chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Discomfort, Erythema, Feeling hot, Hyperhidrosis
Clinical narrative: Report received from Plasma Center on 21-Oct-2008.  An employee received AFLURIA on 21-oct-2008 and has developed numbness in her arm and her fingers are tingling.  Additional information has been requested.  No serious criteria mentioned.  Causality:  Conditional/ Unclassified.  Follow-up information received on 22-Oct-2008 from Plasma Center.  A 19 year-old non-pregnant female received AFLURIA, lot 03549111A, on 21-Oct-2008 14:15.  Vaccine administered IM to right deltoid.  Immediately following vaccination, the patient experienced pain.  At 18:30, the patient complained of tingling and numbness in fingers that spread to entire arm.  Reactions occurred on the same arm as the vaccination.  Patient was warm to the touch and red; temperature was 99.1 F.  She continued feeling warm and became sweaty.  She was instructed to go to the emergency room for evaluation and treatment.  As of 22-Oct-2008, the tingling/numbness has resolved but the pain continues.  At the time of the vaccination, patient was not ill.  Patient does have seasonal allergies.  Additional information has been requested.  No change in assessment.  The company considered events to be probably related to the suspect drug.  Follow-up information received on 22-Oct-2008 from Plasma Center.  Per reporter, the tingling and pain (hurting) continues.  The patient has not contacted her physician about this reaction.  Follow-up information received on 05-Nov-2008 from Plasma Center.  Per the reporter, the symptoms resolved within a couple of days.  Patient did seek medical attention; details are not known by reporter.  Follow-up information received on 06-Nov-2008 from a nurse at Plasma Center.  Per the reporter, patient has recovered and did receive treatment (unspecified) at the hospital, and she was told to take IBUPROFEN.  Hospital told patient that it (reaction) was just the muscle pushing against the nerve.  Follow-up information received on 07-Nov-2008 from a medical staff associate at the Plasma Center.  Along with the tingling in her fingers, patient also had discomfort.  No further information is expected.  Information derived from this AE report does not change the current safety profile of AFLURIA (CSL influenza vaccine).  Results of batch review for 0354911A received on 18-NOV-2008:  All deviations related to the manufacture of this lot were assessed as having no impact on product.  All deviations related to the manufacture of this lot were assessed as having no impact on product quality.  All QC testing was satisfactory with no out of specification results reported.  There are no outstanding issues for this lot that would potentially affect product quality.  In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site anaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Report received from Plasma Center on 21-Oct-2008.  An employee received AFLURIA on 21-oct-2008 and has developed numbness in her arm and her fingers are tingling.  Additional information has been requested.  No serious criteria mentioned.  Causality:  Conditional/ Unclassified.  Follow-up information received on 22-Oct-2008 from Plasma Center.  A 19 year-old non-pregnant female received AFLURIA, lot 03549111A, on 21-Oct-2008 14:15.  Vaccine administered IM to right deltoid.  Immediately following vaccination, the patient experienced pain.  At 18:30, the patient complained of tingling and numbness in fingers that spread to entire arm.  Reactions occurred on the same arm as the vaccination.  Patient was warm to the touch and red; temperature was 99.1 F.  She continued feeling warm and became sweaty.  She was instructed to go to the emergency room for evaluation and treatment.  As of 22-Oct-2008, the tingling/numbness has resolved but the pain continues.  At the time of the vaccination, patient was not ill.  Patient does have seasonal allergies.  Additional information has been requested.  No change in assessment.  The company considered events to be probably related to the suspect drug.  Follow-up information received on 22-Oct-2008 from Plasma Center.  Per reporter, the tingling and pain (hurting) continues.  The patient has not contacted her physician about this reaction.  Follow-up information received on 05-Nov-2008 from Plasma Center.  Per the reporter, the symptoms resolved within a couple of days.  Patient did seek medical attention; details are not known by reporter.  Follow-up information received on 06-Nov-2008 from a nurse at Plasma Center.  Per the reporter, patient has recovered and did receive treatment (unspecified) at the hospital, and she was told to take IBUPROFEN.  Hospital told patient that it (reaction) was just the muscle pushing against the nerve.  Follow-up information received on 07-Nov-2008 from a medical staff associate at the Plasma Center.  Along with the tingling in her fingers, patient also had discomfort.  No further information is expected.  Information derived from this AE report does not change the current safety profile of AFLURIA (CSL influenza vaccine).  Results of batch review for 0354911A received on 18-NOV-2008:  All deviations related to the manufacture of this lot were assessed as having no impact on product.  All deviations related to the manufacture of this lot were assessed as having no impact on product quality.  All QC testing was satisfactory with no out of specification results reported.  There are no outstanding issues for this lot that would potentially affect product quality.  In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Report received from Plasma Center on 21-Oct-2008.  An employee received AFLURIA on 21-oct-2008 and has developed numbness in her arm and her fingers are tingling.  Additional information has been requested.  No serious criteria mentioned.  Causality:  Conditional/ Unclassified.  Follow-up information received on 22-Oct-2008 from Plasma Center.  A 19 year-old non-pregnant female received AFLURIA, lot 03549111A, on 21-Oct-2008 14:15.  