chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Joint swelling, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Swelling
Clinical narrative: 1 month of symptoms starting 10 days after her 2nd HPV vaccine Gardisal (1st HPV on 2/24/12, 2nd 2/25/13) multiple joint pain, intermittent migratory joint pain and abdominal pain, weakness and fatigue lasting about a month. 10 days after vaccine ago woke up in the night with bilateral knee pain with mild swelling; over the next few days had bilateral ankle and wrist pain. The joint pain seemed to migrate to different areas, moving around every 5-10 minutes, no more than 1 hour in one particular joint. The swelling was present over the wrist / ankles / knees, resolved in around 2 weeks.  The pain seems to persist however until 1 month. Cold water tends to help the pains. Upon waking the morning she has no pain or no stiffness.  She has been waking up in the middle of the night with pain, but less so this week than last week. Chest, back, abdominal pain present  5 days after the joint pains. Each pain was brief in duration. Chest pain is resolved. Abdominal pain is bilateral periumbilical, but improved. No diarrhea / vomiting / blood in stool.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at injection site-left deltoid.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Maternal exposure before pregnancy, Pregnancy test positive
Clinical narrative: Pregnancy test done 4/05/2014. Negative result. Pt Became Pregnant 4/21/2013. Pregnancy test positive & 4/24/2013 Pregnancy test done in OBGYN Positive results.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: When getting ready for bed, we noticed his left upper arm was red, swollen, and hot.  When asked if his arm hurt, he said it did.  He appears to move it fine, so it is not acute pain.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema genital, Pain, Pruritus, Pyrexia, Vaginal oedema
Clinical narrative: Rt vaginal labial edema, pain and pruritis. Rt axilla swelling and pruritus with fever per pt, unrecorded temp.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to 69 year old female patient. On 140-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and route was not reported). On an unspecified dates, the patient complained of burning sensation and stinging. The outcome of the reported events were unknown. This is one of the 8 reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 12-APR-2013, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (Lot number 671378/0811AA, expiry date was 15-MAR-2013, route and dose were not reported). No adverse effect reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination
Clinical narrative: This spontaneous report was received from an unknown reporter regarding a 24 year old female patient. No medical history was reported. On an unknown date 2 years ago in 2011, the patient was vaccinated with first dose of GARDASIL (lot #, expiry not reported0, subdermally. No concomitant medications were reported. The patient experienced did not get second or third dose after getting the first one 2 years ago. The patient was referred to her physician. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a male patient of unknown age. No medical history was reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry, dose, route not reported). No concomitant medications were reported. On an unknown date, the patient developed a big red swollen spot after receiving a dose of ZOSTAVAX. No laboratory tests were performed. Patient sought medical attention (called the pharmacist). The outcome of big red swollen spot was unknown. The relationship of the events with ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age. No medical history was reported. On 19-APR-2013, the patient was inadvertently administered with a single dose of ZOSTAVAX (lot # 672563/1649AA) subcutaneously that had expired on 21-JAN-2013. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: This spontaneous report as received from a 75 year old male patient with diabetes and no allergies. On 16-APR-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot # unknown). Concomitant therapies included metformin, pravastatin sodium, carvedilol and glyburide. On 17-APR-2013, the patient experienced an incidence of 10 to 14 "splotches" under his left arm measuring approximately "quarter sized". The patient stated that these "splotches" were not painful or itching. The patient did not seek any medical attention or receive any treatment. No lab test was performed. The outcome was reported as not recovered. The patient would contact his physician. ZOSTAVAX was not discontinued. The causality between the event and ZOSTAVAX was unknown. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to 70 year old female patient. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and route was not reported). On an unspecified date, the patient complained of burning sensation and stinging. The outcome of the reported events were unknown. This is one of the 8 reports received from the same reporter. Additional information is not expected.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to 82 year old male patient. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and route was not reported). On an unspecified date, the patient complained of burning sensation and stinging. The outcome of the reported events were unknown. This is one of the 8 reports received from the same reporter. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to 61 year old female patient. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and route was not reported). On an unspecified date, the patient complained of burning sensation and stinging. The outcome of the reported events were unknown. This is one of the 8 reports received from the same reporter. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuralgia
Clinical narrative: This spontaneous report was received from a 74 year old female consumer referring on herself with collagenous colitis and atrial fibrillation. On 24-DEC-2012, the patient was vaccinated with a dose of ZOSTAVAX in the left arm (lot # not reported). Concomitant therapies included lisinopril (manufacturer unknown), simvastatin (manufacturer unknown), TIKOSYN, ASACOL, colestipol hydrochloride, zorelto and diclofenac. In approximately January-2013, (also reported as two weeks after injection) the patient broke out with shingles around the waist and back area left side. She sought medical attention and was treated with gabapentin 300 mg three times a day and with ointment fluocinonide. Patient stated blisters have healed but was still experiencing the nerve pain and wants to know how long this would last. At the time of this report the outcome of shingles was not recovered/not resolved. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Electromyogram abnormal, Mononeuropathy, Nerve conduction studies abnormal, Neuralgia
Clinical narrative: Bilateral sural mononeuropathies. Neuropathic pain approximately 2 years after.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Eschar, Scab
Clinical narrative: Onset time is unknown, patient was re-admitted to our facility 3/27/13 at 8:53 AM. Nurse noticed a large scab and eschar during assessment. The patient explained that it had been there for a while ever since she received the vaccination. Wound care nurse was consulted, provider notifed.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, MNQ, TDAP, TYP, VARCEL, YF
Symptoms: Urticaria
Clinical narrative: The mother of the client called stating that the client broke out in hives after taking the first dose of the oral Typhoid vaccine.
