chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Blood pressure decreased, Body temperature decreased, Cold sweat, Dizziness, Hyperhidrosis
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 year old male patient with asthma and no allergies or drug reactions who on 27-APR-2011 was intramuscularly vaccinated with a dose of GARDASIL (Lot# 666987/1016Z, expiration: 22-NOV-2012). Concomitant therapy included albuterol. On 27-APR-2011 after 10 minutes of receiving GARDASIL the patient experienced felt lightheaded. The patient's blood pressure fell and the patient began to sweat profusely. The patient's temperature fell and the patient got cold and clammy. Epinephrine was given but the patient continued to not feel well and thus the patient was transferred to the emergency department. No laboratories were performed. On 27-APR-2011 the patient recovered. Upon internal review the events were considered to be other important medical event because the patient was treated with epinephrine. This one of two reports from the same source. Follow up information has been received from a licensed practical nurse concerning a 15 year old male patient on 29-NOV-2011 was vaccinated with the first dose of GARDASIL (Lot# 666598/0786Z, expiration: 18-OCT-2012) and on 27-APR-2011 was intramuscularly vaccinated with the second dose of GARDASIL (Lot# 666987/1016Z, expiration: 22-NOV-2012). It was reported that the patient received the second dose and did not received any concomitant vaccinations at that time. The patient expressed that he was "afraid of needles". About 10 minutes after receiving the GARDASIL the patient began having symptoms (as previously reported). The patient received epinephrine IM. The patient was sent to the emergency room but was not admitted to the hospital. The patient was diagnosed with vasovagal syncope. The patient recovered. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Malaise, Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 year old male patient with asthma and no allergies or drug reactions who on 27-APR-2011 was intramuscularly vaccinated with a dose of GARDASIL (Lot# 666987/1016Z, expiration: 22-NOV-2012). Concomitant therapy included albuterol. On 27-APR-2011 after 10 minutes of receiving GARDASIL the patient experienced felt lightheaded. The patient's blood pressure fell and the patient began to sweat profusely. The patient's temperature fell and the patient got cold and clammy. Epinephrine was given but the patient continued to not feel well and thus the patient was transferred to the emergency department. No laboratories were performed. On 27-APR-2011 the patient recovered. Upon internal review the events were considered to be other important medical event because the patient was treated with epinephrine. This one of two reports from the same source. Follow up information has been received from a licensed practical nurse concerning a 15 year old male patient on 29-NOV-2011 was vaccinated with the first dose of GARDASIL (Lot# 666598/0786Z, expiration: 18-OCT-2012) and on 27-APR-2011 was intramuscularly vaccinated with the second dose of GARDASIL (Lot# 666987/1016Z, expiration: 22-NOV-2012). It was reported that the patient received the second dose and did not received any concomitant vaccinations at that time. The patient expressed that he was "afraid of needles". About 10 minutes after receiving the GARDASIL the patient began having symptoms (as previously reported). The patient received epinephrine IM. The patient was sent to the emergency room but was not admitted to the hospital. The patient was diagnosed with vasovagal syncope. The patient recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Disorientation, Dyskinesia, Loss of consciousness, Pallor, Vision blurred
Clinical narrative: Within less than 1 minute of administering 2nd vaccine which was Gardasil the patient began to lean forward. She was sitting on an exam table. Patient was speaking and continued to lean more forward she would later tell me that her vision was becoming blurred but at that time she did not voice this to the clinic staff. She continued to slump forward then passed out. Nurse was able to hook her arm and guide her to the floor. Her arms /shoulder area began to have jerking movements, then her body/lower extremites jerked. We began to tap her chest to get her to wake up. She woke as quickly as she went down but was disoriented. She became reoriented quickly. We had her stay lying on the floor for awhile then began to bring her to a sitting position which she became pale again but did not pass out. She left the clinic fine. No other injuries. Did not hit head when she pased out. I called the parent 2 weeks later and mother of patient reports she is fine. This was her 2nd dose of Gardasil. 1st dose Gardasil on 20 Sep 2010.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Local reaction
Clinical narrative: Local allergic reaction to vaccine RUE.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Joint range of motion decreased
Clinical narrative: Patient reported following PNEUMOVAX vaccine, she went home & cleaned her house. That evening, she started having chills and she was unable to move left arm. She applied heat and took ASA 2 tabs. Examined 4/29/11 and skin on (L) deltoid without edema, erythema, or warmth, decreased ROM. Instructed use ice and gave TYLENOL with codeine Elixir.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Head injury, Syncope
Clinical narrative: Patient received MENACTRA immunization. He laid on the table for approximately 10 minutes then sat up. Patient and mother were informed to stay 15 minutes. It was unclear how long the child sat on the bed before leaving for check out. During checkout the patient fainted. He bumped his head on the wall. Physicians and nurse were with him immediately. Dr. stayed with him until the child was stable.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Diarrhoea, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Nausea 4/28/11 that evening diarrhea and febrile on Fri 4/29/11 into 5/1/11 achy joints mainly in her fingers redness and swelling at site rash all over body.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Nausea 4/28/11 that evening diarrhea and febrile on Fri 4/29/11 into 5/1/11 achy joints mainly in her fingers redness and swelling at site rash all over body.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Gait disturbance, Muscular weakness, Tremor
Clinical narrative: Not able to walk with assistance, wobbly, upper extremity shaky and tremors. Put in physical therapy for 3 months.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cough, Irritability, Pruritus generalised, Sneezing, Urticaria
Clinical narrative: Approximately 5-10 minutes after receiving vaccines, mom states child sneezed & started "whining" & scratching all over". She noticed he was breaking out in hives then he started coughing. She took him directly to the emergency room at the hospital where he was given epinephrine.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of (R) upper arm - tx KEFLEX.
