chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Pain
Clinical narrative: Soreness in right arm area of flu shot yesterday.  Soreness comes and goes to this day when I move arm 01/14/2014.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Vomiting
Clinical narrative: Vomiting four instances over the course of an hour and a half three hours and 45min after administration of the vaccine.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: UPPER ARM REDNESS, SWELLING, PAIN.
Age: 12.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Paraesthesia
Clinical narrative: One week after receiving Zostavax vaccine for shingles, I began to feel tingling along the course of nerves on my back where I had previously had shingles several years ago. The next day I broke out in blisters. I am sure it is herpes zoster as I have had it in the past. I did not seek medical attention, though.
Age: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Injection site pain, Injection site swelling, Local swelling, Pain
Clinical narrative: Local swelling and redness, hot to the touch, painful to touch according to mother's statements. After leaving clinic, later in the afternoon, patient had some swelling and pain when touched to injection site.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Skin warm
Clinical narrative: Local swelling and redness, hot to the touch, painful to touch according to mother's statements. After leaving clinic, later in the afternoon, patient had some swelling and pain when touched to injection site.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Disturbance in attention, Excessive eye blinking, Nervousness
Clinical narrative: Unable to concentrate, seems nervous at times blinks eyes uncontrollably at times since.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Headache, Hyperhidrosis, Neutropenia, Neutrophil count decreased
Clinical narrative: Subjective symptoms: arm pain, fatigue, diaphoresis, shaky, headache. Serious adverse event: neutropenia and thrombocytopenia. Patient required filgastrim 480mcg subcutaneous once.
Age: 69.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Platelet count decreased, Thrombocytopenia, Tremor, White blood cell count decreased
Clinical narrative: Subjective symptoms: arm pain, fatigue, diaphoresis, shaky, headache. Serious adverse event: neutropenia and thrombocytopenia. Patient required filgastrim 480mcg subcutaneous once.
Age: 16.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: There were no adverse events.
Age: 14.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 18.0
Sex: F
Vaccine: FLU3, HEPA, TDAP
Symptoms: Chills, Myalgia, Nausea, Pyrexia, Urine analysis
Clinical narrative: Fever 101.5 oral; Nausea; Myalgias; Chills.
Age: 17.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: NONE.
Age: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None per Mother.
Age: 16.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: THIS INDIVIDUAL RECEIVED FLUCELVAX WHILE UNDER THE AGE OF 18 YEARS WITH NOT ADVERSE REACTIONS.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Musculoskeletal pain, Pain in extremity
Clinical narrative: Sore left arm and shoulder. Shortness of breath.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, HEPA, PNC13
Symptoms: Convulsion, Crying, Dyskinesia, Electroencephalogram abnormal, Fatigue
Clinical narrative: Before the vaccinations, patient showed no signs of seizures. Approximately two weeks after vaccinations, she experienced seizures involving severe jerking of head and limbs and crying. CRNP prescribed KEPPRA 100 mg/ml. She continues to experience at least four seizures a day. This limits her ability to progress in normal development because the seizures tire her out.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, HEPA, PNC13
Symptoms: Activities of daily living impaired, Convulsion, Dyskinesia, Performance status decreased
Clinical narrative: Before the vaccinations, patient showed no signs of seizures. Approximately two weeks after vaccinations, she experienced seizures involving severe jerking of head and limbs and crying. CRNP prescribed KEPPRA 100 mg/ml. She continues to experience at least four seizures a day. This limits her ability to progress in normal development because the seizures tire her out.
Age: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No symptoms, Flucelvax influenza vaccine indicated for 18 years old and over, vaccine adimistered to patient under 18.
Age: 11.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No symptoms, Flucelvax influenza vaccine indicated for 18 years old and over, vaccine adimistered to patient under 18.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pain, Pruritus, Rash
Clinical narrative: Swelling, erythema rash itch and pain 6cm diameter.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Vertigo
Clinical narrative: Extreme vertigo, fell on bathroom floor when got out of bed. Vertigo lasted approx. 8 hrs.
Age: 13.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, Pain in extremity
Clinical narrative: Patient had sore arm, patient received vaccine indicated for 18 years and older.
Age: 35.0
Sex: F
Vaccine: FLUN4
Symptoms: Allergy test, Blood test, Chills, Cognitive disorder, Computerised tomogram
Clinical narrative: Immediately following vaccine, I experienced momentary dizziness.  Later in the evening, I experienced body aches, chills, and fatigue. The next morning I experienced extreme muscle stiffness with minimal range of motion in my neck.  Over the course of the following weeks I experienced dizziness, lightheadedness, headaches, nausea, muscle aches, paresthesia, tinnitus, confusion, decreased cognitive functioning.  I was treated by various ER doctors as well as my primary doctor, an audiologist, ENT, and a neurologist.  I have received extensive testing to include an MRI, 2CT scans, blood work, allergy testing and Neuro psych testing.  It has been just over 3 months since the vaccination, and I am still experiencing symptoms of dizziness, lightheadedness, headaches, and mental fatigue.