Age: 1.53
Sex: F
Vaccine: HEP
Symptoms: Abnormal behaviour, Aggression
Clinical narrative: Behavior changes-became defiant and physically aggressive.  Behavior is still occurring.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Arm swelling, pain, fever to 104, fatigue.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site induration
Clinical narrative: Bruised mild erythema (L) upper arm faded after BENADRYL dose, slightly firm at injection site, otherwise supple.
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of PROQUAD (Merck) (dose, route and lot number unspecified). Other suspect therapies included KINRIX (dose, route and lot number unspecified). On an unknown date the patient experienced "hard, red, and hot" around the injection site of KINRIX. The outcome of the events was unknown. The relatedness of the events to PROQUAD (Merck) was unknown. The patient did office visit on an unspecified date for medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Amniotic fluid volume decreased, Exposure during pregnancy, Foetal disorder, Induced labour, Renal disorder
Clinical narrative: This spontaneous report as received from the Nurse Practitioner, for GARDASIL, a Pregnant Registry product, refers to a patient of unknown age. The patient's 26 years old mother received her third dose of GARDASIL (lot # was 1696AA; exp. date was 12-SEP-2014) 0.5ml, intramuscularly on 26-JUL-2012. At the time of the third dose, the patient's mother was "one week to ten days pregnant". The last menstrual period was approximately on 16-JUL-2012 and the estimated delivery date was on 22-APR-2013. The fetus was followed throughout the pregnancy and monitored for "fetal pyelectasis" which the nurse practitioner described as a "congenital abnormality of the kidneys" with unspecified diagnostic testing. The mother was induced as a result of low amniotic fluid, and the baby was delivered on 24-MAR-2013. The baby was diagnosed with the kidney abnormality mentioned above with unspecified diagnostic testing, and the Nurse practitioner stated it had not resolved by her check up appointment in January. The mother's report was captured in Marss#1304USA013840. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Amniotic fluid volume decreased, Congenital anomaly, Foetal exposure during pregnancy, Pyelocaliectasis
Clinical narrative: This spontaneous report as received from the Nurse Practitioner, for GARDASIL, a Pregnant Registry product, refers to a patient of unknown age. The patient's 26 years old mother received her third dose of GARDASIL (lot # was 1696AA; exp. date was 12-SEP-2014) 0.5ml, intramuscularly on 26-JUL-2012. At the time of the third dose, the patient's mother was "one week to ten days pregnant". The last menstrual period was approximately on 16-JUL-2012 and the estimated delivery date was on 22-APR-2013. The fetus was followed throughout the pregnancy and monitored for "fetal pyelectasis" which the nurse practitioner described as a "congenital abnormality of the kidneys" with unspecified diagnostic testing. The mother was induced as a result of low amniotic fluid, and the baby was delivered on 24-MAR-2013. The baby was diagnosed with the kidney abnormality mentioned above with unspecified diagnostic testing, and the Nurse practitioner stated it had not resolved by her check up appointment in January. The mother's report was captured in Marss#1304USA013840. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Amniotic fluid volume decreased, Exposure during pregnancy, Foetal disorder, Induced labour, Renal disorder
