chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to a 63 years old male patient who on 31-AUG-2012, was vaccinated SQ in the left arm with a 0.5 ml dose of VARIVAX (merck) (lot# 0973AA, exp 17-JUN-2013). It was reported that the patient was inadvertently vaccinated with VARIVAX (Merck) instead of ZOSTAVAX today "on 31-AUG-2012". No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a 21 years old female patient with no pertinent medical history and no drug reactions/allergy. The patient was intramuscularly vaccinated with first dose 0.5 ml GARDASIL in August 2012. Lot # was unspecified. In August 2012, after the patient received her first dose of GARDASIL, she had hives and itchy on an unspecified area of her body. The outcome of itchy and hives was reported as not recovered/not resolved. The patient sought unspecified medical attention. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray, Injection site erythema, Injection site swelling, Pneumonia, Pyrexia
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 65 year old female patient. Patient current conditions included asthma, allergies, insomnia, chronic sinusitis and osteoporosis. On 31-AUG-2012, the patient was vaccinated with a dose of PNEUMOVAX23 intramuscularly. Lot number and expiry date was provided as 0491AE and 15-SEP-2013. Concomitant medications included FLOVENT, AMBIEN, SEREVENT, theophyline, ASTELIN, FLONASE, ALLEGRA, calcium (unspecified) (+) vitamin D (unspecified), omega-3 marine triglycerides (fish oil) and aspirin. On 01-SEP-2012, the patient experienced pneumonia, fever of 103 Fahrenheit (F), swelling and redness in the left arm at the injection site. The patient came to the physician office. Treatment was provided with ZITHROMAX and ADVIL. On an unknown date, chest X-Ray was performed and the result was unknown at the time of reporting. A lot check was requested. The patient was recovering from all the events. The relatedness for all the events was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: FLU3
Symptoms: Abdominal pain, Bone scan normal, Colonoscopy normal, Computerised tomogram normal, Diarrhoea
Clinical narrative: Abdominal pain - vomiting - headaches - diarrhea - dizziness 2 hospitals over 1 1/2 years. 14 local doctors. 12 ER visits. 1-2 day observation. Nothing.
Age: 64.0
Sex: U
Vaccine: FLU3
Symptoms: Dizziness, Endoscopy normal, Headache, Hepatobiliary scan, Laboratory test normal
Clinical narrative: Abdominal pain - vomiting - headaches - diarrhea - dizziness 2 hospitals over 1 1/2 years. 14 local doctors. 12 ER visits. 1-2 day observation. Nothing.
Age: 64.0
Sex: U
Vaccine: FLU3
Symptoms: Ultrasound scan normal, Vomiting, X-ray normal
Clinical narrative: Abdominal pain - vomiting - headaches - diarrhea - dizziness 2 hospitals over 1 1/2 years. 14 local doctors. 12 ER visits. 1-2 day observation. Nothing.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2012US067285 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 456182) on 06 Aug 2012 with a follow up information received from quality assurance department (reference number: 174862) on 14 Sep 2012. This case refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO vaccine (batch number: M10032) intramuscularly into his left deltoid muscle on 22 May 2012. On the same day he was also vaccinated with GARDASIL vaccine (batch number: 1537AA) intramuscularly into his right arm, and ADACEL (other manufacturer, batch number: U3486AA) intramuscularly into his left deltoid muscle. On 23 May 2012, he developed pain, swelling and erythema of the left deltoid muscle. He was diagnosed with cellulitis of left upper arm. He recovered completely on an unspecified date. Causality and seriousness was not reported. No other information was available. The quality assurance department registered a complaint with reference number 174862. Based on the documents review received from quality assurance department on 14 Sep 2012, it was concluded that the concerned MENVEO batch, M10032 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from quality assurance department on 14 Sep 2012: Quality reference number and batch summary updated.
