chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: TD
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Local reaction, Pyrexia
Clinical narrative: Cluster of 3 cases out of an unspecified number of vaccinees who received DECAVAC lot# U1923HA. Initial report received on 23 March 2007 from a healthcare professional. A 43 year old male patient, received on 13 March 2007 a dose of DECAVAC (lot # U1923HA), intra-muscular into the left deltoid, (needle size - 25 gauge). No other vaccines were given at that time. On 15 March 2007, approximately 2 days post vaccination, the patient experienced fever and local reaction. On 19 March 2007, he was seen in the clinic with a 2x2 cm circumference area of erythema and swelling at injection site. Lump was palpitated. Resistant range of motion to left shoulder. He required a doctor visit. Treatment included ice and MOTRIN. The patient's outcome was unknown. Medical history included allergic to therapy. Had Td over 10 years ago with no adverse reactions. Denied illness, medical conditions, other vaccinations and other medications at vaccination time. Follow-up information received on 16 July 2007 from a health care professional. The case was reviewed by the reporter, and there was no additional information at this time. The reporter is the same as in case 2007-00900 and 2007-00901.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Pain, Swelling, Tenderness
Clinical narrative: Cluster of 3 cases out of an unspecified number of vaccines who received DECAVAC lot# U1923HA. Initial report received on 23 March 2007 from a healthcare professional. A 55 year old female patient, received on 02 March 2007 a dose of DECAVAC (lot# 01923HA), intramuscular into the left deltoid (needle size- 25 gauge). No other vaccines were given at that time. On 05 March 2007, 3 days post vaccination, the patient experienced tenderness in the left axillary region, redness and swelling was noted at the deltoid, extending to fingers below elbow. Pain continued on 14 March 2007. Treated with LEVOQUIN and  BENADRYL. The patient had not recovered. Medical history included fibromyalgia and penicillin allergy. Concomitant medications included NAPROXEN. The reporter denied illness and adverse event following prior vaccination. Dose and date of last Td vaccine were unknown. Unknown if other vaccines were given 4 weeks prior. Follow-up information received on 16 July 2007 from a health care professional. Per the reporter, the case was reviewed, and there was no additional information at this time. The reporter is the same as in cases 2007-00899 and 2007-00900.
Age: 88.0
Sex: F
Vaccine: TD
Symptoms: Injection site nodule, Local reaction
Clinical narrative: Cluster of 3 cases (no individual patient identification provided) of local reactions with DECAVAC (lot number U1943AA) received from a health care professional on 09 May 2007. Case 1: Two (2) patients developed hard nodules lasting for approximately 9 days after intramuscularly receiving DECAVAC (lot number U1943AA, site and date of administration not reported). One (1) other patient who experienced a reaction is detailed in case 2007-01645. Follow-up information received on 06 June 2007. Patient identification was provided for 1 patient. The patient was an 88 year old, female who received DECAVAC on 26 April 2007. It was reported that she recovered.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Drug administered at inappropriate site, Feeling cold, Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Initial report received from a physician on 17 May 2007. A 42 year old, female patient (who is a smoker) received 0.5 ml of DECAVAC (lot number U1928CA) subsequently in the right forearm in error instead of PPD on 16 May 2007. She had immedictae pain at the site and coolness of the right arm. 24 hours later, she developed 2 cm of erythema/induration with increasing pain and inability to flex/extend her wrist. She did not have any illness at the time of vaccination. At the time of the report, it was unknown if she recovered. Follow-up information received on 17 August 2007 from a health care professional; The reporter indicated that as of 10 August 2007, there was no recent follow up. The patient was referred to a neurologist for continued nerve concerned, at the patient's request. Follow-up information on 23 October 2007. At the time of this report, the patient had recovered. No further information is expected.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Initial report received from a physician on 17 May 2007. A 42 year old, female patient (who is a smoker) received 0.5 ml of DECAVAC (lot number U1928CA) subsequently in the right forearm in error instead of PPD on 16 May 2007. She had immedictae pain at the site and coolness of the right arm. 24 hours later, she developed 2 cm of erythema/induration with increasing pain and inability to flex/extend her wrist. She did not have any illness at the time of vaccination. At the time of the report, it was unknown if she recovered. Follow-up information received on 17 August 2007 from a health care professional; The reporter indicated that as of 10 August 2007, there was no recent follow up. The patient was referred to a neurologist for continued nerve concerned, at the patient's request. Follow-up information on 23 October 2007. At the time of this report, the patient had recovered. No further information is expected.
Age: 35.0
Sex: F
Vaccine: MMR, TD
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Initial report received from a health care professional on 13 June 2007. A 35 year old (with no medical history), inflammation of the lymph nodes on the neck, armpit and groin area, 1 week after she received DECAVAC (lot number U195386A, site of administration not reported) intramuscularly, TUBERSOL (lot number C2671AA, site of administration not reported) and MMR (Merck, lot number 0182U, site not reported) subsequently on 01 June 2007. Her lymph nodes were also painful. At the time of vaccination, she did not have any illness and was not taking any medications. The physician recommended fluid therapy and anti-inflammatory. At the time of the report, the patient had not recovered. Follow-up information received on 30 July 2007 from a health care professional. The reporter provided information pertaining to vaccine and TB test administration. DECAVAC dosage 0.5cc had been administered in the patient's right arm, TUBERSOL dosage 0.1cc with an expiration date of 21 June 2009 had been administered in the patient's left forearm, and MMR dosage 0.5cc had been administered in the patient's left arm. Diagnostic tests and laboratory data were listed as "not applicable". The patient had no illness at the time of vaccination and their recovery status was listed as recovered. No additional information was provided.