Clinical narrative: This spontaneous report as received from the Nurse Practitioner, for GARDASIL, a Pregnant Registry product, refers to a patient of unknown age. The patient's 26 years old mother received her third dose of GARDASIL (lot # was 1696AA; exp. date was 12-SEP-2014) 0.5ml, intramuscularly on 26-JUL-2012. At the time of the third dose, the patient's mother was "one week to ten days pregnant". The last menstrual period was approximately on 16-JUL-2012 and the estimated delivery date was on 22-APR-2013. The fetus was followed throughout the pregnancy and monitored for "fetal pyelectasis" which the nurse practitioner described as "congenital abnormality of the kidneys" with unspecified diagnostic testing. The mother was induced as a result of low amniotic fluid, and the baby was delivered on 24-MAR-2013. The baby was diagnosed with the kidney abnormality mentioned above with unspecified diagnostic testing, and the Nurse Practitioner stated it had not resolved by her check up appointment in January. The mother's report was captured in Marss#1304USA013840. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Amniotic fluid volume decreased, Congenital anomaly, Foetal exposure during pregnancy, Pyelocaliectasis
Clinical narrative: This spontaneous report as received from the Nurse Practitioner, for GARDASIL, a Pregnant Registry product, refers to a patient of unknown age. The patient's 26 years old mother received her third dose of GARDASIL (lot # was 1696AA; exp. date was 12-SEP-2014) 0.5ml, intramuscularly on 26-JUL-2012. At the time of the third dose, the patient's mother was "one week to ten days pregnant". The last menstrual period was approximately on 16-JUL-2012 and the estimated delivery date was on 22-APR-2013. The fetus was followed throughout the pregnancy and monitored for "fetal pyelectasis" which the nurse practitioner described as "congenital abnormality of the kidneys" with unspecified diagnostic testing. The mother was induced as a result of low amniotic fluid, and the baby was delivered on 24-MAR-2013. The baby was diagnosed with the kidney abnormality mentioned above with unspecified diagnostic testing, and the Nurse Practitioner stated it had not resolved by her check up appointment in January. The mother's report was captured in Marss#1304USA013840. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Pt. developed skin rash (typical rash of herpes zoster) on the lt. side of her neck in a dermatomal distribution for 5 days prior to her presentation to the clinic on 04/24/13. Just started her on Valcyclovir 1gx2x7 days.
Age: 0.37
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Chest X-ray normal, Pyrexia
Clinical narrative: Had fever of 101 degrees 4-23-12 in the evening. Gave TYLENOL. Fever 104 on 4-24-12 at 0430. Took to ER. No cough. No foul urine. No rash. No rhinorrhea. No vomiting/diarrhea. CXR = no obvious infiltrate.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Oedema peripheral
Clinical narrative: 4/24/2013 High school nurse called to report that yesterday patient had (R) arm swelling, redness and hard 4cm area. Mom took child to get checked at Doctor's office. Not sure of outcome.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Tenderness
Clinical narrative: 4/23/13 Patient called saying near inj site her arm is tender, also has rash on arm and back. Rph advised to take BENADRYL (OTC). 4/24/13 A follow-up call made. Patient doing much better. Rash resolved. No fever. MD informed - no action.
Age: 25.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Patient present cellulitis in left arm was PNEUMOVAX vaccine was administered.
Age: 39.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Convulsion, Depressed level of consciousness, Feeling abnormal, Loss of consciousness
Clinical narrative: Pt received vaccines, stated she felt weird, then passed out in chair. She remained semi-conscious and convulsing for 30 seconds-1 minute, she then woke up on her own and recovered. EMS came and cleared pt.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt. developed swelling/redness at site of injection.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Pt. developed 3 inch red swollen circle at administration site. Extremely itchy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: Received vaccine at about 3 pm, 6 hours later began having redness, swelling and pain at the site of the injection as well as episodes of urticaria (hives) that would come and go. Saw the patient in clinic 4 days later and still was having symptoms. Had induration approximately 1.5 cm at injection site and 2 rings of erythema and swelling 8 cm diameter and 12 cm diameter around injection site. No hives seen at time of the appointment, but reported there earlier that day.