Vaccine administered IM to right deltoid.  Immediately following vaccination, the patient experienced pain.  At 18:30, the patient complained of tingling and numbness in fingers that spread to entire arm.  Reactions occurred on the same arm as the vaccination.  Patient was warm to the touch and red; temperature was 99.1 F.  She continued feeling warm and became sweaty.  She was instructed to go to the emergency room for evaluation and treatment.  As of 22-Oct-2008, the tingling/numbness has resolved but the pain continues.  At the time of the vaccination, patient was not ill.  Patient does have seasonal allergies.  Additional information has been requested.  No change in assessment.  The company considered events to be probably related to the suspect drug.  Follow-up information received on 22-Oct-2008 from Plasma Center.  Per reporter, the tingling and pain (hurting) continues.  The patient has not contacted her physician about this reaction.  Follow-up information received on 05-Nov-2008 from Plasma Center.  Per the reporter, the symptoms resolved within a couple of days.  Patient did seek medical attention; details are not known by reporter.  Follow-up information received on 06-Nov-2008 from a nurse at Plasma Center.  Per the reporter, patient has recovered and did receive treatment (unspecified) at the hospital, and she was told to take IBUPROFEN.  Hospital told patient that it (reaction) was just the muscle pushing against the nerve.  Follow-up information received on 07-Nov-2008 from a medical staff associate at the Plasma Center.  Along with the tingling in her fingers, patient also had discomfort.  No further information is expected.  Information derived from this AE report does not change the current safety profile of AFLURIA (CSL influenza vaccine).  Results of batch review for 0354911A received on 18-NOV-2008:  All deviations related to the manufacture of this lot were assessed as having no impact on product.  All deviations related to the manufacture of this lot were assessed as having no impact on product quality.  All QC testing was satisfactory with no out of specification results reported.  There are no outstanding issues for this lot that would potentially affect product quality.  In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Nausea, Pain in extremity
Clinical narrative: Felt nauseous, dizzy, headache, right arm pain (injection arm). Report received on 10/21/2008. A 30 year-old female (D.P., DOB 07/12/1978) received AFLURLA IM at right deltoid on 21-Oct-2008 9:40am. AFLURLA lot number administered: 03549111A, exp date 30-Jul-2009. The patient had no illness at the time of vaccination and had no pre-existing allergies, or medical conditions. Patient is not taking and medication. At approximately 12:00pm on 21-oct-2008, patient started 12:00pm on 21-Oct-2008, patient started to feel nauseous, dizzy, complained of headache, and complained of right arm pain. The reporter considered the event as non-serious. No further information is expected.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus generalised, Urticaria
Clinical narrative: Report received from a Registered Nurse (RN) on 20-OCT-2008.  An adult female patient (age and patient initials unknown) received a dose of AFLURIA (0.5 ml) from the pre-filled syringe at 3:00pm.  At 7:30pm, she experienced itching.  She felt itching on feet and it progressed all over her body.  There was some redness after she scratched.  One source other than the RN said the patient was showing hives.  Patient had no respiratory symptoms.  She went to the emergency room (ER) around 8:00pm and received BENADRYL as well as a prescription for PREDNISONE.  She left the ER at 9:00pm.  The next day patient stated that she was doing ok.  It is not known if the patient is allergic to any food or drugs.  Additional information has been requested.  No serious criteria mentioned.  Causality: Possible.  Follow-up information was received on 21-Oct-2008 from the RN.  The RN provided a few additional details.  The patient is an employee at the nursing home.  On 15-Oct-2008, AFLURIA was administered to all employees and residents at the nursing home.  The patient, is a 39 year-old female employee at the nursing home.  RN reiterated that subject experienced itching after vaccination.  She felt itching on feet and it progressed all over her body.  Patient is fine now.  Per the RN, approximately 240 doses were given and this was the only reaction.  RN "did not consider this as an adverse reaction but rather a known side-effect from the vaccination".  No additional information is expected.  No change in assessment.  Information derived from this AE report does not change the current safety profile of the product.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary mass, Axillary pain
Clinical narrative: Swelling under armpit, tenderness under armpit. A female patient received AFLURIA (prefilled syringe) on 15-Oct-2008 (PM) in the hospital and complained of swelling under the armpit on the morning of 17-Oct-2008 at 6:00 AM (06:00 hours). The injection was given in the left deltoid, IM injection. The nurse palpated the area and did not feel that a lymph node was involved, nor was any redness observed. The patient stated it feels tender. patient has allergies to sulfa and Tylenol(acetaminophen. Follow-up information was provided by patient and nurse on 20-Oct02008. The 50 year-old patient (DOB 11-Jan-1958) reports she is not yet recovered and that she is to visit with her physician on 20-Oct-2008. The patient reports she does not receive any other vaccinations within the past 4 weeks and reports no known pre-existing medical conditions. Patient had no illness at time of vaccination. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever(105F). Report received from physician on 03-Oct-2008. A 60 year-old patient received AFLURIA (batch number unknown) on 01-Oct-2008. The patient called the physician's office on 03-Oct-2008 to report a fever of 103 F. the patient consulted with the physician. Awaiting further information.
