chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Case number PHHY2012US010620 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 445054) on 07 Feb 2012 with a follow up received from the quality assurance department (reference number: 146779) on 20 Feb 2012 and a follow up report received on 26 Mar 2012. This case refers to a 70-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1101701) intramuscularly into her right arm on 18 Oct 2011. On the same day she was also vaccinated with pneumococcal polysaccharide vaccine (other manufacturer, batch number: 0895AA) intramuscularly also into her right arm. On the same day she developed 5-6 inches redness below the right deltoid area (right upper arm to inner arm), which was swollen and hot to touch. She also had fever. She had an emergency doctor visit due to these events. She was diagnosed with cellulitis. She received therapy with ibuprofen, TYLENOL and BENADRYL. She had recovered completely on an unspecified date. The quality assurance department opened a complaint for this case with reference number 146779. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 1101701 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from the quality assurance department (reference number: 146779) on 20 Feb 2012: Updated reference number. Follow up received from the quality assurance department (reference number: 146779) on 26 Mar 2012. Batch review report updated.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Infection, Pain, Swelling
Clinical narrative: Case number PHHY2012US010709 is an initial spontaneous report received via a health care professional from the Vaccine Adverse Event Reporting System (VAERS reference number: 445438) website on 07 Feb 2012 with a follow up received from the quality assurance department (reference number: 146626) on 20 Feb 2012, with a follow up batch review report received from quality assurance department on 26 Mar 2012. This report refers to a 63-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1101701) intramuscularly into the right arm along with PPV vaccine (other manufacturer, batch number: 0895AA) intramuscularly into the left arm on 01 Sep 2011. On 10 Nov 2011 he developed an infection with redness, swelling and soreness. He was taken to the emergency room (ER) following these events. He was prescribed unspecified antibiotics for the reaction. The final outcome was reported as complete recovery of the patient on an undetermined date. No further information was provided. The quality assurance department opened a complaint for this case with reference number 146626. The quality assurance department reported that based on the document review, it was stated that the FLUVIRIN (batch number: 1101701) 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 the quality assurance department (reference number: 146626) on 20 Feb 2012: Updated reference number. Follow up report received from quality assurance department on 26 Mar 2012: Updated batch review report analysis.
Age: 24.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Erythema multiforme, Fatigue, Headache, Rash, Vomiting
Clinical narrative: This case was received on 29 March 2012 via a third party query tool search on VAERS database, under reference number 447173. A 24-year-old female patient received the following vaccinations on 17 December 2011: ACAM2000 (SP Biologics Co. lot number VV0400A) and BIOTHRAX (Emergent, lot number FAV304). On 26 December 2011, the patient experienced a rash on arms and feet, headaches, vomiting, fatigue and erythema multiforme. No laboratory data was taken. Current illnesses and history were reported as none. Other medications and prior vaccinations were not reported. The patient's outcome was unknown. Documents held by sender: None.
Age: 63.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Urticaria
Clinical narrative: 3/13/2012: Patient presented to clinic. States she received dtap & pneumococcal 3/12/12 approx 1530. At 2230 broke out in generalized hives. Patient has strong hx of urticaria. Sees allergist for this. Took BENADRYL & hives went away. Needed lab work but lab would not do until cleared by provider. Uncertain if immunizations reaction. Same pt has history of urticaria.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Deafness unilateral, Tinnitus
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning a female patient with a negative titer, who on unknown date was vaccinated with the first dose of VARIVAX (Merck) (lot#, dose and route not reported). It was reported that one week later following vaccination, the patient experienced deafness in her left ear and tinnitus in the right ear. The patient was not recovered from the events at the time of reporting. The patient sought unspecified attention (unknown location). Upon internal review, deafness was determined to be an other important medical event. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Cervix disorder, Colposcopy abnormal, Dysplasia, Laboratory test abnormal, Loop electrosurgical excision procedure
Clinical narrative: Information has been received from a physician concerning a currently 23 year old female patient who at another doctor's office was vaccinated with the entire regimen of GARDASIL, intramuscularly, 0.5 ml all three doses (lot numbers not provided). There was no concomitant medication. On 30-JAN-2012, the patient after having a pap smear, it was found to have atypia cells. On 23-FEB-2012, the patient had a colposcopy done and it revealed moderate dysplasia. The results also came back positive for P16. The patient sought medical attention. Treatment for the adverse event included a "leep" performed on 13-MAR-2012 (results pending). The patient was working with their health care provider to address the situation. At the time of the report, the patient had not recovered (ongoing). Follow-up information has been received from a physician who reported that the female medical assistant patient with no pre-existing allergies, birth defects or medical conditions and no illness at the time of vaccination and unknown events following prior vaccination on 10-JUL-2007 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot # 0323D not valid lot # for GARDASIL), IM, at unknown time. On 12-SEP-2007 was vaccinated with a second 0.5ml dose of GARDASIL (Lot # 658222/0927U), IM, in the right deltoid at unknown time and on 18-JAN-2008, was vaccinated with a third 0.5ml dose of GARDASIL (Lot# 1268U, not valid lot # for GARDASIL), IM, Right deltoid, at unknown time. The physician stated that the patient received the series of GARDSAIL and the patient was not sexually active at that time. She has since been diagnosed with Human papilloma virus (HPV) and labs showed high grade of dysplasia. A cervical smear, surgical pathology of colposcopies and LEEP procedure were performed not results provided. At the time of reporting, the patient's outcome was unknown. The events Moderate dysplasia (High grade dysplasia), Positive for P16 and Human papilloma virus (HPV) were considered to be an important medical events by the physician. (according to the reporter the events required medical/surgical intervention to prevent one of the outcomes listed). Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Pathology test, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a currently 23 year old female patient who at another doctor's office was vaccinated with the entire regimen of GARDASIL, intramuscularly, 0.5 ml all three doses (lot numbers not provided). There was no concomitant medication. On 30-JAN-2012, the patient after having a pap smear, it was found to have atypia cells. On 23-FEB-2012, the patient had a colposcopy done and it revealed moderate dysplasia. The results also came back positive for P16. The patient sought medical attention. Treatment for the adverse event included a "leep" performed on 13-MAR-2012 (results pending). The patient was working with their health care provider to address the situation. At the time of the report, the patient had not recovered (ongoing). Follow-up information has been received from a physician who reported that the female medical assistant patient with no pre-existing allergies, birth defects or medical conditions and no illness at the time of vaccination and unknown events following prior vaccination on 10-JUL-2007 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot # 0323D not valid lot # for GARDASIL), IM, at unknown time. On 12-SEP-2007 was vaccinated with a second 0.5ml dose of GARDASIL (Lot # 658222/0927U), IM, in the right deltoid at unknown time and on 18-JAN-2008, was vaccinated with a third 0.5ml dose of GARDASIL (Lot# 1268U, not valid lot # for GARDASIL), IM, Right deltoid, at unknown time. The physician stated that the patient received the series of GARDSAIL and the patient was not sexually active at that time. She has since been diagnosed with Human papilloma virus (HPV) and labs showed high grade of dysplasia. A cervical smear, surgical pathology of colposcopies and LEEP procedure were performed not results provided. At the time of reporting, the patient's outcome was unknown. The events Moderate dysplasia (High grade dysplasia), Positive for P16 and Human papilloma virus (HPV) were considered to be an important medical events by the physician. (according to the reporter the events required medical/surgical intervention to prevent one of the outcomes listed). Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Malaise, Rash, Rash erythematous, Rash pustular, Scab
Clinical narrative: 4/2/12 - c/o not feeling well. Afebrile. Had approximate 25-35 red, raised pustules on abd, back, chest & legs. 4/4/12 lesion scabbing. Remain afebrile.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mom reported by phone that child had swelling & redness at injection site on right arm on the back of arm 1st noticed the next morning on 3/7/12.
Age: 2.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Apathy, Cough, Decreased appetite, Gastrointestinal disorder, Mental disorder
Clinical narrative: 2 cycles of illness. Day 1 and 4: fever, loss of appetite, sinus/cough. Day 2 and 5: same & apathy, unresponsive mental state & intestinal rumbling. Day 3 and 6: improved state: sinus/cough & light appetite.
Age: 2.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Pyrexia, Sinus disorder, Unresponsive to stimuli
Clinical narrative: 2 cycles of illness. Day 1 and 4: fever, loss of appetite, sinus/cough. Day 2 and 5: same & apathy, unresponsive mental state & intestinal rumbling. Day 3 and 6: improved state: sinus/cough & light appetite.
Age: 40.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Anxiety, Confusional state, Dizziness, Emotional disorder, Erythema
Clinical narrative: Dizzy, emotional and not knowing why, confusion, being very uneasy. Pain in (L) arm/erythema.
Age: 40.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pain in extremity
Clinical narrative: Dizzy, emotional and not knowing why, confusion, being very uneasy. Pain in (L) arm/erythema.
Age: 38.0
Sex: M
Vaccine: SMALL
Symptoms: Pruritus, Rash
Clinical narrative: Pt noticed itch and then rash on arm. Pt explains rash spread to chest and abd over the next 24hrs. Rash continued to lower ext.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Abscess limb, Erythema, Skin warm, Wound drainage, Wound secretion
Clinical narrative: Abscess left arm with warm, erythema and drainage, needed wound drainage and packing of wound for more than 1 week.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Wound treatment
Clinical narrative: Abscess left arm with warm, erythema and drainage, needed wound drainage and packing of wound for more than 1 week.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Gait disturbance, Laboratory test, Loss of consciousness, Pallor
Clinical narrative: Patient received 3 vaccines while sitting on the exam table after 5 minutes patient was walked to the lab waiting area to wait the rest of her time there. While walking patient began to wobble and her color became pale. I held the patient and walked her back to the room, Dr. assisted patient then lost consciousness once we reach the room.   No reaction at the injection site but patient did lose consciousness. Vitals taken, Physicians informed. Elevation, ice pack, ammonia cap done, oxygen given,  Ambulance called and patient transported to  Hospital. Patient did not regain consciousness.
