chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Apnoea, Crying, Feeding disorder of infancy or early childhood
Clinical narrative: Pt had episodes on significant crying and apnea. Pt also experienced difficulty feeding so he was admitted for observation overnight. 9/25/09 Medical records received for DOS 9/1/09 to 9/2/09. Presenting symptoms: difficulty breathing, increase crying/fussiness hard to console. Admit and D/C DX: Stridor   Suspect: underlying mild laryngo/trechea malacies. Admit and D/C DX: Stridor. 786.1.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Oedema peripheral, Pain in extremity
Clinical narrative: Flu shot administered about 5:30 PM.  Phone call at 7 PM stating edema in left arm from elbow to fingers.  Some mild pain in fingers (had to remove rings) and wrist.  Reaction started around 6:15 PM per patient.  Had flu shot 1 previous time last year 2008.  Instructed patient to call primary care doctor if conditioned worsen.  Tonight or go to ER.  Instructed patient to call MD in morning even if feeling better.  Pt took 2 BENADRYL & 4 MOTIN at 8:15 PM swelling decreased.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Pneumonia, Skin striae
Clinical narrative: Patient described "pain in arm with striations." Patient was diagnosed with Pneumonia on 9/07/09.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Headache, Hypoaesthesia
Clinical narrative: Headache, dizziness and shortness of breath following vaccine, then left sided numbness to ear, face, hand and arm x 1 week. 1/5/2010 ED records for 9/8/2009, patient with c/o's left facial and arm numbness, neuro exam wnl 1/5/2010 ED records for 9/9/2009, patient with c/o's lightheadedness, nausea, dull chest pain, felt flushed and faint, Impression Near syncope
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Burning sensation, Chills, Cough, Pain
Clinical narrative: Had "asthma-like" attack, body aches, chills, "violent coughing", says lungs felt like they were on fire.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling jittery, Nervousness, Palpitations
Clinical narrative: Pt experienced "heart racing" followed by "jittery/nervous felling". Pt took alprazolam, which helped calmed her  and heart. Symptoms returned next morning, called pharmacy at 1pm. Instructed to call MD, who instructed pt to take another, alprazolam; which helped to relieve symptoms. Pt reports getting several in past with no problems.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site dermatitis, Injection site erythema, Injection site swelling
Clinical narrative: 6.5 x 4.5 cm raised erythematous dermatitis over right deltoid. Treatment: BANADRYL elixir.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, C-reactive protein, Fatigue, Full blood count, Myalgia
Clinical narrative: Myalgia, muscle joint pain, fatigue, nausea.  States reaction 4-5 days post vaccine x 5 years.  Onset within hours after flu vaccine.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Myalgia, muscle joint pain, fatigue, nausea.  States reaction 4-5 days post vaccine x 5 years.  Onset within hours after flu vaccine.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Dyspnoea, Throat tightness, Wheezing
Clinical narrative: Child received vaccine on 9/1/09.  At 1:30 am 9/2/09 child had "throat closing, audible wheezing and difficulty breathing.  Benadryl given & symptoms resolved.  Denied hives or facial swelling.  Were preparing to take child to ER but did not due to improved symptoms.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt only reported sharp pain in left arm 30 min after injection. She took OTC pain tabs and used an ice pack. Pain started to go away 15 to 20 min. later.
Age: 16.0
Sex: M
Vaccine: HEP, MNQ, TDAP
Symptoms: Erythema, Pain in extremity
Clinical narrative: Erythema and pain in upper deltoid area  upper arm above elbow and trunk.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: 15 minutes after patient received injection she stated that the area where she was injected itched a little bit.  We had her wait another 5 minutes or so and only the area at the injection site itched still.  I recommended some ice and ZYRTEC and a phone call to her Dr if no improvement.
Age: 38.0
Sex: M
Vaccine: MMR
Symptoms: Anxiety, Asthenia, Body temperature, Borrelia burgdorferi serology negative, Decreased appetite
Clinical narrative: T 97.2 - loss of appetite, fatigue, vague weakness of joints, anxiety.
Age: 38.0
Sex: M
Vaccine: MMR
Symptoms: Fatigue, Haematology test normal, Laboratory test normal
Clinical narrative: T 97.2 - loss of appetite, fatigue, vague weakness of joints, anxiety.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dysphonia, Dyspnoea, Wheezing
Clinical narrative: Hoarseness, wheezing, weakness, difficulty breathing. Sent employee to medical center for evaluation. TX with steroids.