Sex: M
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. In the 1980s and in the 1990s the patient was vaccinated with 2 doses of hepatitis b vaccine (recombinant) (names of vaccines were unknown) (lot# and route not reported), respectively. Nurse reported that a patient did not respond to the 2 series of hepatitis B vaccinations (names of vaccines are unknown). Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients. On an unknown date, the patients were vaccinated with doses of RECOMBIVAX HB (Lot # not reported) that were exposed to unsupported temperatures. No adverse effect was reported. This is one of several reports received from the same source. 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 registered nurse refers to an unspecified number of patients. On an unknown date, the patients were vaccinated with doses of GARDASIL (Lot # not reported) that were exposed to unsupported temperatures. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: TD
Symptoms: Erythema multiforme, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Fever, Erythema Multiform and injection site pain, erythema, and mild fever 102.7 F. ACETAMINOPHEN 325-600 MG QID.
Age: 1.1
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 13 month old patient (unknown gender). Who on approximately 27-MAR-2013 "about three weeks ago" was inadvertently vaccinated with PNEUMOVAX 23 injection 25/0.5 Y, 5 ml, intramuscular (lot# reported as H010917 exp date: 17-FEB-2014). No adverse event was reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 21 year old female patient with ulcerative colitis. The reporter stated that when patient was 4 years of age (approximately in 2009) was vaccinated with VARIVAX (merck) (lot # and exp date unspecified) injection (dose, route and anatomical location unspecified). The patient was vaccinated with second dose of VARIVAX (merck) (lot # and exp date unspecified) when she was 18 years of age (approximately in 1995) (dose, route and anatomical location unspecified). Healthcare worker stated that antibody titers were drawn on 16-APR-2013 and result was that patient failed to seroconvert. Patient has ulcerative colitis and caller questions if that could have been why patient did not seroconvert to the VARIVAX (merck) vaccine. Patient sought medical attention. Additional information is not expected.
Age: 50.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a male consumer over his 50 years old reporting on himself. In 2012, "over 5 months ago", the consumer was vaccinated with a dose of GARDASIL (route, dose and Lot # not reported0. No adverse event was reported. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, concentration, route and lot number not specified) (reported as "patient was a candidate"). On an unknown date (reported as 6 months after receiving ZOSTAVAX) the patient developed a mild case of shingles. The outcome of developed a mild case of shingles was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site pain, Pyrexia
Clinical narrative: This spontaneous report was received from agency and was assigned manufacturer report number US13-004789 for CIMZIA regarding a 45 year old female patient. On 10-APR-2013, the patient was vaccinated with PNEUMOVAX23 (dose, duration and indication not reported). No other suspect therapies were reported. Concomitant therapies included CIMZIA. On the evening of 10-APR-2013, the patient experienced pain at the injection site of the vaccine, fever and fatigue. The treatment was an "8 hours TYLENOL". No laboratories were reported. On 11-APR-2013, the patient was improving. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to an unspecified number of patients. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (Lot # not reported). The pharmacist reported that on unknown dates, the patients might have experienced bleeding after administration of ZOSTAVAX. At the time of the report, the patients' outcome was unknown. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia, Neck pain
Clinical narrative: Muscle pain, pain from neck to elbow. Ibuprofen.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Abnormal behaviour, Activities of daily living impaired, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: It got administered at 11:30 and signs of side effects and allergic reaction, began at 1:30. Signs were, fast heart beat, difficult breathing, wheezing, sweating, hives, paleness, weakness, dizziness and sharp numbness pain in arm.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Hypersensitivity, Injected limb mobility decreased, Injection site erythema, Injection site pain, Joint range of motion decreased
Clinical narrative: It got administered at 11:30 and signs of side effects and allergic reaction, began at 1:30. Signs were, fast heart beat, difficult breathing, wheezing, sweating, hives, paleness, weakness, dizziness and sharp numbness pain in arm.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Joint swelling, Myositis, Pain, Pain in extremity, Pyrexia
Clinical narrative: It got administered at 11:30 and signs of side effects and allergic reaction, began at 1:30. Signs were, fast heart beat, difficult breathing, wheezing, sweating, hives, paleness, weakness, dizziness and sharp numbness pain in arm.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Tremor
Clinical narrative: It got administered at 11:30 and signs of side effects and allergic reaction, began at 1:30. Signs were, fast heart beat, difficult breathing, wheezing, sweating, hives, paleness, weakness, dizziness and sharp numbness pain in arm.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Dizziness, Dyspnoea, Heart rate increased, Hyperhidrosis
