chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a dose of hepatitis b vaccine (manufacturer unknown) (lot number not reported, expired date 27-APR-2012) on 27-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to 3 unspecified patients. The patients were vaccinated with ZOSTAVAX (lot number, route, dose, site not reported) in early June 2012. No other co-suspects or concomitant medications were reported. Subsequently the patients developed injection site reactions described as swelling and redness, and varying in size, from 4 inches in diameter to near what another patient also reported by the nurse experienced (the arm turned red and swelled from elbow to shoulder). No treatment information was reported. The outcome of the events was unknown. It was unspecified if the patients had sought medical attention. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified patient. The patient was vaccinated with the first dose of VAQTA 25/05 U/ml (lot number, dose, site, route not reported) at age 2, then received the second dose five months later. No other co-suspects or concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 years old female patient. The patient's medical history included a previous surgery (date of surgery unspecified). On an unspecified date, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # not reported). The patient developed zoster on her leg 3 days after receiving ZOSTAVAX. The location of the rash coincided with an area where the patient had had a previous surgery. The pharmacist stated that the patient was not immuno-compromised. The rash was treated by an unspecified topical prescribed by her doctor. There was no hospitalization. The outcome of the patient was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin lesion
Clinical narrative: This spontaneous report was received from a female consumer who was vaccinated SQ with a dose of 0.65 ml ZOSTAVAX (lot# not reported) on an unspecified date. It was reported that the patient developed lesions and rash on her back that continued to spread. The patient stated that it felt like she was being bitten from the inside. Patient received allergy and other unspecified treatments to treat the condition unsuccessfully. The patient received STROMECTOL (MSD) prescribed by her physician, in 2009 which treated the condition successfully for 6 months and 10 days. After this 6 month and 10 day period the rash returned at full force. Since the return of her symptoms the patient had gone through additional testing and unsuccessful treatments including having ZOSTAVAX as a possible treatment if the condition were related to a shingles outbreak, which the patient later confirmed was not the cause of her rash. The patient was also treated with permethrin cream (manufacturer unspecified), which made her condition worse. The patient was also on NEURONTIN, DOXYCLIN, and "D3" (manufacturer unspecified), and put on an unspecified bisphosphonate therapy beginning with "A". The patient's current physician had been made aware of her various treatments and symptoms. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Metabolic function test, Muscle spasms, Tic
Clinical narrative: Muscle spasms in spine and up back one day post vaccination. No previous hx. No hx injury. Spasms occur every 10 min. Inc with stress and etoh, but would not disturb sleep. Had URI early July. Relieved by clonidine. Assessed by neuro as having a tic disorder possibly related to strep.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Muscle spasms, Musculoskeletal disorder, Nervousness, Nuclear magnetic resonance imaging brain normal, Streptococcus test positive
Clinical narrative: Muscle spasms in spine and up back one day post vaccination. No previous hx. No hx injury. Spasms occur every 10 min. Inc with stress and etoh, but would not disturb sleep. Had URI early July. Relieved by clonidine. Assessed by neuro as having a tic disorder possibly related to strep.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Tic, Upper respiratory tract infection
Clinical narrative: Muscle spasms in spine and up back one day post vaccination. No previous hx. No hx injury. Spasms occur every 10 min. Inc with stress and etoh, but would not disturb sleep. Had URI early July. Relieved by clonidine. Assessed by neuro as having a tic disorder possibly related to strep.
