chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: YF, YF
Symptoms: Asthenia, Chest pain, Hypoaesthesia, Musculoskeletal pain, Myalgia
Clinical narrative: Initial report was received on 12 July 2013 from a health care professional and a consumer who is also the patient. A 52 year-old male patient with no reported past medical history had received on 09 May 2013, an intramuscular injection of YF VAX, lot number UH598AA (site not reported) and within 24 hours on 10 May 2013 experienced index finger numbness, intermittent pain of the arm, chest and scapula to the neck. The patient also has tingling and numbness down arm into the fingers, general weakness and muscle aches. According to the patient, the index finger numbness had resolved and his strength had returned. The patient reported that all symptoms had resolved until he resumed his usual workout routine and the next day the symptoms returned but not as severe. The patient was evaluated in the ER (emergency room) and was referred to a neurologist, appointment pending. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 52.0
Sex: M
Vaccine: YF, YF
Symptoms: Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Initial report was received on 12 July 2013 from a health care professional and a consumer who is also the patient. A 52 year-old male patient with no reported past medical history had received on 09 May 2013, an intramuscular injection of YF VAX, lot number UH598AA (site not reported) and within 24 hours on 10 May 2013 experienced index finger numbness, intermittent pain of the arm, chest and scapula to the neck. The patient also has tingling and numbness down arm into the fingers, general weakness and muscle aches. According to the patient, the index finger numbness had resolved and his strength had returned. The patient reported that all symptoms had resolved until he resumed his usual workout routine and the next day the symptoms returned but not as severe. The patient was evaluated in the ER (emergency room) and was referred to a neurologist, appointment pending. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 22.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Corneal reflex decreased, Headache, Hypoaesthesia, Vision blurred, Vomiting
Clinical narrative: 7/2/13 pt had numb tongue, loss of taste. 7/3/13 continued symptoms, plus numbness and droopiness in lower part of face.
Age: 22.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Ageusia, Hypoaesthesia, Hypoaesthesia oral, VIIth nerve paralysis
Clinical narrative: 7/2/13 pt had numb tongue, loss of taste. 7/3/13 continued symptoms, plus numbness and droopiness in lower part of face.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Pt developed redness, and bruising at site of injection.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Pt developed redness, and bruising at site of injection.
Age: 41.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Local swelling, Pain, Pyrexia, Skin warm
Clinical narrative: Low grade fever, body aches, (Lt) arm hot to touch, swollen and red lines in area where vaccine was given.
Age: 41.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Low grade fever, body aches, (Lt) arm hot to touch, swollen and red lines in area where vaccine was given.
Age: 41.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: Low grade fever, body aches, (Lt) arm hot to touch, swollen and red lines in area where vaccine was given.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (registered radiologist assistant) refers to a patient of unknown age and gender. On an unknown date in September 2012, the patient was vaccinated with dose 1 GARDASIL (lot #, expiry not reported). On 18-JUL-2013, the patient was in the office to receive the second dose of GARDASIL (lot # H009746, expiry 11-JAN-2015). No adverse effects reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 years old female patient with high cholesterol. The patient had no drug reactions/allergies. On 14-JUN-2013 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # H018510, expiration date: 15-JAN-2014), subcutaneous injection at unspecified location. Concomitant therapy included with pravastatin. Within 24 hours of receiving date (14-JUN-2013), the patient developed an injection site reaction of redness, swelling and bruising after the vaccination. The patient had sought medical attention via contacted pharmacy. Non lab diagnostics studies performed. No treatment was given for the events. Currently the patient had no more redness and swelling but she had a bruise at the injection site. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Laceration, Suture insertion, Syncope
Clinical narrative: Syncope LAC chin - sutures.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Upper extremity mass
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 16 year old female patient. On an unknown date, the patient was vaccinated with a second dose of GARDASIL,(lot number, expiry date was not reported and route was intramuscular). Concomitant medications were not reported. On an unknown date, the patient noticed a painless pea size lump in her arm after the patient received the second dose. The outcome of painless pea size lump in her arm was unknown. The patient sought medical attention. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pneumonia
