chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report as received from a 57 year old male consumer with no pertinent medical history and no drug reactions or allergies reporting on himself. On 29-APR-2013, the consumer was vaccinated with a dose of ZOSTAVAX (Lot # not reported). There was no concomitant medication. The consumer reported that on 03-MAY-2013, 4 days after vaccine, he developed a rash at the injection site. This rash did not have any blisters, but rather had very small bumps at the site. The injection site was red and itchy. This reaction site was several inches long and 1 inch in diameter. As of 15-MAY-2013, most of this reaction was gone. There were no more bumps and the color of the injection site was just a shadow now, almost skin colored. The patient did not receive treatment for the adverse event. The patient did not seek medical attention. At the time of the report, the patient had not recovered. Additional information is not expected.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse for VARIVAX (merck) a Pregnancy Registry Product, refers to a 33 year old female patient. On 15-MAY-2013, the patient was vaccinated with a 0.5 ml dose of VARIVAX (merck) (Lot # reported as H018781, expiration date 15-OCT-2014) subcutaneously. The nurse reported that the patient denied pregnancy at time she received VARIVAX (merck). The nurse stated that patient completed a home pregnancy test after she received VARIVAX (merck) and the home pregnancy test was positive on 15-MAY-2013. The patient informed the nurse that she believed she was 4 weeks of gestation. The patient's LMP was on approximately 17-APR-2013 and her EDD would be in 22-JAN-2014. No adverse event was reported. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a health worker office manager refers to a 13 month old female patient. Pertinent medical history and drug/ reactions/allergies were not reported. On 10-MAY-2013, the patient was vaccinated with a first dose of PROQUAD (merck)0.5 ml (lot number an expiration date were not reported). Other suspect therapies included VARIVAX (merck) 0.5ml. Concomitant medications were unspecified by reporter. On 10-MAY-2013, the patient had inadvertently received "PROQUAD (merck) and VARIVAX (merck)" together instead of PROQUAD (merck) and MMR II." The patient had gotten a 0.5mL dose of both PROQUAD (merck) and VARIVAX (merck). No adverse experiences were reported. The patient sought medical attention was still in physician's office. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Headache, Injection site pain, Oedema peripheral
Clinical narrative: This spontaneous report was received from a 65 years old female consumer reporting on herself, with "thyroid" and no drug reactions or allergies. On 07-MAY-2013 the patient was vaccinated with ZOSTAVAX, (lot number and expiration date not reported) (subcutaneous on her left arm, dose not reported). No other suspect therapies were reported. Concomitant therapies included levothyroxine sodium (manufacturer unknown) 150mcg tablet daily, multivitamin unspecified and vitamin D. The patient reported that on 08-MAY-2013 after receiving the ZOSTAVAX in her left arm, it became swollen, red, had fever and pain at the site. The patient stated she continued to have pain, she was given an antibiotic IV (not specified), and she stated she developed cellulitis, which she said, her doctor diagnosed, after getting the vaccine. The patient stated she had pain in her joints, and headaches, and is continuing follow up at her physician. The outcome for the above mentioned events was unknown at the time of the report. The patient was given treatment with KEFLEX 500mg "5-10" 2 times daily and "BASTERIN". No laboratory diagnostic studies were performed. It was reported that the patient sought medical attention. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a 65 years old female consumer reporting on herself, with "thyroid" and no drug reactions or allergies. On 07-MAY-2013 the patient was vaccinated with ZOSTAVAX, (lot number and expiration date not reported) (subcutaneous on her left arm, dose not reported). No other suspect therapies were reported. Concomitant therapies included levothyroxine sodium (manufacturer unknown) 150mcg tablet daily, multivitamin unspecified and vitamin D. The patient reported that on 08-MAY-2013 after receiving the ZOSTAVAX in her left arm, it became swollen, red, had fever and pain at the site. The patient stated she continued to have pain, she was given an antibiotic IV (not specified), and she stated she developed cellulitis, which she said, her doctor diagnosed, after getting the vaccine. The patient stated she had pain in her joints, and headaches, and is continuing follow up at her physician. The outcome for the above mentioned events was unknown at the time of the report. The patient was given treatment with KEFLEX 500mg "5-10" 2 times daily and "BASTERIN". No laboratory diagnostic studies were performed. It was reported that the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an unknown age and gender patient with no pertinent medical history reported. Approximately on 14-MAY-2011 (reported as over two years ago) the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (dose and route not specified). No other suspect therapies or concomitant medications were reported. The medical assistant reported that the patient received her first dose of GARDASIL over two years ago and was now in the office, about to receive the second dos eof GARDASIL. No adverse effect reported. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 14.5 year old patient (unknown gender). In 2010 the patient received a first dose of GARDASIL (lot number not reported) (0.5 ml, intramuscular route), a second dose of GARDASIL in 2011 (lot number not reported) (0.5 ml, intramuscular route), a third dose in 2012 (0.5 ml, intramuscular route) and in 2013 a fourth dose of GARDASIL (lot number not reported) (0.5 ml, intramuscular route). The patient did not sought medical attention. No adverse effects reported. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site reaction, Rash, Rash pruritic, Vaccine positive rechallenge
Clinical narrative: Rash soon after injection locally, resolved after 1-2 hours. Over next several weeks, a pruitic rash occured for approx 1/2 hour daily at various times at injection site. Per pt he has had same reaction with each injection of anthrax vaccine he has received but never reported.
