chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Muscular weakness, Nervousness, Vision blurred
Clinical narrative: Blurred vision, weak legs, shaky feeling, chills only lasted on the afternoon after getting flu shot (24 hours later) and was gone by next day.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Local reaction, Pain, Pruritus
Clinical narrative: Local reaction: red, swollen, itchy, painful. Area of inflammation approx. 2-2 1/2 inches across.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Local reaction: red, swollen, itchy, painful. Area of inflammation approx. 2-2 1/2 inches across.
Age: 1.27
Sex: M
Vaccine: FLU3
Symptoms: Petechiae, Urticaria
Clinical narrative: Pt presented with hives on face that spread to limbs and trunk. Pin-point rash on stomach. No respiratory issues. Pt given epinephrine.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Urticaria, Vaccination site erythema, Vaccination site pain, Vaccination site reaction
Clinical narrative: Swelling - covered with bright red welt over vaccination site. Apprx 6" in diameter tender to the touch, itching.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site swelling
Clinical narrative: Swelling - covered with bright red welt over vaccination site. Apprx 6" in diameter tender to the touch, itching.
Age: 4.0
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Erythema, Food allergy, Oedema peripheral, Urticaria, Vaccination site swelling
Clinical narrative: Pt received first dose ever flu vaccine, and MMR/varicella. Approx 10min post vaccination pt presented w/ local redness, swelling on both arms' vaccination site. Assessed pt, known allergy to eggs. Symptoms progressed in swelling of hands & urticaria. Treated successfully w/ BENADRYL, monitored for reaction 1hr and released.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Injected limb mobility decreased, Injection site joint pain, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Patient was given Hepatitis A #2 of 1 pm 1-14-13. At 2 AM on 1-15-13 wake up with sharp pain upper left deltoid at injection site & radiated from upper left neck; back of left shoulder & radiated from upper left fingertips. Pain worsened on 1-15-13 during day & relieved slightly with ibuprofen "can lift left arm only half way up & having trouble lifting anything with left hand."
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Abdominal pain upper, Aphagia, Asthenia, Diarrhoea, Myalgia
Clinical narrative: Stomach cramping, muscle pain in arms, torso, legs, severe diarrhea, weak, unable to eat.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Oedema peripheral
Clinical narrative: Pt has a swelling on her lt arm. Mom notice today. Pt not complaining any itchiness or pain.
Age: 0.98
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Varicella post vaccine
Clinical narrative: This spontaneous report as received from an employee referred to her daughter who was a 3 years old female patient with no Pertinent Medical History and no Drug Reactions/Allergies. The patient was subcutaneously vaccinated with 0.5 ml VARIVAX (merck) (lot# unspecified) in September 2010. There was no concomitant medications. On 05-JAN-2013 the patient experienced had a few breakthrough chicken pox. She experienced a fever up to 103.8 which resolved by Monday (07-JAN-2013). She had three spots on her neck, one on her back and belly and one on her right calf. She wasn't getting any new spots. She was recovering and acting normal. She was not seen by her physician. Patient did not seek medical attention. No lab Diagnostics Studies Performed. Ibuprofen was given as treatment for the event. The outcome of a few breakthrough chicken pox was reported as recovering/resolving. The relatedness for a few breakthrough chicken pox was unknown for VARIVAX (Merck). Additional information is not expected.