Age: 88.0
Sex: U
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Report received from a physician on 03-OCT-2008.  An 88 year-old patient received AFLURIA (batch unknown) on 30-Sep-2008 and experienced a fever of about 103F within 2 days of administration (02-Oct-2008).  The fever resolved (date unknown).  Awaiting further information.  Serious criteria: None; Causality: The company assessed this case as possibly related.  Information derived from this AE report does not change the current safety profile of the product.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Exfoliative rash, Rash
Clinical narrative: Rash on chest and stomach.  Spots subsided but still visible 1.5 months after vaccine.  They are red and scaly.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Confusional state, Delusional perception, Lethargy, Myalgia
Clinical narrative: Lethargic, temperature that lasted 3 hours after injection, muscle pains in arms and legs, confusion that has continually lasted, disorganized thoughts and delusional thinking.  Sought treatment from Dr. for medical evaluation and treatment.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Pyrexia, Rash, Swelling face
Clinical narrative: Swelling and rash on the face (Lips, eyes, and cheeks) and fever.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Barium double contrast, Enema administration, Explorative laparotomy, Intussusception
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 12 week male patient with congenital hydronephrosis resolved by 3 months of age and upper respiratory infection 1 week prior (records received on 20-NOV-2008) who on 27-AUG-2008, was vaccinated with the second dose of ROTATEQ (lot # 660425/0278X) by mouth. Other therapy given on the same date included second dose of PEDIARIX (Lot # AC21B150AA) IM into the right leg, second dose of ACTHIB (Lot # UF465AB) IM into the left leg and second dose of PREVNAR (Lot # C50457) IM into the left leg. On 25-SEP-2008, the patient developed intussusception. Air enema reduction was unsuccessful and patient had to have surgical reduction of intussusception bowel. On 20-NOV-2008, records received for date of service 26-SEP-2008 and 28-SEP-2008 diagnosis was intussusception. The patient presented to the Emergency Department with nonreducible intussusception and increasing lethargic, emesis bilious. Exploratory laparotomy with manual reduction of ileocolic intussusception. Laboratory data reported include: on 20-NOV-2008 (record received): upper GI study concern of malrotation. Abdominal films demonstrating contrast in small bowel and did not appear dilated. Ultrasound positive. Air contrast enema unsuccessful in reducing intussusception. The listing indicated that one or more of the events required hospitalization, and was considered to be immediately life-threatening. No further information is available. This original reporting source was not provided. 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 for Biologics Evaluation and Research and was released.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Laboratory test abnormal, Lethargy, Ultrasound abdomen abnormal, Vomiting, X-ray gastrointestinal tract 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. A 12 week male patient with congenital hydronephrosis resolved by 3 months of age and upper respiratory infection 1 week prior (records received on 20-NOV-2008) who on 27-AUG-2008, was vaccinated with the second dose of ROTATEQ (lot # 660425/0278X) by mouth. Other therapy given on the same date included second dose of PEDIARIX (Lot # AC21B150AA) IM into the right leg, second dose of ACTHIB (Lot # UF465AB) IM into the left leg and second dose of PREVNAR (Lot # C50457) IM into the left leg. On 25-SEP-2008, the patient developed intussusception. Air enema reduction was unsuccessful and patient had to have surgical reduction of intussusception bowel. On 20-NOV-2008, records received for date of service 26-SEP-2008 and 28-SEP-2008 diagnosis was intussusception. The patient presented to the Emergency Department with nonreducible intussusception and increasing lethargic, emesis bilious. Exploratory laparotomy with manual reduction of ileocolic intussusception. Laboratory data reported include: on 20-NOV-2008 (record received): upper GI study concern of malrotation. Abdominal films demonstrating contrast in small bowel and did not appear dilated. Ultrasound positive. Air contrast enema unsuccessful in reducing intussusception. The listing indicated that one or more of the events required hospitalization, and was considered to be immediately life-threatening. No further information is available. This original reporting source was not provided. 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 for Biologics Evaluation and Research and was released.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, TD, FLU3, PPV, TD
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pruritus, Rash
Clinical narrative: Vaccinations on 10/29/2008. Pt states had vaccinations on 10/29/08. Pneumonia & flu on the R arm and Td on the L arm. On 11/4/08 in the pm pt states L arm started itching. That evening pt noticed that L arm was red, swollen, warm to touch, hurting and with a rash. On 11/5/08 pt calls the clinic with above complaints. Adivsed pt to come to clinic for further evalutions. On evaluation it was found that arm was red, swollen (area at 6x3 inches with 3mm elevation) warm to touch, itching and painful. Small milia-like shape bumps were also noticed. Pt was advised to place cold compresses on arm, take BENADRYL for itching and TYLENOL for the pain. Also advised pt that if symptoms got worse to go to the ER.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, TD, FLU3, PPV, TD
Symptoms: Skin warm
