination to abdomen and tenderness to palpation (TTP). Hospital course characterized by intravenous fluids repletion (IVF); insulin titration; diabetic education. Discharge in stable condition to follow up Primary Care Physician (PCP) at endocrinologist. On 10-AUG-2011. Hospital records: Blood glucose 456 mg/dL (High), blood ketones: positive. Urine ketones: positive. U/A: urine glucose 301-1000 mg/dL (High). Urine ketones >/= 80 mg/dL (High). Urine blood: small (High). Urine protein: small (High). Labs/diagnostics. : Islet cell antigen-2: 9.6 u/mL (High). Glutamic acid decarboxylase Ab >250 IU/mL (High). Potassium (K) 3.1 mmol/L (Low), chloride (CI) 114 mmol/L (High), Phosphorus test (PO4) 2.6 mg/dL (Low). The patient required an emergency room visit. This report was considered serious by the agency. The events were considered lift threatening. The original reporting source was not provided. The VAERS ID # is 428606. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Type 1 diabetes mellitus, Urine ketone body present, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 year old male patient with heart murmur, no previous illness and no known drug allergies and a history of tympanostomy who on 18-JUL-2011 was vaccinated IM with the first dose of GARDASIL into the right arm (lot number: 669308/0636AA). Concomitant therapy included the first dose IM of MENACTRA into the left arm (lot number: U4000AA) and the sixth dose IM of ADACEL (lot number: U3979DA). On 20-JUL-2011, child became ill 2 days after vaccinations. He was diagnosed 12 days later with new onset Type 1 Diabetes Mellitus. The patient was diagnosed with Diabetic ketoacidosis (DKA). Concurrent condition included nausea, vomiting, decreased appetite, fatigue, lethargic, excessive sleepiness, sunken eyes, headache, increased thirst, dehydration, increased urination, abdominal pain, excessive weight loss. Physical examination to abdomen and tenderness to palpation (TTP). Hospital course characterized by intravenous fluids repletion (IVF); insulin titration; diabetic education. Discharge in stable condition to follow up Primary Care Physician (PCP) at endocrinologist. On 10-AUG-2011. Hospital records: Blood glucose 456 mg/dL (High), blood ketones: positive. Urine ketones: positive. U/A: urine glucose 301-1000 mg/dL (High). Urine ketones >/= 80 mg/dL (High). Urine blood: small (High). Urine protein: small (High). Labs/diagnostics. : Islet cell antigen-2: 9.6 u/mL (High). Glutamic acid decarboxylase Ab >250 IU/mL (High). Potassium (K) 3.1 mmol/L (Low), chloride (CI) 114 mmol/L (High), Phosphorus test (PO4) 2.6 mg/dL (Low). The patient required an emergency room visit. This report was considered serious by the agency. The events were considered lift threatening. The original reporting source was not provided. The VAERS ID # is 428606. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Amnesia, Chronic inflammatory demyelinating polyradiculoneuropathy, Depression, Disturbance in attention, Dysphemia
Clinical narrative: Case number PHHY2011US95033 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 431992) website on 27 Oct 2011. This report refers to a 49-year-old male patient. His concomitant medications included CRESTOR, LEVOXYL and baby aspirin. He was allergic to tetracycline. He was vaccinated with FLUVIRIN (batch number: 112946P1) intramuscularly on 19 Nov 2010. The same day after vaccination he experienced severe tremors, pain and numbness in feet and legs, which moved to upper extremities, trouble concentrating and had memory loss, he also developed chronic inflammatory polyneuropathy (CIDP), severe depression and his speech consisted of constant stuttering. He got three epidurals steroids injections in his back on an unspecified date and his laboratory tests included nerve study and magnetic resonance imaging (MRI) of low back, cervical and head. However, the results of these tests were not reported. The events were ongoing at the time of reporting. No further information was available.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Nerve stimulation test, Nuclear magnetic resonance imaging, Pain in extremity, Tremor
Clinical narrative: Case number PHHY2011US95033 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 431992) website on 27 Oct 2011. This report refers to a 49-year-old male patient. His concomitant medications included CRESTOR, LEVOXYL and baby aspirin. He was allergic to tetracycline. He was vaccinated with FLUVIRIN (batch number: 112946P1) intramuscularly on 19 Nov 2010. The same day after vaccination he experienced severe tremors, pain and numbness in feet and legs, which moved to upper extremities, trouble concentrating and had memory loss, he also developed chronic inflammatory polyneuropathy (CIDP), severe depression and his speech consisted of constant stuttering. He got three epidurals steroids injections in his back on an unspecified date and his laboratory tests included nerve study and magnetic resonance imaging (MRI) of low back, cervical and head. However, the results of these tests were not reported. The events were ongoing at the time of reporting. No further information was available.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Nerve conduction studies, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Pain in extremity