Clinical narrative: This spontaneous report as received from a 50 years old male patient who is also a physician with hypothyroidism, multiple vitamin deficiencies due to a bowl resection and penicillin allergy. The patient's medical history included bowel resection and peritonitis. In 2009 ("About 4 years ago"), the patient "had two outbreaks of shingles" and on an unspecified date "two months after the second outbreak" he "was vaccinated with ZOSTAVAX, lot#, dose and route unspecified. Concomitant therapies included vitamin d, folic acid, vitamin B 12, vitamin K and vitamin e. The patient reported that on an unspecified date "less than 12 months after" receiving ZOSTAVAX, he "had a shingles outbreak". The patient reported that he "has had a shingles outbreak about every 6 to 7 months". The patient reported that "each outbreak of shingles was multi-dermatomal and varies in severity. The primary dermatomes affected are C7, C8, T2 and T8". The physician also reported that "each time a shingles outbreak occurred", he also "had pneumonia at the same time". The patient went to physician's office for medical attention and VALTREX was given for treatment. No lab diagnostics studies performed. The patient reported that he was currently "recovering" from a shingles outbreak that began on an unspecified date. VZVIP packet faxed. The reporter considered pneumonia and shingles as significant disability or incapacity. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 42 year old male patient. On 24-JUN-2013 the patient was vaccinated with the second dose of RECOMBIVX HB, two 0.5 ml pediatric doses were administered to equal one adult dose of 1 ml, in the left arm (route and lot # not reported). The expiry date was reported as 17-MAY-2013. No adverse events reported at that time. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 19 year old male patient. The nurse reported that on 01-AUG-2012 the patient received the first dose of RECOMBIVAX HB 5/0.5 (lot number, dose and indication were not provided) for prophylaxis (when he was 18 years old), and on 11-JUL-2013, was in the office to receive his second dose of RECOMBIVAX HB (lot number, dose and indication were not provided) for prophylaxis. Concomitant medications were not reported. No adverse symptoms reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a mother refers to her 4 year old daughter. On 12-JUL-2013 the patient was vaccinated with M-M-R II (lot # H017437, expire date 20-SEP-2014). Other concomitant therapies included DAPTACEL. Concomitant therapies included NASONEX, VARIVAX, and IPOL. On 13-JUL-2013 the patient experienced a "2.5 to 3 inch, almost circular, swollen, red, very hard, hot and itchy area round the injection site of M-M-R II), on 07/13/2013. Patient also received VARIVAX (Merck),  DAPTACEL and IPOL. DAPTACEL was administered in the same arm as the M-M-R II and VARIVAX and IPOL were administered in the other arm; however, there were no injection site reactions to the other vaccines. The patient sought medial attention via called physician office. Mother contacted physician's office 07/13/2013, 07/14/2013 and 07/15/2013. Treatment was given by ice pack locally, ibuprofen, TYLENOL. At the time of the report, the event outcome was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash generalised
Clinical narrative: This spontaneous report refers to herself: a 64 year old female patient. There was no pertinent medical history, drug reactions/allergies included codeine. On an unknown date in April 2012 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous for prevention of shingles. There was no concomitant medication. On an unknown date in October 2012 the patient developed "a mild case of shingles". The rash was mostly limited to the right side of her face. Then on 23-JUN-2013 she broke out in a new shingles rash which developed on both sides of her face and neck as well as both arms and legs. The patient had not recovered from this rash. She stated it was a much more severe case and very painful. There were no lab diagnostics studies performed. The patient sought unspecified medical attention. Patient's doctor prescribed valacyclovir for the symptoms.  Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 03-JUL-2013 the patient was vaccinated with VARIVAX (Merck) (h021386, expire date 30-NOV-2014). Concomitant therapies included terazosin hydrochloride. In July 2013 (exact date of development of the chicken pox was unspecified) the patient developed chicken pox with-in 7 days of receiving the VARIVAX (Merck). The event outcome was unknown. This is one of several reports from the same reporter concerning the same adverse event. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to her son(age not reported). On 07-JUL-2011 the patient was vaccinated with GARDASIL for vaccination. It was reported that the patient might have received two doses of GARDASIL that were expired (lot# and expiration dates were unspecified, dates expired GARDASIL was administered was unspecified). No adverse event reported. Additional information is not expected.