Age: 35.0
Sex: F
Vaccine: FLUN4
Symptoms: Confusional state, Dizziness, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: Immediately following vaccine, I experienced momentary dizziness.  Later in the evening, I experienced body aches, chills, and fatigue. The next morning I experienced extreme muscle stiffness with minimal range of motion in my neck.  Over the course of the following weeks I experienced dizziness, lightheadedness, headaches, nausea, muscle aches, paresthesia, tinnitus, confusion, decreased cognitive functioning.  I was treated by various ER doctors as well as my primary doctor, an audiologist, ENT, and a neurologist.  I have received extensive testing to include an MRI, 2CT scans, blood work, allergy testing and Neuro psych testing.  It has been just over 3 months since the vaccination, and I am still experiencing symptoms of dizziness, lightheadedness, headaches, and mental fatigue.
Age: 35.0
Sex: F
Vaccine: FLUN4
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Nausea, Neuropsychological test, Nuclear magnetic resonance imaging
Clinical narrative: Immediately following vaccine, I experienced momentary dizziness.  Later in the evening, I experienced body aches, chills, and fatigue. The next morning I experienced extreme muscle stiffness with minimal range of motion in my neck.  Over the course of the following weeks I experienced dizziness, lightheadedness, headaches, nausea, muscle aches, paresthesia, tinnitus, confusion, decreased cognitive functioning.  I was treated by various ER doctors as well as my primary doctor, an audiologist, ENT, and a neurologist.  I have received extensive testing to include an MRI, 2CT scans, blood work, allergy testing and Neuro psych testing.  It has been just over 3 months since the vaccination, and I am still experiencing symptoms of dizziness, lightheadedness, headaches, and mental fatigue.
Age: 35.0
Sex: F
Vaccine: FLUN4
Symptoms: Pain, Paraesthesia, Tinnitus
Clinical narrative: Immediately following vaccine, I experienced momentary dizziness.  Later in the evening, I experienced body aches, chills, and fatigue. The next morning I experienced extreme muscle stiffness with minimal range of motion in my neck.  Over the course of the following weeks I experienced dizziness, lightheadedness, headaches, nausea, muscle aches, paresthesia, tinnitus, confusion, decreased cognitive functioning.  I was treated by various ER doctors as well as my primary doctor, an audiologist, ENT, and a neurologist.  I have received extensive testing to include an MRI, 2CT scans, blood work, allergy testing and Neuro psych testing.  It has been just over 3 months since the vaccination, and I am still experiencing symptoms of dizziness, lightheadedness, headaches, and mental fatigue.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Asthenia, Back pain, Biopsy, Blood test
Clinical narrative: Nausea, vomiting, muscle spasms, excruciating headaches, fatigue, sleeping 20 hours per day, back and leg pain, sensitivity to light and sound, weakness, stomach cramps, lightheadedness, digestive issues.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspepsia, Endoscopy gastrointestinal, Fatigue, Headache
Clinical narrative: Nausea, vomiting, muscle spasms, excruciating headaches, fatigue, sleeping 20 hours per day, back and leg pain, sensitivity to light and sound, weakness, stomach cramps, lightheadedness, digestive issues.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperacusis, Hypersomnia, Muscle spasms, Nausea, Pain in extremity
Clinical narrative: Nausea, vomiting, muscle spasms, excruciating headaches, fatigue, sleeping 20 hours per day, back and leg pain, sensitivity to light and sound, weakness, stomach cramps, lightheadedness, digestive issues.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Photophobia, Protein urine present, Vomiting
Clinical narrative: Nausea, vomiting, muscle spasms, excruciating headaches, fatigue, sleeping 20 hours per day, back and leg pain, sensitivity to light and sound, weakness, stomach cramps, lightheadedness, digestive issues.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Lymphadenopathy, Pain in extremity, Pyrexia, Rash
Clinical narrative: Rash appeared on Weds (1/8/14) on back and right thigh, followed by lymph node swelling (bikini line area) on Fri (1/10/14) accompanied by fever and pain (hip to knee deep in leg).
Age: 63.0
Sex: F
Vaccine: HEPA
Symptoms: Dysphonia, Dyspnoea, Muscle tightness, Throat tightness
Clinical narrative: Patient developed hoarse voice, feeling of tightness in the throat/neck, and feeling of SOB approximately 6 minutes after vaccine was administered.  She was in no acute distress, normal O2 saturation, VSS.  Administered 0.3 cc epi SQ, 50 mg Benadryl IM, prednisone, Solumedrol and an albuterol treatment.  Symptoms resolved.  She was monitored in clinic for a couple of hours and eventually discharged home.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Headache, Induration, Neck pain, Skin warm
Clinical narrative: Red shoulder, hot, hard (L) shoulder swelling and redness 7 x 7 cm area, headache neck pain.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling
Clinical narrative: Red shoulder, hot, hard (L) shoulder swelling and redness 7 x 7 cm area, headache neck pain.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site rash, Pain, Skin warm
Clinical narrative: Red, warm, raised area from lt. shoulder to elbow. Painful.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Flushing, Paraesthesia, Pruritus
Clinical narrative: Tingling, feeling hot sensation, flushing, itching. Gave pt 2 caps of BENADRYL 25 mg (52 mg).
