chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician (M.D.) via a representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route, injection site and lot# not provided). On an unknown date the patient developed shingles. It was not reported that if the patient had sought medical attention. The outcome of shingles was unknown. The physician did not provide the causal relationship between ZOSTAVAX and adverse event. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to approximately 4 year old male patient. On 18-FEB-2013 the patient was vaccinated with MMR II (dosage, lot # and expiry unspecified) dose 1 for vaccination. The healthcare worker reported that on 31-JAN-2014, the patient was administered an expired dose of MMR II (lot 0232AE expiry date 26-JAN-2014). No adverse event reported. No other information was reported. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age with a family history of autoimmune disorders. On an unknown date the patient was vaccinated with GARDASIL injection (dose, route and lot# not reported). It was reported that the patient experienced joint pain, two months after receiving GARDASIL. The outcome of joint pain was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: This spontaneous report as received from a Licensed Practice Nurse refers to a 66 year old patient. On 29-JAN-2014 the patient was vaccinated subcutaneously in the left deltoid with 0.65 mL ZOSTAVAX, the lot number was reported as J005849, with expiry date 17-AUG-2014. The ZOSTAVAX dose was reconstituted with expired sterile diluent (lot number E010688, expiry date 29-FEB-2012). No adverse effect was observed or reported. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, Infectious mononucleosis, No therapeutic response, Tonsillitis
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. Nurse reporting that the patient received the primary series of RECOMBIVAX HB and did not respond (date unspecified). Dates of administration were 01-SEP-1996, 01-OCT-1996 and 03-JUN-1997. The physician decided to have the patient restart the series. On 04-JAN-2014, the patient was vaccinated with Dose 4 of RECOMBIVAX HB, dose(unknown), frequency (unknown). No concomitants were reported. On an unknown date in 2014, the patient developed tonsillitis (hospitalization) and mononucleosis (hospitalization) after receiving the fourth dose of RECOMBIVAX HB. The patient was hospitalized at an unspecified hospital. Patient sought medical attention due to hospitalization. He has been released on an unknown date and was recovering. Nurse says the tonsillitis and mononucleosis were unrelated (not related) to the RECOMBIVAX HB. The patient has not received any further doses of RECOMBIVAX HB. No product quality complaint was reported. No other details were provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via another pharmacist refers to a patient (age and gender unspecified). Patients medical history was unspecified. On 30-JAN-2014, the patient was inadvertently vaccinated with expiry dose of PNEUMOVAX 23 vial, (Lot number 672962/0025AE, expiry date 18-OCT-2013), 0.5 ml, intramuscular. Concomitant therapy was unspecified. No adverse effect was reported. No product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from registered nurse, refers to a female patient of unknown age. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that, on 04-OCT-2013, the patient, who was 4 weeks pregnant at the time, was vaccinated with GARDASIL INJ (dose, route and lot number not provided), and with VARIVAX (Merck) (dose, route and lot number not provided). Concomitant therapies included BOOSTRIX (also reported as BOOSTERIX, administered on 04-OCT-2014). The patient became pregnant with Last Menstrual Period (LMP) of 06-SEP-2013 and Estimated Date of Delivery (EDD) of 13-JUN-2014. The pregnancy outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Ear operation, Exposure during pregnancy, Foetal disorder, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from registered nurse, refers to a female patient of unknown age. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that, on 04-OCT-2013, the patient, who was 4 weeks pregnant at the time, was vaccinated with GARDASIL INJ (dose, route and lot number not provided), and with VARIVAX (Merck) (dose, route and lot number not provided). Concomitant therapies included BOOSTRIX (also reported as BOOSTERIX, administered on 04-OCT-2014). The patient became pregnant with Last Menstrual Period (LMP) of 06-SEP-2013 and Estimated Date of Delivery (EDD) of 13-JUN-2014. The pregnancy outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Congenital anomaly, Foetal exposure during pregnancy, Pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from registered nurse, refers to a female patient of unknown age. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that, on 04-OCT-2013, the patient, who was 4 weeks pregnant at the time, was vaccinated with GARDASIL INJ (dose, route and lot number not provided), and with VARIVAX (Merck) (dose, route and lot number not provided). Concomitant therapies included BOOSTRIX (also reported as BOOSTERIX, administered on 04-OCT-2014). The patient became pregnant with Last Menstrual Period (LMP) of 06-SEP-2013 and Estimated Date of Delivery (EDD) of 13-JUN-2014. The pregnancy outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Exposure during pregnancy, Foetal disorder, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from registered nurse, refers to a female patient of unknown age. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that, on 04-OCT-2013, the patient, who was 4 weeks pregnant at the time, was vaccinated with GARDASIL INJ (dose, route and lot number not provided), and with VARIVAX (Merck) (dose, route and lot number not provided). Concomitant therapies included BOOSTRIX (also reported as BOOSTERIX, administered on 04-OCT-2014). The patient became pregnant with Last Menstrual Period (LMP) of 06-SEP-2013 and Estimated Date of Delivery (EDD) of 13-JUN-2014. The pregnancy outcome was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 3" x 2" red, itchy area at injection site pt. called to let us know of reaction on 2/13 at 9:28 am.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a consumer refers to his mother who on an unknown date, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). The consumer believed that his mother has received the ZOSTAVAX vaccine twice. He was not 100% sure and said that he would further investigate the issue and call if his mother got ZOSTAVAX twice. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown demography. The physician reported that the patient was vaccinated with ZOSTAVAX (dose, route and frequency was not reported) on 30-JAN-2013 (also reported as the year confirmed to be 2013 and not 2014) and on 07-FEB-2014. No adverse symptoms reported. No further information provided. Additional information has been requested.
Age: 0.14
Sex: M
Vaccine: RV5
Symptoms: Infantile spitting up, Oral administration complication
Clinical narrative: This spontaneous report as received from a physician refers to a 7 week old male infant. Patient's pertinent medical history reported as none. Patient drug allergies included lactose sensitive. On 11-FEB-2014, the patient was vaccinated with ROTATEQ oral liquid, (lot number # H013164, expiry date unspecified), dose and frequency unspecified (reported as routine). Concomitant medication were reported as none. On 11-FEB-2014, the patient spit up immediately after receiving ROTATEQ. No treatment was given for the adverse event. No lab diagnostic studies were performed. No intervention performed to prevent any serious criteria. There was no significant disability or incapacity to the patient due to the event. No hospitalization required. The event was not life threatening. No product quality complaint was involved. The outcome of the event was reported as recovered on 11-FEB-2014. The reporters causality assessment for the event with the therapy of ROTATEQ was not reported. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pyrexia
Clinical narrative: This spontaneous report as received from a physician via a Company Representative refers to a 81 year old male patient. Medical history and concurrent conditions were not reported. In 2009, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (lot number was not reported). Secondary and concomitant therapies were not reported. In December 2013, the patient experienced severe case of shingles. There were massive blisters and low grade fever. Patient was referred to an infectious disease specialist for treatment. Treatment given was an unspecified antibiotic and an unspecified antiviral. At the time of the report, the patient was recovering from the events. It was reported that therapy with ZOSTAVAX was discontinued. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rash erythematous
Clinical narrative: Fine red rash beginning on right arm and radiating to the chest area.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: 100.0 F TEMP X 1 DAY AFTER. SEVERE REDNESS/PAIN/HIVES 6 IN BELOW INJECTION SITE THAT LASTED 1-3 DAYS.
Age: 51.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Discomfort, Immediate post-injection reaction, Incorrect route of drug administration, Injection site pain, Pain
Clinical narrative: Pain at injection site and area.  Injection given higher than usual and pain felt unusual.  Pain worse upon moving arm out from body, over head, and behind body (seems to correspond to engaging deltoid muscle).  Difficult to put on and take off jackets or take shirt off over head.  Some discomfort sleeping on left side/upper arm.  Pain seems to be getting worse and not better with time.  No pain or injury to that arm before flu shot.  Started right after vaccine administration and has been there ever since - no relief at all.
Age: 51.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Pain at injection site and area.  Injection given higher than usual and pain felt unusual.  Pain worse upon moving arm out from body, over head, and behind body (seems to correspond to engaging deltoid muscle).  Difficult to put on and take off jackets or take shirt off over head.  Some discomfort sleeping on left side/upper arm.  Pain seems to be getting worse and not better with time.  No pain or injury to that arm before flu shot.  Started right after vaccine administration and has been there ever since - no relief at all.