Clinical narrative: It got administered at 11:30 and signs of side effects and allergic reaction, began at 1:30. Signs were, fast heart beat, difficult breathing, wheezing, sweating, hives, paleness, weakness, dizziness and sharp numbness pain in arm.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Hypersensitivity, Hypoaesthesia, Pain in extremity, Pallor, Ultrasound scan
Clinical narrative: It got administered at 11:30 and signs of side effects and allergic reaction, began at 1:30. Signs were, fast heart beat, difficult breathing, wheezing, sweating, hives, paleness, weakness, dizziness and sharp numbness pain in arm.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Urticaria, Wheezing, X-ray
Clinical narrative: It got administered at 11:30 and signs of side effects and allergic reaction, began at 1:30. Signs were, fast heart beat, difficult breathing, wheezing, sweating, hives, paleness, weakness, dizziness and sharp numbness pain in arm.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from an other company refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# unspecified) and had an unspecified adverse reaction on an unknown date. The outcome of adverse reaction was unknown. The patient had presented a claim to the pharmacy. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from an other company refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# unspecified) and had an unspecified adverse reaction on an unknown date. The outcome of adverse reaction was unknown. The patient had presented a claim to the pharmacy. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Full blood count, Laboratory test, Malaise, Nausea
Clinical narrative: Patient report (today on 4/25/13) nausea, vomiting, arthralgia and malaise since the first rabies vaccine on 03/25/2013.  She report that it is getting better.
Age: 12.0
Sex: F
Vaccine: RAB
Symptoms: Urine analysis, Vomiting
Clinical narrative: Patient report (today on 4/25/13) nausea, vomiting, arthralgia and malaise since the first rabies vaccine on 03/25/2013.  She report that it is getting better.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Food poisoning, Heat rash, Rash, Skin papilloma
Clinical narrative: This spontaneous report as received from a 67 year old female patient with diabetes type 2, niacin allergy, oro allergy, erythromycin allergy, steroids allergy and beta blockers allergy. In February 2013 the patient was vaccinated with a dose of ZOSTAVAX (dose and lot # unknown), 1 time vaccine, subcutaneous in the left arm. Concomitant therapies included JANUVIA, "DIAVION", high blood pressure medication, CRESTOR and vitamins (unspecified). On 15-APR-2013 the patient had gotten a rash around her neck that had "prickly heat". She also stated that since getting the ZOSTAVAX vaccine, she had a wart that had increased in size under her right armpit. The hospitalization listed (hospitalization date unknown) was because she had food poisoning, per the patient. The patient did not receive any treatment or seek any medical attention. The outcome of the events was unknown. Relationship between the events and ZOSTAVAX were unknown. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Crohn's disease, Dehydration, Diarrhoea, Fatigue
Clinical narrative: Exchange student, 3-20-13 - diarrhea, cramping, vomiting - on 3/23/13 he was admitted to hospital with dehydration - still having N, V, and D. Discharged 3/25 - p.m no more vomiting, 3/26 started cramping, diarrhea and V again. Admitted to hospital on 3/29/13 - 4/6/13. Had PIC line in till 4/18/13. 4/22/13 - back to school - finally. Still weak and tired.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Muscle spasms, Nausea, Vomiting
Clinical narrative: Exchange student, 3-20-13 - diarrhea, cramping, vomiting - on 3/23/13 he was admitted to hospital with dehydration - still having N, V, and D. Discharged 3/25 - p.m no more vomiting, 3/26 started cramping, diarrhea and V again. Admitted to hospital on 3/29/13 - 4/6/13. Had PIC line in till 4/18/13. 4/22/13 - back to school - finally. Still weak and tired.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Incomplete course of vaccination
Clinical narrative: This spontaneous report was received from a consumer concerning her 18 year old son. Approximately on an unknown date in October 2011 (reported as October or November 2011), the patient was vaccinated with the first dose of 0.5 milliliter (ml) (reported as standard dose) of GARDASIL (lot number and expiry date unspecified), intramuscularly. Approximately on an unknown date in January 2012, the patient was vaccinated with the second dose of 0.5 ml (reported as standard dose) of GARDASIL (lot number and expiry date unspecified), intramuscularly. The patient did not receive his third dose of GARDASIL. No concomitant medications were reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a consumer refers to a 56 year old female patient with allergic reaction and rheumatoid arthritis (ra). The patient's medical history included peripheral neuropathy. History drug included methotrexate, leflunomide, sulfathalidine and doxycycline. On 12-APR-2013 the patient was vaccinated with ZOSTAVAX, injection, 19400 PFU for Prevent shingles. Concomitant therapies included vitamin d and thyroid pills. On approximately 13-APR-2013 (one day after receiving the vaccination), the patient experienced injection site reaction. The patient did not seek medical attention. No treatment was given for event. On an unknown date the patient was recovered from the event (on therapy). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On an unknown date, approximately one third of the patients who were vaccinated with a dose of ZOSTAVAX (Lot number, expiry date and dose were not reported), subcutaneously in the arm (reported as deltoid) returned to the pharmacy complaining of redness swelling heat and pain at the injection site. The patients arm would often swell to a size of an orange. The patients sought medical attention, visited the pharmacy. The patients were advised to treat with ice packs, over the counter non-steroidal anti-inflammatories, the symptoms typically resolved with 2 weeks. On an unknown date (reported as with 2 weeks), the events of redness swelling heat and pain at the injection site was recovered/resolved. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a pediatric patient of unknown age and gender. On 21-APR-2013, the patient was inadvertently administered with a dose of VARIVAX (Merck) (Lot number was reported as H018526, expiry date was 09-OCT-2014), 0.5 milliliter (ml), subcutaneously and a dose of PROQUAD (Merck) (Lot number was reported as H021362, expiry date was 29-MAY-2014) 0.5 ml subcutaneously in the same vaccination session. No adverse effects reported. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic, Scab
Clinical narrative: This spontaneous report as received from a physician refers to a 39 year old female patient. There was no pertinent medical history or drug reactions or allergies. On 08-APR-2013 the patient was vaccinated with (oka/merck) VARIVAX dose 1, 0.5 ml, subcutaneous prophylaxis against varicella. Concomitant therapies included SINGULAIR and an unspecified thyroid supplement. On 14-MAR-2013 the patient experienced rash that was itchy with little bumps and some scabbing over. Patient was treated with BENADRYL and topical cortisone cream. The outcome of rash that was very itchy with little bumps and some scabbing over, was reported as recovering. The relatedness for the adverse event was not reported for SINGULAIR. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Endotracheal intubation, Pyrexia, Swelling, Swelling face, Wheezing
Clinical narrative: This spontaneous report as received from a physician refers to a 2 year old female patient with no pertinent medical history, no drug reactions and no known allergies. Physician stated she is a healthy 2 year old. On 16-APR-2013 the patient was vaccinated with VAQTA injection (lot # and exp date unspecified) (dose, route and anatomical location unspecified). Other suspect therapies included PREVENAR (dose, route, anatomical location and indication unspecified). There were not concomitant medications. The physician reported that on 17-APR-2013 received a call to her office stating that patient had a fever of 101. The patient was then brought into the physician's office on 19-APR-2013 and presented with facial swelling and wheezing. The patient was admitted to hospital at an unspecified location on 19-APR-2013. Physician stated that in April 2013 the patient's whole body started swelling and the patient "coded" while in the hospital. The patient required intubation at that time. At the time of the report the patient's outcome was reported as not recovered. Facial swelling, body swelling, patient "coded", wheezing and fever of 101 were considered to be disabling, medically significant and life threatening by the physician. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Injection site reaction.
Age: 19.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Patient received pneumonia vaccine. Local reaction, redness and swelling in a semi circular shape, anterior of arm toward armpit.
Age: 39.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site discomfort, Injection site erythema
Clinical narrative: Upper left arm (injection site) patient expereinced discomfort, worsening erythema, cellulitis possibly secondary to vaccine.  Treatment given included: vancomycin 1gm and ciprofloxacin 500mg every 12hrs X 3day.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema
Clinical narrative: Erthyma and pain on elbow.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: Patient had reaction and received cold compress and Benadryl.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site atrophy, Injection site discomfort, Injection site reaction, Nuclear magnetic resonance imaging abnormal, Skin disorder
Clinical narrative: Pt. developed a dimpling/indent of the skin where the intradermal flu vaccine was administered. There was some discomfort noted. The indent worsened over the next few months, but has since stopped. Indent remains to left upper arm.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Discomfort, Pain in extremity
Clinical narrative: Upon administration of my TDAP shot, my arm was extremely sore (perhaps consistent with a normal response). In the days immediately following the vaccination, my arm remained incredibly sore, making it difficult for me to perform normal activities (such as dressing). It is now 3 weeks after the vaccine was administered and my arm still has a constant dull ache that grows progressively worse if I am at my desk working. I have been taking OTC anti-inflammatory medication which helps only minimally. I returned to the clinic yesterday to report the ongoing discomfort and was told there is nothing that can be done at this point.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left leg is swollen, red and warm.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Oedema peripheral, Pain in extremity, Rash, Skin warm
Clinical narrative: Swollen and sore arm.  Rash over area of approximately 8 by 9 inches.  Very warm to touch.