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old female patient with no pertinent medical history and no drug reactions or allergies who on 08-JAN-2014, was vaccinated subcutaneously with a single dose of ZOSTAVAX (lot number J011333, Exp. Date: 13-DEC-2014) in the left arm. It was reported that on 09-JAN-2014, the patient developed swelling and redness at the injection site. Hydrocortisone cream was given as a treatment for the experience. No lab diagnostic studies were performed. At the time of the report, the patient had not recovered. The relatedness for redness and swelling at the injection site and ZOSTAVAX was unknown. Additional information is not expected.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Cough, Dizziness, Pain, Peripheral coldness
Clinical narrative: Fever, achiness, chest burning, cold hands, coughing, dizziness.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever, achiness, chest burning, cold hands, coughing, dizziness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Local swelling, Pain in extremity
Clinical narrative: Administered on Jan. 8, 2014, came in on Jan. 11, 2014 and arm was swollen, red and sore to touch. Patient was advised to go to the ER and diagnosed with Cellulitis.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Dizziness, Erythema, Flushing, Vision blurred
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 66 year old male patient with no pertinent medical history and no drug reactions or allergies. On 10-JAN-2014, the patient was vaccinated with a dose of ZOSTAVAX (Lot # J007208, expiration date 20-SEP-2014) subcutaneously. Concomitant therapies included metoprolol, AMBIEN, FLONASE, ursodiol and LASIX. The pharmacist reported that on 10-JAN-2014, 30 seconds after receiving ZOSTAVAX, the patient developed a red flushed face and experienced dizziness, blurry vision and upset stomach. The patient did not receive treatment for the adverse events. There were no lab diagnostics or studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Eructation, Erythema, Feeling abnormal, Flushing
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 66 year old male patient with no pertinent medical history and no drug reactions or allergies. On 10-JAN-2014, the patient was vaccinated with a dose of ZOSTAVAX (Lot # J007208, expiration date 20-SEP-2014) subcutaneously. Concomitant therapies included metoprolol, AMBIEN, FLONASE, ursodiol and LASIX. The pharmacist reported that on 10-JAN-2014, 30 seconds after receiving ZOSTAVAX, the patient developed a red flushed face and experienced dizziness, blurry vision and upset stomach. The patient did not receive treatment for the adverse events. There were no lab diagnostics or studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Throat irritation, Vision blurred
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 66 year old male patient with no pertinent medical history and no drug reactions or allergies. On 10-JAN-2014, the patient was vaccinated with a dose of ZOSTAVAX (Lot # J007208, expiration date 20-SEP-2014) subcutaneously. Concomitant therapies included metoprolol, AMBIEN, FLONASE, ursodiol and LASIX. The pharmacist reported that on 10-JAN-2014, 30 seconds after receiving ZOSTAVAX, the patient developed a red flushed face and experienced dizziness, blurry vision and upset stomach. The patient did not receive treatment for the adverse events. There were no lab diagnostics or studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Nausea, Ultrasound abdomen normal, Vomiting
Clinical narrative: Nausea and vomiting within 2 hr of vaccine administration. Increase in wheezing, relieved by albuterol (known asthmatic). Given ZOFRAN in ER.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Nausea and vomiting within 2 hr of vaccine administration. Increase in wheezing, relieved by albuterol (known asthmatic). Given ZOFRAN in ER.
Age: 0.48
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to a 5 months old (also reported as "6 months") patient of unknown gender. On 13-DEC-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot# J013344, expiry date: 22-JAN-2015 as reported) (dose and frequency unspecified), route as intramuscular, at right leg. No adverse effect had been observed or reported. The patient did not seek medical attention. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Pt called pharmacy 2 weeks after the ZOSTAVAX vaccine was administered, stating that her arm had swollen at the injection site. No medical attention seeked. Pt is just looking for some type of compensation. Never stop by the pharmacy so we could look at her arm or go to doctor.