Sex: F
Vaccine: VARCEL, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from registered nurse concerning an increased number of patients with unspecified age, gender, pertinent medical history or drug reaction / allergies. On an unspecified date, the patients were vaccinated with a subcutaneous 0.5 ml dose of PNEUMOVAX 23 (lot number not reported). No other co-suspects or concomitant medications were reported. The patients in the practice experienced severe injection site reactions after subcutaneous administration of a dose of PNEUMOVAX 23 (dates not reported). The reaction included redness (disability), pain (disability), tenderness (disability), with extensive swelling of the arm from shoulder to elbow (disability). The nurse also added that the pain and tenderness was so severe that "clothing could not touch the skin in the area of the reaction". The patients recovered on unspecified dates. There were not lab diagnostic tests. Treatment was not reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received from registered nurse concerning a female patient, who on 07-AUG-2012 was vaccinated with a subcutaneous 0.5 ml dose of PNEUMOVAX 23 (lot number 0568AE, in validation). It was reported that, on 08-AUG-2012, the patient experienced injection site redness, injection site pain, application site tenderness and extensive swelling of vaccinated limb. This is one of several reports from the same reporter. The other linked reports include case # 1208USA002950, 1209USA008632 and 1209USA008633. Additional information has been requested.
Sex: F
Vaccine: VARCEL, PPV
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site hypersensitivity, Injection site pain
Clinical narrative: This spontaneous report was received from registered nurse concerning an increased number of patients with unspecified age, gender, pertinent medical history or drug reaction / allergies. On an unspecified date, the patients were vaccinated with a subcutaneous 0.5 ml dose of PNEUMOVAX 23 (lot number not reported). No other co-suspects or concomitant medications were reported. The patients in the practice experienced severe injection site reactions after subcutaneous administration of a dose of PNEUMOVAX 23 (dates not reported). The reaction included redness (disability), pain (disability), tenderness (disability), with extensive swelling of the arm from shoulder to elbow (disability). The nurse also added that the pain and tenderness was so severe that "clothing could not touch the skin in the area of the reaction". The patients recovered on unspecified dates. There were not lab diagnostic tests. Treatment was not reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received from registered nurse concerning a female patient, who on 07-AUG-2012 was vaccinated with a subcutaneous 0.5 ml dose of PNEUMOVAX 23 (lot number 0568AE, in validation). It was reported that, on 08-AUG-2012, the patient experienced injection site redness, injection site pain, application site tenderness and extensive swelling of vaccinated limb. This is one of several reports from the same reporter. The other linked reports include case # 1208USA002950, 1209USA008632 and 1209USA008633. Additional information has been requested.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Oral pruritus, Throat irritation
Clinical narrative: Initial report was received from a health care professional on 13 September 2012. A patient of unknown age and gender had received FLUZONE INTRADERMAL, lot number UT4470AA (route, site and dates of administration not reported) and after an unspecified time experienced an anaphylactic reaction. No further information was available at the time of the report. The patient outcome was not reported. This case is linked to case 2012-08138. Documents held by sender: None.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Initial report was received from a health care professional on 13 September 2012. A patient of unknown age and gender had received FLUZONE INTRADERMAL, lot number UT4470AA (route, site and dates of administration not reported) and after an unspecified time experienced an anaphylactic reaction. No further information was available at the time of the report. The patient outcome was not reported. This case is linked to case 2012-08138. Documents held by sender: None.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Confusional state, Influenza virus test, Neurological examination, Pyrexia, Seizure like phenomena
Clinical narrative: This spontaneous report as received from a physician referring to a 15 years old male patient with no concurrent conditions and no pertinent medical history who was vaccinated with a 0.5ml dose of GARDASIL, (Lot# H010123), IM on 10-SEP-2012. No other co-suspects were reported. There were no concomitant medications reported. The physician stated that on 10-SEP-2012 the patient experienced jerky movements, delirium, sleep walking, shaking chills and high fever the evening after receiving his 3rd dose of GARDASIL. On 11-SEP-2012 the patient went to the office where the patient's mother relayed to the physician that the patient "woke up this morning feeling much better: and the patient was afebrile while taking MOTRIN. There were no labs performed. The patient sought medical attention by a doctor's visit. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Somnambulism