Age: 54.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal discomfort, Activities of daily living impaired, Diarrhoea, Fatigue, Influenza like illness
Clinical narrative: Had other previous vaccine shots the morning before at the same site & lt. deltoid. Vaccines give before were Hep B- GSK-HEP-B, Batch AHBVC200AA, exp- 2/6/2015 & FLU- NOVARTIS-FLUVRIN Batch= 1340 3P exp.= 3/1/2014.  Already had possible mild reaction to these & then had addition shot of MMR -MERCK-MMR, Batch# H020257, exp. 11/8/14, given at same site & lt. deltoid on 2/3/2014.  Initial symptoms included lt. deltoid pain, mild flu-like symptoms, GI upset, mild diarrhea, fatigue, drowsiness, & lethargy.  Later on the evening of 2/3/2014 symptoms began to become more severe & included lt. arm & hand pain.  The pain was severe enough to take analgesics & also resulted in the loss of sleep.  I was only able to sleep for 2 hours.  I am also an MD & had a similar reaction over a year ago at this same location at my employers old cafeteria building were an outside contractor gave the shots. Feeling somewhat better on 2/14/14, but due to lack of sleep, fatigue, & other symptoms called in sick to employer this morning.  The symptoms are so far not acute. Thank You.
Age: 54.0
Sex: M
Vaccine: MMR
Symptoms: Injection site pain, Insomnia, Lethargy, Pain in extremity, Somnolence
Clinical narrative: Had other previous vaccine shots the morning before at the same site & lt. deltoid. Vaccines give before were Hep B- GSK-HEP-B, Batch AHBVC200AA, exp- 2/6/2015 & FLU- NOVARTIS-FLUVRIN Batch= 1340 3P exp.= 3/1/2014.  Already had possible mild reaction to these & then had addition shot of MMR -MERCK-MMR, Batch# H020257, exp. 11/8/14, given at same site & lt. deltoid on 2/3/2014.  Initial symptoms included lt. deltoid pain, mild flu-like symptoms, GI upset, mild diarrhea, fatigue, drowsiness, & lethargy.  Later on the evening of 2/3/2014 symptoms began to become more severe & included lt. arm & hand pain.  The pain was severe enough to take analgesics & also resulted in the loss of sleep.  I was only able to sleep for 2 hours.  I am also an MD & had a similar reaction over a year ago at this same location at my employers old cafeteria building were an outside contractor gave the shots. Feeling somewhat better on 2/14/14, but due to lack of sleep, fatigue, & other symptoms called in sick to employer this morning.  The symptoms are so far not acute. Thank You.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Nausea, Pain, Pain in extremity
Clinical narrative: Moderate arm pain, immediate, lasting 4 days; moderate body aches, starting about an hour later, lasting 2 days; nausea, starting about 30 min later, lasting 1 day.
Age: 3.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Muscle contractions involuntary
Clinical narrative: Mom noted pt clenching her fists on the evening of vaccines were administered. As of 2-13-14, pt ws still occasionally clenching fists but will stop when mom tells her to. Mom unsure if this is a side effect ofg vaccine.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Sudden infant death syndrome
Clinical narrative: SUID/SIDS (Medical Examiner report not yet avail.).
Age: 0.62
Sex: F
Vaccine: RV5
Symptoms: Intussusception, Ultrasound abdomen abnormal, Vitello-intestinal duct remnant, Vomiting projectile
Clinical narrative: Pt developed projectile vomiting, found on ultrasound to have intussusception; in OR noted to have Meckel's diverticulum.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Excoriation, Headache, Injection site discolouration, Injection site nodule, Pruritus
Clinical narrative: 9-14-13 Patient erroneously received anthrax vaccine subcutaneously instead of PPD at immunization clinic in August 2013. It has been 1 month and he has small 7mm nodule on left forearm where anthrax vaccine was given. Patient told to let us know if it causes him any problems. 2-8-14 Patient received anthrax vaccine 6 months ago. No issues since that time - had a small nodule at the site - now only has slight hyperpigmentation - no nodule. Over last week or so patient noted rash on b/l lower extremities. Somewhat itchy, no pustules. Has a "HA" off and on, but no other sx of URI, fever, pain etc. O: Gen. alert, WD/WN NAD. (L) arm: 3 mm circular area of hyperpigmentation on forearm. Lower ext: mult. excoriated eryth. or scabbed discrete lesions of various sizes. No pustules, no ulceration. A/P: Rash. New onset rash - don't think related to anthrax. Recommended topical abx and bleach baths. If no improvement should f/u w/ primary care.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Rash, Skin lesion
Clinical narrative: 9-14-13 Patient erroneously received anthrax vaccine subcutaneously instead of PPD at immunization clinic in August 2013. It has been 1 month and he has small 7mm nodule on left forearm where anthrax vaccine was given. Patient told to let us know if it causes him any problems. 2-8-14 Patient received anthrax vaccine 6 months ago. No issues since that time - had a small nodule at the site - now only has slight hyperpigmentation - no nodule. Over last week or so patient noted rash on b/l lower extremities. Somewhat itchy, no pustules. Has a "HA" off and on, but no other sx of URI, fever, pain etc. O: Gen. alert, WD/WN NAD. (L) arm: 3 mm circular area of hyperpigmentation on forearm. Lower ext: mult. excoriated eryth. or scabbed discrete lesions of various sizes. No pustules, no ulceration. A/P: Rash. New onset rash - don't think related to anthrax. Recommended topical abx and bleach baths. If no improvement should f/u w/ primary care.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Dizziness, Headache, Pain, Tremor