Age: 75.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a 75 year old patient of unknown gender. On 18-JUL-2013, the patient was accidentally vaccinated with 0.5 milliliter (ml) of VARIVAX (Merck) (lot number and expiry date unspecified), subcutaneously instead of ZOSTAVAX. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 50 year old female patient. No known pertinent medical history or drug reactions/allergies. On 27-JUN-2013, the patient was vaccinated with ZOSTAVAX (lot # J001008., exp. date: 24-APR-2014), 0.65 ml, subcutaneous. Concomitant therapies included nortriptylene and losartan potassium (manufacturer unknown). On an unknown date, the patient developed an injection site reaction. The immediate area was red and raised and the size of a quarter. Surrounding the area was an area 3 inches in diameter that was swollen and pink. The injection site area was sore to the touch. The patient sought medical attention by pharmacy visit. The pharmacist told the patient to treat the area with ice and to take ibuprofen (manufacturer unknown). No laboratory tests were performed. On 01-JUL-2013, the patient said she was feeling better. The patient outcome was reported as recovering. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 46 years old male patient of unknown age. On 03-JUL-2013 the patient was vaccinated with VARIVAX (Merck) (H021386, expire date 30-NOV-2014). Concomitant therapies included terazosin hydrochloride (TERAZOSIN HYDROCHLORIDE). In July 2013 (exact date of development of the chicken pox was unspecified) the patient developed chicken pox with-in 7 days after receiving VARIVAX (Merck). The event outcome was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from an approximately 64 year old female patient (also reported gender as male) regarding herself. Current condition of the patient included high cholesterol, aspirin allergy, sulfa allergy, BETADINE allergy, food allergy and pollen allergy. On 10-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified) in the left arm. Concomitant therapies included CRESTOR (reported as 5 CRESTOR), ZYRTEC, calcium (unspecified), vitamins (unspecified) (reported as multivitamin), vitamin D (unspecified) and Omeprazole, 20 milligrams). On 11-JUL-2013 (reported as the next day after injection was given), the patient experienced headache. On 17-JUL-2013 (reported as this morning), the patient woke up and found a red spot at the site of the injection that was about 1 1/4 by 1 1/2, it was a raised red bump at the injection site that had grown in size over the course of the morning. The patient did not seek any medical attention. Outcome of the events was unknown. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age (gender was unknown). On 11-JUL-2013 the patient was vaccinated with an expired dose of VARIVAX (Merck) (lot # 671126/1062AA, exp. date: 05-JUL-2013). No symptoms reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 24.0
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Nausea, Vomiting
Clinical narrative: Nausea/vomiting after 1st dose. Discontinued.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. On 16-JUL-2013, the patient was vaccinated with an expired dose of 0.5 milliliter (ml) of M-M-R II (lot number and expiry date reported as 671320/1121AA and 12-JUL-2013 respectively), subcutaneously. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Eye swelling, Injection site urticaria, Local swelling, Oedema peripheral, Swelling face
Clinical narrative: 7/22/13 - Dad called states 7/18/13 patient presented with hive at site which now is swelling on (L) face and (L) eye, (R) hand and forearm, (L) neck and mid neck. BENADRYL being administered by parents.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Dysphonia, Pain in extremity
Clinical narrative: Hoarseness for several days and arm ached like a toothache for several days/weeks. Patient was advised by physician to use ibuprofen as directed and to not finish vaccine series.
Age: 31.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Rash, Vaccinia virus infection
Clinical narrative: Diffuse rash to limbs and trunk A & P. Suspect vaccinia.
Age: 1.37
Sex: M
Vaccine: FLUX, MMR
Symptoms: Agitation, Blood test, Dehydration, Fatigue, Hyperglycaemia
Clinical narrative: On 09/23/2009 our son had a well-check with his pediatrician, was diagnosed in very good health and given an MMR vaccine.  It was recommended at that time he receive a flu shot too, but that they were currently out of stock.  On 09/25/2009 he returned and was given an Influenza PF vaccine.  For several days following the vaccinations our son had a persistent low grade fever.  The following week he appeared to be in good health.  Two weeks after vaccination he began to develop extreme thirst, frequent urination, dehydration, fatigue, weight loss and became very agitated. On 10/14/2009 we took him to his pediatrician who advised that his symptoms were most likely due to an onset of type 1 diabetes.  He sent us immediately to the local hospital lab for blood work to confirm.  Shortly after we were notified that our son was experiencing severe hyperglycemia and ketoacidosis and were advised to immediately take him to the hospital where he was admitted to the pediatric ICU.
Age: 1.37
Sex: M
Vaccine: FLUX, MMR
Symptoms: Intensive care, Ketoacidosis, Polyuria, Pyrexia, Thirst
Clinical narrative: On 09/23/2009 our son had a well-check with his pediatrician, was diagnosed in very good health and given an MMR vaccine.  It was recommended at that time he receive a flu shot too, but that they were currently out of stock.  On 09/25/2009 he returned and was given an Influenza PF vaccine.  For several days following the vaccinations our son had a persistent low grade fever.  The following week he appeared to be in good health.  Two weeks after vaccination he began to develop extreme thirst, frequent urination, dehydration, fatigue, weight loss and became very agitated. On 10/14/2009 we took him to his pediatrician who advised that his symptoms were most likely due to an onset of type 1 diabetes.  He sent us immediately to the local hospital lab for blood work to confirm.  Shortly after we were notified that our son was experiencing severe hyperglycemia and ketoacidosis and were advised to immediately take him to the hospital where he was admitted to the pediatric ICU.
