chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Local swelling, Pain in extremity, Skin warm
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 10 year old male patient with allergy to amoxicillin. There was no pertinent medical history. On 20-JAN-2014 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # J009827, expiration date 10-AUG-2014, 0.5 ml, intramuscular in the left arm) for history of hereditary spherocytosis. On 20-JAN-2014 the patient's left arm swelled up, was really red, hot to the touch, and had pain from mid deltoid down to the wrist. There was no treatment given for the events. No lab diagnostics studies performed. The patient sought medical attention by an office visit. The outcome of the events was unknown. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient was administered dose 1 of GARDASIL on 17-OCT-2013, dose 2 on 14-nOV-2013 and dose 3 on 04-FEb-2014. Lot numbers, route and dose were not reported. No adverse effects were reported. Additional information has been requested.
Age: 1.28
Sex: F
Vaccine: DTAPIPVHIB, MMR
Symptoms: Gait disturbance, Irritability, Rash
Clinical narrative: Rash on stomach on 2/5/14. 2/5/14 Child irritable. Wobbly gait after bath. Seen in ED ? water in ears. Same sx the next day. Possible dizziness and nausea. 2/7/14 Seen in office by Dr.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Condition aggravated, Iritis
Clinical narrative: Striking inflammation of the right eye ball having appearance of being sudden re-occurrence of iritis (in the same eye) which had been in complete remission for six years. Visited the original treating ophthalmologist (MD) at first opportunity on 12/24/2014 confirming likelihood of iritis and began treatment with ophthalmic steroid (Pred Forte to start). After six weeks, still being weaned from steroids. Hopefully sooner than later. Last occurrence six/seven years ago took more than a year to resolve.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Condition aggravated, Eye inflammation, Iritis, Vitreous floaters
Clinical narrative: Striking inflammation of the right eye ball having appearance of being sudden re-occurrence of iritis (in the same eye) which had been in complete remission for six years. Visited the original treating ophthalmologist (MD) at first opportunity on 12/24/2014 confirming likelihood of iritis and began treatment with ophthalmic steroid (Pred Forte to start). After six weeks, still being weaned from steroids. Hopefully sooner than later. Last occurrence six/seven years ago took more than a year to resolve.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Rash generalised, Rash papular, Rash pruritic
Clinical narrative: Sudden onset of pruritic papular vesicular rash to bilateral feet.  Over several days, spread to bilateral legs and arms (mainly extensor surfaces) and finally cheeks.  No involvement of trunk.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Injection site mass, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: Swelling at injection site within hrs worsening over the next few days. Large baseball size lump at injection site. Sore arm, neck, and shoulder on side of injection. Body aches for 3 days.  Headache for 3 days.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Swelling at injection site within hrs worsening over the next few days. Large baseball size lump at injection site. Sore arm, neck, and shoulder on side of injection. Body aches for 3 days.  Headache for 3 days.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Red, and very itchy.
Age: 10.0
Sex: M
Vaccine: FLUX
Symptoms: Axillary mass, Headache, Mass, Musculoskeletal pain, Pain
Clinical narrative: Felt a pain in his shoulder. Found the lump at the time. Had small headache all day. This morning has grown to 2" length x 1.75" wide. Hurts to move arm. Lump in armpit now as well.
Age: 10.0
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Felt a pain in his shoulder. Found the lump at the time. Had small headache all day. This morning has grown to 2" length x 1.75" wide. Hurts to move arm. Lump in armpit now as well.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Feeling abnormal, Immediate post-injection reaction, Nervousness
Clinical narrative: Directly following SQ administration patient felt woozy, shaky and head spinning also mentioned tongue tingling, all dissipated within minutes.  Spoke with patient about 2 hours after event and she still felt weak and not good overall but no other symptoms reported at the time.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral, Vertigo
Clinical narrative: Directly following SQ administration patient felt woozy, shaky and head spinning also mentioned tongue tingling, all dissipated within minutes.  Spoke with patient about 2 hours after event and she still felt weak and not good overall but no other symptoms reported at the time.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain
Clinical narrative: Local soreness in shoulder, varies in severity and is still present as of 2/8/14.  Also, loss of range of motion, times when it is very painful to lift arm above head to put on clothes, reach for items on high shelves, etc.