Clinical narrative: Received my third GARDASIL shot. Within 6 hours of receiving my shot, I had a temp of 102.7, severe aches and body shakes. In the following 48 hours my temperature decreased down to 101.2 but intense headache and dizziness occurred.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Vaccination failure
Clinical narrative: Was given GARDASIL vaccine against HPV. My MD stated this covers stands 16 and 18. I have acquired stand 16! The vaccine did not work. This is within the 10 years,
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Colposcopy abnormal, Dysplasia, Papilloma viral infection, Smear cervix
Clinical narrative: Was given GARDASIL vaccine against HPV. My MD stated this covers stands 16 and 18. I have acquired stand 16! The vaccine did not work. This is within the 10 years,
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient describes pain at injection site that radiated down the arm.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Photopsia
Clinical narrative: 2 weeks after vaccine, there was a light going back and forth in my eye sight, it did that for about 14 days little better, pain in my left leg.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Anosmia, Asthenia, Blood pressure increased, Chills, Ear congestion
Clinical narrative: Flu-like symptoms recurring about every 2 weeks chills, weakness, sore throat, nasal drip while sleep mainly. I did not notice the loss of smell totally until end of Nov. Ignored it but went to pharmacy in Dec. I have been concerned of my continued flu-like illness after the flu shot in Nov. 7, 2013. But I am not concerned about anything other than getting better and to the bottom of my illness. Ironically, when I contacted you the thing you told me to do was to go to the doctor. Well, I went yesterday 1-7-2014. And they could not find anything that was too unreal. The doctor told me my blood pressure was up. I had not taken the B/P meds prescribed because I couldn't function. The main thing that made me feel better was the pain in my (Rt) side of face sinus areas and ear were found. But my left ear was unable to be seen clearly due to white matter. My (Rt) ear was tender due to me always touching it by it being itchy and painful. Then I remembered - I just underwent a complete house clean-up due to mildew on the walls. And at about the same time I got the flu shot. I was in contact with going into a closet and finding mold. This is one of my biggest allergies. I had a Dr check for mold problems in Feb 2012. When I found the walls mildewed. Areas were repainted and treated. I have been hard of hearing for a while. People would ask me why am I hollering. So, it's possible I already had sinus or nasal problems. Because I was on FLONASE nasal spray before. So, the Dr Rx was FLONASE both nostrils. She stated if I had problems with the nose I possibly couldn't smell. That sounds normal for me. So, I'm O.K. I'm just better to know there's a reason. The flu-like symptoms, are getting weaker and weaker, On the 7th of this month it was not too bad. I've also tried to increase vitamins and stay in more and away from other sick people. Thank you for sending me the papers to get information. I'm sure this will clear up in time. Colds have always been the main illness that stops me.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Exposure to mould, Facial pain, Hypoacusis, Influenza like illness
Clinical narrative: Flu-like symptoms recurring about every 2 weeks chills, weakness, sore throat, nasal drip while sleep mainly. I did not notice the loss of smell totally until end of Nov. Ignored it but went to pharmacy in Dec. I have been concerned of my continued flu-like illness after the flu shot in Nov. 7, 2013. But I am not concerned about anything other than getting better and to the bottom of my illness. Ironically, when I contacted you the thing you told me to do was to go to the doctor. Well, I went yesterday 1-7-2014. And they could not find anything that was too unreal. The doctor told me my blood pressure was up. I had not taken the B/P meds prescribed because I couldn't function. The main thing that made me feel better was the pain in my (Rt) side of face sinus areas and ear were found. But my left ear was unable to be seen clearly due to white matter. My (Rt) ear was tender due to me always touching it by it being itchy and painful. Then I remembered - I just underwent a complete house clean-up due to mildew on the walls. And at about the same time I got the flu shot. I was in contact with going into a closet and finding mold. This is one of my biggest allergies. I had a Dr check for mold problems in Feb 2012. When I found the walls mildewed. Areas were repainted and treated. I have been hard of hearing for a while. People would ask me why am I hollering. So, it's possible I already had sinus or nasal problems. Because I was on FLONASE nasal spray before. So, the Dr Rx was FLONASE both nostrils. She stated if I had problems with the nose I possibly couldn't smell. That sounds normal for me. So, I'm O.K. I'm just better to know there's a reason. The flu-like symptoms, are getting weaker and weaker, On the 7th of this month it was not too bad. I've also tried to increase vitamins and stay in more and away from other sick people. Thank you for sending me the papers to get information. I'm sure this will clear up in time. Colds have always been the main illness that stops me.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pruritus, Tenderness, Treatment noncompliance, Upper-airway cough syndrome