Age: 1.07
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Childhood disintegrative disorder, Electroencephalogram, Expressive language disorder, Infantile spasms, Laboratory test
Clinical narrative: Infantile spasms began a few weeks following vaccine. Currently patient has 15+ clustered 5-10 spasms each day. Patient has gone backwards as far as mental and social development. He has also lost vocabulary.
Age: 1.07
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Infantile spasms began a few weeks following vaccine. Currently patient has 15+ clustered 5-10 spasms each day. Patient has gone backwards as far as mental and social development. He has also lost vocabulary.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Confusional state, Dysarthria, Gaze palsy, Musculoskeletal stiffness, Posture abnormal
Clinical narrative: Two-3 hours after shots, whole body and head curled to right and stiff, eyes rolling, dazed, slurred vocalizations.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red area approx. 5 cm in diameter - warm to touch on (R) arm at injection site of MENACTRA. No pain, no fever.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: CSF test normal, Convulsion, Differential white blood cell count normal, Full blood count normal, Pyrexia
Clinical narrative: Pt received MMR, VARIVAX and Hep A on 04/13/11 8-9 days later, pt had a high fever, then started to seize. Seizure lasted for 1 hour. Pt was sent to ER where he continued to seize despite ATIVAN & other anticonvulsant therapy. He was shipped to another facility. Rash on torso 4/29/11.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Urine analysis normal
Clinical narrative: Pt received MMR, VARIVAX and Hep A on 04/13/11 8-9 days later, pt had a high fever, then started to seize. Seizure lasted for 1 hour. Pt was sent to ER where he continued to seize despite ATIVAN & other anticonvulsant therapy. He was shipped to another facility. Rash on torso 4/29/11.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Skin irritation
Clinical narrative: Pt. received PNEUMOVAX vaccine on 5/2/11. Iz site became very swollen, red and hot to touch, body aches, skin feels irritated.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Chills, Full blood count normal, Injection site oedema, Injection site pain
Clinical narrative: Fever over 102 degrees F, chills, severe arm pain & swelling at site, warmth at site, persistent edema of entire right upper arm & severe pain 7 days post vaccination, on antibiotics for presumed cellulitis, received IM steroids.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity, Pyrexia, White blood cell count normal
Clinical narrative: Fever over 102 degrees F, chills, severe arm pain & swelling at site, warmth at site, persistent edema of entire right upper arm & severe pain 7 days post vaccination, on antibiotics for presumed cellulitis, received IM steroids.
Age: 1.6
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Gait disturbance, Hypersensitivity, Injection site swelling
Clinical narrative: Allergic local reaction (L) thigh swollen leg - difficulty ambulating, no fever.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Feeling hot, Hyperhidrosis
Clinical narrative: Patient stated sweating & feeling hot less than 1 min after shots given s/s lasted 3 min. Resolved after patient laid down.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site scab, Injection site swelling, Injection site warmth
Clinical narrative: Pt received vaccine 5/2/11 on (R) thigh. On 5/3 site had small area of erythema & scab where needle injected. On 5/3, pt scratched scab & evening of 5/4 parents saw large area of erythema. They saw me, the PMD 5/5 with 13 cm erythema around injection site, warm, swelling. C/O pruritus, but none witnessed. I started KEFLEX today as it looks infected to me. Pt feels well & is AF.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Scratch
Clinical narrative: Pt received vaccine 5/2/11 on (R) thigh. On 5/3 site had small area of erythema & scab where needle injected. On 5/3, pt scratched scab & evening of 5/4 parents saw large area of erythema. They saw me, the PMD 5/5 with 13 cm erythema around injection site, warm, swelling. C/O pruritus, but none witnessed. I started KEFLEX today as it looks infected to me. Pt feels well & is AF.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Inj. given 5/3/11 - following day mom noted redness in 'R' upper arm. Brought to clinic on 5/6/11 - seen by RN & MD. Area about 8cm diameter red/warm. Instructed.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Joint swelling
Clinical narrative: Patient went to the ER because his elbow swelled below injection site. He was placed on antibiotics.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pyrexia
Clinical narrative: Developed fever and malaise for 2 days post injection - and another 3 days before feeling "well again".