Age: 1.53
Sex: M
Vaccine: HEPA, MMR
Symptoms: Pyrexia
Clinical narrative: FEVER 104 DEGREES.
Age: 51.0
Sex: M
Vaccine: SMALL
Symptoms: Headache, Hyperhidrosis, Nausea, Pyrexia, Vomiting
Clinical narrative: Headache; Fever; Nausea; Vomiting and Sweats.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Local swelling, Skin warm, Vertigo
Clinical narrative: Raised red circular area (hot to touch) which grew larger each day through 4th day following vaccine. Frontal and temple area dull headache. Slight vertigo.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Throat irritation, Urticaria
Clinical narrative: Itching, hives on neck, ?itchy throat. Took PO Benadryl 6-7 hours later, slept, and symptoms were gone the next morning. Pt reported this on 4/25/13 at 0900.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Chest X-ray, Chills, Dyspnoea, Electrocardiogram normal, Rash pustular
Clinical narrative: SMALL WHITE PUSTULES STOMACH, BACK, THIGHS, MOUTH, INTERMITTENT SHORTNESS OF BREATH, CHILLS, AND SWEATS.
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site infection, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, and warmth at and around injection site. Was seen in office 4/25/13 and treated with Cephalexin for infection of injection site.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Body temperature increased, Fatigue, Injection site pain, Pain
Clinical narrative: Client states when he went to bed his arm ached where injection was given. When client woke in AM he felt tired, general body aches and temperature of 100 degrees F.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Pain, Swelling
Clinical narrative: COMPLAINED OF SWELLING AND REDNESS STARTING EVENING OF SHOT AND PEAKING 4-16 AT AS A 2 INCH CIRCLE AND RAISED ABOUT HALF AN INCH AND COMPLAINED VERY ACHY ALL OVER AND TIRED. LASTED UNTIL 4-21.
Age: 19.0
Sex: F
Vaccine: ADEN_4_7, DTAP, FLU3, HEP, MNQ
Symptoms: Dysphagia, Dyspnoea, Hypopnoea, Respiratory rate increased, Wheezing
Clinical narrative: Labored, rapid shallow breathing. Lungs wheezing, skin warm, difficulty breathing and difficulty swallowing. 1 dose of Benadryl and 2 doses of epinephrine.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Pt deveoloped red, itchy rash at injection site, hot to touch.  Lasted 2-3 weeks.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy, Odynophagia
Clinical narrative: Right side lymphadenopathy on neck with redness and swelling at injection site. Painful swallowing.
Age: 21.0
Sex: M
Vaccine: ADEN_4_7, FLU3, HEPA, MNQ, TDAP
Symptoms: Dysphagia, Flushing, Pruritus, Rash, Skin warm
Clinical narrative: Wheezing, skin hot, flushed, itching, rash, difficulty swallowing. 1 dose of Benadryl and 1 dose of epinephrine.
Age: 21.0
Sex: M
Vaccine: ADEN_4_7, FLU3, HEPA, MNQ, TDAP
Symptoms: Wheezing
Clinical narrative: Wheezing, skin hot, flushed, itching, rash, difficulty swallowing. 1 dose of Benadryl and 1 dose of epinephrine.
