chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Dyspnoea, Fatigue, Hypersomnia, Muscle atrophy, Muscle contractions involuntary
Clinical narrative: This spontaneous report was received from a physician, concerning a male patient of unknown age. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (Lot #, dose and route not reported). Other suspect therapy included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) (Lot #, dose and route not reported). Concomitant therapy was not reported. The physician reported that he read in the obituary section of the newspaper, on 21-AUG-2013 that the patient died from an illness that began on 11-APR-2013 after receiving the vaccines (whether the vaccinations precipitated the exacerbation of a possible lime disease infection was still in question). It was reported that the physician was not the patient's physician and that the physician just read it in the obituary section of the newspaper. It was reported that the patient died on 18-AUG-2013 and the case of death was reported as illness. This report was serious due to life threatening (considered by the physician) and death. Additional information is not expected.
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Muscular weakness, Rhinorrhoea, Tremor, Weight decreased
Clinical narrative: This spontaneous report was received from a physician, concerning a male patient of unknown age. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (Lot #, dose and route not reported). Other suspect therapy included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) (Lot #, dose and route not reported). Concomitant therapy was not reported. The physician reported that he read in the obituary section of the newspaper, on 21-AUG-2013 that the patient died from an illness that began on 11-APR-2013 after receiving the vaccines (whether the vaccinations precipitated the exacerbation of a possible lime disease infection was still in question). It was reported that the physician was not the patient's physician and that the physician just read it in the obituary section of the newspaper. It was reported that the patient died on 18-AUG-2013 and the case of death was reported as illness. This report was serious due to life threatening (considered by the physician) and death. Additional information is not expected.
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Activities of daily living impaired, Antibody test, Asthenia, Blood immunoglobulin M increased, Borrelia test
Clinical narrative: This spontaneous report was received from a physician, concerning a male patient of unknown age. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (Lot #, dose and route not reported). Other suspect therapy included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) (Lot #, dose and route not reported). Concomitant therapy was not reported. The physician reported that he read in the obituary section of the newspaper, on 21-AUG-2013 that the patient died from an illness that began on 11-APR-2013 after receiving the vaccines (whether the vaccinations precipitated the exacerbation of a possible lime disease infection was still in question). It was reported that the physician was not the patient's physician and that the physician just read it in the obituary section of the newspaper. It was reported that the patient died on 18-AUG-2013 and the case of death was reported as illness. This report was serious due to life threatening (considered by the physician) and death. Additional information is not expected.
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Borrelia test negative, Chest X-ray normal, Clonus, Cough, Decreased activity
Clinical narrative: This spontaneous report was received from a physician, concerning a male patient of unknown age. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (Lot #, dose and route not reported). Other suspect therapy included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) (Lot #, dose and route not reported). Concomitant therapy was not reported. The physician reported that he read in the obituary section of the newspaper, on 21-AUG-2013 that the patient died from an illness that began on 11-APR-2013 after receiving the vaccines (whether the vaccinations precipitated the exacerbation of a possible lime disease infection was still in question). It was reported that the physician was not the patient's physician and that the physician just read it in the obituary section of the newspaper. It was reported that the patient died on 18-AUG-2013 and the case of death was reported as illness. This report was serious due to life threatening (considered by the physician) and death. Additional information is not expected.
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Decreased appetite, Dysphonia, Dyspnoea, Electromyogram abnormal, Fatigue
Clinical narrative: This spontaneous report was received from a physician, concerning a male patient of unknown age. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (Lot #, dose and route not reported). Other suspect therapy included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) (Lot #, dose and route not reported). Concomitant therapy was not reported. The physician reported that he read in the obituary section of the newspaper, on 21-AUG-2013 that the patient died from an illness that began on 11-APR-2013 after receiving the vaccines (whether the vaccinations precipitated the exacerbation of a possible lime disease infection was still in question). It was reported that the physician was not the patient's physician and that the physician just read it in the obituary section of the newspaper. It was reported that the patient died on 18-AUG-2013 and the case of death was reported as illness. This report was serious due to life threatening (considered by the physician) and death. Additional information is not expected.
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Head titubation, Laboratory test normal, Muscle atrophy, Muscle contractions involuntary, Muscular weakness
Clinical narrative: This spontaneous report was received from a physician, concerning a male patient of unknown age. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (Lot #, dose and route not reported). Other suspect therapy included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) (Lot #, dose and route not reported). Concomitant therapy was not reported. The physician reported that he read in the obituary section of the newspaper, on 21-AUG-2013 that the patient died from an illness that began on 11-APR-2013 after receiving the vaccines (whether the vaccinations precipitated the exacerbation of a possible lime disease infection was still in question). It was reported that the physician was not the patient's physician and that the physician just read it in the obituary section of the newspaper. It was reported that the patient died on 18-AUG-2013 and the case of death was reported as illness. This report was serious due to life threatening (considered by the physician) and death. Additional information is not expected.