Age: 23.0
Sex: M
Vaccine: HEPA, TD, HEPA, TTOX
Symptoms: Fatigue, Headache, Neck pain, Pain in jaw
Clinical narrative: Initial report was received from a healthcare professional on 10 September 2012. A 23-year-old male patient receive a right deltoid intramuscular injection of Tetanus Toxoid, Sanofi Pasteur, lot unknown (previous doses not reported) and a left deltoid intramuscular injection of Hepatitis A vaccine, other manufacturer, lot number unknown, (previous doses not reported) on 03 August 2012. On 08 August 2012, five days following vaccination, the patient experienced lightheadedness, soreness at back of neck and tiredness. The patient sought treatment at an urgent care center on 12 August 2012. The physician had not known the patient's vaccine history and diagnosed patient with a sinus infection. Treatment included CLARITIN D, FLONASE and ZITHROMAX (reported as start date 31August 2012 to stop date 04 September 2012). On 27 August 2012, the patient experienced soreness, right sided jaw tightness, soreness at back of neck and pressure at temples. On 31/August 2012 the patient started taking ZITHROMAX, and he completed ZITHROMAX on 04 September 2012 (5 days duration). On 06 September 2012, 34 days following vaccination, the patient experienced joint pain in right hand, then experienced in left hand to palm area and digital phalange joints. On 09 September 2012, he experienced right elbow soreness, was sleeping 10 hours (hrs) a day, and felt extremely fatigued. The symptoms are continuing per reporter. On an unspecified date, a CBC, "blood panel" was done. The reporter stated all blood work was normal, except elevated sedimentation (sed.) rate. The patient's past history, illness at time of vaccination, and any other vaccinations within past four weeks of vaccination were reported as unknown. To be noted, the physician who provided vaccine was different from reporter. The patient's outcome was reported as not recovered. Documents held by sender: None.
Age: 23.0
Sex: M
Vaccine: HEPA, TD, HEPA, TTOX
Symptoms: Arthralgia, Blood test normal, Dizziness, Fatigue, Full blood count
Clinical narrative: Initial report was received from a healthcare professional on 10 September 2012. A 23-year-old male patient receive a right deltoid intramuscular injection of Tetanus Toxoid, Sanofi Pasteur, lot unknown (previous doses not reported) and a left deltoid intramuscular injection of Hepatitis A vaccine, other manufacturer, lot number unknown, (previous doses not reported) on 03 August 2012. On 08 August 2012, five days following vaccination, the patient experienced lightheadedness, soreness at back of neck and tiredness. The patient sought treatment at an urgent care center on 12 August 2012. The physician had not known the patient's vaccine history and diagnosed patient with a sinus infection. Treatment included CLARITIN D, FLONASE and ZITHROMAX (reported as start date 31August 2012 to stop date 04 September 2012). On 27 August 2012, the patient experienced soreness, right sided jaw tightness, soreness at back of neck and pressure at temples. On 31/August 2012 the patient started taking ZITHROMAX, and he completed ZITHROMAX on 04 September 2012 (5 days duration). On 06 September 2012, 34 days following vaccination, the patient experienced joint pain in right hand, then experienced in left hand to palm area and digital phalange joints. On 09 September 2012, he experienced right elbow soreness, was sleeping 10 hours (hrs) a day, and felt extremely fatigued. The symptoms are continuing per reporter. On an unspecified date, a CBC, "blood panel" was done. The reporter stated all blood work was normal, except elevated sedimentation (sed.) rate. The patient's past history, illness at time of vaccination, and any other vaccinations within past four weeks of vaccination were reported as unknown. To be noted, the physician who provided vaccine was different from reporter. The patient's outcome was reported as not recovered. Documents held by sender: None.
Age: 23.0
Sex: M
Vaccine: HEPA, TD, HEPA, TTOX
Symptoms: Headache, Hypersomnia, Muscle tightness, Neck pain, Red blood cell sedimentation rate increased
Clinical narrative: Initial report was received from a healthcare professional on 10 September 2012. A 23-year-old male patient receive a right deltoid intramuscular injection of Tetanus Toxoid, Sanofi Pasteur, lot unknown (previous doses not reported) and a left deltoid intramuscular injection of Hepatitis A vaccine, other manufacturer, lot number unknown, (previous doses not reported) on 03 August 2012. On 08 August 2012, five days following vaccination, the patient experienced lightheadedness, soreness at back of neck and tiredness. The patient sought treatment at an urgent care center on 12 August 2012. The physician had not known the patient's vaccine history and diagnosed patient with a sinus infection. Treatment included CLARITIN D, FLONASE and ZITHROMAX (reported as start date 31August 2012 to stop date 04 September 2012). On 27 August 2012, the patient experienced soreness, right sided jaw tightness, soreness at back of neck and pressure at temples. On 31/August 2012 the patient started taking ZITHROMAX, and he completed ZITHROMAX on 04 September 2012 (5 days duration). On 06 September 2012, 34 days following vaccination, the patient experienced joint pain in right hand, then experienced in left hand to palm area and digital phalange joints. On 09 September 2012, he experienced right elbow soreness, was sleeping 10 hours (hrs) a day, and felt extremely fatigued. The symptoms are continuing per reporter. On an unspecified date, a CBC, "blood panel" was done. The reporter stated all blood work was normal, except elevated sedimentation (sed.) rate. The patient's past history, illness at time of vaccination, and any other vaccinations within past four weeks of vaccination were reported as unknown. To be noted, the physician who provided vaccine was different from reporter. The patient's outcome was reported as not recovered. Documents held by sender: None.