Age: 47.0
Sex: M
Vaccine: MNQ, PPV, TD
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: This case was received from a health professional on 25 July 2007. A 46-year-old male patient with no reported medical history received an intramuscular right deltoid injection of DECAVAC (lot number U1956AA), right deltoid injection of MENACTRA (lot number U2377BA) and left deltoid injection of PNEUMO (Merck, lot number 1005F) on 24 July 2007. Approximately ten hours later, on 25 July 2007, the patient began experiencing fever, chills, and body aches. Outcome was not provided. A corrective version was created to change the preferred term for body aches from "generalized aching" to "generalized muscle aches". No new information has been added to the case. Follow-up information was received from the health professional on 02 November 2007. The patient was prescribed ibuprofen, and the events resolved on 26 July 2007. Per the reporter, the patient did not keep a follow-up appointment.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Drug exposure during pregnancy, Dyspnoea, Migraine, Ultrasound scan normal
Clinical narrative: Initial report received from a nurse on 02 August 2007. A 23 year old, female patient (with a history of no unknown allergies) developed a migraine, headache and had difficulty breathing that evening after she received DECAVAC (lot number, route and site of administration unknown) on 24 July 2007, for stepping on a nail. She went to the emergency room and was treated with BENADRYL. It was reported that she recovered. She had her last Td >10 years (before). The patient was pregnant at the time of the vaccination. She has had 2 previous pregnancies - with 1 normal/viable pregnancy outcome and full term delivery and 1 spontaneous abortion. Her last menstrual period was 20 April 2007 and her expected date of delivery is 25 January 2008. She had an ultrasound on 19 June 2007 with normal results - 8 weeks 4 days. She was taking Prenatal and CITRACAL PRENATAL RX + DHA - for pregnancy. Follow-up information was received on 07 September 2007 from the health professional with provided DECAVAC lot number as U1880DA. No other medically significant information was provided.
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Initial report received on 29 October 2007 from a health care professional. Five adult patients (demographics not provided) with unknown medical histories, had received an intramuscular dose of DECAVAC (Lot number U1981AA) in the deltoid (left or right not reported) between August to September 2007. At an unspecified amount of time later, all patients experienced redness, swelling, pain, and perisitent nodules at the injection site. None of the patients sought medical sought medical attention. Treatment received, and diagnostic testing's performed were not provided. The recovery status of the patients were not reported.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis
Clinical narrative: Initial report received on 14 December 2007 from a health care professional. A 52-year-old female patient, with no illness at the time of vaccination, had received a right deltoid, intramuscular injection of DECAVAC, lot number U1954BB, on 10 December 2007. One day post-vaccination, the patient developed cellulitis from the shoulder to the elbow of her right arm which was diagnosed by a physician. She was treated with BACTRIM and recovered from the event.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Urticaria
Clinical narrative: Initial report received from a patient on 19 April 2007. A 62 year old, female patient developed hives, 4 days after receiving DECAVAC (lot number U1703AA, route of administration not reported) in the left arm on 19 December 2006. She took some homeopathic allergy drops and she stated "they kept coming back". She was evaluated by a physician on 31 December 2006 and given a "shot of something". She was also seen by a homeopath as well. The homeopathic computer indicated "tetanus" probes. It was reported that she recovered.