Age: 1.09
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema
Clinical narrative: Redness, no swelling dr notice today.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Pimple sized welts - radiating towards torso, pain in arm.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Diarrhoea, Dry eye, Dysphonia, Electrocardiogram
Clinical narrative: 8 PM - eyes dry, puffy, blurry - soon throat and chest got tight - then uncontrollable vomiting and diarrhea. 9 PM - called 911 - ambulance to ER. Barely able to speak.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Laboratory test, Throat tightness, Vision blurred, Vomiting
Clinical narrative: 8 PM - eyes dry, puffy, blurry - soon throat and chest got tight - then uncontrollable vomiting and diarrhea. 9 PM - called 911 - ambulance to ER. Barely able to speak.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis on right arm. Tx round of antibiotics.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Pt called and stated that she had pain on her hip and radiating down her leg.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Initial information has been received from a physician via field representative concerning a female patient with an unspecified age, pertinent medical history or drug reactions/allergies. On 03-JAN-2013, the patient was vaccinated with PNEUMOVAX23 (lot H018441) (dose was not reported). No other co-suspects were reported. No concomitant medications were reported. On 04-JAN-2013, the patient had significant "pain, swelling and soreness at the injection site and a lack of mobility. As a treatment, the patient received physical therapy. On an unspecified date, the patient recovered from the events. There was not laboratory test performed. The patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient vaccinated with ZOSTAVAX (route, dose and lot # were unknown) on an unknown age. No other co-suspects were reported. No concomitant medications were reported. The pharmacist noted that the patient had a one-inch-by-about-one-inch size redness around the injection site which was warm, swollen, and hard, but no blistering. The outcome of the event was unknown. The relatedness of event was unknown for ZOSTAVAX. This is one of several reports received from the same source. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 58 years old female patient with allergy to sulfa, amoxicillin and penicillin and osteoarthritis. The patient's medical history included shingles. The patient was vaccinated with liveZOSTAVAX (lot # reported as was H018188, expiration date 04-JAN-2014, dose was unknown) subcutaneously on 09-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. The pharmacist noted that "on 10-JAN-2013 the patient a one-inch-by-one-inch size redness around the injection site which was warm, swollen, and hard, but no blistering." The present patient status was not recovered. No treatment was given for adverse event. No lab diagnosis studies performed. The patient presented at the pharmacy to the reporting pharmacist for medical attention. The relatedness of event was unknown for live ZOSTAVAX. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Initial information has been received from a physician via field representative concerning a female patient with an unspecified age, pertinent medical history or drug reactions/allergies. On 03-JAN-2012, the patient was vaccinated with PNEUMOVAX23 (lot H018441) (dose was not reported). No other co-suspects were reported. No concomitant medications were reported. On 04-JAN-2013, the patient had significant "pain, swelling and soreness at the injection site and a lack of mobility. As a treatment, the patient received physical therapy. On an unspecified date, the patient recovered from the events. There was not laboratory test performed. The patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Information has been received from a physician via field representative concerning a female patient with an unspecified age, pertinent medical history or drug reactions / allergies. On 03-JAN-2012, the patient was vaccinated with PNEUMOVAX23 (lot H018441) (dose was not reported). No other co-suspects were reported. No concomitant medications were reported. On 04-JAN-2013, the patient had significant "pain, swelling and soreness at the injection site and a lack of mobility. As a treatment, the patient received physical therapy and oral steroids. On an unspecified date, the patient recovered from the events. There was not laboratory test performed. The patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Initial information has been received from a physician via field representative concerning a female patient with an unspecified age, pertinent medical history or drug reactions / allergies. On 03-JAN-2012, the patient was vaccinated with PNEUMOVAX23 (lot H018441) (dose was not reported). No other co-suspects were reported. No concomitant medications were reported. On 04-JAN-2013, the patient had significant "pain, swelling and soreness at the injection site and a lack of mobility. As a treatment, the patient received physical therapy. On an unspecified date, the patient recovered from the events. There was not laboratory test performed. The patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Vaccination complication
Clinical narrative: Pain at site, arm and hand went numb. Patient ended up with infection that required surgery, cutting muscle. Edema fluid and "some flesh" was removed.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypoaesthesia, Infection, Injection site pain, Oedema, Surgery