Age: 23.0
Sex: M
Vaccine: HEPA, TD, HEPA, TTOX
Symptoms: Sinusitis
Clinical narrative: Initial report was received from a healthcare professional on 10 September 2012. A 23-year-old male patient receive a right deltoid intramuscular injection of Tetanus Toxoid, Sanofi Pasteur, lot unknown (previous doses not reported) and a left deltoid intramuscular injection of Hepatitis A vaccine, other manufacturer, lot number unknown, (previous doses not reported) on 03 August 2012. On 08 August 2012, five days following vaccination, the patient experienced lightheadedness, soreness at back of neck and tiredness. The patient sought treatment at an urgent care center on 12 August 2012. The physician had not known the patient's vaccine history and diagnosed patient with a sinus infection. Treatment included CLARITIN D, FLONASE and ZITHROMAX (reported as start date 31August 2012 to stop date 04 September 2012). On 27 August 2012, the patient experienced soreness, right sided jaw tightness, soreness at back of neck and pressure at temples. On 31/August 2012 the patient started taking ZITHROMAX, and he completed ZITHROMAX on 04 September 2012 (5 days duration). On 06 September 2012, 34 days following vaccination, the patient experienced joint pain in right hand, then experienced in left hand to palm area and digital phalange joints. On 09 September 2012, he experienced right elbow soreness, was sleeping 10 hours (hrs) a day, and felt extremely fatigued. The symptoms are continuing per reporter. On an unspecified date, a CBC, "blood panel" was done. The reporter stated all blood work was normal, except elevated sedimentation (sed.) rate. The patient's past history, illness at time of vaccination, and any other vaccinations within past four weeks of vaccination were reported as unknown. To be noted, the physician who provided vaccine was different from reporter. The patient's outcome was reported as not recovered. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Dizziness, Dyspnoea, Gaze palsy, Insomnia
Clinical narrative: After the shot, pt eyes rolled back and he past out. Then he came back shortly, but was pale. EMS was called and assessed the pt. They said he was dehydrated and nervous about shot. Mom called back 9/4/12  and said pt is weak, waking up at night and breathless w/exercise. Advised pt to see MD.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Loss of consciousness
Clinical narrative: After the shot, pt eyes rolled back and he past out. Then he came back shortly, but was pale. EMS was called and assessed the pt. They said he was dehydrated and nervous about shot. Mom called back 9/4/12  and said pt is weak, waking up at night and breathless w/exercise. Advised pt to see MD.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Dehydration, Dyspnoea exertional, Gaze palsy, Loss of consciousness
Clinical narrative: After the shot, pt eyes rolled back and he past out. Then he came back shortly, but was pale. EMS was called and assessed the pt. They said he was dehydrated and nervous about shot. Mom called back 9/4/12  and said pt is weak, waking up at night and breathless w/exercise. Advised pt to see MD.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Middle insomnia, Nervousness, Pallor
Clinical narrative: After the shot, pt eyes rolled back and he past out. Then he came back shortly, but was pale. EMS was called and assessed the pt. They said he was dehydrated and nervous about shot. Mom called back 9/4/12  and said pt is weak, waking up at night and breathless w/exercise. Advised pt to see MD.