Age: 47.0
Sex: F
Vaccine: FLUC3
Symptoms: Asthenia, Blood thyroid stimulating hormone, Body temperature increased, Chest X-ray, Feeling cold
Clinical narrative: Paresthesia: numbness, coldness, weakness, tingling sensation, sneezing runny nose low grade temp.
Age: 47.0
Sex: F
Vaccine: FLUC3
Symptoms: Full blood count, Hypoaesthesia, Metabolic function test, Paraesthesia, Rhinorrhoea
Clinical narrative: Paresthesia: numbness, coldness, weakness, tingling sensation, sneezing runny nose low grade temp.
Age: 47.0
Sex: F
Vaccine: FLUC3
Symptoms: Sneezing
Clinical narrative: Paresthesia: numbness, coldness, weakness, tingling sensation, sneezing runny nose low grade temp.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Staphylococcal infection
Clinical narrative: Patient called pharmacy w/ symptoms of redness and swelling around injection site. Patient also came in person to pharmacy on 2/7 and pt was referred to ER where she received unknown tx. The patient called the pharmacy to inform that she had been diagnosed with a staph infection.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Inflammation, Local swelling
Clinical narrative: Patient called pharmacy the night of receiving vaccination. Right arm was swollen and looked very inflamed. Patient was referred to ER and given a MEDROL Dose pack and BACTRIM DS.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain
Clinical narrative: Redness, pain.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain
Clinical narrative: Redness, pain.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Patient experiencing neck pain and stiffness for past 2 weeks it is not getting better and acetaminophen is not helping.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Syncope
Clinical narrative: Dizzy, fainted (approximately 1 sec) per mom after left the store.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Dizziness, Dyskinesia, Pallor, Syncope
Clinical narrative: Dizzy, lost color in face, fainted (< 5 sec). convulsion (jerk) } per mom * blood pressure was taken 104/70 pulse 75.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to a two week old patient. On 05-FEB-2014, the patient was vaccinated with a dose of GARDASIL mistakenly instead of RECOMBIVAX. No concomitant medication was reported. No adverse effects were reported. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Cough, Decreased appetite, Irritability, Pyrexia, Rhinorrhoea
Clinical narrative: Very runny nose, like 5-6 tissues per hour, cough, fussiness, 2-3 day's later fever ranging from 100.1-102.4. Loss of appetite for solid foods.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Antinuclear antibody positive, Atelectasis, Blood chromogranin A, Complement factor increased, Condition aggravated
Clinical narrative: Within 12 hours of receiving the reported vaccines I had flu like symptoms and wheezing with breathing difficulties. I returned to the doctor on 3/11/13, 3/14/13, 4/3/13 and was finally hospitalized on 4/7/13.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Dyspnoea, Influenza like illness, Neutrophil count increased, Wheezing
Clinical narrative: Within 12 hours of receiving the reported vaccines I had flu like symptoms and wheezing with breathing difficulties. I returned to the doctor on 3/11/13, 3/14/13, 4/3/13 and was finally hospitalized on 4/7/13.
Age: 84.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abasia, Atrial fibrillation, Back pain, Dizziness, Dysphemia
Clinical narrative: Patient started to feel dizzy.  By 12/31 patient was starting to hurt in upper back.  By 1/2 patient stutter stepped when walking and could no longer walk, pain in back because unbearable.
Age: 84.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypopnoea, Sepsis
Clinical narrative: Patient started to feel dizzy.  By 12/31 patient was starting to hurt in upper back.  By 1/2 patient stutter stepped when walking and could no longer walk, pain in back because unbearable.