Clinical narrative: Case number PHHY2011US95033 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 431992) website on 27 Oct 2011. This report refers to a 49-year-old male patient. His concomitant medications included CRESTOR, LEVOXYL and baby aspirin. He was allergic to tetracycline. He was vaccinated with FLUVIRIN (batch number: 112946P1) intramuscularly on 19 Nov 2010. The same day after vaccination he experienced severe tremors, pain and numbness in feet and legs, which moved to upper extremities, trouble concentrating and had memory loss, he also developed chronic inflammatory polyneuropathy (CIDP), severe depression and his speech consisted of constant stuttering. He got three epidurals steroids injections in his back on an unspecified date and his laboratory tests included nerve study and magnetic resonance imaging (MRI) of low back, cervical and head. However, the results of these tests were not reported. The events were ongoing at the time of reporting. No further information was available.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Tremor
Clinical narrative: Case number PHHY2011US95033 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 431992) website on 27 Oct 2011. This report refers to a 49-year-old male patient. His concomitant medications included CRESTOR, LEVOXYL and baby aspirin. He was allergic to tetracycline. He was vaccinated with FLUVIRIN (batch number: 112946P1) intramuscularly on 19 Nov 2010. The same day after vaccination he experienced severe tremors, pain and numbness in feet and legs, which moved to upper extremities, trouble concentrating and had memory loss, he also developed chronic inflammatory polyneuropathy (CIDP), severe depression and his speech consisted of constant stuttering. He got three epidurals steroids injections in his back on an unspecified date and his laboratory tests included nerve study and magnetic resonance imaging (MRI) of low back, cervical and head. However, the results of these tests were not reported. The events were ongoing at the time of reporting. No further information was available.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Loss of consciousness, Malaise
Clinical narrative: Initial report received from a company representative who had received the original report from a nurse on 23 September 2011. This is a non-valid case with missing patient identifiers. This is a cluster of approximately 4 unidentified patients with the same reporter, same vaccine administered (FLUZONE HIGH-DOSE, lot number not reported) and similar events. Approximately 4 unidentified patients had received a dose of FLUZONE HIGH-DOSE (lot number not reported) on unspecified dates. The patients had called the physicians office (dates not reported) after receiving the vaccination reporting the following issues: some passing out/fainting, dizziness/light-headedness, sick, and weakness. No further information was provided. Recovery status for the patients were not reported. Follow-up information received on 25 October 2011 from a nurse who identified all 4 patients. This case is now a valid case as patient identifiers were provided. This case is also now the reference case for 1 of the cluster of 4 patients who had received the same vaccine (FLUZONE HIGH-DOSE) with the same lot number (UH459A), that was from the same reporter. Information regarding the other 3 patients is now captured in case numbers 2011-10381, 2011-10382, and 2011-10383. A 67-year-old female patient with no concurrent illnesses had received a first intramuscular left arm injection of FLUZONE HIGH-DOSE (full lot number UH459AB) on 22 September 2011 at 09:00 am and approximately 6 hours later around 15:00 pm she became extremely sick and weak and passed out landing on the bathroom floor. She was still on the bathroom floor when she woke up and was unsure how long she had been unconscious. The patient was not evaluated by a physician and no diagnostic tests or laboratory data were performed. The patient was reported as recovered. It was noted the patient had no known drug allergies, but did have statin medications and LOPID medication intolerances. The patient had not received any other vaccinations with 4 weeks of receiving the vaccine, and had not experienced any adverse events with past vaccinations. The reporter had written on the completed VAERS form to see an attached list regarding medical history, but no such list was attached. Concomitant medications were not provided. Documents held by sender: None.