Age: 22.0
Sex: M
Vaccine: TD
Symptoms: Fatigue, Oedema peripheral, Pruritus, Rash generalised
Clinical narrative: Initial report received from a consumer on 26 November 2007. A 22-year-old male patient with a medical history of mitral valve prolapse and an amoxicillin allergy, had received an injection of DECAVAC (route and site not reported), lot number U1950CA on 21 November 2007 and the following day, complained of fatigue. On 26 November 2007, five days post vaccination, the patient awoke with a red rash over most of his body. Both feet and hands were swollen and itchy. The patient went to the emergency room and received treatment with ATARAX and PREDNISONE (dose pack). The patient had not received any other vaccines during the four weeks prior to receipt of DECAVAC. At the time of the report, the patient had not recovered from the event. No further information was provided.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Fatigue, Malaise, Nausea, Pain in extremity
Clinical narrative: Initial report received on 17 December 2007 from a patient. A 48 year-old female patient received on an unspecified day in February 2006 (also reported as approximately 1 year ago) DECAVAC (lot# U1879BA) (unsure of site and route of administration) due to injury - she stepped on a rusty nail). That evening, she experienced soreness, redness and swelling in her arm, malaise, fatigue, fever and nausea. She was unable to remember if she had seen a physician at that time. The symptoms persisted for a week. When she was asked if the events resolved she was unsure, therefore, outcome was unknown. The patient did not received any concomitant vaccines. The patient's medical history included: allergy to thimersol, penicillin and hay fever. Last DECAVAC vaccination was given approximately in July 2000.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: Initial report received on 17 December 2007 from a patient. A 48 year-old female patient received on an unspecified day in February 2006 (also reported as approximately 1 year ago) DECAVAC (lot# U1879BA) (unsure of site and route of administration) due to injury - she stepped on a rusty nail). That evening, she experienced soreness, redness and swelling in her arm, malaise, fatigue, fever and nausea. She was unable to remember if she had seen a physician at that time. The symptoms persisted for a week. When she was asked if the events resolved she was unsure, therefore, outcome was unknown. The patient did not received any concomitant vaccines. The patient's medical history included: allergy to thimersol, penicillin and hay fever. Last DECAVAC vaccination was given approximately in July 2000.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Information regarding PREVNAR was received from a newspaper article regarding a 4-month-old male patient who experienced sudden infant death syndrome.  The patient received a dose on 12-Sep-2007.  The patient also received a dose of PEDIARIX (GlaxoSmithKline) and ROTARIX on 12-Sep-2007.  Relevant medical history included healthy infant.  Product was administered on 12-Sep-2007.  Dose regimen was 1 dose.  Additional suspect medication included ROTARIX and PEDIARIX (GlaxoSmithKline).  Concomitant medications were not reported.  The patient experienced sudden infant death syndrome (sudden infant death syndrome) on 15-Sep-2007.  The mother reported that she woke up at 5:15 am on 15-Sep-2007 and noted that the baby was not making any noise.  The baby was warm and his lips were still pink, but he was not moving.  Blood was crusted beneath his eyes and his clothes and toys were covered with a bloody froth.  Emergency Rescue (911) was called and the parents tried to resuscitate him.  In the Emergency Room, the baby was pronounced dead.  The autopsy failed to detect any specific vaccine reactions forcing a determination of sudden infant death syndrome.  Cause of death was reported as sudden infant death syndrome.  No additional information was available at the time of this report.
Age: 16.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Fainted 30 seconds after 2nd inj of Gardasil given in right arm. Symptoms resolved; Patient left 15 min after inj.
Age: 16.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Fainted 30 seconds after 2nd inj of Gardasil given in right arm. Symptoms resolved; Patient left 15 min after inj.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Crying, Dizziness
Clinical narrative: Information has been received from a physician concerning an 11 year old female who on 27-MAR-2008 was vaccinated with GARDASIL (659964/1978U). Concomitant therapy included HAVRIX (lot# not reported). On 27-MAR-2008 the patient experienced wooziness and began crying. Subsequently, the patient recovered from the wooziness and crying. The patient's sister had the same AE after receiving GARDASIL. See SR# 1-2774239749. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from the mother  concerning her daughter (age not provided) who an unspecified date was vaccinated with a first dose of GARDASIL. Subsequently, the patient passed out a couple of times after receiving the first dose of GARDASIL. Subsequently, the patient recovered. Her sister also experienced adverse events after being vaccinated with a first dose of GARDASIL, reported in WAES # 0803USA05046. Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: HEPA
Symptoms: Band neutrophil count decreased, Blood chloride normal, Blood creatinine normal, Blood culture negative, Blood glucose normal
Clinical narrative: Information has been received from an investigator concerning a 14 month old male who entered a study. On 18-AUG-2007 the patient was vaccinated with VAQTA inactivated. The patient received MMR II and PREVNAR on 07-JUL-2007. On 24-AUG-2007 the patient began experiencing diarrhea. The patient was subsequently hospitalized. Treatment medications included PEDIALYTE 20 oz, IV D5 1/4NS (40 cc/hr), IMODIUM 5 ml. All medication were for diarrhea. ON 29-AUG-2007 a stool analysis was performed with normal results. The patient recovered from diarrhea. Follow-up information was received on 18-APR-2008. The SAE was changed to gastroenteritis with dehydration. The patient was also treated with acetaminophen on 30-AUG-2007. The patient's medical history was significant for frequent ear infections. He had no known drug allergies. On 30-AUG-2007 the patient was seen in the emergency room and had been experiencing bouts of diarrhea every day since 27-AUG-2007. The diarrhea was loose and watery with green discoloration. There was no mucous or blood and he had no associated vomiting or fever. Vital signs were: temperature 99.1 F, pulse 124, respirations 24 and pulse oximetry 98%. Oropharyngeal examination showed mild congestion and his lips appeared dry. Labs were: WBC 16.8, neutrophil 14%, no bands, glucose 95, BUN 7, creatinine 0.3, sodium 138, potassium 4.1, chloride 104. Urine was clear and negative for microscopic exam. Blood culture collected on 30-AUG-2007 showed no growth at 5 days. The patient was subsequently admitted to the hospital. The patient recovered from gastroenteritis with dehydration. The investigator considered the gastroenteritis with dehydration to be related to study medication.