Clinical narrative: Pain at site, arm and hand went numb. Patient ended up with infection that required surgery, cutting muscle. Edema fluid and "some flesh" was removed.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Barium enema abnormal, Crying, Diet refusal, Gastroenteritis, Gastrointestinal sounds abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 6 months old male patient without illness at the time of vaccine and with medical history of congenital dysplasia of hips and hospitalized at 3 months of age for fever of unclear etiology treated orally with three doses of ROTATEQ (lot# 05449AA is an invalid lot number for ROTATEQ) the third dose on 16-MAR-2012. Concomitant therapies on the same day included the third dose of PREVNAR (lot#918173), the third dose of ENGERIX-B (lot#AHBVC077CA) and the third dose of PENTACEL (lot# C4158AB). On 25-MAR-2012, the patient developed intermittent episodes of severe irritability followed by vomiting and decreased urine output. He was found to have blood stools on 26-MAR-2012 and was evaluated and found to have an intussusception. It was successfully reduced by air contrast enema. He recovered uneventfully. The following information was obtained through follow-up and/or provided by the government. On 05-JUN-2012 hospital records received for date of service from 26-MAR-2012 to 27-MAR-2012 with diagnosis of intussusception. Patient with vomiting, episodes of arching of back and crying q 15 min with lethargy between episodes, decreased urine output, refusing to feed, cold symptoms (runny stuffy nose, low-grade fever) for several days. Patient to outside ER, physical exam showed increased bowel sounds. The patient was diagnosed with gastroenteritis and discharged to home with care and flu instructions. Patient returned with additional complaint of stool with bright red blood and clots and bilious emesis. Physical exam showed occasional bowel sounds, tachycardia, tacky mucous membranes. Ultrasound showed intussusception and the patient was transferred for higher level care. Air contrast enema successfully reduced intussusception. Patient was admitted for overnight observation, continued to pass small amounts of blood, but no pain, patient was tolerating oral intake without difficulty. Pt was discharged home with care and flu instructions. On 05-JUN-2012 lab/diagnostic records received for date of service from 26-MAR-2012 to 27-MAR-2012. Blood: WBC 19.1(H), Pit 700. US abdomen abnormal. Stool occult blood (+). The status of the patient was unknown at the time of reporting. No further information is available. The original reporting source was not provided. The VAERS ID # is 452691-1.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Haematochezia, Intussusception, Irritability, Lethargy, Mucous membrane disorder
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 6 months old male patient without illness at the time of vaccine and with medical history of congenital dysplasia of hips and hospitalized at 3 months of age for fever of unclear etiology treated orally with three doses of ROTATEQ (lot# 05449AA is an invalid lot number for ROTATEQ) the third dose on 16-MAR-2012. Concomitant therapies on the same day included the third dose of PREVNAR (lot#918173), the third dose of ENGERIX-B (lot#AHBVC077CA) and the third dose of PENTACEL (lot# C4158AB). On 25-MAR-2012, the patient developed intermittent episodes of severe irritability followed by vomiting and decreased urine output. He was found to have blood stools on 26-MAR-2012 and was evaluated and found to have an intussusception. It was successfully reduced by air contrast enema. He recovered uneventfully. The following information was obtained through follow-up and/or provided by the government. On 05-JUN-2012 hospital records received for date of service from 26-MAR-2012 to 27-MAR-2012 with diagnosis of intussusception. Patient with vomiting, episodes of arching of back and crying q 15 min with lethargy between episodes, decreased urine output, refusing to feed, cold symptoms (runny stuffy nose, low-grade fever) for several days. Patient to outside ER, physical exam showed increased bowel sounds. The patient was diagnosed with gastroenteritis and discharged to home with care and flu instructions. Patient returned with additional complaint of stool with bright red blood and clots and bilious emesis. Physical exam showed occasional bowel sounds, tachycardia, tacky mucous membranes. Ultrasound showed intussusception and the patient was transferred for higher level care. Air contrast enema successfully reduced intussusception. Patient was admitted for overnight observation, continued to pass small amounts of blood, but no pain, patient was tolerating oral intake without difficulty. Pt was discharged home with care and flu instructions. On 05-JUN-2012 lab/diagnostic records received for date of service from 26-MAR-2012 to 27-MAR-2012. Blood: WBC 19.1(H), Pit 700. US abdomen abnormal. Stool occult blood (+). The status of the patient was unknown at the time of reporting. No further information is available. The original reporting source was not provided. The VAERS ID # is 452691-1.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Nasal congestion, Nasopharyngitis, Occult blood positive, Opisthotonus, Platelet count increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 6 months old male patient without illness at the time of vaccine and with medical history of congenital dysplasia of hips and hospitalized at 3 months of age for fever of unclear etiology treated orally with three doses of ROTATEQ (lot# 05449AA is an invalid lot number for ROTATEQ) the third dose on 16-MAR-2012. Concomitant therapies on the same day included the third dose of PREVNAR (lot#918173), the third dose of ENGERIX-B (lot#AHBVC077CA) and the third dose of PENTACEL (lot# C4158AB). On 25-MAR-2012, the patient developed intermittent episodes of severe irritability followed by vomiting and decreased urine output. He was found to have blood stools on 26-MAR-2012 and was evaluated and found to have an intussusception. It was successfully reduced by air contrast enema. He recovered uneventfully. The following information was obtained through follow-up and/or provided by the government. On 05-JUN-2012 hospital records received for date of service from 26-MAR-2012 to 27-MAR-2012 with diagnosis of intussusception. Patient with vomiting, episodes of arching of back and crying q 15 min with lethargy between episodes, decreased urine output, refusing to feed, cold symptoms (runny stuffy