Age: 84.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypopnoea, Sensory loss, Sepsis
Clinical narrative: Patient started to feel dizzy.  By 12/31 patient was starting to hurt in upper back.  By 1/2 patient stutter stepped when walking and could no longer walk, pain in back because unbearable.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test, Dizziness, Headache, Hypoaesthesia, Lumbar puncture
Clinical narrative: Fever, muscle aches, numbness on left side of body, headaches, dizziness.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: Fever, muscle aches, numbness on left side of body, headaches, dizziness.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Blood heavy metal test, Blood test, Bone pain, Borrelia test
Clinical narrative: Twitching of muscles, pain in bones, rash, throat constricting, anxiety, severe fatigue, muscle weakness in legs and arms.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: CSF oligoclonal band, Fatigue, Lumbar puncture, Muscle twitching, Muscular weakness
Clinical narrative: Twitching of muscles, pain in bones, rash, throat constricting, anxiety, severe fatigue, muscle weakness in legs and arms.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Nerve conduction studies, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Rash, Scan with contrast
Clinical narrative: Twitching of muscles, pain in bones, rash, throat constricting, anxiety, severe fatigue, muscle weakness in legs and arms.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Throat tightness, Viral test, Visual evoked potentials
Clinical narrative: Twitching of muscles, pain in bones, rash, throat constricting, anxiety, severe fatigue, muscle weakness in legs and arms.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Injection site erythema, Malaise, Vaccination site pain
Clinical narrative: Pain, redness, and swelling at vaccination site, along with mild generalized malaise. Area of erythema and induration reached approximately 6 x 10 cm at its maximal extent on 2/08/2014.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site swelling
Clinical narrative: Pain, redness, and swelling at vaccination site, along with mild generalized malaise. Area of erythema and induration reached approximately 6 x 10 cm at its maximal extent on 2/08/2014.
Age: 12.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: PT received Flucelvax instead of Fluvirin. Flucelvax is indicated to pts 18 yo and over only. Pt had no adverse reactions.
Age: 59.0
Sex: M
Vaccine: FLUC3
Symptoms: Activities of daily living impaired, Feeling cold, Hypoaesthesia, Immediate post-injection reaction, Incorrect dose administered
Clinical narrative: Patient says initial injection caused immediate cold sensation down his arm, RPh said, per patient injection is no good and went back to pharmacy to get a brand new vaccine and then gave patient the vaccine - pt does not think any vaccine was inserted with initial penetration. Says although pain has gotten little better, still cannot sleep on left side or shower with left arm and has limited range of motion with left arm, says pain is just in upper left arm above injection site, although does sometimes have numbness that radiates down his arm. Got pain medication from ER 2-8-14 for his arm.
Age: 59.0
Sex: M
Vaccine: FLUC3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient says initial injection caused immediate cold sensation down his arm, RPh said, per patient injection is no good and went back to pharmacy to get a brand new vaccine and then gave patient the vaccine - pt does not think any vaccine was inserted with initial penetration. Says although pain has gotten little better, still cannot sleep on left side or shower with left arm and has limited range of motion with left arm, says pain is just in upper left arm above injection site, although does sometimes have numbness that radiates down his arm. Got pain medication from ER 2-8-14 for his arm.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Pain, Pain in extremity
Clinical narrative: Patient states soreness in arm for last 28 days. Pain is getting worse. States shot was given higher than normal. Called on 1-13-14 to tell RPh and was just told to drink fluids.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a patient of unknown age. On 22-JAN-2014, the patient was vaccinated with expired GARDASIL lot # 1317AA (Expiry: 13-OCT-2013). No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 60 year old female patient. On 01-FEB-2014, the patient was vaccinated with expired ZOSTAVAX lot # H013021 (Expiry: 09-OCT-2013), 0.65 ml, subcutaneous in the left arm. No adverse effects reported. No further details provided. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demography. On an unknown date in July 2012, the patient was vaccinated with series consisting of 1 dose of CERVARIX and 2 doses of GARDASIL. No adverse effects reported. No further information was available. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, TD
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 15 year old female patient. The patient had a history of fainting, syncope, after blood draws or other vaccinations. On 29-AUG-2013 the patient was vaccinated with an unspecified dose of GARDASIL, (lot #, expiration date, dose and route not reported) for vaccination. On 29-AUG-2013 the patient was also vaccinated with TD vaccines. Post vaccination the patient fainted while still in the physician's office on 29-AUG-2013. EMS were called to the doctor office at that time, but the patient refused to go to the emergency room. The outcome of the event was unknown. The patient had sought medical attention in office. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Balance disorder, Blood pressure decreased, Presyncope, Syncope