Clinical narrative: This spontaneous report as received from a physician referring to a 15 years old male patient with no concurrent conditions and no pertinent medical history who was vaccinated with a 0.5ml dose of GARDASIL, (Lot# H010123), IM on 10-SEP-2012. No other co-suspects were reported. There were no concomitant medications reported. The physician stated that on 10-SEP-2012 the patient experienced jerky movements, delirium, sleep walking, shaking chills and high fever the evening after receiving his 3rd dose of GARDASIL. On 11-SEP-2012 the patient went to the office where the patient's mother relayed to the physician that the patient "woke up this morning feeling much better: and the patient was afebrile while taking MOTRIN. There were no labs performed. The patient sought medical attention by a doctor's visit. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Chills, Delirium, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative
Clinical narrative: This spontaneous report as received from a physician referring to a 15 years old male patient with no concurrent conditions and no pertinent medical history who was vaccinated with a 0.5ml dose of GARDASIL, (Lot# H010123), IM on 10-SEP-2012. No other co-suspects were reported. There were no concomitant medications reported. The physician stated that on 10-SEP-2012 the patient experienced jerky movements, delirium, sleep walking, shaking chills and high fever the evening after receiving his 3rd dose of GARDASIL. On 11-SEP-2012 the patient went to the office where the patient's mother relayed to the physician that the patient "woke up this morning feeling much better: and the patient was afebrile while taking MOTRIN. There were no labs performed. The patient sought medical attention by a doctor's visit. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pyrexia, Somnambulism, Tremor
Clinical narrative: This spontaneous report as received from a physician referring to a 15 years old male patient with no concurrent conditions and no pertinent medical history who was vaccinated with a 0.5ml dose of GARDASIL, (Lot# H010123), IM on 10-SEP-2012. No other co-suspects were reported. There were no concomitant medications reported. The physician stated that on 10-SEP-2012 the patient experienced jerky movements, delirium, sleep walking, shaking chills and high fever the evening after receiving his 3rd dose of GARDASIL. On 11-SEP-2012 the patient went to the office where the patient's mother relayed to the physician that the patient "woke up this morning feeling much better: and the patient was afebrile while taking MOTRIN. There were no labs performed. The patient sought medical attention by a doctor's visit. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Chills, Delirium, Dyskinesia, Pyrexia, Somnambulism
Clinical narrative: This spontaneous report as received from a physician referring to a 15 years old male patient with no concurrent conditions and no pertinent medical history who was vaccinated with a 0.5ml dose of GARDASIL, (Lot# H010123), IM on 10-SEP-2012. No other co-suspects were reported. There were no concomitant medications reported. The physician stated that on 10-SEP-2012 the patient experienced jerky movements, delirium, sleep walking, shaking chills and high fever the evening after receiving his 3rd dose of GARDASIL. On 11-SEP-2012 the patient went to the office where the patient's mother relayed to the physician that the patient "woke up this morning feeling much better: and the patient was afebrile while taking MOTRIN. There were no labs performed. The patient sought medical attention by a doctor's visit. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Adverse reaction, Injection site erythema, Injection site pain, Injection site pruritus, Injection site vesicles
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a 73 years old female patient with no pertinent medical history, drug reactions or allergies. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # not reported) on 14-SEP-2012. No other co-suspects were reported. Concomitant medications included: FLUZONE. The pharmacist reported that on 15-SEP-2012 the patient broke out in rash, pustules, had itching and tenderness after receiving ZOSTAVAX. The patient sought medical attention by contacting the pharmacist, no treatment was given for the events. No lab diagnostic tests were performed. The outcome of broke out in rash, pustules, had itching and tenderness was reported as recovering. The relatedness for the reported events was not provided for ZOSTAVAX. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Pruritus, Rash, Rash pustular, Tenderness
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a 73 years old female patient with no pertinent medical history, drug reactions or allergies. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # not reported) on 14-SEP-2012. No other co-suspects were reported. Concomitant medications included: FLUZONE. The pharmacist reported that on 15-SEP-2012 the patient broke out in rash, pustules, had itching and tenderness after receiving ZOSTAVAX. The patient sought medical attention by contacting the pharmacist, no treatment was given for the events. No lab diagnostic tests were performed. The outcome of broke out in rash, pustules, had itching and tenderness was reported as recovering. The relatedness for the reported events was not provided for ZOSTAVAX. Additional information has been requested.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Dyspnoea, Fatigue, Hyperventilation, Irritability