Clinical narrative: Flu-like symptoms recurring about every 2 weeks chills, weakness, sore throat, nasal drip while sleep mainly. I did not notice the loss of smell totally until end of Nov. Ignored it but went to pharmacy in Dec. I have been concerned of my continued flu-like illness after the flu shot in Nov. 7, 2013. But I am not concerned about anything other than getting better and to the bottom of my illness. Ironically, when I contacted you the thing you told me to do was to go to the doctor. Well, I went yesterday 1-7-2014. And they could not find anything that was too unreal. The doctor told me my blood pressure was up. I had not taken the B/P meds prescribed because I couldn't function. The main thing that made me feel better was the pain in my (Rt) side of face sinus areas and ear were found. But my left ear was unable to be seen clearly due to white matter. My (Rt) ear was tender due to me always touching it by it being itchy and painful. Then I remembered - I just underwent a complete house clean-up due to mildew on the walls. And at about the same time I got the flu shot. I was in contact with going into a closet and finding mold. This is one of my biggest allergies. I had a Dr check for mold problems in Feb 2012. When I found the walls mildewed. Areas were repainted and treated. I have been hard of hearing for a while. People would ask me why am I hollering. So, it's possible I already had sinus or nasal problems. Because I was on FLONASE nasal spray before. So, the Dr Rx was FLONASE both nostrils. She stated if I had problems with the nose I possibly couldn't smell. That sounds normal for me. So, I'm O.K. I'm just better to know there's a reason. The flu-like symptoms, are getting weaker and weaker, On the 7th of this month it was not too bad. I've also tried to increase vitamins and stay in more and away from other sick people. Thank you for sending me the papers to get information. I'm sure this will clear up in time. Colds have always been the main illness that stops me.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Vomiting
Clinical narrative: Pt was given 4 mo shots on 2/5/14. Started vomiting at 11 PM the same day, and repeatedly on 2-6-14. Had one watery stool 2/6/14. Afebrile. Seen by CFNP 2/6/14 and diagnosed with enteritis due to rotavirus. Was given Rx for PHENERGAN nad told to increase flds, PEDIALYTE or rice water.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Urticaria
Clinical narrative: Mom states the day after his last imms (11-22-13) infant broke out in hives to face, body, extremity. No wheezing. Baby did not seem bothered. Hives lasted several days and resolved on their own.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Immediate post-injection reaction, Injection site pain, Local swelling, Lymphadenopathy
Clinical narrative: Significant pain at injection site began immediately following injection. She felt feverish and sick with swollen glands through the weekend following injection. Her arm was red, swollen and warm from about one inch below shoulder to about 1 inch above elbow. There was a significant amount of pus, enough to soak through a heavy sweatshirt. Pain continued to worsen to the point that she needed morphine (prescribed for an unrelated condition). She visited her primary physician and was prescribed an antibiotic (cephalexin) 0n 11/22/13. It took over two months for infection to heal. On 1/9/14, she removed a scab about the size of a half dollar.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Purulent discharge, Pyrexia, Skin warm
Clinical narrative: Significant pain at injection site began immediately following injection. She felt feverish and sick with swollen glands through the weekend following injection. Her arm was red, swollen and warm from about one inch below shoulder to about 1 inch above elbow. There was a significant amount of pus, enough to soak through a heavy sweatshirt. Pain continued to worsen to the point that she needed morphine (prescribed for an unrelated condition). She visited her primary physician and was prescribed an antibiotic (cephalexin) 0n 11/22/13. It took over two months for infection to heal. On 1/9/14, she removed a scab about the size of a half dollar.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site irritation, Injection site pruritus, Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: Rec'd zoster vaccine 2/3. Reported irritation at injection site at 27 hours. Reported swelling and rash at 48 hrs. Seen by PA 4 days after and noted 8cm x 8cm wheal with vesicular center (2 x 5 cm) and continues to itch.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Rec'd zoster vaccine 2/3. Reported irritation at injection site at 27 hours. Reported swelling and rash at 48 hrs. Seen by PA 4 days after and noted 8cm x 8cm wheal with vesicular center (2 x 5 cm) and continues to itch.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site vesicles, Pain, Pain in extremity, Tenderness