Clinical narrative: Case number PHHY2012US098923 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 462534) web site on 01 Nov 2012, with a follow up received from the QA department (reference number: 209553) on 05 Feb 2014. This report refers to a 19-year-old female patient. Her medical history and concomitant medications was not reported. She was vaccinated with FLUVIRIN (batch number: 1204101, Expiry date: 31 May 2013) and MENVEO (batch number: A10053) intramuscularly on 20 Aug 2012. On the same day, the patient's blood pressure decreased and she had vasovagal response. She fainted and subsequently lost balance. She went to emergency room. The outcome of the events was reported as complete recovery as of 20 Aug 2012. Based on the batch review, it was stated that the concerned FLUVIRIN batch number 1204101 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department (reference number: 209553) on 05 Feb 2014: Updated batch report.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Activities of daily living impaired, Asthenia, Back pain, Blood test
Clinical narrative: Case number PHHY2013US03247, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 480659) website on 04 Apr 2013, with a follow up received from the QA department (reference number: 222940) on 05 Feb 2014: This report refers to a 73-year-old female patient. She was healthy and neither took any prescriptions nor had any medical problems before. Concomitant medications included MIRALAX and VIACTIV calcium (over the counter drugs). She was vaccinated with FLUVIRIN (batch number: 1206901) intramuscularly on 05 Dec 2012 (pm). On 09 Dec 2012, she felt sick with pain across lower back and abdomen, fever (103 degrees), chills, shivering, and then felt hot and perspiring and weak. She could not use her muscles normally, was unable to get out of bed most of time and could not answer her phone which was with her in the bed. Sometimes she used to get up after much effort but stumbled while walking. Once when she was alone, she was unable to walk back to bed and while trying she got in to a painful position and finally, she went on her knees and after much effort, she stumbled to bed. She never had these problems before. She had to change her clothes frequently as it was wet with sweat. On 12 Dec 2012, she was taken to emergency where she underwent nose swab tests for flu, blood work and urine specimen test. Test for flu and urine analysis were negative. She was diagnosed with viral infection. The physician advised her to drink lots of liquids, to eat and to drink chicken soup as a need to get the fever down. She was too sick to tell the physician what was happening to her. The physician gave her a steroid shot in one buttocks and an antibiotic shot in the other buttocks. The steroid injection helped her walking, and she could get out of bed that night after the injection. The illness lasted approximately a week until 17 Dec 2012. On 17 Dec 2012, she got out of the house and drove even though she had to gain more strength after that, but she felt that she was recovering. She never had symptoms like this and never took flu vaccine before this. She was thinking not to take the vaccine again in future. The outcome of the events was reported as recovered as of unspecified date. The seriousness and causality of the events were not reported. Based on the batch review, it was concluded that the concerned FLUVIRIN batch number 1206901 was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department (reference number: 222940) on 05 Feb 2014: Updated batch report.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling hot, Gait disturbance, Hyperhidrosis, Influenza virus test negative
Clinical narrative: Case number PHHY2013US03247, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 480659) website on 04 Apr 2013, with a follow up received from the QA department (reference number: 222940) on 05 Feb 2014: This report refers to a 73-year-old female patient. She was healthy and neither took any prescriptions nor had any medical problems before. Concomitant medications included MIRALAX and VIACTIV calcium (over the counter drugs). She was vaccinated with FLUVIRIN (batch number: 1206901) intramuscularly on 05 Dec 2012 (pm). On 09 Dec 2012, she felt sick with pain across lower back and abdomen, fever (103 degrees), chills, shivering, and then felt hot and perspiring and weak. She could not use her muscles normally, was unable to get out of bed most of time and could not answer her phone which was with her in the bed. Sometimes she used to get up after much effort but stumbled while walking. Once when she was alone, she was unable to walk back to bed and while trying she got in to a painful position and finally, she went on her knees and after much effort, she stumbled to bed. She never had these problems before. She had to change her clothes frequently as it was wet with sweat. On 12 Dec 2012, she was taken to emergency where she underwent nose swab tests for flu, blood work and urine specimen test. Test for flu and urine analysis were negative. She was diagnosed with viral infection. The physician advised her to drink lots of liquids, to eat and to drink chicken soup as a need to get the fever down. She was too sick to tell the physician what was happening to her. The physician gave her a steroid shot in one buttocks and an antibiotic shot in the other buttocks. The steroid injection helped her walking, and she could get out of bed that night after the injection. The illness lasted approximately a week until 17 Dec 2012. On 17 Dec 2012, she got out of the house and drove even though she had to gain more strength after that, but she felt that she was recovering. She never had symptoms like this and never took flu vaccine before this. She was thinking not to take the vaccine again in future. The outcome of the events was reported as recovered as of unspecified date. The seriousness and causality of the events were not reported. Based on the batch review, it was concluded that the concerned FLUVIRIN batch number 1206901 was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department (reference number: 222940) on 05 Feb 2014: Updated batch report.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Mobility decreased, Muscle disorder, Pain, Pyrexia