Age: 4.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 years old male patient without pertinent medical history and drug reactions/allergies. The patient received one dose of VARIVAX (merck) (route, dose and lot # not reported) on an unspecified date of doctor's office; the records of that vaccination are not presently available. No other co-suspects were reported. No concomitant medications were reported. The patient presented to doctor's practice today, on 09-JUN-2012, with a complaint of a rash. The nurse reported that the patient presented with scattered vesicles on his face, stomach, mouth, and scalp; she stated that he also" had a few on his legs." The patient's mother reported that the patient "broke out" with the rash on Tuesday, on 09-APR-2012; She states that Dr. did not prescribe any treatment for GAVIN's vesicles, but the patient's mother had been administering BENADRYL, TYLENOL, and Calamine Lotion to him for the adverse event treatment. No lab diagnosis studies performed. The patient sought medical attention via physician consultation. The outcome of rash was reported as not recovered/not resolved. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Rash
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 years old male patient without pertinent medical history and drug reactions/allergies. The patient received one dose of VARIVAX (merck) (route, dose and lot # not reported) on an unspecified date of doctor's office; the records of that vaccination are not presently available. No other co-suspects were reported. No concomitant medications were reported. The patient presented to doctor's practice today, on 09-JUN-2012, with a complaint of a rash. The nurse reported that the patient presented with scattered vesicles on his face, stomach, mouth, and scalp; she stated that he also" had a few on his legs." The patient's mother reported that the patient "broke out" with the rash on Tuesday, on 09-APR-2012; She states that Dr. did not prescribe any treatment for GAVIN's vesicles, but the patient's mother had been administering BENADRYL, TYLENOL, and Calamine Lotion to him for the adverse event treatment. No lab diagnosis studies performed. The patient sought medical attention via physician consultation. The outcome of rash was reported as not recovered/not resolved. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Abdominal pain upper, Dizziness, Lethargy, Vomiting
Clinical narrative: Stomach pain, emesis worsened over two days to emesis every 2hrs, increased lethargy, dizziness.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Eyelid ptosis, Hypoaesthesia
Clinical narrative: This spontaneous report as received from a 80 years old female patient reporting on herself with penicillin allergy, K-flex allergy and morphine allergy. The patient's medical history included carotid artery surgery and shingles in the past. On 05-SEP-2012, the patient was vaccinated SC with a dose of ZOSTAVAX (lot #, dose and site of administration were not provided). No other co-suspects were reported. Concomitant medications included FLUZONE, losartan potassium (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), MAXIDE, simvastatin (manufacturer unknown), naproxen, omeprazole and aspirin. On 06-SEP-2012, the patient experienced that her face was swollen, and her right eye was droopy. She also experienced intermittent numbness on the right hand of her cheek, her tongue, her right arm and right hand. Her skin was itchy at times too. The patient was admitted to a hospital from 07-SEP-2012 to 07-SEP-2012. On an unspecified date, unspecified blood work, electrocardiogram (EKG) and Computerised axial tomography (CAT) was performed (results not provided). The patient sought medical attention by a phone call. At the time of the report, the outcome of her skin was itchy, intermittent numbness on the right hand of her cheek, her tongue, her right arm and right hand, her right eye was droopy and face was swollen was reported as not recovered/not resolved. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral, Pruritus, Swelling face
Clinical narrative: This spontaneous report as received from a 80 years old female patient reporting on herself with penicillin allergy, K-flex allergy and morphine allergy. The patient's medical history included carotid artery surgery and shingles in the past. On 05-SEP-2012, the patient was vaccinated SC with a dose of ZOSTAVAX (lot #, dose and site of administration were not provided). No other co-suspects were reported. Concomitant medications included FLUZONE, losartan potassium (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), MAXIDE, simvastatin (manufacturer unknown), naproxen, omeprazole and aspirin. On 06-SEP-2012, the patient experienced that her face was swollen, and her right eye was droopy. She also experienced intermittent numbness on the right hand of her cheek, her tongue, her right arm and right hand. Her skin was itchy at times too. The patient was admitted to a hospital from 07-SEP-2012 to 07-SEP-2012. On an unspecified date, unspecified blood work, electrocardiogram (EKG) and Computerised axial tomography (CAT) was performed (results not provided). The patient sought medical attention by a phone call. At the time of the report, the outcome of her skin was itchy, intermittent numbness on the right hand of her cheek, her tongue, her right arm and right hand, her right eye was droopy and face was swollen was reported as not recovered/not resolved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Dizziness, Injection site rash, Oropharyngeal pain, Rash
Clinical narrative: Employee has sore throat, diarrhea, dizziness and rash at injection site and on legs. 9/20/12.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient complained of pain at injection site and states injection site still very sore - only slight improvement.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Large rash over entire upper arm over and below elbow into lower arm area.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash - broke out with sl. itchy rash on trunk and extremities since yesterday (9/18).