Age: 1.62
Sex: M
Vaccine: HEPA, MM, VARCEL
Symptoms: Cellulitis, Varicella
Clinical narrative: CHICKEN POX WITH CELLULITIS ON CHIN.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Convulsion, Hyperhidrosis, Loss of consciousness, Nausea, Pallor
Clinical narrative: Patient became slightly pale and diaphoretic after vaccines were administered. Patient was advised to lay down and wait in the room with his mom for 15 minutes. After approximately 10 minutes, mom requested if they could finish their "wait time" in the waiting room and was advised by the doctor that that would be OK. While in the waiting room the patient got up from chair and advised mom he needed some water then passed out into his moms arms. He had convulsion like movements for a few seconds then was assisted to the floor by staff. The patient laid supine on the floor. Slowly became aware of his surrounding and fully oriented after about 30-60 seconds. After a few minutes, patient was assisted to a chair in the waiting room and complained of nausea. After a few minutes, the patient was wheeled into an exam room where he layed down and drank water and soda for apporx. another 10 minutes. He then sat up for another 5 minutes. Doctor cleared the patient to leave. Patient was escorted to their car by a staff member. No further symptoms were noted. Child stated he "felt fine".
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Guillain-Barre syndrome, Immunoglobulin therapy, Miller Fisher syndrome, Paraesthesia
Clinical narrative: Tingling in hands and feet. Balance and equilibrium were off. Guillain Barre Syndrome.
Age: 37.0
Sex: F
Vaccine: VARCEL, YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Dr from one clinic calls this clinic at 15:45 PM on Friday 16MAR12 re 37 y/o f who presents to the clinic he was calling from with growing area of erythema. pruritus at SC injection site LUE at 48 hours s/p receipt of live virus YF and varicella vaccines, given by her medic around noon on 14MAR12. The patient endorses history of chicken pox (disease) at 13-14 yrs of age, thus (?) need for varicella vaccination. Varicella immunization given on (14MAR12) is not documented in records as yet by medic, but YF vaccine given on same date is documented. The patient says she is sure that she was given both YF and varicella, SC in LUE. Medic reports patient to have 11 x 13 cm area of erythema and swelling on posterior aspect of left arm, extending from pt's left axilla to just above pt's left elbow. Per dr, there are also some small pruritic, fluid-filled vesicles/blisters over the initial area of redness, warmth and itching, which measured 4x6 cms in size yesterday (15MAR12) and is demarcated with a black pen. Today (16MAR12), the erythema, swelling, warmth and pruritus have increased to 11 x 13 cms, extending from pt's left axilla to just above her left elbow. Per dr, pt had a low grade fever and malaise yesterday and has the described blistering around the inject site today, with impressive increase in erythema and swelling. No induration, fluid wave or visible pus. NOTE: At f/u visit to clinic on 21MAR12, pt states that she found her old Yellow Immunization Card which indicated that she also received a dose of varicella in OCT of 2006 before going to work.
Age: 37.0
Sex: F
Vaccine: VARCEL, YF
Symptoms: Malaise, Pyrexia
Clinical narrative: Dr from one clinic calls this clinic at 15:45 PM on Friday 16MAR12 re 37 y/o f who presents to the clinic he was calling from with growing area of erythema. pruritus at SC injection site LUE at 48 hours s/p receipt of live virus YF and varicella vaccines, given by her medic around noon on 14MAR12. The patient endorses history of chicken pox (disease) at 13-14 yrs of age, thus (?) need for varicella vaccination. Varicella immunization given on (14MAR12) is not documented in records as yet by medic, but YF vaccine given on same date is documented. The patient says she is sure that she was given both YF and varicella, SC in LUE. Medic reports patient to have 11 x 13 cm area of erythema and swelling on posterior aspect of left arm, extending from pt's left axilla to just above pt's left elbow. Per dr, there are also some small pruritic, fluid-filled vesicles/blisters over the initial area of redness, warmth and itching, which measured 4x6 cms in size yesterday (15MAR12) and is demarcated with a black pen. Today (16MAR12), the erythema, swelling, warmth and pruritus have increased to 11 x 13 cms, extending from pt's left axilla to just above her left elbow. Per dr, pt had a low grade fever and malaise yesterday and has the described blistering around the inject site today, with impressive increase in erythema and swelling. No induration, fluid wave or visible pus. NOTE: At f/u visit to clinic on 21MAR12, pt states that she found her old Yellow Immunization Card which indicated that she also received a dose of varicella in OCT of 2006 before going to work.