Clinical narrative: Case number PHHY2013US03247, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 480659) website on 04 Apr 2013, with a follow up received from the QA department (reference number: 222940) on 05 Feb 2014: This report refers to a 73-year-old female patient. She was healthy and neither took any prescriptions nor had any medical problems before. Concomitant medications included MIRALAX and VIACTIV calcium (over the counter drugs). She was vaccinated with FLUVIRIN (batch number: 1206901) intramuscularly on 05 Dec 2012 (pm). On 09 Dec 2012, she felt sick with pain across lower back and abdomen, fever (103 degrees), chills, shivering, and then felt hot and perspiring and weak. She could not use her muscles normally, was unable to get out of bed most of time and could not answer her phone which was with her in the bed. Sometimes she used to get up after much effort but stumbled while walking. Once when she was alone, she was unable to walk back to bed and while trying she got in to a painful position and finally, she went on her knees and after much effort, she stumbled to bed. She never had these problems before. She had to change her clothes frequently as it was wet with sweat. On 12 Dec 2012, she was taken to emergency where she underwent nose swab tests for flu, blood work and urine specimen test. Test for flu and urine analysis were negative. She was diagnosed with viral infection. The physician advised her to drink lots of liquids, to eat and to drink chicken soup as a need to get the fever down. She was too sick to tell the physician what was happening to her. The physician gave her a steroid shot in one buttocks and an antibiotic shot in the other buttocks. The steroid injection helped her walking, and she could get out of bed that night after the injection. The illness lasted approximately a week until 17 Dec 2012. On 17 Dec 2012, she got out of the house and drove even though she had to gain more strength after that, but she felt that she was recovering. She never had symptoms like this and never took flu vaccine before this. She was thinking not to take the vaccine again in future. The outcome of the events was reported as recovered as of unspecified date. The seriousness and causality of the events were not reported. Based on the batch review, it was concluded that the concerned FLUVIRIN batch number 1206901 was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department (reference number: 222940) on 05 Feb 2014: Updated batch report.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Urine analysis normal, Viral infection
Clinical narrative: Case number PHHY2013US03247, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 480659) website on 04 Apr 2013, with a follow up received from the QA department (reference number: 222940) on 05 Feb 2014: This report refers to a 73-year-old female patient. She was healthy and neither took any prescriptions nor had any medical problems before. Concomitant medications included MIRALAX and VIACTIV calcium (over the counter drugs). She was vaccinated with FLUVIRIN (batch number: 1206901) intramuscularly on 05 Dec 2012 (pm). On 09 Dec 2012, she felt sick with pain across lower back and abdomen, fever (103 degrees), chills, shivering, and then felt hot and perspiring and weak. She could not use her muscles normally, was unable to get out of bed most of time and could not answer her phone which was with her in the bed. Sometimes she used to get up after much effort but stumbled while walking. Once when she was alone, she was unable to walk back to bed and while trying she got in to a painful position and finally, she went on her knees and after much effort, she stumbled to bed. She never had these problems before. She had to change her clothes frequently as it was wet with sweat. On 12 Dec 2012, she was taken to emergency where she underwent nose swab tests for flu, blood work and urine specimen test. Test for flu and urine analysis were negative. She was diagnosed with viral infection. The physician advised her to drink lots of liquids, to eat and to drink chicken soup as a need to get the fever down. She was too sick to tell the physician what was happening to her. The physician gave her a steroid shot in one buttocks and an antibiotic shot in the other buttocks. The steroid injection helped her walking, and she could get out of bed that night after the injection. The illness lasted approximately a week until 17 Dec 2012. On 17 Dec 2012, she got out of the house and drove even though she had to gain more strength after that, but she felt that she was recovering. She never had symptoms like this and never took flu vaccine before this. She was thinking not to take the vaccine again in future. The outcome of the events was reported as recovered as of unspecified date. The seriousness and causality of the events were not reported. Based on the batch review, it was concluded that the concerned FLUVIRIN batch number 1206901 was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department (reference number: 222940) on 05 Feb 2014: Updated batch report.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Presyncope
Clinical narrative: Case number PHHY2013US032534, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 482907) web site on 04 Apr 2013, with the follow-up received from Quality Assurance Department (reference number: 221926) on 05 Feb 2014. This report refers to 41-year-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 1206901) intramuscularly into left arm on 29 Jan 2013. On the same day, the patient developed vasovagal response. The emergency team responded. The patient retained the consciousness. Outcome of the events was recovered. Seriousness and causality of the event was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1206901) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 221926) on 05 Feb 2014: Updated batch review report.