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dehydration, Influenza like illness, Pain, Pyrexia, Vomiting
Clinical narrative: Initial report was received from a consumer on 06 September 2012. A female patient (age not reported) had received an injection of ADACEL, Sanofi Pasteur Ltd. lot number C4210 (Sanofi Pasteur Inc. lot number U4395AA) and an injection of MENACTRA, lot number U3906AB and within 24 hours of receiving the immunizations the patient was hospitalized with flu like symptoms, fever of 103 degrees (39.4 degrees Celsius), vomiting, aches and dehydration. No additional information was provided. The patient's outcome was not reported. Documents held by sender: None.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swollen. Rx. 1.) Prednisone (15/5) 5 mL PO QID x 5 days. 2.) Omnicef (200/5) 2 mL PO BID x 7 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Diarrhoea, Erythema, Swelling
Clinical narrative: Redness, swelling, diarrhea.
Age: 13.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Erythema, Injection site erythema, Swelling
Clinical narrative: Mom states redness & "some puffiness" noted last night at bath time. States she gave patient BENADRYL at that time. Mom brought patient to clinic 9-20-12 0810 2" x 2" red bound reaction noted on (R) deltoid area.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Pyrexia
Clinical narrative: Red and itchy site about 2 days after receiving w/ fever.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Ocular hyperaemia, Scleritis, Sensation of foreign body, Sensory disturbance
Clinical narrative: 1/2 hr post vaccine - odd sensation of tongue. 1 hr post vaccine - throat felt like something stuck in it. 2 hrs post vaccine - sclerosis bilateral bright red in color. 2 hrs post vaccine - barky type of cough.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: 1/2 hr post vaccine - odd sensation of tongue. 1 hr post vaccine - throat felt like something stuck in it. 2 hrs post vaccine - sclerosis bilateral bright red in color. 2 hrs post vaccine - barky type of cough.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 05 September 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in an three-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 C3227AA received on 13 February 2009, 10 April 2009 and 11 June 2009, and 1 dose of DAPTACEL; lot number C3322BA received on 09 June 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms on 12 August 2012, approximately two years after the last dose. On 13 August 2012, the subject developed a cough and a week later (20 August 2012) developed a paroxysmal cough with a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 24 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 24 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 27 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 05 September 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in an three-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 C3227AA received on 13 February 2009, 10 April 2009 and 11 June 2009, and 1 dose of DAPTACEL; lot number C3322BA received on 09 June 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms on 12 August 2012, approximately two years after the last dose. On 13 August 2012, the subject developed a cough and a week later (20 August 2012) developed a paroxysmal cough with a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 24 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 24 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 27 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.06
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pruritus, Pyrexia, Rash generalised
Clinical narrative: Pt received varicella vaccine 9/6/12. On 9/14/12 she developed a rash with just a few spots and it has spread to her whole body - itchy with low grade fever.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Pruritus, Pyrexia, Skin warm
Clinical narrative: After vaccines her left arm - was red, hot, somewhat swollen. Mom thinks she may have had a mild fever but treated her with ibuprofen & BENADRYL, also applied a hydro cortisone cream for her itching. On 9/7/12 went to her dr told them if not better by 9/11/12 to return.
Age: 1.57
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 05 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an 2-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 numbers not reported on 08 March 2010, 10 May 2010 and 08 July 2010 and 1 dose of DAPTACEL; lot number C3618AA received on 05 August 2011 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 18 July 2012, nearly 1 year after the last dose. On 20 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 19 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 19 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 29 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 42 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: 1.57
Sex: F
Vaccine: DTAP
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 05 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an 2-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 numbers not reported on 08 March 2010, 10 May 2010 and 08 July 2010 and 1 dose of DAPTACEL; lot number C3618AA received on 05 August 2011 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 18 July 2012, nearly 1 year after the last dose. On 20 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 19 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 19 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 29 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 42 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.