Clinical narrative: Vaccinations on 10/29/2008. Pt states had vaccinations on 10/29/08. Pneumonia & flu on the R arm and Td on the L arm. On 11/4/08 in the pm pt states L arm started itching. That evening pt noticed that L arm was red, swollen, warm to touch, hurting and with a rash. On 11/5/08 pt calls the clinic with above complaints. Adivsed pt to come to clinic for further evalutions. On evaluation it was found that arm was red, swollen (area at 6x3 inches with 3mm elevation) warm to touch, itching and painful. Small milia-like shape bumps were also noticed. Pt was advised to place cold compresses on arm, take BENADRYL for itching and TYLENOL for the pain. Also advised pt that if symptoms got worse to go to the ER.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Initial report received on 17 November 2008 from a healthcare professional. A 59 year old female patient, with a history of high blood pressure, diabetes, hypothyroidism, hyperlipidemia, cervical disc disease, asthma, migraines and drug allergies (LIPITOR, CELEBREX, VITORIN, and TENEX), received on 26 September 2008 a left deltoid intramuscular injection of FLUZONE (lot number U2750AA). Immediately post vaccination, the patient had a "hard lump" at the injection site which lasted one week. The patient later developed (date not reported) a runny nose, pain above the injection site which radiated to the shoulder joint, a pulling sensation, and increased pain with lifting. The patient consulted a physician on 22 October 2008. The pain was not relieved with heat or ASA. At the time of the report, the pain had improved but it was unknown if it had completely resolved. Follow-up information was received 08 December 2008 from a health care professional. Upon review of follow-up information received, it was determined that this case meets seriousness criteria. According to the reporter, the "patient complained the injection site was hard for one week following vaccination, then after resolved started with following symptoms lasting over two weeks". Corrective treatments consisted of warm soaks. TESSALON PERLE and ULTRAM. On 01 December 2008, the patient still had complaints of consistent pain in the deltoid and bursa area. The patient was seen by a chiropractor who provided treatment by ultrasound and the patient was planning to consult with a acupuncturist. Per the reporter, the patient was unsure of the manufacturer of the previous influenza vaccinations received in the past, however they had no complaints or known reactions following previous influenza vaccinations. The reporter offered to provide prior influenza vaccine lot numbers upon request. At the time of the report, the patient had not recovered from the event. Documents held by sender: None.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, No reaction on previous exposure to drug, Rhinorrhoea
Clinical narrative: Initial report received on 17 November 2008 from a healthcare professional. A 59 year old female patient, with a history of high blood pressure, diabetes, hypothyroidism, hyperlipidemia, cervical disc disease, asthma, migraines and drug allergies (LIPITOR, CELEBREX, VITORIN, and TENEX), received on 26 September 2008 a left deltoid intramuscular injection of FLUZONE (lot number U2750AA). Immediately post vaccination, the patient had a "hard lump" at the injection site which lasted one week. The patient later developed (date not reported) a runny nose, pain above the injection site which radiated to the shoulder joint, a pulling sensation, and increased pain with lifting. The patient consulted a physician on 22 October 2008. The pain was not relieved with heat or ASA. At the time of the report, the pain had improved but it was unknown if it had completely resolved. Follow-up information was received 08 December 2008 from a health care professional. Upon review of follow-up information received, it was determined that this case meets seriousness criteria. According to the reporter, the "patient complained the injection site was hard for one week following vaccination, then after resolved started with following symptoms lasting over two weeks". Corrective treatments consisted of warm soaks. TESSALON PERLE and ULTRAM. On 01 December 2008, the patient still had complaints of consistent pain in the deltoid and bursa area. The patient was seen by a chiropractor who provided treatment by ultrasound and the patient was planning to consult with a acupuncturist. Per the reporter, the patient was unsure of the manufacturer of the previous influenza vaccinations received in the past, however they had no complaints or known reactions following previous influenza vaccinations. The reporter offered to provide prior influenza vaccine lot numbers upon request. At the time of the report, the patient had not recovered from the event. Documents held by sender: None.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Facial palsy
Clinical narrative: Initial report received on 15 December 2008 from a health care professional. A 12-year-old female patient who had no concurrent illness, but who has seasonal allergies that are being treated with CLARITIN, had received a dose of MENACTRA (lot number U2842AA) and a dose of "Hep A" vaccine (manufacturer not unknown, lot number AHAVB320AA) on 08 December 2008. The route and site of administration of both vaccines were not provided. Early in the morning four days post-vaccination, the patient could not move the left side of her face and she was taken to the emergency room for evaluation. The patient was diagnosed with facial palsy and started on steroids (not specified) and was then discharged to home. It was not reported whether any diagnostic tests or laboratory data were performed. At the time of this report, the patient's recovery status was "unknown." Documents held by sender: None
Age: 67.0
Sex: M
Vaccine: BCG
Symptoms: Asthenia, Disorientation, Nausea, Rash, Vomiting
Clinical narrative: Initial report was received on 18 November 2008 from a health care professional. A 67-year-old male patient with a history of grass, mold and shellfish allergies, had received an intramuscular left deltoid injection of FLUZONE SV 2008-2009, lot number U2849AC on 14 November 2008 and 30 minutes later, he developed weakness, nausea and vomiting which persisted at the time of the report. The patient was scheduled to be evaluated by their physician on 18 November 2008. At the time of the report, the patient had not recovered from the event. Follow-up information received on 08 December 2008 from a nurse. Per the reporter, their staff spoke with the patient on 24 November 2008 and he was continuing to feel disoriented. The patient went to the emergency room (date not provided) and reported "no organ damage." The patient reported he had lost 25 pounds since 14 November 2008. He also reported a rash on his elbow below the injection site. The patient is currently on a bland diet and at home. The reporter stated "contact patient for additional information." Per this new information, this case was upgraded to serious. The reporter for this case is the same as case number 2008-03659. Documents held by sender: None.