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Nuclear magnetic resonance imaging spinal normal, Pulmonary function test decreased, Rhinorrhoea
Clinical narrative: This spontaneous report was received from a physician, concerning a male patient of unknown age. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (Lot #, dose and route not reported). Other suspect therapy included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) (Lot #, dose and route not reported). Concomitant therapy was not reported. The physician reported that he read in the obituary section of the newspaper, on 21-AUG-2013 that the patient died from an illness that began on 11-APR-2013 after receiving the vaccines (whether the vaccinations precipitated the exacerbation of a possible lime disease infection was still in question). It was reported that the physician was not the patient's physician and that the physician just read it in the obituary section of the newspaper. It was reported that the patient died on 18-AUG-2013 and the case of death was reported as illness. This report was serious due to life threatening (considered by the physician) and death. Additional information is not expected.
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Tremor, Weight decreased
Clinical narrative: This spontaneous report was received from a physician, concerning a male patient of unknown age. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (Lot #, dose and route not reported). Other suspect therapy included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) (Lot #, dose and route not reported). Concomitant therapy was not reported. The physician reported that he read in the obituary section of the newspaper, on 21-AUG-2013 that the patient died from an illness that began on 11-APR-2013 after receiving the vaccines (whether the vaccinations precipitated the exacerbation of a possible lime disease infection was still in question). It was reported that the physician was not the patient's physician and that the physician just read it in the obituary section of the newspaper. It was reported that the patient died on 18-AUG-2013 and the case of death was reported as illness. This report was serious due to life threatening (considered by the physician) and death. Additional information is not expected.
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Death, Malaise
Clinical narrative: This spontaneous report was received from a physician, concerning a male patient of unknown age. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (Lot #, dose and route not reported). Other suspect therapy included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) (Lot #, dose and route not reported). Concomitant therapy was not reported. The physician reported that he read in the obituary section of the newspaper, on 21-AUG-2013 that the patient died from an illness that began on 11-APR-2013 after receiving the vaccines (whether the vaccinations precipitated the exacerbation of a possible lime disease infection was still in question). It was reported that the physician was not the patient's physician and that the physician just read it in the obituary section of the newspaper. It was reported that the patient died on 18-AUG-2013 and the case of death was reported as illness. This report was serious due to life threatening (considered by the physician) and death. Additional information is not expected.
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Breath odour, Chest X-ray, Cough, Decreased appetite, Dysphonia
Clinical narrative: This spontaneous report as received from a physician who read in the obituary section of the newspaper on 21-AUG-2013 about a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unspecified) (dose, route lot number not reported) and a dose of diphtheria toxoid (+) pertussis whole cell vaccine (+) tetanus toxoid(manufacturer unspecified) (dose, route lot number not reported). On 18-AUG-2013 the patient died from an unspecified illness that began on 11-APR-2013, after receiving the DTAP and Pneumococcal vaccinations. It was noted that whether the vaccinations precipitated the exacerbation of a possible Lyme disease infection was still in question. The causal relationship was not reported. Unspecified illness was considered life threatening by the reporter. Additional information is not expected.
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Dyspnoea, Fatigue, Hypersomnia, Muscle atrophy, Muscle contractions involuntary
Clinical narrative: This spontaneous report as received from a physician who read in the obituary section of the newspaper on 21-AUG-2013 about a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unspecified) (dose, route lot number not reported) and a dose of diphtheria toxoid (+) pertussis whole cell vaccine (+) tetanus toxoid(manufacturer unspecified) (dose, route lot number not reported). On 18-AUG-2013 the patient died from an unspecified illness that began on 11-APR-2013, after receiving the DTAP and Pneumococcal vaccinations. It was noted that whether the vaccinations precipitated the exacerbation of a possible Lyme disease infection was still in question. The causal relationship was not reported. Unspecified illness was considered life threatening by the reporter. Additional information is not expected.
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Muscular weakness, Rhinorrhoea, Tremor, Weight decreased
Clinical narrative: This spontaneous report as received from a physician who read in the obituary section of the newspaper on 21-AUG-2013 about a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unspecified) (dose, route lot number not reported) and a dose of diphtheria toxoid (+) pertussis whole cell vaccine (+) tetanus toxoid(manufacturer unspecified) (dose, route lot number not reported). On 18-AUG-2013 the patient died from an unspecified illness that began on 11-APR-2013, after receiving the DTAP and Pneumococcal vaccinations. It was noted that whether the vaccinations precipitated the exacerbation of a possible Lyme disease infection was still in question. The causal relationship was not reported. Unspecified illness was considered life threatening by the reporter. Additional information is not expected.