Age: 0.44
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right Vastus Lateralis with redness and mild swelling.  Mother reported to health department morning following vaccinations (4/4/2012). Right Vastus Lateralis with redness approximately 5 cm in length by 2-3 cm width.  Mild swelling and warmth noted.  Instructed mother to follow up with primary physician for assessment.  Mother saw NP and was given Bactroban to apply to site and told to report if sx worsen or persist.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Erythema, Feeling hot, Induration, Myalgia
Clinical narrative: Redness, pain, warmth & swelling (hard to touch) about 2 days later. High fever (not measured about 102 degrees) - (aching muscle/joint ). Took ibuprofen. Local symptoms persisted. System rxn subsided in 72 hr.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Redness, pain, warmth & swelling (hard to touch) about 2 days later. High fever (not measured about 102 degrees) - (aching muscle/joint ). Took ibuprofen. Local symptoms persisted. System rxn subsided in 72 hr.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Undetermined cause death occurred nine days after 2nd injection of Gardasil. 1st dose on 01/31/2012.
Age: 36.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Arthralgia, Intensive care, Myalgia, Polymerase chain reaction, Rash
Clinical narrative: 36 y/o patient, admitted to ICU for skin rash and arthralgia 13 days after SPV. Patient was observed, treated, and discharged after a 2 day stay. Symptoms: Muscle Ache.
Age: 36.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Viral test
Clinical narrative: 36 y/o patient, admitted to ICU for skin rash and arthralgia 13 days after SPV. Patient was observed, treated, and discharged after a 2 day stay. Symptoms: Muscle Ache.
Age: 10.0
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Culture stool, Diarrhoea, Rotavirus infection
Clinical narrative: Diarrhea since 2-16-12 ongoing still. Rotavirus 2-20-12 still with diarrhea.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Hypoaesthesia, Injection site erythema, Injection site swelling, Neck pain
Clinical narrative: 4-3-12 Pink swelling at injection site left upper arm (SC). Painful. 4-4-12 Left side of face, neck, arm & hand tingling & numb.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: 4-3-12 Pink swelling at injection site left upper arm (SC). Painful. 4-4-12 Left side of face, neck, arm & hand tingling & numb.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Convulsion, Fall, Loss of consciousness, Syncope
Clinical narrative: About 3 minutes after vaccination of Tdap, MENACTRA, HPV, respectively, patient fainted. Slumping slowly down from sitting position. Caught her and layed her down on table. Patient with loss of consciousness about 10-15 seconds with brief seizure activity towards last 5 seconds. I put smelling salt under patient's nose and she immediately awoke. Patient was monitored for 15-20 minutes afterward.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, HIBV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 45.0
Sex: M
Vaccine: MMR
Symptoms: Back pain, Chest pain, Pain in extremity
Clinical narrative: Patient reports arm, chest and upper back pain in right side due to vaccine administration.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Seizure experienced on same day as immunization. Note - patient taking TRILEPTAL 600 mg BID for seizure control.
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Blood HIV RNA below assay limit, Influenza virus test negative, Muscular weakness, Pain, Pyrexia
Clinical narrative: Note from provider: woke up 3/28 with fevers and body aches, temp 3/28 102 degrees F, 3/29 103 degrees F in office, legs felt weak, no neuro changes, no pain at injection site, labs drawn were negative. Patient called back 3/31 and stated symptoms were worse and going to ER.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Left arm became red, swollen, and hard around injection area. Each day the swelling and redness would grow until it encompassed my entire upper left arm. The arm had a temperature of approx 100 degrees and was still and swollen. It was very uncomfortable to move that arm.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Body temperature increased, Injection site erythema, Vaccination site swelling
Clinical narrative: Mother of child states that she noticed swelling and redness at vaccine sites accompanied with a temp of 102.2 the following day after he received vacines. Mother of child states she gave child Tylenol for symptoms.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Fall, Loss of consciousness, Muscle rigidity, Nausea, Pallor