Age: 60.0
Sex: U
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Pt developed hives 1 day later on inner elbows of both arms.  They are currently fading.  Pt did not seek medical tx & took no medications.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site urticaria, Pain of skin, Urticaria
Clinical narrative: Circular raised silver-dollar sized area around injection site with 2 finger size striations on arm + 1 into side of neck. Sore to the touch.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Pyrexia, Serum sickness, Urticaria
Clinical narrative: Developed serum sickness with hives, fever.
Age: 11.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 5cm x 5cm area of redness & swelling at site of injection of VARIVAX.
Age: 1.4
Sex: M
Vaccine: FLUX, MMR, PNC, VARCEL
Symptoms: Abnormal behaviour, Speech disorder developmental
Clinical narrative: At 16 mo visit on 1/23/09, child had single words and could point to indicate wants. No animal names or noises. Rec. increased reading to child. MMR/Varicella/PREVENAR/Flu given. After this visit, the child's language regressed and he began hand flapping and would not follow directions.   9/8/09 VAERS report received with MR attached.  WCC 1/23/09 with normal exam except abnormal weight gain.  Saying 3 words at this time.  Vax given.  Returned 3/20/09 with parental concerns for speech regression over past few months as well as flapping his hands when excited.  Does maintain eye contact however clear regression of speech noted by MD. Sent for genetic, neuro and developmental testing. Evals (+) for developmental delays, macrocephaly, toe walking. sx c/w autism.
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Erythema, Lethargy, Lymphadenopathy, Oedema peripheral, Somnolence
Clinical narrative: Initial report was received 10 August 2009 from a health care professional. A 14-year-old male patient had received a first dose right arm injection of ADACEL, lot number C3250AA and a first dose left arm injection of MENACTRA, lot number U29057BA (lot number invalid) on 06 August 2009 and two days later, the patient was lethargic, sleepy, he had a large axillary lymph node, and his right arm was red, swollen and tender. He had no known allergies and no history of medical conditions. The patient was scheduled to be evaluated by his physician on 10 August 2009, and at the time of the report, his recovery status was unknown. Follow up information received on 31 August 2009 from a health care professional. The patient did not have an illness at the time of vaccination. The reporter clarified that the patient had swelling to the right axilla. The swelling, lethargy, and sleepiness lasted for one week. The patient was treated with antibiotics, medication name not specified. Labs and diagnostics were not performed. The patient fully recovered. The reporter verified that the lot number for MENACTRA which was administered was U2907BA. No further information was provided. Documents held by sender: None.
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Tenderness
Clinical narrative: Initial report was received 10 August 2009 from a health care professional. A 14-year-old male patient had received a first dose right arm injection of ADACEL, lot number C3250AA and a first dose left arm injection of MENACTRA, lot number U29057BA (lot number invalid) on 06 August 2009 and two days later, the patient was lethargic, sleepy, he had a large axillary lymph node, and his right arm was red, swollen and tender. He had no known allergies and no history of medical conditions. The patient was scheduled to be evaluated by his physician on 10 August 2009, and at the time of the report, his recovery status was unknown. Follow up information received on 31 August 2009 from a health care professional. The patient did not have an illness at the time of vaccination. The reporter clarified that the patient had swelling to the right axilla. The swelling, lethargy, and sleepiness lasted for one week. The patient was treated with antibiotics, medication name not specified. Labs and diagnostics were not performed. The patient fully recovered. The reporter verified that the lot number for MENACTRA which was administered was U2907BA. No further information was provided. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Injection site pain, Pyrexia
Clinical narrative: Fever, headache, injection site pain
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Back pain, Eye pain, Headache, Pyrexia, Rash erythematous
Clinical narrative: Initial information received on 18 August 2009 from health care professional. A 17 to 18 years old female patient received MENACTRA (lot number unknown) subcutaneously on 14 August 2009. That evening, the patient was involved as a passenger in a car accident. The following day, the patient complained of a headache, achy eyes, back pain, a fever of 99 degrees, and a red, fine diffuse rash. On 18 August 2009 the patient was seen in the doctor's office. The patient was treated with Ibuprofen. At the time of the report, the patient had not recovered. List of Documents held by Sender: none.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Road traffic accident
Clinical narrative: Initial information received on 18 August 2009 from health care professional. A 17 to 18 years old female patient received MENACTRA (lot number unknown) subcutaneously on 14 August 2009. That evening, the patient was involved as a passenger in a car accident. The following day, the patient complained of a headache, achy eyes, back pain, a fever of 99 degrees, and a red, fine diffuse rash. On 18 August 2009 the patient was seen in the doctor's office. The patient was treated with Ibuprofen. At the time of the report, the patient had not recovered. List of Documents held by Sender: none.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Body temperature increased, Cough, Full blood count, Headache, Hypoaesthesia