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Received call from client. She states within 1 hour of receiving vaccine left arm started aching. Within 24 hours of injection, the site was swollen and red and tender to touch. Did not do any treatments (cool compresses). Today, client stated injection site is not swollen, red area is about 2 inches long and a little tender to touch. Client states left arm feels much better. Explained to client this is some possible side effects of Zostavax. She stated: "Yes. I know that but I thought you would want to know."
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Balance disorder, Decreased appetite, Fatigue, Palpitations
Clinical narrative: Very weak overall, pounding heart, decreased appetite, equilibrium off balance, and tired.
Age: 1.55
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13
Symptoms: Herpes zoster, Polymerase chain reaction, Varicella virus test positive
Clinical narrative: HZ IN A VARICELLA VACCINE RECIPIENT
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Mass
Clinical narrative: 1 cm palpable lump.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Erythema, Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: Redness, heat, welts & pain in her left arm extending to elbow and into chest, shoulder & neck.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Musculoskeletal pain, Neck pain, Urticaria
Clinical narrative: Redness, heat, welts & pain in her left arm extending to elbow and into chest, shoulder & neck.
Age: 0.5
Sex: M
Vaccine: HEP
Symptoms: Injection site reaction, Rash maculo-papular
Clinical narrative: Mom noticed rash to right thigh 5/4/11 evening. Pt seen 5/5/11 maculopapular rash to right thigh treated with BENADRYL & HC cream. Pt temp 98.6 pulse 110 resp. 30.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Local reaction
Clinical narrative: Child given vaccines Fri. 4/29/11. Mom reported redness to us on Monday & we saw child 5/2/11- local vaccine reaction 6cm long 8.5 cm wide. BENADRYL given. Pt better 5/4/11.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Rt upper arm red, swollen, warm to touch. Size of lemon. Grandmom stated pt. c/o next day arm hurt. Ice applied and BENADRYL ordered.
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration, Joint swelling, Laboratory test
Clinical narrative: Initial report received from the patient on 28 April 2011 via a Company-sponsored web site. Follow-up information received the following day via telephone contact to the patient. This is a case of misuse where the patient received 2 doses of Tdap vaccine 10 months apart. A female patient (date of birth not reported) had received a dose of Tdap vaccine (trade name, manufacturer name, lot number, route and site of administration unknown) on 25 February 2011 in the ED (emergency department) following an accident (type of accident not reported). The patient had received a dose of Tdap 10 months prior. At an unspecified amount of time after receiving the Tdap on 25 February 2011, the patient reported having swollen joints in the feet and knees requiring an ED (emergency department) visit where she was treated with 40 mg of prednisone. Per the patient, some tests (not identified) are pending. At the time of this report, the patient had not recovered. Documents held by sender: None.