Clinical narrative: Infant cried uncontrollably and was unable to be consoled by breastfeeding, holding, nurturing, change of environment, toys, singing, etc. for 4 hours interrupted only by hyperventilating and gasps for air. This crying was followed by physical collapse and exhaustion and she fell into a deep sleep for 6 hours (normally wakes to feed every 3-4 hours). She had a fever that peaked at 101F on the same day and that wavered over the course of 72 hours. On 07/11/2012 she again had a spell of painful, inconsolable crying in the early morning that lasted 3 hours followed again by a long nap of 5 hours. She had fever that day of 100F. On the third day 07/12/2012, she had a period of high-pitched painful crying in the late afternoon that lasted 1.5 hours and was unable to be comforted. By 07/13/2012 she seemed tired and cranky and her fever was down to 99F. No treatment was sought since I (her mother) was unsure this was medically treatable since it was caused, seemingly, by the vaccine. Cool baths, light swaddling, and comforting her and nursing on demand were the only actions we took as course of treatment for this reaction. It was later reported to our Doctor at the next scheduled visit.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pain, Pyrexia
Clinical narrative: Infant cried uncontrollably and was unable to be consoled by breastfeeding, holding, nurturing, change of environment, toys, singing, etc. for 4 hours interrupted only by hyperventilating and gasps for air. This crying was followed by physical collapse and exhaustion and she fell into a deep sleep for 6 hours (normally wakes to feed every 3-4 hours). She had a fever that peaked at 101F on the same day and that wavered over the course of 72 hours. On 07/11/2012 she again had a spell of painful, inconsolable crying in the early morning that lasted 3 hours followed again by a long nap of 5 hours. She had fever that day of 100F. On the third day 07/12/2012, she had a period of high-pitched painful crying in the late afternoon that lasted 1.5 hours and was unable to be comforted. By 07/13/2012 she seemed tired and cranky and her fever was down to 99F. No treatment was sought since I (her mother) was unsure this was medically treatable since it was caused, seemingly, by the vaccine. Cool baths, light swaddling, and comforting her and nursing on demand were the only actions we took as course of treatment for this reaction. It was later reported to our Doctor at the next scheduled visit.
Age: 9.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large red swelling (size of a large chicken egg) at injection site, hot to touch, painful. Lasted 3 days; gone completely by fourth day.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Abdominal pain upper, Abnormal faeces, Aphasia, Asperger's disorder, Attention deficit/hyperactivity disorder
Clinical narrative: Screaming, inconsolable crying and fever. Doctors office and ER both said was normal reaction. To give Tylenol and Motrin.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Autism, Autism spectrum disorder, Childhood disintegrative disorder, Crying, Ear infection
Clinical narrative: Screaming, inconsolable crying and fever. Doctors office and ER both said was normal reaction. To give Tylenol and Motrin.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Gastric infection, Malaise, Pyrexia, Respiratory tract infection, Screaming
Clinical narrative: Screaming, inconsolable crying and fever. Doctors office and ER both said was normal reaction. To give Tylenol and Motrin.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Sensory integrative dysfunction, Sinusitis, Speech disorder developmental
Clinical narrative: Screaming, inconsolable crying and fever. Doctors office and ER both said was normal reaction. To give Tylenol and Motrin.
Age: 45.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site urticaria, Pain in extremity
Clinical narrative: Bled a little right after injection from the way it was injected, then around 8 pm heaviness/soreness in arm, pain at injection site, pink raised hive at injection site about 2 inches in diameter. Around 2 am arm still heavy/sore, pain at injection site, hive is gone.
Age: 45.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Sensation of heaviness
Clinical narrative: Bled a little right after injection from the way it was injected, then around 8 pm heaviness/soreness in arm, pain at injection site, pink raised hive at injection site about 2 inches in diameter. Around 2 am arm still heavy/sore, pain at injection site, hive is gone.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Decreased appetite, Fatigue, Oropharyngeal pain
Clinical narrative: Early symptoms were no appetite, nausea, extreme fatigue which lasted just over two days (did not have any energy). Then a sore throat and some mild coughing started and has lasted 6 + days (took aspirin).