Age: 25.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Brain oedema, Confusional state, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Case number PHHY2013US140344 is an initial spontaneous report from a Vaccine Adverse Event Reporting System (reference number: 506484) received on 03 Dec 2013 and a follow-up information was received from Quality Assurance Department (reference number: 269586) on 11 Dec 2013 and another follow up was received from QA department on 04 Feb 2014. This report refers to a 25-year-old male patient. His concurrent condition included penicillin allergy. Concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1307601, expiry date: 31 Mar 2014) intramuscularly on right arm on 05 Sep 2013. On the same day, he was also vaccinated with PNEUMOVAX (other manufacturer, batch number: 1947AA) intramuscularly in the left arm. On 06 Sep 2013, he developed redness and swelling at injection site followed by increased pain and confusion. He reported to emergency room and was told that he had edema of the brain. He was given ibuprofen and the swelling came down, everything was normal after 2 days. Final outcome of the events was reported as recovered. Seriousness and causality of the events was not reported. Based on the batch review performed, it was concluded that FLUAD (batch number: 1307601) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 269586) on 11 Dec 2013: Updated QA reference number only. Follow up received from Quality Assurance Department on 04 Feb 2014: Updated Batch review report.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Pain, Urticaria
Clinical narrative: Case number PHHY2014US000934 is an initial report received from vaccine adverse event reporting system (VAERS reference number: 508073) on 06 Jan 2014, with the follow-up received from Quality Assurance Department (reference number: 273742) on 05 Feb 2014. This report refers to a 73 year old female patient. She was vaccinated with FLUVIRIN (batch number: 1308501) and PNEUMOVAX (batch number: H018944) intramuscularly to her left arm on 04 Oct 2013. On the same day, she developed cellulitis on left arm. Patient started getting really sore and developed a large welt (as big as man's hand). Patient went to urgent care and was told to watch. The welt decreased in size and patient informed that it was getting better. Final outcome of the event was reported complete recovery. Seriousness and causality were not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1308501) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Non-significant follow up received from the QA department (reference number: 273742) on 10 Jan 2014: Updated QA reference number. Follow-up received from Quality Assurance Department (reference number: 273742) on 05 Feb 2014: Updated batch review report.
Age: 11.0
Sex: M
Vaccine: FLUN4, HEPA, HPV4, MNQ, TDAP
Symptoms: Erythema, Hypersensitivity, Pain in extremity, Skin infection, Swelling
Clinical narrative: Case number PHHY2014US000732, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 508913) website on 06 Jan 2014, with the follow-up received from Quality Assurance Department (reference number: 273553) on 05 Feb 2014: This report refers to 11-year-old male patient. His medical history included autism. His concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M13011 and expiry date: Sep 2014) and BOOSTRIX (other manufacturer, batch number: 4ZB4N) both intramuscularly in the left arm and HAVRIX (other manufacturer, batch number: 9735D) and GARDASIL (other manufacturer, batch number: J008423) both intramuscularly in the right arm and FLUMIST QUADRIVALENT (other manufacturer, batch number: BH2124) via intranasal route on 07 Oct 2013. On 08 Oct 2013, he developed a raised red lump on the left arm with pain. It was reported that the lump was initially the size of a coin. The patient also had swelling. Redness began to spread. On 09 Oct 2013, he was prescribed KEFLEX for suspected skin infection. On 10 Oct 2013, he visited the emergency room and was prescribed prednisone for allergic reaction as redness was still spreading. It was reported the by 14 Oct 2013, swelling and redness improved and on an unspecified date the events were recovered. The seriousness and causality was not reported. Based on the investigation performed, QA department concluded that the MENVEO vaccine (batch number: M13011) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 273553) on 05 Feb 2014: Updated batch review report.