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Dad reported today that at last vaccines pt had fever 103 x 24 hours, both legs swollen with red x 24 hours.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Ear infection, Headache, Upper respiratory tract infection, Urinary tract infection, Vertigo
Clinical narrative: Within 2-4 days of GARDASIL vaccine - blurred vision bilateral, room spinning - continuous. 3 wks after vaccine - went to ER with dx UTI, URI, ear inf. - and room spinning was relieved. Appt. being made with eye doctor today. Date to be determined. Also c/o headache - intermittent relieved by Ibuprofen.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Vision blurred
Clinical narrative: Within 2-4 days of GARDASIL vaccine - blurred vision bilateral, room spinning - continuous. 3 wks after vaccine - went to ER with dx UTI, URI, ear inf. - and room spinning was relieved. Appt. being made with eye doctor today. Date to be determined. Also c/o headache - intermittent relieved by Ibuprofen.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a treating pharmacist via a company representative refers to multiple, unspecified patients, during the past three days, had received ZOSTAVAX (Lot# unspecified) single dose injection (dose and location unspecified), and returned to the pharmacy within three days post-vaccination, with symptoms of "cellulitis" at the injection site and surrounding areas. The patient did not reintroduce the therapy, the patient had sought medical attention via contacted pharmacist. At the time of report, the outcome of the event was unknown. Follow up information has been received from a pharmacy manager refers to a 70 year old female patient. On 13-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # H019998, no expiration date available) (dose and route not reported). The pharmacy manager confirmed that the adverse event of injection cellulitis did occur 3 days after receiving the vaccination approximately on 16-MAY-2013. Treatment: Primary care physician prescribed KEFLEX to the patient, Pharmacy manager stated that this patient recovered and did not need to be admitted to a hospital for further treatment. This is one of several reports received from the same reporter. It was linked to MARRS# 1312USA010651, and MARRS#1401USA005669. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: No adverse events - given wrong dose. Child dose given to adult.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Rash erythematous, Swelling
Clinical narrative: Soreness at site of injection, red rash, swelling.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Arm still "hurting".
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient had severe pain radiating down the arm.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: CSF protein increased, Childhood disintegrative disorder, Decreased activity, Nuclear magnetic resonance imaging brain abnormal, Pyrexia
Clinical narrative: 2 wks after 12 month shots (MMR, varicella, hib, and PCV13) decreased activity and recurrent fevers. There was a loss of milestones. Admitted to hospital. Increased protein CSF, white matter changes MRI transferred to another hospital for rehab until 10/13, slowly regaining skills.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: White matter lesion
Clinical narrative: 2 wks after 12 month shots (MMR, varicella, hib, and PCV13) decreased activity and recurrent fevers. There was a loss of milestones. Admitted to hospital. Increased protein CSF, white matter changes MRI transferred to another hospital for rehab until 10/13, slowly regaining skills.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Dysarthria, Loss of consciousness, Slow speech, Somnolence
Clinical narrative: Case number PHHY2012US111622 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System website (VAERS reference number: 469043) on 04 Dec 2012 and a follow-up information was received from Quality Assurance Department (reference number: 209990) on 12 Feb 2013 and another follow up information was received from QA department on 09 Jan 2014 This report refers to a 62-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1203801) intramuscularly into the left arm on 10 Oct 2012. Approximately 10-15 minutes after vaccination, she passed out while sitting in a chair, she presented with slow slurred speech and was unalert upon waking up. Emergency Medical Service (EMS) was called but she refused hospital transport. The final outcome was reported as complete recovery of the patient on an undetermined date. No further information about seriousness and causality was reported. Batch review report (reference number: 209990) received from quality assurance department on 10 Jan 2014. Based on the document review, it was stated that FLUVIRIN (batch number: 1203801) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up information was received from Quality Assurance Department (reference number: 209990) on 12 Feb 2013. Significant follow up received from Quality Assurance Department on 09 Jan 2014: Updated Batch review report.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dizziness, Dysphagia, Dyspnoea, Feeling jittery