Sex: M
Vaccine: FLUX
Symptoms: Blindness
Clinical narrative: Initial report was received on 12 September 2012 from a consumer from an unverified internet source. An unidentified male patient (reported as older man) had received the Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later "became blind". No further information was available at the time of the report. The patient's outcome was not reported. The reporter for this case is the same as for case 2012-08539.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: VIIth nerve paralysis
Clinical narrative: Initial report was received from a health care professional on 10 September 2012. A 16-year-old female patient developed Bell's Palsy on 08 September 2012, 18 hours after receiving a intramuscular injection in the left deltoid of MENACTRA, lot number U4341AA on 07 September 2012. The patient had no past medical history and no known allergies. The patient's outcome was not recovered. Documents held by sender: None.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site oedema
Clinical narrative: (L) deltoid edema/erythema immediately after vaccination.
Age: 28.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Feeling hot, Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Patient had PNEUMOVAX left arm on 9/5/12, called physician on 9/7/12 to report local redness 8 to 9 inches, hot, headache, neck stiffness, fever 101.8 patient was instructed to go to ED to R/O cellulitis and antibiotics.
Age: 28.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Full blood count abnormal, Headache, Injection site erythema, Injection site warmth
Clinical narrative: Patient had PNEUMOVAX left arm on 9/5/12, called physician on 9/7/12 to report local redness 8 to 9 inches, hot, headache, neck stiffness, fever 101.8 patient was instructed to go to ED to R/O cellulitis and antibiotics.
Age: 28.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Leukocytosis, Musculoskeletal stiffness, Pyrexia, White blood cell count normal
Clinical narrative: Patient had PNEUMOVAX left arm on 9/5/12, called physician on 9/7/12 to report local redness 8 to 9 inches, hot, headache, neck stiffness, fever 101.8 patient was instructed to go to ED to R/O cellulitis and antibiotics.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Rash, Skin warm
Clinical narrative: Patient had swelling on upper left arm and rash on arm. Warm to touch (according to patient). She came in 7 days later and swelling/redness visible, but fading. Gave BENADRYL and told her to take 1 later.
Age: 30.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Cheilitis, Pyrexia, Rash
Clinical narrative: Initial report was received on 10 September 2012 from a health care professional. A 35 year-old female patient with a diabetic, hypothyroid and allergy to codeine - rash history had received on 28 August 2012 (also reported as 28/08/2012) an intramuscular right deltoid injection of FLUZONE, lot number UH719AD. On 03 September 2012 (also reported as 03/09/2012), the patient developed a 104 fever and a rash on torso, hands, face and lips. The patient was evaluated by her primary care physician on 07 September 2012 (also reported as 07/09/2012) and was treated with Prednisone for three days. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: None.
Age: 1.03
Sex: F
Vaccine: DTAP
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis
Clinical narrative: Initial report received on 05 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an three-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 C3199AA received on 12 September 2008 and 21 November 2008, and lot number C3180AA received on 22 January 2009, and 1 dose of DAPTACEL; lot number C2999AA received on 14 August 2009 (routes and sites of administration not reported). The subject developed a cough on 27 June 2012, nearly three years after the last dose. On 31 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced post-tussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 12 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 12 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 20 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 54 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.03
Sex: F
Vaccine: DTAP
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 05 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an three-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 C3199AA received on 12 September 2008 and 21 November 2008, and lot number C3180AA received on 22 January 2009, and 1 dose of DAPTACEL; lot number C2999AA received on 14 August 2009 (routes and sites of administration not reported). The subject developed a cough on 27 June 2012, nearly three years after the last dose. On 31 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced post-tussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 12 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 12 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 20 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 54 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Chest discomfort, Dizziness, Rash, Rash erythematous
Clinical narrative: Client states on 8-26-12 - started having rash on face, neck and chest. Went to Urgent Care on 8-27-12. Gave her Prednisone IM and a PO script. Also c/o tightness in chest and throat, feeling dizzy/faint with aching joints, arms and legs heavy. Bumps now on stomach and legs - very bright red - also c/o having a cluster rash on face, "sunburn looking". Bumps itch and resemble chickenpox (had C-pox as child). Advised to return to ER Urgent Care if tightness in chest does not go away. 09/17/2012 F/u call. Spoke to client this morning. Stated the rash has since disappeared. Client stated that she did have an adverse reaction to the MMR, but also is allergic to the Prednisone that was given in Urgent Care. Any all symptoms have dissipated.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Rash vesicular, Sensation of heaviness, Throat tightness
Clinical narrative: Client states on 8-26-12 - started having rash on face, neck and chest. Went to Urgent Care on 8-27-12. Gave her Prednisone IM and a PO script. Also c/o tightness in chest and throat, feeling dizzy/faint with aching joints, arms and legs heavy. Bumps now on stomach and legs - very bright red - also c/o having a cluster rash on face, "sunburn looking". Bumps itch and resemble chickenpox (had C-pox as child). Advised to return to ER Urgent Care if tightness in chest does not go away. 09/17/2012 F/u call. Spoke to client this morning. Stated the rash has since disappeared. Client stated that she did have an adverse reaction to the MMR, but also is allergic to the Prednisone that was given in Urgent Care. Any all symptoms have dissipated.