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Neck pain
Clinical narrative: Severe sharp pain from injection site up to base of neck and down to wrist. Inability to raise arm for 24 hours after injection, starting 3 hours after injection.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Ocular hyperaemia
Clinical narrative: Bilateral bright red eyes.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Injection site joint movement impairment, Injection site joint pain
Clinical narrative: Left shoulder joint pain and limited mobility for 4 months. Treatment consisted of 400-800 mg Ibuprofen every 6-8 hours (dose was dependent on pain level that day). Also: the vaccine was given very high on the arm, close to the shoulder joint.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC, VARCEL
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: This spontaneous report as received from a company representative via physician refers to a 12 months old female patient. The patient was vaccinated with dose 1, 0.5 VARIVAX (Merck) (also reported as 04-APR-2012) (Lot number reported as 1629AA) and VAQTA on 17-APR-2012. Concomitant medications included PREVNAR. On 20-APR-2012 (also reported as 04-APR-2012), the patient  had a temperature of 103.4 and experienced febrile seizure (medically significant), 4 days after onset of therapy. The patient was sent to neurology. On an unknown date in 2012, the patient recovered from the event. Upon internal review the event 'Febrile seizure' is considered as medically significant. The patient subsequently suffered another seizure after therapy with MMR II (1209USA007036). Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL, HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age. The patient was vaccinated with a dose of VARIVAX (Merck) (route, dose, lot# unknown) on an unspecified date. It was reported on an unknown date the patient had a full blown rash that persisted for several weeks and was hospitalized at hospital on an unspecified date. The rash only resolved with treatment. At the time of reporting, the patient's outcome was unknown. It was unspecified whether the patient sought medical attention. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL, HEPA, MMR, VARCEL
Symptoms: Polymerase chain reaction, Pyrexia, Rash, Varicella post vaccine, Varicella virus test positive
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown age. The patient was vaccinated with a dose of VARIVAX (Merck) (route, dose, lot# unknown) on an unspecified date. It was reported on an unknown date the patient had a full blown rash that persisted for several weeks and was hospitalized at hospital on an unspecified date. The rash only resolved with treatment. At the time of reporting, the patient's outcome was unknown. It was unspecified whether the patient sought medical attention. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Right arm became red (redness spread), warm to touch & painful. Visited the ER after 2nd day and was given KEFLEX 500mg QID for possible infection. Started antibiotic on 9/20/12.
Age: 1.02
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Immediate post-injection reaction, Urticaria
Clinical narrative: Received VARIVAX right arm. Immediately had a distinct hive (s) pt had no respiratory distress. Pt given BENADRYL.
Age: 1.01
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: On 9-20-2012/0940 pr received one year old vaccines per dr orders. Pt s/s of allergic reax approx two to three minutes after vaccine given noted. Hives on pt face, neck area per dr order pt given 2.5 mL cetirizine. Pt tolerated well. Pt status check at 1000 pt ok.
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Initial case was received from the scientific literature on 10 September 2012. The unidentified patients mentioned in the article received inactivated influenza vaccine, some of which were FLUZONE, Sanofi Pasteur, live attenuated influenza vaccine (other manufacturer) or FLUZONE HIGH DOSE, Sanofi Pasteur, (lot numbers, routes, site and dates of administration not reported). Method: A case-control study was done comparing vaccination histories between subjects with acute respiratory illness with positive real-time reverse transcription polymerase chain reaction for influenza and influenza test-negative controls. Subjects with acute respiratory illness of less than or equal to 7 days duration were enrolled in hospitals, emergency departments, or outpatient clinics in communities. History of immunization with the 2010-2011 vaccine was ascertained from vaccine registries or medical records. Vaccine effectiveness (VE) was estimated in logistic regression models adjusted for study community, age, race, insurance status, enrollment site, and presence of high-risk medical condition. Results: A total of 1040 influenza-positive cases and 3717 influenza-negative controls were included from the influenza season, including 373 cases of influenza A (H1N1), 334 cases of influenza A (H3N2), and 333 cases of influenza B. Overall adjusted VE was 60%. Age-specific VE estimates ranged from 69% in children aged 6 months to 8 years to 38% in adults aged greater than or equal to 65 years. Conclusion: The 2010-2011 influenza vaccines were moderately effective in preventing medically attended influenza during a season when all 3 vaccine strains were antigenically similar to circulating viruses. Continued monitoring of influenza vaccines in all groups is important, particularly as new vaccines are introduced. The patients' outcomes were not reported. Documents held by sender: None.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: Rash on top of head (scalp) and on lateral portion of his ankles. Described as hives, small, red, raised, no drainage, pruritus only to scalp.