Age: 67.0
Sex: M
Vaccine: BCG
Symptoms: Weight decreased
Clinical narrative: Initial report was received on 18 November 2008 from a health care professional. A 67-year-old male patient with a history of grass, mold and shellfish allergies, had received an intramuscular left deltoid injection of FLUZONE SV 2008-2009, lot number U2849AC on 14 November 2008 and 30 minutes later, he developed weakness, nausea and vomiting which persisted at the time of the report. The patient was scheduled to be evaluated by their physician on 18 November 2008. At the time of the report, the patient had not recovered from the event. Follow-up information received on 08 December 2008 from a nurse. Per the reporter, their staff spoke with the patient on 24 November 2008 and he was continuing to feel disoriented. The patient went to the emergency room (date not provided) and reported "no organ damage." The patient reported he had lost 25 pounds since 14 November 2008. He also reported a rash on his elbow below the injection site. The patient is currently on a bland diet and at home. The reporter stated "contact patient for additional information." Per this new information, this case was upgraded to serious. The reporter for this case is the same as case number 2008-03659. Documents held by sender: None.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Coma, Endotracheal intubation, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from Company representative who was told by a friend of the patient's family. The patient was a 24 year old female patient who was vaccinated in approximately November-2008 with the third dose of GARDASIL. Concomitant therapy included influenza virus vaccine (unspecified). In approximately November-2008, the patient reported tingling in her fingers and toes shortly after the vaccinations. It got worse over night and she went to the Hospital the next day. The hospital did test for persistent numbness and the patient was sent home. The patient's mother found her crawling on the floor a few days later and she was taken by ambulance to the hospital where she was admitted, intubated and in coma. The patient was diagnosed with Guillain-Barre. As of 16-DEC-2008, the patient was still in coma. Guillain-Barre syndrome and coma were considered to be immediately life-threatening and disabling and other important medical event. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Bone pain, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from an advanced registered nurse practitioner concerning a female patient with no drug reactions/allergies, who on 10-DEC-2008 was vaccinated subcutaneously with 0.65 mL dose of ZOSTAVAX (Lot # 663196/1417X). There was no concomitant medication. Within 48 hours of vaccination, the patient experienced pain, tenderness and redness at injection site. Additionally, the patient felt pain in her spine at T6 to T7. The patient had been taking Ibuprofen (ADVIL) and was using a heating pad and was feeling better. The patient had missed two days of work because of the pain in her spine but she was returning to work on 16-DEC-2008. Pain in her spine at T6 to T7 was considered to be disabling. This is one of several cases from the same source. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Hyperhidrosis, Malaise, Renal failure acute, Tremor
Clinical narrative: Vaccine TdaP 11/14/08 - felt sick 11/15/08, shaky, sweats, chills - went medical center 11/18/08 - admitted - "acute renal failure" - antibiotics & IV - medical center said not bacterial infection - 3 days in hospital - kidney function returned.  1/26/09 Reviewed hospital medical records of 11/19-11/20/2009. FINAL DX: no d/c summary available.  ER dx: acute renal failure, anion gap acidosis & elevated LFTs. Records reveal patient experienced fever, chills, myalgias, dizzy/lightheaded, abdominal & lower back pain, nausea, anorexia x 4 days.  Had bloody/brown vaginal discharge.  OB/GYN consult done & WNL.  Tx w/IVF & antibiotics. Improved markedly overnight w/fluids & antibiotics.  D/C to home.  .
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Computerised tomogram normal, Head injury, Scan brain, Syncope
Clinical narrative: Pt had syncopal episode 5 mins after receiving vaccine pt hit head during episode; slow to recover Admitted to hospital for observation 12/29/08-records received for DOS 12/4-12/5/08-DC DX: Syncopal episode. C/O feeling warm and pale after receiving vaccine, felt dizzy, fell, losing consciousness. C/O headache and ears hurting, hit the right side of had on door frame. Remained drowsy and pale.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Blood culture, Body temperature increased, Cough, Dyspnoea, Oxygen saturation
Clinical narrative: Received FLUMIST Wed. 11-19-08. Began coughing that night. On Thursday cough had gotten worse. Thursday night child became pale, had difficulty breathing, was taken to local ED and transferred via ambulance to medical center. Treated with Albuterol, FLOVENT and Prednisolone. Temperature 101.4 (rectal) 1/2/09-ED records received for DOS 11/21/08-Presented with C/O difficulty breathing, fever intermittent for 2 days then began to have clear rhinorrhea/cough times 4 days prior to presentation. Increased respiratory rate, subcostal retraction, occasional wheeze.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Pallor
Clinical narrative: Received FLUMIST Wed. 11-19-08. Began coughing that night. On Thursday cough had gotten worse. Thursday night child became pale, had difficulty breathing, was taken to local ED and transferred via ambulance to medical center. Treated with Albuterol, FLOVENT and Prednisolone. Temperature 101.4 (rectal) 1/2/09-ED records received for DOS 11/21/08-Presented with C/O difficulty breathing, fever intermittent for 2 days then began to have clear rhinorrhea/cough times 4 days prior to presentation. Increased respiratory rate, subcostal retraction, occasional wheeze.