Age: 1.37
Sex: M
Vaccine: FLUX, MMR
Symptoms: Type 1 diabetes mellitus, Weight decreased
Clinical narrative: On 09/23/2009 our son had a well-check with his pediatrician, was diagnosed in very good health and given an MMR vaccine.  It was recommended at that time he receive a flu shot too, but that they were currently out of stock.  On 09/25/2009 he returned and was given an Influenza PF vaccine.  For several days following the vaccinations our son had a persistent low grade fever.  The following week he appeared to be in good health.  Two weeks after vaccination he began to develop extreme thirst, frequent urination, dehydration, fatigue, weight loss and became very agitated. On 10/14/2009 we took him to his pediatrician who advised that his symptoms were most likely due to an onset of type 1 diabetes.  He sent us immediately to the local hospital lab for blood work to confirm.  Shortly after we were notified that our son was experiencing severe hyperglycemia and ketoacidosis and were advised to immediately take him to the hospital where he was admitted to the pediatric ICU.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Migraine, Nuclear magnetic resonance imaging
Clinical narrative: Patient reported in conversation 2 years after his vaccination that he day he received his Zostavax, he thought he was having a stroke (had all symptoms). He called a doctor and the Dr. told him to come in for an MRI. Not having a stroke but said it was an ocular migraine and they could only trace it back to the vaccine he had earlier that day. Patient diagnosed with ocular migraine after vaccine administered.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin irritation
Clinical narrative: (Left arm) arm irritation, large red spot that is itchy on spot and surrounding area. Erythematous. Referred to MD to be seen.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Band neutrophil percentage, Gaze palsy, Lip dry, Lymphocyte percentage, Metabolic function test normal
Clinical narrative: Fever 101.8, puckered lips, eyes crossed and rolled back very stiff, lasted 1 minute, sleepy afterwards, seen at hospital ER and stayed 8 hours. Mom with history of 2 grand mal seizures from computer flickering.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Musculoskeletal stiffness, Neutrophil percentage, Pyrexia, Somnolence, Strabismus
Clinical narrative: Fever 101.8, puckered lips, eyes crossed and rolled back very stiff, lasted 1 minute, sleepy afterwards, seen at hospital ER and stayed 8 hours. Mom with history of 2 grand mal seizures from computer flickering.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Urine analysis normal, White blood cell count increased
Clinical narrative: Fever 101.8, puckered lips, eyes crossed and rolled back very stiff, lasted 1 minute, sleepy afterwards, seen at hospital ER and stayed 8 hours. Mom with history of 2 grand mal seizures from computer flickering.
Sex: F
Vaccine: RAB
Symptoms: Confusional state, Disturbance in attention, Hallucination, auditory, Nausea, Pain
Clinical narrative: Initial report was received on 09 July 2013 from a non health care professional. A female patient (date of birth not reported) with a history of depression, had received on 07 July 2013 IMOVAX (sanofi pasteur lot number and site of administration not reported) and IMOGAM (sanofi pasteur lot number and site of administration not reported) and on the way home from the ER (date not reported) felt nauseous, vomited and became confused on directions home. "Over the weekend" experienced body aches, concentration issues and auditory hallucinations. The patient heard water running and continued to hear brother's voice after hanging up phone. Concomitant medication included CELEXA (antidepressant) and tramadol. Relevant diagnostic test/laboratory data was unknown. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Sex: F
Vaccine: RAB
Symptoms: Vomiting
Clinical narrative: Initial report was received on 09 July 2013 from a non health care professional. A female patient (date of birth not reported) with a history of depression, had received on 07 July 2013 IMOVAX (sanofi pasteur lot number and site of administration not reported) and IMOGAM (sanofi pasteur lot number and site of administration not reported) and on the way home from the ER (date not reported) felt nauseous, vomited and became confused on directions home. "Over the weekend" experienced body aches, concentration issues and auditory hallucinations. The patient heard water running and continued to hear brother's voice after hanging up phone. Concomitant medication included CELEXA (antidepressant) and tramadol. Relevant diagnostic test/laboratory data was unknown. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness on (R) thigh measuring 2.5in x 2.5in. advised cold compress and ibuprofen.