Age: 11.0
Sex: M
Vaccine: FLUN4, HEPA, HPV4, MNQ, TDAP
Symptoms: Upper extremity mass
Clinical narrative: Case number PHHY2014US000732, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 508913) website on 06 Jan 2014, with the follow-up received from Quality Assurance Department (reference number: 273553) on 05 Feb 2014: This report refers to 11-year-old male patient. His medical history included autism. His concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M13011 and expiry date: Sep 2014) and BOOSTRIX (other manufacturer, batch number: 4ZB4N) both intramuscularly in the left arm and HAVRIX (other manufacturer, batch number: 9735D) and GARDASIL (other manufacturer, batch number: J008423) both intramuscularly in the right arm and FLUMIST QUADRIVALENT (other manufacturer, batch number: BH2124) via intranasal route on 07 Oct 2013. On 08 Oct 2013, he developed a raised red lump on the left arm with pain. It was reported that the lump was initially the size of a coin. The patient also had swelling. Redness began to spread. On 09 Oct 2013, he was prescribed KEFLEX for suspected skin infection. On 10 Oct 2013, he visited the emergency room and was prescribed prednisone for allergic reaction as redness was still spreading. It was reported the by 14 Oct 2013, swelling and redness improved and on an unspecified date the events were recovered. The seriousness and causality was not reported. Based on the investigation performed, QA department concluded that the MENVEO vaccine (batch number: M13011) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 273553) on 05 Feb 2014: Updated batch review report.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Pruritus, Urticaria
Clinical narrative: Case number PHHY2014US000856, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 509003) website on 06 Jan 2014 with a follow up report received from the quality assurance department (QA reference number: 273852) on 04 Feb 2014. This report refers to 24 year old female patient. Her medical history included asthma. Her concomitant medication included Albuterol inhaler. She was vaccinated with FLUVIRIN (batch number: 1309501, expiry date: 30 Apr 2014) in the left arm on 22 Oct 2013 at 14:35 PM. On the same day, she visited the emergency room with chest tightness, urticaria and itching. She was prescribed epinephrine and 0.3 ml subcutaneously in the left arm at 16:36. The event outcome was condition unchanged as of 22 Oct 2013. The seriousness and causality was not reported. Based on the review performed, it was concluded that this batch (1309501) was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up was received from the quality assurance department (QA reference number: 273852) on 04 Feb 2014: The expiry date and the batch review report were updated.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Apnoea, Pulse absent, Syncope
Clinical narrative: Case number PHHY2014US000969, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number:  509141) website on 06 Jan 2014 and a follow up received from Quality Assurance Department (QA, reference number: 275272) on 27 Jan 2014. This report refers to 18-year-old female patient. Her medical history included asthma. Her concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A13017, Exp date: Sep 2014) intramuscularly in the left arm on 17 Oct 2013. Five minutes after vaccination, she experienced syncope with brief absence of respirations and pulse. She visited the emergency room. It was reported that she recovered during observation. The seriousness and causality were not reported. Based on the investigation performed, the QA department stated that, the MENVEO (batch number: A13017) 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 (QA, reference number: 275272) on 27 Jan 2014: Updated batch review report.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Papule
Clinical narrative: Case number PHHY2014US001265 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 509674) website on 06 Jan 2014, with a follow up received from the Quality Assurance department (QA ref: 274889) on 30 Jan 2014. This report refers to a 16-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO, (batch number: M12130, Expiry date: Aug 2014) intramuscularly in the right arm, VARIVAX (other manufacturer, batch number: J003219) subcutaneously in the right arm, GARDASIL (other manufacturer, batch number: H021608) intramuscularly in the left arm and ADACEL (other manufacturer, batch number: U4567AA) intramuscularly in the left arm on 24 Aug 2013. On 31 Aug 2013, his mother stated several pin sized to quart size non inflamed, no colored papules appeared on bilateral inner thighs and bilateral forearms. No treatment needed and events lasted for 2 days. She denied any other problems. The outcome of the events was reported as completely recovery. The seriousness and causality of the events were not reported. Based on the batch review, it was stated that the concerned MENVEO batch number M12130 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow up information received from quality assurance department on 15 Jan 2014: Updated QA reference number (reference number: 274889). Follow up received from the QA department on 30 Jan 2014: Updated batch report.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Heart rate increased, Skin warm, Throat tightness