Age: 14.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Arthralgia, Asthenia, Blood creatine phosphokinase, Blood thyroid stimulating hormone, Differential white blood cell count
Clinical narrative: Odd sensation to feet. Persistent myalgias, fatigue "not feeling well", c/o joint pain, weakness. labs = CBC with diff, ESR, TSH, T4, CPK, LFT's, Tick panel. Referral to Rheumatologist, MD. Referral to neurologist, MD. Electrodiagnostic studies (performed at Neurologist).   12/22/08 MR received with VAERS report with DX:  Acute Inflammatory Demyelinating Polyneuropathy (GBS). WCC 10/9/08 with vax (TDaP and Varicella) given.  Returned 10/20/08 with c/o body soreness, weakness, fatigue and joint pain x 1 week. Assessment:  Myagia and myositis.  Fatigue. Seen again 10/27/08 with worsening sx. PE (+) for enlarged cervical lymph nodes and leg tenderness. Assessment:  Arthralgias and Fatigue.  Referred to Rheumatologist with ? fibromyalgia dx. Reporting difficulty walking by 11/26/08. DX:  Acute infective polyneuritis. Neuro consult 12/1/08. PE (+) for muscle weakness, areflexia, decreased sensation in leghs, and ataxia. DX: GBS to be treated with IVIG.  02/01/2010 Gillian Barre, required Neurologist eval and tx frequently entire year.
Age: 14.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Fatigue, Liver function test, Malaise, Myalgia, Neurological examination
Clinical narrative: Odd sensation to feet. Persistent myalgias, fatigue "not feeling well", c/o joint pain, weakness. labs = CBC with diff, ESR, TSH, T4, CPK, LFT's, Tick panel. Referral to Rheumatologist, MD. Referral to neurologist, MD. Electrodiagnostic studies (performed at Neurologist).   12/22/08 MR received with VAERS report with DX:  Acute Inflammatory Demyelinating Polyneuropathy (GBS). WCC 10/9/08 with vax (TDaP and Varicella) given.  Returned 10/20/08 with c/o body soreness, weakness, fatigue and joint pain x 1 week. Assessment:  Myagia and myositis.  Fatigue. Seen again 10/27/08 with worsening sx. PE (+) for enlarged cervical lymph nodes and leg tenderness. Assessment:  Arthralgias and Fatigue.  Referred to Rheumatologist with ? fibromyalgia dx. Reporting difficulty walking by 11/26/08. DX:  Acute infective polyneuritis. Neuro consult 12/1/08. PE (+) for muscle weakness, areflexia, decreased sensation in leghs, and ataxia. DX: GBS to be treated with IVIG.  02/01/2010 Gillian Barre, required Neurologist eval and tx frequently entire year.
Age: 14.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Red blood cell sedimentation rate, Thyroxine
Clinical narrative: Odd sensation to feet. Persistent myalgias, fatigue "not feeling well", c/o joint pain, weakness. labs = CBC with diff, ESR, TSH, T4, CPK, LFT's, Tick panel. Referral to Rheumatologist, MD. Referral to neurologist, MD. Electrodiagnostic studies (performed at Neurologist).   12/22/08 MR received with VAERS report with DX:  Acute Inflammatory Demyelinating Polyneuropathy (GBS). WCC 10/9/08 with vax (TDaP and Varicella) given.  Returned 10/20/08 with c/o body soreness, weakness, fatigue and joint pain x 1 week. Assessment:  Myagia and myositis.  Fatigue. Seen again 10/27/08 with worsening sx. PE (+) for enlarged cervical lymph nodes and leg tenderness. Assessment:  Arthralgias and Fatigue.  Referred to Rheumatologist with ? fibromyalgia dx. Reporting difficulty walking by 11/26/08. DX:  Acute infective polyneuritis. Neuro consult 12/1/08. PE (+) for muscle weakness, areflexia, decreased sensation in leghs, and ataxia. DX: GBS to be treated with IVIG.  02/01/2010 Gillian Barre, required Neurologist eval and tx frequently entire year.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Insomnia
Clinical narrative: Patient complained the soreness of injection sites lasted until now. Some nights she couldn't sleep.
Age: 15.0
Sex: F
Vaccine: FLUN3, HEPA, HPV4
Symptoms: Blood thyroid stimulating hormone, Computerised tomogram, Dizziness, Full blood count, Headache
Clinical narrative: Headache, occasional blurring vision, tingling numbness, dizziness.
