chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Computerised tomogram normal, Convulsion
Clinical narrative: This case was considered medically important. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old female patient who experienced seizure type activity. The patient received the first dose on 16-Apr-2010. On or about 18-Apr-2010, the patient experienced a seizure type activity. The child was taken to the emergency room but was not admitted although an unspecified computerized axial tomogram was performed and was reported as "normal". The child was afebrile. No treatment was reported. As of 23-Apr-2010, no further seizure activity had occurred. The patient was considered recovered. No additional information was available at the time of this report.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old female patient who experienced injection site redness. That patient received her catch-up dose on an unspecified date. The patient experienced injection site redness and recovered. No additional information was available at the time of this report. See related case(s): US-WYE-H15021410 (adverse event, expedited) for another patient in same clinical practice with adverse events after PREVNAR 13.
Sex: M
Vaccine: PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a male patient who experienced rash and hives. The patient received a dose on 07-May-2010. The patient experienced rash and hives on 10-May-2010, three days after receiving PREVNAR 13. The patient visited the physician. Treatment was not reported. The outcome was unknown. See related case(s): US-WYE-H15212810 (adverse event, non-expedited) and US-WYE-H15212910 (adverse event, non-expedited). No additional information is available.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old male patient who experienced 9 X 9 centimeter swelling at the injection site.  At 3 years of age, the patient received the first dose on 06-May-2010. The patient experienced 9 X 9 centimeter swelling at the injection site on 07-May-2010.  The outcome is unknown.  No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced rash and hives. The patient received a dose on an unspecified date. On an unspecified date, the patient experienced rash and hives. The patient visited a physician. Treatment was not reported. The outcome was unknown. See related case (s): US-WYE-H15155310 (adverse event, non-expedited) and US-WYE-H15212910 (adverse event, non-expedited). No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced rash and hives. The patient received a dose on an unspecified date and a dose on an unspecified date. On an unspecified date, the patient experienced rash and hives. The patient visited a physician. Treatment was not reported. The patient's outcome was unknown. See related case(s): US-WYE-H15155310 (adverse event, non-expedited) and US-WYE-H15212810 (adverse event, non-expedited). No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13, PNC13, PNC13
Symptoms: Pyrexia
Clinical narrative: This case was considered medically important. Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced high fever. The patient received a dose on 07-May-2010. Patient received PREVENAR therapy on 07-May-2010. It was reported on 10-May-2010, that the patient over the weekend had been treated at the hospital or was hospitalized with a high fever. Outcome was not provided. See related cases(s): US-WYE-H15094610 (adverse event, expedited) and US-WYE-H15094510 (adverse event, expedited).
Sex: U
Vaccine: PNC13, PNC13, PNC13
Symptoms: Pyrexia
Clinical narrative: This case was considered medically important because it was not sure if either the patient had to be treated at the hospital or was hospitalized. Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced a high fever. The patient received a dose on 07-May-2010. The patient experienced a high fever in May-2010. It was reported that either the patient had to be treated at the hospital or was hospitalized. The outcome was unknown. See related case(s): US-WYE-H15094610 (adverse event, expedited) and US-WYE-H15093710 (adverse event, expedited). No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13, PNC13, PNC13
Symptoms: Pyrexia
Clinical narrative: This case was considered medically important since the reporter was unsure if patient had to be treated at a hospital or was hospitalized. Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced high fever. The patient received a dose on 07-May-2010. The patient experienced high fever in May-2010. It was reported that either the patient had to be treated at the hospital or was hospitalized. The outcome is unknown. NO additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a nurse regarding an unknown patient who experienced injection site redness and swelling at the injection site. The patient received a dose in 2010. An unknown patient experience injection site redness and swelling at injection site in 2010. Both events were not resolved. No additional information was available at the time of this report. See related case(s): US-WYE-H15507310 (adverse event, non-expedited).
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Information regarding PREVNAR 13 was received from a nurse regarding an unknown number of patients who experienced severe pain during injection of vaccine and high fever lasting for a long time as compared other vaccines. The patients received a dose in 2010. The patients experienced severe pain during injection of vaccine and high fever lasting for a long time as compared other vaccines in 2010.  The outcomes are unknown.  No additional information was available at the time of this report.
Age: 0.5
Sex: M
Vaccine: PNC13
Symptoms: Crying, Vomiting
Clinical narrative: Information regarding PREVNAR 13 was received from a physician regarding her (son) 6-month-old male patient who experienced vomiting and crying.  At 6 months of age, the patient received a dose on an unknown day in May-2010.  The patient experienced vomiting and crying in May-2010.  Both events resolved.  No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a nurse regarding an unknown number of patients who experience injection site redness and swelling at the injection site. The patients received a dose on an unspecified date. The patients experienced injection site redness and swelling at the injection site on unknown dates in 2010. No additional information was available at the time of this report.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Pyrexia
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 37-month-old female patient who experienced high fever and possible pneumonia. At 37 months of age, the patient received the first dose on 20-Apr-2010 along with a second dose of VAQTA (Merck Sharp & Dome). On 21-Apr-2010, the patient experienced high fever, visited the emergency room and was subsequently hospitalized on 22-Apr-2010. A possible pneumonia was suspected. Treatment was not reported. On an unspecified date in Apr-2010, the fever resolved and the patient was discharged from the hospital. The outcome of the possible pneumonia was unknown. No additional information was available at the time of this report.