Clinical narrative: Rec'd zoster vaccine 2/3. Reported irritation at injection site at 27 hours. Reported swelling and rash at 48 hrs. Seen by PA 4 days after and noted 8cm x 8cm wheal with vesicular center (2 x 5 cm) and continues to itch.
Age: 1.3
Sex: U
Vaccine: HEP, HIBV, PNC13
Symptoms: Local swelling, Rash erythematous
Clinical narrative: Assessed to have a rash-patchy red-slightly swollen areas to trunk and upper, lower extremities, (more to trunk). Lasted only one day. (One day after administration of vaccine).
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria, Lymphadenopathy, Pyrexia
Clinical narrative: Local redness at injection site forming wheal later swollen lymph node (axillary), patient felt feverish (didn't take temp.). All symptoms started next day 2/8. Patient was advised to apply BENADRYL gel on inj. site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Rash, Rash papular, Vomiting
Clinical narrative: Once child got home breaking out in rash and vomited x 2, erythema surrounding injection site and red papular rash on legs and trunk, vomited 3 times BENADRYL 18.625 mg given.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to a female acquaintance patient that is in her 70's. Pertinent medical history and drug reactions/ allergies were not reported. On an unknown date (within the last 5 years), the patient was vaccinated with ZOSTAVAX (dose, lot number and route were not reported). Concomitant therapy was not reported. On an unknown date, after receiving ZOSTAVAX patient developed shingles. It was unspecified if the patient sought medical attention. The outcome of the event was unknown. This is one of two reports from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to a male acquaintance patient that was in his 70's. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date (within the last 5 years), the patient was vaccinated with ZOSTAVAX (dose, lot number and route were not reported). Concomitant therapy was not reported. On an unknown date, after receiving ZOSTAVAX, patient developed shingles. It was unspecified if the patient sought medical attention. The outcome of the event was unknown. This is one of two reports from the same source. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Amniocentesis, Blood test abnormal, Chromosome analysis abnormal, Congenital anomaly, Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a consumer (pregnant mother) and described the occurrence of trisomy 18 in a foetus subject of unspecified gender who was exposed to FLUARIX quadrivalent (GlaxoSmithKline) in utero when the mother received. A physician or other health care professional has not verified this report. On 16 September 2013 the 33-year-old mother of the fetal subject received a dose of FLUARIX Quadrivalent (.5 ml, intramuscularly). On 22 December 2013, 97 days after vaccination with FLUARIX Quadrivalent, the subject experienced trisomy 18 and maternal vaccine exposure. The mother's estimated delivery date was 09 June 2014. Her last menstrual period (LMP) was not provided; calculations based on estimated delivery date estimate the LMP to be 02 September 2013 and 16 September possible date of conception. Prenatal diagnostic tests revealed evidence of a defect. A blood test done and on 22 December 2013 the mother was told that the fetus was positive for Trisomy 18 and Trisomy 22. The test was repeated and ruled out Trisomy 22, however Trisomy 18 showed up. The mother had an amniocentesis done on 06 February 2014, but she does not know the result of that test yet. The mother saw a genetic counselor after receiving her blood test results and the counselor discussed what her options were at this point. At the time of the reporting the Trisomy 18 was unresolved; the pregnancy was ongoing. Please see report A1060745A for details regarding the mother case.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Trisomy 18
Clinical narrative: This prospective pregnancy case was reported by a consumer (pregnant mother) and described the occurrence of trisomy 18 in a foetus subject of unspecified gender who was exposed to FLUARIX quadrivalent (GlaxoSmithKline) in utero when the mother received. A physician or other health care professional has not verified this report. On 16 September 2013 the 33-year-old mother of the fetal subject received a dose of FLUARIX Quadrivalent (.5 ml, intramuscularly). On 22 December 2013, 97 days after vaccination with FLUARIX Quadrivalent, the subject experienced trisomy 18 and maternal vaccine exposure. The mother's estimated delivery date was 09 June 2014. Her last menstrual period (LMP) was not provided; calculations based on estimated delivery date estimate the LMP to be 02 September 2013 and 16 September possible date of conception. Prenatal diagnostic tests revealed evidence of a defect. A blood test done and on 22 December 2013 the mother was told that the fetus was positive for Trisomy 18 and Trisomy 22. The test was repeated and ruled out Trisomy 22, however Trisomy 18 showed up. The mother had an amniocentesis done on 06 February 2014, but she does not know the result of that test yet. The mother saw a genetic counselor after receiving her blood test results and the counselor discussed what her options were at this point. At the time of the reporting the Trisomy 18 was unresolved; the pregnancy was ongoing. Please see report A1060745A for details regarding the mother case.