Clinical narrative: Case number PHHY2013US000764, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number:  469803) website on 02 Jan 2013 and a follow-up received from Quality Assurance Department (QA, reference number: 209099) on 09 Jan 2014. This report refers to a 21-years-old female patient. Her medical history included asthma and concomitant medication included albuterol inhalant PRN and epinephrine 0.3 mg/ml. She was vaccinated with FLUVIRIN (batch number: 1203801) intramuscularly in the left arm on 16 Oct 2012. On the same day after vaccination, she experienced red rash on face, felt jittery, dizzy, faint, chest pain, difficulty breathing, tightening of throat and difficulty swallowing. She visited to emergency room (ER) or doctor. The outcome of the events was reported as condition unchanged as of 16 Oct 2012. The causality and seriousness of the events was not reported. Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1203801) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 209099) on 09 Jan 2014: Updated batch review report.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Throat tightness
Clinical narrative: Case number PHHY2013US000764, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number:  469803) website on 02 Jan 2013 and a follow-up received from Quality Assurance Department (QA, reference number: 209099) on 09 Jan 2014. This report refers to a 21-years-old female patient. Her medical history included asthma and concomitant medication included albuterol inhalant PRN and epinephrine 0.3 mg/ml. She was vaccinated with FLUVIRIN (batch number: 1203801) intramuscularly in the left arm on 16 Oct 2012. On the same day after vaccination, she experienced red rash on face, felt jittery, dizzy, faint, chest pain, difficulty breathing, tightening of throat and difficulty swallowing. She visited to emergency room (ER) or doctor. The outcome of the events was reported as condition unchanged as of 16 Oct 2012. The causality and seriousness of the events was not reported. Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1203801) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 209099) on 09 Jan 2014: Updated batch review report.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pyrexia, Staphylococcal infection
Clinical narrative: Case number PHHY2013US140201 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 503042) website on 03 Dec 2013 with a follow up information received from quality assurance department on 14 Jan 2014. This report refers to a 72 year old male patient. His medical history included high blood pressure. He was vaccinated with FLUVIRIN (batch number: 1308501, expiry date: 31 Mar 2014) intramuscularly into left arm and PNEUMOVAX (other manufacturer, batch number: H014561) intramuscularly into left arm on 13 Sep 2013. On 15 Sep 2013, he experienced swelling in his arm down to elbow and felt feverish. He was advised to go to physician. He went to the emergency room and was diagnosed with staphylococcus infection. Based on the review performed it was concluded that this batch of FLUVIRIN batch number: 1308501 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Outcome of the events was reported as not recovered as of 18 Sep 2013. No seriousness and causality was reported for the events. Non significant follow up received from quality assurance department (reference number: 269200) on 10 Dec 2013: Updated QA reference number only. Follow up information received from QA department on 14 Jan 2014: Updated batch review report.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: Guillain Barre.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Abdominal pain upper, Adenovirus test, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood immunoglobulin M
Clinical narrative: This 21 year old patient received primary Smallpox (VV04-003A), Anthrax #1 (FAV328A), and IM Typhoid (H1482) vaccines on 11/13/2013. He received seasonal IM influenza (007011A Novartis) on 11/6/2013. He denied any adverse reactions to these vaccinations with medical records documenting a major take at his SPV site. On 12/30/2013 after traveling home; he began to complain of stomach ache with nausea, vomiting and diarrhea (brown-clear liquid) that night. By 6 am 12/31/13 his vomiting had stopped and his diarrhea ceased on 1/1/2014. He denied fever, sweats, or eating any new foods, seafood, and family was not ill (ate similar food at home). He awoke 1/2/2014 with a burning 8/10 pressure to mid chest and could feel his heart beating, his jaw was tight as if he'd just chewed or clenched teeth, and had tingling pain to left >right shoulder. He vomited once and had dry heaves. He stated it hurt to breathe deep but no shortness of breath. Position changes did not affect the pain. He drove himself to nearby facility and was referred to nearby hospital. At the ER his EKG showed NSR with 1mm ST depression V4-5, normal CXR, and elevated cardiac enzymes: CK 391 (H), CKMB 13.5 (H), CK% 3.4, Troponin POC 0.56, Troponin T 0.19, normal BMP, CBC, PT and INR. His pain was treated with ASA, 1L NS bolus and one NORCO 5/325 with pain easing to 2/10 (like a sore muscle in his chest). He was transferred and admitted. That evening about 7pm his pain again worsened to 8/10 as dull intense chest pain without nausea or radiating pain. His EKG remained in NSR and he was treated with MOTRIN and colchicine with minimal relief of pain. One PERCOCET resolved his pain (0/10). He was started on routine IV then oral NSAIDS with no reoccurrence of pain as of 1/7/2014.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Blood magnesium normal, Blood phosphorus normal, Borrelia test negative, Bruxism, C-reactive protein increased