Age: 1.4
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Periorbital oedema, Urticaria
Clinical narrative: 24 hrs after vaccine administration, patient developed wheals on his trunk, face and upper extremities. Patient's parents also report periorbital edema symptoms improved in 24 hrs. Parents were advised to give BENADRYL on 9/6/12 if urticaria persisted.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Reported by physician's office: red, swollen injection site with possible cellulitis having a red streak towards the axillary (armpit).
Age: 0.5
Sex: M
Vaccine: DTAPIPV, HEP, HIBV, PNC13
Symptoms: Drug administered to patient of inappropriate age, Dyspnoea, Pyrexia, Underdose, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 6-month-old male subject who was vaccinated with KINRIX (GlaxoSmithKline), PCV 13 (non-gsk). Concurrent vaccination included Hib (non-gsk); Sanofi; unknown; unknown given on 10 September 2012; ENGERIX B; GlaxoSmithKline; unknown; unknown given on 10 September 2012. On 10 September 2012 the subject received 2nd dose of KINRIX (.25 ml, unknown, unknown thigh) and 2nd dose of PCV 13 (Non-GSK) (unknown). On 10 September 2012, at the time of vaccination with KINRIX, the subject experienced inappropriate age at vaccine administration and vaccine underdose. KINRIX was administered on 10 September 2012. The subject was meant to have received DTaP and IPV. On 10 September 2012, less than one day after vaccination with KINRIX and Pneumococcal vaccines (Non-GSK), the subject experienced fever. At an unspecified time after vaccination with KINRIX and PCV 13, the subject experienced shortness of breath. The subject was hospitalized on 16 September for shortness of breath. The healthcare professional stated the fever had improved but at that time of the report the subject's status was unknown. At the time of reporting the outcome of the fever and shortness of breath were unspecified.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Syncope
Clinical narrative: Fainted, lightheaded, dizzy, improved slightly over 5-10 minutes.
Age: 64.0
Sex: F
Vaccine: MEN, YF
Symptoms: Dysphagia, Feeling abnormal
Clinical narrative: About 15-20 min after vaccine - "felt funny, weird. Reported having a hard time swallowing (especially on right side of throat) ok with drinking juice. VSS 1009>120/80 75 20, 1022>122/82 62 16, 1045> 124/76 72 16, lungs clear at all checks; lips pink at all checks.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: (L) th leg (Hep A, varicella) nickel sz red area warm compress to sites.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Within 10 min. of having the shot, her face went numb on her cheek just below her left eye down to her neck.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head, Dizziness, Full blood count, Laboratory test, Nausea
Clinical narrative: Patient received HD flu vaccine approximately noon 9/17/2012, at 11:00 AM 9/18/2012 patient became ill with nausea and vomiting. Went to the Emergency Room about 1:00pm on 9/18/2012. Was told it was a viral illness but the patient also received diagnosis of vertical vertigo. Had lab work and CT scan done. Received Meclizine and PHENERGAN. Sent home. 9/20/2012 patient is feeling better but remains dizzy of head.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo, Viral infection, Vomiting
Clinical narrative: Patient received HD flu vaccine approximately noon 9/17/2012, at 11:00 AM 9/18/2012 patient became ill with nausea and vomiting. Went to the Emergency Room about 1:00pm on 9/18/2012. Was told it was a viral illness but the patient also received diagnosis of vertical vertigo. Had lab work and CT scan done. Received Meclizine and PHENERGAN. Sent home. 9/20/2012 patient is feeling better but remains dizzy of head.