nose, low-grade fever) for several days. Patient to outside ER, physical exam showed increased bowel sounds. The patient was diagnosed with gastroenteritis and discharged to home with care and flu instructions. Patient returned with additional complaint of stool with bright red blood and clots and bilious emesis. Physical exam showed occasional bowel sounds, tachycardia, tacky mucous membranes. Ultrasound showed intussusception and the patient was transferred for higher level care. Air contrast enema successfully reduced intussusception. Patient was admitted for overnight observation, continued to pass small amounts of blood, but no pain, patient was tolerating oral intake without difficulty. Pt was discharged home with care and flu instructions. On 05-JUN-2012 lab/diagnostic records received for date of service from 26-MAR-2012 to 27-MAR-2012. Blood: WBC 19.1(H), Pit 700. US abdomen abnormal. Stool occult blood (+). The status of the patient was unknown at the time of reporting. No further information is available. The original reporting source was not provided. The VAERS ID # is 452691-1.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Pyrexia, Rhinorrhoea, Tachycardia, Thrombosis, Ultrasound abdomen abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 6 months old male patient without illness at the time of vaccine and with medical history of congenital dysplasia of hips and hospitalized at 3 months of age for fever of unclear etiology treated orally with three doses of ROTATEQ (lot# 05449AA is an invalid lot number for ROTATEQ) the third dose on 16-MAR-2012. Concomitant therapies on the same day included the third dose of PREVNAR (lot#918173), the third dose of ENGERIX-B (lot#AHBVC077CA) and the third dose of PENTACEL (lot# C4158AB). On 25-MAR-2012, the patient developed intermittent episodes of severe irritability followed by vomiting and decreased urine output. He was found to have blood stools on 26-MAR-2012 and was evaluated and found to have an intussusception. It was successfully reduced by air contrast enema. He recovered uneventfully. The following information was obtained through follow-up and/or provided by the government. On 05-JUN-2012 hospital records received for date of service from 26-MAR-2012 to 27-MAR-2012 with diagnosis of intussusception. Patient with vomiting, episodes of arching of back and crying q 15 min with lethargy between episodes, decreased urine output, refusing to feed, cold symptoms (runny stuffy nose, low-grade fever) for several days. Patient to outside ER, physical exam showed increased bowel sounds. The patient was diagnosed with gastroenteritis and discharged to home with care and flu instructions. Patient returned with additional complaint of stool with bright red blood and clots and bilious emesis. Physical exam showed occasional bowel sounds, tachycardia, tacky mucous membranes. Ultrasound showed intussusception and the patient was transferred for higher level care. Air contrast enema successfully reduced intussusception. Patient was admitted for overnight observation, continued to pass small amounts of blood, but no pain, patient was tolerating oral intake without difficulty. Pt was discharged home with care and flu instructions. On 05-JUN-2012 lab/diagnostic records received for date of service from 26-MAR-2012 to 27-MAR-2012. Blood: WBC 19.1(H), Pit 700. US abdomen abnormal. Stool occult blood (+). The status of the patient was unknown at the time of reporting. No further information is available. The original reporting source was not provided. The VAERS ID # is 452691-1.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Ultrasound scan abnormal, Urine output decreased, Vomiting, White blood cell count increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 6 months old male patient without illness at the time of vaccine and with medical history of congenital dysplasia of hips and hospitalized at 3 months of age for fever of unclear etiology treated orally with three doses of ROTATEQ (lot# 05449AA is an invalid lot number for ROTATEQ) the third dose on 16-MAR-2012. Concomitant therapies on the same day included the third dose of PREVNAR (lot#918173), the third dose of ENGERIX-B (lot#AHBVC077CA) and the third dose of PENTACEL (lot# C4158AB). On 25-MAR-2012, the patient developed intermittent episodes of severe irritability followed by vomiting and decreased urine output. He was found to have blood stools on 26-MAR-2012 and was evaluated and found to have an intussusception. It was successfully reduced by air contrast enema. He recovered uneventfully. The following information was obtained through follow-up and/or provided by the government. On 05-JUN-2012 hospital records received for date of service from 26-MAR-2012 to 27-MAR-2012 with diagnosis of intussusception. Patient with vomiting, episodes of arching of back and crying q 15 min with lethargy between episodes, decreased urine output, refusing to feed, cold symptoms (runny stuffy nose, low-grade fever) for several days. Patient to outside ER, physical exam showed increased bowel sounds. The patient was diagnosed with gastroenteritis and discharged to home with care and flu instructions. Patient returned with additional complaint of stool with bright red blood and clots and bilious emesis. Physical exam showed occasional bowel sounds, tachycardia, tacky mucous membranes. Ultrasound showed intussusception and the patient was transferred for higher level care. Air contrast enema successfully reduced intussusception. Patient was admitted for overnight observation, continued to pass small amounts of blood, but no pain, patient was tolerating oral intake without difficulty. Pt was discharged home with care and flu instructions. On 05-JUN-2012 lab/diagnostic records received for date of service from 26-MAR-2012 to 27-MAR-2012. Blood: WBC 19.1(H), Pit 700. US abdomen abnormal. Stool occult blood (+). The status of the patient was unknown at the time of reporting. No further information is available. The original reporting source was not provided. The VAERS ID # is 452691-1.