Age: 0.59
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Pyrexia
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 7-month-old male patient who experienced fever. The patient received the first dose on 07-May-2010 along with a second dose of PENTACEL (Aventis-Pasteur) and ENGERIX B (Smith Kline & French Laboratories). On 08-May-2010, the patient experienced fever and was hospitalized. Treatment was not reported. On an unspecified date, the patient was discharged from the hospital. The outcome of the event was unknown. no additional information was available at the time of this report.
Age: 0.4
Sex: F
Vaccine: PNC13, RV1
Symptoms: Body temperature increased, Injection site erythema, Pyrexia
Clinical narrative: This case was considered medically important for the event of pyrexia. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 5 month 3-week-old female patient who experienced redness at the injection site measured at 2x3 cm and fever of 103. At 23 months of age, the patient received the first dose in May-2010. The patient also received a dose of ROTARIX (GlaxoSmithKline) in May-2010. After receiving her vaccinations on an unspecified date in May-2010, the patient experienced fever of 103 and redness at the injection site measured at 2x3 cm. The patient was taken to the office the next day; treatment was not specified. The reaction is being monitored. The outcome of the events is unknown. The event of pyrexia was considered medically important. The reporter noted that PREVNAR 7 was being saved to be given on next visit instead of PREVNAR 13. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: Information regarding PREVANR 13 was received from a healthcare professional regarding a patient who experienced injection site reaction and high fever. The patient received a dose on an unspecified date. The patient experienced injection site reactions and high fever on an unspecified date. The Physician commented that these events didn't seem to happen with PREVANR 7. The patient's outcome was not reported.
Sex: F
Vaccine: PNC13
Symptoms: Gait disturbance, Injection site pain, Injection site swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old female patient who experienced limping and severe local reaction of pain and swelling after vaccination.  The patient received a catch-up dose on an unspecified date.  Relevant medical history was not provided.  Indication for PREVNAR 13 was immunisation.  Product was administered on an unspecified date.  Dose regimen was 1 dose 1 time per day (intramuscular).  Concomitant medications were not reported.  The patient experienced limping and severe local reaction of pain and swelling after vaccination.  The patient recovered.  No additional information was available at the time of this report.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Wrong technique in drug usage process
Clinical narrative: Information regarding PREVENAR 13 was received from a healthcare professional regarding a 24-month-old female patient who experienced a 3 inch red swollen circle at the injection site 30 minutes after injection and PREVENAR 13 not shaken immediately prior to administration. The patient received the first dose on 06-May-2010. On 06-May-2010 the patient experienced a 3 inch red swollen circle at the injection site 30 minutes after injection and PREVENAR 13 not shaken immediately prior to administration. The PREVENAR 13 was shaken when removed from the refrigerator but not immediately prior to administration. Following vaccination the mother took her child to have blood drawn in the same medical building and returned within 30 minutes to have the nurse check the injection site reaction. The area was marked and instructions were given for the mother to contact the office if fever or other problems developed. The mother had not contacted the office therefore, the outcome of these events is unknown and no additional information was available at the time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Information regarding PREVNAR 13 was received from a nurse regarding an unknown number of patients who experienced painful reaction during vaccine administration. The patient received a dose in 2010. The patient experienced painful reaction during vaccine administration (pain) in 2010. The outcome was unknown. No additional information was available at the time of this report.
Sex: F
Vaccine: MMR, PNC13
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Information regarding PREVNAR 13 was received from a nurse regarding a 3-year-old female patient who experienced local skin reaction involving redness and swelling of the whole right thigh. The patient received a dose on an unknown date in 2010. The patient experienced local skin reaction involving redness and swelling of the whole right thigh on an unknown date in 2010. The patient was brought back to the doctor's office because the area of swelling had gotten larger. BENADRYL was administered as treatment. The erythema and swelling resolved on an unknown date. No additional information was available at the time of this report.