Age: 1.2
Sex: M
Vaccine: HEPA
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, Body temperature, Dehydration
Clinical narrative: Information has been received from an investigator concerning a 14 month old male who entered a study. On 18-AUG-2007 the patient was vaccinated with VAQTA inactivated. The patient received MMR II and PREVNAR on 07-JUL-2007. On 24-AUG-2007 the patient began experiencing diarrhea. The patient was subsequently hospitalized. Treatment medications included PEDIALYTE 20 oz, IV D5 1/4NS (40 cc/hr), IMODIUM 5 ml. All medication were for diarrhea. ON 29-AUG-2007 a stool analysis was performed with normal results. The patient recovered from diarrhea. Follow-up information was received on 18-APR-2008. The SAE was changed to gastroenteritis with dehydration. The patient was also treated with acetaminophen on 30-AUG-2007. The patient's medical history was significant for frequent ear infections. He had no known drug allergies. On 30-AUG-2007 the patient was seen in the emergency room and had been experiencing bouts of diarrhea every day since 27-AUG-2007. The diarrhea was loose and watery with green discoloration. There was no mucous or blood and he had no associated vomiting or fever. Vital signs were: temperature 99.1 F, pulse 124, respirations 24 and pulse oximetry 98%. Oropharyngeal examination showed mild congestion and his lips appeared dry. Labs were: WBC 16.8, neutrophil 14%, no bands, glucose 95, BUN 7, creatinine 0.3, sodium 138, potassium 4.1, chloride 104. Urine was clear and negative for microscopic exam. Blood culture collected on 30-AUG-2007 showed no growth at 5 days. The patient was subsequently admitted to the hospital. The patient recovered from gastroenteritis with dehydration. The investigator considered the gastroenteritis with dehydration to be related to study medication.
Age: 1.2
Sex: M
Vaccine: HEPA
Symptoms: Diarrhoea, Faeces discoloured, Gastroenteritis, Heart rate normal, Lip dry
Clinical narrative: Information has been received from an investigator concerning a 14 month old male who entered a study. On 18-AUG-2007 the patient was vaccinated with VAQTA inactivated. The patient received MMR II and PREVNAR on 07-JUL-2007. On 24-AUG-2007 the patient began experiencing diarrhea. The patient was subsequently hospitalized. Treatment medications included PEDIALYTE 20 oz, IV D5 1/4NS (40 cc/hr), IMODIUM 5 ml. All medication were for diarrhea. ON 29-AUG-2007 a stool analysis was performed with normal results. The patient recovered from diarrhea. Follow-up information was received on 18-APR-2008. The SAE was changed to gastroenteritis with dehydration. The patient was also treated with acetaminophen on 30-AUG-2007. The patient's medical history was significant for frequent ear infections. He had no known drug allergies. On 30-AUG-2007 the patient was seen in the emergency room and had been experiencing bouts of diarrhea every day since 27-AUG-2007. The diarrhea was loose and watery with green discoloration. There was no mucous or blood and he had no associated vomiting or fever. Vital signs were: temperature 99.1 F, pulse 124, respirations 24 and pulse oximetry 98%. Oropharyngeal examination showed mild congestion and his lips appeared dry. Labs were: WBC 16.8, neutrophil 14%, no bands, glucose 95, BUN 7, creatinine 0.3, sodium 138, potassium 4.1, chloride 104. Urine was clear and negative for microscopic exam. Blood culture collected on 30-AUG-2007 showed no growth at 5 days. The patient was subsequently admitted to the hospital. The patient recovered from gastroenteritis with dehydration. The investigator considered the gastroenteritis with dehydration to be related to study medication.