Age: 33.0
Sex: M
Vaccine: PER, TD
Symptoms: Adverse reaction, Dizziness, Erythema, Fatigue, Hypoaesthesia
Clinical narrative: After being given a vaccination for Tetanus, Diphtheria, and Pertussis my body began reacting to it. I began to feel dizzy, nauseous, and tired even though I had felt good prior to the vaccine. My left arm was swollen and red. I had severe pain where the shot was given up to my shoulder for the next 3 and a half days. I felt a numbness in my middle finger the next day as well as other parts of my hand.
Age: 33.0
Sex: M
Vaccine: PER, TD
Symptoms: Injection site pain, Nausea, Oedema peripheral, Pain
Clinical narrative: After being given a vaccination for Tetanus, Diphtheria, and Pertussis my body began reacting to it. I began to feel dizzy, nauseous, and tired even though I had felt good prior to the vaccine. My left arm was swollen and red. I had severe pain where the shot was given up to my shoulder for the next 3 and a half days. I felt a numbness in my middle finger the next day as well as other parts of my hand.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site very sore with large area of swelling and skin redness by AM of 05/16.  Skin very warm to touch.  AM of 5/17 less soreness reduced swelling and redness. Skin still warm and symptoms moved down the arm closer to elbow.  Am of 5/18 redness and swelling almost gone, some soreness remained. Used hot and cold packs on site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Right thigh 2x2in red swollen, no fever slightly sore and itchy. Administer ibuprofen for pain, warm compress, Benadryl for itching.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles, Paraesthesia
Clinical narrative: Around injection site, large red swollen area...itching and small blisters...tingling in fingers.
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Erythema, Pyrexia
Clinical narrative: S/S Patient reported having the chills and a fever. Pt. went to PMD on 5/14/2013 when noticing red lines running down his arm and a continued fever. PMD Rx'd Bactrim for 5 days.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Coordination abnormal, Fall, Pyrexia
Clinical narrative: ON 4/15/13 STARTED WITH FEVER TO 102.8.  ON 4/17/13, FEVER RESOLVED BUT PATIENT BECAME "UNCOORDINATED", GOING FROM PREVIOUSLY ABLE TO RUN AROUND TO FALLING AFTER 2 STEPS AND HAVING TO BE CARRIED AROUND. BY THE TIME OF THE OFFICE VISIT, HE HAD REGAINED MUCH OF HIS EQUILIBRIUM AND WAS ALMOST BACK TO NORMAL.  DAD WAS ADVISED TO F/U IN 1-2 DAYS IF THERE WAS NOT FULL RECOVERY.  NO F/U WAS NEEDED.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Dysphonia, Dyspnoea, Fatigue, Headache, Influenza like illness
Clinical narrative: I STARTED HAVING PAIN IN MY HANDS, HAD DIFFICULTIES BREATHING, LOW GRADE FEVER, FLU-LIKE SYMPTOMS, TIREDNESS, HOARSE VOICE, HEADACHE, ONE EPISODE OF VISION IMPAIRMENT WHEN MY VISION WENT WHITE.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity, Pyrexia, Visual impairment
Clinical narrative: I STARTED HAVING PAIN IN MY HANDS, HAD DIFFICULTIES BREATHING, LOW GRADE FEVER, FLU-LIKE SYMPTOMS, TIREDNESS, HOARSE VOICE, HEADACHE, ONE EPISODE OF VISION IMPAIRMENT WHEN MY VISION WENT WHITE.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Full blood count normal, Insomnia, Laboratory test normal, Malaise
Clinical narrative: Mumps-like break out on arms and face, petechia on face, neck and chest, high fever, malaise, blotching all over body, anorexia, unable to sleep.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Mumps, Petechiae, Pyrexia, Rash generalised, Rash macular
Clinical narrative: Mumps-like break out on arms and face, petechia on face, neck and chest, high fever, malaise, blotching all over body, anorexia, unable to sleep.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Urine analysis normal
Clinical narrative: Mumps-like break out on arms and face, petechia on face, neck and chest, high fever, malaise, blotching all over body, anorexia, unable to sleep.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Mobility decreased, Musculoskeletal stiffness, Oedema peripheral