Age: 34.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Alopecia, Blood testosterone free normal, Blood thyroid stimulating hormone normal, Full blood count normal, Laboratory test normal
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of hair loss in a 34-year-old female subject who was vaccinated with ENGERIX (GlaxoSmithKline). Concurrent vaccination included MMR vaccine (non-gsk) ;Merck;unknown;unknown given on 19 June 2012; tdap vaccine (non-gsk) ;Sanofi;unknown;unknown given on 19 June 2012. On 19 June 2012 the subject received 1st dose of ENGERIX B (1 ml, unknown route, left deltoid). On approximately 21 June 2012, 2 days after vaccination with ENGERIX B, the subject experienced hair loss. The subject reported to the healthcare professional that she started losing hair a couple days after vaccination. The hair loss continued for a couple of weeks so she saw her family physician and "got tests done". The subject reported to the healthcare professional the tests were "normal". The healthcare professional thinks the hair loss is ongoing, but was not sure. At the time of reporting the event was unresolved. Follow-up information was received on 13 August 2012 via healthcare professional who reported the onset of the subject's symptoms was 01 July 2012 (previously reported 21 June 2012). The healthcare professional clarified that MMR vaccine (non-gsk); Merck, was administered; left arm given on 19 June 2012 and ADACEL (non-gsk); Sanofi Pasteur MSD; unknown; right deltoid given on 19 June 2012. Concurrent medical condition of alopecia started on 01 July 2012 and continues. Diagnostic tests performed in July 2012 included Thyroid stimulation hormone, cell blood count and testosterone free, all were within normal limits. Immunization series with ENGERIX B was discontinued. At the time of the report the hair loss was unresolved.
Sex: M
Vaccine: HEP
Symptoms: Musculoskeletal pain, No therapeutic response, Pain, Pruritus, Urticaria
Clinical narrative: This case was reported by a consumer and described the occurrence of hive in a male subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline) and Hepatitis B vaccine. A physician or other health care professional has not verified this report. Concurrent vaccination included ENGERIX B GlaxoSmithKline; unknown; unknown given on an unspecified date. On an unspecified dates the subjects received 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (unknown). At an unspecified time after the hepatitis B series, the subject experienced not responding to therapy. The subject received a second series; the fourth dose was administered on an unspecified date. On 23 July 2012 between 9:00 and 10:00, the subject received 5th dose of ENGERIX B (1 ml, unknown, right arm). On 23 July 2012, less than one day after vaccination with the 5th dose of ENGERIX B, the subject experienced pain. On 27 July 2012, four days after vaccination with the 5th dose, the subject experienced hives. The subject stated he had no response to a "hepatitis series in life" (unknown if ENGERIX B) so he was receiving a second series. With the second dose he had pain for three days. The pain went away but then hives started. The hives improved with CLARITIN, but when it wears off the hives return. Most recently they came back worse. The subjects was planning to see a physician regarding the hives. On 26 July 2012, the pain resolved. At the time of reporting the outcome of hives were worse. Follow-up information was received on 01 August 2012 via consumer who reported he never had immunity to ENGERIX B series that he received in 2006. Additional information regarding current ENGERIX B series reported by the subject included his shoulder hurt for three days after receiving ENGERIX B 2nd dose in the second series. The hives had developed once his shoulder started to feel better. The subject also stated getting hives anytime he sweats and "really itchy". The subject reported he was given several medications which help with the hives, but now they have come back more vigorous. At the time of the report the shoulder pain resolved, the hives were worse, and the outcome of the itchiness was not specified.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatomyositis, Dysphagia, Herpes zoster, Muscular weakness, Polymyositis
Clinical narrative: Muscle weakness, difficulty swallowing -> polymyositis dermatomyositis. Shingles - 6/14/11.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Full blood count, Rash generalised, Rash maculo-papular, Rash pruritic
Clinical narrative: This spontaneous report as received from a physician and a pharmacist refers to a 60 year old male patient with no drug allergy or reactions. The patient was vaccinated with a dose of live ZOSTAVAX (lot # 0565AE; EXP Date 23-MAR-2013) on 16-AUG-2012. No other co-suspects were reported. Concomitant medications included: CRESTOR. On an unknown date the patient developed a head to toe maculopapular rash (reported by the physician) and a itchy rash on his trunk area (reported by the pharmacist). The physician mentioned the patient was first treated with a short course of steroids and antihistamines and the rash came back after the stopping of steroids. The physician prescribed a higher dose of steroids for a longer period of time and the rash resolved. A CBC blood test was performed without result reported. Pharmacist reported that the patient was seen an unspecified physician regarding the rash. Pharmacist stated that the patient was recovering but still has a slight rash. The pharmacist requested lot check of live ZOSTAVAX (lot # 0565AE; EXP Date 23-MAR-2013). Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Acute disseminated encephalomyelitis, Asthenia, Oropharyngeal pain, Vomiting
Clinical narrative: Vomiting, weakness, sore throat.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: Head ache and fever.  Also had a rash on my torso, but I believe that was related to fever as that is the normal reaction I typically have when I have a fever.  Head ache and fever resolved after approximately 48 hours after onset.