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Within 4 hours of receiving vaccination my arm blew up 3-4 inches all around, fever 103 for 3 days.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Head lag, Hypotonia, Injected limb mobility decreased, Mechanical ventilation
Clinical narrative: Initial report was received on 04 May 2011 from a consumer who is also the patient. A 50 year-old male patient who had no illness at the time of vaccination had received an intramuscular left arm injection of FLUZONE SV2007-2008, lot number U2507AA and approximately two months later developed shortness of breath and could  not lie flat. His left arm became useless and "floppy" and in January to February 2008 both arms became affected and he was unable to use them. The patient was diagnosed with Motor neuron disease (date not reported) and stated he is unable to hold his head up. According to the patient, his lower extremities have not been affected. Treatment since May 2008 included a "special type of ventilator, which uses nasal prongs or face mask". Other medications, pre-existing conditions and adverse events following prior vaccinations and other vaccines with in four weeks of suspect vaccine were reported as none. No further information was available at the time of the report. The patient's outcome was reported as not recovered and resulted in permanent disability. Documents held by sender: none.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Motor neurone disease, Orthopnoea, Paresis
Clinical narrative: Initial report was received on 04 May 2011 from a consumer who is also the patient. A 50 year-old male patient who had no illness at the time of vaccination had received an intramuscular left arm injection of FLUZONE SV2007-2008, lot number U2507AA and approximately two months later developed shortness of breath and could  not lie flat. His left arm became useless and "floppy" and in January to February 2008 both arms became affected and he was unable to use them. The patient was diagnosed with Motor neuron disease (date not reported) and stated he is unable to hold his head up. According to the patient, his lower extremities have not been affected. Treatment since May 2008 included a "special type of ventilator, which uses nasal prongs or face mask". Other medications, pre-existing conditions and adverse events following prior vaccinations and other vaccines with in four weeks of suspect vaccine were reported as none. No further information was available at the time of the report. The patient's outcome was reported as not recovered and resulted in permanent disability. Documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Erythema, Lymphadenopathy, Nausea, Pain in extremity
Clinical narrative: nausea 3-4 hours after, then arm pain, redness below injection site, swollen lymph node in neck and pain along sternum starting the following day
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Convulsion, Electroencephalogram abnormal
Clinical narrative: Information has been received from a nurse practitioner, concerning a 13 year old female patient, who on 20-APR-2011 was vaccinated intramuscularly, with her first dose of GARDASIL (lot # and dose not reported). Nurse practitioner stated that patient had seizures four days later, on 24-APR-2011, and was admitted to the hospital. An electroencephalogram (EEG) was performed and confirmed the seizure. On an unknown date patient recovered from the event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Chemotherapy, Rheumatoid arthritis
Clinical narrative: Information has been received from a physician concerning her daughter who approximately 2 years ago, in approximately 2009 was vaccinated with the first dose of GARDASIL. Within one month after vaccination, the patient was diagnosed with rheumatoid arthritis. The patient never received any additional doses of GARDASIL. The patient continued to see a specialist for her condition and had been undergoing chemotherapy with methotrexate (manufacturer unknown). Upon the time of the report, the patient was not recovered. Rheumatoid arthritis was considered to be disabling and an other important medical event by the physician. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac fibrillation, Deafness unilateral, Ear pain, Neuralgia, Pain
Clinical narrative: Information has been received from a consumer concerning her 70 year old husband with no pertinent medical history or drug reactions/allergies who on 31-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot# not reported) into his arm. Concomitant therapy included COUMADIN as well as unspecified blood pressure and cholesterol medications. On 02-APR-2011 the patient woke up with a terrible pain in his ear and he could not hear out of that ear. He never had rash, but he had blotches on his face. He was experiencing nerve pain that came and went, but he always had an ache. The nerve pain started at his right temple and spread to his jaw and ear. Since all of this started, they had gone to an ENT (ear, nose and throat doctor) and the patient was prescribed an antibiotic (unspecified). Later, the patient was prescribed a viral medication (unspecified) after the ENT realized the pain was related to his nerves. The reporter believed the patient was experiencing postherpetic neuralgia. The patient went for the vaccine as a healthy individual. The patient was treated with VALTREX, prednisone, NEURONTIN and codeine medication (unspecified). Recently, the patient went to ER (emergency room) because he had H.O.Fibrillation and was not admitted. No lab diagnostics study was performed. At the time of reporting, the patient had not recovered. Upon internal review, deafness was considered to be an other important event. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Rash macular
Clinical narrative: Information has been received from a consumer concerning her 70 year old husband with no pertinent medical history or drug reactions/allergies who on 31-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot# not reported) into his arm. Concomitant therapy included COUMADIN as well as unspecified blood pressure and cholesterol medications. On 02-APR-2011 the patient woke up with a terrible pain in his ear and he could not hear out of that ear. He never had rash, but he had blotches on his face. He was experiencing nerve pain that came and went, but he always had an ache. The nerve pain started at his right temple and spread to his jaw and ear. Since all of this started, they had gone to an ENT (ear, nose and throat doctor) and the patient was prescribed an antibiotic (unspecified). Later, the patient was prescribed a viral medication (unspecified) after the ENT realized the pain was related to his nerves. The reporter believed the patient was experiencing postherpetic neuralgia. The patient went for the vaccine as a healthy individual. The patient was treated with VALTREX, prednisone, NEURONTIN and codeine medication (unspecified). Recently, the patient went to ER (emergency room) because he had H.O.Fibrillation and was not admitted. No lab diagnostics study was performed. At the time of reporting, the patient had not recovered. Upon internal review, deafness was considered to be an other important event. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Body temperature increased, Dehydration, Lethargy, Rotavirus test positive, Sepsis