Clinical narrative: Swelling redness and heat of deltoid, pain of 5 (0-10 scale), stiffness, inability to lift arm above past 45* angle, inability to move arm behind abdomen, inability to rotate shoulder. Unable to assess at this point if further medical attention required. Will see provider if symptoms last longer than a week from date of vaccine.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Swelling redness and heat of deltoid, pain of 5 (0-10 scale), stiffness, inability to lift arm above past 45* angle, inability to move arm behind abdomen, inability to rotate shoulder. Unable to assess at this point if further medical attention required. Will see provider if symptoms last longer than a week from date of vaccine.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient developed a rash under arms, breast and groin area. I observed rash on 5/17/13 about 7pm. It looked like a possible heat rash, fungal maybe. She went to an exercise gym for the first time this week. Patient did go to ER after seeing me. The doctor there said it was a possible allergic reaction to something. He wanted to give patient prednisone but she refused. She has been taking BENADRYL.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue
Clinical narrative: Long red streak (not like blood poisoning) took week to go away. Just that/tired. No other adverse effects.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site induration, Injection site swelling, Injection site warmth, Mobility decreased
Clinical narrative: This spontaneous report as received from a 51 year old female consumer to herself. The patient had none pertinent medical history. The patient had none drug allergies. On 08-MAY-2013 at 11:00 am, the patient was vaccinated with ZOSTAVAX (lot # not reported) (strength and total daily dose not reported). The patient stated that it was given in her upper arm but did not known if it was intramuscularly or subcutaneously. By the evening of 08-MAY-2013, the patient was unable to move her arm and developed a headache, terrible neck pain and a fever of 102 F. And the injection site was hard, hot touch and the area was the size of a baseball. The patient did not seek medical attention. ALEVE was given as treatment. The patient was not recovered. The causality between adverse events and ZOSTAVAX was unknown. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pyrexia
Clinical narrative: This spontaneous report as received from a 51 year old female consumer to herself. The patient had none pertinent medical history. The patient had none drug allergies. On 08-MAY-2013 at 11:00 am, the patient was vaccinated with ZOSTAVAX (lot # not reported) (strength and total daily dose not reported). The patient stated that it was given in her upper arm but did not known if it was intramuscularly or subcutaneously. By the evening of 08-MAY-2013, the patient was unable to move her arm and developed a headache, terrible neck pain and a fever of 102 F. And the injection site was hard, hot touch and the area was the size of a baseball. The patient did not seek medical attention. ALEVE was given as treatment. The patient was not recovered. The causality between adverse events and ZOSTAVAX was unknown. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 19 week old female patient. On 06-MAY-2013 the patient was vaccinated with first 2 ml dose of ROTATEQ (lot# J000034, expired date 23-APR-2014) orally. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 1.05
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Injection site rash, Rash generalised
Clinical narrative: following morning child awoke with rash over back, chest, abdomen, progressed to arms, legs, bottom, and face/neck.  Treated with po pediatric BENADRYL.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Pt noticed red raised rash on trunk and arm. Pt evaluated by physician diagnosed with post vaccine urticaria.  Advised to take OTC Benadryl and f/u with PCP/ER for worsening s/s. Pt provided with telephone number for the vaccine healthcare center network.
Age: 43.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient presented with swelling, pain and redness around vaccination site.
Age: 0.89
Sex: F
Vaccine: PNC13
Symptoms: Convulsion, Decreased appetite, Diarrhoea, Dyskinesia, Injection site erythema
Clinical narrative: 11/6/12: At time of appointment (9:20 AM): Bright-eyed, healthy, happy, energetic baby. No runny nose or sneezing. During exam doctor comments: "You look like a lot of fun!" By 5 PM: Fever of 100.1, extremely irritable (cries when she attempts to move body), redness, hardness, tenderness at injection site. Decreased appetite. Before midnight: Seizure (violent jerking/spasming of body which woke baby and made her cry). Have never seen her do this before or since. 11/7/12: Fever of 100.2, extreme irritability -- cries and demands to be held all day. Seems to be in pain if she tries to move -- interferes with limb movement. Decreased appetite. 11/8/12: Fever of 102.5. Extreme drowsiness -- falls asleep repeatedly, even shortly after waking from a long nap. Diarrhea. Extremely irritable, demands to be held all the time. Decreased appetite. Parent called doctor's office to report concerns, speaks to nurse. 11/9/12: Fever continues all night.  Back to normal in the morning.