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Activities of daily living impaired, Antibody test, Asthenia, Blood immunoglobulin M increased, Borrelia test
Clinical narrative: This spontaneous report as received from a physician who read in the obituary section of the newspaper on 21-AUG-2013 about a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unspecified) (dose, route lot number not reported) and a dose of diphtheria toxoid (+) pertussis whole cell vaccine (+) tetanus toxoid(manufacturer unspecified) (dose, route lot number not reported). On 18-AUG-2013 the patient died from an unspecified illness that began on 11-APR-2013, after receiving the DTAP and Pneumococcal vaccinations. It was noted that whether the vaccinations precipitated the exacerbation of a possible Lyme disease infection was still in question. The causal relationship was not reported. Unspecified illness was considered life threatening by the reporter. Additional information is not expected.
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Borrelia test negative, Chest X-ray normal, Clonus, Cough, Decreased activity
Clinical narrative: This spontaneous report as received from a physician who read in the obituary section of the newspaper on 21-AUG-2013 about a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unspecified) (dose, route lot number not reported) and a dose of diphtheria toxoid (+) pertussis whole cell vaccine (+) tetanus toxoid(manufacturer unspecified) (dose, route lot number not reported). On 18-AUG-2013 the patient died from an unspecified illness that began on 11-APR-2013, after receiving the DTAP and Pneumococcal vaccinations. It was noted that whether the vaccinations precipitated the exacerbation of a possible Lyme disease infection was still in question. The causal relationship was not reported. Unspecified illness was considered life threatening by the reporter. Additional information is not expected.
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Decreased appetite, Dysphonia, Dyspnoea, Electromyogram abnormal, Fatigue
Clinical narrative: This spontaneous report as received from a physician who read in the obituary section of the newspaper on 21-AUG-2013 about a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unspecified) (dose, route lot number not reported) and a dose of diphtheria toxoid (+) pertussis whole cell vaccine (+) tetanus toxoid(manufacturer unspecified) (dose, route lot number not reported). On 18-AUG-2013 the patient died from an unspecified illness that began on 11-APR-2013, after receiving the DTAP and Pneumococcal vaccinations. It was noted that whether the vaccinations precipitated the exacerbation of a possible Lyme disease infection was still in question. The causal relationship was not reported. Unspecified illness was considered life threatening by the reporter. Additional information is not expected.
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Head titubation, Laboratory test normal, Muscle atrophy, Muscle contractions involuntary, Muscular weakness
Clinical narrative: This spontaneous report as received from a physician who read in the obituary section of the newspaper on 21-AUG-2013 about a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unspecified) (dose, route lot number not reported) and a dose of diphtheria toxoid (+) pertussis whole cell vaccine (+) tetanus toxoid(manufacturer unspecified) (dose, route lot number not reported). On 18-AUG-2013 the patient died from an unspecified illness that began on 11-APR-2013, after receiving the DTAP and Pneumococcal vaccinations. It was noted that whether the vaccinations precipitated the exacerbation of a possible Lyme disease infection was still in question. The causal relationship was not reported. Unspecified illness was considered life threatening by the reporter. Additional information is not expected.
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Nuclear magnetic resonance imaging spinal normal, Pulmonary function test decreased, Rhinorrhoea
Clinical narrative: This spontaneous report as received from a physician who read in the obituary section of the newspaper on 21-AUG-2013 about a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unspecified) (dose, route lot number not reported) and a dose of diphtheria toxoid (+) pertussis whole cell vaccine (+) tetanus toxoid(manufacturer unspecified) (dose, route lot number not reported). On 18-AUG-2013 the patient died from an unspecified illness that began on 11-APR-2013, after receiving the DTAP and Pneumococcal vaccinations. It was noted that whether the vaccinations precipitated the exacerbation of a possible Lyme disease infection was still in question. The causal relationship was not reported. Unspecified illness was considered life threatening by the reporter. Additional information is not expected.
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Tremor, Weight decreased
Clinical narrative: This spontaneous report as received from a physician who read in the obituary section of the newspaper on 21-AUG-2013 about a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unspecified) (dose, route lot number not reported) and a dose of diphtheria toxoid (+) pertussis whole cell vaccine (+) tetanus toxoid(manufacturer unspecified) (dose, route lot number not reported). On 18-AUG-2013 the patient died from an unspecified illness that began on 11-APR-2013, after receiving the DTAP and Pneumococcal vaccinations. It was noted that whether the vaccinations precipitated the exacerbation of a possible Lyme disease infection was still in question. The causal relationship was not reported. Unspecified illness was considered life threatening by the reporter. Additional information is not expected.