Age: 84.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Borrelia test negative, Chills, Confusional state, Full blood count, Hallucination
Clinical narrative: Initial report received on 25 October 2011 from a nurse. This case involved 1 of a cluster of 4 patients who had received the same vaccine FLUZONE HIGH-DOSE with the same lot number (UH459A), that was from the same reporter. Information regarding the other 3 patients is captured in case numbers 2011-09291, 2011-10381, and 2011-10382. An 84-year-old male patient with no concurrent illnesses had received a first intramuscular right deltoid injection of FLUZONE HIGH-DOSE (full lot number UH459AC) on 14 September 2011 at 09:36 am and approximately 15 minutes later experienced fever, chills, sweats, cramping in the LE's (lower extremities), pain in his shoulders, and confusion with hallucinations. Diagnostic tests and laboratory data performed included a CBC (complete blood count) that revealed elevated WBCs of 12.5; and the patient also had a test to rule out Lyme disease, urine culture, CMP (complete metabolic panel), and lipid profile, all of which were negative. The patient was subsequently treated with doxycycline 5 days after onset of symptoms and all symptoms resolved on 19 September 2011. Per the reporter, the patient had not been back to the office for re-evaluation. It was noted the patient is allergic to PCN (penicillin), and had medical history of CAD (Coronary Artery disease), hyperlipidemia, HTN (Hypertension), BPH (benign prostatic hypertrophy), and DM ? (question - diabetes Mellitus, word illegible). Concomitant medications were not provided. Documents held by sender: None.
Age: 84.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Lipids, Metabolic function test, Muscle spasms
Clinical narrative: Initial report received on 25 October 2011 from a nurse. This case involved 1 of a cluster of 4 patients who had received the same vaccine FLUZONE HIGH-DOSE with the same lot number (UH459A), that was from the same reporter. Information regarding the other 3 patients is captured in case numbers 2011-09291, 2011-10381, and 2011-10382. An 84-year-old male patient with no concurrent illnesses had received a first intramuscular right deltoid injection of FLUZONE HIGH-DOSE (full lot number UH459AC) on 14 September 2011 at 09:36 am and approximately 15 minutes later experienced fever, chills, sweats, cramping in the LE's (lower extremities), pain in his shoulders, and confusion with hallucinations. Diagnostic tests and laboratory data performed included a CBC (complete blood count) that revealed elevated WBCs of 12.5; and the patient also had a test to rule out Lyme disease, urine culture, CMP (complete metabolic panel), and lipid profile, all of which were negative. The patient was subsequently treated with doxycycline 5 days after onset of symptoms and all symptoms resolved on 19 September 2011. Per the reporter, the patient had not been back to the office for re-evaluation. It was noted the patient is allergic to PCN (penicillin), and had medical history of CAD (Coronary Artery disease), hyperlipidemia, HTN (Hypertension), BPH (benign prostatic hypertrophy), and DM ? (question - diabetes Mellitus, word illegible). Concomitant medications were not provided. Documents held by sender: None.