Sex: U
Vaccine: TDAP
Symptoms: Foetal exposure during pregnancy, Talipes
Clinical narrative: Initial report was received from a healthcare professional on 12 July 2013. This case is linked with the mother case number 2012-07526. An infant (age, gender and date of birth not reported) was exposed in utero to ADACEL, lot number U43938A, on 09 August 2012. The patient's birth outcome was not normal with a unilateral clubbed foot. Outcome was not reported. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: Firm warm patch upper R arm near delt. at injection site. No discharge, no fluctuance treatment-cephalexin 250 mg/5 ml, 5 milliliter three times daily x 7 days, 105 milliliters, 7 days, 07/20/2013.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Hyporeflexia, Weight bearing difficulty
Clinical narrative: Initial report was received from a healthcare professional on 12 July 2013. A 25-year-old male patient received an intramuscular injection in the left deltoid of ADACEL (lot number C4366AA) on 27 June 2013. By the afternoon of the same day, the patient's left hand and foot became numb. The symptoms were progressing, as the patient could not bear weight and had decreased reflexes of the left foot. No other symptoms were reported. The patient had no illness at the time of vaccination. There were no relevant diagnostic tests or labs. Any allergies or pre-existing conditions were unknown. The patient's outcome was reported as not recovered. Documents held by sender: None.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Blister rupture, Erythema, Swelling, Tenderness
Clinical narrative: Redness, swelling, tenderness 2 days after vaccine. 3 days after - blisters which broke open into an open wound/burn. Seen for follow up on 7/15/13.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Blister, Rash maculo-papular, Skin lesion, Varicella post vaccine
Clinical narrative: Multiple-Macula Papula lesion. 1-2 vesicula; chicken pox - mild disease. Afebrile. No lesions in mouth (belly, back-all over). Calamine lotion/Benadryl 1/2 tsp Q 4-6 hr.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Full blood count, Gaze palsy, Headache, Hyperhidrosis
Clinical narrative: This spontaneous report as received from another health professional (healthcare worker) refers to a 12 year old female patient. The patient had no relevant medical history and no concomitant medication. On 21-JUN-2013 at 3 pm, the patient was vaccinated with GARDASIL(dose number not reported) lot # J003727,  0.5 ml, intramuscular. The patient was observed for 15 minutes afterward with no adverse effects. The healthcare worker reported that later that night, the patient had fainted at home, was limp, pale, sweaty and her eyes rolled back in her head. The patient was seen in the ER of unspecified hospital at 12:45 am and complained of sore throat and a headache. The patient was treated with sodium chloride 0.9% IV and ibuprofen. The patient reported to the healthcare worker that today (25-JUN-2013) she began menstruating and that it was heavier than normal and she was experiencing severe abdominal pain. The patient was planned to be seen in the office later today. The outcome of patient fainted at home, headache, sore throat, her eyes rolled back in her head, sweaty, pale and was limb was reported as recovering/resolving. The outcome of menstruation heavier than normal and experiencing severe abdominal pain was unknown. Reporter causality assessment was not provided. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Hypotonia, Menorrhagia, Oropharyngeal pain, Pallor, Syncope
Clinical narrative: This spontaneous report as received from another health professional (healthcare worker) refers to a 12 year old female patient. The patient had no relevant medical history and no concomitant medication. On 21-JUN-2013 at 3 pm, the patient was vaccinated with GARDASIL(dose number not reported) lot # J003727,  0.5 ml, intramuscular. The patient was observed for 15 minutes afterward with no adverse effects. The healthcare worker reported that later that night, the patient had fainted at home, was limp, pale, sweaty and her eyes rolled back in her head. The patient was seen in the ER of unspecified hospital at 12:45 am and complained of sore throat and a headache. The patient was treated with sodium chloride 0.9% IV and ibuprofen. The patient reported to the healthcare worker that today (25-JUN-2013) she began menstruating and that it was heavier than normal and she was experiencing severe abdominal pain. The patient was planned to be seen in the office later today. The outcome of patient fainted at home, headache, sore throat, her eyes rolled back in her head, sweaty, pale and was limb was reported as recovering/resolving. The outcome of menstruation heavier than normal and experiencing severe abdominal pain was unknown. Reporter causality assessment was not provided. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Haemorrhage, Immediate post-injection reaction, Mass, Swelling
Clinical narrative: Had a large swelling/knot and some bleeding immediately after injection. Patient took BENADRYL and the swelling resolved later on 10/4/12. Did not seek medical care.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot# and expiration date not reported) subcutaneously. On an unknown date the patient experienced developed shingles after receiving ZOSTAVAX. The outcome of the event was unknown at the time of this report. Treatment information and lab diagnostic studies were unspecified by the reporter. Patient sought medical attention by visiting the doctor. Causality was not reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Severe black and blue at injection site took over 6 wks to go away, red mark at site now pain at injection site and all of left arm, pain in left thumb.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Pt lost consciousness 30 seconds after immunization. Lasted 5 seconds. No treatment needed. Pt's mother stated pt passes out when blood drawn.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.01
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site mass
Clinical narrative: Lump at injection site on (L) thigh.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 19.0
Sex: F
Vaccine: PPV, RAB
Symptoms: Band neutrophil percentage, Blood potassium normal, Blood sodium decreased, Cellulitis, Injection site reaction
Clinical narrative: Felt ill the day after vaccination. 2 days afterwards noted red blotches R arm especially around proximal injection site. Fever to 103.3 documented about 60 hrs after injection, seen in ED, treated with IV hydrating Toradol, Keflex, KCL, cellulitis or cellulitis like picture.