Clinical narrative: Initial report was received 20 August 2009 from a health care professional, who is also the patient's parent. A 17-year-old female patient with no concurrent illness and no pre-existing medical conditions had received a first dose intramuscular injection of MENACTRA (lot number unknown) on 18 August 2009, and one day later, she experienced a frontal and temporal headache with numbness of the forehead, upper palate and upper dental area, a dry cough and an axillary temperature of 100 degrees. MOTRIN and TYLENOL were administered every six hours as corrective treatment. The patient was scheduled for a physical evaluation on 20 August 2009 and per the reporter, laboratory testing (CBS and sed rate) was to be performed. The patient's recovery status was not reported. Document held by sender: None
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Hypoaesthesia oral, Red blood cell sedimentation rate
Clinical narrative: Initial report was received 20 August 2009 from a health care professional, who is also the patient's parent. A 17-year-old female patient with no concurrent illness and no pre-existing medical conditions had received a first dose intramuscular injection of MENACTRA (lot number unknown) on 18 August 2009, and one day later, she experienced a frontal and temporal headache with numbness of the forehead, upper palate and upper dental area, a dry cough and an axillary temperature of 100 degrees. MOTRIN and TYLENOL were administered every six hours as corrective treatment. The patient was scheduled for a physical evaluation on 20 August 2009 and per the reporter, laboratory testing (CBS and sed rate) was to be performed. The patient's recovery status was not reported. Document held by sender: None
Age: 22.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Inappropriate schedule of drug administration, Vertigo
Clinical narrative: Inappropriate schedule of vaccine administered.  Initial information received on 25 August 2009 from a health care professional.  A male patient with an unknown past medical history experienced a reaction after he received a second dose of MENACTRA (lot number not known) on either 19 August 2009 or 20 August 2009.  One day post vaccination the patient developed dizziness.  On 25 August 2009 the patient complained of continued severe vertigo.  The patient reported receiving a first dose of MENACTRA one year prior without a reaction.  At the time of the report the patient was not recovered.  List of Documents held by Sender: none.
Age: 0.18
Sex: M
Vaccine: RV1
Symptoms: Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vomiting in a 2-month-old male subject who was vaccinated with ROTARIX, GlaxoSmithKline).  On 20 May 2009 the subject received 1st dose of ROTARIX (1 ml, oral).  On 21 May 2009, 1 day after vaccination with ROTARIX, the subject experienced vomiting.  The event resolved.  For details involving the second dose of ROTARIX and vomiting, refer to case A0799188A.
Age: 0.38
Sex: M
Vaccine: RV1
Symptoms: Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vomiting in a 4-month-old male subject (reported as less than 20 weeks of age) who was vaccinated with ROTARIX (GlaxoSmithKline).  There were no known concomitant medications.  On 27 August 2009 at 17:30 the subject received unspecified dose of ROTARIX (oral).  On 27 August 2009, immediately after vaccination with ROTARIX, the subject experienced vomiting.  The subject vomited after the dose of ROTARIX and per reporter, majority of the dose was vomited.  The reporter requested to know if a ROTARIX dose can be repeated.  The subject was still in the office at the time of reporting and no other adverse events were noted.  At the time of reporting the outcome of the event was was unspecified.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4
Symptoms: Abdominal pain, Aphonia, Asthenia, Chest discomfort, Cough
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. A 13 year old female who on 14-JUN-2007, was vaccinated with the third dose of GARDASIL IM into her left arm (lot # 655154/1210U). On 14-JUN-2007 the patient experienced abdominal pain, aphonia, asthenia, chest discomfort, cough, crying, dizziness, dysgeusia, dyspnoea, fatigue, headache, hypersensitivity, injection site pain, injection site swelling, laryngitis, malaise, respiratory tract congestion and restless legs syndrome. The symptoms included coughing, trouble breathing, loss of voice, malaise, crying, headache, chest discomfort, pain at injection site with swelling, dizziness, abdominal pain, weakness, fatigue, restless legs. There was no pre-existing illness. The patient required an emergency room visit (ER) visit. On 10-JUL-2009 ER medical records of 10-MAY-2007 was received. The final diagnosis was laryngitis. Records revealed patient had had chest congestion, dry cough and abnormal taste for 1 week. The patient was seen by a primary care physician (PCP) and diagnosed with allergies. Over the counter (OTC) allergy medication was not helpful. A chest X-ray (CXR) was within normal limits. The patient was treated with oral antibiotics and cough syrup. The patient was discharged to home with PCP follow up. The listing indicated that one or more of the events was considered to be disabling and immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID# is 351067. A standard lot check investigation was performed. 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 and was released.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4
Symptoms: Crying, Dizziness, Dyspnoea, Fatigue, Headache