Age: 0.89
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Injection site pain, Irritability, Muscle spasms, Pain
Clinical narrative: 11/6/12: At time of appointment (9:20 AM): Bright-eyed, healthy, happy, energetic baby. No runny nose or sneezing. During exam doctor comments: "You look like a lot of fun!" By 5 PM: Fever of 100.1, extremely irritable (cries when she attempts to move body), redness, hardness, tenderness at injection site. Decreased appetite. Before midnight: Seizure (violent jerking/spasming of body which woke baby and made her cry). Have never seen her do this before or since. 11/7/12: Fever of 100.2, extreme irritability -- cries and demands to be held all day. Seems to be in pain if she tries to move -- interferes with limb movement. Decreased appetite. 11/8/12: Fever of 102.5. Extreme drowsiness -- falls asleep repeatedly, even shortly after waking from a long nap. Diarrhea. Extremely irritable, demands to be held all the time. Decreased appetite. Parent called doctor's office to report concerns, speaks to nurse. 11/9/12: Fever continues all night.  Back to normal in the morning.
Age: 0.89
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Somnolence
Clinical narrative: 11/6/12: At time of appointment (9:20 AM): Bright-eyed, healthy, happy, energetic baby. No runny nose or sneezing. During exam doctor comments: "You look like a lot of fun!" By 5 PM: Fever of 100.1, extremely irritable (cries when she attempts to move body), redness, hardness, tenderness at injection site. Decreased appetite. Before midnight: Seizure (violent jerking/spasming of body which woke baby and made her cry). Have never seen her do this before or since. 11/7/12: Fever of 100.2, extreme irritability -- cries and demands to be held all day. Seems to be in pain if she tries to move -- interferes with limb movement. Decreased appetite. 11/8/12: Fever of 102.5. Extreme drowsiness -- falls asleep repeatedly, even shortly after waking from a long nap. Diarrhea. Extremely irritable, demands to be held all the time. Decreased appetite. Parent called doctor's office to report concerns, speaks to nurse. 11/9/12: Fever continues all night.  Back to normal in the morning.
Age: 59.0
Sex: M
Vaccine: HEP, HEPA, TYP
Symptoms: Abdominal discomfort, Allergy test, Colitis microscopic, Dry skin, Laboratory test abnormal
Clinical narrative: Dry skin on hands and feet, skin cracking and bleeding, gastrointestinal distress.
Age: 59.0
Sex: M
Vaccine: HEP, HEPA, TYP
Symptoms: Psoriasis, Rheumatoid factor, Skin fissures, Skin haemorrhage
Clinical narrative: Dry skin on hands and feet, skin cracking and bleeding, gastrointestinal distress.
Age: 11.0
Sex: M
Vaccine: RAB
Symptoms: Ataxia, Blood culture, Differential white blood cell count, Full blood count, Headache
Clinical narrative: Approximately 15 min. post rabies vaccine, pt. developed headache, ataxia, nausea and vomited x1. Vaccine administered in outpatient clinic and pt. brought to the ER for further evaluation. PO TYLENOL and ZOFRAN given in ER.
Age: 11.0
Sex: M
Vaccine: RAB
Symptoms: International normalised ratio, Metabolic function test, Nausea, Prothrombin time, Urine analysis
Clinical narrative: Approximately 15 min. post rabies vaccine, pt. developed headache, ataxia, nausea and vomited x1. Vaccine administered in outpatient clinic and pt. brought to the ER for further evaluation. PO TYLENOL and ZOFRAN given in ER.
Age: 11.0
Sex: M
Vaccine: RAB
Symptoms: Vomiting
Clinical narrative: Approximately 15 min. post rabies vaccine, pt. developed headache, ataxia, nausea and vomited x1. Vaccine administered in outpatient clinic and pt. brought to the ER for further evaluation. PO TYLENOL and ZOFRAN given in ER.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Swelling
Clinical narrative: At the site of the immunization there was significant redness, swelling, and warm to the touch. The swelling spread beyond the elbow.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Inj given on Monday 5/6/13 - in left upper arm - area is red / swollen / hot itching all the way to elbow.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Rheumatoid arthritis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with rheumatoid arthritis and no drug reactions or allergies. On an unknown date the patient was vaccinates with a dose of ZOSTAVAX (lot # J000435, exp. date:10-APR-2014) for vaccination. There was no concomitant medication. On an unknown date the patient was started HUMIRA for the treatment of rheumatoid arthritis following vaccination with ZOSTAVAX. The pharmacist could not provide the reason for the use of HUMIRA. The pharmacist could not provide if the patient was having problems with their rheumatoid arthritis following vaccination with ZOSTAVAX. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a physician refers to unspecified patients of unknown age and sex. Physician reported that GARDASIL exposed to 74F for upwards of 4 months and the improperly stored vaccines had been being administered to unspecified patients on unspecified dates (strength, formulation, lot #, dose/frequency, route and duration were unspecified). It was unknown whether the patient had sought medical attention or not. The outcome was unknown. This was one of several reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a physician refers to unspecified patients of unknown age and sex. Physician reported that VARIVAX (Merck) exposed to 73F for upwards of 4 months and the improperly stored vaccines had been being administered to unspecified patients on unspecified dates(strength, formulation, lot#, dose/frequency, route and duration were unspecified). It was unknown whether the patient had sought medical attention or not. The outcome was unknown. This was one of several reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # H011333, exp :30-SEP-2013 ,subcutaneous,once). On an unknown date the patient experienced cellulitis-like reaction, and went to the Emergency Room (Hospital unspecified-treated and released). Episode of cellulitis was reported after introduction of ZOSTAVAX. The outcome of cellulitis-like reaction was unknown. This is one of the several report from the same source