Clinical narrative: This 21 year old patient received primary Smallpox (VV04-003A), Anthrax #1 (FAV328A), and IM Typhoid (H1482) vaccines on 11/13/2013. He received seasonal IM influenza (007011A Novartis) on 11/6/2013. He denied any adverse reactions to these vaccinations with medical records documenting a major take at his SPV site. On 12/30/2013 after traveling home; he began to complain of stomach ache with nausea, vomiting and diarrhea (brown-clear liquid) that night. By 6 am 12/31/13 his vomiting had stopped and his diarrhea ceased on 1/1/2014. He denied fever, sweats, or eating any new foods, seafood, and family was not ill (ate similar food at home). He awoke 1/2/2014 with a burning 8/10 pressure to mid chest and could feel his heart beating, his jaw was tight as if he'd just chewed or clenched teeth, and had tingling pain to left >right shoulder. He vomited once and had dry heaves. He stated it hurt to breathe deep but no shortness of breath. Position changes did not affect the pain. He drove himself to nearby facility and was referred to nearby hospital. At the ER his EKG showed NSR with 1mm ST depression V4-5, normal CXR, and elevated cardiac enzymes: CK 391 (H), CKMB 13.5 (H), CK% 3.4, Troponin POC 0.56, Troponin T 0.19, normal BMP, CBC, PT and INR. His pain was treated with ASA, 1L NS bolus and one NORCO 5/325 with pain easing to 2/10 (like a sore muscle in his chest). He was transferred and admitted. That evening about 7pm his pain again worsened to 8/10 as dull intense chest pain without nausea or radiating pain. His EKG remained in NSR and he was treated with MOTRIN and colchicine with minimal relief of pain. One PERCOCET resolved his pain (0/10). He was started on routine IV then oral NSAIDS with no reoccurrence of pain as of 1/7/2014.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Cardiac enzymes increased, Cardiac imaging procedure abnormal, Cardiac stress test normal, Chest X-ray normal, Chest discomfort
Clinical narrative: This 21 year old patient received primary Smallpox (VV04-003A), Anthrax #1 (FAV328A), and IM Typhoid (H1482) vaccines on 11/13/2013. He received seasonal IM influenza (007011A Novartis) on 11/6/2013. He denied any adverse reactions to these vaccinations with medical records documenting a major take at his SPV site. On 12/30/2013 after traveling home; he began to complain of stomach ache with nausea, vomiting and diarrhea (brown-clear liquid) that night. By 6 am 12/31/13 his vomiting had stopped and his diarrhea ceased on 1/1/2014. He denied fever, sweats, or eating any new foods, seafood, and family was not ill (ate similar food at home). He awoke 1/2/2014 with a burning 8/10 pressure to mid chest and could feel his heart beating, his jaw was tight as if he'd just chewed or clenched teeth, and had tingling pain to left >right shoulder. He vomited once and had dry heaves. He stated it hurt to breathe deep but no shortness of breath. Position changes did not affect the pain. He drove himself to nearby facility and was referred to nearby hospital. At the ER his EKG showed NSR with 1mm ST depression V4-5, normal CXR, and elevated cardiac enzymes: CK 391 (H), CKMB 13.5 (H), CK% 3.4, Troponin POC 0.56, Troponin T 0.19, normal BMP, CBC, PT and INR. His pain was treated with ASA, 1L NS bolus and one NORCO 5/325 with pain easing to 2/10 (like a sore muscle in his chest). He was transferred and admitted. That evening about 7pm his pain again worsened to 8/10 as dull intense chest pain without nausea or radiating pain. His EKG remained in NSR and he was treated with MOTRIN and colchicine with minimal relief of pain. One PERCOCET resolved his pain (0/10). He was started on routine IV then oral NSAIDS with no reoccurrence of pain as of 1/7/2014.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Chest pain, Coxsackie virus test negative, Cytomegalovirus test negative, Diarrhoea, Echocardiogram normal
Clinical narrative: This 21 year old patient received primary Smallpox (VV04-003A), Anthrax #1 (FAV328A), and IM Typhoid (H1482) vaccines on 11/13/2013. He received seasonal IM influenza (007011A Novartis) on 11/6/2013. He denied any adverse reactions to these vaccinations with medical records documenting a major take at his SPV site. On 12/30/2013 after traveling home; he began to complain of stomach ache with nausea, vomiting and diarrhea (brown-clear liquid) that night. By 6 am 12/31/13 his vomiting had stopped and his diarrhea ceased on 1/1/2014. He denied fever, sweats, or eating any new foods, seafood, and family was not ill (ate similar food at home). He awoke 1/2/2014 with a burning 8/10 pressure to mid chest and could feel his heart beating, his jaw was tight as if he'd just chewed or clenched teeth, and had tingling pain to left >right shoulder. He vomited once and had dry heaves. He stated it hurt to breathe deep but no shortness of breath. Position changes did not affect the pain. He drove himself to nearby facility and was referred to nearby hospital. At the ER his EKG showed NSR with 1mm ST depression V4-5, normal CXR, and elevated cardiac enzymes: CK 391 (H), CKMB 13.5 (H), CK% 3.4, Troponin POC 0.56, Troponin T 0.19, normal BMP, CBC, PT and INR. His pain was treated with ASA, 1L NS bolus and one NORCO 5/325 with pain easing to 2/10 (like a sore muscle in his chest). He was transferred and admitted. That evening about 7pm his pain again worsened to 8/10 as dull intense chest pain without nausea or radiating pain. His EKG remained in NSR and he was treated with MOTRIN and colchicine with minimal relief of pain. One PERCOCET resolved his pain (0/10). He was started on routine IV then oral NSAIDS with no reoccurrence of pain as of 1/7/2014.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Ejection fraction normal, Electrocardiogram ST segment depression, Electrocardiogram abnormal, Enterovirus test negative, Epstein-Barr virus antibody negative