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Malaise
Clinical narrative: This spontaneous report was received from a receptionist at the physician's office, via a sales representative, concerning a female friend of unknown age with sickness. On an unknown date, the patient was vaccinated with a dose of GARDASIL, (dosage, route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. On an unknown date, it was reported that the patient got really sick after she received a dose of GARDASIL. The patient was sick before, and the GARDASIL made it worse. It was unknown if the patient received any treatment for the event, or if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. The event was considered to be possibly related to suspect therapy, GARDASIL (made it worse). Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis, Injection site pain
Clinical narrative: Left shoulder pain, bursitis.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: This is one case out of cumulative total of 226 cases solicited from the EDSS databases during the surveillance period from 01 January 2010 to 04 February 2014. These 226 cases represent children who received 3 or more doses of sanofi pasteur vaccines; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 04 February 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis in a 12-month-old female subject (initials not collected) 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 C4358AA) received on 17 January 2013, (lot number C4359AA) received on 18 March 2013 and lot number C4358AA received on 17 May 2013, (routes and sites of administration not reported). The subject developed cold-like symptoms on 04 November 2013, approximately six months after the last dose. The subject developed a cough on 04 November 2013 and with a whoop on 02 January 2014. The subject also experienced post-tussive vomiting and apnea and sleep disturbance, date not reported. Laboratory testing included positive PCR on 22 November 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments  consisted of azithromycin starting on 09 January 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 10 January 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 67 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder, Vomiting
Clinical narrative: This is one case out of cumulative total of 226 cases solicited from the EDSS databases during the surveillance period from 01 January 2010 to 04 February 2014. These 226 cases represent children who received 3 or more doses of sanofi pasteur vaccines; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 04 February 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis in a 12-month-old female subject (initials not collected) 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 C4358AA) received on 17 January 2013, (lot number C4359AA) received on 18 March 2013 and lot number C4358AA received on 17 May 2013, (routes and sites of administration not reported). The subject developed cold-like symptoms on 04 November 2013, approximately six months after the last dose. The subject developed a cough on 04 November 2013 and with a whoop on 02 January 2014. The subject also experienced post-tussive vomiting and apnea and sleep disturbance, date not reported. Laboratory testing included positive PCR on 22 November 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments  consisted of azithromycin starting on 09 January 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 10 January 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 67 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.26
Sex: M
Vaccine: FLU3
Symptoms: Cough, Influenza, Influenza A virus test positive, Pyrexia
Clinical narrative: Initial report received on 05 February 2014 from a healthcare professional. A 16 month old male patient received a second dose of Pediatric FLUZONE 25 mL PFS Quad, batch # U4696EA on 12 December 2013 (route and site of administration were not reported). The first dose was received on 05 November 2013, batch U4696E, (route and site of administration were not reported). The patient's medical history and concomitant medications were not reported. The patient went to the emergency department on 02 January 2014 with a fever for 3 days up to 105 degrees and a mild cough. The patient had a rapid influenza test which was positive for influenza A on 01 February 2014. The patient was seen by a healthcare professional on 04 February 2014 and was feeling much better and no more fevers. The patient outcome is recovering. Documents held by sender: None.