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: Initial report was received from a consumer on 07 September 2012. A male patient (age not reported) received a dose, injection of ADACEL, sanofi pasteur, Ltd., (lot number, route, site and side, dose in series not reported) on an unspecified date. On an unspecified date the patient reported "he might be getting Parkinson's" disease. Past medical history, concomitant medications, complementary investigations and treatments were not reported. No other information was provided. The patient's outcome was not reported. Documents held by sender: None.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives to all extremities.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, hot circle raised around injection site - 2 in diameter painful to touch.
Age: 29.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Dizziness, Dyskinesia, Flushing, Throat tightness
Clinical narrative: 9/20/12 at 11:15am Tdap and influenza vaccines administered to patient. Patient began c/o feeling "jerky", throat tight, feeling as though she was going to "pass out". Assessment revealed: flushed face, no swelling of throat; no loss of consciousness. BP 103/78, P 62, R 24. EMS 911 notified and patient was transported via ambulance at 11:28am to ER.
Age: 89.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache
Clinical narrative: Patient complaining of ongoing headache, approximately 7 days.
Age: 89.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration
Clinical narrative: Patient complaining of ongoing headache, approximately 7 days.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous, Vaccination complication
Clinical narrative: Received flu shot afternoon of 9/13/12. Reporting having red rash on stomach, breasts, back and neck on 9/14/12. Pt. had dermatology appointment on 9/18/12 for eczema. Practitioner gave her medication for itching and told her she had reaction to flu shot. She called on 9/19/12 at 4PM to report.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 11 September 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject was identified by the investigator based on review of data form the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL (lot numbers not reported) on 07 January 2009, 04 March 2009 and 12 May 2009, and one dose of TRIPEDIA, lot number U2470BA on 22 February 2010 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 26 July 2012, approximately 29 months after the last dose. On 28 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced apnea and sleep disturbance. Laboratory testing included positive PCR on 29 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 31 July 2012 for five days. The subject was not hospitalized. At the time of final contact on 07 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 43 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Pertussis, Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 11 September 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject was identified by the investigator based on review of data form the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL (lot numbers not reported) on 07 January 2009, 04 March 2009 and 12 May 2009, and one dose of TRIPEDIA, lot number U2470BA on 22 February 2010 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 26 July 2012, approximately 29 months after the last dose. On 28 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced apnea and sleep disturbance. Laboratory testing included positive PCR on 29 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 31 July 2012 for five days. The subject was not hospitalized. At the time of final contact on 07 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 43 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Vaccination complication
Clinical narrative: Arm where PNEUMOVAX 23 was injected was red, swollen, and painful.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 11 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 13-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3842AA/C3752AA received on 28 July 2011, lot number C3812BA/C3930AA received on 10 October 2011 and lot number C3967AB/C3834AA received on 29 November 2011 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 20 July 2012, approximately seven months after the last dose. On 30 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 01 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 01 August 2012 for five days. The subject was not hospitalized. At the time of final contact on 30 August 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 11 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 13-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3842AA/C3752AA received on 28 July 2011, lot number C3812BA/C3930AA received on 10 October 2011 and lot number C3967AB/C3834AA received on 29 November 2011 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 20 July 2012, approximately seven months after the last dose. On 30 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 01 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 01 August 2012 for five days. The subject was not hospitalized. At the time of final contact on 30 August 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Sex: F