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a physician refers to unspecified patients of unknown age and sex. Physician reported that VAQTA exposed to 74F for upwards of 4 months and the improperly stored vaccines had been being administered to unspecified patients on unspecified dates(strength, formulation, lot#, dose/frequency, route and duration were unspecified). It was unknown whether the patient had sought medical attention or not. The outcome was unknown. This was one of several reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a physician refers to unspecified patients of unknown age and sex. Physician reported that MMR II exposed to 73F for upwards of 4 months and the improperly stored vaccines had been being administered to unspecified patients on unspecified dates (therapy type, strength, formulation, lot#, dose/frequency, route and duration were unspecified). It was unknown whether the patient had sought medical attention or not. The outcome was unknown. This was one of several reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a physician refers to unspecified patients of unknown age and sex. Physician reported that RECOMBIVAX HB exposed to 74F for upwards of 4 months and the improperly stored vaccines had been being administered to unspecified patients on unspecified dates (strength, formulation, lot #, dose/frequency, route and duration were unspecified). It was unknown whether the patient had sought medical attention or not. The outcome was unknown. This was one of several reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a physician refers to unspecified patients of unknown age and sex. Physician reported that oral ROTATEQ exposed to 74F for upwards of 4 months and the improperly stored vaccines had been being administered to unspecified patients on unspecified dates (strength, formulation, lot #, dose/frequency, route and duration were unspecified). It was unknown whether the patient had sought medical attention or not. The outcome was unknown. This was one of several reports that received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site erythema, Oedema peripheral, Vaccination site swelling
Clinical narrative: Initial misuse report received from a healthcare professional on 03 August 2012. A 04-year-old female patient, whose medical history and concomitant medications were not reported, inadvertently received 3ml dose of IPOL vaccine, Sanofi Pasteur ltd. (lot number H1305 (possibly H1305-1), route and site of vaccination not reported) on an unspecified date. It was reported that, the patient received 3ml of vaccine instead of 0.5ml. On an unspecified date, the patient developed redness and swelling of the arm following vaccine administration. Corrective medications and laboratory investigations were not reported. The outcome of the event was unknown. List of documents held by sender: None. Follow up received on 09 October 2012: The patient received IPOL subcutaneously on left arm on 02 August 2012. She also received MMR vaccine on right arm subcutaneously (mfg. by Merck) (Lot no. 1122 AA) and DTaP vaccine (lot no. AC14B149AA) intramuscularly on left arm on 02 August 2012. The patient was not administered any vaccine within 04 weeks, and she had no known allergies. It was reported that the patient did not receive any medication. It was also reported that till 03 October 2012 no side effect has been observed in patient except swelling and redness on the vaccination site that resolved within 03 days. At the time of report outcome was recovered but date was not specified. Second Follow-up information was received from healthcare professional on 12 December 2012 and 17 December 2012. No laboratory testing was performed. The patient was on no medication and did not receive any medication after vaccination.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Crying, Food allergy, Milk allergy
Clinical narrative: Initial report received from a healthcare professional on 03 August 2012. A 04-month-old male patient, whose medical history or illness at the time of vaccination included none and whose concomitant medications were not reported, received a dose of ACTHIB vaccine Sanofi Pasteur ltd. (lot number UH573AA) intramuscularly in the left thigh and IPOL vaccine Sanofi Pasteur ltd. (lot number H1305-1) intramuscularly in the left thigh on 18 May 2012. On 18 May 2012, same day of vaccination, the patient experienced intense high pitch crying on and off. She did not state when the crying bouts ended. Laboratory investigations and corrective medications were not reported. The patient's outcome was recovered on an unspecified date. List of documents held by sender: None. Follow-up received on 04 October 2012: The patient was breast fed. The patient was suspected with milk protein allergy and other foods allergies. The patient eczema was flared up when mom taking eggs, nuts/tree nuts. The mo was eliminated these foods in her diet as well. The patient mom had dairy products in her diet the patient had colic, so dairy products was avoided in her diet. The patient did well. The patient will see an allergist next month. The patient had RECOMBIVAX HB (Merck) in right thigh (Lot no. 0231AA) and PREVNAR 13 (Wyeth) on left thigh (Lot no. F75398) on 20 April 2012. The patient received intramuscular DAPTACEL on right thigh (other than previous vaccines) (Lot no. C4050AA) on 18 May 2012. The patient administered IPOL vaccine on right arm and not on right thigh as reported earlier. The patient was recovered from the event on same day i.e. 18 May 2012.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4, TDAP