Age: 27.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Antiphospholipid syndrome, Arthralgia, Beta-2 glycoprotein antibody positive, Blood immunoglobulin G increased, Cardiolipin antibody positive
Clinical narrative: Pt developed varicose vein in left leg. Developed some minor systemic symptoms such as fatigue and arthralgias with exercise. In 2007 varicosity became extremely painful and swollen, 3 DVTs found and diagnosed with antiphospholipid antibody syndrome. Comprehensive evaluation for vaccine causality conducted by the clinic with rheumatology input. RESULTS: After extensive investigation by the clinic and Rheumatology consultants, it is our expert opinion that patient's antiphospholipid antibody syndrome should be considered a LINE OF DUTY YES based on recommendation 1 above and the following variables: a. He was symptom and disease-free at entry level of job with indeterminate/negative autoantibodies. b. He developed the 1st symptoms of thrombosis while at work in 2004-5 one month after experiencing hand trauma. c. He received multiple vaccinations during service and antibody levels continued to rise sequentially. These vaccinations include the vaccine (tetanus) which has a biologically plausible mechanism described for triggering autoimmunity via a molecular mimicry mechanism.
Age: 27.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Deep vein thrombosis, Fatigue, Limb injury, Pain in extremity, Protein S increased
Clinical narrative: Pt developed varicose vein in left leg. Developed some minor systemic symptoms such as fatigue and arthralgias with exercise. In 2007 varicosity became extremely painful and swollen, 3 DVTs found and diagnosed with antiphospholipid antibody syndrome. Comprehensive evaluation for vaccine causality conducted by the clinic with rheumatology input. RESULTS: After extensive investigation by the clinic and Rheumatology consultants, it is our expert opinion that patient's antiphospholipid antibody syndrome should be considered a LINE OF DUTY YES based on recommendation 1 above and the following variables: a. He was symptom and disease-free at entry level of job with indeterminate/negative autoantibodies. b. He developed the 1st symptoms of thrombosis while at work in 2004-5 one month after experiencing hand trauma. c. He received multiple vaccinations during service and antibody levels continued to rise sequentially. These vaccinations include the vaccine (tetanus) which has a biologically plausible mechanism described for triggering autoimmunity via a molecular mimicry mechanism.
Age: 27.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Varicophlebitis
Clinical narrative: Pt developed varicose vein in left leg. Developed some minor systemic symptoms such as fatigue and arthralgias with exercise. In 2007 varicosity became extremely painful and swollen, 3 DVTs found and diagnosed with antiphospholipid antibody syndrome. Comprehensive evaluation for vaccine causality conducted by the clinic with rheumatology input. RESULTS: After extensive investigation by the clinic and Rheumatology consultants, it is our expert opinion that patient's antiphospholipid antibody syndrome should be considered a LINE OF DUTY YES based on recommendation 1 above and the following variables: a. He was symptom and disease-free at entry level of job with indeterminate/negative autoantibodies. b. He developed the 1st symptoms of thrombosis while at work in 2004-5 one month after experiencing hand trauma. c. He received multiple vaccinations during service and antibody levels continued to rise sequentially. These vaccinations include the vaccine (tetanus) which has a biologically plausible mechanism described for triggering autoimmunity via a molecular mimicry mechanism.