Age: 19.0
Sex: F
Vaccine: PPV, RAB
Symptoms: Lymphocyte morphology abnormal, Lymphocyte percentage decreased, Malaise, Neutrophil percentage increased, Pyrexia
Clinical narrative: Felt ill the day after vaccination. 2 days afterwards noted red blotches R arm especially around proximal injection site. Fever to 103.3 documented about 60 hrs after injection, seen in ED, treated with IV hydrating Toradol, Keflex, KCL, cellulitis or cellulitis like picture.
Age: 19.0
Sex: F
Vaccine: PPV, RAB
Symptoms: Rash macular, White blood cell count increased
Clinical narrative: Felt ill the day after vaccination. 2 days afterwards noted red blotches R arm especially around proximal injection site. Fever to 103.3 documented about 60 hrs after injection, seen in ED, treated with IV hydrating Toradol, Keflex, KCL, cellulitis or cellulitis like picture.
Age: 0.52
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pyrexia, Streptococcus test negative, Urine analysis normal
Clinical narrative: Fevere 102.6.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Oedema
Clinical narrative: 4x4 cm edematous, errytheric area.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle rigidity, Oropharyngeal discomfort, Pallor, Syncope
Clinical narrative: Client had a syncopial episode approx. 15 min. after injection. Arms and legs become rigid. Very pale. Able to respond. Stated throat felt "funny". Benadryl given per standing order. Condition improved. Vital signs stable. Client able to walk out of clinic unassisted.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Received Varivax 7/10/13 - developed 10 "pox" lesions on legs and trunk (bilateral). No systemic symptoms, no fever, no cough - seen in office 7/20/13 to evaluate.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Rash on rt. lower leg. Shin bone area rash is flat-dark red-uneven 4" x 2". No pain or/itching or/heat as I report this.
Age: 41.0
Sex: F
Vaccine: RAB
Symptoms: Tinnitus
Clinical narrative: Pt reported ringing in ears since 7:30 PM on 7-19-13. Rated ringing as a "10" at onset. Ringing today (7-17-13) equals "3". Denies h/o ringing in ears. Referred to PMD since package insert did not list this as an adverse reaction. Pt. saw Dr who does not feel this is related to the Rabivert vaccine. Pt states that Dr said it is a "coincidence". Dr gave pt a Rx for Augmentin, 'steroids" and Zyrtec. PMH: Hypothyroidism. Takes Synthroid and multivitamins. Allergies: Bactrim, Pseudoephedrine. No ENT consult ordered. Pt is receiving pre-exposure rabies vaccinations. To receive last dose 7-30-13. Pt states that PMD said it is ok to receive next dose.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Herpes zoster, Pain, Polymerase chain reaction, Rash, Varicella virus test positive
Clinical narrative: Patient developed shingles, pain started 10 days after vaccine. Rash started 11-12 days after vaccine.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion, Haemoglobin normal, Laboratory test, Urine analysis normal, White blood cell count normal
Clinical narrative: Febrile seizure 3 days after MMR/Varivax
Age: 14.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Blood pressure decreased, Hyperhidrosis, Pallor
Clinical narrative: Shortly after receiving vaccinations, patient became pale and diaphoretic. He was transported to the triage area, placed in a supine position with his legs elevated and was observed until his blood pressure came back up. He was given juice and crackers.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Exposure during pregnancy, Live birth, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 21 years old female patient with no persistent medical history and no drug reactions/allergies. The patient's history of previous pregnancies and live births was not known. The patient was intramuscularly vaccinated with a dose of 0.5 ml GARDASIL (lot # 667165/1167Z) on 10-OCT-2012. There were no concomitant medications. Subsequently, the patient became pregnant with an LMP on 13-AUG-2012 and an EDD of 20-MAY-2013. Initial exposure to GARDASIL was at 8 week(s). The patient was exposed to GARDASIL during trimester 1. The patient had sought medical attention via nurse practitioner visit. The patient performed urine pregnancy test. Additional information has been received from the nurse practitioner. Reporter stated that the patient delivered s healthy baby on 24-MAY-2013, with no complications. Physician stated that both the patient and baby were doing fine. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an other healthcare worker refers to a patient of unknown age and gender. On an unknown date, an unspecified number of patient were vaccinated with an unsupported temperature doses of ROTATEQ (strength, dose, route and lot numbers were not reported). Concomitant medications were not reported. No adverse effects was reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Rotator cuff syndrome
Clinical narrative: July 10, 2013 my doc. said "I have tendinitis/cuff and thickening of acromion, but no way to tell if it's life, or improper vaccination. Received flu" shot 9/2012 into my shoulder top, instead of muscle. Enclosed copy or signature and date at pharmacy. Please notify fellow to stop administering vaccinations this way!  Thank you!