Sex: F
Vaccine: HEP, PNC13
Symptoms: Injection site swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 2-month-old female patient who experienced left thigh swelling.  The patient received a dose on 05-APR-2010.  Relevant medical history was not provided.  Indication for PREVNAR 13 was immunisation.  Product was administered on 05-Apr-2010.  Dose regimen was 1 dose 1 time per day (intramuscular).  Additional suspect medication included HEPATITIS B Vaccine.  Concomitant medications included "Penicil" vaccine.  The patient experienced left thigh swelling (injection site swelling) in Apr-2010.  Treatment included a cold and warm compress.  Patient recovered in April 2010.  No additional information was available at the time of this report.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a 6 month old male with a full term "WD" history of bronchitis who in 2008 was vaccinated with a third dose of ROTATEQ. On unspecified date of 2008 the patient experienced intussusception and was hospitalized. On unspecified date of 2008 the patient recovered with sequelae. The reporter felt that intussusception was related to therapy with ROTATEQ. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia facial
Clinical narrative: Initial case was received on 11 June 2010 from a healthcare professional. A 44 year old male patient received a left arm intramuscular injection of ADACEL (lot number C3475AA) at 3:15 p.m. on 08 June 2010. At 4:48 p.m. on 08 June 2010 he experienced lightheadedness and numbness on the face. The patient had no illness at the time of the vaccination. He had no pre-existing medical conditions and no known allergies. There were no reported adverse events to prior vaccinations. The patient went to the emergency room (ER) and was treated with BENADRYL. At the time of this report it was unknown if the patient had recovered. Follow-up information was received on 17 June 2010 from a healthcare professional (who received information from the patient). Upon receipt of this information it was determined that the case meets seriousness criteria, and it has been upgraded to serious. After receiving the ADACEL vaccination on 08 June 2010 the patient waited 30 minutes as advised by the pharmacist. On his way home he began feeling lightheaded and a numb, tingling sensation on his right side from the cheek, down his arm to his hand. He felt that he might pass out. Upon arriving home, he laid down, began feeling worse and the numbness moved across his chest and throat. His chest felt tight and he had difficulty breathing. He was seen in the emergency room and the doctor told him he was having an allergic reaction. He was advised in the emergency room to "avoid tetanus shots in the future." The patient's treatment included Albuterol HFA oral inhaler 2 puffs each 6 hours for 1 week, prednisone 20 mg 3 orally every day for 5 days and BENADRYL 25 mg 2 every 6 hours as needed. The patient was to follow-up with his physician within two days. As of 16 June 2010, the patient still has some numbness on the right side of his face. Documents held by sender: None.
Age: 44.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Hypersensitivity, Hypoaesthesia
Clinical narrative: Initial case was received on 11 June 2010 from a healthcare professional. A 44 year old male patient received a left arm intramuscular injection of ADACEL (lot number C3475AA) at 3:15 p.m. on 08 June 2010. At 4:48 p.m. on 08 June 2010 he experienced lightheadedness and numbness on the face. The patient had no illness at the time of the vaccination. He had no pre-existing medical conditions and no known allergies. There were no reported adverse events to prior vaccinations. The patient went to the emergency room (ER) and was treated with BENADRYL. At the time of this report it was unknown if the patient had recovered. Follow-up information was received on 17 June 2010 from a healthcare professional (who received information from the patient). Upon receipt of this information it was determined that the case meets seriousness criteria, and it has been upgraded to serious. After receiving the ADACEL vaccination on 08 June 2010 the patient waited 30 minutes as advised by the pharmacist. On his way home he began feeling lightheaded and a numb, tingling sensation on his right side from the cheek, down his arm to his hand. He felt that he might pass out. Upon arriving home, he laid down, began feeling worse and the numbness moved across his chest and throat. His chest felt tight and he had difficulty breathing. He was seen in the emergency room and the doctor told him he was having an allergic reaction. He was advised in the emergency room to "avoid tetanus shots in the future." The patient's treatment included Albuterol HFA oral inhaler 2 puffs each 6 hours for 1 week, prednisone 20 mg 3 orally every day for 5 days and BENADRYL 25 mg 2 every 6 hours as needed. The patient was to follow-up with his physician within two days. As of 16 June 2010, the patient still has some numbness on the right side of his face. Documents held by sender: None.
Age: 44.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia facial, Paraesthesia, Pharyngeal hypoaesthesia
Clinical narrative: Initial case was received on 11 June 2010 from a healthcare professional. A 44 year old male patient received a left arm intramuscular injection of ADACEL (lot number C3475AA) at 3:15 p.m. on 08 June 2010. At 4:48 p.m. on 08 June 2010 he experienced lightheadedness and numbness on the face. The patient had no illness at the time of the vaccination. He had no pre-existing medical conditions and no known allergies. There were no reported adverse events to prior vaccinations. The patient went to the emergency room (ER) and was treated with BENADRYL. At the time of this report it was unknown if the patient had recovered. Follow-up information was received on 17 June 2010 from a healthcare professional (who received information from the patient). Upon receipt of this information it was determined that the case meets seriousness criteria, and it has been upgraded to serious. After receiving the ADACEL vaccination on 08 June 2010 the patient waited 30 minutes as advised by the pharmacist. On his way home he began feeling lightheaded and a numb, tingling sensation on his right side from the cheek, down his arm to his hand. He felt that he might pass out. Upon arriving home, he laid down, began feeling worse and the numbness moved across his chest and throat. His chest felt tight and he had difficulty breathing. He was seen in the emergency room and the doctor told him he was having an allergic reaction. He was advised in the emergency room to "avoid tetanus shots in the future." The patient's treatment included Albuterol HFA oral inhaler 2 puffs each 6 hours for 1 week, prednisone 20 mg 3 orally every day for 5 days and BENADRYL 25 mg 2 every 6 hours as needed. The patient was to follow-up with his physician within two days. As of 16 June 2010, the patient still has some numbness on the right side of his face. Documents held by sender: None.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture, Muscular weakness, Nerve conduction studies
Clinical narrative: Patient given PNEUMOVAX while undergoing evaluation and follow up for non-cardiac chest pain. Left upper extremity pain, paresthesia, and weakness, and feet numbness. Subsequently developed weakness in all extremities. Currently being treated for suspected Guillain Barre syndrome.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Patient given PNEUMOVAX while undergoing evaluation and follow up for non-cardiac chest pain. Left upper extremity pain, paresthesia, and weakness, and feet numbness. Subsequently developed weakness in all extremities. Currently being treated for suspected Guillain Barre syndrome.