Age: 1.2
Sex: M
Vaccine: HEPA
Symptoms: Respiratory rate, Respiratory tract congestion, Stool analysis normal, Urine analysis normal, White blood cell count normal
Clinical narrative: Information has been received from an investigator concerning a 14 month old male who entered a study. On 18-AUG-2007 the patient was vaccinated with VAQTA inactivated. The patient received MMR II and PREVNAR on 07-JUL-2007. On 24-AUG-2007 the patient began experiencing diarrhea. The patient was subsequently hospitalized. Treatment medications included PEDIALYTE 20 oz, IV D5 1/4NS (40 cc/hr), IMODIUM 5 ml. All medication were for diarrhea. ON 29-AUG-2007 a stool analysis was performed with normal results. The patient recovered from diarrhea. Follow-up information was received on 18-APR-2008. The SAE was changed to gastroenteritis with dehydration. The patient was also treated with acetaminophen on 30-AUG-2007. The patient's medical history was significant for frequent ear infections. He had no known drug allergies. On 30-AUG-2007 the patient was seen in the emergency room and had been experiencing bouts of diarrhea every day since 27-AUG-2007. The diarrhea was loose and watery with green discoloration. There was no mucous or blood and he had no associated vomiting or fever. Vital signs were: temperature 99.1 F, pulse 124, respirations 24 and pulse oximetry 98%. Oropharyngeal examination showed mild congestion and his lips appeared dry. Labs were: WBC 16.8, neutrophil 14%, no bands, glucose 95, BUN 7, creatinine 0.3, sodium 138, potassium 4.1, chloride 104. Urine was clear and negative for microscopic exam. Blood culture collected on 30-AUG-2007 showed no growth at 5 days. The patient was subsequently admitted to the hospital. The patient recovered from gastroenteritis with dehydration. The investigator considered the gastroenteritis with dehydration to be related to study medication.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Anaphylactic shock, Dyspnoea, Swollen tongue, Vomiting
Clinical narrative: Information has been received from a physician and with a follow up telephone call concerning a 17 year old female patient with no pertinent medical history who on 16-APR-2008 at 11:30 AM was vaccinated with a first dose of GARDASIL (lot # 659657/1487U) and with a dose of MENACTRA. Concomitant suspect therapy included amoxicillin (dose, duration not indicated) for sinus infection. The physician reported that "patient received her first injection on 16-APR-2008 and left the doctor's office fine. She picked up a prescription for amoxicillin and took it with a bowl of taco soup. Within two hours after she received GARDASIL and MENACTRA at 01:30 PM she had tongue swelling, vomiting and trouble breathing. The ambulance came and the patient went to the emergency room where she was treated with steroid injections. The patient was not admitted to the hospital. She left the emergency room recovered and was placed on oral steroids. The emergency room physician felt amoxicillin was the cause of the anaphylactic shock. The reporting physician was not sure of cause of the anaphylactic shock was either from MENATRA, amoxicillin or GARDASIL. The reporting physician considered anaphylactic shock to be disabling and life threatening. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Asthenia, Asthma exercise induced, Back pain, Chest X-ray, Dizziness
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no medical history and an allergy to naproxen, who on 17-JAN-2008 was vaccinated IM in one arm with a dose of GARDASIL (Lot# 6596553/1448U) and a dose of MENACTRA, administered in the other arm. On approximately 01-FEB-2008, fifteen days post vaccination, the patient developed a rash. The rash was predominantly on the neck and the face. The rash was diffuse, macular, itchy, and was hive-like in some areas. The patient complained of a marked lack of energy and several episodes of wheezing and respiratory discomfort. On 05-FEB-2008 the patient went to the emergency room because she was experiencing difficulty breathing, headache, and a swelling sensation in the throat. The patient was diagnosed with allergic reactions and/or exercise-induced asthma. The patient was treated with albuterol and an unspecified steroid. On 07-FEB-2008 the patient went to the emergency room because she experienced difficulty breathing after taking her inhaler  for two days and the steroid for one day. The patient was diagnosed with atypical pneumonia and treated with ZITHROMAX. On 15-FEB-2008 the patient was seen for back pain and "cholerectic pain." The shortness of breath had resolved. The patient's chest x-ray had no change. The patient had positive convalescent mycoplasma. On 04-MAR-2008 the patient followed up at the office to recheck pneumonia and upper respiratory infection, which were resolved. It was reported that the patient's back pain was 80% better. The blood counts were normal. On 07-MAR-2008 the patient was seen by her primary pediatrician. It was reported that the patient may have used ALEVE during the week for relief of pain. It was reported that there was no wheezing, lungs were cleared, and the patient was referred to an allergist. The patient was started on FLOVENT. On 11-MAR-2008 there was a call to the office for an unspecified reason. The patient was prescribed an EPIPEN . On 12-MAR-2008 the patient saw an allergist who said that her pulmonary functions were normal. The allergist did not think that the patient required respiratory medications. On 10-APR-2008 the patient came back to the office due to a cold, and complained of a headache, dizziness, and vertigo. The patient had no other neurological conditions. The patient had experienced persistent malaise and fatigue since the onset of the rash. At the time of the report, the patient was not recovered from all events. No product quality complaint was involved. Upon internal review the allergic reaction, exercise induced asthma, difficulty breathing, headache, swelling sensation in throat, and atypical pneumonia were considered to be other important medical events. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dyspnoea, Fatigue, Full blood count normal, Headache, Hypersensitivity