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hypoaesthesia, Throat tightness, Visual impairment
Clinical narrative: 7/16/13 at 12:35 pm patient received HPV vaccine. After a few moments patient c/o feeling dizzy and vision changes. Patient remained alert and oriented breathing exercises initiated. C/o numbness to arms legs and tightness in throat airway maintained. Within few minutes sx improved. Pt taken by parents to her doctor. EMS had been called per parents request but did not transferred patient due to improvement of symptoms. Mom called to tell us patient was fine.
Age: 43.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Headache, Pyrexia
Clinical narrative: Headache, mild abdominal pain, fever.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Blood pressure increased, Condition aggravated, Headache
Clinical narrative: Blood pressure would not come down 195/105. Severe headache.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Atrial fibrillation, Bundle branch block right, Cardiac enzymes normal, Cardiac telemetry normal, Condition aggravated
Clinical narrative: She was set to be discharged on September 18, 2012; however, after having received her Pneumovax vaccine, she began to feel dizzy and subsequently was noted to lose consciousness. She was standing at the time, fell back into her chair, was helped into bed and noted to be mildly tachycardic in atrial fibrillation with a rate in the low 100s with a stable blood pressure. She came to on her own after approximately 1 minute time, was noted to be diaphoretic. EKG done at the time revealed no ischemic changes, but did have at new incomplete right bundle branch block. She was monitored overnight on telemetry with no further events. She had 3 sets of cardiac enzymes cycled, which were negative. Orthostatic vital signs were checked and negative. Repeat EKG in the morning revealed resolution of her right bundle branch block. This was discussed briefly with Cardiology and felt to not be the cause of her event. She was hydrated overnight as well for any possible orthostasis that may have contributed to the episode, given that she was standing; however, it was felt to likely be a vasovagal event from vaccine administration given her symptoms.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Electrocardiogram abnormal, Fall, Hyperhidrosis, Loss of consciousness
Clinical narrative: She was set to be discharged on September 18, 2012; however, after having received her Pneumovax vaccine, she began to feel dizzy and subsequently was noted to lose consciousness. She was standing at the time, fell back into her chair, was helped into bed and noted to be mildly tachycardic in atrial fibrillation with a rate in the low 100s with a stable blood pressure. She came to on her own after approximately 1 minute time, was noted to be diaphoretic. EKG done at the time revealed no ischemic changes, but did have at new incomplete right bundle branch block. She was monitored overnight on telemetry with no further events. She had 3 sets of cardiac enzymes cycled, which were negative. Orthostatic vital signs were checked and negative. Repeat EKG in the morning revealed resolution of her right bundle branch block. This was discussed briefly with Cardiology and felt to not be the cause of her event. She was hydrated overnight as well for any possible orthostasis that may have contributed to the episode, given that she was standing; however, it was felt to likely be a vasovagal event from vaccine administration given her symptoms.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Presyncope, Tachycardia
Clinical narrative: She was set to be discharged on September 18, 2012; however, after having received her Pneumovax vaccine, she began to feel dizzy and subsequently was noted to lose consciousness. She was standing at the time, fell back into her chair, was helped into bed and noted to be mildly tachycardic in atrial fibrillation with a rate in the low 100s with a stable blood pressure. She came to on her own after approximately 1 minute time, was noted to be diaphoretic. EKG done at the time revealed no ischemic changes, but did have at new incomplete right bundle branch block. She was monitored overnight on telemetry with no further events. She had 3 sets of cardiac enzymes cycled, which were negative. Orthostatic vital signs were checked and negative. Repeat EKG in the morning revealed resolution of her right bundle branch block. This was discussed briefly with Cardiology and felt to not be the cause of her event. She was hydrated overnight as well for any possible orthostasis that may have contributed to the episode, given that she was standing; however, it was felt to likely be a vasovagal event from vaccine administration given her symptoms.
Age: 1.33
Sex: M
Vaccine: DTAP
Symptoms: Gaze palsy, Increased upper airway secretion, Seizure like phenomena
Clinical narrative: Mother noted the child looked dazed and rolled his eyes few minutes after the shots.  He did not cry after the shots (however he usually does not cry that much after shots). He slept off right away in the car. Not shown to a Dr. the symptoms reported to me next visit on 06-20-2013 - 9 days after the apparent adverse reaction. She also reports other seizure like event- choking noise rhythmic that happened a few times after that day.