Age: 46.0
Sex: M
Vaccine: HEPAB, MMR, TD
Symptoms: Arthralgia, Conjunctivitis, Headache, Pyrexia, Rash macular
Clinical narrative: Reported by MD achy joints, conjunctivitis, fever, h/a, macular rash on face, trunk, extremities.
Age: 27.0
Sex: F
Vaccine: MNQ, YF
Symptoms: Pyrexia, Urticaria
Clinical narrative: Urticaria to arms, back, legs - BENADRYL/ZYRTEC. Fever 101-102 x 6 days - TYLENOL/ADVIL.
Age: 1.57
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Abdominal discomfort, Body temperature increased, Injection site erythema, Injection site warmth
Clinical narrative: 06/22/2010 MILD, Other, 6/19/10 Temp of 100.6. 6/21/10 Upset stomach: Quarter sized red spot on (LA) warm to mother's touch.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP
Symptoms: Cellulitis, Hypersensitivity, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Pt. had PENTACEL and Hep B given in same leg at same time - came back to office 6/21/10 (about 6 days later) with quarter sized knot on (L) leg. Area tender/swollen. Cellulitis vs. allergic rxn - Pt tx with Augmentin and f/u one week.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Injection site rash, Myalgia, Pyrexia, Rash erythematous
Clinical narrative: Fever 100 degrees, muscular/joint aches and pains, rash at injection site and fine reddened rash under chin.
Sex: U
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial report received from the lawyer on 18 Dec 2009: The patient was vaccinated with FLUVIRIN suspension for intramuscular injection 2009-2010 formula on 02 Sep 2009. The patient presented with GUILLAIN BARRE syndrome after receiving the vaccine and was hospitalized on an unspecified date. The outcome of event was not reported. Following internal review on 12 Apr 2010 of the data received on 18 Dec 2009, it was noted that suspect vaccine was incorrectly reported as FLUVIRIN. The patient received seasonal FLUVIRIN vaccine and not the pandemic one. Therefore, drug coding was changed to FLUVIRIN seasonal 2009/2010. Follow-up report received on 03 Apr 2010: Onset of the incident was about 2-3 weeks after the flu injection.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Similar reaction on previous exposure to drug, Skin reaction
Clinical narrative: Patient given Tdap (routine 6/18/2010) and had severe local skin reaction/cellulitis?, then admits in past he also had a reaction approximately 2005 to Td with skin rxn/cellulitis.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Febrile convulsion, Injection site erythema, Pyrexia
Clinical narrative: REPORTED BY MOTHER ON 2/9/10.  CHILD WAS HOSPITALIZED ON 1/8/10 WITH FEVER OVER 105 DEGREES.  FEBRILE SEIZURE AND REDNESS TO BOTH LEGS WHICH DEVELOPED POST INJECTIONS.  SPENT 2 DAYS AT HOSPITAL AND WAS RELEASED WITH ORAL ANTIBIOTIC.
Age: 27.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Disturbance in attention, Feeling abnormal, Feeling cold, Memory impairment, Peripheral coldness
Clinical narrative: STATED HE FELT "LOOPY" STARTING AT 30 MINUTES AFTER GETTING THE VACCINE, HAD DIFFICULTY FOCUSING AND REMEMBERING.  ALSO, FEELING COLD OFF AND ON, SKIN IS COLD.  NO RASH, ITCHING, OR DIFFICULTY BREATHING.  ADVERSE REACTION HAPPENED ONCE BEFORE AFTER A FLU SHOT WHEN HE WAS A CHILD.  HE HAD THE SEASONAL SHOT WITH NO REACTION.  MD ON DUTY TREATED ON SITE CLINIC AND RELEASED.
Age: 27.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Reaction to previous exposure to any vaccine
Clinical narrative: STATED HE FELT "LOOPY" STARTING AT 30 MINUTES AFTER GETTING THE VACCINE, HAD DIFFICULTY FOCUSING AND REMEMBERING.  ALSO, FEELING COLD OFF AND ON, SKIN IS COLD.  NO RASH, ITCHING, OR DIFFICULTY BREATHING.  ADVERSE REACTION HAPPENED ONCE BEFORE AFTER A FLU SHOT WHEN HE WAS A CHILD.  HE HAD THE SEASONAL SHOT WITH NO REACTION.  MD ON DUTY TREATED ON SITE CLINIC AND RELEASED.