Clinical narrative: Case number PHHY2014US000951 is an initial spontaneous report received from the vaccine adverse event reporting system (reference number: 510409) on 06 Jan 2014 and a follow up information was received from Quality Assurance Department (QA reference number: 273842) on 05 Feb 2014. This report refers to a 30 year old female patient. Her preexisting condition included hypertension and allergy to sulfonamide. She was vaccinated with FLUVIRIN (batch number: 1308901, expiry date: 30 Apr 2014) intramuscularly into right arm on 01 Oct 2013. On the same day, she thought her throat was feeling a little tight. On the same day at 11:05 hours her blood pressure was 140/104 with a pulse rate of 112/minute. She was given BENADRYL at a dose of 25 mg and oxygen mask (at 11:08 hour) at a flow rate of 8 liter/minute. At 11:14 hour, her blood pressure was 145/90 and pulse rate measured 100/minute. She was given intramuscular epinephrine at a dose of 0.3 ml but her blood pressure became 182/90 with a pulse rate of 100/minute. She was given the treatment with intravenous normal saline at a dose of 1000 ml by paramedics and was taken to medical center for further medical support. She did not loss her consciousness. Throughout the time her skin was warm to touch but her skin color remained pink with no pallor or diaphoresis. She stated that her condition did not exacerbate at the hospital. On 02 Oct 2013 on the same afternoon, she was released from emergency room after 4 hours of treatment. She was prescribed with prednisone and EPIPEN. On 02 Oct 2013, she returned to her work. On 07 Oct 2013, she returned to medical center for checkup. The outcome of the event was reported as complete recovery. The causality and seriousness of the events were not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1308901) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 273842) on 10 Jan 2014: Updated QA reference number. Follow-up received from Quality Assurance Department (reference number: 273842) on 05 Feb 2014: Updated batch review report.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eye discharge, Eye swelling, Eyelid oedema, Hypersomnia
Clinical narrative: Case number PHHY2014US001012 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 510701) website on 06 Jan 2014, with the follow-up received from Quality Assurance Department (reference number: 273107) on 07 Feb 2014: This report refers to a 62-year-old female patient. Current condition included mild allergies and rhinitis. Her concomitant medication included ADVIL. Her vaccination history included 16 annual flu shots. On 19 Oct 2013, she was vaccinated with FLUVIRIN (batch number: 13415P, Expiry date: 31 Mar 2014). It was reported that since shot, she had respiratory symptoms and aches. On 23 Oct 2013, she began to vomit. Her eyes started to swell and were completely swollen shut, oozing out liquid. Her nose also had swollen three times of its size and she could not breathe. She experienced facial and eye swelling for the first time after receiving flu shot. She also slept until 25 Oct 2013. Following the events she was taken by ambulance to the Emergency Room (ER). She was administered saline intravenously and was treated with prednisone and BENADRYL. The final outcome was reported as completely recovered as of 01 Nov 2013. The events were assessed as life threatening. The causality was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 13415P) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 273107) on 07 Feb 2014: Updated batch review report.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal oedema, Pain, Respiratory disorder, Swelling face, Vomiting
Clinical narrative: Case number PHHY2014US001012 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 510701) website on 06 Jan 2014, with the follow-up received from Quality Assurance Department (reference number: 273107) on 07 Feb 2014: This report refers to a 62-year-old female patient. Current condition included mild allergies and rhinitis. Her concomitant medication included ADVIL. Her vaccination history included 16 annual flu shots. On 19 Oct 2013, she was vaccinated with FLUVIRIN (batch number: 13415P, Expiry date: 31 Mar 2014). It was reported that since shot, she had respiratory symptoms and aches. On 23 Oct 2013, she began to vomit. Her eyes started to swell and were completely swollen shut, oozing out liquid. Her nose also had swollen three times of its size and she could not breathe. She experienced facial and eye swelling for the first time after receiving flu shot. She also slept until 25 Oct 2013. Following the events she was taken by ambulance to the Emergency Room (ER). She was administered saline intravenously and was treated with prednisone and BENADRYL. The final outcome was reported as completely recovered as of 01 Nov 2013. The events were assessed as life threatening. The causality was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 13415P) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 273107) on 07 Feb 2014: Updated batch review report.