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning a 11 weeks old baby, who on 20-APR-2011 was vaccinated, orally, with a dose of ROTATEQ (Lot # and dose not reported). Physician reported that after receiving the ROTATEQ, on 21-APR-2011, the baby experienced severely dehydrated, became septic and lethargic and had a temperature of 101 degrees. After the physician examined the infant, rotavirus was detected in the baby's stool. On an unknown date, baby was hospitalized. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Death, Epistaxis
Clinical narrative: Pt noted to be lifeless on awaking in morning.  Epistaxis reported by father.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Abdominal discomfort, Activities of daily living impaired, Anaemia, Depression, Dyspnoea
Clinical narrative: Patient passed out after Gardasil vaccine.  A few weeks after first injection, she started showing signs of being unusually afraid of things (being alone, strangers, etc).  She also complained of being tired, shortness of breath and stomache issues.  She completed the series of shots in December of 2008 and continued to have 'strange' symptoms more often.  She was tested for mono and thyroid issues.  Her doctor said she was borderline anemic and suggested vitamins.  She continued to deteriorate and we finally realized she was having severe panic attacks.  Eventually, she was diagnosed with Panic Disorder with Agoraphobia and Depression.  She was terrified to leave our house and we had to pull her out of school and enroll her in a psychiatric partial hospitalization program for 6 weeks.  She continues to be treated by a physician to this day.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Fatigue, Fear, General physical health deterioration, Laboratory test, Loss of consciousness
Clinical narrative: Patient passed out after Gardasil vaccine.  A few weeks after first injection, she started showing signs of being unusually afraid of things (being alone, strangers, etc).  She also complained of being tired, shortness of breath and stomache issues.  She completed the series of shots in December of 2008 and continued to have 'strange' symptoms more often.  She was tested for mono and thyroid issues.  Her doctor said she was borderline anemic and suggested vitamins.  She continued to deteriorate and we finally realized she was having severe panic attacks.  Eventually, she was diagnosed with Panic Disorder with Agoraphobia and Depression.  She was terrified to leave our house and we had to pull her out of school and enroll her in a psychiatric partial hospitalization program for 6 weeks.  She continues to be treated by a physician to this day.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Mononucleosis heterophile test, Panic attack, Panic disorder with agoraphobia
Clinical narrative: Patient passed out after Gardasil vaccine.  A few weeks after first injection, she started showing signs of being unusually afraid of things (being alone, strangers, etc).  She also complained of being tired, shortness of breath and stomache issues.  She completed the series of shots in December of 2008 and continued to have 'strange' symptoms more often.  She was tested for mono and thyroid issues.  Her doctor said she was borderline anemic and suggested vitamins.  She continued to deteriorate and we finally realized she was having severe panic attacks.  Eventually, she was diagnosed with Panic Disorder with Agoraphobia and Depression.  She was terrified to leave our house and we had to pull her out of school and enroll her in a psychiatric partial hospitalization program for 6 weeks.  She continues to be treated by a physician to this day.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Lethargy, Urticaria
Clinical narrative: Generalized urticaria & lethargy 15 min after vaccines. Rx BENADRYL, SC epi, and 1 dose prednisolone. Resolution in about 45 minutes.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Eye swelling, Lethargy, Retching
Clinical narrative: Mother reports child with gagging, swelling to eyes, & lethargy 30 min after vaccine. Mother report via TC. Mother told to get child to Emergency Room.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Irritability, Pruritus, Rash, Urticaria
Clinical narrative: Urticarial eruptions on trunk, with itching and fussiness. BENADRYL elixir produced improvement in rash and symptoms.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Drug exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a physician and described the occurrence of vaccine exposure during pregnancy in a 25-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medications included Prenatal vitamins. On 6 April 2011 at 12:04 (19 weeks gestation) the subject received a dose of BOOSTRIX at 0.5 ml in the left arm as part of a pre-employment physical. The subject experienced vaccine exposure during pregnancy. Her estimated date of delivery was 28 August 2011. The pregnancy was ongoing. No additional details were reported. Follow-up information was received from a physician on 06 May 2011. Conception was normal. The physician reported an unspecified congenital anomaly. No additional details concerning the congenital anomaly were provided at the time of reporting.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: pain, redness, extensive swelling and feels like a hard bunch right near where the Tdap shot was given on my arm and its still there
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: After HPV vaccination patient felt dizzy. Escorted patient to lie flat. BP 104/68. Patient stated was feeling better. Raised to a sitting position. BP 110/72. Escorted patient to take 5 steps and BP 109/55. 2 min after 114/60. Escorted patient to car and notified if dizziness reoccurs to lie patient to a flat position.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Rash & itching all over body.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiac stress test normal, Echocardiogram normal, Muscular weakness, Nuclear magnetic resonance imaging, Rash
Clinical narrative: Rash over trunk & legs approximately equal to 2-4 wks after injection excessive day time sleepiness. Dx complex sleep apnea. Primary central sleep apnea. General muscle weakness. Increased thru day.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Sleep apnoea syndrome, Sleep study abnormal, Somnolence
Clinical narrative: Rash over trunk & legs approximately equal to 2-4 wks after injection excessive day time sleepiness. Dx complex sleep apnea. Primary central sleep apnea. General muscle weakness. Increased thru day.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: C-reactive protein, Full blood count normal, Headache, Malaise, Myalgia
Clinical narrative: Headache, malaise, myalgias, nausea. All sx began about 24 hrs after administration (5-6-11).