Clinical narrative: PATIENT'S COLORING TURNED PALE; PATIENT FAINTED; PATIENT BECAME RIGID AND POSTURED THEN BEGAN TO SLIDE DOWN SEAT. SECURED PATIENT FROM SLIDING TO GROUND. APPLIED COLD COMPRESS TO FOREHEAD & NECK AREA. FANNED. PATIENT RETURNED TO CONSCIOUSNESS AND STATED "I FEEL NAUSEOUS". PATIENT MOTHER STATED "I PASS OUT FREQUENTLY WHEN I EXPERIENCE PAIN. DR. TOLD ME I HAVE VASOVAGAL RESPONSE. GUESS SHE INHERITED IT FROM ME." PATIENT RESPONSIVE AND COLORING RETURNED TO CHEEKS. STATED "NOT NAUSEOUS ANY MORE. HYDRATED PATIENT WITH FRUIT JUICE. PATIENT STEADY UPON RISING AND AMBULATING. LEFT WITH MOTHER.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: PATIENT'S COLORING TURNED PALE; PATIENT FAINTED; PATIENT BECAME RIGID AND POSTURED THEN BEGAN TO SLIDE DOWN SEAT. SECURED PATIENT FROM SLIDING TO GROUND. APPLIED COLD COMPRESS TO FOREHEAD & NECK AREA. FANNED. PATIENT RETURNED TO CONSCIOUSNESS AND STATED "I FEEL NAUSEOUS". PATIENT MOTHER STATED "I PASS OUT FREQUENTLY WHEN I EXPERIENCE PAIN. DR. TOLD ME I HAVE VASOVAGAL RESPONSE. GUESS SHE INHERITED IT FROM ME." PATIENT RESPONSIVE AND COLORING RETURNED TO CHEEKS. STATED "NOT NAUSEOUS ANY MORE. HYDRATED PATIENT WITH FRUIT JUICE. PATIENT STEADY UPON RISING AND AMBULATING. LEFT WITH MOTHER.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Fall, Muscle rigidity, Nausea, Pallor, Posture abnormal
Clinical narrative: PATIENT'S COLORING TURNED PALE; PATIENT FAINTED; PATIENT BECAME RIGID AND POSTURED THEN BEGAN TO SLIDE DOWN SEAT. SECURED PATIENT FROM SLIDING TO GROUND. APPLIED COLD COMPRESS TO FOREHEAD & NECK AREA. FANNED. PATIENT RETURNED TO CONSCIOUSNESS AND STATED "I FEEL NAUSEOUS". PATIENT MOTHER STATED "I PASS OUT FREQUENTLY WHEN I EXPERIENCE PAIN. DR. TOLD ME I HAVE VASOVAGAL RESPONSE. GUESS SHE INHERITED IT FROM ME." PATIENT RESPONSIVE AND COLORING RETURNED TO CHEEKS. STATED "NOT NAUSEOUS ANY MORE. HYDRATED PATIENT WITH FRUIT JUICE. PATIENT STEADY UPON RISING AND AMBULATING. LEFT WITH MOTHER.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Patient was discharged from hospital on Friday and received a Pneumovax injection prior to discharge.  Patient states about 16 hours later developed pain, redness, and swelling at the site of the injection which extended into the entire arm and down through the elbow.  Patient was seen in ED, placed on antibiotics and told to follow up with primary care provider on Monday.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Patient was discharged from hospital on Friday and received a Pneumovax injection prior to discharge.  Patient states about 16 hours later developed pain, redness, and swelling at the site of the injection which extended into the entire arm and down through the elbow.  Patient was seen in ED, placed on antibiotics and told to follow up with primary care provider on Monday.
Age: 69.0
Sex: M
Vaccine: PER, TD
Symptoms: Back pain, Fatigue, Headache, Insomnia
Clinical narrative: Headache, lower back pain, fatigue, sleeplessness.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Agitation, Hypotonia, Injection site mass, Injection site swelling, Nightmare
Clinical narrative: Child agitated after vaccination & had nightmares.  By next day developed significant "lump and swelling" and inflammation in vaccinated arm.  Child had to wear too-large t-shirts because of extent of swelling.  Decreased mobility for several days. Was taken to see primary care physician, and remains under care 4 weeks later. Symptoms gradually decreasing, but nightmares continue.  Father has also experienced Arthus-type reaction after vaccinations.
Age: 53.0
Sex: M
Vaccine: DTAP
Symptoms: Back pain, Chills, Feeling abnormal, Malaise, Nausea
Clinical narrative: Started feeling bad like nausea, I was hungry and ate a hamburger 12:15 PM the immediately got worse started vomiting, vomiting from about 12:30 PM , still vomiting at 4:00 pm.  Back body aches, chills, Still feel the very sick and vomiting at this time.
Age: 53.0
Sex: M
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: Started feeling bad like nausea, I was hungry and ate a hamburger 12:15 PM the immediately got worse started vomiting, vomiting from about 12:30 PM , still vomiting at 4:00 pm.  Back body aches, chills, Still feel the very sick and vomiting at this time.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B antigen, Pruritus
Clinical narrative: On 3/23/12 visit pat. reports itching on his back and stomach. Lasted 2 weeks.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alopecia, Back pain, Cardiac monitoring abnormal, Cervix carcinoma, Convulsion
Clinical narrative: Heart palpations, headaches, back and neck aches, hair loss, weight loss, fainting, convulsions, severe fatigue, lesions, dizziness, HPV and cervical cancer.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Fatigue, Headache, Lumbar puncture normal, Neck pain
Clinical narrative: Heart palpations, headaches, back and neck aches, hair loss, weight loss, fainting, convulsions, severe fatigue, lesions, dizziness, HPV and cervical cancer.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Palpitations, Papilloma viral infection, Skin lesion, Syncope
Clinical narrative: Heart palpations, headaches, back and neck aches, hair loss, weight loss, fainting, convulsions, severe fatigue, lesions, dizziness, HPV and cervical cancer.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alopecia, Back pain, Cardiac monitoring, Cervix carcinoma, Convulsion
Clinical narrative: Heart palpations, headaches, back and neck aches, hair loss, weight loss, fainting, convulsions, severe fatigue, lesions, dizziness, HPV and cervical cancer.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Weight decreased
Clinical narrative: Heart palpations, headaches, back and neck aches, hair loss, weight loss, fainting, convulsions, severe fatigue, lesions, dizziness, HPV and cervical cancer.