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no medical history and an allergy to naproxen, who on 17-JAN-2008 was vaccinated IM in one arm with a dose of GARDASIL (Lot# 6596553/1448U) and a dose of MENACTRA, administered in the other arm. On approximately 01-FEB-2008, fifteen days post vaccination, the patient developed a rash. The rash was predominantly on the neck and the face. The rash was diffuse, macular, itchy, and was hive-like in some areas. The patient complained of a marked lack of energy and several episodes of wheezing and respiratory discomfort. On 05-FEB-2008 the patient went to the emergency room because she was experiencing difficulty breathing, headache, and a swelling sensation in the throat. The patient was diagnosed with allergic reactions and/or exercise-induced asthma. The patient was treated with albuterol and an unspecified steroid. On 07-FEB-2008 the patient went to the emergency room because she experienced difficulty breathing after taking her inhaler  for two days and the steroid for one day. The patient was diagnosed with atypical pneumonia and treated with ZITHROMAX. On 15-FEB-2008 the patient was seen for back pain and "cholerectic pain." The shortness of breath had resolved. The patient's chest x-ray had no change. The patient had positive convalescent mycoplasma. On 04-MAR-2008 the patient followed up at the office to recheck pneumonia and upper respiratory infection, which were resolved. It was reported that the patient's back pain was 80% better. The blood counts were normal. On 07-MAR-2008 the patient was seen by her primary pediatrician. It was reported that the patient may have used ALEVE during the week for relief of pain. It was reported that there was no wheezing, lungs were cleared, and the patient was referred to an allergist. The patient was started on FLOVENT. On 11-MAR-2008 there was a call to the office for an unspecified reason. The patient was prescribed an EPIPEN . On 12-MAR-2008 the patient saw an allergist who said that her pulmonary functions were normal. The allergist did not think that the patient required respiratory medications. On 10-APR-2008 the patient came back to the office due to a cold, and complained of a headache, dizziness, and vertigo. The patient had no other neurological conditions. The patient had experienced persistent malaise and fatigue since the onset of the rash. At the time of the report, the patient was not recovered from all events. No product quality complaint was involved. Upon internal review the allergic reaction, exercise induced asthma, difficulty breathing, headache, swelling sensation in throat, and atypical pneumonia were considered to be other important medical events. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Malaise, Mycoplasma infection, Mycoplasma serology positive, Nasopharyngitis, Pain
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no medical history and an allergy to naproxen, who on 17-JAN-2008 was vaccinated IM in one arm with a dose of GARDASIL (Lot# 6596553/1448U) and a dose of MENACTRA, administered in the other arm. On approximately 01-FEB-2008, fifteen days post vaccination, the patient developed a rash. The rash was predominantly on the neck and the face. The rash was diffuse, macular, itchy, and was hive-like in some areas. The patient complained of a marked lack of energy and several episodes of wheezing and respiratory discomfort. On 05-FEB-2008 the patient went to the emergency room because she was experiencing difficulty breathing, headache, and a swelling sensation in the throat. The patient was diagnosed with allergic reactions and/or exercise-induced asthma. The patient was treated with albuterol and an unspecified steroid. On 07-FEB-2008 the patient went to the emergency room because she experienced difficulty breathing after taking her inhaler  for two days and the steroid for one day. The patient was diagnosed with atypical pneumonia and treated with ZITHROMAX. On 15-FEB-2008 the patient was seen for back pain and "cholerectic pain." The shortness of breath had resolved. The patient's chest x-ray had no change. The patient had positive convalescent mycoplasma. On 04-MAR-2008 the patient followed up at the office to recheck pneumonia and upper respiratory infection, which were resolved. It was reported that the patient's back pain was 80% better. The blood counts were normal. On 07-MAR-2008 the patient was seen by her primary pediatrician. It was reported that the patient may have used ALEVE during the week for relief of pain. It was reported that there was no wheezing, lungs were cleared, and the patient was referred to an allergist. The patient was started on FLOVENT. On 11-MAR-2008 there was a call to the office for an unspecified reason. The patient was prescribed an EPIPEN . On 12-MAR-2008 the patient saw an allergist who said that her pulmonary functions were normal. The allergist did not think that the patient required respiratory medications. On 10-APR-2008 the patient came back to the office due to a cold, and complained of a headache, dizziness, and vertigo. The patient had no other neurological conditions. The patient had experienced persistent malaise and fatigue since the onset of the rash. At the time of the report, the patient was not recovered from all events. No product quality complaint was involved. Upon internal review the allergic reaction, exercise induced asthma, difficulty breathing, headache, swelling sensation in throat, and atypical pneumonia were considered to be other important medical events. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Painful respiration, Pharyngeal oedema, Physical examination normal, Pneumonia, Pneumonia primary atypical