Sex: M
Vaccine: PPV, TDAP, DTAP, PPV, DTAP, PPV, DTAP, PPV
Symptoms: Death, Malaise
Clinical narrative: This spontaneous report as received from a physician who read in the obituary section of the newspaper on 21-AUG-2013 about a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unspecified) (dose, route lot number not reported) and a dose of diphtheria toxoid (+) pertussis whole cell vaccine (+) tetanus toxoid(manufacturer unspecified) (dose, route lot number not reported). On 18-AUG-2013 the patient died from an unspecified illness that began on 11-APR-2013, after receiving the DTAP and Pneumococcal vaccinations. It was noted that whether the vaccinations precipitated the exacerbation of a possible Lyme disease infection was still in question. The causal relationship was not reported. Unspecified illness was considered life threatening by the reporter. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: DTAP
Symptoms: Activities of daily living impaired, Chills, Injected limb mobility decreased, Injection site haematoma, Pain
Clinical narrative: On 08/06/2013 I had chills, fever (39.9 C), hematoma (unable to lift up my arm) on the injection site. Took the following medications, Hydrocodone and Tylenol. I did not attend work for 2 days due to the pain.
Age: 54.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: On 08/06/2013 I had chills, fever (39.9 C), hematoma (unable to lift up my arm) on the injection site. Took the following medications, Hydrocodone and Tylenol. I did not attend work for 2 days due to the pain.
Age: 1.22
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Decreased appetite, Malaise, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: Small tiny red rash from head to toe, fever of 101.3, general feeling unwell, no appetite, lasted for 5 days.
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Patient reported back to medical facility with urticaria 30 min s/p HPV vaccine.
Age: 35.0
Sex: M
Vaccine: DTAP
Symptoms: Pruritus, Urticaria
Clinical narrative: NOTICED MY UPPER THIGHS AND BUTTOCKS WAS ITCHING A LOT. WHEN I WENT TO BED I LOOKED AT MY LEGS AND NOTICED I HAD A LOT OF HIVES ALL AROUND MY THIGHS AND BUTT. NOW GETTING THEM UP MY ARMS.
Age: 79.0
Sex: F
Vaccine: YF
Symptoms: Asthenia, Diarrhoea, Pyrexia, Stool analysis normal
Clinical narrative: 7-28-13 fever, weakness, diarrhea. Stool sample - negative results, given IMODIUM. 8-14-13 rehospitalized overnight - diarrhea continues.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Paraesthesia, Rash
Clinical narrative: Patient states c/o numbness/tingling to his face s/p 2 hrs prior to vaccine administration on 8/19/2013. Patient called this author 8/20/13 to c/o continued numbness tingling rash to left side of body - and was advised to ER.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On an unknown date in 2009 the patient was vaccinated with the first dose of GARDASIL. The patient received the second dose of GARDASIL in February 2013. No adverse effects had been reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cervix carcinoma stage II, Human papilloma virus test positive, Loop electrosurgical excision procedure
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 20 year old female patient. On an unknown date the patient was received all three doses of GARDASIL (lot#, dose, frequency and route unspecified). On an unknown date in recently the patient was diagnosed as being positive for HPV 16 and 18 and was also diagnosed with carcinoma, stage II. Patient underwent LEEP procedure, no results available. The patient sought medical attention via office visit. The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Gestational hypertension, Wrong drug administered
Clinical narrative: Case number PHEH2012US021386 is an initial spontaneous report received from a nurse on 22 Oct 2012 with the follow-up received on 22 Oct 2012 with the follow-up received on 27 Nov 2012 and a follow up report from nurse received on 20 Aug 2013: This case refers to a 28-year-old female patient. She was 37-weeks of pregnant. Her last menstrual period was reported as 02 Feb 2012 and expected date of delivery reported as on 10 Nov 2012. Concomitant drug included prenatal tablets as vitamins supplementation from 02 Feb 2012 till 10 Nov 2012. She was vaccinated with FLUVIRIN (batch number: 1205401 and expiry date: Jun 2012) intramuscularly on 05 Oct 2012 and accidentally again vaccinated with FLUVIRIN (batch number: 1205401 and expiry date: Jun 2012) at dose of 0.5 ml intramuscularly on 22 Oct 2012 instead of her scheduled BOOSTRIX. It was reported that during pregnancy she had pregnancy induced hypertension which was reported as a non serious event by the nurse. The patient had a normal full term delivery and gave birth to a normal male neonate with seven and half pounds/ounces weight. She had no maternal complications related to birth. No adverse event was reported to the patient and the neonate following the delivery. Follow-up received on 22 Oct 2012: Updated vaccines expiry date (Jun 2013). Follow-up received on 27 Nov 2012: Updated patient weight, weeks of pregnancy, dose and route of vaccination, booster vaccine name and adverse event (vaccine exposure during pregnancy). Follow up information received on 13 Aug 2013: Multiple attempts were made to obtain outcome of event without success. This case is considered lost to follow up. Follow up report from nurse received on 20 Aug 2013: The pregnancy details (last menstrual period, expected date of delivery, delivery type, outcome and neonate details), concomitant drug, event (pregnancy induced hypertension) and final outcome of the patient and neonate were added.