Age: 29.0
Sex: M
Vaccine: DTAP
Symptoms: Dysphagia, Dyspnoea, Pruritus, Rash, Swelling face
Clinical narrative: Shortness of breath, facial swelling, trouble swallowing, rash, itching.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Local reaction
Clinical narrative: LOCAL REACTION
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Pt developed rash on 6/21/10.  Seen in office 6/23/10 and dx with varicella. No associated symptoms.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Lymphadenopathy, Skin lesion
Clinical narrative: Pt got severe amount of satellite lesions surrounding smallpox injection site. Roughly 20 sides. Pt's armpit also swollen around lymph nodes (smallpox).
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Keloid scar, Pain in extremity, Pruritus, Skin warm
Clinical narrative: 9.5 cm x 7.5 cm flare warm to the touch. Painful and itchy. This happened the next day after. Also a 1 cm keloid looking mark (left deltoid area).
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Blood test normal, Chest X-ray abnormal, Computerised tomogram normal, Electroencephalogram, Hypotonia
Clinical narrative: Child became limp. Was taken to ER. Some seizure-like activity noted. Transferred to another hospital. CXR suggests pneumonia. CT and blood work WNL. EEG result pending. Expected to be discharged today (6-23-10). Will followup with DR. in 1 week.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Pneumonia
Clinical narrative: Child became limp. Was taken to ER. Some seizure-like activity noted. Transferred to another hospital. CXR suggests pneumonia. CT and blood work WNL. EEG result pending. Expected to be discharged today (6-23-10). Will followup with DR. in 1 week.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Information has been received from a registered pharmacist concerning a 73 year old female patient with no known drug reactions/allergies and a history of gastrointestinal digestive issues and shingles who on 09-JUN-2010 was vaccinated SC with a dose of ZOSTAVAX (Merck) (lot# 664671/0149Z) into her left arm. Concomitant therapy included mirtazapine, CREON and NEXIUM. On 09-JUN-2010 upon receiving the injection, there was a burning sensation. After this, the patient developed a 3 inch by 1.5 inch hard, red and warm area at the site of injection. She reported this to the pharmacist on 11-JUN-2010. The pharmacist suggested that the patient massage the area and use TYLENOL. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. No laboratory or diagnostic studies were performed. The reporting pharmacist considered burning sensation upon receiving injection of ZOSTAVAX (Merck), 3x1.5 inch hard area at site of injection, 3x1.5 inch red area at site of injection and 3x1.5 inch warm area at site of injection to be other important medical events. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect route of drug administration
Clinical narrative: Information has been received from an office manager concerning a 70 year old female with no pertinent medical history and no drug reactions/allergies who on 13-JUN-2008 was vaccinated intramuscularly with a dose of ZOSTAVAX (Merck) (LOT# 659407/0295X). Concomitant therapy included ACIPHEX. On 10-JUN-2010 the patient experienced shingles. There was no lab diagnostics study performed. FAMVIR and prednisone was given for treatment of shingles. The patient sought unspecified medical attention. At the time of this report, the patient has not recovered yet. The office manager considered shingles to be an other important medical event. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Haematoma, Herpes zoster
Clinical narrative: Information has been received from a nurse concerning a male patient who on 07-JUN-2010 was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot #664627/0876Y). On 10-JUN-2010 the patient developed hematoma in the arm and a classic shingles rash across the trunk. The patient sought unspecified medical attention. there was not lab test performed. At the time of this report, the patient's outcome was unknown. The reporter considered hematoma in the arm and a classic shingles rash across the trunk as other important medical events due to intervention to prevent serious criteria with VALTREX. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEP, HEPA, MNQ, TDAP, VARCEL
Symptoms: Decreased appetite, Headache, Injection site reaction, Laboratory test, Malaise
Clinical narrative: Around 7 PM pt had headache, fever, emesis, malaise, unable to tolerate POS therefore went to the ED. Received IVF in ED, labs drawn and pt was told it was vaccine reaction, next day fever and emesis resolved. By day #2 post shots, 6 rating pos et at baseline. Had ZEFRAN x 1 day on day1 post vaccine. Records requested from hospital.
Age: 13.0
Sex: M
Vaccine: HEP, HEPA, MNQ, TDAP, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Around 7 PM pt had headache, fever, emesis, malaise, unable to tolerate POS therefore went to the ED. Received IVF in ED, labs drawn and pt was told it was vaccine reaction, next day fever and emesis resolved. By day #2 post shots, 6 rating pos et at baseline. Had ZEFRAN x 1 day on day1 post vaccine. Records requested from hospital.