Age: 1.91
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Pyrexia, Weight bearing difficulty
Clinical narrative: Complaining of leg hurting, wouldn't put pressure on leg, fever began reached 103.7 degrees by 6:30pm.  Gave ibuprofen.  Fever continued to stay high for a few more hours and were advised to give Tylenol as well.  Day 1, Day 2 and Day 3 fever has continued to spike to 104.7 and possibly higher if ibuprofen was not given every 6 hours.  Day 1 and Day 2 Tylenol had to be given as well to keep temp low enough during the 6 hours between ibuprofen.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Balance disorder, Dizziness, Nausea
Clinical narrative: Dizziness, nausea, weak, wobbly.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Condition aggravated, Erythema, Full blood count, Local reaction
Clinical narrative: Skin reaction in the local area, redness, peeling of skin. Asthma flare up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Metabolic function test, Skin exfoliation, Skin reaction
Clinical narrative: Skin reaction in the local area, redness, peeling of skin. Asthma flare up.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Syncope episode while walking out of building. Tx- vitals, ice pack, juice and sitting while being monitored.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Angiogram, Back pain, Balance disorder, Bladder dysfunction
Clinical narrative: (2:00 AM) On about 2/9/10, I woke up paralyzed from the waist down. My legs were ice cold to the touch, and a strange sensation was ascending my body. I called out for help but no one could hear me. In 3-4 hours, my legs began to warm and a pins and needles sensation began. Tingling began and continues to date. My legs regained movement by mid morning. A friend took me to my doctor and a nurse practitioner did not consider my explanation of what happened to be serious. Over succeeding weeks I lost bladder and bowel function. My left eye experienced vision loss, blurry sight, double images, and chronic infection. My speech changed. First I experienced hoarseness, then slurring, and loss of volume. From the morning of onset I have had extreme pain in my lower back, radiating down both legs. My legs and arms became weak and continue to be weak. I fell easily and often. I have developed pressure headaches, I started walking with a strange gait and could not climb stairs without assistance. I had heightened senses and extreme pain when touched. I experienced tremors in my arms and legs. It is extremely painful to sit. I developed balance problems. I could not get out of bed without help. It is challenging to walk. I can no longer do many things I once did easily (i.e. dressing, cooking my meals). I have cognitive problems. I cannot express myself at times and I have difficulty with short term memory. I have difficulty using my hands. I once had beautiful penmanship.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Blindness, Cognitive disorder, Computerised tomogram, Diplopia, Dysarthria
Clinical narrative: (2:00 AM) On about 2/9/10, I woke up paralyzed from the waist down. My legs were ice cold to the touch, and a strange sensation was ascending my body. I called out for help but no one could hear me. In 3-4 hours, my legs began to warm and a pins and needles sensation began. Tingling began and continues to date. My legs regained movement by mid morning. A friend took me to my doctor and a nurse practitioner did not consider my explanation of what happened to be serious. Over succeeding weeks I lost bladder and bowel function. My left eye experienced vision loss, blurry sight, double images, and chronic infection. My speech changed. First I experienced hoarseness, then slurring, and loss of volume. From the morning of onset I have had extreme pain in my lower back, radiating down both legs. My legs and arms became weak and continue to be weak. I fell easily and often. I have developed pressure headaches, I started walking with a strange gait and could not climb stairs without assistance. I had heightened senses and extreme pain when touched. I experienced tremors in my arms and legs. It is extremely painful to sit. I developed balance problems. I could not get out of bed without help. It is challenging to walk. I can no longer do many things I once did easily (i.e. dressing, cooking my meals). I have cognitive problems. I cannot express myself at times and I have difficulty with short term memory. I have difficulty using my hands. I once had beautiful penmanship.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Expressive language disorder, Eye infection, Fall, Functional gastrointestinal disorder
Clinical narrative: (2:00 AM) On about 2/9/10, I woke up paralyzed from the waist down. My legs were ice cold to the touch, and a strange sensation was ascending my body. I called out for help but no one could hear me. In 3-4 hours, my legs began to warm and a pins and needles sensation began. Tingling began and continues to date. My legs regained movement by mid morning. A friend took me to my doctor and a nurse practitioner did not consider my explanation of what happened to be serious. Over succeeding weeks I lost bladder and bowel function. My left eye experienced vision loss, blurry sight, double images, and chronic infection. My speech changed. First I experienced hoarseness, then slurring, and loss of volume. From the morning of onset I have had extreme pain in my lower back, radiating down both legs. My legs and arms became weak and continue to be weak. I fell easily and often. I have developed pressure headaches, I started walking with a strange gait and could not climb stairs without assistance. I had heightened senses and extreme pain when touched. I experienced tremors in my arms and legs. It is extremely painful to sit. I developed balance problems. I could not get out of bed without help. It is challenging to walk. I can no longer do many things I once did easily (i.e. dressing, cooking my meals). I have cognitive problems. I cannot express myself at times and I have difficulty with short term memory. I have difficulty using my hands. I once had beautiful penmanship.