Age: 40.0
Sex: M
Vaccine: FLUN3
Symptoms: Ageusia, Allergy to animal, Allergy to plants, Anosmia, Computerised tomogram abnormal
Clinical narrative: A report has been received from a physician via medical representative concerning a 40 year old male patient. No information regarding relevant history, concomitant disease, and concomitant medications was provided. Patient had received nasal FLUMIST (intranasal) on 01-Oct-2012. The physician reported that the day of FLUMIST administration he had a severe runny nose after dosing. He also experienced the inability to perceive odor, anosmia and loss of taste beginning one-two weeks after the vaccine. He also had a nasal CT on 24-Jan-2013 that revealed right side nasal polyps. The patient was prescribed AUGMENTIN for two weeks and was switched to clindamycin for two weeks. He still was having problems, so a sinus endoscopy was performed. The turbinates were shaved and triple antibiotic ointment and packing applied. After the surgery, he saw an allergist who diagnosed him with allergies to dust mites, grass, dogs, cats, and trees. He was started on allergy shots. In May-2013, a repeat scan showed sinus disease also in the left sinus. He was prescribed LEVAQUIN for three weeks. On 18-Jun-2013, the surgeon removed the remaining packing. Action taken with the FLUMIST was not applicable. The outcome of the event of anosmia, loss of taste, runny nose, nasal polyp, sinus disease and allergies was unknown. The reporter considered the events of anosmia, runny nose, loss of taste to be serious with seriousness criteria of important medical event and events of sinus disease, nasal polyp and allergies to be non-serious. Follow-up information received by AstraZeneca/MedImmune on 12-Aug-2013 from Physician originating from spontaneous source upgraded this case to expeditable: Due to patient having surgery, seriousness for the events of anosmia, runny nose was updated to serious from non serious. New serious event of loss of taste and non serious events of sinus disease and allergies were added. Corrected report 19-Aug-2013: Action taken was corrected to not applicable from unknown. Reporters were renumbered. Confidential was ticked for primary reporter.
Age: 40.0
Sex: M
Vaccine: FLUN3
Symptoms: Endoscopy abnormal, House dust allergy, Nasal polyps, Rhinorrhoea, Seasonal allergy
Clinical narrative: A report has been received from a physician via medical representative concerning a 40 year old male patient. No information regarding relevant history, concomitant disease, and concomitant medications was provided. Patient had received nasal FLUMIST (intranasal) on 01-Oct-2012. The physician reported that the day of FLUMIST administration he had a severe runny nose after dosing. He also experienced the inability to perceive odor, anosmia and loss of taste beginning one-two weeks after the vaccine. He also had a nasal CT on 24-Jan-2013 that revealed right side nasal polyps. The patient was prescribed AUGMENTIN for two weeks and was switched to clindamycin for two weeks. He still was having problems, so a sinus endoscopy was performed. The turbinates were shaved and triple antibiotic ointment and packing applied. After the surgery, he saw an allergist who diagnosed him with allergies to dust mites, grass, dogs, cats, and trees. He was started on allergy shots. In May-2013, a repeat scan showed sinus disease also in the left sinus. He was prescribed LEVAQUIN for three weeks. On 18-Jun-2013, the surgeon removed the remaining packing. Action taken with the FLUMIST was not applicable. The outcome of the event of anosmia, loss of taste, runny nose, nasal polyp, sinus disease and allergies was unknown. The reporter considered the events of anosmia, runny nose, loss of taste to be serious with seriousness criteria of important medical event and events of sinus disease, nasal polyp and allergies to be non-serious. Follow-up information received by AstraZeneca/MedImmune on 12-Aug-2013 from Physician originating from spontaneous source upgraded this case to expeditable: Due to patient having surgery, seriousness for the events of anosmia, runny nose was updated to serious from non serious. New serious event of loss of taste and non serious events of sinus disease and allergies were added. Corrected report 19-Aug-2013: Action taken was corrected to not applicable from unknown. Reporters were renumbered. Confidential was ticked for primary reporter.