Age: 0.61
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Incorrect dose administered
Clinical narrative: Pt was given 0.5 ml  (+3xs vaccine) of flu virus instead of 0.25 ml of flu virus. Pt had fever prior to vaccines. Pt continued to have fever reaching levels of 102.0 at 11:30 pm the night of vaccinations. Mom states pt is doing well and fever is down as of 4/13/12 mom denies any other symptoms occurring after vaccination.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warm, tender to touch at site approx 24 hrs after administration. At 220pm 09-19-12 area measured & marked. 9-20-12 area remains reddened, swollen, tender & warm to touch 3" x 3". Instructed to use cold compress & call 24 hrs.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Pyrexia, Vomiting
Clinical narrative: Mom states child with father at 6 PM child was OK on 9/5/12 on 9/6/12 10 AM father noticed red area & rash at site of KINRIX that PM had vomiting / fever on 9/7/12 child was OK redness of arm only.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain at inj. site.
Age: 30.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Client developed fever, HA, exhaustion secondary to > vaccine & lasting x 24 hours - 30 hours.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Neck pain, Rash
Clinical narrative: RASH, HEADACHE, NECK PAIN, ARTHRALGIAS.
Age: 14.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever and Vomiting.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Injection site erythema, Injection site induration, Injection site nodule, Injection site warmth
Clinical narrative: Migraine, swollen arm, hard knot in injection site, redness and fever in injection site, states feels crummy.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine, Oedema peripheral
Clinical narrative: Migraine, swollen arm, hard knot in injection site, redness and fever in injection site, states feels crummy.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Resident initially expirienced tingling in both hands. This progressed to her experiencing numbness to both arms and trunk of her body and both feet. She said she has felt this way since the day after her vaccination with the intradermal vaccine for Influenza on 09/13/2012. Symptoms began on 09/14/2012. When she reported adverse event to local health department, She was advised to be evaluated at nearest hospital.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema, Pain, Pruritus, Urticaria
Clinical narrative: At 5:00 on 9-17-12 - pt c/o itching, increase redness. On 9-18-12 in am increased redness (3") increase itching, pain and edema. Wheal increased in size. Denies fever, body aches etc. On 9-18-12 contacted office and orders given to take OTC Benadryl 25 mg and ice pack. On 9-19-12 - contacted pt redness, itching, edmesa and pain had improved - wheal remains. On 9-20-12 improving with s/s.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Pain in arm that radiates down to the wrist, hand, fingers. Tingling and numbers in hand/fingers that has lasted continuously since the shot was administered.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, RVX
Symptoms: Abnormal behaviour, Candidiasis, Crying, Emotional distress, Injection site erythema
Clinical narrative: My 2 month old was administered the DTAP-IPV/Hib (Pentacel). She cried as usual and got over it relatively quickly. However, later that night, several hours later, she started screaming uncontrollably as if something was terribly wrong. I had never seen her or any baby scream like this. It was like a different child. No matter what I did, I could not console her. She acted lie she was trying to go to sleep and would drift off, but it didn't last long before she was screaming again.  Her leg was swollen and red as well. After a couple of hours of trying to calm her, I called the pediatrician's office. Over the screaming, I explained what was happening and they told me it was "normal"! I was shocked. I couldn't believe that if this was a typical reaction, why it would be administered. (My 3 year old had received all recommended vaccines and no reactions like this) Something seemed terribly wrong with her. After getting off the phone, I felt no better, but she eventually fell asleep and stopped the screaming. About a week later, she developed thrush and it persisted for about 3 months. We tried all the prescripts for this, but eventually, the only thing that worked was to give her regular probiotics daily. The doctor still insists that she didn't have a reaction and that they almost never have reactions to the vaccines. I have no idea whether there was permanent damage, but I hope and pray not.