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Red blood cell sedimentation rate
Clinical narrative: Headache, malaise, myalgias, nausea. All sx began about 24 hrs after administration (5-6-11).
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Dyspnoea, Eye pruritus, Lacrimation increased, Ocular hyperaemia, Rhinorrhoea
Clinical narrative: Throat tightness, SOB, trouble getting breath, watery itchy eyes.  Used Albuterol inhaler but continued to have trouble breathing thru the night.  Reports no difficult breathing now, but eyes watery, itchy and red.  Also has runny nose.  Instructed client to go to his physician or clinic to get evaluated.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Throat tightness
Clinical narrative: Throat tightness, SOB, trouble getting breath, watery itchy eyes.  Used Albuterol inhaler but continued to have trouble breathing thru the night.  Reports no difficult breathing now, but eyes watery, itchy and red.  Also has runny nose.  Instructed client to go to his physician or clinic to get evaluated.
Age: 0.19
Sex: F
Vaccine: HEPA, MMR, PNC
Symptoms: Diarrhoea, Irritability, Pyrexia, Rash, Vomiting
Clinical narrative: Low grade fever, changed to high fever 6 hours later, vomiting 2 hours later. Vomiting next 4 days, fever next 3 days, irritable, Rash on back and torso began 05/07/2011 9:00PM, Diarrhea on 05/08/11 through 05/09/11. Rash remains.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: RASH STARTED FROM THE ABDOMEN THE NEXT DAY AFTER THE VACCINES WERE GIVEN AND AN A FEW DAYS IT WAS ALL AVER THE BODY PER CHILD MOTHER.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site mass, Oedema peripheral
Clinical narrative: swelling and redness on left arm; lump at injection site (left deltoid)
Age: 1.15
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood test normal, Convulsion, Pyrexia, Urine analysis normal
Clinical narrative: Generalized seizures associated with fever. Two separate convulsions approximately one hour apart.
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Feeding disorder, Irritability
Clinical narrative: Increased irritability and feeding difficulties following administration of vaccine (had a similar reaction after the first dose of the vaccine at 2 months).
Age: 13.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Location where vaccination received is red, hard, swollen. Size: 15cm diameter.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Contusion, Mobility decreased, Pain in extremity
Clinical narrative: Patient called office on 5/2/11 with complaints of her arm hurting and having a hard time raising her arm due to the pain. At the the time the patient was on vacation and was not seen by this provider for this problem. She stated she had been swimming, but had a hard time raising her arm (left) and that it hurt. She stated that there was no lump or red spot on her arm. She did have a bruise from the injection, but it was resolving. She was advised to take Motrin for the pain and ice the area. She was also advised to seek medical care if she was in increasing pain. She called on 5/3/11 with the same complaints and was given the same advice. She was not due home until 5/9/11 and was advised that she could be seen then at the office. She did not make an appointment. When attempted to contact the patient on 5/10/11 there was no answer at her given phone number. It is not know if she sought care for this arm pain.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient called office on 5/2/11 with complaints of her arm hurting and having a hard time raising her arm due to the pain. At the the time the patient was on vacation and was not seen by this provider for this problem. She stated she had been swimming, but had a hard time raising her arm (left) and that it hurt. She stated that there was no lump or red spot on her arm. She did have a bruise from the injection, but it was resolving. She was advised to take Motrin for the pain and ice the area. She was also advised to seek medical care if she was in increasing pain. She called on 5/3/11 with the same complaints and was given the same advice. She was not due home until 5/9/11 and was advised that she could be seen then at the office. She did not make an appointment. When attempted to contact the patient on 5/10/11 there was no answer at her given phone number. It is not know if she sought care for this arm pain.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Blister, Erythema, Induration, Skin lesion
Clinical narrative: Redness - 6 cm of raised induration with 3 cm of small blistering lesions in center.
Age: 1.79
Sex: M
Vaccine: PNC
Symptoms: Crying, Induration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Received vaccine on 5/9/11. Overnight pt cried all night & was extremely fussy. Emesis 1x. IAM of 5/10/11. Refused to bear wt/walk. Mom appreciated red swollen Rt thigh which was painful to touch. Seen at clinic at 4pm with 3 in x 2 in area of painful induration & temp=100.8.