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. A 13 year old female who on 14-JUN-2007, was vaccinated with the third dose of GARDASIL IM into her left arm (lot # 655154/1210U). On 14-JUN-2007 the patient experienced abdominal pain, aphonia, asthenia, chest discomfort, cough, crying, dizziness, dysgeusia, dyspnoea, fatigue, headache, hypersensitivity, injection site pain, injection site swelling, laryngitis, malaise, respiratory tract congestion and restless legs syndrome. The symptoms included coughing, trouble breathing, loss of voice, malaise, crying, headache, chest discomfort, pain at injection site with swelling, dizziness, abdominal pain, weakness, fatigue, restless legs. There was no pre-existing illness. The patient required an emergency room visit (ER) visit. On 10-JUL-2009 ER medical records of 10-MAY-2007 was received. The final diagnosis was laryngitis. Records revealed patient had had chest congestion, dry cough and abnormal taste for 1 week. The patient was seen by a primary care physician (PCP) and diagnosed with allergies. Over the counter (OTC) allergy medication was not helpful. A chest X-ray (CXR) was within normal limits. The patient was treated with oral antibiotics and cough syrup. The patient was discharged to home with PCP follow up. The listing indicated that one or more of the events was considered to be disabling and immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID# is 351067. A standard lot check investigation was performed. 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 and was released.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4
Symptoms: Injection site pain, Injection site swelling, Malaise, Restless legs syndrome
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. A 13 year old female who on 14-JUN-2007, was vaccinated with the third dose of GARDASIL IM into her left arm (lot # 655154/1210U). On 14-JUN-2007 the patient experienced abdominal pain, aphonia, asthenia, chest discomfort, cough, crying, dizziness, dysgeusia, dyspnoea, fatigue, headache, hypersensitivity, injection site pain, injection site swelling, laryngitis, malaise, respiratory tract congestion and restless legs syndrome. The symptoms included coughing, trouble breathing, loss of voice, malaise, crying, headache, chest discomfort, pain at injection site with swelling, dizziness, abdominal pain, weakness, fatigue, restless legs. There was no pre-existing illness. The patient required an emergency room visit (ER) visit. On 10-JUL-2009 ER medical records of 10-MAY-2007 was received. The final diagnosis was laryngitis. Records revealed patient had had chest congestion, dry cough and abnormal taste for 1 week. The patient was seen by a primary care physician (PCP) and diagnosed with allergies. Over the counter (OTC) allergy medication was not helpful. A chest X-ray (CXR) was within normal limits. The patient was treated with oral antibiotics and cough syrup. The patient was discharged to home with PCP follow up. The listing indicated that one or more of the events was considered to be disabling and immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID# is 351067. A standard lot check investigation was performed. 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 and was released.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4
Symptoms: Abdominal pain, Aphonia, Asthenia, Chest X-ray normal, Chest discomfort
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. A 13 year old female who on 14-JUN-2007, was vaccinated with the third dose of GARDASIL IM into her left arm (lot # 655154/1210U). On 14-JUN-2007 the patient experienced abdominal pain, aphonia, asthenia, chest discomfort, cough, crying, dizziness, dysgeusia, dyspnoea, fatigue, headache, hypersensitivity, injection site pain, injection site swelling, laryngitis, malaise, respiratory tract congestion and restless legs syndrome. The symptoms included coughing, trouble breathing, loss of voice, malaise, crying, headache, chest discomfort, pain at injection site with swelling, dizziness, abdominal pain, weakness, fatigue, restless legs. There was no pre-existing illness. The patient required an emergency room visit (ER) visit. On 10-JUL-2009 ER medical records of 10-MAY-2007 was received. The final diagnosis was laryngitis. Records revealed patient had had chest congestion, dry cough and abnormal taste for 1 week. The patient was seen by a primary care physician (PCP) and diagnosed with allergies. Over the counter (OTC) allergy medication was not helpful. A chest X-ray (CXR) was within normal limits. The patient was treated with oral antibiotics and cough syrup. The patient was discharged to home with PCP follow up. The listing indicated that one or more of the events was considered to be disabling and immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID# is 351067. A standard lot check investigation was performed. 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 and was released.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4
Symptoms: Cough, Crying, Dizziness, Dysgeusia, Dyspnoea