Clinical narrative: This 21 year old patient received primary Smallpox (VV04-003A), Anthrax #1 (FAV328A), and IM Typhoid (H1482) vaccines on 11/13/2013. He received seasonal IM influenza (007011A Novartis) on 11/6/2013. He denied any adverse reactions to these vaccinations with medical records documenting a major take at his SPV site. On 12/30/2013 after traveling home; he began to complain of stomach ache with nausea, vomiting and diarrhea (brown-clear liquid) that night. By 6 am 12/31/13 his vomiting had stopped and his diarrhea ceased on 1/1/2014. He denied fever, sweats, or eating any new foods, seafood, and family was not ill (ate similar food at home). He awoke 1/2/2014 with a burning 8/10 pressure to mid chest and could feel his heart beating, his jaw was tight as if he'd just chewed or clenched teeth, and had tingling pain to left >right shoulder. He vomited once and had dry heaves. He stated it hurt to breathe deep but no shortness of breath. Position changes did not affect the pain. He drove himself to nearby facility and was referred to nearby hospital. At the ER his EKG showed NSR with 1mm ST depression V4-5, normal CXR, and elevated cardiac enzymes: CK 391 (H), CKMB 13.5 (H), CK% 3.4, Troponin POC 0.56, Troponin T 0.19, normal BMP, CBC, PT and INR. His pain was treated with ASA, 1L NS bolus and one NORCO 5/325 with pain easing to 2/10 (like a sore muscle in his chest). He was transferred and admitted. That evening about 7pm his pain again worsened to 8/10 as dull intense chest pain without nausea or radiating pain. His EKG remained in NSR and he was treated with MOTRIN and colchicine with minimal relief of pain. One PERCOCET resolved his pain (0/10). He was started on routine IV then oral NSAIDS with no reoccurrence of pain as of 1/7/2014.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Epstein-Barr virus antibody positive, Full blood count normal, Hepatitis B surface antibody positive, Human herpes virus 6 serology negative, Influenza A virus test
Clinical narrative: This 21 year old patient received primary Smallpox (VV04-003A), Anthrax #1 (FAV328A), and IM Typhoid (H1482) vaccines on 11/13/2013. He received seasonal IM influenza (007011A Novartis) on 11/6/2013. He denied any adverse reactions to these vaccinations with medical records documenting a major take at his SPV site. On 12/30/2013 after traveling home; he began to complain of stomach ache with nausea, vomiting and diarrhea (brown-clear liquid) that night. By 6 am 12/31/13 his vomiting had stopped and his diarrhea ceased on 1/1/2014. He denied fever, sweats, or eating any new foods, seafood, and family was not ill (ate similar food at home). He awoke 1/2/2014 with a burning 8/10 pressure to mid chest and could feel his heart beating, his jaw was tight as if he'd just chewed or clenched teeth, and had tingling pain to left >right shoulder. He vomited once and had dry heaves. He stated it hurt to breathe deep but no shortness of breath. Position changes did not affect the pain. He drove himself to nearby facility and was referred to nearby hospital. At the ER his EKG showed NSR with 1mm ST depression V4-5, normal CXR, and elevated cardiac enzymes: CK 391 (H), CKMB 13.5 (H), CK% 3.4, Troponin POC 0.56, Troponin T 0.19, normal BMP, CBC, PT and INR. His pain was treated with ASA, 1L NS bolus and one NORCO 5/325 with pain easing to 2/10 (like a sore muscle in his chest). He was transferred and admitted. That evening about 7pm his pain again worsened to 8/10 as dull intense chest pain without nausea or radiating pain. His EKG remained in NSR and he was treated with MOTRIN and colchicine with minimal relief of pain. One PERCOCET resolved his pain (0/10). He was started on routine IV then oral NSAIDS with no reoccurrence of pain as of 1/7/2014.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Influenza B virus test, International normalised ratio normal, Laboratory test normal, Lipids normal, Liver function test normal
Clinical narrative: This 21 year old patient received primary Smallpox (VV04-003A), Anthrax #1 (FAV328A), and IM Typhoid (H1482) vaccines on 11/13/2013. He received seasonal IM influenza (007011A Novartis) on 11/6/2013. He denied any adverse reactions to these vaccinations with medical records documenting a major take at his SPV site. On 12/30/2013 after traveling home; he began to complain of stomach ache with nausea, vomiting and diarrhea (brown-clear liquid) that night. By 6 am 12/31/13 his vomiting had stopped and his diarrhea ceased on 1/1/2014. He denied fever, sweats, or eating any new foods, seafood, and family was not ill (ate similar food at home). He awoke 1/2/2014 with a burning 8/10 pressure to mid chest and could feel his heart beating, his jaw was tight as if he'd just chewed or clenched teeth, and had tingling pain to left >right shoulder. He vomited once and had dry heaves. He stated it hurt to breathe deep but no shortness of breath. Position changes did not affect the pain. He drove himself to nearby facility and was referred to nearby hospital. At the ER his EKG showed NSR with 1mm ST depression V4-5, normal CXR, and elevated cardiac enzymes: CK 391 (H), CKMB 13.5 (H), CK% 3.4, Troponin POC 0.56, Troponin T 0.19, normal BMP, CBC, PT and INR. His pain was treated with ASA, 1L NS bolus and one NORCO 5/325 with pain easing to 2/10 (like a sore muscle in his chest). He was transferred and admitted. That evening about 7pm his pain again worsened to 8/10 as dull intense chest pain without nausea or radiating pain. His EKG remained in NSR and he was treated with MOTRIN and colchicine with minimal relief of pain. One PERCOCET resolved his pain (0/10). He was started on routine IV then oral NSAIDS with no reoccurrence of pain as of 1/7/2014.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Metabolic function test normal, Muscle tightness, Myalgia, Myocarditis, Nausea