Vaccine: ANTH, FLUX, SMALL, TYP
Symptoms: Chest discomfort, Chest pain, Electrocardiogram normal, Palpitations, Troponin normal
Clinical narrative: This study case was received from the investigator on 12 September 2012. A female subject experienced chest pain and palpitations on 27 August 2012, five days after the subject had received on 22 August 2012 the following vaccines: ACAM2000 (lot number and route of administration not reported), an injection of TYPHOID VACCINE (lot number, route and site of administration not reported), an injection of INFLUENZA VACCINE (lot number, route and site not reported) and an injection of ANTHRAX VACCINE (lot number, route and site of administration not reported). The subject experienced palpitations, chest pain and pressure after physical training (PT) /exercise that was relieved by sitting down. The one time episode lasted approximately 2 hours. According to the investigator, it was unlikely to be cardiac in nature. The subject had an ECG done on 30 August 2012 which was normal. Rapid troponin on 30 August 2012 was also normal. The subject had no past medical history and no cardiac history. Concomitant therapy included BURN 60 once daily. No further information was available at the time of the report. The subject's outcome was recovered on 27 August 2012. According to the investigator, chest pain and palpitations were remotely related to the trial product. Documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Ocular hyperaemia, Oropharyngeal pain, Throat tightness
Clinical narrative: Within 2 hours of exposure patient reported soreness/tightness of throat, redness of eyes, dry persistent cough. Used BENADRYL and eye drops. Report symptom improvement on 9/21/12.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pain, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Mild fever, achiness, (Rt) arm - swollen, painful, hot to touch.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Eye swelling, Generalised erythema, Vomiting, Wheezing
Clinical narrative: (L) eye swelling, redness to entire body, wheezing. BENADRYL 12.5 mg, pt vomited up. Was re-dosed. Albuterol neb treatment, DECADRON 9 mg IM. Observed x 1 hour, stable.
Age: 0.62
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Apnoeic attack, Autopsy, Brain death, Cyanosis, Death
Clinical narrative: Vaccines given 8/28/12, 850am. Catastrophic event about 6pm 8/30/12. Found by family to be apneic, blue, unresponsive. To ER then to Hosp PICU. Hypoxic ischemic encephalopathy & multisystem organ failure. Brain dead & expired 09/02/12. Law enforcement & DSS notified - autopsy pending. No indication that death related to immunizations.
Age: 0.62
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Hypoxic-ischaemic encephalopathy, Intensive care, Multi-organ failure, Unresponsive to stimuli
Clinical narrative: Vaccines given 8/28/12, 850am. Catastrophic event about 6pm 8/30/12. Found by family to be apneic, blue, unresponsive. To ER then to Hosp PICU. Hypoxic ischemic encephalopathy & multisystem organ failure. Brain dead & expired 09/02/12. Law enforcement & DSS notified - autopsy pending. No indication that death related to immunizations.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Appendicectomy, Haematochezia, Intussusception, Nausea, Ultrasound scan
Clinical narrative: Nausea & vomiting, blood in stool. Open reduction of ileocolic intuss with incidental appendectomy.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Vomiting, X-ray
Clinical narrative: Nausea & vomiting, blood in stool. Open reduction of ileocolic intuss with incidental appendectomy.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test normal, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 10 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 13-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3842AA received on 30 June 2011, lot number C3926AC received on 26 August 2011 and lot number C3977AA received on 26 October 2011 (routes and sites of administration not reported). The subject developed a cough on 24 June 2012, approximately eight months after the last dose. The subject also developed a paroxysmal cough (date of onset unknown). Laboratory testing included negative PCR on 26 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of an unknown antibiotic starting on 24 June 2012 (duration unknown). The subject was not hospitalized. At the time of final contact on 10 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 8 x 8 cm red, swollen area to left arm where VARIVAX was given.