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. A 13 year old female who on 14-JUN-2007, was vaccinated with the third dose of GARDASIL IM into her left arm (lot # 655154/1210U). On 14-JUN-2007 the patient experienced abdominal pain, aphonia, asthenia, chest discomfort, cough, crying, dizziness, dysgeusia, dyspnoea, fatigue, headache, hypersensitivity, injection site pain, injection site swelling, laryngitis, malaise, respiratory tract congestion and restless legs syndrome. The symptoms included coughing, trouble breathing, loss of voice, malaise, crying, headache, chest discomfort, pain at injection site with swelling, dizziness, abdominal pain, weakness, fatigue, restless legs. There was no pre-existing illness. The patient required an emergency room visit (ER) visit. On 10-JUL-2009 ER medical records of 10-MAY-2007 was received. The final diagnosis was laryngitis. Records revealed patient had had chest congestion, dry cough and abnormal taste for 1 week. The patient was seen by a primary care physician (PCP) and diagnosed with allergies. Over the counter (OTC) allergy medication was not helpful. A chest X-ray (CXR) was within normal limits. The patient was treated with oral antibiotics and cough syrup. The patient was discharged to home with PCP follow up. The listing indicated that one or more of the events was considered to be disabling and immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID# is 351067. A standard lot check investigation was performed. 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 and was released.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4
Symptoms: Fatigue, Headache, Hypersensitivity, Injection site pain, Injection site swelling
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. A 13 year old female who on 14-JUN-2007, was vaccinated with the third dose of GARDASIL IM into her left arm (lot # 655154/1210U). On 14-JUN-2007 the patient experienced abdominal pain, aphonia, asthenia, chest discomfort, cough, crying, dizziness, dysgeusia, dyspnoea, fatigue, headache, hypersensitivity, injection site pain, injection site swelling, laryngitis, malaise, respiratory tract congestion and restless legs syndrome. The symptoms included coughing, trouble breathing, loss of voice, malaise, crying, headache, chest discomfort, pain at injection site with swelling, dizziness, abdominal pain, weakness, fatigue, restless legs. There was no pre-existing illness. The patient required an emergency room visit (ER) visit. On 10-JUL-2009 ER medical records of 10-MAY-2007 was received. The final diagnosis was laryngitis. Records revealed patient had had chest congestion, dry cough and abnormal taste for 1 week. The patient was seen by a primary care physician (PCP) and diagnosed with allergies. Over the counter (OTC) allergy medication was not helpful. A chest X-ray (CXR) was within normal limits. The patient was treated with oral antibiotics and cough syrup. The patient was discharged to home with PCP follow up. The listing indicated that one or more of the events was considered to be disabling and immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID# is 351067. A standard lot check investigation was performed. 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 and was released.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL, HPV4
Symptoms: Laryngitis, Malaise, Respiratory tract congestion, Restless legs syndrome
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. A 13 year old female who on 14-JUN-2007, was vaccinated with the third dose of GARDASIL IM into her left arm (lot # 655154/1210U). On 14-JUN-2007 the patient experienced abdominal pain, aphonia, asthenia, chest discomfort, cough, crying, dizziness, dysgeusia, dyspnoea, fatigue, headache, hypersensitivity, injection site pain, injection site swelling, laryngitis, malaise, respiratory tract congestion and restless legs syndrome. The symptoms included coughing, trouble breathing, loss of voice, malaise, crying, headache, chest discomfort, pain at injection site with swelling, dizziness, abdominal pain, weakness, fatigue, restless legs. There was no pre-existing illness. The patient required an emergency room visit (ER) visit. On 10-JUL-2009 ER medical records of 10-MAY-2007 was received. The final diagnosis was laryngitis. Records revealed patient had had chest congestion, dry cough and abnormal taste for 1 week. The patient was seen by a primary care physician (PCP) and diagnosed with allergies. Over the counter (OTC) allergy medication was not helpful. A chest X-ray (CXR) was within normal limits. The patient was treated with oral antibiotics and cough syrup. The patient was discharged to home with PCP follow up. The listing indicated that one or more of the events was considered to be disabling and immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID# is 351067. A standard lot check investigation was performed. 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 and was released.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Blister, Headache, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: 2 weeks after administration of Gardisil, patient developed severe chickenpox.  1 week of fever, 3 weeks of rash.  Patient still has severe scarring of face.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Varicella
Clinical narrative: 2 weeks after administration of Gardisil, patient developed severe chickenpox.  1 week of fever, 3 weeks of rash.  Patient still has severe scarring of face.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Pyrexia, Rash, Scar, Varicella
Clinical narrative: 2 weeks after administration of Gardisil, patient developed severe chickenpox.  1 week of fever, 3 weeks of rash.  Patient still has severe scarring of face.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abasia, Arthralgia, Muscular weakness, Smear cervix abnormal, Vaginal lesion
Clinical narrative: Seen 4/29/08 with joint pain of approx 3 mo. time - eventually diagnosed with RF & polyarthritis.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Wheelchair user
Clinical narrative: Seen 4/29/08 with joint pain of approx 3 mo. time - eventually diagnosed with RF & polyarthritis.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Polyarthritis, Respiratory failure
Clinical narrative: Seen 4/29/08 with joint pain of approx 3 mo. time - eventually diagnosed with RF & polyarthritis.