Symptoms: Cough, Fatigue, Pain, Pyrexia, Vaccination error
Clinical narrative: Initial report received from a consumer who was also the patient's parent on 07 February 2013. A 13-year-old female patient, with no medical history and had no illness at the time of vaccination, had received intradermal dose of FLUZONE ID (lot number was not reported) in left deltoid on 30 January 2013. The patient also received Tdap vaccine from unknown manufacturer and HPV (Human Papilloma Virus)from other manufacturer (lot number and route and site of administration were not reported) on 30 January 2013. On 31 January 2013, the patient experienced migraine, fever, chills, fatigue and had difficulty in concentrating. At the time of this report, the symptoms were improving, but were still present. Laboratory investigations were not done and no information about corrective treatments. The patient's outcome was not recovered. List of documents held by the sender: None.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4, TDAP
Symptoms: Chills, Disturbance in attention, Fatigue, Migraine, Pyrexia
Clinical narrative: Initial report received from a consumer who was also the patient's parent on 07 February 2013. A 13-year-old female patient, with no medical history and had no illness at the time of vaccination, had received intradermal dose of FLUZONE ID (lot number was not reported) in left deltoid on 30 January 2013. The patient also received Tdap vaccine from unknown manufacturer and HPV (Human Papilloma Virus)from other manufacturer (lot number and route and site of administration were not reported) on 30 January 2013. On 31 January 2013, the patient experienced migraine, fever, chills, fatigue and had difficulty in concentrating. At the time of this report, the symptoms were improving, but were still present. Laboratory investigations were not done and no information about corrective treatments. The patient's outcome was not recovered. List of documents held by the sender: None.
Age: 0.19
Sex: M
Vaccine: PNC13, RV5, RV5
Symptoms: Faeces discoloured, Irritability, Mucous stools
Clinical narrative: Fussiness for 1-2 days within 6 hours of the vaccine. Followed by a pinkish, mucousy stool.
Age: 0.19
Sex: M
Vaccine: PNC13, RV5, RV5
Symptoms: Intussusception
Clinical narrative: Fussiness for 1-2 days within 6 hours of the vaccine. Followed by a pinkish, mucousy stool.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Lip swelling, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a 70 year old female patient. The patient had none drug allergies. On an unspecified date "last week", in approximately May 2013, the patient was vaccinated with ZOSTAVAX (lot # J000494, expiry date 14-APR-2014)(subcutaneous in the left arm, 0.65 ml, strength not reported). It was reported that on the same day after ZOSTAVAX was given, the patient developed a red rash with 2 "bumps" on her left arm at the injection site. The patient also experienced swelling to her lip. The patient sought for medical attention by calling to pharmacy. No treatment was given. Lab diagnostics studies performed were reported as none. The patient was not recovered. The causality between adverse events and ZOSTAVAX was unknown. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Lip swelling, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a 70 year old female patient. The patient had none drug allergies. On an unspecified date "last week", in approximately May 2013, the patient was vaccinated with ZOSTAVAX (lot # J000494, expiry date 14-APR-2014)(subcutaneous in the left arm, 0.65 ml, strength not reported). It was reported that on the same day after ZOSTAVAX was given, the patient developed a red rash with 2 "bumps" on her left arm at the injection site. The patient also experienced swelling to her lip. The patient sought for medical attention by calling to pharmacy. No treatment was given. Lab diagnostics studies performed were reported as none. The patient was not recovered. The causality between adverse events and ZOSTAVAX was unknown. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site vesicles, Oedema peripheral, Skin papilloma
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 79 year old male patient without drug reactions/allergies. The patient's medical history included history of cancer, leukemia or other unspecified immunocompromising disease. On 15-MAR-2013 the patient was vaccinated with 0.65ml ZOSTAVAX (lot # J000433, expiry date 10-APR-2014) subcutaneously. Concomitant therapies included lisinopril(manufacturer unknown), TRILIPIX, omeprazole(manufacturer unknown), metoprolol ER(manufacturer unknown) and LIPITOR. On an unspecified date after administration, he developed "significant swelling that covered most of his upper arm". The "swelling went away" on an unspecified date and 'left a spot at the injection site that looked like a wart of vesicle". The patient thought it was a "scab" but he had been "picking at it and it won't come off". The patient had "no pain, but was very concerned about the spot still being present on his arm". No treatment was given for adverse event. No lab diagnostics studies were performed. The patient was recovering from the adverse event. The patient spoke to pharmacist for seeking medical attention. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Musculoskeletal pain, Nodule, Pyrexia
Clinical narrative: Redness, sore and tender at injection site, initially, then at 3:30 PM fever started and lasted until morning of 5/19/2013 (reported by patient).  Highest temperature was 101 by mouth, was relieved by ibuprofen.  Afternoon of 5/19/2013 patient noticed soreness in left shoulder and "bump" towards medial end of left clavicle.  This is slowly resolving, though tenderness remains.