Age: 84.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Pyrexia, Urine analysis normal, White blood cell count increased
Clinical narrative: Initial report received on 25 October 2011 from a nurse. This case involved 1 of a cluster of 4 patients who had received the same vaccine FLUZONE HIGH-DOSE with the same lot number (UH459A), that was from the same reporter. Information regarding the other 3 patients is captured in case numbers 2011-09291, 2011-10381, and 2011-10382. An 84-year-old male patient with no concurrent illnesses had received a first intramuscular right deltoid injection of FLUZONE HIGH-DOSE (full lot number UH459AC) on 14 September 2011 at 09:36 am and approximately 15 minutes later experienced fever, chills, sweats, cramping in the LE's (lower extremities), pain in his shoulders, and confusion with hallucinations. Diagnostic tests and laboratory data performed included a CBC (complete blood count) that revealed elevated WBCs of 12.5; and the patient also had a test to rule out Lyme disease, urine culture, CMP (complete metabolic panel), and lipid profile, all of which were negative. The patient was subsequently treated with doxycycline 5 days after onset of symptoms and all symptoms resolved on 19 September 2011. Per the reporter, the patient had not been back to the office for re-evaluation. It was noted the patient is allergic to PCN (penicillin), and had medical history of CAD (Coronary Artery disease), hyperlipidemia, HTN (Hypertension), BPH (benign prostatic hypertrophy), and DM ? (question - diabetes Mellitus, word illegible). Concomitant medications were not provided. Documents held by sender: None.
Age: 84.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Borrelia test negative, Chills, Confusional state, Culture urine negative, Full blood count abnormal
Clinical narrative: Initial report received on 25 October 2011 from a nurse. This case involved 1 of a cluster of 4 patients who had received the same vaccine FLUZONE HIGH-DOSE with the same lot number (UH459A), that was from the same reporter. Information regarding the other 3 patients is captured in case numbers 2011-09291, 2011-10381, and 2011-10382. An 84-year-old male patient with no concurrent illnesses had received a first intramuscular right deltoid injection of FLUZONE HIGH-DOSE (full lot number UH459AC) on 14 September 2011 at 09:36 am and approximately 15 minutes later experienced fever, chills, sweats, cramping in the LE's (lower extremities), pain in his shoulders, and confusion with hallucinations. Diagnostic tests and laboratory data performed included a CBC (complete blood count) that revealed elevated WBCs of 12.5; and the patient also had a test to rule out Lyme disease, urine culture, CMP (complete metabolic panel), and lipid profile, all of which were negative. The patient was subsequently treated with doxycycline 5 days after onset of symptoms and all symptoms resolved on 19 September 2011. Per the reporter, the patient had not been back to the office for re-evaluation. It was noted the patient is allergic to PCN (penicillin), and had medical history of CAD (Coronary Artery disease), hyperlipidemia, HTN (Hypertension), BPH (benign prostatic hypertrophy), and DM ? (question - diabetes Mellitus, word illegible). Concomitant medications were not provided. Documents held by sender: None.
Age: 84.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hallucination, Hyperhidrosis, Lipids normal, Metabolic function test, Muscle spasms
Clinical narrative: Initial report received on 25 October 2011 from a nurse. This case involved 1 of a cluster of 4 patients who had received the same vaccine FLUZONE HIGH-DOSE with the same lot number (UH459A), that was from the same reporter. Information regarding the other 3 patients is captured in case numbers 2011-09291, 2011-10381, and 2011-10382. An 84-year-old male patient with no concurrent illnesses had received a first intramuscular right deltoid injection of FLUZONE HIGH-DOSE (full lot number UH459AC) on 14 September 2011 at 09:36 am and approximately 15 minutes later experienced fever, chills, sweats, cramping in the LE's (lower extremities), pain in his shoulders, and confusion with hallucinations. Diagnostic tests and laboratory data performed included a CBC (complete blood count) that revealed elevated WBCs of 12.5; and the patient also had a test to rule out Lyme disease, urine culture, CMP (complete metabolic panel), and lipid profile, all of which were negative. The patient was subsequently treated with doxycycline 5 days after onset of symptoms and all symptoms resolved on 19 September 2011. Per the reporter, the patient had not been back to the office for re-evaluation. It was noted the patient is allergic to PCN (penicillin), and had medical history of CAD (Coronary Artery disease), hyperlipidemia, HTN (Hypertension), BPH (benign prostatic hypertrophy), and DM ? (question - diabetes Mellitus, word illegible). Concomitant medications were not provided. Documents held by sender: None.