Age: 13.0
Sex: F
Vaccine: MEN, MEN
Symptoms: Back pain, Decreased appetite, Headache, Human herpes virus 6 serology negative, Lumbar puncture
Clinical narrative: Headache, myalgias, neck pain, fevers, pain in legs/knees/ankles/back - progressive. 8-12-09 Head/neck/back pain with fever started. 8-13-09 Leg/knee/ankle pains started. Initial report received on 21 August 2009 from a health care professional in the United States. a 13-year-old female patient, with unknown medical history, had received a dose of Menomune (lot number, route and site not reported) on 11 August 2009 (date uncertain by reporter). One day post-vaccination, the patient started having a headache, backache, and fever of 105.0 degree Fahrenheit. The patient sought treatment at the emergency room on 14 August 2009 and again on 15 August 2009 and was admitted that day to the hospital. One day two of hospitalization, the patient developed severe nausea, decreased appetite and rash on her trunk and legs. Treatments received and diagnostic tests performed were not reported. The patient was discharged on day four of hospitalization. Subsequently, the patient returned to her health care provided for evaluation of continued "problems", and a "spinal tap" (lumbar puncture test) was performed on 20 August 2009, however the results were not reported. At the time of this report, the patient was in the hospital with a diagnosis of meningitis. No strain had been identified. Recovery status was not reported. Follow up information received on 18 September 2009 from a health care professional in the United States who reported that the patient was diagnosed with viral meningitis. Lot number was provided for Menomune. UF389AA. The patient was reported as recovered. No further information was provided. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: MEN, MEN
Symptoms: Nausea, Neutrophil count increased, Parosmia, Pyrexia, Rash
Clinical narrative: Headache, myalgias, neck pain, fevers, pain in legs/knees/ankles/back - progressive. 8-12-09 Head/neck/back pain with fever started. 8-13-09 Leg/knee/ankle pains started. Initial report received on 21 August 2009 from a health care professional in the United States. a 13-year-old female patient, with unknown medical history, had received a dose of Menomune (lot number, route and site not reported) on 11 August 2009 (date uncertain by reporter). One day post-vaccination, the patient started having a headache, backache, and fever of 105.0 degree Fahrenheit. The patient sought treatment at the emergency room on 14 August 2009 and again on 15 August 2009 and was admitted that day to the hospital. One day two of hospitalization, the patient developed severe nausea, decreased appetite and rash on her trunk and legs. Treatments received and diagnostic tests performed were not reported. The patient was discharged on day four of hospitalization. Subsequently, the patient returned to her health care provided for evaluation of continued "problems", and a "spinal tap" (lumbar puncture test) was performed on 20 August 2009, however the results were not reported. At the time of this report, the patient was in the hospital with a diagnosis of meningitis. No strain had been identified. Recovery status was not reported. Follow up information received on 18 September 2009 from a health care professional in the United States who reported that the patient was diagnosed with viral meningitis. Lot number was provided for Menomune. UF389AA. The patient was reported as recovered. No further information was provided. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: MEN, MEN
Symptoms: Arthralgia, Back pain, CSF white blood cell count increased, Headache, Lumbar puncture
Clinical narrative: Headache, myalgias, neck pain, fevers, pain in legs/knees/ankles/back - progressive. 8-12-09 Head/neck/back pain with fever started. 8-13-09 Leg/knee/ankle pains started. Initial report received on 21 August 2009 from a health care professional in the United States. a 13-year-old female patient, with unknown medical history, had received a dose of Menomune (lot number, route and site not reported) on 11 August 2009 (date uncertain by reporter). One day post-vaccination, the patient started having a headache, backache, and fever of 105.0 degree Fahrenheit. The patient sought treatment at the emergency room on 14 August 2009 and again on 15 August 2009 and was admitted that day to the hospital. One day two of hospitalization, the patient developed severe nausea, decreased appetite and rash on her trunk and legs. Treatments received and diagnostic tests performed were not reported. The patient was discharged on day four of hospitalization. Subsequently, the patient returned to her health care provided for evaluation of continued "problems", and a "spinal tap" (lumbar puncture test) was performed on 20 August 2009, however the results were not reported. At the time of this report, the patient was in the hospital with a diagnosis of meningitis. No strain had been identified. Recovery status was not reported. Follow up information received on 18 September 2009 from a health care professional in the United States who reported that the patient was diagnosed with viral meningitis. Lot number was provided for Menomune. UF389AA. The patient was reported as recovered. No further information was provided. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: MEN, MEN