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no medical history and an allergy to naproxen, who on 17-JAN-2008 was vaccinated IM in one arm with a dose of GARDASIL (Lot# 6596553/1448U) and a dose of MENACTRA, administered in the other arm. On approximately 01-FEB-2008, fifteen days post vaccination, the patient developed a rash. The rash was predominantly on the neck and the face. The rash was diffuse, macular, itchy, and was hive-like in some areas. The patient complained of a marked lack of energy and several episodes of wheezing and respiratory discomfort. On 05-FEB-2008 the patient went to the emergency room because she was experiencing difficulty breathing, headache, and a swelling sensation in the throat. The patient was diagnosed with allergic reactions and/or exercise-induced asthma. The patient was treated with albuterol and an unspecified steroid. On 07-FEB-2008 the patient went to the emergency room because she experienced difficulty breathing after taking her inhaler  for two days and the steroid for one day. The patient was diagnosed with atypical pneumonia and treated with ZITHROMAX. On 15-FEB-2008 the patient was seen for back pain and "cholerectic pain." The shortness of breath had resolved. The patient's chest x-ray had no change. The patient had positive convalescent mycoplasma. On 04-MAR-2008 the patient followed up at the office to recheck pneumonia and upper respiratory infection, which were resolved. It was reported that the patient's back pain was 80% better. The blood counts were normal. On 07-MAR-2008 the patient was seen by her primary pediatrician. It was reported that the patient may have used ALEVE during the week for relief of pain. It was reported that there was no wheezing, lungs were cleared, and the patient was referred to an allergist. The patient was started on FLOVENT. On 11-MAR-2008 there was a call to the office for an unspecified reason. The patient was prescribed an EPIPEN . On 12-MAR-2008 the patient saw an allergist who said that her pulmonary functions were normal. The allergist did not think that the patient required respiratory medications. On 10-APR-2008 the patient came back to the office due to a cold, and complained of a headache, dizziness, and vertigo. The patient had no other neurological conditions. The patient had experienced persistent malaise and fatigue since the onset of the rash. At the time of the report, the patient was not recovered from all events. No product quality complaint was involved. Upon internal review the allergic reaction, exercise induced asthma, difficulty breathing, headache, swelling sensation in throat, and atypical pneumonia were considered to be other important medical events. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pulmonary function test normal, Rash, Rash macular, Rash pruritic, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no medical history and an allergy to naproxen, who on 17-JAN-2008 was vaccinated IM in one arm with a dose of GARDASIL (Lot# 6596553/1448U) and a dose of MENACTRA, administered in the other arm. On approximately 01-FEB-2008, fifteen days post vaccination, the patient developed a rash. The rash was predominantly on the neck and the face. The rash was diffuse, macular, itchy, and was hive-like in some areas. The patient complained of a marked lack of energy and several episodes of wheezing and respiratory discomfort. On 05-FEB-2008 the patient went to the emergency room because she was experiencing difficulty breathing, headache, and a swelling sensation in the throat. The patient was diagnosed with allergic reactions and/or exercise-induced asthma. The patient was treated with albuterol and an unspecified steroid. On 07-FEB-2008 the patient went to the emergency room because she experienced difficulty breathing after taking her inhaler  for two days and the steroid for one day. The patient was diagnosed with atypical pneumonia and treated with ZITHROMAX. On 15-FEB-2008 the patient was seen for back pain and "cholerectic pain." The shortness of breath had resolved. The patient's chest x-ray had no change. The patient had positive convalescent mycoplasma. On 04-MAR-2008 the patient followed up at the office to recheck pneumonia and upper respiratory infection, which were resolved. It was reported that the patient's back pain was 80% better. The blood counts were normal. On 07-MAR-2008 the patient was seen by her primary pediatrician. It was reported that the patient may have used ALEVE during the week for relief of pain. It was reported that there was no wheezing, lungs were cleared, and the patient was referred to an allergist. The patient was started on FLOVENT. On 11-MAR-2008 there was a call to the office for an unspecified reason. The patient was prescribed an EPIPEN . On 12-MAR-2008 the patient saw an allergist who said that her pulmonary functions were normal. The allergist did not think that the patient required respiratory medications. On 10-APR-2008 the patient came back to the office due to a cold, and complained of a headache, dizziness, and vertigo. The patient had no other neurological conditions. The patient had experienced persistent malaise and fatigue since the onset of the rash. At the time of the report, the patient was not recovered from all events. No product quality complaint was involved. Upon internal review the allergic reaction, exercise induced asthma, difficulty breathing, headache, swelling sensation in throat, and atypical pneumonia were considered to be other important medical events. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Upper respiratory tract infection, Urticaria, Vertigo, Wheezing
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no medical history and an allergy to naproxen, who on 17-JAN-2008 was vaccinated IM in one arm with a dose of GARDASIL (Lot# 6596553/1448U) and a dose of MENACTRA, administered in the other arm. On approximately 01-FEB-2008, fifteen days post vaccination, the patient developed a rash. The rash was predominantly on the neck and the face. The rash was diffuse, macular, itchy, and was hive-like in some areas. The patient complained of a marked lack of energy and several episodes of wheezing and respiratory discomfort. On 05-FEB-2008 the patient went to the emergency room because she was experiencing difficulty breathing, headache, and a swelling sensation in the throat. The patient was diagnosed with allergic reactions and/or exercise-induced asthma. The patient was treated with albuterol and an unspecified steroid. On 07-FEB-2008 the patient went to the emergency room because she experienced difficulty breathing after taking her inhaler  for two days and the steroid for one day. The patient was diagnosed with atypical pneumonia and treated with ZITHROMAX. On 15-FEB-2008 the patient was seen for back pain and "cholerectic pain." The shortness of breath had resolved. The patient's chest x-ray had no change. The patient had positive convalescent mycoplasma. On 04-MAR-2008 the patient followed up at the office to recheck pneumonia and upper respiratory infection, which were resolved. It was reported that the patient's back pain was 