Age: 25.0
Sex: M
Vaccine: MNQ
Symptoms: Swelling, Tenderness
Clinical narrative: Redness, sore and tender at injection site, initially, then at 3:30 PM fever started and lasted until morning of 5/19/2013 (reported by patient).  Highest temperature was 101 by mouth, was relieved by ibuprofen.  Afternoon of 5/19/2013 patient noticed soreness in left shoulder and "bump" towards medial end of left clavicle.  This is slowly resolving, though tenderness remains.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Parent reporting large red swollen area at injection site.
Age: 23.0
Sex: F
Vaccine: IPV, MNQ, TDAP, TYP, YF
Symptoms: Urticaria
Clinical narrative: Hives---3 patches, patient self medicated with Benadryl. Next day, 2 patches appeared, patient again self-medicated. Third day only 1 patch appeared, again self-medicated with Benadryl.
Age: 1.47
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Convulsion
Clinical narrative: Seizure.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Injection site bruising, Oedema peripheral, Skin warm
Clinical narrative: Patient's mother called the Health Dept. at 8:00 AM on 5-20-13 to report that she had taken patient to facility because of a reaction she had from her immunizations. The Health Department had held an immunization clinic at patient's school on 05-16-2013. At that clinic, patient received T-dap via intramuscular injection in her right deltoid, varicella via subcutaneous injection in the back of her right arm and Menactra via intramuscular injection in her left arm. Patient's mother reported that she noticed that patient's right arm was warm to the touch and had redness, and swelling Friday evening. She also noticed that she had bruising to both deltoids. She took patient to facility where they circled the area. Later, they returned to facility and the area had grown 2". Patient was placed on Augmentin and Benadryl. She was instructed to return to facility in 5 days if it was not getting better. Patient's mother reported that facility did not think that it was the Tdap because the location of the redness, swelling and heat was coming from the back of her right arm. Her mother also said that the medicine seemed to be working because the area of redness and swelling was getting smaller.
Age: 0.1
Sex: F
Vaccine: DTAP
Symptoms: Adenotonsillectomy, Antibody test negative, Blister, Ear infection, Ear tube insertion
Clinical narrative: Patient became white, began screaming-which lasted for hours, she began running a fever of 103.  I called the pediatrician and reported this event, and was "blown off" concerning it.  I was treated as an "over reacting" parent.  Patient began with ear infections and respiratory infections within days of this vaccine, the DTaP.  This child was PERFECTLY healthy until this vaccine was given.  Her illnesses with ear infections and respiratory infections has continued her whole life-the last 12+ years!  She has had ear tubes, adenoids and tonsils removed, she has episodes of severe blisters in her mouth, on her face hands and feet.  She has not made antibiodies to some vaccines that have been forced upon us. She was diagnosed with an IgA deficiency around age 3.  This child's illnesses have wreaked havoc on her life, and that of our family, and on our financial health, as well. I have NO doubt, after completing extensive research that the DTaP is the cause of my child's health issues.
Age: 0.1
Sex: F
Vaccine: DTAP
Symptoms: Laboratory test, Oral mucosal blistering, Pallor, Pyrexia, Quality of life decreased
Clinical narrative: Patient became white, began screaming-which lasted for hours, she began running a fever of 103.  I called the pediatrician and reported this event, and was "blown off" concerning it.  I was treated as an "over reacting" parent.  Patient began with ear infections and respiratory infections within days of this vaccine, the DTaP.  This child was PERFECTLY healthy until this vaccine was given.  Her illnesses with ear infections and respiratory infections has continued her whole life-the last 12+ years!  She has had ear tubes, adenoids and tonsils removed, she has episodes of severe blisters in her mouth, on her face hands and feet.  She has not made antibiodies to some vaccines that have been forced upon us. She was diagnosed with an IgA deficiency around age 3.  This child's illnesses have wreaked havoc on her life, and that of our family, and on our financial health, as well. I have NO doubt, after completing extensive research that the DTaP is the cause of my child's health issues.