Age: 40.0
Sex: M
Vaccine: FLUN3
Symptoms: Sinus disorder, Surgery
Clinical narrative: A report has been received from a physician via medical representative concerning a 40 year old male patient. No information regarding relevant history, concomitant disease, and concomitant medications was provided. Patient had received nasal FLUMIST (intranasal) on 01-Oct-2012. The physician reported that the day of FLUMIST administration he had a severe runny nose after dosing. He also experienced the inability to perceive odor, anosmia and loss of taste beginning one-two weeks after the vaccine. He also had a nasal CT on 24-Jan-2013 that revealed right side nasal polyps. The patient was prescribed AUGMENTIN for two weeks and was switched to clindamycin for two weeks. He still was having problems, so a sinus endoscopy was performed. The turbinates were shaved and triple antibiotic ointment and packing applied. After the surgery, he saw an allergist who diagnosed him with allergies to dust mites, grass, dogs, cats, and trees. He was started on allergy shots. In May-2013, a repeat scan showed sinus disease also in the left sinus. He was prescribed LEVAQUIN for three weeks. On 18-Jun-2013, the surgeon removed the remaining packing. Action taken with the FLUMIST was not applicable. The outcome of the event of anosmia, loss of taste, runny nose, nasal polyp, sinus disease and allergies was unknown. The reporter considered the events of anosmia, runny nose, loss of taste to be serious with seriousness criteria of important medical event and events of sinus disease, nasal polyp and allergies to be non-serious. Follow-up information received by AstraZeneca/MedImmune on 12-Aug-2013 from Physician originating from spontaneous source upgraded this case to expeditable: Due to patient having surgery, seriousness for the events of anosmia, runny nose was updated to serious from non serious. New serious event of loss of taste and non serious events of sinus disease and allergies were added. Corrected report 19-Aug-2013: Action taken was corrected to not applicable from unknown. Reporters were renumbered. Confidential was ticked for primary reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pain in extremity
Clinical narrative: 8/25 reported warmth, redness, pain from shoulder to elbow - ice pack.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, RV1
Symptoms: Computerised tomogram head normal, Laboratory test normal, Muscle twitching, Nuclear magnetic resonance imaging brain normal, Partial seizures
Clinical narrative: Focal seizure - head turning to left and face twitching. No post-ictal. 4 episodes on 8/24. Chem panel normal. Head CT, MRI normal. Pt s/p loading dose phenobarbital 15 mg/kg IV. Discharged on 30mg qhs. Will follow up w/ neurology.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, RV1
Symptoms: Posture abnormal
Clinical narrative: Focal seizure - head turning to left and face twitching. No post-ictal. 4 episodes on 8/24. Chem panel normal. Head CT, MRI normal. Pt s/p loading dose phenobarbital 15 mg/kg IV. Discharged on 30mg qhs. Will follow up w/ neurology.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a registered nurse concerning a male patient of unknown age. On an unknown date (reported as one unspecified patient received the vaccine about a year ago and the other unspecified patient received the vaccine about a couple of years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date (reported as recently, the patient was diagnosed with shingles after receiving ZOSTAVAX. The patient sought an unspecified medical attention. An unspecified treatment was given to the patient. It was unspecified if any lab tests were performed. On an unknown date, the patient was recovered from shingles. The relatedness for shingles was unknown for ZOSTAVAX. This is one of the two reports from the same source. Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Balance disorder, Dysarthria, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture abnormal
Clinical narrative: Flu vaccine given 12/10. Two weeks later (Jan. 2011) I experienced loss of balance, tingling in hands and feet, slurred speech which resulted in ER visit/hospitalization for 1 wk, required physical therapy, speech therapy and occupational therapy, IVIG treatment. Occasional tingling in hands.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Neurological examination abnormal, Nuclear magnetic resonance imaging abnormal, Paraesthesia
Clinical narrative: Flu vaccine given 12/10. Two weeks later (Jan. 2011) I experienced loss of balance, tingling in hands and feet, slurred speech which resulted in ER visit/hospitalization for 1 wk, required physical therapy, speech therapy and occupational therapy, IVIG treatment. Occasional tingling in hands.