Age: 9.0
Sex: U
Vaccine: TD
Symptoms: Pertussis
Clinical narrative: Initial report was received 17 June 2010 via a lay press publication dated 16 June 2010 which involved six patients in the same geographical area who had been diagnosed with pertussis after they had received five previous DTaP vaccinations (lot number not reported). The information contained in the lay press publication had been retrieved from an immediate publication news released posted on 16 June 2010. This case represents one out of the six reported patients. The other patients are captured in case numbers 2010-03434, 2010-03435, 2010-03436, 2010-03437 and 2010-03438. A nine-year-old patient (gender not reported) had received five prior dose of DTaP vaccine (manufacturers, lot numbers, routes, sites and dates of administration not reported) and an unspecified amount of time after receiving their fifth dose DTaP vaccination, the patient was diagnosed with pertussis. This patient was one out of six local children who had been diagnosed with pertussis. Outcome was not reported. NO additional information was provided at the time of the report. Documents held by sender: News Release.
Age: 9.0
Sex: U
Vaccine: DTAP
Symptoms: Pertussis
Clinical narrative: Initial report was received 17 June 2010 via a lay press publication from a News Service dated 16 June 2010 which involved six patients in the same geographical area who had been diagnosed with pertussis after they had received five previous DTaP vaccinations (lot number not reported). The information contained in the lay press publication had been retrieved from an immediate publication news released posted by a Agency on 16 June 2010. A copy of this news release was retrieved on 17 June 2010. This case represents one of the six reported patients. The other patients have been captured in case numbers 2010-03433, 2010-03435, 2010-03436, 2010-03437 and 2010-03438. A nine-year-old patient (gender not reported) had received five prior doses of DTaP vaccine (manufacturer, lot numbers, routes, sites and dates of administration not reported) and an unspecified amount of time after receiving their fifth dose DTaP vaccination, the patient was diagnosed with pertussis. This patient was one out of six local children who had been diagnosed with pertussis. Outcome was not reported. No additional information was provided at the time of the report. Documents held by sender: News Release.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Pertussis
Clinical narrative: Initial report was received 17 June 2010 via a lay press publication dated 16 June 2010 which involved six patients in the same geographical area who had been diagnosed with pertussis after they had received five previous DTAP vaccinations (lot number not reported). The information contained in the lay press publication had been retrieved from an immediate publication news released posted by a Agency on 16 June 2010. A copy of this news release was retrieved on 17 June 2010. This case represents one of the six of reported patients. The other patients are captured in case numbers 2010-03433, 2010-03434, 2010-03436, 2010-03437 and 2010-03438. An 11-year-old male patient had received five prior doses of DTAP and "also had his booster shot" (manufacturers, lot numbers, routes, sites and dates of administration not reported) and an unspecified amount of time after receiving his booster vaccination, he was diagnosed with pertussis. This patient was one out of six local children who had been diagnosed with pertussis. Outcome was not reported. No additional information was provided at the time of the report. Documents held by sender: News Release.
Age: 12.0
Sex: U
Vaccine: DTAP
Symptoms: Pertussis
Clinical narrative: Initial report was received 17 June 2010 via a lay press publication from dated 16 June 2010 which involved six patients in the same geographical area who had been diagnosed with pertussis after they had received five previous DTaP vaccinations (lot number not reported). The information contained in the lay press publication had been retrieved from an immediate publication news released posted by a County Health and Human Services Agency (HHSA) on 16 June 2010. A copy of this HHSA news release was retrieved on 17 June 2010. This case represents one of the six reported patients. The other patients are captured in case numbers 2010-03433, 2010-03434, 2010-03435, 2010-03437 and 2010-03438. A 12-year-old patient (gender not reported) had received five prior doses of DTaP vaccine (manufacturers, lot numbers, routes, sites and dates of administration not reported) and an unspecified amount of time after receiving their fifth dose of DTaP vaccination, the patient was diagnosed with pertussis. This patient was one out of six local children who had been diagnosed with pertussis. Outcome was not reported. No additional information was provided at the time of the report. Documents held by sender: New Release.
Age: 12.0
Sex: U
Vaccine: DTAP
Symptoms: Pertussis
Clinical narrative: Initial report was received 17 June 2010 via lay press publication from an agency dated 16 June 2010 which involved six patients in the same geographical area who had been diagnosed with pertussis after they had received five previous DTaP vaccinations (lot number not reported). the information contained in the lay press publication had been retrieved from an immediate publication news released posted by a County Health and Human Services (HHSA) on 16 June 2010. This case represents one of the six reported patients. The other patient are captured in case numbers 2010-03433, 2010-03434, 2010-03435, 2010-03436 and 2010-03438. A 12-year-old patient (gender not reported) had received five prior doses of DTaP vaccine (manufacturers, lot numbers, routes, sites and dates of administration not reported) and an unspecified amount of time after receiving their fifth dose of DTaP vaccination, the patient was diagnosed with pertussis. This patient was one out of six local children who had been diagnosed with pertussis. Outcome was not reported. No additional information was provided at the time of the report.