Age: 21.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Abdominal pain, Arthralgia, Decreased appetite, Dysphagia, Fatigue
Clinical narrative: Numbness of all extremities, body wide pain, muscle weakness, Raynaud's phenomenon, paresthesia, fatigue, muscle spasms, muscle fasciculations, body wide pain, dysphagia, photophobia, tinnitus, headaches, nausea, loss of appetite, abdominal pain, muscle and joint pain.
Age: 21.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Headache, Hypoaesthesia, Muscle contractions involuntary, Muscle spasms, Muscular weakness
Clinical narrative: Numbness of all extremities, body wide pain, muscle weakness, Raynaud's phenomenon, paresthesia, fatigue, muscle spasms, muscle fasciculations, body wide pain, dysphagia, photophobia, tinnitus, headaches, nausea, loss of appetite, abdominal pain, muscle and joint pain.
Age: 21.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Myalgia, Nausea, Pain, Paraesthesia, Photophobia
Clinical narrative: Numbness of all extremities, body wide pain, muscle weakness, Raynaud's phenomenon, paresthesia, fatigue, muscle spasms, muscle fasciculations, body wide pain, dysphagia, photophobia, tinnitus, headaches, nausea, loss of appetite, abdominal pain, muscle and joint pain.
Age: 21.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Raynaud's phenomenon, Tinnitus
Clinical narrative: Numbness of all extremities, body wide pain, muscle weakness, Raynaud's phenomenon, paresthesia, fatigue, muscle spasms, muscle fasciculations, body wide pain, dysphagia, photophobia, tinnitus, headaches, nausea, loss of appetite, abdominal pain, muscle and joint pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Daycare called around 3:00PM to let me know that patient was running a low grade fever (100.9) and was complaining that her right leg was hurting.  I picked her up and looked at her leg when we got home and noticed two small red whelps at the site of the injection. I gave her Tylenol for the pain and put an ice pack on it.  The next morning (4/03/2012) I noticed that the area was red and swollen and felt warm to the touch.  I gave her Motrin, put and ice pack on it and took her to school.  The school called in the afternoon because she was still complaining about her leg.  I gave her Tylenol and put an ice pack on it.  Later that evening, I gave her Motrin, gave her a warm bath and afterwards put an ice pack on it.  The next morning (4/4/2012) we called the doctors office to report this.  I missed the call back from the nurse and called her back but have not heard from them yet. The daycare suggested giving her Benadryl for the swelling and Tylenol for the pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Daycare called around 3:00PM to let me know that patient was running a low grade fever (100.9) and was complaining that her right leg was hurting.  I picked her up and looked at her leg when we got home and noticed two small red whelps at the site of the injection. I gave her Tylenol for the pain and put an ice pack on it.  The next morning (4/03/2012) I noticed that the area was red and swollen and felt warm to the touch.  I gave her Motrin, put and ice pack on it and took her to school.  The school called in the afternoon because she was still complaining about her leg.  I gave her Tylenol and put an ice pack on it.  Later that evening, I gave her Motrin, gave her a warm bath and afterwards put an ice pack on it.  The next morning (4/4/2012) we called the doctors office to report this.  I missed the call back from the nurse and called her back but have not heard from them yet. The daycare suggested giving her Benadryl for the swelling and Tylenol for the pain.
Age: 3.0
Sex: F
Vaccine: HEP, PNC13
Symptoms: Adverse drug reaction, Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Left deltoid: Erythema/ T T palp/warmth (oval 8 cm x 10 cm patch). Cellulitis vs Drug rx. No abscess. BENADRYL 1 1/2 tsp PO QID. SEPTRA 2 tsp po BID x 14 day. MOTRIN.