Sex: U
Vaccine: HPV4, MMR, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unknown age and gender. On an unknown date, the unknown number of patients may have received M-M-R II, GARDASIL or ROTATEQ that was stored improperly. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a female patient of unknown age. No medical history or drug reactions/allergies were reported. On 14-AUG-2013, the patient was vaccinated with the second dose in the GARDASIL series (Lot #, dose, and route not provided). The pharmacist reported that on an unspecified date, in August 2012, a year ago the patient received the first dose of GARDASIL series (Lot #, dose and route not provided). No adverse effect was reported. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC13, RV5
Symptoms: Abnormal behaviour, Posture abnormal
Clinical narrative: Parents describe him as being "Drunk" after vaccines. Not holding his head up. Just not himself.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised
Clinical narrative: Full body rash developed approximately 30 min after receiving varicella vacc.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Dysgeusia, Dyspnoea, Palpitations
Clinical narrative: 5-10 minutes after injection ct presented to clinic with metallic taste in her mouth, "racing heart", and sob. Obtained ct bp first time 169/109 second time 158/88. Ct did not appear in distress. After taking BP ct stated that she was feeling better. She stated she was breathing fine and felt like her heart slowed down. Ct refused to follow up at ER or primary care.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Convulsion
Clinical narrative: Seizure - Lasting less than 10 seconds.
Age: 0.52
Sex: F
Vaccine: HEPAB, TD
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Spouse reported that it started as a "minor rash" under the arms or "few bumps". Spouse reports that it "slowly worsened" and by Friday it was "much worse" and had "hives" all down the arms to the waist and on the chest. Tried generic "Benadryl" on Friday that helped the itching but did not significantly improve the hives, so also tried "Zyrtec that did not touch it". She continues with "hives" today without change.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Fatigue, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: RED, ITCHY RASH COVERING BOTH ARMS, BACK, NECK, SHOULDERS, CHEST, AND FACE. SEVERE FATIGUE.
Age: 83.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site haematoma, Injection site rash
Clinical narrative: Hematoma of injection site. Rash.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen & Sore. Lymphadenopathy, axillary.
Age: 62.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Headache, Infection, Injection site erythema, Injection site pain
Clinical narrative: Horrible throbbing pain near the injection spreading under my arm and shoulder. Had chills and headache. Took ibuprofen, hot packs. It began turning red and the redness spread.  08/23 had a fever of 100, redness continued to spread down to my elbow.  Went into Urgent Care.  They prescribed a pain reliever and Bactrim.
Age: 62.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Horrible throbbing pain near the injection spreading under my arm and shoulder. Had chills and headache. Took ibuprofen, hot packs. It began turning red and the redness spread.  08/23 had a fever of 100, redness continued to spread down to my elbow.  Went into Urgent Care.  They prescribed a pain reliever and Bactrim.
Age: 9.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV, MNQ
Symptoms: Headache, Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Mother reports child complaining of evening headaches for the last 7 days, child being given Tylenol as needed. Mother also reports swelling, knot redness and sore right deltoid.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Rash erythematous
Clinical narrative: Pimple-like red spots (20-30 of them) on my right chest under my breast. Still appearing on this date, 08/26/2013. Vaccine was given in my left arm. I haven't done anything to treat it. It doesn't seem to itch or hurt at this time.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Neuralgia, Skin burning sensation
Clinical narrative: Skin burns on left flank near abdomen and buttock on the same side as the injection was administered on my arm. Neuralgia like symptoms. Also experienced by my wife in the same area who had her injection administered on the same side at the same time as me.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site induration, Injection site warmth
Clinical narrative: She had a shingles vaccine last Thursday at facility and went to the ER yesterday evening as her upper arm around the injection site was hot and hard.  She was diagnosed with cellulitis and started on clindamycin.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pt complained that she had a red round ring around the injection site.  The injection site felt hard, warm and little swollen.
Age: 55.0
Sex: F
Vaccine: TYP
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: CLINIC HDC/CHD RECEIVED CALL FROM CLIENT @ 11:30 AM ON 8/26/2013 REPORTING THE FOLLOWING SYMPTOMS: CHILLS, HEADACHE, WEAKNESS, NAUSEA (NO VOMITING), FATIGUE AND PAIN AT INJECTION SITE (LD)/ARM. CLIENT REPORTED THAT THESE SYMPTOMS PRESENTED ON THE EVENING OF 8/23/13. CLIENT STATED THAT SHE HAD NOT BEEN EVALUATED BY MEDICAL PERSONNEL OR HER PHYSICIAN FOR THESE SYMPTOMS AT THIS TIME. CLIENT URGED TO SEEK MEDICAL EVALUATION OF SYMPTOMS WITH PHYSICIAN OR ER.  CLIENT SPOKE WITH CLINIC SPV RN WHO ALSO URGED CLIENT TO SEEK MEDICAL EVALUATION OF SYMPTOMS. RN REPORTED CLIENT TO REPORT A MD APPT THIS AFTERNOON FOR EVALUATION.