Age: 16.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Rash
Clinical narrative: Pt. received Hep A & flu shot on 1/11/13; states on 1/12/13 started breaking out on arms & hands.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site anaesthesia, Injection site reaction, Paraesthesia, Reaction to preservatives
Clinical narrative: Patient report numbness and tingling along right jaw and drooping of corner of mouth (slight), initially. After several minutes patient said she had numbness and tingling from shot and up her arm. Note: Hospital called asking if vaccine contained Thimerosal because they thought patient was having a reaction to it.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Patient report numbness and tingling along right jaw and drooping of corner of mouth (slight), initially. After several minutes patient said she had numbness and tingling from shot and up her arm. Note: Hospital called asking if vaccine contained Thimerosal because they thought patient was having a reaction to it.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site joint swelling, Injection site swelling
Clinical narrative: Whole deltoid area/shoulder was swollen for 1 day, 1 day following the injection on left side.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Fatigue, Full blood count, Headache, Heart rate increased
Clinical narrative: Redness, soreness, and swelling where shot was given. Fatigue, headache, bodyache, diarhea, nausea, and difficulty sleeping.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Insomnia, Nausea
Clinical narrative: Redness, soreness, and swelling where shot was given. Fatigue, headache, bodyache, diarhea, nausea, and difficulty sleeping.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Urine analysis normal
Clinical narrative: Redness, soreness, and swelling where shot was given. Fatigue, headache, bodyache, diarhea, nausea, and difficulty sleeping.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Feeling hot, Influenza, Pain, Pyrexia
Clinical narrative: Extreme body aches starting at vaccine spot; fever within 12 hrs; chills & hot alternating - in other words the flu - dose should be adjusted by weight class not age;  my 17 yr old son received a lower dose b/c he is 17 even though he outweighs me by at lest 30 lbs - much closer to my husbands size than I am yet my husband & I received the same dose b/c we are both over 18 - this is not a good system & does not make sense scientifically - and you know that.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Vaccination site pain
Clinical narrative: Extreme body aches starting at vaccine spot; fever within 12 hrs; chills & hot alternating - in other words the flu - dose should be adjusted by weight class not age;  my 17 yr old son received a lower dose b/c he is 17 even though he outweighs me by at lest 30 lbs - much closer to my husbands size than I am yet my husband & I received the same dose b/c we are both over 18 - this is not a good system & does not make sense scientifically - and you know that.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Cold sweat, Dizziness, Dyspnoea, Hypoaesthesia, Muscular weakness
Clinical narrative: Numbness and extreme weakness in arm, heart palpitations, shortness of breath, shakiness, dizziness, cold fingertips, cold sweating extremities.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Palpitations, Peripheral coldness, Tremor
Clinical narrative: Numbness and extreme weakness in arm, heart palpitations, shortness of breath, shakiness, dizziness, cold fingertips, cold sweating extremities.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received a double dose of flu vaccine. Should have been given 0.25 mL and was given 0.5 mL dose. No adverse reaction noted. Doctor and parent notified.
Age: 69.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Abdominal pain, Blood creatinine increased, Blood urea increased, Diarrhoea, Nausea
Clinical narrative: Patient awoke with fevers, nausea, vomiting and some abdominal pain. She had some mild diarrhea and was in mild acute renal failure as well.
Age: 69.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Pyrexia, Renal failure acute, Vomiting, White blood cell count increased
Clinical narrative: Patient awoke with fevers, nausea, vomiting and some abdominal pain. She had some mild diarrhea and was in mild acute renal failure as well.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Tenderness
Clinical narrative: Increasing redness on left upper arm at site. Severe tenderness and mild redness.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Patient felt nauseated and lightheaded. Patient lied down, slowly drank some orange juice and within 10 minutes felt fine.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis contained to upper arm following ZOSTAVAX administration.
Age: 47.0
Sex: F
Vaccine: TYP
Symptoms: Central nervous system inflammation, Full blood count normal, Hypoaesthesia, Metabolic function test normal, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Developed (L) facial numbness and pain beginning one day after typhoid vaccine. Seen in ED and MRI showed inflammation in (L) cerebellar peduncle. Seen by neurologist. DX: Trigeminal neuralgia.