Age: 1.07
Sex: F
Vaccine: HEPA, HIBV, MMR
Symptoms: Diet refusal, Dry skin, Fatigue, Hypersomnia, Irritability
Clinical narrative: Fever of 102.7 along with irritability, fussiness, and refusal of food or drink on Wednesday night. Thursday morning the fever was present but at a mild rate and manageable with Tylenol. Still fussy and refusing food other than a bite here and there. She was very tired and slept the majority of the day. On Friday the same symptoms persisted along with severely dry skin patches. On Saturday morning the patches had turned into a deep red lost purple rash that started on lower body. Took child to Urgent MD and was given cream for the area. On Sunday the rash had spread over back, arms, and face. Went to Dermatologist on Monday AM at 9:00 and was diagnosed with severe reaction to MMR VACCINE and was given a treatment plan that included ointments for three weeks, an additional ointment until pigmentation returned to normal, and Tylenol for continuous fever. Went by PED office and nurse refused to let us speak with doctor for a moment about filing the report without making an appointment to see him so we filed ourselves in case Dermatologist doesn't file as well.
Age: 1.07
Sex: F
Vaccine: HEPA, HIBV, MMR
Symptoms: Pyrexia, Rash erythematous, Vaccination complication
Clinical narrative: Fever of 102.7 along with irritability, fussiness, and refusal of food or drink on Wednesday night. Thursday morning the fever was present but at a mild rate and manageable with Tylenol. Still fussy and refusing food other than a bite here and there. She was very tired and slept the majority of the day. On Friday the same symptoms persisted along with severely dry skin patches. On Saturday morning the patches had turned into a deep red lost purple rash that started on lower body. Took child to Urgent MD and was given cream for the area. On Sunday the rash had spread over back, arms, and face. Went to Dermatologist on Monday AM at 9:00 and was diagnosed with severe reaction to MMR VACCINE and was given a treatment plan that included ointments for three weeks, an additional ointment until pigmentation returned to normal, and Tylenol for continuous fever. Went by PED office and nurse refused to let us speak with doctor for a moment about filing the report without making an appointment to see him so we filed ourselves in case Dermatologist doesn't file as well.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Dehydration, Diarrhoea, Gait disturbance, Loss of consciousness, Nausea
Clinical narrative: Diarrhea on 7/18/2013; short blackout approx. 11:00 PM. nausea, vomiting and diarrhea on 7/19/2013. concern was too unstable to walk. arrived at emergency room approx 9:00 AM. Treated for nausea and dehydration; released from hospital emergency room approx 1:00 PM 7/19/2013.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Diarrhea on 7/18/2013; short blackout approx. 11:00 PM. nausea, vomiting and diarrhea on 7/19/2013. concern was too unstable to walk. arrived at emergency room approx 9:00 AM. Treated for nausea and dehydration; released from hospital emergency room approx 1:00 PM 7/19/2013.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Fatigue, Headache, Nausea
Clinical narrative: The day she received the vaccine she got worst headache and had extreme nausea. She has had extreme fatigue. The next Am 7-19-13 she had 4 bumps on her breast that blistered up and felt very itchy. She continued to be tired and has been taking naps every day since vaccine. Her left arm is also red and hot to touch. She took 2 extra strength Tylenol on 7-19. Pharmacy called prescriber and left message with nurse. She will discuss with MD and call patient.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: The day she received the vaccine she got worst headache and had extreme nausea. She has had extreme fatigue. The next Am 7-19-13 she had 4 bumps on her breast that blistered up and felt very itchy. She continued to be tired and has been taking naps every day since vaccine. Her left arm is also red and hot to touch. She took 2 extra strength Tylenol on 7-19. Pharmacy called prescriber and left message with nurse. She will discuss with MD and call patient.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: Bloody diarrhea (6-8 episodes) in a well appearing well hydrated child.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pruritus, Rash generalised, Rash papular
Clinical narrative: Parent returned to clinic with child with full body raised rash, scratching.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Urticaria
Clinical narrative: Welts to deltoid area (over ~ 5x6 cm) with mildly erythema base. Given 25 mg Diphenhydramine.
Age: 59.0
Sex: F
Vaccine: FLUN3
Symptoms: Anti-islet cell antibody positive, Blood glucose increased, Diabetic ketoacidosis
Clinical narrative: PRESENTED WITH DKA.   BLOOD GLUCOSE 480.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA, MMRV
Symptoms: Blood culture, Chest X-ray, Full blood count, Muscle twitching, Pyrexia
Clinical narrative: Fever 103 degrees and twitching.  Went to the Emergency Room.  Ibruprofen given.