Age: 1.87
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Inflammation, Lymphadenopathy
Clinical narrative: Hyperinflammation of groin and cervical lymph nodes after injection. Swelling chronic > 2 weeks. Enlargement noted from vaccines given in 2011 as well. Nodes < 10mm.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Injection site urticaria, Pain in extremity
Clinical narrative: Redness & soreness on right arm hives around injection site.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: C-reactive protein normal, Erythema, Full blood count normal, Pain, Red blood cell sedimentation rate normal
Clinical narrative: 3/15/12 Pt. received MENACTRA and ADACEL at (R) deltoid. Started to develop pain/redness/swelling 1-2 days after. Seen in ED. Started on oral Clindamycin. Redness/pain continued and spread downward/distally. Clinda was changed to oral BACTRIM and Prednisone was started 1+ week. Redness spread down to wrist. Symptoms started to improve day 13 and completely resolved by day 17. CBC/CRP x 2 normal.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Swelling
Clinical narrative: 3/15/12 Pt. received MENACTRA and ADACEL at (R) deltoid. Started to develop pain/redness/swelling 1-2 days after. Seen in ED. Started on oral Clindamycin. Redness/pain continued and spread downward/distally. Clinda was changed to oral BACTRIM and Prednisone was started 1+ week. Redness spread down to wrist. Symptoms started to improve day 13 and completely resolved by day 17. CBC/CRP x 2 normal.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site induration, Pain
Clinical narrative: (R) arm local erythema 3cm-4cm with induration, body aches, fatigue.
Age: 0.66
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Body temperature increased, Chest X-ray, Full blood count, Pneumonia, Screaming
Clinical narrative: Child spent the day (of vaccination) with dad (10-21-11). Did not appear ill at time of vaccination. Evening: Child was hot, screaming 6 am- Mom took temp 106 degrees. Gave children's TYLENOL and went to ER. Temp there was 105 degrees. Dx Pneumonia. Child had history of high fevers (103 degrees-104 degrees). History of bronchitis/pneumonia 5/2011.
Age: 0.66
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Skin warm, Urine analysis
Clinical narrative: Child spent the day (of vaccination) with dad (10-21-11). Did not appear ill at time of vaccination. Evening: Child was hot, screaming 6 am- Mom took temp 106 degrees. Gave children's TYLENOL and went to ER. Temp there was 105 degrees. Dx Pneumonia. Child had history of high fevers (103 degrees-104 degrees). History of bronchitis/pneumonia 5/2011.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP, VARCEL
Symptoms: Hypoaesthesia, Vision blurred
Clinical narrative: Approx 10 mins after vaccines given pt stated her "feet feel funny" before pt left numbness almost totally resolved. When pt went home f/u call was made pt had a moment with a little blurred vision.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, induration, warmth at site of MCV - 7.75cm x 7cm and TDAP 3cm x 5cm. (Seen on 3/23/12).
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Case number PHHY2011US114933 is an initial spontaneous report derived from vaccine adverse event reporting system website (VAERS reference number: 414508) on 01 Mar 2011 and a follow up received from the quality assurance department on 05 Mar 2012, with a batch review report received from the quality assurance department on 26 Mar 2012. This case refers to a 56-year-old female patient. Her medical history included of lumpectomy on right side. She was vaccinated with FLUVIRIN (batch number: 111797P1) intramuscularly into her left arm on 01 Nov 2010. On 02 Nov 2010, she complained of cellulitis at the site of injection. She had an emergency doctor visit twice and was confirmed with cellulitis of injection site. She was on antibiotics for ten days and got better. She had recovered completely on an unspecified date. A quality assurance investigation had been requested with reference number 148860. The quality assurance department reported that based on the document review, it was stated that the FLUVIRIN (batch number: 111797P1) 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 the quality assurance department on 05 Mar 2012: Updated only the quality reference number. Follow up batch review report received from quality assurance department on 26 Mar 2012. Updated batch review report analysis.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Case number PHHY2011US115063 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 429475) website on 30 Sep 2011, with a follow up report received from quality assurance department on 05 Mar 2012 and a follow up information received on 26 Mar 2012. This report refers to 35 year old female patient. The patient was vaccinated with FLUVIRIN (batch: 1100201) intramuscularly in the left arm and PNEUMOVAX (manufactured by Merck), batch number: 0595AA) intramuscularly in the left arm on 05 Aug 2011. On 06 Aug 2011, she experienced swollen and red painful left arm. She went to ER twice where she was given IV antibiotics (unknown) and she was on a 7 day course of Clindamycin 300 mg QID. She was diagnosed with cellulitis. The outcome of event was reported condition unchanged as of 10 Aug 2011. The quality assurance department opened a complaint for this case with reference number 148861. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 1100201 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow-up received from the quality assurance department (reference number: 148861) on 05 Mar 2012: Updated reference number. Follow up received from the quality assurance department (reference number: 148861) on 26 Mar 2012. Batch review report updated.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Dyspnoea, Injected limb mobility decreased, Injection site erythema, Injection site infection