Age: 1.05
Sex: M
Vaccine: FLU3
Symptoms: Cognitive disorder, Emotional poverty, Feeling abnormal, Lethargy, Social avoidant behaviour
Clinical narrative: Initial information received from a consumer who is the patient's parent on 03 February 2014. A 12 month old male patient was vaccinated on 16 November 2011 with FLUZONE Batch U4159BB intramuscularly, site of administration unknown. The reporter denied that the patient had any illness at the time of vaccination and pre-existing medical conditions and allergies were reported as none. The patient had received a 1 dose of FLUZONE vaccine intramuscularly on 21 September 2011, batch U4159BB, site unknown. At an unspecified time on 16 November 2011, the patient was withdrawn and zombie like after the vaccine. He was less vocal, lethargic, with no emotion and less babbling. He never "snapped out of it". The patient is speech delayed and has processing issues. He was on a delayed schedule of other vaccines, but by 21 September 2011 he had at least 3 DTaP, polio, hib, chickenpox and Hep B vaccines. He did not receive a Hep A or MMR vaccine. The patient required an ER/doctor visit on an unreported date. Concomitant medications were not reported. Further details at the time of this event were not reported. The outcome was not reported. Documents held by sender: none.
Age: 1.05
Sex: M
Vaccine: FLU3
Symptoms: Speech disorder developmental
Clinical narrative: Initial information received from a consumer who is the patient's parent on 03 February 2014. A 12 month old male patient was vaccinated on 16 November 2011 with FLUZONE Batch U4159BB intramuscularly, site of administration unknown. The reporter denied that the patient had any illness at the time of vaccination and pre-existing medical conditions and allergies were reported as none. The patient had received a 1 dose of FLUZONE vaccine intramuscularly on 21 September 2011, batch U4159BB, site unknown. At an unspecified time on 16 November 2011, the patient was withdrawn and zombie like after the vaccine. He was less vocal, lethargic, with no emotion and less babbling. He never "snapped out of it". The patient is speech delayed and has processing issues. He was on a delayed schedule of other vaccines, but by 21 September 2011 he had at least 3 DTaP, polio, hib, chickenpox and Hep B vaccines. He did not receive a Hep A or MMR vaccine. The patient required an ER/doctor visit on an unreported date. Concomitant medications were not reported. Further details at the time of this event were not reported. The outcome was not reported. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Initial case received from a nurse via Merck (reference number 1-10215440073) on 03 February 2014. A patient, with no reported medical history or concomitant medications, received a dose of FLUZONE (lot number not reported) on an unspecified date. According to the reporter, the patient was later diagnosed with strain A influenza virus. No additional information was reported. Note: This case was forwarded by Merck, who was only able to provide a name for the nurse who reported the event. Since the contact information from the reporter is not sufficient to obtain an address or phone number, no additional follow-up requests can be sent.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: This is one case out of a cumulative total of 225 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 04 February 2014. These 225 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 04 February 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an 11-month-old male subject (initials not collected) 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 not reported) received on 17 February 2013, (lot number not reported) received on 18 April 2013 and lot number C4359AA received on 20 June 2013, (routes and sites of administration not reported). The subject developed a cough on 18 November 2013 without a whoop approximately 5 months after the last dose. The subject also experienced post-tussive vomiting and sleep apnea, data not reported. Laboratory testing included positive PCR on 22 November 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 22 November 2013 for 4 days. The subject was not hospitalized. At the time of final contact on 20 December 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 32 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Post-tussive vomiting, Sleep apnoea syndrome
Clinical narrative: This is one case out of a cumulative total of 225 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 04 February 2014. These 225 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 04 February 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an 11-month-old male subject (initials not collected) 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 not reported) received on 17 February 2013, (lot number not reported) received on 18 April 2013 and lot number C4359AA received on 20 June 2013, (routes and sites of administration not reported). The subject developed a cough on 18 November 2013 without a whoop approximately 5 months after the last dose. The subject also experienced post-tussive vomiting and sleep apnea, data not reported. Laboratory testing included positive PCR on 22 November 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 22 November 2013 for 4 days. The subject was not hospitalized. At the time of final contact on 20 December 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 32 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.