Age: 47.0
Sex: F
Vaccine: TYP
Symptoms: Pain, Red blood cell sedimentation rate normal, Trigeminal neuralgia
Clinical narrative: Developed (L) facial numbness and pain beginning one day after typhoid vaccine. Seen in ED and MRI showed inflammation in (L) cerebellar peduncle. Seen by neurologist. DX: Trigeminal neuralgia.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot# unspecified) series on an unspecified date and the second dose of the GARDASIL (lot# unspecified) series in approximately January 2013("about 1 year ago"). No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that the patient was in the office to receive the third dose(lot# unspecified) on 09-JAN-2013. No adverse effects reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Discomfort, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 years old male patient with hypothyroidism. The patient did not have any drug reactions/allergies. The patient was vaccinated with PNEUMOVAX23 (0.5 ml, lot # H014283, expiration date 17-APR-2014) intramuscularly in left arm on 04-JAN-2013. No other co-suspects were reported. Concomitant medications included benazepril hydrochloride and SYNTHROID. On 04-JAN-2013 the patient experienced extreme pain described as muscular, a fever of 100F lasting for 2 hours, and nausea and vomiting. The patient reported that he took ibuprofen and acetaminophen, PERCOCET (manufacturer unspecified) and it did not relieve the pain. He was seen by physician at unspecified date, and reported that the fever, nausea and vomiting had resolved, but the pain and difficulty using his arms remains, although it had improved slightly. Patient was now taking ibuprofen to manage discomfort. The relatedness for event was unknown for PNEUMOVAX23. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The nurse reported that GARDASIL administered too soon after the second dose of GARDASIL was given. The patient was vaccinated with the second and third dose of GARDASIL (dose, route and lot # not provided) respectively on 13-NOV-2012 and 14-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare worker reported that GARDASIL were exposed to unspecified temperature conditions during a power failure for an unspecified period of time, were then administered to unspecified patients on unspecified dates. The indication, dose, route and lot # of the vaccine was not reported. No concomitant medications were reported. No adverse effect reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to a 56 years old female patient with allergy to penicillin. The patient's medical history included herpes simplex. On 07-JAN-2013 the patient was vaccinated in her left arm with ZOSTAVAX (lot # and route not reported). Concomitant medications included influenza virus vaccine (unspecified) on 07-JAN-2013 in her right arm and VALTREX occasionally for herpes simplex. On 08-JAN-2013 the patient developed a red, hard lump on her left arm at the injection site after receiving ZOSTAVAX. The patient also had developed a bilateral vesicular like rash to her body, arms and legs. The patient took one dose of VALTREX when she first noticed the rash. The patient sought unspecified medical attention by office visit. The outcome of the events was reported as not recovered. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning an approximately 13 year old male patient. The patient was vaccinated with first and second dose of 0.5 milliliter (ml) GARDASIL (lot number, expiry date unspecified), intramuscularly in the right arm on 12-JAN-2012 and on 02-JAN-2013 (today) respectively. No concomitant medications were reported. No adverse effects were reported. Additional information is not expected.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: Patient developed rashes on both arms the night after flu shot. Patient also had fever and chills. Patient went to Urgent Care on 1/15/13 and got a prescription for prednisone to treat the reaction.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache
Clinical narrative: Bad shaking like I was freezing for 3 hours super bad headache and still have the headache. One of the worse headaches in my life.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphagia, Eye discharge, Eye irritation, Ocular hyperaemia
Clinical narrative: Red bloodshot eyes that burned and kept getting goofy with whitish yellowish mucus. Coughing and clearing throat fit that lasted one hour. Pain and difficulty swallowing.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Throat irritation
Clinical narrative: Red bloodshot eyes that burned and kept getting goofy with whitish yellowish mucus. Coughing and clearing throat fit that lasted one hour. Pain and difficulty swallowing.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Contusion, Erythema, Pruritus, Swelling
Clinical narrative: Day of shot had bruising from Varicella vaccine.  Day after shot had raised red swelling, a little itching. About 3 inches across.  1 week later, still red but swelling gone and redness decreasing in circumference.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itching over torso, legs and buttocks.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Laboratory test, Musculoskeletal pain, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of arm pain ("pain on arm that radiates to the shoulder") in a 49-year-old male subject who was vaccinated with ENGERIX B, (GlaxoSmithKline). On 10 February 2012 at 09:15 the subject received 1st dose of ENGERIX B (unknown route, right arm). Less than one week after vaccination with ENGERIX B, the subject experienced arm pain ("pain on arm that radiates to the shoulder"). The subject had had "many" labs and has seen different physicians. No further information was provided. The healthcare professional considered the event was disabling and clinically significant (or requiring intervention). At the time of reporting the event was worse. The healthcare professional considered the event was possibly related to vaccination with ENGERIX B.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 years old female patient with melanoma and hypertension and none Drug reactions/Allergies who on an unspecified date was vaccinated subcutaneously with 0.65 ml dose of live ZOSTAVAX, vial 29400 (lot # (h013943, Exp date:25-OCT-2013) and developed a red area, 2 inches in diameter at the injection site (onset date unknown). No other co-suspects were reported. Concomitant medications included losartan potassium (manufacturer unknown), hydrochlorothiazide (manufacturer unknown) and potassium supplement. The patient reported no vesicles or itchiness at injection site. He reported that after three days the redness decreased, but was still present. No treatment was given to the patient. No lab test were performed. The patient did not seek medical attention. The relatedness for the event was unknown for live ZOSTAVAX. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: This spontaneous report was received from a 68 years old female consumer reporting on herself who on 03-JAN-2013 was vaccinated with a dose of live ZOSTAVAX (route, lot # and dose not reported). No other co-suspects were reported. No concomitant medications were reported. On 06-JAN-2013, the patient had a pain in her hip at the joint that will not go away, and did not wish to share additional information. The outcome of the event was unknown. No labs were performed. The relatedness for the event was unknown for live ZOSTAVAX. Additional information is not expected.