Age: 1.54
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Inappropriate schedule of drug administration, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 10 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16 which involved a case of misuse (inappropriate schedule of vaccine administered). A case of pertussis disease in a two-year old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3657AA received on 22 September 2010, lot number C3793AA received on 19 November 2010 and lot number C4115AA received on 27 January 2012 (routes and sites of administration not reported). The subject developed a paroxysmal cough without a whoop on 18 July 2012, approximately five months after the last dose. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing for PCR was not reported. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 02 August 2012 for five days. The subject was not hospitalized. At the time of final contact on 07 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time 20 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.54
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 10 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16 which involved a case of misuse (inappropriate schedule of vaccine administered). A case of pertussis disease in a two-year old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3657AA received on 22 September 2010, lot number C3793AA received on 19 November 2010 and lot number C4115AA received on 27 January 2012 (routes and sites of administration not reported). The subject developed a paroxysmal cough without a whoop on 18 July 2012, approximately five months after the last dose. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing for PCR was not reported. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 02 August 2012 for five days. The subject was not hospitalized. At the time of final contact on 07 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time 20 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Feeling hot, Malaise, Presyncope, Pyrexia
Clinical narrative: Five hrs after receiving GARDASIL became "feverish" didn't take temp. Dizziness, near syncope hot all over, felt "fluey" for several hrs. No symptoms next day. No site reaction.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Paraesthesia, Pruritus, Urticaria
Clinical narrative: Patient received flu vaccine (R) deltoid. Red area at injection site noted, size of quarter. (Screened negative for allergy). I sat w/ patient x 30 min, redness subsided at 15 min. At 30 min, she developed 1 itching hive under chin, lips "tingly". Patient took BENADRYL 25 mg P.O. and I contacted Dr. for orders. "BENADRYL 25mg po now and additional 50mg in 4 hrs. Go to ER for SOB, tongue swelling." I advised patient not to drive/operate machines if drowsy. Agreed. Follow-up call to patient revealed no further systemic allergic symptoms or signs.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Nausea, Vertigo, Vomiting
Clinical narrative: 5 - 10 minutes in receipt of vaccine, pt started N/V, cool clammy skin, light headed/vertigo. Tx Benadryl 25mg and Ondausetion 4g 4 one time 1000ml sodium chloride.
Age: 28.0
Sex: M
Vaccine: RAB
Symptoms: Bursitis, Injection site pain, Lymphangitis, Musculoskeletal pain
Clinical narrative: Patient has experienced worsening right shoulder pain, radiating to distal clavicle and upper arm, ever since he was immunized with rabies post exposure prophylaxis series (after having been bit feral dog during routine patrol).  Reported lymphangitis has resolved put pain syndrome persists.  Patient was given steroid injections for presumptive bursitis in June and August.  He was also given short dose of oral prednisone.  Patient is currently awaiting appointments with sports medicine specialist and physical therapy.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Approximately 24 hours after flu vaccination, patient developed diffuse rash to arms and trunk (anterior). C/O "mild itching to arms", relieved with hydrocortisone cream 0.01%.
Age: 2.0
Sex: M
Vaccine: HEP, HIBV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: SITE OF VACCINE- SWOLLEN, HIVES FROM FRONT OF THIGH DOWN AROUND KNEE. RAISED, EXTREMELY RED AND ITCHY.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Induration, Oedema peripheral
Clinical narrative: Upper arm red and swollen, induration 5 inches by 6 inches.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Arm where immunization given became red, swollen, and hot to touch.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient called complaining of swollen and red arm near injection site.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Malaise, Pain, Throat irritation
Clinical narrative: Very achy, fatigue, malaise, scratchy throat  lasted about 12 hours.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Pyrexia, Rash pruritic, Skin lesion, Urticaria papular
Clinical narrative: Well visit 9/14 at which time she had flu mist. >24hr later began with fever, cough & papular urticaria later afternoon 9/15. Cough and fever resolved 9/16; rash continued. Rash itchy. One lesion on right shoulder has gradually gotten bigger as she has scratched it. Trial Zantac & Atarax & ice to shoulder lesion. To call if lesion is continuing to enlarge.
Age: 40.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Erythema, Feeling hot, Induration, Pain, Tenderness
Clinical narrative: Patient got vaccine at a clinic this weekend. Our store was open at the time and she called here complaining of warm, red, solid, tender, hurts to touch.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: PT COMPLAINED OF PAIN AT INJECTION SITE AND ALSO OF PAIN IN L ARM AFTER ADMINISTRATION.