Age: 0.1
Sex: F
Vaccine: DTAP
Symptoms: Respiratory tract infection, Screaming, Selective IgA immunodeficiency
Clinical narrative: Patient became white, began screaming-which lasted for hours, she began running a fever of 103.  I called the pediatrician and reported this event, and was "blown off" concerning it.  I was treated as an "over reacting" parent.  Patient began with ear infections and respiratory infections within days of this vaccine, the DTaP.  This child was PERFECTLY healthy until this vaccine was given.  Her illnesses with ear infections and respiratory infections has continued her whole life-the last 12+ years!  She has had ear tubes, adenoids and tonsils removed, she has episodes of severe blisters in her mouth, on her face hands and feet.  She has not made antibiodies to some vaccines that have been forced upon us. She was diagnosed with an IgA deficiency around age 3.  This child's illnesses have wreaked havoc on her life, and that of our family, and on our financial health, as well. I have NO doubt, after completing extensive research that the DTaP is the cause of my child's health issues.
Age: 47.0
Sex: M
Vaccine: TYP, YF
Symptoms: Dysphonia, Dyspnoea, Fatigue, Headache
Clinical narrative: Shortness of breath, headache, tired feeling, hoarseness; states took ibuprofen and it helped some.  Told to called doctor on 5-20-13.
Sex: M
Vaccine: PNC13
Symptoms: Conjunctival haemorrhage, International normalised ratio increased
Clinical narrative: This is a spontaneous report from a Study Program -Pfizer for Professional Customer Support Line- for a contactable physician. A patient of unknown age, gender received PREVNAR 13 on an unknown date and COUMADIN since an unknown date at an unknown dose and frequency for an unknown indication. Relevant medical history and relevant concomitant medications of the patient were unknown. On 02May2013, while on warfarin sodium and after the administration of PREVNAR 13, INR test result was found very high at 16 (unknown units). Previously on 22Mar2013, the result of INR test was 2.7 (unknown units). Additionally, on 07May2013, while on warfarin sodium and after the administration of PREVNAR 13, the patient had conjunctival hemorrhage in eye, after which he/she was brought to the emergency room on an unspecified date in May2013. Last action taken with warfarin sodium was unknown. Therapeutic measures taken in response to the reported events were unknown. Clinical outcome of the reported events was unknown at the time of report.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Local swelling
Clinical narrative: Local swelling, erythema around injection site. Rx BENADRYL, ibuprofen.
Age: 1.06
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Culture positive, Varicella virus test positive
Clinical narrative: Pt. received varicella vaccine on Friday and began breaking out in blisters on Saturday. Pt brought into clinic 5/6/13 and varicella and aerobic culture done. Varicella isolated.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal infection, Coccidioidomycosis, Death, Immediate post-injection reaction, Immune system disorder
Clinical narrative: Spontaneous information received on 03MAY2013 and 08MAY2013 from a family member of a consumer. An adult male experienced Valley Fever (coccidioidomycosis), and subsequently died. Medical history - the subject was reportedly in good physical condition. No known medical history. History of events per adult subject's father. Subject was immunized in October of 2007. Within a day of vaccination he experienced pain and illness, though the father could not remember the nature of immediate post-vaccination symptoms. He was eventually diagnosed with Valley Fever (coccidioidomycosis) contracted during his time at work. "He did not respond to treatment. The doctors said his immune system was not working. He had several surgeries. He was given many drugs that did not stop the infection." Reportedly, he was let go due to his illness. In 2011 he had 3 surgeries to remove 2 1/2 ribs and portions of his spinal bones, and further surgery to reinforce his spine. In 2013, he had "pockets" of infection in his bones; belly, and brain as well as his lungs. He refused treatment with a ventilator and subsequently died on 22APR2013. Per the subject's father: "His work gave him the vaccines. The doctors treated his infection. The doctors said the vaccine did not cause his infection. They said the vaccines did not cause his immune system to stop working. The employer said we could not sue. The employer is not telling us everything."
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Infection, Laboratory test, Lung infection, Malaise, Osteomyelitis
Clinical narrative: Spontaneous information received on 03MAY2013 and 08MAY2013 from a family member of a consumer. An adult male experienced Valley Fever (coccidioidomycosis), and subsequently died. Medical history - the subject was reportedly in good physical condition. No known medical history. History of events per adult subject's father. Subject was immunized in October of 2007. Within a day of vaccination he experienced pain and illness, though the father could not remember the nature of immediate post-vaccination symptoms. He was eventually diagnosed with Valley Fever (coccidioidomycosis) contracted during his time at work. "He did not respond to treatment. The doctors said his immune system was not working. He had several surgeries. He was given many drugs that did not stop the infection." Reportedly, he was let go due to his illness. In 2011 he had 3 surgeries to remove 2 1/2 ribs and portions of his spinal bones, and further surgery to reinforce his spine. In 2013, he had "pockets" of infection in his bones; belly, and brain as well as his lungs. He refused treatment with a ventilator and subsequently died on 22APR2013. Per the subject's father: "His work gave him the vaccines. The doctors treated his infection. The doctors said the vaccine did not cause his infection. They said the vaccines did not cause his immune system to stop working. The employer said we could not sue. The employer is not telling us everything."