Age: 1.79
Sex: M
Vaccine: PNC
Symptoms: Irritability, Vomiting, Weight bearing difficulty
Clinical narrative: Received vaccine on 5/9/11. Overnight pt cried all night & was extremely fussy. Emesis 1x. IAM of 5/10/11. Refused to bear wt/walk. Mom appreciated red swollen Rt thigh which was painful to touch. Seen at clinic at 4pm with 3 in x 2 in area of painful induration & temp=100.8.
Age: 24.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abscess limb, Induration, Pain, Skin warm, White blood cell count increased
Clinical narrative: Pt received PNEUMOVAX & flu vax on 4/28/11, both in (L) deltoid. Pt quickly developed a very large abscess w/warmth, induration and severe pain. Elevated HR in the 160s, temp of 36.7 degrees C. Pt seen at medical center & ED as well as by this examiner in office. Required abx & pain meds.
Age: 0.69
Sex: M
Vaccine: DTAP
Symptoms: Body temperature increased, Respiratory distress, Wheezing
Clinical narrative: 5-10-11 Mother reported to pediatrician, that infant developed wheezing (heard by stethoscope by mother) mild resp. distress. These symptoms all cleared with one albuterol aerosol. Wheezing developed within 12 hrs of administration of DTaP on 1-10-11. Mother also reported Temp 101 - 101.5 also. Mother also reports that baby was fussy after first IPV at age 3 mo of age.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Myalgia, Presyncope
Clinical narrative: After vaccine 5/6 - 2 days later felt pre-syncopal w/chills & muscle aches & sx resolved in 2 days. Site was without redness, swelling or increased warmth - did not take temp.
Age: 61.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Erythema, Pruritus, Skin exfoliation
Clinical narrative: Reported redness, itch on 4/22/11. Instructed if not better in a day or two to call office, voiced understanding. Denied pain, swelling, numbness, fever, no decrease in ROM. Pt seen by RN on 5-7-11 socially, still has quarter size red on underarm which is scaly, itch persists. Declines to come to doctor to have it checked.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Colonoscopy, Fatigue, Oesophagogastroduodenoscopy, Pain, Ulcer haemorrhage
Clinical narrative: Patient developed a large localized swelling at the vaccine site with body aches and fatigue approximately 2 days after receiving Tdap. She took Ibuprofen to treat symptoms & then ended up in the hospital with a bleeding ulcer.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site swelling
Clinical narrative: Patient developed a large localized swelling at the vaccine site with body aches and fatigue approximately 2 days after receiving Tdap. She took Ibuprofen to treat symptoms & then ended up in the hospital with a bleeding ulcer.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Feeling of body temperature change, Headache, Malaise, Nausea
Clinical narrative: "On 10-11-10 I received vaccine at 4PM. At 8:30PM I had a severe headache unrelieved with TYLENOL. Hot/cold, diarrhea, nausea & vomiting, ill enough to go to ER but did not. Very ill for 8 hours."
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: "On 10-11-10 I received vaccine at 4PM. At 8:30PM I had a severe headache unrelieved with TYLENOL. Hot/cold, diarrhea, nausea & vomiting, ill enough to go to ER but did not. Very ill for 8 hours."
Age: 1.78
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Injection site rash, Rash
Clinical narrative: Rash throughout thigh, abd., little in groin. Minimally raised mostly flat. BENADRYL & cortisone cream prn. Started in Lt leg moved to Rt. leg on B/L at O.V.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test abnormal, Convulsion, Electroencephalogram abnormal, Epilepsy, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with no known pre-existing illness at time of vaccination and no drug allergy and no medical history on 07-AUG-2007 was vaccinated IM with her second dose of GARDASIL (lot # 0530U) into her right arm. She was on TRI-SPRINTEC at time of vaccination for birth control. On 01-MAR-2009 the patient experienced seizure, syncope, vomiting, sudden onset of tunnel vision, lightheadedness, hands/feet numb. The patient was sent to emergency room. Electroencephalography (EEG), magnetic resonance imaging (MRI) and blood work were performed with the results of abnormal EEG and sodium 135 (L). The patient was diagnosed with seizure disorder (epilepsy). The patient was treated with TOPAMAX. The patient was discharged home in stable condition. The listing indicated that one or more of the events was considered to be immediately life-threatening. The event was considered to be serious. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The original reporting source was not provided. The VAERS ID# is 417370.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with no known pre-existing illness at time of vaccination and no drug allergy and no medical history on 07-AUG-2007 was vaccinated IM with her second dose of GARDASIL (lot # 0530U) into her right arm. She was on TRI-SPRINTEC at time of vaccination for birth control. On 01-MAR-2009 the patient experienced seizure, syncope, vomiting, sudden onset of tunnel vision, lightheadedness, hands/feet numb. The patient was sent to emergency room. Electroencephalography (EEG), magnetic resonance imaging (MRI) and blood work were performed with the results of abnormal EEG and sodium 135 (L). The patient was diagnosed with seizure disorder (epilepsy). The patient was treated with TOPAMAX. The patient was discharged home in stable condition. The listing indicated that one or more of the events was considered to be immediately life-threatening. The event was considered to be serious. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The original reporting source was not provided. The VAERS ID# is 417370.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood sodium decreased, Convulsion, Dizziness, Electroencephalogram abnormal, Epilepsy