Age: 14.0
Sex: U
Vaccine: DTAP
Symptoms: Pertussis
Clinical narrative: Initial report was received 17 June 2010 via a lay press publication dated 16 June 2010 which involved six patients in the same geographical area who had been diagnosed with pertussis after they had received five previous DTaP vaccinations (lot number not reported). The information contained in the lay press publication had been retrieved on 16 June 2010. This case represents one of the six reported patients. The other patients are captured in case numbers 2010-03433, 2010-03434, 2010-03435, 2010-03436 and 2010-03437. A 14-year-old patient (gender not reported) had received five prior doses of DTaP vaccine (manufacturers, lot numbers, routes, sites and dates of administration not reported) and an unspecified amount of time after receiving their fifth dose DTaP vaccination, the patient was diagnosed with pertussis. This patient was one out of six local children who had been diagnosed with pertussis. Outcome was not reported. No additional information was provided at the time of the report. Documents held by sender: News Release.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, RVX
Symptoms: Conversion disorder, Crying
Clinical narrative: Patient cried and would become hysterical if not being held. Patient was repeatedly trying to pinch himself at the injection site. Patient normally doesn't cry long or often cried for 3 hours (almost nonstop) that evening.  The next morning, there was a small amount of blood in the diaper (in the front).
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncope episode following administration of Tdap and MCV4.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood culture, C-reactive protein increased, Chest X-ray normal, Grand mal convulsion, Lymphocyte percentage decreased
Clinical narrative: Clonic tonic seizure lasting less than one minute. Taken to ER. Occurred about 9 1/2 hours after vaccines given.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Neutrophil percentage increased, White blood cell count increased
Clinical narrative: Clonic tonic seizure lasting less than one minute. Taken to ER. Occurred about 9 1/2 hours after vaccines given.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Mass
Clinical narrative: Shoulder became sore (too sore to raise arm), small lump formed size about 1/2 cm. No redness, warmth or fever.
Age: 44.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Deafness, Dizziness, Nausea, Pruritus
Clinical narrative: WITHIN 5 MINUTES OF RECEIVING VACCINE COMPLAINED OF ITCHING HEAD, MOUTH, LIPS. BP 158/UNABLE TO HEAR, HR 88, GIVEN BENADRYL 50 MG PO AT 10:40AM. AFTER 10 MINUTES, ITCHING GONE BUT COMPLAINED OF DIZZINESS/NAUSEA.  GIVEN SNACK AND A SODA AND TRANSPORTED TO SCHOOL CLINIC.  RESTED 1 HOUR BP 150/80-160/90.  PRIVATE PHYSICIAN NOTIFIED.  HE RECOMMENDED ER.  HUSBAND TRANSPORTED HER TO ER BY PRIVATE VEHICLE AT 12:15.  ER GAVE BENADRYL, PEPCID AND STEROID INJECTION AND SENT HOME. RETURN TO WORK ON 1/15 WITH PEPCID AND PREDNISONE XQD.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 21 year old female patient who on 15-MAR-2010 was vaccinated with a first dose of VARIVAX (Merck) (dose and route not reported) (lot number 665503/1165Y). On 12-APR-2010, the patient received a second dose of VARIVAX (Merck) (dose and route not reported) (lot number 665503/1165Y). The nurse reported that the patient may had been pregnant at that time. The patient's last menstrual period was on 17-MAR-2010. No adverse reactions reported. The patient sought medical attention through an office visit. Follow up information has been received from a licensed practical nurse  who indicated that on 27-APR-2010 the patient experienced spontaneous abortion, 6 weeks from LMP. It was unknown whether the fetus was normal or products of conceptions were examined. At the time of the report, the outcome of the patient was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. Upon internal review, spontaneous abortion (<20 weeks) was considered to be an other important medical event. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure before pregnancy, Pregnancy test urine
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female with no medical history who on 02-DEC-2009 was vaccinated intramuscularly with the first dose of GARDASIL (lot # 663454/0672Y, 0.5 ml). On 03-FEB-2010, the patient was vaccinated intramuscularly with the second dose of GARDASIL (lot # 661758/1480Y, 0.5 ml). There was no concomitant medication. The reporter became pregnant after receiving the vaccine. No adverse effect reported. Urine test was performed (result not provided). The LMP was 08-JAN-2010. The estimated delivery date was on 15-Oct-2010. At the time of the report, the outcome was unknown. Follow up information was received from the physician reported that the patient experienced an early miscarriage on an unspecified date. Upon internal review, an early miscarriage was considered to be an other important medical event. Additional information is not expected.
Age: 48.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Paraesthesia, Throat tightness
Clinical narrative: PATIENT REPORTED FEELING TINGLING/TIGHTNESS TO THE BACK OF THROAT.  BP 146/86 HR 88, BENADRYL 50 MG PO GIVEN AT 11:30 AM.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Rash erythematous, Skin exfoliation
Clinical narrative: RIGHT LEG, ERYTHEMATOUS RASH, 3 CM, NONBLANCHING (SITE OF INJECTION)  BLISTERS ON HANDS, ERYTHEMA WITH SKIN PEELING NO DISCHARGE AND NO STREAKING.