80% better. The blood counts were normal. On 07-MAR-2008 the patient was seen by her primary pediatrician. It was reported that the patient may have used ALEVE during the week for relief of pain. It was reported that there was no wheezing, lungs were cleared, and the patient was referred to an allergist. The patient was started on FLOVENT. On 11-MAR-2008 there was a call to the office for an unspecified reason. The patient was prescribed an EPIPEN . On 12-MAR-2008 the patient saw an allergist who said that her pulmonary functions were normal. The allergist did not think that the patient required respiratory medications. On 10-APR-2008 the patient came back to the office due to a cold, and complained of a headache, dizziness, and vertigo. The patient had no other neurological conditions. The patient had experienced persistent malaise and fatigue since the onset of the rash. At the time of the report, the patient was not recovered from all events. No product quality complaint was involved. Upon internal review the allergic reaction, exercise induced asthma, difficulty breathing, headache, swelling sensation in throat, and atypical pneumonia were considered to be other important medical events. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Crying, Screaming
Clinical narrative: high-pitched screaming. Periods of being inconsolable for 1 wk. -Started 4 hours after shot.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Erythema, Induration
Clinical narrative: 6x8cm erythema/induration; no warmth on right arm.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Ear pain, Eye movement disorder, Facial paresis, Headache, Insomnia
Clinical narrative: 11/26/07 Seen by PCP-for headache with watery eyes, skin rash. 11/27/07 weakness in facial and lip area, (L) eye would not shut. 12/3/07 Headache, insomnia, 12/7/07 weakness, earache, 12/10/07 weakness, 12/14/07 weakness; 1/4/08 weakness; 2/4/08 Idiopathic peripheral neuropathy 5/7/08-records received for DOS 12/14-12/21/07-DC DX: Guillain-Barre syndrome. Onset of left side of face Bell's palsy on 11/25/07. Day before experienced bifrontal headache. Two weeks ago experienced weakness of lower extremities and became progressive to point he could no longer ambulate. Difficult time standing from sitting . Now has mild weakness in upper extremities. Paresthesias of all four extremities. Fell recently. DTRs absent throughout. Lumbar puncture unremarkable. IVIG treatment.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test, Lacrimation increased, Neuropathy peripheral, Rash
Clinical narrative: 11/26/07 Seen by PCP-for headache with watery eyes, skin rash. 11/27/07 weakness in facial and lip area, (L) eye would not shut. 12/3/07 Headache, insomnia, 12/7/07 weakness, earache, 12/10/07 weakness, 12/14/07 weakness; 1/4/08 weakness; 2/4/08 Idiopathic peripheral neuropathy 5/7/08-records received for DOS 12/14-12/21/07-DC DX: Guillain-Barre syndrome. Onset of left side of face Bell's palsy on 11/25/07. Day before experienced bifrontal headache. Two weeks ago experienced weakness of lower extremities and became progressive to point he could no longer ambulate. Difficult time standing from sitting . Now has mild weakness in upper extremities. Paresthesias of all four extremities. Fell recently. DTRs absent throughout. Lumbar puncture unremarkable. IVIG treatment.
Age: 11.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Area of erythema at VARIVAX site - 1-2 in diameter - no treatment - observe only.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: 8 hives on scalp; 6 hives on neck; 5 hives on right arm; 1 hive on left arm; 1 hive on left ankle; 21 hives total-popped out on April 18, 19, 20, 21, 22. No temperature; Doctor prescribed Zyrtec
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema
Clinical narrative: 6 x 9 area erythema bilateral upper arms.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Petechiae
Clinical narrative: 10 minutes after vaccines administered, pt developed a petechiae rash to neck and around eyes. Pt denies itching. No respiratory difficulty. Dr examined pt. Benadryl one teaspoon administered. Pt waited x 45 minutes in office. No further change in pt. 4-23-08 called to check on pt. rash persists. Denies itching.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin discolouration, Skin swelling, Skin warm
Clinical narrative: 5x4" Mildly swollen bright pink area upper left arm, warm to touch
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Rash erythematous, Rash macular
Clinical narrative: 6x4cm pink macular rash below injection site on L arm in deltoid area.  No fever or itching.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Pyrexia
Clinical narrative: 9x8cm pink pruritic, macular, rash below injection site.  Fever 101.3 tender to touch.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash macular
Clinical narrative: 9x8cm pink pruritic, macular, rash below injection site.  Fever 101.3 tender to touch.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen 8x8cm erythema left upper arm, hot to touch, no fever.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: MOM REPORTED PATIENT HAD ITCHING AND RASH 1 HR AFTER ADMINISTRATION LASTING LESS THAN 45 MINUTES; EXACERBATE BY HOT SHOWER; CLEARED WITH BENADRYL.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site rash
Clinical narrative: Child developed a rash on the back of her right arm, at the site of the MMR vaccination.  The vaccine was given on the 22 of April.
Age: 23.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Convulsion, Dizziness, Dysgeusia, Musculoskeletal stiffness, Nausea
Clinical narrative: Approx 8-10 min after vaccines administered client c/o nausea and dizziness, body became stiff with "seizure like" activity, was unresponsive but quickly became responsive, c/o "metal like" taste and "felt like she had just awakened from a nap." EMS was called and client was transported to the ED.
Age: 23.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Somnolence, Unresponsive to stimuli
Clinical narrative: Approx 8-10 min after vaccines administered client c/o nausea and dizziness, body became stiff with "seizure like" activity, was unresponsive but quickly became responsive, c/o "metal like" taste and "felt like she had just awakened from a nap." EMS was called and client was transported to the ED.