Clinical narrative: This 21 year old patient received primary Smallpox (VV04-003A), Anthrax #1 (FAV328A), and IM Typhoid (H1482) vaccines on 11/13/2013. He received seasonal IM influenza (007011A Novartis) on 11/6/2013. He denied any adverse reactions to these vaccinations with medical records documenting a major take at his SPV site. On 12/30/2013 after traveling home; he began to complain of stomach ache with nausea, vomiting and diarrhea (brown-clear liquid) that night. By 6 am 12/31/13 his vomiting had stopped and his diarrhea ceased on 1/1/2014. He denied fever, sweats, or eating any new foods, seafood, and family was not ill (ate similar food at home). He awoke 1/2/2014 with a burning 8/10 pressure to mid chest and could feel his heart beating, his jaw was tight as if he'd just chewed or clenched teeth, and had tingling pain to left >right shoulder. He vomited once and had dry heaves. He stated it hurt to breathe deep but no shortness of breath. Position changes did not affect the pain. He drove himself to nearby facility and was referred to nearby hospital. At the ER his EKG showed NSR with 1mm ST depression V4-5, normal CXR, and elevated cardiac enzymes: CK 391 (H), CKMB 13.5 (H), CK% 3.4, Troponin POC 0.56, Troponin T 0.19, normal BMP, CBC, PT and INR. His pain was treated with ASA, 1L NS bolus and one NORCO 5/325 with pain easing to 2/10 (like a sore muscle in his chest). He was transferred and admitted. That evening about 7pm his pain again worsened to 8/10 as dull intense chest pain without nausea or radiating pain. His EKG remained in NSR and he was treated with MOTRIN and colchicine with minimal relief of pain. One PERCOCET resolved his pain (0/10). He was started on routine IV then oral NSAIDS with no reoccurrence of pain as of 1/7/2014.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Pain, Painful respiration, Palpitations, Paraesthesia, Parvovirus B19 test negative
Clinical narrative: This 21 year old patient received primary Smallpox (VV04-003A), Anthrax #1 (FAV328A), and IM Typhoid (H1482) vaccines on 11/13/2013. He received seasonal IM influenza (007011A Novartis) on 11/6/2013. He denied any adverse reactions to these vaccinations with medical records documenting a major take at his SPV site. On 12/30/2013 after traveling home; he began to complain of stomach ache with nausea, vomiting and diarrhea (brown-clear liquid) that night. By 6 am 12/31/13 his vomiting had stopped and his diarrhea ceased on 1/1/2014. He denied fever, sweats, or eating any new foods, seafood, and family was not ill (ate similar food at home). He awoke 1/2/2014 with a burning 8/10 pressure to mid chest and could feel his heart beating, his jaw was tight as if he'd just chewed or clenched teeth, and had tingling pain to left >right shoulder. He vomited once and had dry heaves. He stated it hurt to breathe deep but no shortness of breath. Position changes did not affect the pain. He drove himself to nearby facility and was referred to nearby hospital. At the ER his EKG showed NSR with 1mm ST depression V4-5, normal CXR, and elevated cardiac enzymes: CK 391 (H), CKMB 13.5 (H), CK% 3.4, Troponin POC 0.56, Troponin T 0.19, normal BMP, CBC, PT and INR. His pain was treated with ASA, 1L NS bolus and one NORCO 5/325 with pain easing to 2/10 (like a sore muscle in his chest). He was transferred and admitted. That evening about 7pm his pain again worsened to 8/10 as dull intense chest pain without nausea or radiating pain. His EKG remained in NSR and he was treated with MOTRIN and colchicine with minimal relief of pain. One PERCOCET resolved his pain (0/10). He was started on routine IV then oral NSAIDS with no reoccurrence of pain as of 1/7/2014.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Prothrombin time normal, Red blood cell sedimentation rate normal, Respiratory syncytial virus test negative, Retching, Troponin T normal
Clinical narrative: This 21 year old patient received primary Smallpox (VV04-003A), Anthrax #1 (FAV328A), and IM Typhoid (H1482) vaccines on 11/13/2013. He received seasonal IM influenza (007011A Novartis) on 11/6/2013. He denied any adverse reactions to these vaccinations with medical records documenting a major take at his SPV site. On 12/30/2013 after traveling home; he began to complain of stomach ache with nausea, vomiting and diarrhea (brown-clear liquid) that night. By 6 am 12/31/13 his vomiting had stopped and his diarrhea ceased on 1/1/2014. He denied fever, sweats, or eating any new foods, seafood, and family was not ill (ate similar food at home). He awoke 1/2/2014 with a burning 8/10 pressure to mid chest and could feel his heart beating, his jaw was tight as if he'd just chewed or clenched teeth, and had tingling pain to left >right shoulder. He vomited once and had dry heaves. He stated it hurt to breathe deep but no shortness of breath. Position changes did not affect the pain. He drove himself to nearby facility and was referred to nearby hospital. At the ER his EKG showed NSR with 1mm ST depression V4-5, normal CXR, and elevated cardiac enzymes: CK 391 (H), CKMB 13.5 (H), CK% 3.4, Troponin POC 0.56, Troponin T 0.19, normal BMP, CBC, PT and INR. His pain was treated with ASA, 1L NS bolus and one NORCO 5/325 with pain easing to 2/10 (like a sore muscle in his chest). He was transferred and admitted. That evening about 7pm his pain again worsened to 8/10 as dull intense chest pain without nausea or radiating pain. His EKG remained in NSR and he was treated with MOTRIN and colchicine with minimal relief of pain. One PERCOCET resolved his pain (0/10). He was started on routine IV then oral NSAIDS with no reoccurrence of pain as of 1/7/2014.