Age: 1.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Crying, Erythema, Eye swelling, Irritability, Screaming
Clinical narrative: Broke out in generalized hives.  Eyes swelling.   Mom gave Benadryl and returned to Dr. Office.  0.2cc Epinephrine 1:1000 given SQ.  Extreme fussiness and crying. Follow-up: Pt was treated with Epinephrine and oral steroids X 3 days from reaction on 06/23/2010. On 06/24/2010 she woke up screaming uncontrollably and was covered over body with "blood red" welts. She was given BENADRYL taken to ER where she was given a steroid shot and put on 5 days of oral steroids.
Age: 1.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Urticaria
Clinical narrative: Broke out in generalized hives.  Eyes swelling.   Mom gave Benadryl and returned to Dr. Office.  0.2cc Epinephrine 1:1000 given SQ.  Extreme fussiness and crying. Follow-up: Pt was treated with Epinephrine and oral steroids X 3 days from reaction on 06/23/2010. On 06/24/2010 she woke up screaming uncontrollably and was covered over body with "blood red" welts. She was given BENADRYL taken to ER where she was given a steroid shot and put on 5 days of oral steroids.
Age: 1.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Crying, Erythema, Eye swelling, Irritability, No reaction on previous exposure to drug
Clinical narrative: Broke out in generalized hives.  Eyes swelling.   Mom gave Benadryl and returned to Dr. Office.  0.2cc Epinephrine 1:1000 given SQ.  Extreme fussiness and crying. Follow-up: Pt was treated with Epinephrine and oral steroids X 3 days from reaction on 06/23/2010. On 06/24/2010 she woke up screaming uncontrollably and was covered over body with "blood red" welts. She was given BENADRYL taken to ER where she was given a steroid shot and put on 5 days of oral steroids.
Age: 1.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Screaming, Swelling face, Urticaria
Clinical narrative: Broke out in generalized hives.  Eyes swelling.   Mom gave Benadryl and returned to Dr. Office.  0.2cc Epinephrine 1:1000 given SQ.  Extreme fussiness and crying. Follow-up: Pt was treated with Epinephrine and oral steroids X 3 days from reaction on 06/23/2010. On 06/24/2010 she woke up screaming uncontrollably and was covered over body with "blood red" welts. She was given BENADRYL taken to ER where she was given a steroid shot and put on 5 days of oral steroids.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Oral mucosal exfoliation, Oropharyngeal pain, Periorbital oedema, Throat tightness
Clinical narrative: At 1330 6/17/10 Hep B Vaccine administered to Rt deltiod IM. Employee reports that evening around 7pm began to feel like had a sore throat with "throat a little tight". Employee reports went to bed and awoke in AM on 6/18/10 with noticeable periorbital and buccal muscoa edema present. Employee reported to Employee health Clinic at 0855 on 6/18. Oral mucosa inspected with visible white lesions/patches that appears to look like musocal sloughing with out ulcerations. Slight periorbital edema still present. Employee vital signs obtained and stable; denies any difficulty breathing. Site of injection visibly inspected without redness or edema present. Employee also denies any recent illness or exposure to anyone ill in family. No uticaria, fever, headache, nausea, vomiting or abdominal pain post vaccination was reported. Employee provided with OTC Benadryl 25mg po at 905 AM on 6/18/10. At 1600 hours on 6/18/190 employee reports relief with med and denies need for further treatment.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Body temperature increased, Diet refusal, Hyperhidrosis, Nausea
Clinical narrative: Elevated body temperature, severe body aches, sweating, severe nausea, unwilling to attempt food or fluids by mouth for fear of vomiting, generalized weakness.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Pain
Clinical narrative: Elevated body temperature, severe body aches, sweating, severe nausea, unwilling to attempt food or fluids by mouth for fear of vomiting, generalized weakness.
Age: 0.52
Sex: F
Vaccine: 6VAX-F, RVX
Symptoms: Crying, Diarrhoea, Pyrexia, Restlessness, Vomiting
Clinical narrative: Fever of 103.5 not controlled by acetaminophen, vomiting, loose stools, crying, inability to rest well.
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Loss of consciousness, Pain, Pyrexia
Clinical narrative: Fever up to 103.6 oral, weakness, body aches, passed out x 1. Advised to increase oral fluids and begin wtih Tylenol 500mg; take 2 tabs initially and then 1 tab every 6 hours thereafter x 48 hours per recommendation of Dr. To be seen in Occ. Health in am if no improvement.
Age: 1.61
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever of 103 degrees Fahrenheit for 2 days.
Age: 54.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Anxiety, Dysphagia, Lip swelling, Paraesthesia oral
Clinical narrative: Received 3 adult vaccines, approx 15 minutes later began to feel tingling and swelling of lips (not visible on outside) and sensation of increasing difficulty in swallowing. Had own Albuterol inhaler that she would normally use, took 2 puffs and within 10-15 minutes began to feel fine. Did not have respiratory distress but was somewhat anxious. (Did notice that her inhaler had exp date of 8/09-pointed out to her that she should refill).