Age: 15.0
Sex: F
Vaccine: FLUN3, HEPA, HPV4
Symptoms: Hypoaesthesia, Metabolic function test, Paraesthesia, Thyroxine, Vision blurred
Clinical narrative: Headache, occasional blurring vision, tingling numbness, dizziness.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pain
Clinical narrative: Patient called stating left side if neck was swollen at pneumonia and flu shot on 10-21-08. Asked patient to go to family Dr and to call and seeing him. patient called 10-23-08. States family Dr gave a cortisone shot and pain meds. Told to apply cold compress 20 min then off 10 min, then back on neck 20 min. Patient states pain is less and swelling is going away. Told by Dr and health dept to never take another pneumonia shot.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood culture negative, Blood test normal, Chest X-ray normal, Chills
Clinical narrative: Both hands broke out with raised red oval shaped papules, mostly on palmar surface of fingers and knuckles of right hand about 24 hours after vaccine, then within an hour or so, pt felt very weak, hurt all over, ached from scalp to toes, had chills and fever, no improvement , so saw PMD. 10/13 had X-ray of lungs, UA blood work and blood cultures 30 "apart" all negative. Frontal HA (headache) x 2 weeks, relieve with TYLENOL or ADVIL. No respiratory symptoms. Tired for the next month . Hands began to peel about 3 weeks after immunization, face swelled for about 2 weeks after immunization, "lip looked like had been in a fight, red around eyes". Now 5 weeks after shot his slight fatigue and weakness of legs.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Induration, Lip swelling, Ocular hyperaemia
Clinical narrative: Both hands broke out with raised red oval shaped papules, mostly on palmar surface of fingers and knuckles of right hand about 24 hours after vaccine, then within an hour or so, pt felt very weak, hurt all over, ached from scalp to toes, had chills and fever, no improvement , so saw PMD. 10/13 had X-ray of lungs, UA blood work and blood cultures 30 "apart" all negative. Frontal HA (headache) x 2 weeks, relieve with TYLENOL or ADVIL. No respiratory symptoms. Tired for the next month . Hands began to peel about 3 weeks after immunization, face swelled for about 2 weeks after immunization, "lip looked like had been in a fight, red around eyes". Now 5 weeks after shot his slight fatigue and weakness of legs.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Rash papular, Skin exfoliation, Swelling face
Clinical narrative: Both hands broke out with raised red oval shaped papules, mostly on palmar surface of fingers and knuckles of right hand about 24 hours after vaccine, then within an hour or so, pt felt very weak, hurt all over, ached from scalp to toes, had chills and fever, no improvement , so saw PMD. 10/13 had X-ray of lungs, UA blood work and blood cultures 30 "apart" all negative. Frontal HA (headache) x 2 weeks, relieve with TYLENOL or ADVIL. No respiratory symptoms. Tired for the next month . Hands began to peel about 3 weeks after immunization, face swelled for about 2 weeks after immunization, "lip looked like had been in a fight, red around eyes". Now 5 weeks after shot his slight fatigue and weakness of legs.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Urine analysis normal
Clinical narrative: Both hands broke out with raised red oval shaped papules, mostly on palmar surface of fingers and knuckles of right hand about 24 hours after vaccine, then within an hour or so, pt felt very weak, hurt all over, ached from scalp to toes, had chills and fever, no improvement , so saw PMD. 10/13 had X-ray of lungs, UA blood work and blood cultures 30 "apart" all negative. Frontal HA (headache) x 2 weeks, relieve with TYLENOL or ADVIL. No respiratory symptoms. Tired for the next month . Hands began to peel about 3 weeks after immunization, face swelled for about 2 weeks after immunization, "lip looked like had been in a fight, red around eyes". Now 5 weeks after shot his slight fatigue and weakness of legs.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Body temperature increased, Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 11/13/08 Left arm started swelling, itching. Became red, hot. Body temperature was 102 degrees. 11-14-08 went to ER, diagnosis cellulitis treated with antibiotic and BENADRYL. 11-25-08 the arm is fine now except for some itching that remains.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site warmth
Clinical narrative: 11/13/08 Left arm started swelling, itching. Became red, hot. Body temperature was 102 degrees. 11-14-08 went to ER, diagnosis cellulitis treated with antibiotic and BENADRYL. 11-25-08 the arm is fine now except for some itching that remains.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Axillary pain, Dizziness, Erythema, Hypersensitivity, Injection site mass
Clinical narrative: 4:20 patient says, dizzy, "arm on fire", burning and stiff, left arm. had 102 degree fever. 11 th and 12th noted lump size of lemon at injection site, tight and painful. Whole arm burning and very hot. 13th and 14th swelling extend to below elbow with redness and burning around arm. Also lump under armpit red and sensitive. Later blisters at injection site, itching at elbow. Patient said she put ice on the same. Follow up 11/21/08, patient went to the Emergency room and was given pain medication, and the Doctor informed her that she had an allergic reaction. She was given SULFADERM x 20 days, and instructed to apply alternately heat and cold. She stated that after two weeks she was better.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site vesicles, Lymphadenitis, Musculoskeletal stiffness