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with no known pre-existing illness at time of vaccination and no drug allergy and no medical history on 07-AUG-2007 was vaccinated IM with her second dose of GARDASIL (lot # 0530U) into her right arm. She was on TRI-SPRINTEC at time of vaccination for birth control. On 01-MAR-2009 the patient experienced seizure, syncope, vomiting, sudden onset of tunnel vision, lightheadedness, hands/feet numb. The patient was sent to emergency room. Electroencephalography (EEG), magnetic resonance imaging (MRI) and blood work were performed with the results of abnormal EEG and sodium 135 (L). The patient was diagnosed with seizure disorder (epilepsy). The patient was treated with TOPAMAX. The patient was discharged home in stable condition. The listing indicated that one or more of the events was considered to be immediately life-threatening. The event was considered to be serious. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The original reporting source was not provided. The VAERS ID# is 417370.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging abnormal, Syncope, Tunnel vision, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with no known pre-existing illness at time of vaccination and no drug allergy and no medical history on 07-AUG-2007 was vaccinated IM with her second dose of GARDASIL (lot # 0530U) into her right arm. She was on TRI-SPRINTEC at time of vaccination for birth control. On 01-MAR-2009 the patient experienced seizure, syncope, vomiting, sudden onset of tunnel vision, lightheadedness, hands/feet numb. The patient was sent to emergency room. Electroencephalography (EEG), magnetic resonance imaging (MRI) and blood work were performed with the results of abnormal EEG and sodium 135 (L). The patient was diagnosed with seizure disorder (epilepsy). The patient was treated with TOPAMAX. The patient was discharged home in stable condition. The listing indicated that one or more of the events was considered to be immediately life-threatening. The event was considered to be serious. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The original reporting source was not provided. The VAERS ID# is 417370.
Age: 35.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Anxiety, Axillary pain, Chest pain, Electrocardiogram normal, Generalised vaccinia
Clinical narrative: On 05/08/2011, patient presented to clinic with adverse reaction to small pox vaccination.  Patient obtained EKG, with normal limits.  Patient returned today, 05/11/2011 and complained of increased bumps on back, both arms, chest and abdomen.  Patient also complained of pain in left hand.  Member was treated with convalescent leave for 2 weeks, deployment restricted until 1 Jun 2011 and prescribed ibuprofen and triamcinolone acet.
Age: 35.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Injection site vesicles, Oedema peripheral, Paraesthesia, Rash
Clinical narrative: On 05/08/2011, patient presented to clinic with adverse reaction to small pox vaccination.  Patient obtained EKG, with normal limits.  Patient returned today, 05/11/2011 and complained of increased bumps on back, both arms, chest and abdomen.  Patient also complained of pain in left hand.  Member was treated with convalescent leave for 2 weeks, deployment restricted until 1 Jun 2011 and prescribed ibuprofen and triamcinolone acet.
Age: 35.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Activities of daily living impaired, Adverse reaction, Electrocardiogram normal, Pain in extremity, Rash
Clinical narrative: On 05/08/2011, patient presented to clinic with adverse reaction to small pox vaccination.  Patient obtained EKG, with normal limits.  Patient returned today, 05/11/2011 and complained of increased bumps on back, both arms, chest and abdomen.  Patient also complained of pain in left hand.  Member was treated with convalescent leave for 2 weeks, deployment restricted until 1 Jun 2011 and prescribed ibuprofen and triamcinolone acet.
Age: 35.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Injection site vesicles, Local swelling, Paraesthesia, Rash
Clinical narrative: On 05/08/2011, patient presented to clinic with adverse reaction to small pox vaccination.  Patient obtained EKG, with normal limits.  Patient returned today, 05/11/2011 and complained of increased bumps on back, both arms, chest and abdomen.  Patient also complained of pain in left hand.  Member was treated with convalescent leave for 2 weeks, deployment restricted until 1 Jun 2011 and prescribed ibuprofen and triamcinolone acet.