Clinical narrative: Case number PHHY2011US114321 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 437384) website on 30 Dec 2011 with the follow-up received from Quality assurance department (reference number: 140859) on 10 Jan 2012 and a follow up report received on 26 Mar 2012: This report refers to a 68-year-old female patient. She was vaccinated with FUVIRIN (batch number: 1101701) intramuscularly into the left arm and with PPV (other manufacturer, batch number: 0898AA) intramuscularly into the right arm on 05 Oct 2011. On the same day after vaccination she was unable to move her arm and experienced pain, redness, and rash at the injection site. She vomited, became dizzy, and experienced shortness of breath. She was transported to hospital and diagnosed with an infection at the injection site. She was hospitalized for three days. The final outcome was reported as not yet recovered. A quality investigation had been registered with reference number 140859. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 1101701 was manufactured in accordance with the 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 on 10 Jan 2012: Updated Quality complaint number. Follow up received from the quality assurance department (reference number: 140859) on 26 Mar 2012. Batch review report updated.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site rash, Vomiting
Clinical narrative: Case number PHHY2011US114321 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 437384) website on 30 Dec 2011 with the follow-up received from Quality assurance department (reference number: 140859) on 10 Jan 2012 and a follow up report received on 26 Mar 2012: This report refers to a 68-year-old female patient. She was vaccinated with FUVIRIN (batch number: 1101701) intramuscularly into the left arm and with PPV (other manufacturer, batch number: 0898AA) intramuscularly into the right arm on 05 Oct 2011. On the same day after vaccination she was unable to move her arm and experienced pain, redness, and rash at the injection site. She vomited, became dizzy, and experienced shortness of breath. She was transported to hospital and diagnosed with an infection at the injection site. She was hospitalized for three days. The final outcome was reported as not yet recovered. A quality investigation had been registered with reference number 140859. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 1101701 was manufactured in accordance with the 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 on 10 Jan 2012: Updated Quality complaint number. Follow up received from the quality assurance department (reference number: 140859) on 26 Mar 2012. Batch review report updated.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Cellulitis, Chills, Lymphadenitis, Pain
Clinical narrative: Case number PHHY2011US114043 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 439029) website on 30 Dec 2011 with a follow up received from the quality assurance department on 10 Jan 2012 and a follow up received on 26 Mar 2012. This report refers to 64 year old female patient. The patient's medical history included arthritis, diabetes, hypertension, heart murmur, elevated cholesterol, peripheral neuropathy. The polymedicated patient was vaccinated with FLUVIRIN (batch number: 1100501) intramuscularly in the right arm and PNEUMOVAX (batch number: 12112, manufactured by Merck & C0) intramuscularly in the right arm on 18 Oct 2011. On 18 Oct 2011, the patient experienced cellulitis, fever, chills, body ache, back ache and lymphadenitis. The outcome of events was reported as condition unchanged as of 19 Oct 2011. A quality investigation had been registered with reference number 140738. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 1100501 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow up received from the quality assurance department on 10 Jan 2012: updated only the quality reference number. Follow up received from the quality assurance department (reference number: 140738) on 26 Mar 2012. Batch review report updated.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2011US114043 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS: 439029) website on 30 Dec 2011 with a follow up received from the quality assurance department on 10 Jan 2012 and a follow up received on 26 Mar 2012. This report refers to 64 year old female patient. The patient's medical history included arthritis, diabetes, hypertension, heart murmur, elevated cholesterol, peripheral neuropathy. The polymedicated patient was vaccinated with FLUVIRIN (batch number: 1100501) intramuscularly in the right arm and PNEUMOVAX (batch number: 12112, manufactured by Merck & C0) intramuscularly in the right arm on 18 Oct 2011. On 18 Oct 2011, the patient experienced cellulitis, fever, chills, body ache, back ache and lymphadenitis. The outcome of events was reported as condition unchanged as of 19 Oct 2011. A quality investigation had been registered with reference number 140738. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 1100501 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow up received from the quality assurance department on 10 Jan 2012: updated only the quality reference number. Follow up received from the quality assurance department (reference number: 140738) on 26 Mar 2012. Batch review report updated.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Retching, Vomiting
Clinical narrative: Severe vomiting and dry heaving/wretching.   She couldn't even keep down water or Pedialyte, and the wretching was prolonged (more that just a typical dry heave).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash generalised, Rash papular
Clinical narrative: Erythematous papular rash all over.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Colleague began with soreness at the injection site on 4-3-12 about 5 pm. This morning (4-14-12) at 0300, she had swelling at the site, fatigue, and chills. She took ADVIL at 0330 and 1330 (400 mg each time). Feels back to normal other then swelling.
Age: 0.54
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Chest X-ray, Unevaluable event
Clinical narrative: None stated.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pain, Papule, Pruritus
Clinical narrative: CC: Rash upper chest, started 4/03/12 evening burning, itching, painful. Exam: B/L erythema with small papules C4 dermatome.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: CC: Rash upper chest, started 4/03/12 evening burning, itching, painful. Exam: B/L erythema with small papules C4 dermatome.
Age: 0.28
Sex: F
Vaccine: PNC
Symptoms: Lip disorder, Tic
Clinical narrative: Pt's mother called MD to see pt. She states that within 1st 2 minutes after PREVNAR #1 given she noticed Pt moving head to right side  it seemed as though her lip seemed to drop on right side. Mom stated it seemed to like a tic. I saw infant about 4-5 minutes after vacc given. Pt was breastfeeding comfortably.