Clinical narrative: 4:20 patient says, dizzy, "arm on fire", burning and stiff, left arm. had 102 degree fever. 11 th and 12th noted lump size of lemon at injection site, tight and painful. Whole arm burning and very hot. 13th and 14th swelling extend to below elbow with redness and burning around arm. Also lump under armpit red and sensitive. Later blisters at injection site, itching at elbow. Patient said she put ice on the same. Follow up 11/21/08, patient went to the Emergency room and was given pain medication, and the Doctor informed her that she had an allergic reaction. She was given SULFADERM x 20 days, and instructed to apply alternately heat and cold. She stated that after two weeks she was better.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pruritus, Pyrexia, Skin burning sensation, Skin warm, Swelling
Clinical narrative: 4:20 patient says, dizzy, "arm on fire", burning and stiff, left arm. had 102 degree fever. 11 th and 12th noted lump size of lemon at injection site, tight and painful. Whole arm burning and very hot. 13th and 14th swelling extend to below elbow with redness and burning around arm. Also lump under armpit red and sensitive. Later blisters at injection site, itching at elbow. Patient said she put ice on the same. Follow up 11/21/08, patient went to the Emergency room and was given pain medication, and the Doctor informed her that she had an allergic reaction. She was given SULFADERM x 20 days, and instructed to apply alternately heat and cold. She stated that after two weeks she was better.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Axillary pain, Chills, Pain
Clinical narrative: Patient reported, 10/11/08. Chills, body ache and fever 10/12/08  and Monday seemed to get worse. Left arm sore under arm, right hip pain, said can't get out of bed or move. Has hives on her face. Instructed her to contact her Doctor and requested that she contact me with update of her status. 11/15/08,11/17/08,11/19/08 and 11/21/08 attempted to contact her, left ,messages but without any response.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Tenderness, Urticaria
Clinical narrative: Patient reported, 10/11/08. Chills, body ache and fever 10/12/08  and Monday seemed to get worse. Left arm sore under arm, right hip pain, said can't get out of bed or move. Has hives on her face. Instructed her to contact her Doctor and requested that she contact me with update of her status. 11/15/08,11/17/08,11/19/08 and 11/21/08 attempted to contact her, left ,messages but without any response.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash
Clinical narrative: Patient report, at 3:00pm noted neck / chest with redness, Injection site without redness or itching. She took atarax  1.0 mg at 3:40pm rash clearing. Patient used the Triamcinolone Ointment on neck and chest that seem to clear up the redness.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: First time recipient of Influenza Vaccine, reported itching and small rash under eyes, patient monitored vital signs and went back to normal
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling cold, Hypersensitivity, Injection site pain, Injection site swelling, Lymphangitis
Clinical narrative: Patient reported: at 5:30 on 10/15/2008, fever 99.8, felt cold and had soreness at inj. site. 10/16/06: swelling at site and 2" below down to her elbow. at 0830 arm "tight as drum". She called the ER, Recommend ice and Ibuprofen: 10/17/08: Dr visit says Lymphangitis with allergic reaction to vaccine. Treatment Keflex and Periactin.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Patient reported: at 5:30 on 10/15/2008, fever 99.8, felt cold and had soreness at inj. site. 10/16/06: swelling at site and 2" below down to her elbow. at 0830 arm "tight as drum". She called the ER, Recommend ice and Ibuprofen: 10/17/08: Dr visit says Lymphangitis with allergic reaction to vaccine. Treatment Keflex and Periactin.
Age: 1.1
Sex: F
Vaccine: DTAP, FLU3, HEPA, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Parent-please describe: 11/20/08- noticed red rash on left thigh, appeared larger (1/2 dollar) next day, itchy. Began to fade by 11/23/08.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Clinical narrative: Four days after vaccine administration, Pt became unable to walk. Was evaluated by neurologist who advised pt to never again take the GARDASIL vaccine. 3/13/09 Received Neuro medical records of 9/24/08. FINAL DX:generalized weakness, fatigue, N/V s/p HPV vaccine Records reveal patient experienced weakness.  States patient developed weakness, N/V/D, fatigue, HA, abdominal pain, flushing, diaphoresis within 2 days of HPV #1.  Seen in ER & referred to Neuro.  Examination WNL & referred back to PCP.  3/16/09 Received ER medical records of 9/24/2008. FINAL DX: medication reaction; r/o GBS Records reveal patient experienced weakness, N/V/D, difficulty walking.
Age: 0.1
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea
Clinical narrative: Patient received PEDIARIX, PREVNAR, Act HIB, and ROTATEQ vaccines on 12-3-08. Per mom patients had diarrhea ever since, even up to 15 episodes in a 24 hour  period. Diarrhea symptoms have gotten better.
Age: 18.0
Sex: F
Vaccine: FLUN3, HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: 12/12/08 received TC from patient stating she is having a reaction to shots. Her lower right arm has a large bump about 4 cm. It hurts, is red, swollen and itches. Instructed to apply ice and take TYLENOL. 12/15/08 TC patient made to RN at child's school. She reports pt has no redness, swelling or probs with either arm.