Symptoms: Meningitis viral, Myalgia, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Headache, myalgias, neck pain, fevers, pain in legs/knees/ankles/back - progressive. 8-12-09 Head/neck/back pain with fever started. 8-13-09 Leg/knee/ankle pains started. Initial report received on 21 August 2009 from a health care professional in the United States. a 13-year-old female patient, with unknown medical history, had received a dose of Menomune (lot number, route and site not reported) on 11 August 2009 (date uncertain by reporter). One day post-vaccination, the patient started having a headache, backache, and fever of 105.0 degree Fahrenheit. The patient sought treatment at the emergency room on 14 August 2009 and again on 15 August 2009 and was admitted that day to the hospital. One day two of hospitalization, the patient developed severe nausea, decreased appetite and rash on her trunk and legs. Treatments received and diagnostic tests performed were not reported. The patient was discharged on day four of hospitalization. Subsequently, the patient returned to her health care provided for evaluation of continued "problems", and a "spinal tap" (lumbar puncture test) was performed on 20 August 2009, however the results were not reported. At the time of this report, the patient was in the hospital with a diagnosis of meningitis. No strain had been identified. Recovery status was not reported. Follow up information received on 18 September 2009 from a health care professional in the United States who reported that the patient was diagnosed with viral meningitis. Lot number was provided for Menomune. UF389AA. The patient was reported as recovered. No further information was provided. Documents held by sender: None.
Age: 35.0
Sex: F
Vaccine: DTAP, PPV, PPV, TDAP
Symptoms: Angioedema, Erythema, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: 8/19 2:00 IM given. 4:30 large knot at inject site; itchy; pain. 6:00 seen by doctor & given hydroxyzine. 8/20 9:00pm arm & elbow severely swollen seen in ER & give prednisone; very painful, red, hot. 8/26 swelling subsided.
Age: 35.0
Sex: F
Vaccine: DTAP, PPV, PPV, TDAP
Symptoms: Skin warm, Urticaria
Clinical narrative: 8/19 2:00 IM given. 4:30 large knot at inject site; itchy; pain. 6:00 seen by doctor & given hydroxyzine. 8/20 9:00pm arm & elbow severely swollen seen in ER & give prednisone; very painful, red, hot. 8/26 swelling subsided.
Age: 35.0
Sex: F
Vaccine: DTAP, PPV, PPV, TDAP
Symptoms: Angioedema, Erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: 8/19 2:00 IM given. 4:30 large knot at inject site; itchy; pain. 6:00 seen by doctor & given hydroxyzine. 8/20 9:00pm arm & elbow severely swollen seen in ER & give prednisone; very painful, red, hot. 8/26 swelling subsided.
Age: 35.0
Sex: F
Vaccine: DTAP, PPV, PPV, TDAP
Symptoms: Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: 8/19 2:00 IM given. 4:30 large knot at inject site; itchy; pain. 6:00 seen by doctor & given hydroxyzine. 8/20 9:00pm arm & elbow severely swollen seen in ER & give prednisone; very painful, red, hot. 8/26 swelling subsided.
Age: 1.1
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, PNC, VARCEL
Symptoms: Pruritus, Rash generalised
Clinical narrative: Head to toe rash, itching, no temp, no exposure, Tx:  Tylenol prn.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Malaise, Pyrexia, Tenderness
Clinical narrative: Patient reported that he had not receive Pneumo vaccine in the past.  Patient received Flu vaccine (left arm) and Pneumo vaccine (right arm) on Friday 9/4/09. On Monday 9/7/09 pt reported fever (100.6) for 2 days, chills and malaise for 2-3 days, tenderness and redness on right arm til present. Currently pt is feeling "normal" except for the slight tenderness on the right arm. He now recalled that he did received a pneumo vaccine 2 years ago and experienced chills after the vaccination.  Patient stated that he will see MD on Thursday.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: None Stated.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Chest discomfort, Injection site erythema, Injection site reaction, Rash papular, Urticaria
Clinical narrative: Hives appeared within 6 hours of vaccine admin.  Responded to BENADRYL liquid but continued to recur for 48-72h.  1 episode of tightness in chest.  Local reaction also with redness with "bumps".