Age: 55.0
Sex: F
Vaccine: TYP
Symptoms: Nausea
Clinical narrative: CLINIC HDC/CHD RECEIVED CALL FROM CLIENT @ 11:30 AM ON 8/26/2013 REPORTING THE FOLLOWING SYMPTOMS: CHILLS, HEADACHE, WEAKNESS, NAUSEA (NO VOMITING), FATIGUE AND PAIN AT INJECTION SITE (LD)/ARM. CLIENT REPORTED THAT THESE SYMPTOMS PRESENTED ON THE EVENING OF 8/23/13. CLIENT STATED THAT SHE HAD NOT BEEN EVALUATED BY MEDICAL PERSONNEL OR HER PHYSICIAN FOR THESE SYMPTOMS AT THIS TIME. CLIENT URGED TO SEEK MEDICAL EVALUATION OF SYMPTOMS WITH PHYSICIAN OR ER.  CLIENT SPOKE WITH CLINIC SPV RN WHO ALSO URGED CLIENT TO SEEK MEDICAL EVALUATION OF SYMPTOMS. RN REPORTED CLIENT TO REPORT A MD APPT THIS AFTERNOON FOR EVALUATION.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Body temperature increased, Headache, Pharyngitis streptococcal, Rash generalised, Streptococcus test negative
Clinical narrative: He started to complain, "My brain hurts".  About an hour later, his temperature was 101.  I called and the Dr. says if it goes over 102 to call her back.  By 4:00 pm, his temperature is over 102.  We called the Dr. and her response through the nurse was that "it cannot be the vaccine, the reaction is too close to the shot, these symptoms don't happen that quickly. It must be a coincidence."  By 7:30 pm, patient's temperature is at 103.6 and the only way to bring his temperature down was to rub white vinager on his feet and forehead.  We kept his temperature around 102 for the rest of the night.  He woke up the next day with a 101 and remained just below 102 for the entire day.  The third day, his temperature was back to normal.  Friday afternoon, 08/23/2013, patient's body was covered with a rash.  We call the Dr. once again and are told it cannot be related since it's too early for those symptoms.  The best thing to do is to bring him in to check for a strep throat.  Even though the child never complained about a sore throat, that's what they were positive it is.  We bring patient in and all his tests are negative, and the lab results the next day came back negative again and the Dr. on duty said it was strep throat and that patient had an adverse reaction to the MMR shot.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Vaccination complication
Clinical narrative: He started to complain, "My brain hurts".  About an hour later, his temperature was 101.  I called and the Dr. says if it goes over 102 to call her back.  By 4:00 pm, his temperature is over 102.  We called the Dr. and her response through the nurse was that "it cannot be the vaccine, the reaction is too close to the shot, these symptoms don't happen that quickly. It must be a coincidence."  By 7:30 pm, patient's temperature is at 103.6 and the only way to bring his temperature down was to rub white vinager on his feet and forehead.  We kept his temperature around 102 for the rest of the night.  He woke up the next day with a 101 and remained just below 102 for the entire day.  The third day, his temperature was back to normal.  Friday afternoon, 08/23/2013, patient's body was covered with a rash.  We call the Dr. once again and are told it cannot be related since it's too early for those symptoms.  The best thing to do is to bring him in to check for a strep throat.  Even though the child never complained about a sore throat, that's what they were positive it is.  We bring patient in and all his tests are negative, and the lab results the next day came back negative again and the Dr. on duty said it was strep throat and that patient had an adverse reaction to the MMR shot.
Age: 0.17
Sex: F
Vaccine: 6VAX-F, RVX
Symptoms: Drooling
Clinical narrative: SIGNIFICANTLY INCREASED DROOLING.
Age: 0.17
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Rash, Red blood cell sedimentation rate increased
Clinical narrative: Redness at injection site. Rash.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Rt upper arm became red, swollen, hard, painful, itchy almost immed per mom.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site warmth
Clinical narrative: Rt upper arm became red, swollen, hard, painful, itchy almost immed per mom.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Throat tightness
Clinical narrative: Severe chest pain then within about 15 minutes, throat closing breathing restriction---Given shot Epipen Pen on sight transferred to ER.
Age: 20.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Injection site pain, Injection site swelling, Pyrexia, Syncope
Clinical narrative: Fainted about 20 minutes after receiving vaccine. Later that night developed fever. Today pain and swelling at injection site. Taken to ER on night of vaccine. Temperature over 102 F.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Blister, Varicella
Clinical narrative: Vesicles in face that came in crops. There is one open vesicle that measures about 1 cm in diameter.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Pt reports mild, itchy, light pink rash to L arm & L upper thigh x 1 week post 1st injection.
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: SWELLING AT SITE WARM TO TOUCH. CONTINUE TO OBSERVE, REPORT IF NOT GETTING BETTER.