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic reaction, Swelling face, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 5 year old male student with a delayed delivery who on 27-AUG-2009 at 10:00 am, was vaccinated with the second dose of MMR II (Lot number: 664364/0707Y) subcutaneously in the right thigh. On 27-AUG-2009 at 11:00 am, the patient experienced a systemic reaction; hives and facial swelling. The patient required a visit to his physician and the symptoms were treated with oral BENADRYL. At the time of the report, the patient status was unknown. Upon internal review systemic reaction was considered an other important medical event. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Brachial plexus injury, Injected limb mobility decreased, Muscular weakness, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 65 year old male with no significant medical history who on 08-AUG-2009 was vaccinated with a dose of PNEUMOVAX (lot no. not reported) into the left arm. On 09-AUG-2009 the experienced weakness and pain in the injection arm. The patient also had fever of 1002F which continued for 6 days. Physician reported that the area was not cellulitic and there was no obvious source of fever. The physician stated that patient had brachial plexus and the patient was not able to move his arm at all. At the time of the report the patient had not recovered. The patient sought medical attention at the doctor's office. Follow up information has been received from the physician, concerning 69 year old (previously reported as 65 years old) retired male patient with no illness at the time of vaccination and no known allergies, who on 08-AUG-2009 at 8:30 am, was vaccinated with the first dose of PNEUMOVAX, intramuscularly in the left deltoid. 48 hours after injection, the patient complained of severe pain, weakness of left shoulder and left arm, with no erythema. In the medical examination the patient had marked tenderness on left deltoid and severe weakness of left shoulder abduction, left elbow flexion and extension; left hand grip, left wrist extension and flexion. There was no sensory deficit. The physician diagnosed the patient with left brachial plexitis. On an unspecified date, the patient recovered with full strength after the physician injected 80 mg DEPO MEDROL into the left subdeltoid bursa. The physician considered left brachial plexitis to be disabling and other important medical event. No further information is expected.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from a physician concerning a 65 year old male with no significant medical history who on 08-AUG-2009 was vaccinated with a dose of PNEUMOVAX (lot no. not reported) into the left arm. On 09-AUG-2009 the experienced weakness and pain in the injection arm. The patient also had fever of 1002F which continued for 6 days. Physician reported that the area was not cellulitic and there was no obvious source of fever. The physician stated that patient had brachial plexus and the patient was not able to move his arm at all. At the time of the report the patient had not recovered. The patient sought medical attention at the doctor's office. Follow up information has been received from the physician, concerning 69 year old (previously reported as 65 years old) retired male patient with no illness at the time of vaccination and no known allergies, who on 08-AUG-2009 at 8:30 am, was vaccinated with the first dose of PNEUMOVAX, intramuscularly in the left deltoid. 48 hours after injection, the patient complained of severe pain, weakness of left shoulder and left arm, with no erythema. In the medical examination the patient had marked tenderness on left deltoid and severe weakness of left shoulder abduction, left elbow flexion and extension; left hand grip, left wrist extension and flexion. There was no sensory deficit. The physician diagnosed the patient with left brachial plexitis. On an unspecified date, the patient recovered with full strength after the physician injected 80 mg DEPO MEDROL into the left subdeltoid bursa. The physician considered left brachial plexitis to be disabling and other important medical event. No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Haemophilus infection
Clinical narrative: Information has been received from a physician concerning a patient "who just came out of hospital received series of three PNEUMOVAX vaccines in the past. The last was given about 2 years ago and the patient just developed haemophilus. "Hospital demographics were unspecified. Reason for hospitalization was unspecified. Lot # was not available. The patient spoke with the physician for medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Foetal disorder, Ultrasound scan
Clinical narrative: Information has been received from a registered nurse certificated concerning a 22 year old female patient with no significant past medical history and no concurrent medical conditions who on 19-SEP-2008 was vaccinated with the first dose of GARDASIL (Lot # 660620/0571X). No concomitant medication was reported. On 19-NOV-2008 was vaccinated with the second dose of GARDASIL (Lot # 661044/0548X). On 20-JAN-2009, an ultrasound was performed for dating which showed single live intrauterine pregnancy (SLIUP), 12 weeks, 2 days. (LMP 31-OCT-2008, EDD 07-JUL-2009). A MSAFP was declined by the patient. Follow up information was received from a registered nurse certified. She reported that on 08-AUG-2009, at 40 1/7 weeks from LMP, the patient gave birth to a normal male infant with no congenital anomalies weighing 8 pounds and 0 ounces, apgar score 9/9. It was reported that the patient required a c-section for fetal bradycardia due to cord compression (cord pH 7.257). There were no other complications during pregnancy neither infections nor illnesses. Laboratory testing during pregnancy included routine screening (results not provided). Upon internal review c-section, fetal bradycardia and cord compression were determined to be other important medical events. Additional information has been requested.